Title 1 VAC — Administration

Agency 7 Virginia Code Commission

Chapter 10 Regulations for Filing and Publishing Agency Regulations

Part I General Provisions

1VAC7-10-10 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§ 2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Adopt textual matter by reference" means to include text from a document or publication in the regulation as a requirement or provision of the regulation.

"Agency" means any authority, instrumentality, officer, board, or other unit of the government of the Commonwealth empowered by the basic laws to adopt regulations or decide cases, except as exempted by the Virginia Register Act.

"Commission" means the Virginia Code Commission.

"File" means to submit to the registrar so that the registrar receives the regulation submission package, or required or requested information.

"Registrar" means the Registrar of Regulations, or his designee, as provided in § 2.2-4102 of the Code of Virginia.

"Regulation" means any statement of general application, having the force of law and affecting the rights or conduct of any person, promulgated by an agency in accordance with the authority conferred on it by applicable basic laws.

"Regulation submission package" means the regulation text and other information required to be submitted by the Administrative Process Act or the Virginia Register Act.

"Regulatory Information System" means the web-enabled application of the Office of the Registrar of Regulations that is used by an agency to file regulations, regulation submission packages, and related information and used by the Office of the Registrar to publish the Virginia Register of Regulations and update the Virginia Administrative Code.

"Virginia Administrative Code" or "VAC" means the codified publication of regulations under the provisions of Chapter 15 (§ 30-145 et seq.) of Title 30 of the Code of Virginia.

"Virginia Register Act" means Chapter 41 (§ 2.2-4100 et seq.) of Title 2.2 of the Code of Virginia.

"Virginia Register of Regulations" or "Register" means the publication issued under the provisions of Article 6 (§ 2.2-4031 et seq.) of the Administrative Process Act. Test

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

1VAC7-10-20 Computation of time

When Article 2 (§ 2.2-4006 et seq.) or 6 (§ 2.2-4031 et seq.) of the Administrative Process Act or the Virginia Register Act prescribes a time period that is contingent upon publication in the Register, whether before, after, or upon publication, the day of publication shall not be counted as part of the required time period. This section shall not apply to the comment period designated in § 2.2-4007.06 of the Code of Virginia to begin on the date of publication of the notice in the Register.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

1VAC7-10-30 General rules of construction

This section shall be used in the construction of the Virginia Administrative Code.

1. Catchlines of sections. The catchline or title of a section following the section number is intended as a description to indicate the content of the section and does not constitute part of the regulation.

2. Gender. A word used in the masculine includes the feminine and neuter.

3. Number. A word used in the singular includes the plural, and a word used in the plural includes the singular unless the context clearly indicates otherwise.

4. The word "includes" means includes, but not limited to.

5. The word "or" means any one or all of the items listed or any combination thereof.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

1VAC7-10-40 Form and style of regulations

A. The registrar shall develop a manual to advise agencies regarding the form and style of regulations and the codification of regulations.

B. The registrar shall provide procedures stipulating how agencies shall prepare and file with the registrar's office (i) regulations, (ii) regulation submission packages and other information concerning regulatory actions, or (iii) other information requested by the registrar for publication in the Virginia Register of Regulations or the Virginia Administrative Code.

C. Pursuant to § 30-150 of the Code of Virginia, the registrar may omit from publication in the Virginia Register of Regulations or inclusion in the Virginia Administrative Code (i) effective date clauses, (ii) severability clauses, (iii) purpose statements, and (iv) provisions that are nonregulatory in nature, such as a defined word, term, or phrase that is not used in the regulatory text.

D. The registrar may accept any of the items or provisions listed in subsection C of this section if the agency establishes a need to the satisfaction of the registrar.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

1VAC7-10-50 Method of filing

An agency shall file regulations, regulation submissions packages, and requested information electronically through the Regulatory Information System, commonly known as "RIS," unless specifically approved by the registrar to file through other means.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

1VAC7-10-60 Internet address; contact information; consequential changes

A. If an agency includes an Internetaddress in the text of a regulation, the agency is responsible for maintaining the accuracy and currency of the Internet address.

B. If an agency includes contact information in the text of a regulation, the agency is responsible for maintaining the accuracy and currency of the contact information. Contact information includes a title, mailing address, telephone number, email address, or similar information.

C. The agency must (i) promptly notify the registrar's office when an Internet address or contact information changes and (ii) provide the correct Internet address or contact information. The agency shall file a request for amendment as directed by the registrar and provide the revised text of the regulation.

D. The registrar may correct an Internet address or contact information upon request by an agency. In addition, the registrar may, in his discretion, make other consequential corrections pursuant to §§ 2.2-4102 and 30-150 of the Code of Virginia.

E. The registrar will publish notice of the correction.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

1VAC7-10-70 Waiver by registrar

The registrar may waive a provision of this chapter, provided that the waiver is consistent with applicable state law.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

1VAC7-10-80 Agency regulatory coordinator

The head of each agency, or his designee, shall appoint or designate an individual as the agency regulatory coordinator who shall coordinate the regulatory activities of the agency with the Office of the Registrar of Regulations.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

Part II Filing Regulations and Regulation Submission Packages with the Registrar

1VAC7-10-90 Filing regulations

A. An agency must file all regulations, including materials incorporated by reference and forms used in administering the regulation, with the registrar. The regulations shall be filed through the Regulatory Information System or as directed by the registrar.

B. The agency shall file the full text of a regulation with the registrar, except text that is incorporated by reference pursuant to § 2.2-4103 of the Code of Virginia shall be filed in accordance with Part III (1VAC7-10-140 et seq.) of this chapter.

C. No regulation, or amendment or repeal thereof, is effective until filed with the registrar pursuant to § 2.2-4103 of the Code of Virginia. If the regulation, or amendment or repeal thereof, is incomplete, the registrar may decline to publish the regulation.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

1VAC7-10-100 Final agency action date; effective date; statutory authority

A. An agency shall provide the date of final agency action and the effective date of a regulation when filing a regulation submission package for a fast-track or final regulatory action, or other equivalent action.

B. When Virginia law allows a regulation to be effective upon the filing of the regulation with the registrar, the agency ordinarily should select an effective date at least three business days after filing. This subsection does not apply to emergency regulations adopted pursuant to § 2.2-4011 of the Code of Virginia.

C. An agency shall provide the effective date and expiration date of an emergency regulation when filing the emergency regulation and accompanying regulation submission package. If the expiration date of the emergency regulation is extended, the agency shall notify the registrar within three business days of the Governor's approval of the extension.

D. Pursuant to § 2.2-4012 D of the Code of Virginia, a regulation shall contain the statutory authority for the regulation. An agency shall include in the regulatory submission package the complete citation for each statute or regulation that serves as the statutory authority, as follows:

1. For a codified Virginia statute, the citation shall be to the applicable section of the Code of Virginia.

2. For an uncodified Virginia statute, the citation shall be to the applicable chapter of the designated Act of Assembly.

3. When a regulation is required to conform with federal law or regulation, the agency shall provide a citation to the specific federal law or regulation to which conformity is required.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

1VAC7-10-110 Supplemental information; exemption from Administrative Process Act

A. Pursuant to § 2.2-4103 of the Code of Virginia, the registrar may request information in addition to the full text of a regulation for the purpose of publishing the Register and VAC.

B. An agency shall respond to a request from the registrar within three business days of the request, unless a different response time is approved by the registrar.

C. When claiming an exemption from the Administrative Process Act, an agency shall provide the specific statutory citation for the claimed exemption. Upon request of the registrar, an agency should provide confirmation from the Office of the Attorney General of the specific statute upon which the exemption is based.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

1VAC7-10-120 Withdrawal of a final regulation; publication

A. When an agency withdraws a final regulation pursuant to § 2.2-4016 of the Code of Virginia, the agency shall file a written notice of withdrawal with the registrar prior to the effective date of the regulation being withdrawn. The notice shall include:

1. The reason for the withdrawal of the regulation;

2. Agency contact information;

3. The publication information; and

4. The date of agency action.

B. The notice of withdrawal will be published in the Register.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

1VAC7-10-130 Omissions and errors

A. An agency shall notify the registrar of all omissions or errors that the agency becomes aware of in any of the information (i) submitted for publication or (ii) published in the Register or the Virginia Administrative Code.

B. The notification shall be filed with the registrar within seven business days of the date that the agency becomes aware of the omission or error.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

Part III Adoption of Textual Matter by Incorporation by Reference

1VAC7-10-140 Incorporation by reference permitted

A. A regulation may adopt textual matter by reference to all or any part of a publication or document. For the purposes of this part, a publication and a document are interchangeable. The material in the document becomes the text of the regulation and an enforceable part of the regulation.

B. The agency must comply with the provisions of 1VAC7-10-150 and 1VAC7-10-160 when incorporating a document by reference except as provided in 1VAC7-10-170.

C. Effective January 1, 2016, an agency may not adopt prospective changes to an incorporated document by referring to a future edition or revision of the document or by using "as updated," "as may be amended," "future editions," or similar language. When a document that an agency has incorporated by reference subsequently is modified by the publisher, the agency may adopt the modification but shall do so through a regulatory action. However, when an agency incorporates by reference provisions of the Code of Virginia, the Virginia Acts of Assembly, or the Virginia Administrative Code into a regulation, future amendments to the incorporated provisions are included unless other intent is specifically stated in the regulation.

D. Effective January 1, 2016, an agency may not incorporate one of its own documents by reference unless the agency establishes that the documents or circumstances are unique and highly unusual.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

1VAC7-10-150 Filing requirements

A. When an agency adopts textual matter in a regulation by reference to a document, the agency shall file a copy of the referenced document with the regulation submission package. The document shall be filed in its entirety, unless the registrar has approved a request for the document to be filed by descriptive statement as provided in 1VAC7-10-170. The agency shall also provide information as to where copies of the incorporated publications may be procured.

B. When an agency adopts textual matter by reference to Internet content, the agency shall file the Internet content with the registrar. The agency shall file a read-only electronic copy or a printed copy of the Internet content.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

1VAC7-10-160 Regulation text

When incorporating material by reference, an agency shall include in the regulatory text (i) a statement that the document is incorporated by reference; (ii) the complete name of the document; (iii) the effective, issue, revision, or publication date; (iv) the version or edition, if any; and (v) the publisher or entity that produced the document.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

1VAC7-10-170 Exemptions from filing of documents adopted or incorporated by reference; requirements

A. The requirements established in 1VAC7-10-150 and 1VAC7-10-160 do not apply to incorporation of textual matter by reference to material published in the Federal Register or the Code of Federal Regulations, or by reference to regulations of other Virginia agencies. Where such references are made, the regulatory text must contain a citation sufficient for accurate identification of the referenced material.

1. Where the material has been published in the Code of Federal Regulations, the agency must:

a. Include in the regulatory text the title, part or section, and the date of publication. Example: 40 CFR Part 260 (July 1, 2014 update) or 40 CFR §§ 260.1 through 260.11 (July 1, 2014 update); or

b. Include a section listing the applicability of the cited CFR text and stating that when a federal regulation is incorporated in the chapter, that regulation shall be as it exists and has been published on a certain date.

2. Where the referenced material has not been published in the Code of Federal Regulations but appears in the Federal Register, the agency must include in the regulatory text the volume, page, and date of the Federal Register. Example: 79 FR 264, January 2, 2014.

B. The registrar may exempt an agency from the requirement of filing the incorporated document in its entirety if such filing would be impractical or cause an undue hardship on the agency. The document shall be filed as directed by the registrar.

C. The agency shall request an exemption from this filing requirement by submitting a request to the registrar. The registrar will notify the agency whether the exemption is approved.

D. Even if exempted under subsections A and B of this section, an agency must maintain on file and make available to the public the full text of all materials adopted by reference.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

Part IV Forms

1VAC7-10-180 Filing requirements

A. An agency shall file any form that the agency intends to incorporate into or use in administering the regulation with the proposed or final, including fast-track, regulation submission package for publication in the Register pursuant to § 2.2-4031 A of the Code of Virginia. The agency shall include on the face of the form (i) the date of issuance or revision and (ii) a form number.

B. A form is not a substitute for regulation text and may not contain requirements that are not in the Code of Virginia or VAC.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

1VAC7-10-190 Exemption from filing a form

A. An agency may request an exemption from filing a form if the form (i) may be completed only online or electronically or (ii) is not in a printable format.

B. The agency shall make a request for an exemption from filing by submitting a request to the registrar. The registrar will notify the agency whether the exemption is approved.

C. If an exemption is approved, the Internet address for the form will be included in VAC.

D. The agency shall notify the registrar in writing if an Internet address for the form changes. Under the authority of § 30-150 of the Code of Virginia, the registrar may correct the Internet address in the Virginia Administrative Code.

E. The granting of an exemption under this section does not relieve an agency from maintaining the forms on file and making the forms available to the public.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

1VAC7-10-200 Modification of forms in the Virginia Administrative Code

A. The provisions of this section apply when a form for a regulation is added, amended, or removed, provided that (i) the regulatory text is not changing and (ii) the change to the form is not making a substantive change to the regulation.

B. An agency shall file form changes as directed by the registrar.

C. Notice of revised forms will be published in the Register, and forms will be updated in the Virginia Administrative Code online on the date of publication of the volume and issue of the Register in which it appears.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

1VAC7-10-210 Publication

A. For the purposes of § 2.2-4031 of the Code of Virginia, a form shall be considered to be published in the Virginia Register of Regulations if (i) the form is published in full, (ii) a hyperlink to the form is published, or (iii) a notice identifying where the form may be obtained is published.

B. The registrar shall determine how a form will be published.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

Part V Virginia Register of Regulations

1VAC7-10-220 Availability and official version

As provided in § 2.2-4031 of the Code of Virginia, the Virginia Register of Regulations is published by posting the Register on the Virginia Code Commission's website. The portable document format (PDF) file is the official version of the Register.

History

• Statutory Authority: § 2.2-4104 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. January 1, 2016.

Agency 20 State Board of Elections

Chapter 40 Voter Registration

Article 1 General Provisions

1VAC20-40-10 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Abode" or "place of abode" means a physical place where a person dwells. One may have multiple places of abode, such as a second home.

"Address" or "residence address" for purposes of voter registration and address confirmation means the address of residence in the precinct required for voter registration. An alternative mailing address may be included on a voter registration application when: (i) the residence address of the applicant cannot receive mail; or (ii) the voter is otherwise eligible by law to provide an alternative mailing address. Alternative mailing addresses must be sufficient to enable the delivery of mail by the United States Postal Service. The post office box for published lists may be provided either by the United States Postal Service or a commercial mail receiving agency (CMRA) described in the United States Postal Service Domestic Mail Manual.

"Authorized personnel" means the designated individuals of a general registrar's office or the Department of Elections who are permitted to access the voter registration database and capture information necessary to generate photo identification cards.

"Domicile" means a person's primary home, the place where a person dwells and which he considers to be the center of his domestic, social, and civil life. Domicile is primarily a matter of intention, supported by an individual's factual circumstances. Once a person has established domicile, establishing a new domicile requires that he intentionally abandon his old domicile. For any applicant, the registrar shall presume that domicile is at the address of residence given by the person on the application. The registrar shall not solicit evidence to rebut this presumption if the application appears to be legitimate, except as provided in 1VAC20-40-40 B and C.

"Permanent satellite location" means an office managed, maintained, and operated under the control of the general registrar for the locality that is consistently operational throughout the year and is not the principal office of the general registrar. Offices of other agencies where registration takes place pursuant to § 24.2-412 B of the Code of Virginia are not considered permanent satellite locations.

"Residence," "residency," or "resident" for all purposes of qualification to register and vote means and requires both domicile and a place of abode.

"Valid" for all purposes related to voter identification means (i) the document appears to be genuinely issued by the agency or issuing entity appearing upon the document, and (ii) the document shall be current or have expired within the preceding 12 months. The expiration date on a Virginia driver's license shall not be considered when determining the validity of a driver's license offered for voting purposes. The officer of election shall determine whether the document is officially acceptable based on its face.

"Voter photo identification card" means the official voter registration card containing the voter's photograph and signature referenced in § 24.2-404 A 3 of the Code of Virginia.

History

• Statutory Authority: § 24.2-103 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 4, eff. October 13, 2011; amended, Virginia Register Volume 30, Issue 22, eff. June 12, 2014; Volume 30, Issue 26, eff. August 11, 2014; Volume 37, Issue 1, eff. September 23, 2020.

Article 2 Residency for Voter Registration

1VAC20-40-20 Required intent for voter registration

A. Nothing in this article shall be construed to confer upon any person any privileges or benefits other than the right to register to vote and to be qualified to vote in an election.

B. Pursuant to the requirements of § 24.2-404 D of the Code of Virginia, the following shall apply only in determining a person's residence under Article II, Sec. 1 of the Constitution of Virginia and Title 24.2 of the Code of Virginia.

1. A person who intends to remain in a location for an unlimited time has established the intent required to establish domicile.

2. A person who intends to remain in his current location for an unlimited time has established the intent required to establish domicile even if he may leave upon the happening of a future contingency. Examples of such future contingencies include, but are not limited to, a change in job status or location, graduation from school, military transfer deployments or other relocations, and medical emergencies.

3. A person who presently intends to leave his current location at a fixed and certain date may not have established the intent required to establish domicile depending on the facts and circumstances of each case, as determined by the registrar, with all due consideration given to persons in the circumstances contained in 1VAC20-40-30 B.

4. A person who applies to register to vote in a precinct for the primary purpose of registering to vote or voting in that precinct has not established the intent to establish domicile there.

History

• Statutory Authority: § 24.2-103 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 4, eff. October 13, 2011.

1VAC20-40-30 Presumptions

A. Residency shall be broadly construed to provide the greatest opportunity to register and to vote. A residence can be established in a commercial, industrial, or other building that is not normally used for residential purposes if the building serves as the applicant's primary nighttime residence. A homeless person will be considered resident in the location where the homeless person usually sleeps at night. In cases involving nontraditional habitations, the location of the person's usual sleeping area shall be controlling as to the residency of that person.

B. No presumption in favor of or against residence may arise merely on the basis of a person's presence or absence in the following circumstances:

1. While employed in the service of the Commonwealth or United States, whether military or civilian;

2. While engaged in the navigation of the waters of the United States or of the high seas;

3. While employed by or enrolled as a student in any educational institution, or residing in any housing commonly occupied by students or faculty;

4. While confined in any jail or other correctional facility as a nonfelon;

5. While receiving treatment or being confined for any reason in a nursing home, hospital, rehabilitation or short term care facility, retirement or veterans' home, or like institution or private facility;

6. While remaining in a location only during the workweek in order to conduct business; or

7. While residing in an area within the boundaries of Virginia that has been ceded to or acquired by the federal government.

C. If a person resides in an area lacking a specific mailing address, the general registrar shall ask him to provide a mailing address along with a description indicating where the person resides. However, no person shall be denied registration for failure to submit a mailing address. The description must identify the location with sufficient specificity to allow the general registrar to place the location in a defined precinct. The general registrar shall assign the person to the precinct containing the location where he resides.

D. A person whose home is destroyed or rendered uninhabitable does not lose residence at that home if he intends to return to the home when it is reconstructed or made habitable, unless he has either established a new domicile or has changed his voter registration.

E. A person whose residence is divided by a jurisdictional boundary line or election district boundary line shall be deemed to reside in the location of his bedroom or usual sleeping area.

F. The general registrar shall not automatically presume the residence of one spouse to be that of the other spouse, but shall determine the other spouse's residence in accordance with the applicable statutes and regulations.

G. A person loses voting residence in any county or city in Virginia by registering to vote or voting in any other county, city, or state. An otherwise qualified voter shall not lose their residence at an address until they have established their residence at another address.

History

• Statutory Authority: § 24.2-103 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 4, eff. October 13, 2011.

1VAC20-40-40 Review of application

A. In the event (i) an application to register to vote is not signed or is missing information required by law, or (ii) the general registrar cannot determine from the information provided on the application the location at which the applicant intended to register, the general registrar shall deny the application and process it in accordance with § 24.2-422 of the Code of Virginia.

B. If an application to register to vote contains all information required by law but contains other apparent discrepancies, the general registrar may promptly resolve the discrepancies through informal means. Informal means include ascertainment of information through the statewide, voter registration system, the Division of Motor Vehicles, and any form of communication with the applicant.

C. If an application to register to vote contains all information required by law, and if any of the situations in the subdivisions of this subsection apply, the general registrar shall not deny the application, but shall ask the applicant to provide additional information in support of the application. The general registrar shall request the information in writing on a form prescribed by the board and the applicant shall respond in writing. The application shall not be accepted or denied while the registrar is awaiting the applicant's response. The general registrar shall act promptly to resolve the question of residency as soon as possible. In the event the applicant does not provide the requested information by the last day to register as established in § 24.2-416 of the Code of Virginia and the general registrar is unable to determine the applicant's residency through any other means, the general registrar shall deny the application in accordance with § 24.2-422 B of the Code of Virginia.

1. The applicant provides a mailing address in a different county, city, or state from his residential address. In this situation, the general registrar shall reconfirm the residential address and mailing address by asking the supplemental questions provided in 1VAC20-40-50 and mailing the questions to both the residential and mailing addresses;

2. The applicant provides a residential address that cannot receive mail, or from which mail sent by the registrar's office is returned. In this situation, the general registrar shall ask for an alternate mailing address;

3. The applicant provides an address that is temporary in nature. Temporary addresses shall include hotels, motels, motor homes, hospitals and other short term medical care facilities, houseboats, campgrounds or other facilities that have durational restrictions, such as a 30-day limitation, or any other transient address that would not be considered as a typical permanent residence address. Temporary addresses shall not include apartments or other facilities, such as dormitories, that provide for leases or other rental agreements of at least six months duration. The general registrar shall treat these addresses as permanent ones. In the event the applicant provides an address that is temporary in nature, the general registrar shall ask the supplemental questions provided in 1VAC20-40-50;

4. The applicant provides a residential address that is a commercial, industrial, or other building that is not normally used for residential purposes, or other nontraditional residential address; or

5. The application causes a conflict with another existing voter in the statewide, voter registration system, such as a duplication of the social security number with an existing voter.

History

• Statutory Authority: § 24.2-103 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 4, eff. October 13, 2011; amended, Virginia Register Volume 38, Issue 10, eff. December 21, 2021.

1VAC20-40-50 Supplemental questions

When warranted by the situations described in 1VAC20-40-40 C and where any other information on the voter registration application is unclear, the general registrar shall ask the following questions on a form prescribed by the board after notifying the applicant that any response he makes is subject to the same oath he took to sign the application:

1. Are you currently registered to vote at another address? The general registrar shall not ask this question unless the applicant failed to provide the information on the voter registration application.

a. If yes to subdivision 1 of this section, what is that address, and in what county, city, or state is that address located?

b. If yes to subdivision 1 of this section or as indicated on the voter registration application, do you wish to cancel your registration in that county, city, or state and register and establish residence in this county or city in Virginia?

2. Do you have a specific plan to move away from this county or city at a fixed date in the future? If so, when?

History

• Statutory Authority: § 24.2-103 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 4, eff. October 13, 2011; amended, Virginia Register Volume 30, Issue 22, eff. June 10, 2014.

1VAC20-40-60 Review of supplemental questions

A. If the applicant answers the questions asked pursuant to 1VAC20-40-50 with information sufficient to assign him a polling place within the precinct and to cancel his current registration elsewhere, if any, the applicant shall be registered and added to the voting rolls of the locality and the jurisdiction where the voter was previously registered shall be notified to remove the registrant from their rolls.

B. If the applicant does not provide information sufficient to assign him a polling place within the precinct, the application shall be denied.

C. If the applicant indicates that the application was in error or filed incorrectly the registrar shall provide him voting information that could allow the applicant to register or vote absentee in the Commonwealth.

D. No new or changed voter registration application is effective until an applicant provides answers to the supplemental questions. Any such answers must be in writing and must be returned before the last day to register as established in § 24.2-416 of the Code of Virginia. Any supplemental information based upon an application made prior to the close of books shall be accepted and the applicant registered if the response is received before the last day to register as established in § 24.2-416 of the Code of Virginia.

History

• Statutory Authority: § 24.2-103 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 4, eff. October 13, 2011.

1VAC20-40-70 Applications for voter registration; affirmation of United States citizenship

A. Applications for voter registration shall be on a form approved by the State Board of Elections or appropriate federal agency.

B. The following omissions are not material and a voter registration application shall not be denied for failure to include one or more of the following:

1. Social security number if the applicant checks the box indicating no SSN was ever issued;

2. Gender;

3. Generational suffix;

4. Middle name if the voter checks the box indicating none;

5. Email address;

6. Daytime telephone number;

7. Response indicating protected voter status, military status, overseas status, or any other information requested in Box 4;

8. Mailing address;

9. State in which the applicant is currently registered if the applicant is currently registered in Virginia;

10. Response indicating interest in serving as an officer of election;

11. Signature of applicant if applicant indicates that he is an individual with physical disabilities;

12. Response indicating the applicant has a physical disability if the application is signed by the applicant; or

13. Date of the application.

C. Middle name may be material to determining eligibility to vote. If the applicant does not include a middle name and does not check the box indicating none, the registrar shall:

1. As far as practical, attempt to contact the applicant and obtain his middle name or lack thereof to determine if the application is complete.

a. If the applicant indicates that he has no middle name, the registrar shall process the application.

b. If the applicant indicates that he has a middle name, the registrar shall inform the applicant that the middle name is required, deny the application, and send the applicant a new application.

2. If the registrar is unable to contact the applicant and therefore unable to determine if the application is incomplete, he shall give the benefit of doubt to the applicant and process the application.

D. A general registrar shall not change information provided by an applicant on an application for voter registration without written authorization signed by the applicant.

E. Persons identified as noncitizens in reports from the Department of Motor Vehicles or other state or federal government sources shall have the opportunity to affirm United States citizenship status using any approved voter registration application or other form containing the required affirmation. The State Board of Elections shall automate the process for requesting affirmation of United States citizenship prior to cancellation.

F. If the individual submitting the application is currently a registered voter in Virginia, then the registrar must process the application as a request to update or change the registered voter's information if the application contains new information and is signed by the voter.

G. For cases not covered by this section, the general registrar in consultation with the Department of Elections shall determine materiality on a case-by-case basis. When this occurs, the Department of Elections shall make recommendations to the State Board of Elections that may result in further amendment of this regulation.

H. General registrars must provide the voter notice of having accepted or denied a voter registration applicant within 30 days of receiving a voter registration application. Days during which registration records are closed before elections pursuant to § 24.2-416 of the Code of Virginia shall not be applicable to the calculation of the 30-day processing time.

I. General registrars may not ask for additional information regarding the applicant's restoration of rights from any applicant who indicates that his voting rights have been restored if the applicant's restoration information appears in the Secretary of the Commonwealth's database accessible to general registrars.

J. Prior versions of any voter registration application shall be accepted for registration. Prior versions of any voter registration application may not be denied for failure to provide information that is deemed not material in this section.

K. If a general registrar receives an application by mail after the voter registration records have been closed pursuant to § 24.2-416 of the Code of Virginia from an applicant who indicates (i) active duty uniformed services member, (ii) spouse or dependent of an active duty uniformed services member, or (iii) overseas citizen status, then the general registrar must contact the applicant to determine whether the applicant qualifies for an extended voter registration deadline. The general registrar may accept information from the applicant indicating that the applicant is qualified either orally or in writing.

History

• Statutory Authority: § 24.2-103 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 6, eff. November 1, 2011; amended, Virginia Register Volume 30, Issue 22, eff. June 10, 2014; Volume 32, Issue 21, eff. June 1, 2016.

1VAC20-40-80 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 28, Issue 4, eff. September 30, 2011; repealed, Virginia Register Volume 30, Issue 22, eff. June 10, 2014.

1VAC20-40-90 (Repealed.)

1VAC20-40-90. (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 30, Issue 22, eff. June 12, 2014; repealed, Virginia Register Volume 37, Issue 6, eff. November 27, 2020.

Agency 30 Department of General Services

Chapter 11 Public Participation Guidelines

Part I Purpose and Definitions

1VAC30-11-10 Purpose

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the Department of General Services. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

History

• Statutory Authority: §§ 2.2-1102 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. January 21, 2009.

1VAC30-11-20 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§ 2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Department of General Services, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§ 2.2-4031 et seq.) of the Administrative Process Act.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. January 21, 2009.

Part II Notification of Interested Persons

1VAC30-11-30 Notification list

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. January 21, 2009.

1VAC30-11-40 Information to be sent to persons on the notification list

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 1VAC30-11-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. January 21, 2009.

Part III Public Participation Procedures

1VAC30-11-50 Public comment

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to (i) submit data, views, and arguments, either orally or in writing, to the agency; and (ii) be accompanied by and represented by counsel or other representative. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. January 21, 2009; amended, Virginia Register Volume 39, Issue 7, eff. January 5, 2023.

1VAC30-11-60 Petition for rulemaking

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. January 21, 2009.

1VAC30-11-70 Appointment of regulatory advisory panel

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. January 21, 2009.

1VAC30-11-80 Appointment of negotiated rulemaking panel

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. January 21, 2009.

1VAC30-11-90 Meetings

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. January 21, 2009.

1VAC30-11-100 Public hearings on regulations

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working daysprior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. January 21, 2009.

1VAC30-11-110 Periodic review of regulations

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. January 21, 2009.

Chapter 41 Regulation for the Certification of Laboratories Analyzing Drinking Water

Part I General Provisions

1VAC30-41-10 Purpose

A. This chapter establishes the requirements for certification of drinking water laboratories.

B. The federal Safe Drinking Water Act (SDWA) mandates the establishment of a national drinking water program to protect public health. The U.S. Environmental Protection Agency (EPA) at 40 CFR 141.28 requires that laboratories be certified to analyze samples of drinking water for compliance purposes. EPA at 40 CFR 142.10(b)(3)(i) requires states to establish and maintain programs for the certification of drinking water laboratories.

C. The Virginia Department of Health, Office of Drinking Water (VDH-ODW) maintains primary enforcement responsibility (primacy) under the SDWA and the federal SDWA regulations for the Commonwealth of Virginia. The VDH-ODW at 12VAC5-590-340 requires that all analyses done to demonstrate compliance with primary and secondary maximum contaminant levels or action levels be performed by the Division of Consolidated Laboratory Services of the Department of General Services (DCLS) or by laboratories certified by DCLS. VDH-ODW at 12VAC5-590-440 further requires that laboratories seeking certification to perform drinking water analyses shall comply with this chapter.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-20 Applicability

A. This chapter applies to the following:

1. Owners of drinking water laboratories in Virginia.

2. Owners of drinking water laboratories located outside Virginia who seek reciprocal certification under 1VAC30-41-90.

B. Covered contaminants.

1. This chapter covers the contaminants regulated in 40 CFR Parts 141 and 143 as specified in 12VAC5-590, Waterworks Regulations, of the Virginia Department of Health.

2. Laboratory testing for alkalinity, calcium, chlorite, conductivity, disinfectant residual, orthophosphate, pH, silica, temperature, and turbidity for compliance purposes may be performed by laboratories or persons not certified under this chapter but acceptable to VDH-ODW.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-30 Alternative certification for drinking water laboratories

Drinking water laboratories may become certified by meeting the requirements for accreditation set out in 1VAC30-46.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-40 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Analyst" means a chemist, microbiologist, physicist, or technician who actually performs a test. The analyst may carry out the complete test or participate jointly with other analysts.

"Certification officer" means a DCLS employee who has the responsibility for evaluating drinking water laboratories for certification.

"Contaminant" means any objectionable or hazardous physical, chemical, biological, or radiological substance or matter in water. Contaminants are the analytes for which drinking water laboratories test in the drinking water samples they analyze.

"Corrective action" means the action taken to eliminate the causes of an existing nonconformity, defect, or other undesirable situation in order to prevent recurrence.

"DCLS" means the Division of Consolidated Laboratory Services of the Department of General Services.

"Drinking water laboratory" or "laboratory" means a laboratory that performs analyses to demonstrate compliance with primary or secondary maximum contaminant levels or action levels or any combination of these specified in 12VAC5-590.

"EPA" means the United States Environmental Protection Agency.

"Findings" means factual, objective statements that provide evidence of deficiencies in meeting the requirements of this chapter.

"Laboratory director" or "laboratory supervisor" means the person who directs the operation of the drinking water laboratory on a day-to-day basis.

"Manual" means the EPA Office of Water, Manual for the Certification of Laboratories Analyzing Drinking Water: Criteria and Procedures Quality Assurance, Fifth Edition, EPA 815-R-05-004 (January 2005).

"Manual Supplement" means the EPA Office of Water, Supplement 1 to the Fifth Edition of the Manual for the Certification of Laboratories Analyzing Drinking Water, EPA 815-F-08-006 (June 2008).

"Maximum contaminant level" or "MCL" means the maximum permissible level of a contaminant in pure water that is delivered to any user of a waterworks. MCLs are set as close to the MCLGs as feasible using the best available treatment technology. Maximum contaminant levels may be either "primary" (PMCL), meaning based on health considerations, or "secondary" (SMCL), meaning based on aesthetic considerations.

"Maximum contaminant level goal" or "MCLG" means the level of a contaminant in drinking water below which there is no known or expected risk to health. MCLGs allow for a margin of safety.

"National Environmental Laboratory Accreditation Program" or "NELAP" means the national program to establish and implement a program for the accreditation of environmental laboratories. NELAP relies on consensus standards representing the best professional practices in the industry to establish the requirements for this program, which is then implemented by state agencies recognized by the NELAC Institute (TNI) as accreditation bodies.

"Owner" means any person who owns, operates, leases, or controls a drinking water laboratory.

"Persistent" means to continue an activity without change in spite of opposition or warning.

"Private laboratory" means a laboratory that is, or is part of, a commercial entity.

"Proficiency testing sample" or "PT sample" means a sample, the composition of which is unknown to both the analyst and the laboratory. The PT sample tests whether the analyst or laboratory or both can produce analytical results within specified acceptance criteria.

"Public laboratory" means a laboratory that is, or is part of, a local, state, or U.S. governmental agency.

"Pure water" means water fit for human consumption and domestic use that is sanitary and normally free of minerals, organic substances, and toxic agents in excess of reasonable amounts for domestic usage in the area served and normally adequate in quantity and quality for the minimum health requirements of the persons served (see Article 2 (§ 32.1-167 et seq.) of Chapter 6 of Title 32.1 of the Code of Virginia).

"Quality assurance" means an integrated system of management activities involving planning, quality control, quality assessment, reporting, and quality improvement to ensure that a product or service meets defined standards of quality with a stated level of confidence.

"Quality assurance plan" or "QA plan" means a comprehensive plan detailing the aspects of quality assurance needed to adequately fulfill the data needs of a program.

"Quality control" means:

1. The overall system of technical activities whose purpose is to measure and control the quality of a product or service so that it meets the needs of the users.

2. The operational techniques and activities that are used to fulfill requirements for quality.

"SDWA" means the Safe Drinking Water Act (42 USC § 300f et seq.).

"VDH-ODW" means the Virginia Department of Health - Office of Drinking Water.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-50 Incorporation by reference - EPA guidance documents

A. The following EPA guidance documents are incorporated by reference into this chapter:

1. Manual for the Certification of Laboratories Analyzing Drinking Water: Criteria and Procedures Quality Assurance, Fifth Edition, EPA 815-R-05-004 (January 2005).

2. Supplement 1 to the Fifth Edition of the Manual for the Certification of Laboratories Analyzing Drinking Water, EPA 815-F-08-006 (June 2008).

B. The federal regulatory requirements incorporated by reference into 1VAC30-41-55 shall govern if a conflict is found between the requirements of the Manual or the Manual Supplement and the requirements incorporated by reference into 1VAC30-41-55.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-55 Incorporation by reference - federal regulations

A. The sampling, analytical methodology, and laboratory certification requirements of 40 CFR 141 and 40 CFR 143 in effect as of July 1, 2023, are incorporated by reference into this chapter.

B. The alternative test methods published at 89 FR 5780 through 5794 on January 30, 2024, and the corrections to those alternative test methods published at 89 FR 7624 through 7625 on February 5, 2024, are incorporated by reference into this chapter.

C. The specific sampling, analytical methodology, and laboratory certification requirements incorporated by reference are listed as follows by category for information purposes:

1. Inorganic chemistry: 40 CFR 141.23, 40 CFR 141.89, and 40 CFR 141.131.

2. Organic chemistry: 40 CFR 141.24 and 40 CFR 141.131.

3. Microbiology: 40 CFR 141.21, 40 CFR 141.74, 40 CFR 141.174, 40 CFR 141.402(c)(2), 40 CFR 141.704, 40 CFR 141.705, and 40 CFR 141.852. 40 CFR 136.3(a) for E. coli requirements under 40 CFR 141.704.

4. Radiochemistry: 40 CFR 141.25.

5. Alternative testing methods: 40 CFR Part 141, Subpart C, Appendix A.

6. Test methods specified for secondary maximum contaminant levels: 40 CFR 143.4.

D. The exceptions to the requirements for laboratory certification in 40 CFR 141.28, 40 CFR 141.74(a), 40 CFR 141.89(a)(1), 40 CFR 141.131(b)(3), and 40 CFR 141.131(c)(3) are incorporated by reference into this chapter.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014; amended, Virginia Register Volume 35, Issue 6, eff. December 12, 2018; Volume 40, Issue 24, eff. August 14, 2024.

Part II Certification of Laboratories - General Requirements

1VAC30-41-60 Categories of certification

A. Laboratories may apply to be certified for inorganic chemistry, organic chemistry, microbiology, radiochemistry, or any combination of these four categories of certification.

B. Within each category, laboratories may be certified for specific contaminants or contaminant groups and for one or more methods used to determine the levels of these contaminants.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-70 Initial certification application

A. Application for initial certification. Drinking water laboratories applying under this chapter shall submit a completed Application for Certification, obtained by contacting the DCLS Laboratory Certification Office. A complete application contains:

1. Specific laboratory information, including name of organization, name of laboratory director, and contact information.

2. Identification of public water systems served by the laboratory.

3. Identification of the drinking water certification contaminants or contaminant groups and related methods for which the laboratory requests certification.

4. A quality assurance plan that meets the requirements of (i) Chapter III, Section 11 of the Manual and (ii) the Manual Supplement to Chapter III, Section 2 as required by 1VAC30-41-120.

5. A satisfactory report of at least one proficiency test performed within the last 12 months for each method and contaminant for which the laboratory seeks certification.

6. Laboratory personnel list.

7. Requested laboratory data, including at a minimum:

a. For microbiology applications:

(1) Equipment and supply list.

(2) Sampling information and test results for at least 20 analyses for each method and contaminant for which the laboratory seeks certification.

b. For chemistry applications:

(1) Instrumentation and equipment list.

(2) Method detection limit (MDL) documentation for each requested method and contaminant for which the laboratory seeks certification.

(3) Initial demonstration of capability (IDC) documentation for each requested method and contaminant for which the laboratory seeks certification.

c. For radiochemistry applications:

(1) Instrumentation and equipment list.

(2) Minimum detectable activity (MDA) documentation for each requested method and contaminant for which the laboratory seeks certification.

(3) Initial demonstration of capability (IDC) documentation for each requested method and contaminant for which the laboratory seeks certification.

8. Payment of the fee required by 1VAC30-41-270.

B. DCLS review of application submittal.

1. DCLS shall administratively review the application submittal and respond to the applicant laboratory within 60 calendar days.

2. If DCLS finds that the application submittal is complete, a certification officer shall arrange a mutually agreeable time and date with the laboratory for an onsite assessment.

3. If DCLS finds that the application submittal is incomplete, a certification officer shall request the applicant laboratory to submit the additional information or documentation required within 90 days.

4. If the laboratory has not submitted the required additional information within 90 days of the DCLS request for information, DCLS may return the incomplete application and inform the laboratory that the application cannot be processed. The laboratory may then submit a new application.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-80 Certification requirements

To become certified, a laboratory shall meet or successfully complete the following:

1. Requirements for a quality assurance plan in 1VAC30-41-120.

2. Analysis of a proficiency testing sample for each contaminant and each method for which certification is sought. Proficiency testing requirements are set out in 1VAC30-41-130.

3. Specific requirements for chemistry, microbiology, or radiochemistry that are pertinent to the specific laboratory's application for certification. These requirements are set out in Part III (1VAC30-41-300 et seq.) through Part V (1VAC30-41-500) of this chapter.

4. Onsite assessment by DCLS certification officers at least once every three years. Onsite assessment requirements are set out in 1VAC30-41-150.

5. The laboratory ethics and fraud detection and deterrence requirements set out in 1VAC30-41-140.

6. Payment of the fee required by 1VAC30-41-270.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-90 Reciprocity

A. DCLS may grant reciprocal certification to a drinking water laboratory located outside Virginia, provided the laboratory demonstrates the need to serve customers in Virginia and is certified by EPA or another state under equivalent certification criteria.

B. To be considered for certification, the applicant laboratory shall send DCLS the following:

1. A copy of the certificate and scope of certification issued by the laboratory's primary certifying or accrediting authority.

2. A list of the methods and the contaminants tested under each method for which the laboratory is requesting certification.

3. The most recent proficiency testing report for each method and contaminant combination listed by the laboratory under subdivision 2 of this subsection.

4. The fee required under 1VAC30-41-270.

5. Confirmation that the laboratory's proficiency test provider includes DCLS as a certifying authority to which the laboratory's proficiency test results will be reported.

C. Out-of-state laboratories holding National Environmental Laboratory Accreditation Program (NELAP) accreditation for drinking water that seek reciprocal accreditation for drinking water in Virginia shall apply for that accreditation under 1VAC30-46.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-100 Renewal of certification

DCLS shall renew the certification for a drinking water laboratory if the laboratory maintains its certified status as required by 1VAC30-41-180, and pays the annual fee as required by 1VAC30-41-270.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-110 Modification of certification

A. To request the addition of contaminants or methods to its certification, the drinking water laboratory shall submit the following to DCLS:

1. A completed DCLS drinking water certification application form.

2. An acceptable proficiency testing report for each requested method and contaminant, performed within the last 12 months.

3. The standard operating procedures for the requested methods.

4. The current quality assurance plan, if requested.

5. For chemistry:

a. Method detection limit (MDL) documentation for each requested method and contaminant for which the laboratory seeks certification.

b. Initial demonstration of capability (IDC) documentation for each requested method and contaminant for which the laboratory seeks certification.

6. For microbiology, sampling information and test results for at least 20 analyses by the requested method and contaminant combination.

7. Applicable fees as required by 1VAC30-41-270.

B. To drop a contaminant or a method from the laboratory's certification, the laboratory shall submit a request in writing to the DCLS Laboratory Certification Office.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-120 Quality assurance plan

A drinking water laboratory shall develop and maintain a quality assurance plan that meets the requirements of (i) Chapter III, Section 11 of the Manual and (ii) the Manual Supplement to Chapter III, Section 2.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-130 Proficiency testing

A. A drinking water laboratory shall meet the following requirements pertaining to proficiency testing (PT):

1. The requirements of this section.

2. The requirements of Chapter III, Section 13.1 of the Manual.

3. The specific requirements of the Manual for chemistry in Chapter IV, Section 7.2.1; for microbiology in Chapter V, Section 7.2; and for radiochemistry in Chapter VI, Section 7.4 that are pertinent to the laboratory.

4. Proficiency testing requirements incorporated by reference in 1VAC30-41-55.

B. A drinking water laboratory shall successfully participate in at least one water supply (WS) PT study per calendar year for each contaminant and by each method for which the laboratory seeks or wants to maintain certification.

C. Drinking water laboratories shall obtain WS PT studies from PT providers approved by the American Association for Laboratory Accreditation utilizing the National Standards for Water Proficiency Testing Studies.

D. Drinking water laboratories shall instruct the PT providers to send the results of the WS PT studies to the DCLS Laboratory Certification Office.

E. WS PT study results.

1. DCLS shall certify or maintain certification for a drinking water laboratory for which WS PT study results are reported by the proficiency test provider as "acceptable."

2. A drinking water laboratory for which some or all WS PT study results are reported as "not acceptable" shall follow the procedure in subsection F of this section.

F. Procedure and requirements for "not acceptable" PT study results.

1. When a laboratory receives a PT study result of "not acceptable," the laboratory shall perform and document corrective action. The corrective action documentation shall be submitted to DCLS within 30 days of receiving the "not acceptable" PT study result.

2. Upon completion of the corrective action, the laboratory shall perform another PT study for each contaminant that had a "not acceptable" initial PT study result.

3. If the result of the laboratory's makeup PT study is "acceptable," DCLS shall not downgrade the laboratory.

4. If the laboratory fails the makeup PT study, DCLS shall downgrade the laboratory to provisionally certified status for the contaminant or contaminants for which the PT study was "not acceptable."

5. When DCLS becomes aware of a failure to comply with PT study requirements, DCLS shall notify the laboratory of its downgraded status within 14 days of the downgrade. DCLS shall send the notification by certified mail or an equivalent mailing service.

6. The laboratory shall correct the problems that caused the downgrade and satisfactorily analyze another PT study within three months. A laboratory may not be provisionally certified for more than three months.

7. If the result of the second makeup PT study is "acceptable," the laboratory can request DCLS in writing to restore its certified status.

8. If the result of the second makeup PT is "not acceptable," DCLS shall revoke certification for the contaminant or contaminants for which the PT study was unsuccessful.

9. DCLS shall follow the provisions of 1VAC30-41-240 in revoking the laboratory's certification.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-140 Laboratory ethics and fraud detection and deterrence

Drinking water laboratories shall meet the requirements of the Manual Supplement to Chapter III of the Manual concerning laboratory ethics and fraud detection and deterrence.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-150 Onsite laboratory assessment

A. Frequency of onsite laboratory assessments.

1. DCLS shall assess a drinking water laboratory when the laboratory owner initially applies for certification and at least once every three years after initial certification is granted.

2. DCLS may perform an onsite assessment if major changes in personnel or equipment occur at the laboratory or if the location of the laboratory changes.

3. DCLS may perform interim onsite assessments to confirm that a laboratory has carried out a corrective action plan.

4. DCLS may perform unannounced onsite assessments.

B. Action prior to a scheduled onsite assessment.

1. DCLS shall arrange a mutually agreeable date and time for the onsite assessment with the drinking water laboratory's management.

2. Prior to the onsite audit, DCLS shall request and the laboratory shall provide current records and information that are necessary to evaluate the laboratory. These records and information may include the following:

a. Quality manual.

b. Personnel list.

c. Instrument list or equipment list or both.

d. Standard operating procedure (SOP) for each method to be evaluated.

e. A data package specified by the certification officer.

f. For chemistry, the most recent method detection limit (MDL) study for each regulated contaminant to which the MDL requirement applies.

C. Opening conference. The DCLS onsite assessor or team shall begin the process of the onsite assessment by holding a conference to state the purpose of the assessment, identify the assessment team, and set out the tasks to be done during the assessment.

D. Assessment process.

1. The DCLS onsite assessment team shall evaluate laboratory personnel qualifications and training, operations, equipment, supplies, general laboratory practices, sample handling procedures, methodology, written procedures, and records. The team shall perform the assessment for those specific methods and contaminants for which the laboratory has requested certification.

2. DCLS may require a laboratory to demonstrate drinking water testing methods during the assessment.

3. The DCLS onsite assessment team shall perform a data audit on at least one sample and on one PT sample for at least one method.

4. The DCLS onsite assessment team shall discuss observed deviations at the time such deviations are observed.

5. Findings or deviations are considered preliminary until the final report is issued.

E. Closing conference.

1. The onsite assessment team shall conduct a closing conference to review the results of the assessment with laboratory staff and management.

2. The onsite assessment team shall discuss the following:

a. Any deviations in the observed procedures and records.

b. The time frame for any corrective actions needed and the response.

c. Recommendations, if necessary, for changes in equipment and supplies, staffing, and facility.

F. Notification. Within 30 calendar days after the onsite assessment, DCLS shall notify the laboratory of its certification status and send the laboratory the final onsite assessment report.

G. Final report. In its final onsite report, DCLS:

1. Shall list the certification status for each contaminant or, if applicable, each class of contaminants evaluated as determined by DCLS as a result of the onsite assessment.

2. Shall list and describe each finding, providing a reference to the underlying requirement.

3. May recommend changes to correct the problems described in the findings that have resulted in the laboratory not obtaining certification for a particular contaminant.

4. May recommend improvements to laboratory operation, recognize outstanding performance, and provide other information of use to the laboratory.

H. Results of the onsite assessment.

1. DCLS shall certify the laboratory when the onsite assessment shows that the laboratory has established or is maintaining the standards of quality required under this chapter.

2. When DCLS finds during the onsite assessment that the laboratory is not maintaining the standards of quality required under this chapter, the laboratory shall follow the procedure in subsection I of this section.

I. Procedures and requirements when findings are reported.

1. The laboratory shall respond with a corrective action plan for all findings issued in the report within 60 calendar days. This corrective action plan shall specify what immediate corrective actions are being taken and any proposed actions that need the concurrence of DCLS.

2. DCLS shall review the corrective action plan. If DCLS finds that any aspect of the laboratory's corrective action plan is inadequate, it shall notify the laboratory director in writing by certified mail or other equivalent mailing service of its intent to downgrade the laboratory.

3. The laboratory director shall respond within 30 calendar days with an additional corrective action plan. If the additional corrective action plan is still deficient, DCLS shall not issue a certificate for the initial application or shall downgrade the laboratory to provisionally certified status.

4. DCLS shall respond within 14 days of determining the laboratory's letter and corrective action plan are deficient.

5. The laboratory shall correct the problems cited in the initial notification letter within three months of the date the laboratory was downgraded.

6. If within three months the laboratory has not corrected the problems for which DCLS downgraded the laboratory to provisionally certified status, DCLS shall revoke the laboratory's certification status.

7. DCLS shall revoke certification only for the contaminants and methods for which the laboratory was initially cited.

8. DCLS shall follow the provisions of 1VAC30-41-240 in revoking the laboratory's certification.

9. When DCLS reports a finding that had been identified in the previous triennial onsite assessment where the laboratory had not implemented corrective action, DCLS shall downgrade the laboratory to provisionally certified.

10. A provisionally certified laboratory may continue to analyze samples for compliance purposes but shall notify its clients in writing of its downgraded status and shall indicate its downgraded status in writing on any report.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014; Errata, 30:23 VA.R. 2590 July 14, 2014.

1VAC30-41-160 Levels of certification

A. Certified. DCLS shall certify a laboratory that meets the criteria set out in this chapter.

B. Interim certification. DCLS may issue an interim certification when it finds that performing an onsite assessment is unnecessary or when the onsite assessment cannot be scheduled within a reasonable time. This may occur when DCLS reviews a laboratory application for an addition to its certification status or when a laboratory notifies DCLS that its location is changing. The laboratory shall maintain the requirements for certification while awaiting the onsite assessment. DCLS shall perform the onsite assessment as soon as possible. Interim certification status is equivalent to certified status.

C. Provisionally certified. DCLS shall provisionally certify a laboratory that has deficiencies as a preliminary stage prior to revocation. A provisionally certified laboratory may continue to analyze drinking water samples for compliance purposes. The laboratory shall notify its clients of the downgraded status in writing and indicate the status on reports. A laboratory may not be provisionally certified for more than three months.

D. Not certified. DCLS shall not certify a laboratory that possesses deficiencies and, in the opinion of DCLS, cannot consistently produce valid data. A laboratory that has had its certification revoked in whole or in part shall notify its clients of its revoked status in writing.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-170 Term of certification

DCLS shall certify drinking water laboratories for a period of one year.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-180 Maintenance of certified status

To maintain its certified status, a laboratory shall:

1. Continue to meet the requirements for certification listed in 1VAC30-41-80.

2. Successfully pass water supply proficiency testing studies annually as required by 1VAC30-41-130.

3. Notify DCLS in writing within 30 calendar days of major changes in personnel, equipment, or laboratory location as specified in 1VAC30-41-200.

4. Use approved methodology as required by this chapter and incorporated by reference into 1VAC30-41-55.

5. Comply with the reporting requirements specified in 1VAC30-41-190.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-190 Reporting requirements

A. To maintain certification, drinking water laboratories shall comply with the reporting requirements for compliance, monitoring, and exceedances set out in the VDH-ODW regulations in 12VAC5-590-530.

B. Drinking water laboratories shall report the results of analyses to the VDH-ODW within three days of completion unless 12VAC5-590-530 requires a different time limit.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-200 Major changes in personnel or equipment or a change of laboratory location

A. Major change in personnel.

1. The drinking water laboratory shall notify DCLS of a major change in the laboratory's personnel in writing within 30 calendar days of the change.

2. A "major change in personnel" is defined as (i) the loss or replacement of the laboratory director or laboratory supervisor or (ii) the loss of all the trained and experienced analysts who had been available to analyze a particular contaminant for which certification has been granted.

3. DCLS shall follow the procedure in 1VAC30-41-220 to downgrade the laboratory to provisionally certified status if the laboratory fails to notify DCLS within 30 calendar days of a major change in personnel.

B. Change of laboratory location.

1. The laboratory shall notify DCLS of a change in the laboratory's location in writing at least 30 calendar days prior to the location change.

2. DCLS may perform an onsite assessment of the new facility when a laboratory changes location.

3. DCLS shall follow the procedure in 1VAC30-41-220 to downgrade the laboratory to provisionally certified status if the laboratory fails to notify DCLS of a change in the laboratory's location at least 30 days prior to the location change.

C. Equipment.

1. A drinking water laboratory shall notify DCLS in writing within 30 calendar days of a major change in equipment.

2. A drinking water laboratory shall provide the following information to DCLS about new equipment:

a. Make and model of the new instrument.

b. Date of installation and training.

c. Initial demonstration of capability (IDC) and minimum detection limit (MDL).

d. Updated standard operating procedure (SOP).

e. Methods and contaminants for which the instrument will be used.

f. Successful proficiency testing analyzed on the new instrument.

g. Date the instrument was put into service analyzing compliance samples.

3. DCLS shall follow the procedure in 1VAC30-41-220 to downgrade the laboratory to provisionally certified status if the laboratory fails to notify DCLS within 30 calendar days of any major change in equipment.

D. Laboratory action to address major changes to personnel or equipment or a change of location.

1. When a major change to laboratory personnel or equipment or a change of location occurs, the laboratory shall establish a schedule to address the change and provide the schedule in writing to DCLS. The laboratory shall submit the schedule to DCLS along with the notification of the change.

2. If DCLS determines that the laboratory can no longer produce valid data because of the major change in personnel or equipment or the change of location, DCLS shall follow the procedure in 1VAC30-41-240 to revoke certification for the contaminants in question.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-210 Downgrading to provisionally certified status

DCLS shall downgrade a certified drinking water laboratory's status to provisionally certified for each contaminant and by each method for any of the following reasons:

1. Failure to analyze a PT sample each calendar year during the period defined by DCLS and within the acceptance limits specified in the regulations incorporated by reference in 1VAC30-41-55.

2. Failure to successfully analyze a PT sample for a contaminant after participating in two successive PT studies.

3. Failure to notify DCLS within 30 calendar days of major changes in personnel or equipment or a change in laboratory location as required by 1VAC30-41-200.

4. Failure to satisfy DCLS that the laboratory is maintaining the required standard of quality based upon the onsite assessment requirements in 1VAC30-41-150.

5. Failure to comply with the reporting requirements of 1VAC30-41-190 in a timely manner.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-220 Procedure to downgrade to provisionally certified status

A. DCLS shall notify the laboratory director in writing that DCLS intends to downgrade the laboratory to provisionally certified status. DCLS shall send this notification within 14 days of becoming aware of the cause for the downgrade. DCLS shall send the notification by certified mail or other equivalent mailing service.

B. The laboratory director shall review the problems cited in the notice. Within 30 days of receiving the notice, the laboratory director shall send DCLS a letter specifying what immediate corrective actions are being taken and any proposed action that needs the concurrence of DCLS.

C. DCLS shall consider the adequacy of the laboratory's response and notify the laboratory director in writing by certified mail or other equivalent mailing service of the laboratory's certification status. DCLS shall respond within 14 days of receiving the laboratory's letter and corrective action plan.

D. The laboratory shall correct the problems cited in the initial notification letter from DCLS within three months of the date of the DCLS response to the laboratory's corrective action plan.

E. If within three months the laboratory has not corrected the problems for which DCLS downgraded the laboratory to provisionally certified status, DCLS shall revoke the laboratory's certification status. This revocation shall apply only to the contaminants and methods for which the laboratory was initially cited in the DCLS downgrade notification.

F. DCLS shall follow the provisions of 1VAC30-41-240 in revoking the laboratory's certification.

G. A provisionally certified laboratory may continue to analyze samples for compliance purposes but shall notify its clients in writing of its downgraded status and shall indicate its downgraded status in writing on any report.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-230 Revocation of certified status

DCLS shall downgrade a drinking water laboratory's status to not certified from certified or provisionally certified or interim certified status for each contaminant and by each method for any of the following reasons:

1. Falsification of data or use of other deceptive practices.

2. Reporting proficiency testing data from another laboratory as its own.

3. Failure to use the federally-approved methods incorporated by reference into this chapter at 1VAC30-41-55.

4. Refusal to participate in an onsite assessment conducted by DCLS.

5. Failure to pay the annual fee to DCLS.

6. For provisionally certified laboratories, failure to successfully analyze a PT sample or any other unknown test sample for a particular contaminant within the specified acceptance limits.

7. For provisionally certified laboratories, failure to satisfy DCLS that the laboratory has corrected identified deficiencies based on an onsite assessment.

8. For provisionally certified laboratories, persistent failure to comply with the reporting requirements specified in 1VAC30-41-190.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-240 Procedure to revoke certification

A. DCLS shall notify the laboratory owner in writing of its intent to revoke certification. DCLS shall describe in detail the reasons and circumstances that form the basis for revoking certified status in this notice. DCLS shall send the notification by certified mail or an equivalent mailing service.

B. DCLS shall provide an opportunity for an informal fact-finding conference pursuant to § 2.2-4019 of the Code of Virginia prior to making a final decision to revoke certification.

C. A drinking water laboratory that has had its certification revoked for methods and contaminants under the methods shall do the following:

1. Stop analyzing SDWA compliance samples for these contaminants and methods.

2. Send the samples to a laboratory that is certified to perform the analyses.

3. Notify its clients of its revoked status in writing.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-250 Appeal procedure

A laboratory may appeal a final decision to revoke certification by DCLS pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-260 Reinstatement of certification

A. A drinking water laboratory may request in writing to have its certification status upgraded or reinstated.

B. DCLS shall upgrade or reinstate certification when the laboratory can demonstrate that it has corrected the deficiencies that produced the downgrading or revocation of certified status.

C. DCLS may require an onsite assessment or successful completion of a water supply proficiency testing study or both before upgrading or reinstating a drinking water laboratory. If the onsite assessment is necessary, the laboratory shall pay the fees set out in 1VAC30-41-270 H.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-270 Fees

A. DCLS shall charge a fee to certify drinking water laboratories. This fee shall be limited to the cost of administering the certification program.

B. Required fees.

1. Drinking water laboratories shall submit payment of the fee with the initial applications for certification.

2. Drinking water laboratories located out-of-state and applying for reciprocal certification shall submit payment of the fee with the initial applications.

3. Once certified under this chapter, drinking water laboratories shall pay the fee annually. DCLS shall send an invoice to the certified drinking water laboratory.

4. Additional fees may apply under subsection K of this section when changes to the laboratory's certification require DCLS staff time to administer the change.

C. DCLS shall not consider an application to be complete until the applicant laboratory submits payment of the certification fee.

D. All incomplete payments shall be deemed as nonpayment. Nonpayment of fees shall result in denial or revocation of certification.

E. Payment of fees shall be nonrefundable.

F. DCLS, under 1VAC30-41-230, may revoke the certification of any certified laboratory that does not pay its annual fee.

G. Fee computation.

1. Fees for certification of drinking water laboratories shall be applied on an annual basis.

2. Drinking water laboratories shall pay the total of the base year fees as required by subsections H and J of this section for the first 12 months following May 1, 2014.

3. Beginning May 1, 2015, drinking water laboratories shall pay the total of the base year fees required by subsection H and Table 1 of subsection J of this section as adjusted by the method set out in subsection I of this section.

H. Calculation of fees - base year fees May 1, 2014 - April 30, 2015.

1. DCLS charges a fee for the review and certification of the drinking water laboratory's quality system. This includes a review of the test methods for which the drinking water laboratory requests or holds certification. The fees are based on the number of test methods for which the laboratory would be certified within each of the six testing categories set out in Table 1 of subsection J of this section.

2. DCLS shall calculate a laboratory's fees by adding the fees for the number of test methods in each category as set out in Table 1 of subsection J of this section for which the laboratory applies or is certified.

3. For example, a laboratory may be certified for three microbiological methods ($700); five inorganic chemistry, nonmetals methods ($850); two inorganic chemistry, metals methods ($1000); and two organic chemistry methods ($1050). The total annual fee would be $3600.

I. Calculation of fees - fees beginning May 1, 2015.

1. DCLS shall revise the base year fees after the first 12 months following May 1, 2014, and every 12-month period thereafter.

2. DCLS shall increase or decrease the fees set out in Table 1 of subsection J of this section using the Consumer Price Index-Urban (CPI-U) percentage change, average-average for the previous calendar year. (The CPI-U for all urban consumers is published by the U.S. Department of Labor, Bureau of Labor Statistics.)

3. DCLS shall revise each previous year's Table 1 of subsection J of this section so that the revisions will be cumulative, reflecting the changes in the CPI-U over time.

4. DCLS shall round the revised fees to the nearest whole dollar.

5. DCLS shall publish the revised fee table annually on its website for drinking water laboratory certification. This website can be found by going to the DCLS page of the Department of General Services' website at http://dgs.virginia.gov.

J. Fee tables.

1. Fees are calculated using the base year fees in Table 1.

| | Table 1 - Base Year Fees | | | --- | --- | --- | | | Testing Category | Fee ($) | | | Microbiological testing | | | | 1 - 2 methods | 600 | | | 3 - 5 methods | 700 | | | 6+ methods | 800 | | | Inorganic chemistry, nonmetals testing | | | | 1 - 2 methods | 650 | | | 3 - 5 methods | 850 | | | 6 - 8 methods | 1050 | | | 9+ methods | 1250 | | | Inorganic chemistry, metals testing | | | | 1 - 2 methods | 1000 | | | 3 - 5 methods | 1200 | | | 6+ methods | 1400 | | | Organic chemistry | | | | 1 - 2 methods | 1050 | | | 3 - 5 methods | 1250 | | | 6 - 8 methods | 1450 | | | 9+ methods | 1650 | | | Radiochemistry | | | | 1 - 2 methods | 1100 | | | 3 - 5 methods | 1300 | | | 6+ methods | 1500 | | | Asbestos | | | | 1 - 2 methods | 900 | | | 3 - 5 methods | 1100 | | | 6+ methods | 1300 |

2. Table 2 shows the relationship between the testing categories for fees and the drinking water laboratory certification categories.

| | Table 2 - Drinking Water Laboratory Certification Categories | | | --- | --- | --- | | | Fee Testing Category | Laboratory Certification Category | | | Microbiological testing | Microbiology (includes coliform, E. coli, heterotrophic bacteria) | | | Inorganic chemistry, nonmetals testing | Physical/inorganic: aggregate properties (includes turbidity, alkalinity, total dissolved solids, conductivity, pH) Wet chemistry (includes fluoride, nitrate/nitrite, cyanide, sulfate, orthophosphate, pH) Organic aggregate properties (includes DOC, TOC, UV254, Surfactants/SUVA) | | | Inorganic chemistry, metals testing | Trace metals (includes lead, copper, chromium, beryllium, mercury, barium, cadmium) | | | Organic chemistry, trace | Organic chemistry (includes pesticides, herbicides, SOC, PCB, THM, VOC, HAA5, carbamates, fumigants) | | | Radiochemistry | Radiochemistry (includes alpha, beta, radium, gamma, uranium, strontium-89) | | | Asbestos | Asbestos |

K. Additional fees.

1. An additional fee shall be charged to a laboratory:

a. Applying for modification of certification under 1VAC30-41-110.

b. Moving its location when the move requires DCLS to perform an onsite assessment.

c. Requesting reinstatement of certification when DCLS requires an onsite assessment.

2. The fee charged shall be the sum of the total hourly charges for all reviewers plus any onsite assessment cost incurred.

a. An hourly charge per reviewer shall be $61 as of May 1, 2014. DCLS shall revise the hourly charge after the first 12 months following May 1, 2014, and every 12-month period thereafter. The hourly charge shall increase or decrease using the Consumer Price Index-Urban (CPI-U) percentage change, average-average for the previous calendar year.

b. The charge per reviewer shall be determined by multiplying the number of hours expended in the review by the reviewer's hourly charge.

c. If an onsite review is required, travel time and onsite review time shall be charged at the same hourly charge per reviewer, and any travel expenses shall be added.

L. Method of payment. Fees shall be paid by check, draft, or postal money order payable to the Treasurer, Commonwealth of Virginia, or submitted electronically, if available, and must be in U.S. currency, except that agencies and institutions of the Commonwealth of Virginia may submit interagency transfers for the amount of the fee. All fees shall be sent to the following address, or submitted electronically, if available: DCLS, Attn: Lab Certification, 600 North 5th Street, Richmond, VA 23219. Laboratories may also pay fees using credit cards. Laboratories shall fill out the DCLS Fee Payment Form for Virginia Laboratory Certification Programs and send the completed form with the fee.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014. Publication of recalculated fees: General Notices, 33:15 VA.R. 1902-1903 March 20, 2017; 34:18 VA.R. 1971-1972 April 30, 2018; 35:17 VA.R. 2092-2093 April 15, 2019; 36:19 VA.R. 2256 May 11, 2020; 37:16 VA.R. 2376 March 29, 2021; 38:18 VA.R. 2421 April 25, 2022; 39:18 VA.R. 2312 April 24, 2023; 40:18 VA.R 1579 April 22, 2024; 41:19 VA.R XXXX May 5, 2025.

1VAC30-41-280 [Reserved]

Historical Notes

Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-290 [Reserved]

Historical Notes

Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

Part III Chemistry

1VAC30-41-300 Personnel

Drinking water laboratories shall meet the requirements of Chapter III, Section 10 and Chapter IV, Section 1 of the Manual.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-310 Laboratory facilities

Drinking water laboratories shall meet the requirements of Chapter IV, Section 2 of the Manual.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-320 Laboratory equipment and instrumentation

A. Drinking water laboratories shall meet the requirements set out in the approved methods incorporated by reference into 1VAC30-41-55 and in use by the laboratory.

B. Drinking water laboratories shall meet the requirements of Chapter IV, Section 3 of the Manual.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-330 General laboratory practices

A. Drinking water laboratories shall meet the requirements set out in the approved methods incorporated by reference into 1VAC30-41-55 and in use by the laboratory.

B. Drinking water laboratories shall meet the requirements of Chapter IV, Section 4 of the Manual with the exception of Table IV-1.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-340 Analytical methodology

A. Laboratories shall meet the sampling and analytical methodology requirements incorporated by reference at 1VAC30-41-55 for primary inorganic chemical contaminants, primary organic chemical contaminants, alternative testing methods for chemistry, and secondary maximum contaminant levels.

B. Laboratories shall meet the requirements of Chapter IV, Section 5.1 of the Manual with the exception of Tables IV-2 through IV-5 and Table IV-11.

C. A drinking water laboratory shall perform a minimum of five water analyses monthly for each chemical contaminant for which the laboratory is certified in order to maintain certification status or qualify for initial certification.

D. Exceptions to laboratory certification requirements of 1VAC30-41-20 B 2.

1. Laboratory testing for alkalinity, calcium, chlorite, conductivity, disinfectant residual, orthophosphate, pH, silica, temperature, and turbidity for compliance purposes may be performed by laboratories or persons not certified under this chapter but acceptable to VDH-ODW.

2. This testing shall be performed using approved sampling and analytical methodology as incorporated by reference into 1VAC30-41-55 C.

3. Laboratories performing this testing shall meet the requirements of Chapter IV, Section 5.2 of the Manual, with the exception of Tables IV-2 through IV-5.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-350 Sample collection, handling, and preservation

A. Drinking water laboratories shall meet the sample container, required preservation, and maximum holding time requirements incorporated by reference at 1VAC30-41-55 for primary inorganic chemical contaminants, primary organic chemical contaminants, alternative testing methods for chemistry, and secondary maximum contaminant levels.

B. Drinking water laboratories shall meet the requirements of Chapter IV, Section 6 of the Manual with the exception of Table IV-6, and the Manual Supplement to Chapter IV, Section 6 of the Manual.

C. Drinking water laboratories shall reject any sample not meeting the criteria of this section and notify the system or individual requesting the analyses.

D. The laboratory shall have a written sample rejection policy covering samples that do not meet sampling requirements.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-360 Quality assurance

Drinking water laboratories shall meet the quality assurance and quality control requirements of both the Manual and the required analytical methods incorporated by reference into 1VAC30-41-55. These requirements include the following:

1. The approved test methods and associated quality assurance and quality control requirements incorporated by reference into 1VAC30-41-55.

2. Chapter III, Section 11 of the Manual.

3. Chapter IV, Section 7 of the Manual with the exception of Tables IV-7 through IV-10.

4. The Manual Supplement to Chapter III, Section 2 of the Manual.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-370 Recordkeeping and data reporting

Drinking water laboratories shall meet the recordkeeping and data reporting requirements of the following:

1. The approved test methods incorporated by reference into 1VAC30-41-55.

2. Chapter IV, Section 8 of the Manual.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-380 Action response to laboratory results

Drinking water laboratories shall meet the action response requirement of Chapter IV, Section 9 of the Manual and the requirements of 1VAC30-41-190.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-390 [Reserved]

Historical Notes

Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

Part IV Microbiology

1VAC30-41-400 Personnel

Drinking water laboratories shall meet the requirements of Chapter III, Section 10 and Chapter V, Section 1 of the Manual.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-410 Laboratory facilities

A. Drinking water laboratories shall meet the requirements of Chapter V, Section 2 of the Manual.

B. The laboratory facilities shall include sufficient space to process and examine samples proportionate with the total work load.

C. The laboratory shall have provisions for decontamination and disposal of microbiological waste.

D. Office areas for clerical work and recordkeeping shall be segregated from laboratory work areas.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-420 Laboratory equipment and supplies

Drinking water laboratories shall meet the following requirements:

1. The requirements set out in the approved methods incorporated by reference into 1VAC30-41-55 and in use by the laboratory.

2. The requirements of Chapter V, Section 3 of the Manual.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-430 General laboratory practices

Drinking water laboratories shall meet general laboratory practices of the following:

1. The requirements set out in the approved methods incorporated by reference into 1VAC30-41-55 and in use by the laboratory.

2. The requirements of Chapter V, Section 4 of the Manual.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-440 Analytical methodology

A. Drinking water laboratories shall meet the sampling and analytical methodology requirements incorporated by reference into 1VAC30-41-55 for microbiology and alternative testing methods for microbiology.

B. Drinking water laboratories shall meet the requirements of Chapter V, Section 5 of the Manual and the Manual Supplement to Chapter V, Section 5 of the Manual unless these requirements conflict with the requirements specified in subsection A of this section.

C. A drinking water laboratory shall perform a minimum of 20 coliform analyses monthly by each coliform method for which it is certified in order to maintain certification status or qualify for initial certification. The minimum number of coliform analyses (20) may be performed on a variety of water sample types collected from different stages of the water treatment process, raw source water, and surface or ground water, as well as drinking water samples collected from a distribution system or private wells.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-450 Sample collection, handling, and preservation

A. Laboratories that perform sampling shall meet the sample container, required preservation, and maximum holding time requirements incorporated by reference at 1VAC30-41-55 for microbiology and alternative testing methods for microbiology.

B. Laboratories that perform sampling shall meet the requirements of Chapter V, Section 6 of the Manual and the Manual Supplement to Chapter V, Section 6 of the Manual unless these requirements conflict with the requirements specified in subsection A of this section.

C. Drinking water laboratories shall reject any sample not meeting the sampling criteria of this section and notify the system or individual requesting the analyses.

D. The laboratory shall have a written sample rejection policy covering samples that do not meet sampling requirements.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-460 Quality assurance

Drinking water laboratories shall meet the quality assurance and quality control requirements of both the Manual and the required analytical methods incorporated by reference into 1VAC30-41-55. These requirements include the following:

1. The approved test methods and associated quality assurance and quality control requirements incorporated by reference into 1VAC30-41-55.

2. Chapter III, Section 11 and Chapter V, Section 7 of the Manual.

3. The Manual Supplement to Chapter III, Section 2 of the Manual.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-470 Recordkeeping and data reporting

Laboratories shall meet the recordkeeping and data reporting requirements of the following:

1. The approved test methods incorporated by reference into 1VAC30-41-55.

2. Chapter V, Section 8 of the Manual.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-480 Action response to laboratory results

Drinking water laboratories shall meet the requirements of Chapter V, Section 9 of the Manual and the requirements of 1VAC30-41-190.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

1VAC30-41-490 [Reserved]

Historical Notes

Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

Part V Radiochemistry

1VAC30-41-500 Radiochemistry

A. Drinking water laboratories shall meet the sampling and analytical methodology requirements including the quality assurance and quality control requirements incorporated by reference into 1VAC30-41-55 for radiochemistry and alternative testing methods for radiochemistry.

B. Drinking water laboratories shall meet the requirements of Chapters III and VI of the Manual as follows:

1. Personnel: Chapter III, Section 10 and Chapter VI, Section 1.

2. Laboratory facilities: Chapter VI, Section 2.

3. Laboratory equipment and instrumentation: Chapter VI, Section 3.

4. General laboratory practices: Chapter VI, Section 4.

5. Analytical methods: Chapter VI, Section 5, with the exception of Table VI-1.

6. Sample collection, handling, and preservation: Chapter VI, Section 6, with the exception of Table VI-2.

7. Quality assurance: Chapter III, Section 11 and Chapter VI, Section 7.

8. Recordkeeping and data reporting: Chapter VI, Section 8.

9. Action response to laboratory results: Chapter VI, Section 9 and the requirements of 1VAC30-41-190.

History

• Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.
• Historical Notes: Derived from Virginia Register Volume 30, Issue 14, eff. May 1, 2014.

Chapter 45 Certification for Noncommercial Environmental Laboratories

Part I General Provisions

1VAC30-45-10 Purpose

Section 2.2-1105 of the Code of Virginia directs the Division of Consolidated Laboratory Services to establish a program to certify environmental laboratories that perform tests, analyses, measurements or monitoring required pursuant to the Commonwealth's air, waste and water laws and regulations. This chapter sets out the required standards and the process by which owners of noncommercial environmental laboratories may obtain certification for their laboratories.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-20 Establishment of certification program

A. Once the certification program has been established, laboratory certification shall be required before any environmental analyses performed by a noncommercial environmental laboratory may be used for the purposes of the Virginia Air Pollution Control Law, the Virginia Waste Management Act or the State Water Control Law (§ 10.1-1300 et seq., § 10.1-1400 et seq., and § 62.1-44.2 et seq., respectively of the Code of Virginia).

B. The certification program shall be established on January 1, 2012.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-30 Applicability

A. This chapter applies to any owner of a noncommercial environmental laboratory.

B. Any environmental laboratory owned by an agency of the federal government may be certified as follows:

1. By DCLS to the standards set out in this chapter; or

2. By a federal primary accreditation body to the standards established by TNI.

C. Citizen monitoring groups. Section 62.1-44.19:11 of the Code of Virginia both establishes a citizen water quality monitoring program for Virginia and encourages the growth of the program. The Department of Environmental Quality (DEQ) has a separate program of quality assurance and quality control (QA/QC) standards for citizen monitoring groups and their laboratories to follow. The following laboratories shall meet the DEQ QA/QC requirements developed for the purposes of citizen monitoring of water quality in lieu of the requirements of 1VAC30-45 or 1VAC30-46:

1. Laboratories owned by citizen monitoring groups.

2. Laboratories at institutions of higher education affiliated with citizen monitoring groups for the purposes of analyzing samples for the groups.

D. Institutions of higher education. Environmental laboratories owned by institutions of higher education located in Virginia that perform analyses for the purpose of providing environmental research data to DEQ at DEQ's request shall meet the QA/QC requirements specified by DEQ. An environmental laboratory owned by an institution of higher education located in Virginia that performs environmental research for DEQ shall not be subject to the requirements of either 1VAC30-45 or 1VAC30-46 unless DEQ requires the laboratory to do so.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-40 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise.

"Acceptance criteria" means specified limits placed on characteristics of an item, process, or service defined in requirement documents.

"Accuracy" means the degree of agreement between an observed value and an accepted reference value. Accuracy includes a combination of random error (precision) and systematic error (bias) components that are due to sampling and analytical operations. Accuracy is an indicator of data quality.

"Algae" means simple single-celled, colonial, or multicelled, mostly aquatic plants, containing chlorophyll and lacking roots, stems and leaves that are either suspended in water (phytoplankton) or attached to rocks and other substrates (periphyton).

"Aliquot" means a portion of a sample taken for analysis.

"Analyte" means the substance , organism, physical parameter, or chemical constituent for which an environmental sample is being analyzed.

"Analytical method" means a technical procedure for providing analysis of a sample, defined by a body such as the Environmental Protection Agency or the American Society for Testing and Materials, that may not include the sample preparation method.

"Assessment" means the evaluation process used to measure or establish the performance, effectiveness, and conformance of an organization and its systems or both to defined criteria (i.e., to the standards and requirements of laboratory certification).

"Assessor" means the person assigned by DCLS to perform, alone or as part of an assessment team, an assessment of an environmental laboratory.

"Audit" means a systematic evaluation to determine the conformance to quantitative and qualitative specifications of some operational function or activity.

"Authority" means, in the context of a governmental body or local government, an authority created under the provisions of the Virginia Water and Waste Authorities Act, Chapter 51 (§ 15.2-5100 et seq.) of Title 15.2 of the Code of Virginia.

"Batch" means environmental samples that are prepared together or analyzed together or both with the same process and personnel, using the same lot or lots of reagents. "Analytical batch" means a batch composed of prepared environmental samples (extracts, digestates, or concentrates) that are analyzed together as a group. An analytical batch can include prepared samples originating from various environmental matrices and can exceed 20 samples. "Preparation batch" means a batch composed of one to 20 environmental samples of the same matrix that meets the criteria in this definition for "batch" and with a maximum time between the start of processing of the first and last sample in the batch to be 24 hours.

"Benthic macroinvertebrates" means bottom dwelling animals without backbones that live at least part of their life cycles within or upon available substrates within a body of water.

"Blank" means a sample that has not been exposed to the analyzed sample stream in order to monitor contamination during sampling, transport, storage or analysis. The blank is subjected to the usual analytical and measurement process to establish a zero baseline or background value and is sometimes used to adjust or correct routine analytical results. Blanks include the following types:

1. Field blank. A blank prepared in the field by filling a clean container with pure deionized water and appropriate preservative, if any, for the specific sampling activity being undertaken.

2. Method blank. A sample of a matrix similar to the batch of associated samples (when available) that is free from the analytes of interest and is processed simultaneously with and under the same conditions as samples through all steps of the analytical procedures, and in which no target analytes or interferences are present at concentrations that impact the analytical results for sample analyses.

"Calibration" means to determine, by measurement or comparison with a standard, the correct value of each scale reading on a meter, instrument or other device. The levels of the applied calibration standard should bracket the range of planned or expected sample measurements.

"Calibration curve" means the graphical relationship between the known values, such as concentrations, of a series of calibration standards and their instrument response.

"Calibration standard" means a substance or reference material used to calibrate an instrument.

"Certified reference material" means a reference material one or more of whose property values are certified by a technically valid procedure, accompanied by or traceable to a certificate or other documentation that is issued by a certifying body.

"Client" or "customer" means the Department of Environmental Quality (DEQ) when used in the context of quality assurance and specific quality control provisions.

"Commercial environmental laboratory" means an environmental laboratory where environmental analysis is performed for another person.

"Corrective action" means the action taken to eliminate the causes of an existing nonconformity, defect or other undesirable situation in order to prevent recurrence.

"DCLS" means the Division of Consolidated Laboratory Services of the Department of General Services.

"Demonstration of capability" means the procedure to establish the ability of the analyst to generate data of acceptable accuracy and precision.

"Detection limit" means the lowest concentration or amount of the target analyte that can be determined to be different from zero by a single measurement at a stated degree of confidence.

"Environmental analysis" or "environmental analyses" means any test, analysis, measurement, or monitoring used for the purposes of the Virginia Air Pollution Control Law, the Virginia Waste Management Act or the State Water Control Law (§ 10.1-1300 et seq., § 10.1-1400 et seq., and § 62.1-44.2 et seq., respectively, of the Code of Virginia). For the purposes of these regulations, any test, analysis, measurement, or monitoring required pursuant to the regulations promulgated under these three laws, or by any permit or order issued under the authority of any of these laws or regulations is "used for the purposes" of these laws. The term shall not include the following:

1. Sampling of water, solid and chemical materials, biological tissue, or air and emissions.

2. Field testing and measurement of water, solid and chemical materials, biological tissue, or air and emissions, except when performed in an environmental laboratory rather than at the site where the sample was taken.

3. Taxonomic identification of samples for which there is no national accreditation standard such as algae, benthic macroinvertebrates, macrophytes, vertebrates, and zooplankton.

4. Protocols used pursuant to § 10.1-104.2 of the Code of Virginia to determine soil fertility, animal manure nutrient content, or plant tissue nutrient uptake for the purposes of nutrient management.

5. Geochemical and permeability testing for solid waste compliance.

6. Materials specification for air quality compliance when product certifications specify the data required by an air permit such as fuel type, Btu content, sulfur content, or VOC content.

"Environmental laboratory" or "laboratory" means a facility or a defined area within a facility where environmental analysis is performed. A structure built solely to shelter field personnel and equipment from inclement weather shall not be considered an environmental laboratory.

"Establishment date" means the date set for the accreditation program under 1VAC30-46 and the certification program to be established under this chapter.

"Establishment of certification program" or "established program" means that DCLS has completed the initial accreditation of environmental laboratories covered by 1VAC30-46 and the initial certification of environmental laboratories covered by 1VAC30-45.

"Facility" means something that is built or installed to serve a particular function.

"Field of certification" or "FoC" means those matrix, technology/method, and analyte combinations for which DCLS offers certification.

"Field of proficiency testing" or "FoPT" means the matrix, technology/method, and analyte combinations for which the composition spike concentration ranges and acceptance criteria have been established by the Proficiency Testing Program Executive Committee of TNI.

"Field testing and measurement" means any of the following:

1. Any test for parameters under 40 CFR Part 136 for which the holding time indicated for the sample requires immediate analysis; or

2. Any test defined as a field test in federal regulation.

The following is a limited list of currently recognized field tests or measures that is not intended to be inclusive: continuous emissions monitoring; online monitoring; flow monitoring; tests for pH, residual chlorine, temperature and dissolved oxygen; and field analysis for soil gas.

"Finding" means an assessment conclusion referenced to a laboratory certification standard and supported by objective evidence that identifies a deviation from a laboratory certification standard requirement.

"Governmental body" means any department, agency, bureau, authority, or district of the United States government, of the government of the Commonwealth of Virginia, or of any local government within the Commonwealth of Virginia.

"Holding time" means the maximum time that can elapse between two specified activities.

"International System of Units (SI)" means the coherent system of units adopted and recommended by the General Conference on Weights and Measures.

"Laboratory control sample" or "LCS" means a sample matrix, free from the analytes of interest, spiked with verified known amounts of analytes or a material containing known and verified amounts of analytes. It is generally used to establish intra-laboratory or analyst specific precision and bias or to assess the performance of all or a portion of the measurement system. "Laboratory control sample" or "LCS" may also be named laboratory fortified blank, spiked blank, or QC check sample.

"Laboratory manager" means the person who has overall responsibility for the technical operation of the environmental laboratory and who exercises actual day-to-day supervision of laboratory operation for the appropriate fields of testing and reporting of results. The title of this person may include laboratory director, technical director, laboratory supervisor, or laboratory manager.

"Legal entity" means an entity, other than a natural person, that has sufficient existence in legal contemplation that it can function legally, be sued or sue, and make decisions through agents as in the case of corporations.

"Limit of detection" or "LOD" means an estimate of the minimum amount of a substance that an analytical process can reliably detect. An LOD is analyte and matrix specific and may be laboratory dependent.

"Limit of quantitation" or "LOQ" means the minimum levels, concentrations, or quantities of a target variable (e.g., target analyte) that can be reported with a specified degree of confidence.

"Local government" means a municipality (city or town), county, sanitation district, or authority.

"Macrophytes" means any aquatic or terrestrial plant species that can be identified and observed with the eye, unaided by magnification.

"Matrix" means the component or substrate that may contain the analyte of interest. A matrix can be a field of certification matrix or a quality system matrix.

1. Field of certification matrix. These matrix definitions shall be used when certifying a laboratory.

a. Nonpotable water. Any aqueous sample that has not been designated a potable or potential potable water source. Includes surface water, groundwater, effluents, water treatment chemicals, and TCLP or other extracts.

b. Solid and chemical materials. Includes soils, sediments, sludges, products, and byproducts of an industrial process that results in a matrix not previously defined.

c. Biological tissue. Any sample of a biological origin such as fish tissue, shellfish, or plant material. Such samples shall be grouped according to origin.

d. Air and emissions. Whole gas or vapor samples including those contained in flexible or rigid wall containers and the extracted concentrated analytes of interest from a gas or vapor that are collected with a sorbent tube, impinger solution, filter or other device.

2. Quality system matrix. For purposes of batch and quality control requirement determinations, the following matrix types shall be used:

a. Drinking water. Any aqueous sample that has been designated a potable or potential potable water source.

b. Aqueous. Any aqueous sample excluded from the definition of drinking water matrix or saline/estuarine source. Includes surface water, groundwater, effluents, and TCLP or other extracts.

c. Saline/estuarine. Any aqueous sample from an ocean or estuary, or other salt water source.

d. Nonaqueous liquid. Any organic liquid with less than 15% settleable solids.

e. Biological tissue. Any sample of a biological origin such as fish tissue, shellfish, or plant material. Such samples shall be grouped according to origin.

f. Solids. Includes soils, sediments, sludges, and other matrices with more than 15% settleable solids.

g. Chemical waste. A product or byproduct of an industrial process that results in a matrix not previously defined.

h. Air and emissions. Whole gas or vapor samples including those contained in flexible or rigid wall containers and the extracted concentrated analytes of interest from a gas or vapor that are collected with a sorbent tube, impinger solution, filter, or other device.

"Matrix spike (spiked sample or fortified sample)" means a sample prepared by adding a known mass of target analyte to a specified amount of matrix sample for which an independent estimate of target analyte concentration is available. Matrix spikes are used, for example, to determine the effect of the matrix on a method's recovery efficiency.

"Matrix spike duplicate (spiked sample or fortified sample duplicate)" means a second replicate matrix spike prepared in the laboratory and analyzed to obtain a measure of the precision of the recovery for each analyte.

"National Environmental Laboratory Accreditation Conference" or "NELAC" means a voluntary organization of state and federal environmental officials and interest groups with the primary purpose to establish mutually acceptable standards for accrediting environmental laboratories. NELAC preceded the formation of The NELAC Institute or TNI.

"National Institute of Standards and Technology" or "NIST" means an agency of the U.S. Department of Commerce's Technology Administration that is working with EPA, states, NELAC, and other public and commercial entities to establish a system under which private sector companies and interested states can be certified by NIST to provide NIST-traceable proficiency testing (PT) samples.

"Negative control" means measures taken to ensure that a test, its components, or the environment do not cause undesired effects, or produce incorrect test results.

"Noncommercial environmental laboratory" means either of the following:

1. An environmental laboratory where environmental analysis is performed solely for the owner of the laboratory.

2. An environmental laboratory where the only performance of environmental analysis for another person is one of the following:

a. Environmental analysis performed by an environmental laboratory owned by a local government for an owner of a small wastewater treatment system treating domestic sewage at a flow rate of less than or equal to 1,000 gallons per day.

b. Environmental analysis performed by an environmental laboratory operated by a corporation as part of a general contract issued by a local government to operate and maintain a wastewater treatment system or a waterworks.

c. Environmental analysis performed by an environmental laboratory owned by a corporation as part of the prequalification process or to confirm the identity or characteristics of material supplied by a potential or existing customer or generator as required by a hazardous waste management permit under 9VAC20-60.

d. Environmental analysis performed by an environmental laboratory owned by a Publicly Owned Treatment Works (POTW) for an industrial source of wastewater under a permit issued by the POTW to the industrial source as part of the requirements of a pretreatment program under Part VII (9VAC25-31-730 et seq.) of 9VAC25-31.

e. Environmental analysis performed by an environmental laboratory owned by a county authority for any municipality within the county's geographic jurisdiction when the environmental analysis pertains solely to the purpose for which the authority was created.

f. Environmental analysis performed by an environmental laboratory owned by an authority or a sanitation district for any participating local government of the authority or sanitation district when the environmental analysis pertains solely to the purpose for which the authority or sanitation district was created.

"Owner" means any person who owns, operates, leases, or controls an environmental laboratory.

"Person" means an individual, corporation, partnership, association, company, business, trust, joint venture, or other legal entity.

"Physical," for the purposes of fee test categories, means the tests to determine the physical properties of a sample. Tests for solids, turbidity, and color are examples of physical tests.

"Positive control" means measures taken to ensure that a test or its components are working properly and producing correct or expected results from positive test subjects.

"Precision" means the degree to which a set of observations or measurements of the same property, obtained under similar conditions, conform to themselves. Precision is an indicator of data quality. Precision is expressed usually as standard deviation, variance, or range, in either absolute or relative terms.

"Primary accreditation body" means the accreditation body responsible for assessing a laboratory's total quality system, on-site assessment, and PT performance tracking for fields of accreditation.

"Proficiency test or testing" or "PT" means a process to evaluate a laboratory's performance under controlled conditions relative to a given set of criteria through analysis of unknown samples provided by an external source.

"Proficiency test (PT) sample" means a sample, the composition of which is unknown to the laboratory and is provided to test whether the laboratory can produce analytical results within specified acceptance criteria.

"Proficiency testing (PT) program" means the aggregate of providing rigorously controlled and standardized environmental samples to a laboratory for analysis, reporting of results, statistical evaluation of the results, and the collective demographics and results summary of all participating laboratories.

"Program," in the context of a regulatory program, means the relevant U.S. Environmental Protection Agency program such as the water program under the Clean Water Act (CWA), the air program under the Clean Air Act (CAA), the waste program under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA or Superfund), or the waste program under the Resource Conservation and Recovery Act (RCRA).

"Publicly Owned Treatment Works" or "POTW" means a treatment works as defined by § 212 of the CWA, which is owned by a state or municipality (as defined by § 502(4) of the CWA). This definition includes any devices and systems used in the storage, treatment, recycling, and reclamation of municipal sewage or industrial wastes of a liquid nature. It also includes sewers, pipes, and other conveyances only if they convey wastewater to a POTW treatment plant. The term also means the municipality as defined in § 502(4) of the CWA, which has jurisdiction over the indirect discharges to and the discharges from such a treatment works.

"Quality assurance" or "QA" means an integrated system of management activities involving planning, implementation, assessment, reporting, and quality improvement to ensure that a process, item, or service is of the type and quality needed and expected by the client.

"Quality assurance officer" means the person who has responsibility for the quality system and its implementation. Where staffing is limited, the quality assurance officer may also be the laboratory manager.

"Quality control" or "QC" means the overall system of technical activities that measures the attributes and performance of a process, item, or service against defined standards to verify that they meet the stated requirements established by the customer; operational techniques and activities that are used to fulfill requirements for quality; and also the system of activities and checks used to ensure that measurement systems are maintained within prescribed limits, providing protection against "out of control" conditions and ensuring that the results are of acceptable quality.

"Quality manual" means a document stating the management policies, objectives, principles, organizational structure and authority, responsibilities, accountability, and implementation of an agency, organization, or laboratory, to ensure the quality of its product and the utility of its product to its users.

"Quality system" means a structured and documented management system describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services. The quality system provides the framework for planning, implementing, and assessing work performed by the organization and for carrying out required quality assurance and quality control activities.

"Range" means the difference between the minimum and maximum of a set of values.

"Reference material" means a material or substance one or more properties of which are sufficiently well established to be used for the calibration of an apparatus, the assessment of a measurement test method, or for assigning values to materials.

"Reference standard" means a standard, generally of the highest metrological quality available at a given location, from which measurements made at that location are derived.

"Responsible official" means one of the following, as appropriate:

1. If the laboratory is owned or operated by a private corporation, "responsible official" means (i) a president, secretary, treasurer, or a vice-president of the corporation in charge of a principal business function, or any other person who performs similar policy-making or decision-making functions for the corporation or (ii) the manager of one or more manufacturing, production, or operating facilities employing more than 250 persons or having gross annual sales or expenditures exceeding $25 million (in second-quarter 1980 dollars), if authority to sign documents has been assigned or delegated in accordance with corporate procedures.

2. If the laboratory is owned or operated by a partnership, association, or a sole proprietor, "responsible official" means a general partner, officer of the association, or the proprietor, respectively.

3. If the laboratory is owned or operated by a governmental body, "responsible official" means a director or highest official appointed or designated to oversee the operation and performance of the activities of the environmental laboratory.

4. Any person designated as the responsible official by an individual described in subdivision 1, 2, or 3 of this definition, provided the designation is in writing, the designation specifies an individual or position with responsibility for the overall operation of the environmental laboratory, and the designation is submitted to DCLS.

"Sampling" means an activity related to obtaining a representative sample of the object of conformity assessment, according to a procedure.

"Sanitation district" means a sanitation district created under the provisions of Chapters 3 (§ 21-141 et seq.) through 5 (§ 21-291 et seq.) of Title 21 of the Code of Virginia.

"Selectivity" means the ability to analyze, distinguish, and determine a specific analyte from another component that may be a potential interferent or that may behave similarly to the target analyte within the measurement system.

"Sewage" means the water-carried human wastes from residences, buildings, industrial establishments, or other places together with such industrial wastes and underground, surface, storm, or other water as may be present.

"Simple test procedures" or "STP" means any of the following:

1. Field testing and measurement performed in an environmental laboratory.

2. The test procedures to determine:

a. Biochemical oxygen demand (BOD) or carbonaceous BOD (CBOD);

b. Fecal coliform;

c. Total coliform;

d. Fecal streptococci;

e. E. coli;

f. Enterococci;

g. Settleable solids (SS);

h. Total dissolved solids (TDS);

i. Total solids (TS);

j. Total suspended solids (TSS);

k. Total volatile solids (TVS); and

l. Total volatile suspended solids (TVSS).

"Standard operating procedure" or "SOP" means a written document that details the method for an operation, analysis, or action with thoroughly prescribed techniques and steps. An SOP is officially approved as the method for performing certain routine or repetitive tasks.

"Standardized reference material" or "SRM" means a certified reference material produced by the U.S. National Institute of Standards and Technology or other equivalent organization and characterized for absolute content, independent of analytical method.

"System laboratory" means a noncommercial laboratory that analyzes samples from multiple facilities having the same owner.

"Test" means a technical operation that consists of the determination of one or more characteristics or performance of a given product, material, equipment, organism, physical phenomenon, process, or service according to a specified procedure.

"Test, analysis, measurement or monitoring required pursuant to the Virginia Air Pollution Control Law" means any method of analysis required by the Virginia Air Pollution Control Law (§ 10.1-1300 et seq.); by the regulations promulgated under this law (9VAC5) including any method of analysis listed either in the definition of "reference method" in 9VAC5-10-20, or listed or adopted by reference in 9VAC5; or by any permit or order issued under and in accordance with this law and these regulations.

"Test, analysis, measurement or monitoring required pursuant to the Virginia Waste Management Act" means any method of analysis required by the Virginia Waste Management Act (§ 10.1-1400 et seq.); by the regulations promulgated under this law (9VAC20), including any method of analysis listed or adopted by reference in 9VAC20; or by any permit or order issued under and in accordance with this law and these regulations.

"Test, analysis, measurement or monitoring required pursuant to the Virginia Water Control Law" means any method of analysis required by the Virginia Water Control Law (§ 62.1-44.2 et seq.); by the regulations promulgated under this law (9VAC25), including any method of analysis listed or adopted by reference in 9VAC25; or by any permit or order issued under and in accordance with this law and these regulations.

"Test method" means an adoption of a scientific technique for performing a specific measurement as documented in a laboratory standard operating procedure or as published by a recognized authority.

"The NELAC Institute" or "TNI" means the organization whose standards environmental laboratories must meet to become accredited under 1VAC30-46, the regulation governing commercial environmental laboratories in Virginia.

"Toxicity characteristic leachate procedure" or "TCLP" means Test Method 1311 in "Test Methods for Evaluating Solid Waste, Physical/Chemical Methods," EPA Publication SW-846, as incorporated by reference in 40 CFR 260.11. This method is used to determine whether a solid waste exhibits the characteristic of toxicity (see 40 CFR 261.24).

"Traceability" meansthe property of a result of a measurement whereby it can be related to appropriate standards, generally international or national standards, through an unbroken chain of comparisons.

"U.S. Environmental Protection Agency" or "EPA" means the federal government agency with responsibility for protecting, safeguarding, and improving the natural environment (i.e., air, water, and land) upon which human life depends.

"Virginia Air Pollution Control Law" means Chapter 13 (§ 10.1-1300 et seq.) of Title 10.1 of the Code of Virginia, which is titled "Air Pollution Control Board."

"Virginia Environmental Laboratory Accreditation Program" or "VELAP" means the program DCLS operates to certify environmental laboratories under this chapter.

"Wastewater" means liquid and water-carried industrial wastes and domestic sewage from residential dwellings, commercial buildings, industrial and manufacturing facilities, and institutions.

"Waterworks" means each system of structures and appliances used in connection with the collection, storage, purification, and treatment of water for drinking or domestic use and the distribution thereof to the public, except distribution piping.

"Zooplankton" means microscopic animals that float freely with voluntary movement in a body of water.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 29, Issue 4, eff. November 21, 2012; Volume 32, Issue 22, eff. September 1, 2016; Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-45-50 Scope of certification

A. Noncommercial environmental laboratories shall be certified based on the general laboratory standards set out in Part II (1VAC30-45-200 et seq.) of this chapter and on the specific test methods or analysis, monitoring or measurement required by regulatory permit or other requirement under the Virginia Air Pollution Control Law, Virginia Waste Management Act, or Virginia Water Control Law, the regulations promulgated under these laws, and by permits and orders issued under and in accordance with these laws or regulations.

B. DCLS shall review alternative test methods and procedures for certification when these are proposed by the applicant laboratory. The provisions of 1VAC30-45-70 E and 1VAC30-45-90 B govern alternative test methods and procedures.

C. Certification shall be granted for one or more fields of certification, including the matrix, the technology and methods, and the individual analytes determined by the particular method used by the laboratory.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-60 General: certification requirements

A. Components of certification. The components of certification include review of personnel qualifications, on-site assessment, proficiency testing, and quality systems. The criteria for these components, set out in Part II (1VAC30-45-200 et seq.) of this chapter, shall be fulfilled for certification.

B. Individual laboratory sites and mobile laboratories.

1. Individual laboratory sites are subject to the same application process, assessments, and other requirements as environmental laboratories. Any remote laboratory sites are considered separate sites and subject to separate on-site assessments.

2. Laboratories located at the same physical location shall be considered an individual laboratory site if these laboratories are owned by the same person, and have the same laboratory manager and quality system.

3. A mobile laboratory, which is configured with equipment to perform analyses, whether associated with a fixed-based laboratory or not, is considered an environmental laboratory and shall require separate certification. This certification shall remain with the mobile laboratory and be site independent. Moving the configured mobile laboratory to a different site will not require a new or separate certification. Before performing analyses at each new site, the laboratory shall ensure that instruments and equipment have been checked for performance and have been calibrated.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-70 Process to apply and obtain certification

A. Duty to apply. All owners of noncommercial environmental laboratories shall apply for certification as specified by the provisions of this section. Applications for certification must be obtained from DCLS program staff by email at Lab_Cert@dgs.virginia.gov.

B. Owners of noncommercial environmental laboratories applying for certification under this chapter for the first time shall submit an application to DCLS as specified under subsection F of this section.

C. Renewal and reassessment.

1. DCLS shall renew certification annually for the certified laboratory provided the laboratory does the following:

a. Maintains compliance with this chapter.

b. Attests to this compliance by signing the certificate of compliance provided under subdivision F 3 of this section.

c. Reports acceptable proficiency test values as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter.

d. Pays the fee required by 1VAC30-45-130.

2. DCLS shall reassess the certified environmental laboratory during an on-site assessment as required by Article 2 (1VAC30-45-300 et seq.) of Part II of this chapter.

D. Responsibilities of the owner and operator when the laboratory is owned by one person and operated by another person.

1. When an environmental laboratory is owned by one person but is operated by another person, the operator may submit the application for the owner.

2. If the operator fails to submit the application, the owner is not relieved of his responsibility to apply for certification.

3. While DCLS may notify noncommercial environmental laboratories of the date their applications are due, failure of DCLS to notify does not relieve the owner of his obligation to apply under this chapter.

E. Submission of applications for modifications to certification. An owner of a certified noncommercial environmental laboratory shall follow the process set out in 1VAC30-45-90 B to modify the laboratory's scope of certification.

F. Contents of application.

1. Applications shall include but not be limited to the following information and documents:

a. Legal name of laboratory;

b. Name of owner of laboratory;

c. Name of operator of laboratory, if different than owner;

d. Street address and description of location of laboratory;

e. Mailing address of laboratory, if different from street address;

f. Address of owner, if different from laboratory address;

g. Name, address, telephone number, facsimile number and email, as applicable, of responsible official;

h. Name, address, telephone number, facsimile number and email, as applicable, of laboratory manager;

i. Name, address, telephone number, facsimile number and email, as applicable, of designated quality assurance officer;

j. Name and telephone number of laboratory contact person;

k. Laboratory type (e.g., public water system, public wastewater system or combination of the two, or industrial (with type of industry indicated));

l. Laboratory hours of operation;

m. Fields of certification (matrix, technology/method, and analyte) for which certification is sought;

n. The results of one successful unique PT study for each field of proficiency testing as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter;

o. Quality assurance manual; and

p. For mobile laboratories, a unique vehicle identification number, such as a manufacturer's vehicle identification number (VIN#), serial number, or license number.

2. Fee. The application shall include payment of the fee as specified in 1VAC30-45-130.

3. Certification of compliance.

a. The application shall include a "Certification of Compliance" statement signed and dated by the responsible official, by the quality control officer and by the laboratory manager.

b. The certification of compliance shall state: "The applicant understands and acknowledges that the laboratory is required to be continually in compliance with the Virginia environmental laboratory certification program regulation (1VAC30, Chapter 45) and is subject to the provisions of 1VAC30-45-100 in the event of noncompliance. I certify under penalty of law that this document and all attachments were prepared under my direction or supervision in accordance with a system designed to assure that qualified personnel properly gather and evaluate the information submitted. Based on my inquiry of the person or persons who manage the laboratory or those persons directly responsible for gathering and evaluating the information, the information submitted is, to the best of my knowledge and belief, true, accurate and complete. Submitting false information or data shall result in denial of certification or decertification. I hereby further certify that I am authorized to sign this application."

G. Completeness determination.

1. DCLS shall determine whether an application is complete and notify the laboratory of the result of such determination. DCLS shall provide this notice within 90 calendar days of its receipt of a laboratory's initial application.

2. An application shall be determined complete if it contains all the information required pursuant to subsection F of this section and is sufficient to evaluate the laboratory prior to the on-site assessment. Designating an application complete does not preclude DCLS from requesting or accepting additional information.

3. If DCLS determines that an application is incomplete, the DCLS notification of such determination shall explain why the application is incomplete and specify the additional information needed to make the application complete.

4. If DCLS makes no determination within 90 calendar days of its receipt of either (i) the application or (ii) additional information, in the case of an application determined to be incomplete, the application shall be determined to be complete.

5. If the laboratory has not submitted the required additional information within 90 days of receiving a notice from DCLS requesting additional information, DCLS may inform the laboratory that the application cannot be processed. The laboratory may then submit a new application.

H. Grant of interim certification pending final determination on application.

1. DCLS shall grant a laboratory interim certification status under the following conditions:

a. The laboratory's application is determined to be complete;

b. The laboratory has satisfied all the requirements for certification, including all requests for additional information, with the exception of on-site assessment; and

c. DCLS is unable to schedule the on-site assessment within 120 days of its determination that the application is complete.

2. A laboratory with interim certification status shall have the same rights and status as a laboratory that has been granted certification by DCLS.

3. Interim certification expires when DCLS issues a final determination on certification.

I. On-site assessment. An on-site assessment shall be performed and the follow-up and reporting procedures for such assessments shall be completed in accordance with Article 2 (1VAC30-45-300 et seq.) of Part II of this chapter prior to issuance of a final determination on certification.

J. Final determination on certification. Upon completion of the certification review process and corrective action, if any, DCLS shall grant certification in accordance with subsection K of this section or deny certification in accordance with subsection L of this section.

K. Grant of certification.

1. When a laboratory meets the requirements specified for receiving certification, DCLS shall issue a certificate to the laboratory. DCLS shall send the certificate to the laboratory manager and shall notify the responsible official.

2. The director of DCLS or his designee shall sign the certificate. The certificate shall include the following information:

a. Name of owner of laboratory;

b. Name of operator of laboratory, if different from owner;

c. Name of responsible official;

d. Address and location of laboratory;

e. Laboratory identification number;

f. Fields of certification (matrix, technology/method, and analyte) for which certification is granted;

g. Any addenda or attachments; and

h. Issuance date and expiration date.

3. The laboratory shall post the most recent certificate of certification and any addenda to the certificate issued by DCLS in a prominent place in the laboratory facility.

4. Certification shall expire one year after the date on which certification is granted.

L. Denial of certification.

1. DCLS shall deny certification to an environmental laboratory in total if the laboratory is found to be falsifying any data or providing false information to support certification.

2. Denial of certification in total or in part.

a. DCLS may deny certification to an environmental laboratory in total or in part if the laboratory fails to do any of the following:

(1) Pay the required fees.

(2) Employ laboratory staff to meet the personnel qualifications as required by Part II (1VAC30-45-200 et seq.) of this chapter.

(3) Successfully analyze and report proficiency testing samples as required by Part II of this chapter.

(4) Submit a corrective action plan in accordance with Part II of this chapter in response to a deficiency report from the on-site assessment team within the required 30 calendar days.

(5) Implement the corrective actions detailed in the corrective action plan within the timeframe specified by DCLS.

(6) Pass required on-site assessment as specified in Part II of this chapter.

(7) Implement a quality system as defined in Part II of this chapter.

b. DCLS may deny certification to an environmental laboratory in total or in part if the laboratory's application is not determined to be complete within 90 calendar days following notification of incompleteness because the laboratory is delinquent in submitting information required by DCLS in accordance with this chapter.

c. DCLS may deny certification to an environmental laboratory in total or in part if the DCLS on-site assessment team is unable to carry out the on-site assessment pursuant to Article 2 (1VAC30-45-300 et seq.) of Part II of this chapter because a representative of the environmental laboratory denied the team entry during the laboratory's normal business hours that it specified in its application.

3. DCLS shall follow the process specified in 1VAC30-45-110 when denying certification to an environmental laboratory.

M. Reapplication following denial of certification. DCLS shall not waive application fees for a laboratory reapplying for certification.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-80 Maintaining certification

A. Certification remains in effect until withdrawn by DCLS, withdrawn voluntarily at the written request of the certified laboratory, or until expiration of the certification period. To maintain certification, the certified laboratory shall comply with the elements listed in this section and in 1VAC30-45-90.

B. Quality systems. Laboratories seeking to maintain certification under this chapter shall assure consistency and promote the use of quality assurance and quality control procedures. Article 4 (1VAC30-45-600 et seq.) of Part II of this chapter specifies the quality assurance and quality control requirements that shall be met to maintain certification.

C. Proficiency tests. Laboratories seeking to maintain certification under this chapter shall perform proficiency tests as required under Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter.

D. Recordkeeping and retention. All laboratory records associated with certification parameters shall be kept as provided by the requirements for records under Part II (1VAC30-45-200 et seq.) of this chapter. These records shall be maintained for a minimum of three years unless the records are required to be maintained for a longer period by another section of this regulation or another regulation. All such records shall be available to DCLS upon request.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-90 Notifications and changes to certification elements and status

A. Changes to key certification criteria. The certified laboratory shall notify DCLS in writing of any changes in key certification criteria within 30 calendar days of the change. Key certification criteria are laboratory ownership, location, key personnel, and major instrumentation.

B. Changes to scope of certification.

1. DCLS may approve a laboratory's application to add a new matrix, technology, analyte, or test method to a laboratory's scope of certification or to otherwise modify the laboratory's scope of certification by performing a data review.

2. To apply, the owner of the certified laboratory shall submit the following to DCLS:

a. A written request signed by the owner that briefly summarizes the addition to be made to the laboratory's scope of certification.

b. Pertinent information demonstrating the laboratory's capability to perform the additional matrix, technology/method, or analyte, such as proficiency testing performance and quality control performance.

c. A written standard operating procedure covering the new matrix, technology/method, or analyte.

3. DCLS may approve a laboratory's application for modification to its scope of certification by performing a review of the application materials submitted, without an on-site assessment. The addition of a technology or test method requiring the use of specific equipment may require an on-site assessment. Other reviews of performance and documentation may be carried out by DCLS depending on the modification for which the laboratory applies.

4. Within 90 calendar days of the receipt of the application from the certified environmental laboratory, DCLS shall review and determine whether the proposed modification may be approved.

5. If the proposed modification to the laboratory's scope of certification is approved, DCLS shall amend the laboratory's certificate of certification.

6. DCLS shall not send the amended certificate of certification to the laboratory until DCLS receives the payment of the fee required under 1VAC30-45-130 F 1.

C. Change of ownership or location of laboratory.

1. The certified laboratory shall submit a written notification to DCLS of the change of ownership or location of the laboratory within 30 calendar days of the change. This requirement pertaining to change of location does not apply to mobile laboratories.

2. Certification may be transferred when the legal status or ownership of a certified laboratory changes as long as the transfer does not affect the laboratory's personnel, equipment, or organization.

3. If the laboratory's personnel, equipment, or organization are affected by the change of legal status or ownership, DCLS may require recertification or reapplication in any or all of the categories for which the laboratory is certified.

4. DCLS may require an on-site assessment depending on the nature of the change of legal status or ownership. DCLS shall determine the elements of any on-site assessment required.

5. When there is a change in ownership, the new owner of the certified laboratory shall keep all records and analyses performed by the previous owner pertaining to certification for a period of three years, or longer if required by other regulations. These records and analyses are subject to inspection by DCLS during this three-year period. This provision applies regardless of change of ownership, accountability or liability.

D. Voluntary withdrawal. Any environmental laboratory owner who wishes to withdraw the laboratory from its certification status or from being certified, in total or in part, shall submit written notification to DCLS. DCLS shall provide the laboratory with a written notice of withdrawal.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-95 Suspension of certification

A. DCLS may suspend certification from an environmental laboratory in total or in part to allow the laboratory time to correct the reason for which DCLS may withdraw certification. Suspension is limited to the reasons listed in subsection B of this section.

B. DCLS may suspend certification from an environmental laboratory in part or in total when the laboratory has failed to do any of the following:

1. Participate in the proficiency testing program as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter.

2. Satisfactorily complete proficiency testing studies as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter.

3. Submit an acceptable corrective action plan after two opportunities as specified in 1VAC30-45-390.

4. Maintain a quality system as defined in Article 4 (1VAC30-45-600 et seq.) of Part II of this chapter.

5. Employ staff that meets the personnel qualifications of Article 1 (1VAC30-45-200 et seq.) of Part II of this chapter.

6. Notify DCLS of any changes in key certification criteria as set forth in 1VAC30-45-90.

C. Process to suspend certification.

1. When DCLS becomes aware of a cause to suspend a laboratory, the agency shall send notification to the responsible official and the laboratory manager stating it appears to DCLS that the laboratory has failed to meet the 1VAC30-45 standards for one or more of the reasons listed in subsection B of this section. DCLS shall send the notification by certified mail.

2. The DCLS notification shall do the following:

a. Require the laboratory to provide DCLS with documentation of the corrective action already taken with regard to its failure to meet a standard under subsection B of this section.

b. State the corrective action the laboratory must take and the time allowed for this corrective action to be completed in order to retain certification.

3. The environmental laboratory may proceed to correct the deficiencies for which DCLS may suspend the laboratory's certification.

4. Alternatively the laboratory may state in writing that DCLS is incorrect in its observations regarding potential suspension and give specific reasons why the laboratory believes DCLS should not suspend certification. The laboratory has the right to due process as set forth in 1VAC30-45-110, the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia), and Part 2A of the Rules of the Supreme Court of Virginia.

5. With the exception of subdivision B 4 of this section, DCLS may allow the laboratory up to 60 days to correct the problem for which it may have its certification suspended.

6. DCLS shall set a date for suspension that follows the period provided under subdivision 5 of this subsection to restore certification.

7. If the laboratory does not correct its deficiencies within the time period allowed or pursue options under subdivision 4 of this subsection, DCLS may suspend a laboratory in part or in total.

8. DCLS shall notify the laboratory by letter if the laboratory's certification is suspended in part or in total. DCLS shall send the notification by certified mail. DCLS shall also notify the pertinent Virginia state agency of the laboratory's suspension status.

9. The laboratory may provide information demonstrating why suspension is not warranted in accordance with subdivision 4 of this subsection.

D. Responsibilities of the environmental laboratory and DCLS when certification has been suspended.

1. The term of suspension shall be limited to six months or the period of certification whichever is longer.

2. The environmental laboratory shall not continue to analyze samples or report analysis for the fields of certification for which DCLS has suspended certification.

3. The environmental laboratory shall retain certification for the fields of certification, methods, and analytes where it continues to meet the requirements of this chapter.

4. The laboratory's suspended certification status shall change to certified when the laboratory demonstrates to DCLS that the laboratory has corrected the deficiency or deficiencies for which its certification was suspended.

5. An environmental laboratory with suspended certification shall not have to reapply for certification if the cause or causes for suspension are corrected within the term of suspension.

6. An environmental laboratory that DCLS has suspended in total shall pay the cost of any necessary follow-up on-site assessments or data review or both to determine compliance. This cost shall be calculated under the provisions of 1VAC30-45-130 F and G.

7. If the laboratory fails to correct the causes of suspension within the term of suspension, DCLS shall decertify the laboratory in total or in part.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 22, eff. September 1, 2016; amended, Virginia Register Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-45-100 Decertification

A. DCLS shall decertify an environmental laboratory in total if the laboratory is found to be falsifying any data or providing false information to support certification.

B. DCLS may decertify an environmental laboratory in part or in total when the laboratory has failed to do any of the following:

1. Participate in the proficiency testing program as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter.

2. Satisfactorily complete proficiency testing studies as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter.

3. Maintain a quality system as defined in Article 4 (1VAC30-45-600 et seq.) of Part II of this chapter.

4. Employ staff that meets the personnel qualifications in Article 1 (1VAC30-45-200 et seq.) of Part II of this chapter.

5. Submit an acceptable corrective action plan after two opportunities as specified in 1VAC30-45-390.

6. Implement corrective action specified in the laboratory's corrective action plan as set out under 1VAC30-45-390.

7. Correct the causes of suspension within the term of suspension.

8. Notify DCLS of any changes in key certification criteria as set forth in 1VAC30-45-90.

9. Use accurate references to the laboratory's certification status in the laboratory's documentation.

10. Allow a DCLS assessment team entry during normal business hours to conduct an on-site assessment required by Article 2 (1VAC30-45-300 et seq.) of Part II of this chapter.

11. Pay the required fees specified in 1VAC30-45-130.

12. Meet the provisions regarding communication with others in 1VAC30-45-510 C.

C. DCLS may decertify an environmental laboratory in part or in total when the laboratory has failed three consecutive proficiency testing studies for the same field of certification either by failure to participate in the proficiency testing study or by failure to obtain acceptable results.

D. DCLS shall follow the process specified in 1VAC30-45-110 when decertifying an environmental laboratory.

E. Responsibilities of the environmental laboratory and DCLS when certification has been withdrawn.

1. Laboratories that lose their certification in full shall return their certificate to DCLS.

2. If a laboratory loses certification in part, DCLS shall issue a revised certificate to the laboratory.

3. When the environmental laboratory has lost certification in full or in part, the laboratory shall not continue to analyze samples or report analyses for the fields of certification that DCLS has decertified.

F. After correcting the reason or cause for decertification under subsection A or B of this section, the laboratory owner may reapply for certification under 1VAC30-45-70.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016; Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-45-110 Procedures to deny certification or decertify a laboratory; appeal procedures

A. Notification.

1. If DCLS becomes aware of a cause to deny certification or to decertify an environmental laboratory, DCLS shall notify the environmental laboratory in writing of this information and require a response from the responsible official. DCLS shall send this notification by certified mail to the responsible official and provide a copy to the manager of the environmental laboratory.

2. For a potential denial of certification, the notice shall state that the laboratory has failed to meet the 1VAC30-45 standards and shall specify one or more of the reasons for denial of certification under 1VAC30-45-70 L, providing a detailed explanation of the basis for the denial of certification.

3. For a potential decertification, the notice shall state that the laboratory has failed to meet the 1VAC30-45 standards and shall specify one or more of the reasons for decertification under 1VAC30-45-100 A or B, providing a detailed explanation of the basis for decertification.

4. In its notice, DCLS shall request the laboratory to notify DCLS in writing if the laboratory believes the agency is incorrect in its determination. Before rendering a decision on decertification or denial of certification, DCLS shall provide the opportunity for the laboratory to meet with DCLS in an informal fact-finding proceeding pursuant to § 2.2-4019 of the Code of Virginia.

5. If the laboratory believes DCLS to be incorrect in its determination, the laboratory shall provide DCLS with a detailed written demonstration of why DCLS should not deny certification to or decertify the laboratory. The laboratory shall include this demonstration in the response required under subdivision 6 of this subsection.

6. The laboratory shall provide DCLS with a written response within 30 calendar days of the date of notification from DCLS. The laboratory shall indicate whether it disputes the DCLS determination provided in the agency notice and whether the laboratory requests an informal fact-finding proceeding. If the laboratory does not respond, DCLS shall render its case decision.

B. An environmental laboratory may appeal a final decision by DCLS to deny certification to or decertify a laboratory pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

C. The certification status of an environmental laboratory appealing decertification shall not change pending the final decision of the appeals filed under the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) and Part 2A of the Rules of Supreme Court of Virginia.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-120 Exemptions

A. DCLS may grant a partial or full exemption from the requirements of this chapter based on compliance and performance.

B. DCLS may consider granting an exemption if a laboratory applies for an exemption and has met all certification requirements for a period of four consecutive years.

C. An environmental laboratory may apply for an exemption by submitting a request. The request shall include the following information:

1. The scope of the requested exemption;

2. Whether the exemption should be partial or total;

3. If partial, what form the exemption will take; and

4. Why the exemption is appropriate.

D. Upon receiving an application for an exemption, DCLS shall provide notice of the request for an exemption in the Virginia Register of Regulations.

E. The notice shall provide a 30-day comment period on the request and shall specify the nature of the request.

F. DCLS shall grant or deny the exemption request and provide a written response to the requesting laboratory within 90 calendar days of receipt of the request.

G. Exemptions granted by DCLS shall be for a period of no more than 24 months.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-130 Fees

A. General.

1. Environmental laboratories shall pay a fee with all applications, including reapplications, for certification. DCLS shall not designate an application as complete until it receives payment of the fee.

2. Each certified environmental laboratory shall pay an annual fee to maintain its certification. DCLS shall send an invoice to the certified environmental laboratory.

3. Fees shall be nonrefundable.

4. DCLS, as part of its regular budgetary review of the program, shall determine whether the fees charged under this section offset the program costs as required under § 2.2-1105 of the Code of Virginia.

B. Environmental laboratories performing only simple test procedures shall pay an annual fee of $690.

C. Fee computation for general environmental laboratories.

1. Fees shall be applied on an annual basis.

2. Environmental laboratories shall pay the total of the base fee and the test category fees set out in subsections D and E of this section.

D. Base fees for general environmental laboratories.

1. DCLS determines the base fee for a laboratory by taking into account both the total number of methods and the total number of field of certification matrices for which the laboratory would be certified.

2. DCLS shall charge the base fees set out in Table 1. The base fee for a laboratory is located by first finding the row for the total number of methods to be certified and then finding the box on that row located in the column headed by the total number of matrices to be certified. For example, DCLS charges a base fee of $1495 to a laboratory performing a total of eight methods for one matrix.

| | TABLE 1: BASE FEES | | | | --- | --- | --- | --- | | | Number of Methods | 1 Matrix | 2 Matrices | | | 1 - 9 | $1495 | $1645 | | | 10 - 29 | $1610 | $1811 | | | 30 - 99 | $1783 | $2099 |

E. Test category fees for general environmental laboratories.

1. The test category fees cover the types of testing for which a laboratory may be certified as specified in the laboratory's application or as certified at the time of annual billing.

2. Fees shall be charged for each category of tests to be certified.

3. Fees shall be charged for the total number of field of certification matrices to be certified under the specific test category. For example, if a laboratory is performing inorganic chemistry for both nonpotable water and solid and chemical materials matrices, the fee for this test category would be found in the column for two matrices.

4. The fee for each category includes one or more analytical methods unless otherwise specified.

5. DCLS shall charge the test category fees set out in Table 2. The test category fees for a laboratory are located by first finding the row with the total number of test methods for the test category to be certified. The fee to be charged for the test category will be found on that row in the column headed by the total number of matrices to be certified. A laboratory performing four test methods for inorganic chemistry in nonpotable water and solid and chemical materials (two matrices) would be charged a test category fee of $431.

6. Noncommercial environmental laboratories that perform toxicity, radiochemical, or asbestos testing shall pay the test category fees established for these types of testing in 1VAC30-46-150.

| | TABLE 2: TEST CATEGORY FEES | | | | --- | --- | --- | --- | | | Test Category | Fees by Number of Matrices | | | | | One | Two | | | Oxygen demand | $259 | $385 | | | Bacteriology, 1 - 3 total methods | $201 | $305 | | | Bacteriology, 4 or more total methods | $253 | $380 | | | Physical, 1 - 5 total methods | $201 | $305 | | | Physical, 6 - 10 total methods | $253 | $380 | | | Inorganic chemistry, 1 - 10 total methods | $288 | $431 | | | Inorganic chemistry, 11 - 20 total methods | $362 | $546 | | | Inorganic chemistry, 21 - 49 total methods | $453 | $679 | | | Chemistry metals, 1 - 5 total methods | $374 | $564 | | | Chemistry metals, 6 - 20 total methods | $472 | $707 | | | Organic chemistry, 1 - 5 total methods | $460 | $690 | | | Organic chemistry, 6 - 20 total methods | $575 | $863 |

7. Fee examples. Three examples are provided.

a. Example 1:

| | Base Fee | One matrix and four test methods | $1495 | | --- | --- | --- | --- | | | Test Category Fees | | | | | One Matrix | | | | | Nonpotable Water | Bacteriology (2 methods) | $201 | | | Nonpotable Water | Oxygen demand (1 method) | $259 | | | Nonpotable Water | Physical (1) | $201 | | | TOTAL | | $2156 |

b. Example 2:

| | Base Fee | One matrix and 15 test methods | $1610 | | --- | --- | --- | --- | | | Test Category Fees | | | | | One Matrix | | | | | Nonpotable Water | Bacteriology (2 methods) | $201 | | | Nonpotable Water | Inorganic chemistry (9 methods) | $288 | | | Nonpotable Water | Chemistry metals (2 methods) | $374 | | | Nonpotable Water | Oxygen demand (1 method) | $259 | | | Nonpotable Water | Physical (1) | $201 | | | TOTAL | | $2933 |

c. Example 3:

| | Base Fee | Two matrices and 27 test methods | $1811 | | --- | --- | --- | --- | | | Test Category Fees | | | | | One Matrix | | | | | Nonpotable Water | Bacteriology (4 methods) | $253 | | | Nonpotable Water | Oxygen demand (1 method) | $259 | | | Solid and Chemical Materials | Chemistry metals (1 method) | $374 | | | Two Matrices | | | | | Nonpotable Water and Solid and Chemical Materials | Inorganic chemistry (13 methods) | $546 | | | Nonpotable Water and Solid and Chemical Materials | Physical (7 methods) | $380 | | | TOTAL | | $3623 |

F. Additional fees. Additional fees shall be charged to laboratories applying for the following: (i) modification to scope of certification under 1VAC30-45-90 B, (ii) transfer of ownership under 1VAC30-45-90 C, (iii) review of compliance following total suspension, (iv) exemption under 1VAC30-45-120, or (v) petition for a variance under 1VAC30-45-140.

1. For any certified environmental laboratory that applies to modify its scope of certification as specified under 1VAC30-45-90 B, DCLS shall assess a fee determined by the method in subsection G of this section.

2. Under 1VAC30-45-90 C, DCLS may charge a transfer fee to a certified laboratory that transfers ownership. A fee shall be charged if DCLS (i) needs to review documentation sent by the laboratory about the transfer of ownership or (ii) determines that an on-site assessment is necessary to evaluate the effect of the transfer of ownership. DCLS shall assess a fee determined by the method in subsection G of this section. If, under 1VAC30-45-90 C, DCLS determines that the change of ownership or location of laboratory requires recertification of or reapplication by the laboratory, the laboratory shall pay the application fees required under this section.

3. Under 1VAC30-45-95 D 6, an environmental laboratory that DCLS has suspended in total shall be charged the cost of any necessary follow-up on-site assessments or data review or both to determine compliance. This charge shall be calculated under the method specified in subsection G of this section.

4. General environmental laboratories applying for an exemption under 1VAC30-45-120 shall pay an initial application fee of $700 plus an additional fee based on the actual time needed for DCLS to assess the exemption request. The total fee shall not exceed the actual time DCLS takes to assess the exemption request. Laboratories performing only simple test procedures applying for an exemption under 1VAC30-45-120 shall pay an initial application fee of $300 plus an additional fee based on the actual time needed for DCLS to assess the exemption request. The total fee shall not exceed the actual time DCLS takes to assess the exemption request. The fee assessed shall be calculated using the method in subsection G of this section.

5. Under 1VAC30-45-140, any person regulated by this chapter may petition the director to grant a variance from any requirement of this chapter. DCLS shall charge an initial fee of $700 plus an additional fee based on the actual time needed for DCLS to review the petition, including any on-site assessment required. The total fee shall not exceed the actual time DCLS takes to review and make a determination on the request for a variance. The fee shall be determined by the method specified in subsection G of this section.

G. Fee determination.

1. The fee shall be the sum of the total hourly charges for all reviewers plus any on-site review costs incurred.

2. An hourly charge per reviewer shall be determined by (i) obtaining a yearly cost by multiplying the reviewer's annual salary by 1.35 (accounts for overhead such as taxes and insurance) and then (ii) dividing the yearly cost by 1,642 (number of annual hours established by Fiscal Services, the Department of General Services, for billing purposes).

3. The charge per reviewer shall be determined by multiplying the number of hours expended in the review by the reviewer's hourly charge.

4. If an on-site review is required, travel time and on-site review time shall be charged at the same hourly charge per reviewer, and any travel expenses shall be added.

H. Out-of-state laboratories - travel costs. The owner of an environmental laboratory located in another state who applies for certification under this chapter shall also pay a fee equal to the reasonable travel costs associated with conducting an on-site assessment at the laboratory. Reasonable travel costs include transportation, lodging, per diem, and telephone and duplication charges.

I. DCLS shall derive the travel costs charged under subsections G and H of this section from the Commonwealth of Virginia reimbursement allowances and rates for lodging, per diem, and mileage.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016; Volume 36, Issue 2, eff. September 1, 2019; Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-45-140 Petitioning for a variance

A. Any person regulated by this chapter may petition the director to grant a variance from any requirement of this chapter. Any person submitting a petition to the director shall meet the provisions of this section. Any petition submitted to the director is subject to the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

B. The petition shall be submitted to the director by certified mail and shall include:

1. The petitioner's name and address;

2. A statement of the petitioner's interest in the proposed action;

3. A description of desired action and a citation of the regulation from which a variance is requested;

4. A description of need and justification for the proposed action, including impact of the proposed action on the laboratory's operation;

5. Information demonstrating that the requested variance will meet the purposes and objectives of the relevant regulatory provision and of § 2.2-1105 of the Code of Virginia (Environmental Laboratory Certification Program);

6. The duration of the variance, if applicable;

7. The potential impact of the variance on public health or the environment;

8. Other information believed by the applicant to be pertinent; and

9. The following statement signed by the petitioner or authorized representative: "I certify that I have personally examined and am familiar with the information submitted in this petition and all attached documents, and that, based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment."

C. Petition processing.

1. After receiving a petition that includes the information required in subsection B of this section, the director will determine whether the information received is sufficient to render the decision. If the information is deemed insufficient, the director will specify additional information needed and request that it be furnished.

2. The petitioner may submit the additional information requested, or may attempt to show that no reasonable basis exists for additional information. If the director agrees that no reasonable basis exists for the request for additional information, he will act in accordance with subsection D of this section. If the director finds that a reasonable basis exists to require the submission of such information, he will proceed with the denial action in accordance with the Administrative Process Act.

D. Public review of tentative decision. The director will evaluate the application and issue a draft notice tentatively denying the petition, granting the variance as requested, or granting a modified or partial variance. Notification of this tentative decision will be published in the Virginia Register of Regulations. The director will accept comment on the tentative decision for 30 days, and shall hold a public hearing if a request is received or at his discretion if there is no request. The director will issue a final decision after receipt of comments and after the hearing (if any).

E. Conditions for granting variance request or a modified variance.

1. The director may grant the variance if the applicant demonstrates to the satisfaction of the director that:

a. The proposed variance will meet the goals and purposes of the provisions from which a variance is sought; and

b. The variance does not conflict with federal or state law or regulations.

2. If the director grants a variance request, the notice to the petitioner shall provide that the variance may be terminated upon a finding by the director that the petitioner has failed to comply with any requirements of the variance.

3. When a modified variance is granted, the director may:

a. Specify the termination date of the variance;

b. Include a schedule for:

(1) Compliance, including increments of progress, by the laboratory with each requirement of the variance; and

(2) Implementation by the laboratory of such measures as the director finds necessary in order that the variance may be granted.

F. Decisions to grant or deny a petition in whole or in part, or to modify or terminate a variance are subject to the provisions of Article 3 (§ 2.2-4018 et seq.) of the Virginia Administrative Process Act.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-150 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-160 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-170 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-180 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-190 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

Article 1 Personnel

1VAC30-45-200 Laboratory manager

A. Laboratory manager - general.

1. Each environmental laboratory shall designate a person to be responsible for the general oversight of the operation of the laboratory in accordance with this chapter, including the day-to-day functioning and administration of the laboratory, the technical operations, supervision of laboratory procedures, reporting of laboratory results, and implementation of any corrective actions.

2. The title of this person may include but is not limited to laboratory director, technical director, laboratory supervisor or laboratory manager.

3. A laboratory may appoint one or more technical directors for the appropriate fields of certification for which the laboratory seeks certification.

B. Laboratory manager - qualifications.

1. For an environmental laboratory that performs procedures beyond simple test procedures, a laboratory manager shall have two years of experience managing an environmental laboratory or performing the analyses for which the environmental laboratory seeks certification or both.

2. For an environmental laboratory that performs only simple test procedures, there are no qualification requirements for a laboratory manager except that the responsible official shall designate the laboratory manager.

3. A full-time employee of a drinking water or wastewater treatment facility who holds a valid treatment plant operator's certificate appropriate to the nature and size of such facility shall be deemed to meet the educational and experience requirements serving as the laboratory manager of the certified laboratory devoted exclusively to the examination of environmental samples taken within such facility system and limited to the scope of that facility's regulatory permit.

4. A full-time employee of an industrial waste treatment facility with a minimum of one year of experience under supervision in environmental analysis shall be deemed to meet the requirements for serving as the laboratory manager of a certified laboratory devoted exclusively to the examination of environmental samples taken within such facility for the scope of that facility's regulatory permit.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-210 Quality assurance officer

A. The laboratory shall have a quality assurance officer who shall be responsible for the quality system and its implementation. Where staffing is limited, the quality assurance officer may also be the laboratory manager. The quality assurance officer may be employed on a part-time basis or be a consultant.

B. The quality assurance officer shall have documented training or experience in quality assurance and quality control procedures and be knowledgeable in the quality system as defined in Article 4 (1VAC30-45-600 et seq.) of Part II of this chapter. The quality assurance officer shall have a general knowledge of the analytical test methods for which data review is performed.

C. The responsibilities of the quality assurance officer shall include, but not be limited to, the implementation and oversight of the quality system, the implementation of new quality assurance and control practices, periodic audits of the quality system in place, periodic review of final data reports, and documentation of laboratory quality system deficiencies.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-220 Laboratory personnel requirements and management responsibilities

A. The laboratory shall have sufficient personnel, having the necessary education, training, technical knowledge and experience for their assigned functions.

B. The laboratory manager shall ensure that the training of the laboratory personnel is kept up to date.

C. Laboratory personnel shall be responsible for complying with all quality systems requirements set out in Article 4 (1VAC30-45-600 et seq.) of Part II of this chapter that are pertinent to their assigned functions.

D. The laboratory manager shall ensure that laboratory personnel have demonstrated initial and ongoing capability to perform their assigned functions. See 1VAC30-45-730 E and F.

E. Records on the relevant qualifications, training skills and experience of the laboratory personnel, including records on demonstrated proficiency for each test method, shall be maintained by the laboratory manager.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-230 Absence of laboratory manager

When a laboratory manager will be absent for a period exceeding 15 consecutive calendar days, the laboratory shall designate a qualified replacement to perform the manager's function.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-240 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-250 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-260 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-270 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-280 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-290 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

Article 2 On-Site Assessment

1VAC30-45-300 Frequency of on-site assessment

A. Frequency.

1. A comprehensive on-site assessment shall be conducted of each laboratory as a condition for granting certification initially.

2. DCLS shall reassess each certified laboratory at least once every three years starting from the date of the previous assessment plus or minus six months.

3. DCLS may conduct an on-site assessment of a laboratory every two years plus or minus six months under any of the following circumstances:

a. When a laboratory has received "not acceptable" PT results.

b. When a laboratory's corrective action presented to VELAP for "not acceptable" PT studies does not identify and correct the root cause of the PT study failure.

c. When DCLS has suspended certification for a laboratory in full or in part.

d. When on-site observations include nonconformances previously identified at an on-site assessment, indicating the corrective action was not implemented or not maintained.

e. When on-site observations include failure to qualify nonconforming data to the data user.

f. When on-site observations indicate the laboratory's failure to monitor and maintain regulatory conformance in documentation, traceability, or quality control requirements such that data generated by the laboratory are of questionable quality or defensibility.

B. Other on-site assessments.

1. If DCLS identified a deficiency on a previous on-site assessment, the agency may conduct a follow-up on-site assessment.

2. DCLS may conduct an on-site assessment when a laboratory applies to modify its scope of certification; when a transfer of owner occurs that affects personnel, equipment, or the laboratory facilities; or when a laboratory applies for an exemption or a variance. Any other change occurring in a laboratory's operations that might reasonably be expected to alter or impair analytical capability and quality may trigger an on-site assessment.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-310 Announced and unannounced on-site assessments

A. DCLS may conduct, at its discretion, either announced or unannounced on-site assessments.

B. Advance notice of an assessment shall not be necessary.

C. To the maximum extent practical, DCLS, when necessary, shall work with the owner of an environmental laboratory to obtain government security clearances for assessment personnel as far in advance as possible. The owner of the environmental laboratory shall facilitate expeditious attainment of the necessary clearances.

D. To the maximum extent practical, assessment personnel shall minimize disruption of a laboratory's operations and take into account competing demands on the time of laboratory personnel.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-320 Request for records

Prior to the actual site visit, DCLS may request in writing from a laboratory those records required to be maintained by this chapter.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-330 Areas to be assessed

DCLS shall assess the laboratory against the personnel and quality control standards in Article 1 (1VAC30-45-200 et seq.) and Article 4 (1VAC30-45-600 et seq.) of this part. The specific areas evaluated in an on-site assessment shall include but not be limited to:

1. Adequacy of the laboratory facility.

2. Organization and management of the laboratory.

3. Qualifications and experience of laboratory personnel.

4. Receipt, tracking and handling of samples.

5. Quantity, condition, and performance of laboratory instrumentation and equipment.

6. Preparation and traceability of calibration standards.

7. Test methods (including the adequacy of the laboratory's standard operating procedures as well as confirmation of the analyst's adherence to SOPs, and the analyst's proficiency with the described task).

8. Data reduction procedures, including an examination of raw data and confirmation that final reported results can be traced to the raw data/original observations.

9. Quality assurance and quality control procedures, including adherence to the laboratory's quality assurance plan and adequacy of the plan.

10. Recordkeeping.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-340 National security considerations

A. Assessments at facilities owned or operated by federal agencies or contractors may require security clearances, appropriate badging, or a security briefing before the assessment begins.

B. The laboratory shall notify DCLS in writing of any information that is controlled for national security reasons and cannot be released to the public.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-350 Arrival, admittance, and opening conference

A. Arrival. Assessment personnel shall arrive at the laboratory during established working hours. The laboratory manager (or, if unavailable, the laboratory manager's designee) shall be located as soon as possible after the assessment personnel arrive on the premises.

B. Admittance of assessment personnel.

1. A laboratory's refusal to admit the assessment personnel for an on-site assessment shall result in an automatic failure of the laboratory to receive certification or loss of an existing certification by the laboratory, unless there are extenuating circumstances that are accepted and documented by DCLS. The team leader for the assessment personnel shall notify DCLS as soon as possible after refusal of entry.

2. DCLS shall consider any verbal or physical threat to the health and safety of its assessors or any overt antagonism towards its assessors as a refusal to admit the assessors for the purpose of on-site assessment. The assessors shall vacate the laboratory and shall notify DCLS as soon as possible of the circumstances of this refusal to admit. This refusal to admit shall result in an automatic failure of the laboratory to receive certification or the automatic loss of an existing certification by the laboratory.

C. Health and safety.

1. Under no circumstance, and especially as a precondition to gain access to a laboratory, shall assessment personnel be required or even allowed to sign any waiver of responsibility on the part of the laboratory for injuries incurred during an assessment.

2. Assessment personnel shall comply with all facility and laboratory safety procedures.

D. Opening conference. An opening conference shall be conducted and shall address the following topics:

1. The purpose of the assessment;

2. The identification of assessment personnel;

3. The test methods that will be examined;

4. Any pertinent records and procedures to be examined during the assessment and the names of the individuals in the laboratory responsible for providing assessment personnel with such records;

5. The roles and responsibilities of laboratory staff and managers;

6. Any special safety procedures that the laboratory may think necessary for the protection of assessment personnel;

7. The standards and criteria that will be used in judging the adequacy of the laboratory operation;

8. Confirmation of the tentative time for the exit conference; and

9. Discussion of any questions the laboratory may have about the assessment process.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-360 On-site laboratory records review and collection

A. Records shall be reviewed by assessment personnel for accuracy, completeness and the use of proper methodology for each analyte and test method to be evaluated.

B. Records required to be maintained pursuant to this chapter shall be examined as part of an assessment for certification.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-370 Observations of and interviews with laboratory personnel

A. As an element of the assessment process, the assessment team shall evaluate an analysis regimen by requesting that the analyst normally conducting the procedure give a step-by-step description of exactly what is done and what equipment and supplies are needed to complete the regimen. Any deficiencies shall be noted and discussed with the analyst. In addition, the deficiencies shall be discussed in the closing conference.

B. Assessment personnel may conduct interviews with appropriate laboratory personnel.

C. Calculations, data transfers, calibration procedures, quality control and quality assurance practices, adherence to test methods, and report preparation shall be assessed for the complete scope of certification with appropriate laboratory analysts.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-380 Closing conference

A. Assessment personnel shall meet with representatives of the laboratory following the assessment for a closing conference.

B. During the closing conference, assessment personnel shall inform the laboratory of the preliminary findings and the basis for such findings. The laboratory shall have an opportunity to provide further explanation or clarification relevant to the preliminary findings. If the laboratory objects to the preliminary findings during the closing conference, all objections shall be documented by the assessment personnel and included in the final report to DCLS.

C. Additional problem areas may be identified in the final report.

D. Any potentially illegal activity that may be the subject of further action shall not be discussed in the closing conference.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-390 Follow-up and reporting procedures.

A. DCLS shall present an assessment report to the laboratory within 30 calendar days of the assessment.

B. If there are deficiencies identified in the assessment report, the laboratory shall have 30 calendar days from the date of its receipt of the assessment report to provide a response to DCLS. This response shall be called a corrective action plan.

C. An exception to the deadlines specified in subsections A and B of this section may occur in appropriate circumstances. Two circumstances that may be considered appropriate by DCLS are where a possible enforcement investigation or other action has been initiated or where the laboratory shows good cause for an extension.

D. The corrective action plan shall include the following:

1. Any objections that the laboratory has with regard to the assessment report;

2. The action that the laboratory proposes to implement to correct each deficiency identified in the assessment report; and

3. The time period required to accomplish the corrective action.

E. DCLS shall determine and shall notify the laboratory within 30 calendar days of receipt whether the corrective action plan is an acceptable response to the deficiencies identified in the assessment report.

F. If the corrective action plan (or a portion of the plan) is determined to be unacceptable to remedy the deficiency, DCLS shall provide written notification to the responsible official and manager of the laboratory including a detailed explanation of the basis for such determination. Following receipt of such notification, the laboratory shall have an additional 30 calendar days to submit a revised corrective action plan acceptable to DCLS.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-400 Documentation of on-site assessment

A. Checklists. The checklists used by assessment personnel during the assessment shall become a part of DCLS's file for the laboratory.

B. Assessment report format.

1. The final assessment report shall contain a narrative description of the adequacy of the laboratory as it relates to the assessment standards specified in this chapter and in 1VAC30-45-330.

2. Assessment reports shall contain:

a. Name of owner of the laboratory (or operator of the laboratory, if different from the owner);

b. Identification of the laboratory assessed;

c. Date of the assessment;

d. Identification and affiliation of all assessment personnel;

e. Identification of participants in the assessment process;

f. Identification of analytes and test methods assessed;

g. Statement of the objective of the assessment;

h. Summary;

i. Assessment observations, findings (including any deficiencies), objections noted by the laboratory, and requirements; and

j. Comments and recommendations.

3. The assessment findings and requirements shall be referenced to the standards in Part II (1VAC30-45-200 et seq.) of this chapter so that both the finding is understood and the specific requirement is outlined. The assessor shall specify the laboratory records, documents, equipment, procedures, or staff evaluated and the observations that contributed to each identified deficiency. The assessment report shall support with sufficient data all assessment findings and the overall evaluation of the laboratory.

4. The comments and recommendations section may be used to convey recommendations aimed at helping the laboratory improve.

C. Release of report.

1. The assessment report shall be released initially by DCLS to the responsible official and the laboratory manager. The assessment report shall not be released to the public until findings of the assessment and the corrective actions have been finalized, all information relating to national security has been stricken from the report in accordance with prescribed procedures, and the report has been provided to the laboratory.

2. Once the assessment report has been released to the laboratory, any member of the public may request a copy of the report under the requirements of the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia).

3. Checklists used by assessment personnel during the on-site assessment shall be provided to the laboratory with the final on-site assessment report upon request.

D. The laboratory shall have access to documentation pertaining to any on-site assessment of its facilities. Any laboratory wishing to review its files shall request such assistance of DCLS five days prior to visiting DCLS. A laboratory may request copies of its documents without visiting DCLS. A reasonable fee may be charged for copying, mailing, and staff time.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-410 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-420 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-430 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-440 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-450 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-460 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-470 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-480 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-490 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

Article 3 Proficiency Testing

1VAC30-45-500 Laboratory enrollment in proficiency testing program

A. Required level of participation.

1. To be certified initially and to maintain certification, a laboratory shall participate in PT studies as specified in 1VAC30-45-520 B for the fields of certification (FoC) for which the laboratory seeks or wants to maintain certification.

2. The applicant laboratory shall obtain PT samples from a PT provider approved by TNI. If a PT sample is not available from a TNI-approved provider, the laboratory shall consult DCLS for an approved provider.

B. Requesting certification.

1. When applying for certification, the laboratory owner shall notify DCLS of the fields of certification for which the laboratory chooses to become certified and shall participate in the appropriate PT studies.

2. For all fields of certification for which PT samples are not available, the laboratory shall ensure the reliability of its testing procedures by maintaining a quality system that meets all applicable requirements of Article 4 (1VAC30-45-600 et seq.) of Part II of this chapter.

C. Reporting results. Each laboratory shall authorize the PT study provider to release the results of the final evaluation report of the laboratory's PT study directly to DCLS, in addition to the laboratory.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-510 Requirements for laboratory testing of PT study samples

A. The laboratory shall report the analytical results from its analysis of the PT study to the PT provider on or before the closing date of the study using the reporting format specified by the PT provider.

B. The laboratory's management and all analysts shall ensure that all PT samples are managed, analyzed, and reported in the same manner as real environmental samples utilizing the same staff, methods as used for routine analysis of that analyte, procedures, equipment, and facilities. When analyzing a PT sample, the laboratory shall employ the same calibration, laboratory quality control and acceptance criteria, sequence of analytical steps, number of replicates and other procedures as used when analyzing routine samples.

C. Restrictions on exchanging information. Laboratories shall comply with all of the following restrictions on the transfer of PT samples and communication of PT sample results prior to the time the results of the study are released. Laboratory management or staff shall not:

1. Send any PT sample, or a portion of a PT sample, to another laboratory for any analysis for which it seeks certification or is certified.

2. Knowingly receive any PT sample or portion of a PT sample from another laboratory for any analysis for which the sending laboratory seeks certification or is certified.

3. Communicate with any individual at another laboratory (including intra-company communication) concerning the PT sample.

4. Attempt to obtain the assigned value of any PT sample from their PT provider.

D. Maintenance of records. The laboratory shall maintain copies of all written, printed, and electronic records, including but not limited to bench sheets, instrument strip charts or printouts, data calculations, and data reports, resulting from the analysis of any PT sample for three years or for as long as is required by the applicable regulatory program. These records shall include a copy of the PT study report forms used by the laboratory to record PT results. All of these laboratory records shall be made available to the DCLS assessors during on-site assessments of the laboratory.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-520 PT criteria for laboratory certification

A. Result categories.

1. The criteria described in this section apply individually to each FoPT, as defined by the laboratory seeking to obtain or maintain certification in its certification request. These criteria apply only to the PT portion of the overall certification standard.

2. There are two PT result categories: "acceptable" and "not acceptable."

B. Initial and continuing certification.

1. A laboratory seeking to obtain or maintain certification shall successfully complete one PT study for each requested FoC.

2. Once a laboratory has been granted certification status, it shall continue to complete PT studies for each FoPT and maintain a history of at least one acceptable PT study each calendar year. The laboratory shall complete its PT studies by September 30 of each calendar year.

3. When the PT sample used for initial certification was analyzed by the laboratory prior to the date of application, the analysis date of the PT sample shall be no more than 12 months prior to the application date of certification.

4. For a laboratory performing supplemental testing, the PT studies shall be at least seven calendar days apart from the closing date of one study to the opening date of another study for the same FoPT.

5. When the PT study result is reported by the PT provider as "acceptable" the environmental laboratory has satisfied the PT requirement.

6. When the PT study result is "not acceptable," the environmental laboratory shall follow the procedure in subsection C of this section.

7. DCLS shall consider a laboratory's analytical result for a FoPT not acceptable when the laboratory makes any reporting error or omission that results in a nonspecific match between the analytical result for the FoPT and any criterion that identifies the laboratory or the field of certification for which the PT sample was analyzed for the purpose of initial or continued certification.

C. Procedure and requirements for "not acceptable" PT study results.

1. When a laboratory receives a PT study result of "not acceptable," the laboratory shall determine the cause for the failure and perform and document corrective action. The corrective action documentation shall be completed within 30 days of receiving the "not acceptable" PT study result and be submitted to DCLS upon request. DCLS may extend the time for corrective action and documentation.

2. Upon completion of the corrective action the laboratory shall perform another PT study for each FoPT that had a "not acceptable" result.

3. If the laboratory successfully completes the makeup PT study by receiving an "acceptable" result before December 31, DCLS shall not suspend the laboratory's certification for the pertinent FoC.

4. If the laboratory receives a "not acceptable" result on the makeup PT study, DCLS shall notify the laboratory that there is cause to suspend the laboratory's certification for the FoC for which the PT study was "not acceptable."

5. DCLS shall not extend the period for annual PT study completion beyond December 31 each year. Failure to satisfactorily complete a PT study, including any corrective action and makeup PT study, by December 31 shall result in suspension of certification in total or in part.

6. If the laboratory receives a "not acceptable" result on three successive PT studies, DCLS shall decertify the laboratory for the pertinent FoC until such time that the laboratory:

a. Completes corrective action for all failed studies and submits its corrective action report to DCLS;

b. Obtains an "acceptable" result for the PT studies; and

c. Applies for a change to its scope of certification and pays applicable fees required by 1VAC30-45-90 B and 1VAC30-45-130 F.

7. DCLS shall follow the provisions of 1VAC30-45-110 in decertifying the laboratory.

D. Withdrawal from PT studies. A laboratory may withdraw from a PT study for any FoPT on or before the close date of the study. Withdrawing from a study shall not exempt the laboratory from meeting the annual analysis requirements necessary for continued certification.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016; Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-45-530 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-540 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-550 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-560 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-570 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-580 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-590 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

Article 4 Quality System

1VAC30-45-600 Quality system

A. This article sets out the general requirements that an environmental laboratory has to successfully demonstrate to be recognized as competent to carry out specific environmental tests. The environmental laboratory shall establish, implement and maintain a quality system based on the required elements contained in this article.

B. The quality system shall be appropriate to the type, range and volume of testing, analysis, measurement or monitoring performed by the laboratory.

C. The quality system's documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel. All personnel concerned with testing and calibration activities within the laboratory shall familiarize themselves with the quality documentation and implement the policies and procedures in their work.

D. If more stringent standards or requirements are included in a mandated test method or by regulation, the laboratory shall demonstrate that such requirements are met. If it is not clear which standard or requirement is more stringent, the standard or requirement from the method or regulation is to be followed.

E. Provisions pertaining to the management of the quality system appear in 1VAC30-45-610 through 1VAC30-45-700. Provisions pertaining to the technical requirements for the quality system appear in 1VAC30-45-710 through 1VAC30-45-770.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-610 Quality manual

A. General.

1. The laboratory shall document its quality system in a quality manual. The quality manual shall reflect all quality assurance and quality control practices and programs used by the laboratory. The required elements of the quality system may be described in more than one document.

2. The quality manual shall be maintained current under the responsibility of the quality assurance officer.

3. The quality manual and any related documents shall be communicated to, understood by, available to, and implemented by all laboratory personnel.

4. The quality manual shall include but not be limited to the elements listed in subsections B and C of this section.

B. The elements of a quality manual shall include but not be limited to:

1. A document title;

2. The laboratory's full name and address;

3. The name, address (if different from above), and telephone number of the responsible official, laboratory manager, and quality assurance officer;

4. The laboratory facility or facilities covered by the quality manual;

5. Signed and dated concurrence, with appropriate titles, of the responsible official, laboratory manager, and quality assurance officer;

6. The effective date of the quality manual;

7. Table of contents and applicable lists of references, glossaries, and appendices; and

8. A quality policy statement, including objectives of the quality system and commitment to ethical laboratory practices and to upholding the requirements of this chapter's standards.

C. The quality manual shall include or reference but not be limited to:

1. The organization and management structure of the laboratory, its place in any parent organization and relevant organizational charts.

2. Job descriptions of key staff and reference to the job descriptions of other staff.

3. Processes or procedures for establishing that personnel have adequate training and experience in the duties they are expected to carry out and are receiving any needed training.

4. Mechanisms for ensuring that the laboratory reviews all new work to ensure that it has the appropriate facilities and resources before commencing such work.

5. Procedures to ensure that all records required by this chapter are retained, as well as procedures for control and maintenance of documentation through a document control system that ensures that all standard operating procedures, manuals, or documents clearly indicate the time period during which the procedure or document was in force.

6. Procedures for dealing with complaints.

7. Procedures for audits and data review.

8. Verification practices that may include inter-laboratory comparisons, proficiency testing programs, use of reference materials and internal quality control schemes.

9. Procedures to be followed for feedback and corrective action whenever testing discrepancies are detected, or departures from documented policies and procedures occur.

10. The laboratory management arrangements for permitting departures from documented policies and procedures or from standard specifications when the departures are planned and controlled.

11. The major equipment and reference measurement standards used as well as the physical facility and environment used by the laboratory in conducting tests.

12. Procedures for calibration, verification and maintenance of equipment.

13. A list of all technology/methods under which the laboratory performs its certified testing.

14. Procedures for achieving traceability of measurements, including standards.

15. Procedures for receiving, handling, storing, and disposing of submitted samples.

16. Procedures for reporting analytical results.

17. Policy addressing the use of unique electronic signatures, where applicable.

D. Review and approval of quality manual.

1. The quality assurance officer shall review the laboratory's quality assurance program, manual and any related documentation whenever there is any change in test methods employed by the laboratory, change in equipment, or any other change in the laboratory that affects the quality assurance program.

2. The quality assurance manual shall be reviewed and approved by the quality assurance officer, the laboratory manager, and the responsible official at least annually.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-620 Organization

The laboratory shall specify and document the functional responsibility, level of authority, and interrelationship or lines of communication of all personnel who manage, perform or verify work affecting the quality of tests, analyses, measurements and monitoring. One person may cover more than one organizational function. Each manager and employee of the laboratory shall have a clear understanding of his or her duties and responsibilities and the relationship of those responsibilities to the overall work of the laboratory.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-630 Records

The laboratory shall maintain a record system to suit its particular circumstances and comply with any applicable regulations. This system shall produce unequivocal, accurate records that document all laboratory activities.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-640 Recordkeeping system and design

A. The laboratory shall have a recordkeeping system that allows historical reconstruction of all laboratory activities that produced the analytical data. The history of the sample shall be readily understood through the documentation. This shall include inter-laboratory transfers of samples or extracts or both.

B. The records shall include the identity of personnel involved in sampling, sample preservation, sample receipt, preparation, calibration or testing, all documentation sent by the person transmitting the sample, including a chain of custody record form, if utilized.

C. The laboratory shall document all information relating to the laboratory facility's equipment, analytical test methods, and related laboratory activities, such as sample receipt, sample preparation, or data verification.

D. The laboratory shall have a recordkeeping system that facilitates the retrieval of all working files and archived records for inspection and verification purposes, e.g., set format for naming electronic files.

E. Responsible staff shall sign or initial all changes to records. The reason for the signature or initials shall be clearly indicated in the records such as "sampled by," "prepared by," or "reviewed by."

F. All generated data except those that are generated by automated data collection systems, shall be recorded directly, promptly and legibly in permanent ink.

G. Entries in records shall not be obliterated by methods such as erasures, overwritten files or markings. All corrections to recordkeeping errors shall be made by one line marked through the error. The individual making the correction shall sign or initial and date the correction. These criteria also shall apply to electronically maintained records.

H. The laboratory shall keep computer and electronic data records in accordance with the pertinent provisions of this section, 1VAC30-45-650 C and E and 1VAC30-45-730 K.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-650 Records management and storage

A. The laboratory shall keep all records, certificates, and reports as required by applicable state and federal recordkeeping laws and regulations. The laboratory shall safely store these records and hold them secure.

B. The laboratory shall retain all records for a minimum of three years from generation of the last entry in the records, or longer, if required by an applicable regulatory program, whichever is greater. The laboratory shall maintain all information necessary for the historical reconstruction of data, including all original observations, calculations and derived data, calibration records and a copy of the test report.

C. Records that are stored only on electronic media shall be supported by the hardware and software necessary for their retrieval. Records that are stored or generated by computers or personal computers shall have hard copy or write-protected backup copies.

D. The laboratory shall establish a record management system for control of laboratory notebooks, instrument logbooks, standards logbooks, and records for data reduction, validation storage and reporting.

E. The laboratory shall protect these records against fire, theft, loss, environmental deterioration, vermin and, in the case of electronic records, electronic or magnetic sources.

F. The laboratory shall have a plan to ensure that the records are maintained or transferred in the event that a laboratory transfers ownership or goes out of business. In addition, in cases of bankruptcy, the laboratory shall follow appropriate regulatory and state legal requirements concerning laboratory records.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-45-660 Required records

A. Sample handling.

1. The laboratory shall maintain a record of all procedures to which a sample is subjected while in the possession of the laboratory. These shall include but are not limited to all records pertaining to sample preservation, identification, receipt, acceptance or rejection, log-in, storage and tracking. The laboratory shall also maintain sampling information on each sample. This includes time and date of collection, type of sample (grab or composite), type of container, sampling point and preservation.

2. The laboratory shall have documented procedures for the receipt and retention of samples, including provisions necessary to protect the integrity of the samples.

B. Laboratory support activities. The laboratory shall retain the following documents and data:

1. All original raw data, whether hard copy or electronic, for calibrations, samples and quality control measures, including analysts' work sheets and data output records (chromatograms, strip charts, and other instrument response readout records).

2. A written description or reference to the specific test method used that includes a description of the specific computational steps used to translate parametric observations into a reportable analytical value.

3. Copies of final reports.

4. Archived standard operating procedures.

5. Correspondence relating to laboratory activities.

6. All corrective action plans, audits, and audit responses.

7. Proficiency test results and raw data.

8. Results of data review, verification, and cross-checking procedures.

C. Analytical records. The laboratory shall retain essential information associated with analytical documents, such as strip charts, tabular printouts, computer data files, analytical notebooks, and run logs. This information includes, but is not limited to, all manual calculations (e.g., manual integrations); sample preparation; standard and reagent origin, receipt, preparation, and use; quality control protocols and assessment; and method performance criteria.

D. Administrative records. The laboratory shall maintain the following administrative records:

1. Personnel qualifications, experience and training records.

2. Records of demonstration of capability for each analyst or work cell.

3. A log of names, initials and signatures for all individuals who are responsible for signing or initialing any laboratory record.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-670 Audits

A. Internal audits.

1. The laboratory shall arrange for annual internal audits to verify that its operations continue to comply with the requirements of the laboratory's quality system. It is the responsibility of the quality assurance officer to plan and organize audits as required by a predetermined schedule and requested by management.

2. Trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited shall carry out these audits. Personnel shall not audit their own activities except when it can be demonstrated that an effective audit will be carried out.

3. Where the audit findings cast doubt on the correctness or validity of the laboratory's calibrations or test results, the laboratory shall take immediate corrective action.

4. A laboratory may have an audit performed under contract by an outside source competent to audit the laboratory's operations.

B. Managerial review.

1. The laboratory management shall conduct a review, at least annually, of its quality system and its testing and calibration activities to ensure its continuing suitability and effectiveness and to introduce any necessary changes or improvements in the quality system and laboratory operations.

2. The review shall take account of reports from managerial and supervisory personnel, the outcome of recent internal audits, assessments by external bodies, the results of inter-laboratory comparisons or proficiency tests, corrective actions and other relevant factors.

3. The laboratory shall have a procedure for review by management and maintain records of review findings and actions.

4. Where the staff of a laboratory is limited to a single analyst, a supervisor may perform a managerial review.

C. Audit review. All audit and review findings and any corrective actions that arise from them shall be documented. The laboratory management shall ensure that these actions are discharged within the agreed timeframe as indicated in the quality manual or standard operating procedures or both. For clarification, documentation of audit and review findings should be a simple procedure, essentially a memorandum setting out the findings of the audit and managerial review and any action to follow.

D. Corrective actions.

1. In addition to providing acceptance criteria and specific protocols for corrective actions in the method standard operating procedures, the laboratory shall implement general procedures to be followed to determine consistently when departures from documented policies, procedures and quality control have occurred. These procedures may include but are not limited to the following:

a. Identify the individual or individuals responsible for assessing each quality control data type;

b. Identify the individual or individuals responsible for initiating or recommending corrective actions or both;

c. Define how the analyst shall treat a data set if the associated quality control measurements are unacceptable;

d. Specify how out-of-control situations and subsequent corrective actions are to be documented; and

e. Specify procedures for management (including the quality assurance officer) to review corrective action plans.

2. To the extent possible, samples shall be reported only if all quality control measures are acceptable. If a quality control measure is found to be out of control, and the data are to be reported, all samples associated with the failed quality control measure shall be reported with the appropriate data qualifiers.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-680 Subcontracting analytical samples

A. Where a laboratory subcontracts any part of the testing covered under this chapter, the testing shall only be subcontracted to a laboratory certified under 1VAC30-46.

B. The report from the subcontractor shall be a separate part of the laboratory report and identified as laboratory testing done by a subcontractor.

C. The laboratory shall retain records demonstrating that the requirements of this section have been met.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-690 Outside support services and supplies

A. The laboratory shall have a policy and procedures for the selection and purchasing of services and supplies it uses that affect the quality of environmental tests. Procedures shall exist for the purchase, reception and storage of reagents and laboratory consumable materials relevant for the environmental tests.

B. The laboratory shall ensure that purchased equipment and consumable materials are not used until they have been inspected, calibrated or otherwise verified as complying with standard specifications or requirements defined in the methods for the tests concerned. These services and supplies used shall comply with specified requirements. Records of actions taken to check compliance shall be maintained.

C. The laboratory shall maintain records of all suppliers from whom it obtains support services or supplies required for tests.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-700 Complaints

The laboratory shall have documented policy and procedures for the resolution of complaints about the laboratory's activities. Where a complaint or any other circumstance raises doubt concerning the laboratory's compliance with the laboratory's policies or procedures, or with the requirements of this chapter or otherwise concerning the quality of the laboratory's calibrations or tests, the laboratory shall ensure that those areas of activity and responsibility involved are promptly audited in accordance with 1VAC30-45-670 A. Records of the complaint and subsequent actions shall be maintained.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-710 Environment and work areas

Laboratory accommodations, test areas, energy sources, lighting, heating and ventilation shall be such as to facilitate proper performance of tests. Laboratories shall meet the requirements of subdivisions 1 through 8 of this section as appropriate to provide compliance with this requirement.

1. The environment in which these activities are undertaken shall not invalidate the results or adversely affect the required accuracy of measurement. Particular care shall be taken when such activities are undertaken at sites other than the permanent laboratory premises.

2. The laboratory shall provide for the effective monitoring, control and recording of environmental conditions as appropriate. Such environmental conditions may include biological sterility, dust, electromagnetic interference, humidity, mains voltage, temperature, and sound and vibration levels.

3. In instances where monitoring or control of any of the above-mentioned items are specified in a test method or by regulation, the laboratory shall meet and document adherence to the laboratory facility requirements.

4. There shall be effective separation between neighboring areas in which there are incompatible activities including culture handling or incubation areas and volatile organic chemical handling areas. The laboratory shall take measures to prevent cross-contamination.

5. Access to and use of all areas affecting the quality of these activities shall be defined and controlled.

6. Adequate measures shall be taken to ensure good housekeeping in the laboratory and to ensure that any contamination does not adversely affect data quality.

7. Work spaces shall be available to ensure an unencumbered work area.

8. Work areas include:

a. Access and entryways to the laboratory;

b. Sample receipt areas;

c. Sample storage areas;

d. Chemical and waste storage areas; and

e. Data handling and storage areas.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-720 Equipment and reference materials

A. The laboratory shall be furnished with all items of equipment, including reference materials, required for the correct performance of tests for which certification is sought. The laboratory shall maintain records of reference materials sufficient to provide proper performance of tests. In those cases where the laboratory needs to use equipment outside its permanent control it shall ensure that the relevant requirements of this article are met.

B. All equipment shall be properly maintained, inspected and cleaned. Maintenance procedures shall be documented.

C. Any item of the equipment that has been subjected to overloading or mishandling, or that gives suspect results, or has been shown by verification or otherwise to be defective shall be taken out of service immediately, clearly identified as being out of service and, wherever possible, stored at a specified place until it has been repaired and shown by calibration, verification or test to perform satisfactorily. The laboratory shall examine the effect of this defect on previous calibrations or tests.

D. Each item of equipment including reference materials shall be labeled, marked or otherwise identified to indicate its calibration status.

E. Records of each major item of equipment significant to the tests performed shall be maintained. These records shall include documentation on all routine and nonroutine maintenance activities. The laboratory shall maintain records of reference materials sufficient to provide proper performance of tests. The records shall include:

1. The name of the item of equipment;

2. The manufacturer's name, type identification, and serial number or other unique identification;

3. Current location, where appropriate;

4. Copy of the manufacturer's instructions, where available;

5. Dates and results of calibrations or verifications or both and date of the next calibration or verification;

6. Details of maintenance carried out to date and planned for the future; and

7. History of any damage, malfunction, modification or repair.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-730 Test methods and standard operating procedures

A. Methods documentation.

1. The laboratory shall have documented instructions on the use and operation of all relevant equipment, on the handling and preparation of samples, and for calibration or testing, where the absence of such instructions could jeopardize the calibrations or tests.

2. All instructions, standards, manuals, and reference data relevant to the work of the laboratory shall be maintained up to date and be readily available to the staff.

B. Standard operating procedures (SOPs).

1. Laboratories shall maintain SOPs that accurately reflect all phases of current laboratory activities such as assessing data integrity, corrective actions, handling customer complaints, and all test methods. These documents, for example, may be equipment manuals provided by the manufacturer or internally written documents. The test methods may be copies of published methods as long as any changes or selected options in the methods are documented and included in the laboratory methods manual.

2. The SOPs shall be organized. Each SOP shall clearly indicate the effective date of the document, the revision number, and the signature or signatures of the responsible laboratory manager or managers.

3. Copies of all SOPs shall be accessible to all personnel.

C. SOPs for laboratory methods.

1. The laboratory shall have and maintain an SOP for each certified analyte or test method.

2. This SOP may be a copy of a published or referenced method or may be written by the laboratory. In cases where modifications to the published method have been made by the laboratory or where the referenced test method is ambiguous or provides insufficient detail, these changes or clarifications shall be clearly described. Each test method shall include or reference where applicable:

a. Identification of the test method;

b. Applicable matrix or matrices;

c. Limits of detection or quantitation;

d. Scope and application, including parameters to be analyzed;

e. Summary of the test method;

f. Definitions;

g. Interferences;

h. Safety;

i. Equipment and supplies;

j. Reagents and standards;

k. Sample collection, preservation, shipment, and storage;

l. Quality control;

m. Calibration and standardization;

n. Procedure;

o. Data analysis and calculations;

p. Method performance;

q. Pollution prevention;

r. Data assessment and acceptance criteria for quality control measures;

s. Corrective actions for out-of-control data;

t. Contingencies for handling out-of-control or unacceptable data;

u. Waste management;

v. References; and

w. Any tables, diagrams, flowcharts, and validation data.

D. Test methods.

1. Laboratories shall use (i) promulgated test methods in accordance with the Code of Federal Regulations; (ii) test methods stated in any current permit issued by the State Air Pollution Control Board, the Virginia Waste Management Board, or the State Water Control Board; or (iii) alternate test procedures approved by the board issuing the permit or the Department of Environmental Quality, including applicable quality assurance requirements, and sample preservation, container, storage, and holding time requirements.

2. The laboratory shall use appropriate test methods and procedures for all tests and related activities within its responsibility (including sample handling, transport and storage, preparation, and analysis). The method and procedures shall be consistent with the accuracy required and with any standard specifications relevant to the calibrations or tests concerned.

3. When the use of reference test methods for a sample analysis is mandated, only those methods shall be used.

4. Where test methods are employed that are not required, as in the Performance Based Measurement System approach, the methods shall be fully documented and validated (see subsection E of this section).

E. Demonstration of capability.

1. Prior to acceptance and institution of any test method, satisfactory initial demonstration of method capability is required. In general, this demonstration does not test the performance of the method in real world samples, but in the applicable and available clean quality system matrix sample (a quality system matrix in which no target analytes or interferences are present at concentrations that impact the results of a specific test method), for example, drinking water, solids, biological tissue, and air. Laboratories shall follow the procedure in subsection F of this section to demonstrate capability.

2. Thereafter, ongoing demonstration of method performance, such as laboratory control samples, is required.

3. In cases where a laboratory analyzes samples using a test method that has been in use by the laboratory for at least one year prior to applying for certification, and there have been no significant changes in instrument type, personnel or test method, the continuing demonstration of method performance and the analyst's documentation of continued proficiency shall be acceptable. The laboratory shall have records on file to demonstrate that an initial demonstration of capability is not required.

4. In cases where a laboratory analyzes samples using a test method that has not been in use by an individual in the laboratory for at least one 12-month period, another successful demonstration of capability in accordance with subsection F of this section shall be required for that individual to resume testing by the method.

5. In all cases, the laboratory shall document each demonstration of capability as required by subsection G of this section.

6. The laboratory shall complete a demonstration of capability each time there is a change in instrument type, personnel or test method, including the addition of an analyte to a certified test method.

F. Procedure for demonstration of capability. The following steps shall be performed for mandated test methods. However, before any results are reported using this method, actual sample spike results may be used to meet this standard (i.e., at least four consecutive matrix spikes within the last 12 months). For analytes that do not lend themselves to spiking (e.g., TSS) the demonstration of capability may be performed using quality control samples. The laboratory may document that other approaches to demonstration of capability are adequate. This documentation shall be included in the laboratory's quality manual:

1. A quality control (QC) sample may be obtained from an outside source or may be prepared by the laboratory using alternate source stock standards that are prepared independently from those used in instrument calibration.

2. The analyte or analytes shall be diluted in a volume of clean quality system matrix sufficient to prepare four aliquots at the concentration specified, or if unspecified, to a concentration of one to four times the limit of quantitation.

3. At least four aliquots shall be prepared and analyzed according to the test method either concurrently or over a period of days.

4. Using all of the results, calculate the mean recovery in the appropriate reporting units (such as g/L) and the standard deviations of the population sample (n-1) (in the same units) for each parameter of interest. When it is not possible to determine mean and standard deviations, such as for presence or absence of the analyte and logarithmic values, the laboratory shall assess performance against established and documented criteria.

5. Compare the information from subdivision 4 of this subsection to the corresponding acceptance criteria for precision and accuracy in the test method (if applicable) or in laboratory-generated acceptance criteria (if there are not established mandatory criteria). If all parameters meet the acceptance criteria, the analysis of actual samples may begin. If any one of the parameters do not meet the acceptance criteria, the performance is unacceptable for that parameter.

6. When one or more of the tested parameters fail at least one of the acceptance criteria, the analyst shall proceed according to either subdivision 6 a or 6 b of this subsection.

a. Locate and correct the source of the problem and repeat the test for all parameters of interest beginning with subdivision 3 of this subsection.

b. Beginning with subdivision 3 of this subsection, repeat the test for all parameters that failed to meet criteria. Repeated failure, however, confirms a general problem with the measurement system. If this occurs, locate and correct the source of the problem and repeat the test for all compounds of interest beginning with subdivision 3 of this subsection.

G. Documentation of demonstration of capability. The laboratory shall document each demonstration of capability so that the following information shall be readily available for each employee:

1. Analyst or analysts involved in preparation and analysis.

2. Matrix.

3. Analytes, class of analytes, measured parameters, or organisms.

4. Identification of methods performed.

5. Identification of laboratory-specific SOP used for analysis, including revision number.

6. Date of analysis.

7. All raw data necessary to reconstruct and validate the analyses.

8. Data evaluation required by subsection F of this section.

H. Sample aliquots. Where sampling (as in obtaining sample aliquots from a submitted sample) is carried out as part of the test method, the laboratory shall use documented procedures and appropriate techniques to obtain representative subsamples.

I. Data verification. Calculations and data transfers shall be subject to appropriate checks. The laboratory shall establish standard operating procedures to ensure that (i) the reported data are free from transcription and calculation errors and (ii) all quality control measures are reviewed and evaluated before data are reported. The laboratory also shall establish standard operating procedures addressing manual calculations including manual integrations.

J. Documentation and labeling of standards and reagents. Documented procedures shall exist for the reception and storage of consumable materials used for the technical operations of the laboratory.

1. The laboratory shall retain records for all standards, reagents, reference materials, and media including the manufacturer/vendor, the manufacturer's Certificate of Analysis or purity (if available), the date of receipt, recommended storage conditions, and an expiration date after which the material shall not be used unless its reliability is verified by the laboratory.

2. Original containers (such as provided by the manufacturer or vendor) shall be labeled with an expiration date if this date is provided by the manufacturer or vendor.

3. Records shall be maintained on standard and reference material preparation. These records shall indicate traceability to purchased stocks or neat compounds, reference to the method of preparation, date of preparation, expiration date and preparer's initials.

4. Sufficient identification of containers of prepared reagents and standards shall be provided to ensure proper performance of tests.

K. Computers and electronic data related requirements. Where computers, automated equipment or microprocessors are used for the capture, processing, manipulation, recording, reporting, storage or retrieval of test data, the laboratory shall ensure the following:

1. Computer software developed by the user is documented in sufficient detail and is suitably validated as being adequate for use.

2. Procedures are established and implemented for protecting the integrity of data, such as integrity of data entry or capture, data storage, data transmission and data processing.

3. Computer and automated equipment are maintained to ensure proper functioning and provided with the environmental and operating conditions necessary to maintain the integrity of calibration and test data.

4. Appropriate procedures are established and implemented for the maintenance of security of data including the prevention of unauthorized access to, and the unauthorized amendment of, computer records.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016; Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-45-740 Measurement traceability and calibration

A. General requirements. All equipment used for environmental tests, including equipment for subsidiary measurements (e.g., for environmental conditions) having a significant effect on the accuracy or validity of the result of the environmental test or sampling shall be calibrated before being put into service and on a continuing basis. The laboratory shall have an established program and procedure for the calibration of its equipment. This includes balances, thermistors, thermometers and control standards. Such a program shall include a system for selecting, using, calibrating, checking, controlling and maintaining measurement standards, reference materials used as measurement standards, and measuring and test equipment used to perform environmental tests.

B. Traceability of calibration.

1. The laboratory shall ensure that the equipment used can provide the uncertainty of measurement needed.

2. The overall program of calibration or verification or both and validation of equipment shall be designed and operated so as to ensure that measurements made by the laboratory are traceable to national standards of measurement.

3. Where traceability of measurements to the International System of Units (SI) is not possible or not relevant, the same requirements for traceability to, for example, certified reference materials, agreed methods or consensus standards, are required. The laboratory shall provide satisfactory evidence of correlation of results, for example by participation in a suitable program of inter-laboratory comparisons, proficiency testing, or independent analysis.

C. Reference standards and reference materials.

1. Reference standards. The laboratory shall have a program and procedure for the calibration of its reference standards. Reference standards of measurement shall be calibrated by a body that can provide traceability as described in subsection B of this section. Such reference standards of measurement held by the laboratory (such as Class S or equivalent weights or traceable thermometers) shall be used for calibration only and for no other purpose, unless it can be demonstrated that their performance as reference standards would not be invalidated. Where commercially available, this traceability shall be to a national standard of measurement.

2. Reference materials. Reference materials shall, where commercially available, be traceable to SI units of measurement, or to certified reference materials. Where possible, traceability shall be to national or international standards of measurement, or to national or international standard reference materials. Internal reference materials shall be checked as far as is technically and economically practicable.

D. Calibration. Calibration requirements are divided into two parts: (i) requirements for analytical support equipment and (ii) requirements for instrument calibration. In addition, the requirements for instrument calibration are divided into initial instrument calibration and continuing instrument calibration verification.

1. Support equipment. These standards apply to all devices that may not be the actual test instrument, but are necessary to support laboratory operations. These include but are not limited to balances, ovens, refrigerators, freezers, incubators, water baths, temperature measuring devices (including thermometers and thermistors), thermal/pressure sample preparation devices and volumetric dispensing devices (such as Eppendorf®, or automatic dilutor or dispensing devices) if quantitative results are dependent on their accuracy, as in standard preparation and dispensing or dilution into a specified volume.

a. All support equipment shall be maintained in proper working order. The records of all repair and maintenance activities, including service calls, shall be kept.

b. All support equipment shall be calibrated or verified at least annually, using NIST traceable references when available, over the entire range of use. The results of such calibration shall be within the specifications required of the application for which this equipment is used. If not, the laboratory shall either (i) remove the equipment from service until repaired or (ii) maintain records of established correction factors to correct all measurements.

c. Raw data records shall be retained to document equipment performance.

d. On each day the equipment is used, balances, ovens, refrigerators, freezers, and water baths shall be checked in the expected use range, with NIST traceable references where available. The acceptability for use or continued use shall be according to the needs of the analysis or application for which the equipment is being used.

e. Mechanical volumetric dispensing devices including burettes (except Class A glassware) shall be checked for accuracy on at least a quarterly use basis. Glass microliter syringes are to be considered in the same manner as Class A glassware, but shall come with a certificate attesting to established accuracy or the accuracy shall be initially demonstrated and documented by the laboratory.

f. For chemical tests, the temperature, cycle time and pressure of each run of autoclaves shall be documented by the use of appropriate chemical indicators or temperature recorders and pressure gauges.

g. For biological tests that employ autoclave sterilization, the following requirements apply:

(1) The performance of each autoclave shall be initially evaluated by establishing its functional properties and performance, for example heat distribution characteristics with respect to typical uses. Autoclaves shall meet specified temperature tolerances. Pressure cookers fitted only with a pressure gauge are not recommended for sterilization of media or decontamination of wastes.

(2) Records of autoclave operations including temperature and time shall be maintained. This shall be done for every cycle. Acceptance and rejection criteria shall be established and used to evaluate the autoclave efficiency and effectiveness.

2. Instrument calibration.

a. This standard specifies the essential elements that define the procedures and documentation for initial instrument calibration and continuing instrument calibration verification to ensure that the data shall be of known quality and be appropriate for a given regulation or decision. This standard does not specify detailed procedural steps for calibration, but establishes the essential elements for selection of the appropriate technique or techniques. If more stringent standards or requirements are included in a mandated test method or by regulation, the laboratory shall demonstrate that such requirements are met. If it is not apparent which standard is more stringent, then the requirements of the regulation or mandated test method are to be followed.

b. Initial instrument calibrations. The following items are essential elements of initial instrument calibration:

(1) The laboratory shall include or reference the details of the initial instrument calibration procedures, including calculations, integrations, acceptance criteria and associated statistics in the standard operating procedure for the test method. When initial instrument calibration procedures are referenced in the test method, then the laboratory shall retain the referenced material and make it available for review.

(2) The laboratory shall retain sufficient raw data records to permit reconstruction of the initial instrument calibration (e.g., calibration date, test method, instrument, analysis date, each analyte name, analyst's initials or signature, concentration and response, calibration curve or response factor, or unique equation or coefficient used to reduce instrument responses to concentration).

(3) Sample results shall be quantitated from the initial instrument calibration and may not be quantitated from any continuing instrument calibration verification unless otherwise required by regulation, method, or program.

(4) All initial instrument calibrations shall be verified with a standard obtained from a second manufacturer or lot. Traceability shall be to a national standard, when available. This element does not apply to laboratories performing only simple test procedures.

(5) Criteria for the acceptance of an initial instrument calibration shall be established (e.g., correlation coefficient and relative percent difference). The criteria used shall be 0.995 or greater for the calibration coefficient unless a different criterion is included in the method being used.

(6) Results of samples not bracketed by initial calibration standards (within calibration range) shall be reported as having less certainty (e.g., defined qualifiers or flags or explained in the case narrative). The lowest calibration standard shall be above the detection limit.

(7) If the initial instrument calibration results are outside established acceptance criteria, corrective actions shall be performed. Data associated with an unacceptable initial instrument calibration shall not be reported.

(8) Calibration standards shall include concentrations at or below the regulatory limit or decision level, if these limits or levels are known by the laboratory, unless these concentrations are below the laboratory's demonstrated detection limits.

(9) If a reference or mandated method does not specify the number of calibration standards, the minimum number is two, not including blanks or a zero standard. The laboratory shall have a standard operating procedure for determining the number of points for establishing the initial instrument calibration.

c. Continuing instrument calibration verification.

(1) When an initial instrument calibration is not performed on the day of analysis, the validity of the initial calibration shall be verified prior to sample analyses by a continuing instrument calibration check with each analytical batch. This provision does not apply to laboratories performing only simple test procedures.

(2) The following items are essential elements of continuing instrument calibration verification:

(a) The laboratory shall include or reference the details of the continuing instrument calibration procedure, calculations and associated statistics in the standard operating procedure for the test method.

(b) The laboratory shall verify calibration for each compound, element, or other discrete chemical species, except for multicomponent analytes such as aroclors, total petroleum hydrocarbons, or toxaphene where a representative chemical related substance or mixture can be used.

(c) The laboratory shall perform a continuing instrument calibration verification as follows:

(i) At the beginning and end of each analytical batch. If an internal standard is used, only one verification needs to be performed at the beginning of the analytical batch;

(ii) Whenever it is expected that the analytical system may be out of calibration or might not meet the verification acceptance criteria;

(iii) If the time period for calibration or the most previous calibration verification has expired; or

(iv) For analytical systems that contain a calibration verification requirement.

(d) Sufficient raw data records shall be retained to permit reconstruction of the continuing instrument calibration verification (e.g., or test method, instrument, analysis date, each analyte name, concentration and response, calibration curve or response factor, or unique equations or coefficients used to convert instrument responses into concentrations). Continuing calibration verification records shall explicitly connect the continuing verification data to the initial instrument calibration.

(e) Criteria for the acceptance of a continuing instrument calibration verification shall be established (e.g., percent recovery or relative percent difference).

(f) If the continuing instrument calibration verification results obtained are outside established acceptance criteria, corrective actions shall be performed. If routine corrective action procedures fail to produce a second consecutive (immediate) calibration verification within acceptance criteria, then either the laboratory has to demonstrate acceptable performance after corrective action with two consecutive successful calibration verifications, or a new initial instrument calibration shall be performed. If the laboratory has not verified calibration, sample analyses shall not occur until the analytical system is calibrated or calibration verified. If samples are analyzed using a system on which the calibration has not yet been verified, the results shall be flagged. Data associated with an unacceptable calibration verification may be fully useable under the following special conditions:

(i) When the acceptance criteria for the continuing calibration verification are exceeded high (i.e., high bias) and there are associated samples that are nondetects, then those nondetects may be reported. Otherwise the samples affected by the unacceptable calibration verification shall be reanalyzed after a new calibration curve has been established, evaluated and accepted.

(ii) When the acceptance criteria for the continuing calibration verification are exceeded low (i.e., low bias) those sample results may be reported if they exceed a maximum regulatory limit or decision level. Otherwise the samples affected by the unacceptable verification shall be reanalyzed after a new calibration curve has been established, evaluated and accepted.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-750 Quality assurance

A. General. The laboratory shall have quality control procedures for monitoring the validity of environmental tests undertaken. The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to the reviewing of the results. This monitoring shall be planned and reviewed and may include, but not be limited to, the following:

1. Regular use of certified reference materials or internal quality control using secondary reference materials or both.

2. Participation in interlaboratory comparison or proficiency testing program.

3. Replicate tests using the same or different methods.

4. Retesting of retained samples.

5. Correlation of results for different characteristics of a sample (e.g., total phosphate should be greater than or equal to orthophosphate).

B. Essential quality control procedures. The general quality control principles in subsection C of this section shall apply, where applicable, to all environmental laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory. 1VAC30-45-770 through 1VAC30-45-775, 1VAC30-45-790 through 1VAC30-45-798, and 1VAC30-45-810 through 1VAC30-45-818 specify quality control requirements for chemical testing, microbiological testing, and air testing, respectively. Noncommercial environmental laboratories that analyze environmental samples using toxicity, radiochemical, or asbestos testing shall meet the quality control standards for the specific method and the specific type of testing in Modules 3, 6, and 7 of Volume 1 of the 2016 TNI Standards for Environmental Laboratories. The standards for any given test type shall assure that the applicable principles are addressed.

C. All laboratories shall have detailed written protocols in place to monitor the following quality controls:

1. Positive and negative controls to monitor tests such as blanks, spikes, reference toxicants.

2. Tests to define the variability or repeatability of the laboratory results or both such as replicates.

3. Measures to assure the accuracy of the test method including calibration or continuing calibrations or both, use of certified reference materials, proficiency test samples, or other measures.

4. Measures to evaluate test method capability, such as method detection limits and quantitation limits or range of applicability such as linearity.

5. Selection of appropriate formulae to reduce raw data to final results such as regression analysis, comparison to internal and external standard calculations, and statistical analyses.

6. Selection and use of reagents and standards of appropriate quality.

7. Measures to assure the selectivity of the test for its intended purpose.

8. Measures to assure constant and consistent test conditions (both instrumental and environmental) where required by the test method such as temperature, humidity, light, or specific instrument conditions.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016; Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-45-760 Quality control requirements

A. General.

1. The quality control protocols specified by the laboratory's SOPs shall be followed (1VAC30-45-730 C). The laboratory shall ensure that either the (i) applicable essential standards outlined in this section through 1VAC30-45-775, 1VAC30-45-790 through 1VAC30-45-798, and 1VAC30-45-810 through 1VAC30-45-818 or (ii) mandated methods or regulations, whichever are more stringent, are incorporated into their method SOPs. When it is not apparent which is more stringent, the quality controls in the mandated method or regulations are to be followed.

2. All quality control measures shall be assessed and evaluated on an ongoing basis and quality control acceptance criteria shall be used to determine the validity of the data. The laboratory shall have procedures for the development of acceptance/rejection criteria where no method or regulatory criteria exists.

B. Initial test method evaluation. For all test methods other than microbiology, the requirements of subdivisions 1 and 2 of this subsection apply. For microbiology testing, the initial test method evaluation requirements are contained in 1VAC30-45-790 through 1VAC30-45-798. For the evaluation of precision and bias (subdivision 3 of this subsection), the requirements of subdivision 3 a of this subsection apply to standard methods. The requirements of subdivision 3 b of this subsection apply to the methods referenced in that subdivision.

1. Limit of detection (LOD).

a. The laboratory shall determine the LOD for the method for each target analyte of concern in the quality system matrices when the testing is conducted using approved methods listed in 40 CFR Part 136 for a program under the federal Clean Water Act, except when the procedure for Determination of Method Detection Limit at 40 CFR Part 136 Appendix B states the procedure is not applicable to a measurement.

b. The laboratory shall determine the LOD for the method for each target analyte of concern in the quality system matrices when test results are to be reported to the LOD (versus the limit of quantitation or working range of instrument calibration), according to 1VAC30-45-771 and 1VAC30-45-814. Where an LOD study is not performed, the laboratory may not report a value below the limit of quantitation.

c. When the LOD is required under subdivision 1 a or 1 b of this subsection, all sample processing steps of the analytical method shall be included in the determination of the LOD.

d. The validity of the LOD shall be confirmed as described in 40 CFR Part 136 Appendix B as applicable, or by qualitative identification of the analyte or analytes in a quality control sample in each quality system matrix containing the analyte at no more than two to three times the LOD for single analyte tests and one to four times the LOD for multiple analyte tests. This verification shall be performed on every instrument that is to be used for analysis of samples and reporting of data.

2. Limit of quantitation (LOQ).

a. The laboratory shall determine the LOQ for each analyte of concern according to a defined, documented procedure.

b. The LOQ study is not required for any component or property for which spiking solutions or quality control samples are not commercially available or otherwise inappropriate (e.g., pH).

c. The validity of the LOQ shall be confirmed by successful analysis of a QC sample containing the analytes of concern in each quality system matrix at a concentration at or below the LOQ or no more than two times the concentration of the claimed LOQ. A successful analysis is one where the recovery of each analyte is within the established test method acceptance criteria or client data quality objectives for accuracy. This single analysis is not required if the bias and precision of the measurement system is evaluated at the LOQ.

3. Evaluation of precision and bias.

a. Standard methods. The laboratory shall evaluate the precision and bias of a standard method for each analyte of concern for each quality system matrix according to either of the following:

(1) The single-concentration four-replicate recovery study procedures in 1VAC30-45-730 F; or

(2) An alternate procedure documented in the quality manual when the analyte cannot be spiked into the sample matrix and quality control samples are not commercially available.

b. Nonstandard methods.

(1) For laboratory-developed test methods or nonstandard test methods that were not in use by the laboratory before July 2003, the laboratory shall have a documented procedure to evaluate precision and bias. The laboratory shall also compare results of the precision and bias measurements with criteria given in the reference method or criteria established by the laboratory.

(2) Precision and bias measurements shall evaluate the method across the analytical calibration range of the method. The laboratory shall also evaluate precision and bias in the relevant quality system matrices and shall process the samples through the entire measurement system for each analyte of interest.

(3) The following are examples of a systematic approach to evaluate precision and bias:

(a) Example 1. Analyze QC samples in triplicate containing the analytes of concern at or near the limit of quantitation, at the upper-range of the calibration (upper 20%) and at a mid-range concentration. Process these samples on different days as three sets of samples through the entire measurement system for each analyte of interest. Each day one QC sample at each concentration is analyzed. A separate method blank shall be subjected to the analytical method along with the QC samples on each of the three days. (Note that the three samples at the LOQ concentration can demonstrate sensitivity as well.) For each analyte, calculate the mean recovery for each day, for each level over days, and for all nine samples. Calculate the relative standard deviation for each of the separate means obtained. Compare the standard deviations for the different days and the standard deviations for the different concentrations. If the different standard deviations are all statistically insignificant (e.g., F-test), then compare the overall mean and standard deviation with the established criteria from above.

(b) Example 2. A validation protocol such as the Tier I, Tier II, and Tier III requirements in U.S. EPA Office of Water's Alternate Test Procedure (ATP) approval process.

4. Evaluation of selectivity. The laboratory shall evaluate selectivity by following the checks established within the method. These checks may include mass spectral tuning, second column confirmation, ICP inter-element interference checks, chromatography retention time windows, sample blanks, spectrochemical absorption or fluorescence profiles, co-precipitation evaluations, and electrode response factors.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016; Errata, 32:24 VA.R. 3395 July 25, 2016; Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-45-770 Chemical testing: positive and negative controls

A. Negative control – method performance.

1. Purpose. The method blank is used to assess the preparation batch for possible contamination during the preparation and processing steps. The method blank shall be processed along with and under the same conditions as the associated samples to include all steps of the analytical procedure. Procedures shall be in place to determine if a method blank is contaminated. Any affected samples associated with a contaminated method blank shall be reprocessed for analysis or the results reported with appropriate data qualifying codes.

2. Frequency. The method blank shall be analyzed at a minimum of one per preparation batch. In those instances for which no separate preparation method is used (e.g., volatiles in water) the batch shall be defined as environmental samples that are analyzed together with the same method and personnel, using the same lots of reagents, not to exceed the analysis of 20 environmental samples.

3. Composition. The method blank shall consist of a quality system matrix that is similar to the associated samples and is known to be free of the analytes of interest.

4. Evaluation criteria and corrective action. While the goal is to have no detectable contaminants, each method blank shall be critically evaluated as to the nature of the interference and the effect on the analysis of each sample within the batch. The source of contamination shall be investigated and measures taken to minimize or eliminate the problem and affected samples reprocessed or data shall be appropriately qualified if:

a. The concentration of a targeted analyte in the blank is at or above the reporting limit as established by the test method or by regulation, and is greater than 1/10 of the amount measured in any sample.

b. The blank contamination otherwise affects the sample results as per the test method requirements or the individual project data quality objectives.

c. When a blank is determined to be contaminated, the cause shall be investigated and measures taken to minimize or eliminate the problem. Samples associated with a contaminated blank shall be evaluated as to the best corrective action for the samples (e.g., reprocessing or data qualifying codes). In all cases the corrective action shall be documented.

B. Positive control – method performance. Laboratory control sample (LCS).

1. Purpose. The LCS is used to evaluate the performance of the total analytical system, including all preparation and analysis steps. Results of the LCS are compared to established criteria and, if found to be outside of these criteria, indicates that the analytical system is "out of control." Any affected samples associated with an out of control LCS shall be reprocessed for re-analysis or the results reported with appropriate data qualifying codes.

2. Frequency. The LCS shall be analyzed at a minimum of one per preparation batch. Exceptions would be for those analytes for which no spiking solutions are available such as total suspended solids, total dissolved solids, total volatile solids, total solids, pH, color, odor, temperature, dissolved oxygen or turbidity. In those instances for which no separate preparation method is used (example: volatiles in water) the batch shall be defined as environmental samples that are analyzed together with the same method and personnel, using the same lots of reagents, not to exceed the analysis of 20 environmental samples.

3. Composition. The LCS is a quality system matrix, known to be free of analytes of interest, spiked with known and verified concentrations of analytes. NOTE: the matrix spike may be used in place of this control as long as the acceptance criteria are as stringent as for the LCS. Alternatively the LCS may consist of a media containing known and verified concentrations of analytes or as Certified Reference Material (CRM). All analyte concentrations shall be within the calibration range of the methods. The following shall be used in choosing components for the spike mixtures:

The components to be spiked shall be as specified by the mandated test method or other regulatory requirement or as requested by the client. In the absence of specified spiking components the laboratory shall spike per the following:

a. For those components that interfere with an accurate assessment such as spiking simultaneously with technical chlordane, toxaphene and PCBs, the spike should be chosen that represents the chemistries and elution patterns of the components to be reported.

b. For those test methods that have extremely long lists of analytes, a representative number may be chosen. The analytes selected should be representative of all analytes reported. The following criteria shall be used for determining the minimum number of analytes to be spiked. However, the laboratory shall insure that all targeted components are included in the spike mixture over a two-year period. For methods that include 1-10 targets, spike all components; for methods that include 11-20 targets, spike at least 10 components or 80%, whichever is greater; and for methods with more than 20 targets, spike at least 16 components.

4. Evaluation criteria and corrective action.

a. The results of the individual batch LCS are calculated in percent recovery or other appropriate statistical technique that allows comparison to established acceptance criteria. The laboratory shall document the calculation.

b. The individual LCS is compared to the acceptance criteria as published in the mandated test method. Where there are no established criteria, the laboratory shall determine internal criteria and document the method used to establish the limits or utilize client specified assessment criteria.

c. A LCS that is determined to be within the criteria effectively establishes that the analytical system is in control and validates system performance for the samples in the associated batch. Samples analyzed along with a LCS determined to be "out of control" shall be considered suspect and the samples reprocessed and re-analyzed or the data reported with appropriate data qualifying codes.

5. If a large number of analytes are in the LCS, it becomes statistically likely that a few will be outside control limits. This may not indicate that the system is out of control, therefore corrective action may not be necessary. Upper and lower marginal exceedance (ME) limits can be established to determine when corrective action is necessary. A ME is defined as being beyond the LCS control limit (3 standard deviations), but within the ME limits. ME limits are between 3 and 4 standard deviations around the mean.

a. The number of allowable marginal exceedances is based on the number of analytes in the LCS. If more analytes exceed the LCS control limits than is allowed, or if any one analyte exceeds the ME limits, the LCS fails and corrective action is necessary. This marginal exceedance approach is relevant for methods with long lists of analytes. It will not apply to target analyte lists with fewer than 11 analytes.

b. The number of allowable marginal exceedances is as follows:

| | Number of analytes in LCS | Number of analytes allowed in ME of the LCS control limit | | --- | --- | --- | | | Greater than 90 | Five | | | 71‑90 | Four | | | 51‑70 | Three | | | 31‑50 | Two | | | 11‑30 | One | | | Fewer than 11 | None |

c. Marginal exceedances shall be random. If the same analyte exceeds the LCS control limit repeatedly, it is an indication of a systemic problem. The source of the error shall be located and corrective action taken. Laboratories shall have a written procedure to monitor the application of marginal exceedance allowance to the LCS to ensure random behavior.

C. Sample specific controls - general.

1. The laboratory shall document procedures for determining the effect of the sample matrix on method performance. These procedures relate to the analyses of quality system matrix specific Quality Control (QC) samples and are designed as data quality indicators for a specific sample using the designated test method. These controls alone are not used to judge laboratory performance.

2. Examples of matrix specific QC include: Matrix Spike (MS); Matrix Spike Duplicate (MSD); sample duplicates; and surrogate spikes. The laboratory shall have procedures in place for tracking, managing, and handling matrix specific QC criteria including spiking appropriate components at appropriate concentrations, calculating recoveries and relative percent difference, evaluating and reporting results based on performance of the QC samples.

D. Sample specific controls - matrix spike and matrix spike duplicates.

1. Purpose. Matrix specific QC samples indicate the effect of the sample matrix on the precision and accuracy of the results generated using the selected method. The information from these controls is sample/matrix specific and would not normally be used to determine the validity of the entire batch.

2. Frequency. The frequency of the analysis of matrix specific samples shall be determined as part of a systematic planning process (e.g., Data Quality Objectives) or as specified by the test method.

3. Composition. The components to be spiked shall be as specified by the mandated test method. Any permit specified analytes, as specified by regulation or client requested analytes shall also be included. If there are no specified components, the laboratory shall spike per the following:

a. For those components that interfere with an accurate assessment such as spiking simultaneously with technical chlordane, toxaphene and PCBs, the spike should be chosen that represents the chemistries and elution patterns of the components to be reported.

b. For those test methods that have extremely long lists of analytes, a representative number may be chosen using the following criteria for choosing the number of analytes to be spiked. However, the laboratory shall insure that all targeted components are included in the spike mixture over a two-year period.

(1) For methods that include 1-10 targets, spike all components;

(2) For methods that include 11-20 targets, spike at least 10 components or 80%, whichever is greater;

(3) For methods with more than 20 targets, spike at least 16 components.

4. Evaluation criteria and corrective action.

a. The results from matrix spike/matrix spike duplicate are primarily designed to assess the precision and accuracy of analytical results in a given matrix and are expressed as percent recovery (%R), relative percent difference (RPD), or other appropriate statistical technique that allows comparison to established acceptance criteria. The laboratory shall document the calculation for %R, RPD or other statistical treatment used.

b. The results are compared to the acceptance criteria as published in the mandated test method. Where there are no established criteria, the laboratory shall determine internal criteria and document the method used to establish the limits. For matrix spike results outside established criteria corrective action shall be documented or the data reported with appropriate data qualifying codes.

E. Sample specific controls - matrix duplicates.

1. Purpose. Matrix duplicates are defined as replicate aliquots of the same sample taken through the entire analytical procedure. The results from this analysis indicate the precision of the results for the specific sample using the selected method. The matrix duplicate provides a usable measure of precision only when target analytes are found in the sample chosen for duplication.

2. Frequency. The frequency of the analysis of matrix duplicates may be determined as part of a systematic planning process (e.g., Data Quality Objectives) or as specified by the mandated test method.

3. Composition. Matrix duplicates are performed on replicate aliquots of actual samples. The composition is usually not known.

4. Evaluation criteria and corrective action.

a. The results from matrix duplicates are primarily designed to assess the precision of analytical results in a given matrix and are expressed as relative percent difference (RPD) or another statistical treatment (e.g., absolute differences). The laboratory shall document the calculation for relative percent difference or other statistical treatments.

b. Results are compared to the acceptance criteria as published in the mandated test method. Where there are no established criteria, the laboratory shall determine internal criteria and document the method used to establish the limits. For matrix duplicates results outside established criteria corrective action shall be documented or the data reported with appropriate data qualifying codes.

F. Sample specific controls - surrogate spikes.

1. Purpose. Surrogates are used most often in organic chromatography test methods and are chosen to reflect the chemistries of the targeted components of the method. Added prior to sample preparation/extraction, they provide a measure of recovery for every sample matrix.

2. Frequency. Except where the matrix precludes its use or when not commercially available, surrogate compounds shall be added to all samples, standards, and blanks for all appropriate test methods.

3. Composition. Surrogate compounds are chosen to represent the various chemistries of the target analytes in the method or measurement quality objectives. They are often specified by the mandated method and are deliberately chosen for their being unlikely to occur as an environmental contaminant. Often this is accomplished by using deuterated analogs of select compounds.

4. Evaluation criteria and corrective action. The results are compared to the acceptance criteria as published in the mandated test method. Where there are no established criteria, the laboratory should determine internal criteria and document the method used to establish the limits. Surrogates outside the acceptance criteria shall be evaluated for the effect indicated for the individual sample results. Data quality objectives or other site-specific requirements may guide the appropriate corrective action. Results reported from analyses with surrogate recoveries outside the acceptance criteria should include appropriate data qualifiers.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-771 Chemical testing: limit of detection and limit of quantitation

A. General. All procedures used shall be documented. Documentation shall include the quality system matrix type. All supporting data shall be retained.

B. Limit of detection (LOD). The laboratory shall utilize a test method that provides an LOD that is appropriate and relevant for the intended use of the data. LOD determination and validation are required as specified by 1VAC3045-760 B 1. LODs shall be determined by the protocol in the mandated test method or applicable regulation. If the protocol for determining LODs is not specified, the selection of the procedure shall reflect instrument limitations and the intended application of the test method.

1. The LOD shall be initially determined for the compounds of interest in each test method in a quality system matrix in which there are no target analytes or interferences at a concentration that would impact the results. Alternatively the LOD shall be determined in the quality system matrix of interest (see definition of matrix).

2. LODs shall be determined each time there is a change in the test method that affects how the test is performed, or when a change in instrumentation occurs that affects the sensitivity of the analysis.

3. The LOD shall be verified annually for each quality system matrix, method and analyte according to the procedure as specified in 1VAC30-45-760 B 1.

C. Limit of quantitation (LOQ).

1. Any established LOQ shall be above the LOD.

2. The LOQ shall be verified annually for each quality system matrix, method and analyte according to the procedure specified in 1VAC30-45-760 B 2. Alternatively, the annual LOQ verification is not required if the LOD is reevaluated or verified according to subdivision B 3 of this section.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016; Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-45-772 Chemical testing: data reduction

The procedures for data reduction, such as use of linear regression, shall be documented.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-773 Chemical testing: quality of standards and reagents

A. The source of standards shall comply with 1VAC30-45-740 C.

B. Reagent quality, water quality and checks.

1. Reagents. In methods where the purity of reagents is not specified, analytical reagent grade shall be used. Reagents of lesser purity than those specified by the test method shall not be used. The labels on the container should be checked to verify that the purity of the reagents meets the requirements of the particular test method. Such information shall be documented.

2. Water. The quality of water sources shall be monitored and documented and shall meet method specified requirements.

3. The laboratory will verify the concentration of titrants in accordance with written laboratory procedures.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-774 Chemical testing: selectivity

A. The laboratory shall evaluate selectivity by following the checks established within the method, which may include mass spectral tuning, second column confirmation, ICP inter-element interference checks, chromatography retention time windows, sample blanks, spectrochemical absorption or fluorescence profiles, co-precipitation evaluations, and electrode response factors.

B. A confirmation shall be performed to verify the compound identification when positive results are detected on a sample from a location that has not been previously tested by the laboratory. Such confirmations shall be performed on organic tests such as pesticides, herbicides, or acid extractable or when recommended by the analytical test method except when the analysis involves the use of a mass spectrometer. Confirmation is required unless stipulated in writing by the client. All confirmation shall be documented.

C. The laboratory shall document acceptance criteria for mass spectral tuning.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-775 Chemical testing: constant and consistent test conditions

A. The laboratory shall assure that the test instruments consistently operate within the specifications required of the application for which the equipment is used.

B. Any cleaning and storage procedures that are not specified by the test method shall be documented in laboratory records and SOPs.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-780 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-781 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-782 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-783 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-784 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-785 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-786 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-787 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-788 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-789 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-790 Microbiology testing: general

These standards apply to laboratories undertaking microbiological analysis of environmental samples. Microbiological testing refers to and includes the detection, isolation, enumeration, or identification of microorganisms and/or their metabolites, or determination of the presence or absence of growth in materials and media.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-791 Microbiology testing: sterility checks and blanks, positive and negative controls

A. Sterility checks and blanks. The laboratory shall demonstrate that the filtration equipment and filters, sample containers, media and reagents have not been contaminated through improper handling or preparation, inadequate sterilization, or environmental exposure.

1. A sterility blank shall be analyzed for each lot of pre-prepared, ready-to-use medium (including chromofluorogenic reagent) and for each batch of medium prepared in the laboratory. This shall be done prior to first use of the medium.

2. For filtration technique, the laboratory shall conduct one beginning and one ending sterility check for each filtration series. The filtration series may include single or multiple filtration units, which have been sterilized prior to beginning the series. For presterilized single use funnels a sterility check shall be performed on one funnel per lot. The filtration series is considered ended when more than 30 minutes elapses between successive filtrations. During a filtration series, filter funnels shall be rinsed with three 20-30 ml portions of sterile rinse water after each sample filtration. In addition, laboratories shall insert a sterility blank after every 10 samples or sanitize filtration units by UV light after each sample filtration.

3. For pour plate technique, sterility blanks of the medium shall be made by pouring, at a minimum, one uninoculated plate for each lot of pre-prepared, ready-to-use media and for each batch of medium prepared in the laboratory.

4. Sterility checks on sample containers shall be performed on at least one container for each lot of purchased, presterilized containers with nonselective growth media. For containers prepared and sterilized in the laboratory, a sterility check shall be performed on one container per sterilized batch with nonselective growth media.

5. A sterility blank shall be performed on each batch of dilution water prepared in the laboratory and on each batch of pre-prepared, ready-to-use dilution water with nonselective growth media.

6. At least one filter from each new lot of membrane filters shall be checked for sterility with nonselective growth media.

B. Positive controls.

1. Positive culture controls demonstrate that the medium can support the growth of the target organism or organism, and that the medium produces the specified or expected reaction to the target organism or organism.

2. Each preprepared, ready-to-use lot of medium (including chromofluorogenic reagent) and each batch of medium prepared in the laboratory shall be tested and demonstrate a known positive response. This shall be done prior to first use of the medium.

C. Negative controls. The provisions of this subsection shall not apply to wastewater treatment plants.

1. Negative culture controls demonstrate that the medium does not support the growth of nontarget organisms or does not demonstrate the typical positive reaction of the target organism or organisms.

2. Each pre-prepared, ready-to-use lot of selective medium (including chromofluorogenic reagent) and each batch of selective medium prepared in the laboratory shall be analyzed with one or more known negative culture controls (i.e., nontarget organisms) as appropriate to the method. This shall be done prior to first use of the medium.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016; Errata, 32:24 VA.R. XXX July 25, 2016.

1VAC30-45-792 Microbiology testing: test variability and reproducibility

For test methods that specify colony counts such as membrane filter or plated media, duplicate counts shall be performed monthly on one positive sample, for each month that the test is performed. If the lab has two or more analysts, each analyst shall count typical colonies on the same plate. Counts shall be within 10% difference to be acceptable. In a laboratory with only one microbiology analyst, the analyst shall count the same plate twice, with no more than 5.0% difference between the counts.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-793 Microbiology testing: method evaluation

A. Laboratories are required to demonstrate proficiency with the test method prior to first use. This shall be achieved by comparison to a method already approved for use in the laboratory, or by analyzing a minimum of 10 spiked samples whose quality system matrix is representative of those normally submitted to the laboratory, or by analyzing and passing one proficiency test series provided by an approved proficiency sample provider. The laboratory shall maintain this documentation as long as the method is in use and for at least five years past the date of last use.

B. Laboratories shall participate in the proficiency test programs required by Article 3 (1VAC30-45-500 et seq.). The results of these analyses shall be used to evaluate the ability of the laboratory to produce acceptable data.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-794 Microbiology testing: test performance

A. All growth and recovery media shall be checked to assure that the target organism(s) respond in an acceptable and predictable manner (see 1VAC30-45-791 B).

B. To ensure that analysis results are accurate, target organism identity shall be verified as specified in the method, e.g., by use of the completed test, or by use of secondary verification tests such as a catalase test.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-795 Microbiology testing: data reduction

The calculations, data reduction and statistical interpretations specified by each test method shall be followed.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-796 Microbiology testing: quality of standards, reagents, and media

A. The laboratory shall ensure that the quality of the reagents and media used is appropriate for the test concerned.

B. Culture media may be prepared from commercial dehydrated powders or may be purchased ready to use. The laboratory may prepare media from basic ingredients when commercial media are not available or when it can be demonstrated that commercial media do not provide adequate results. Media prepared by the laboratory from basic ingredients shall be tested for performance (e.g., for selectivity, sensitivity, sterility, growth promotion, growth inhibition) prior to first use. Detailed testing criteria information shall be defined in either the laboratory's test methods, SOPs, quality manual, or similar documentation.

C. Reagents, commercial dehydrated powders and media shall be used within the shelf-life of the product and shall be documented according to 1VAC30-45-730 J.

D. Distilled water, deionized water or reverse osmosis produced water free from bactericidal and inhibitory substances shall be used in the preparation of media, solutions and buffers. The quality of the water shall be monitored for chlorine residual, specific conductance, and heterotrophic bacteria plate count monthly (when in use), when maintenance is performed on the water treatment system, or at startup after a period of disuse longer than one month.

E. Analysis for metals and the Bacteriological Water Quality Test (to determine presence of toxic agents or growth promoting substances) shall be performed annually. Results of these analyses shall meet the specifications of the required method and records of analyses shall be maintained for three years. (An exception to performing the Bacteriological Water Quality Test shall be given to laboratories that can supply documentation to show that their water source meets the criteria, as specified by the method, for Type I or Type II reagent water.)

F. Media, solutions and reagents shall be prepared, used and stored according to a documented procedure following the manufacturer's instructions or the test method. Documentation for media prepared in the laboratory shall include date of preparation, preparer's initials, type and amount of media prepared, manufacturer and lot number, final pH of the media, and expiration date. Documentation for media purchased pre-prepared, ready to use shall include manufacturer, lot number, type of media received, date of receipt, expiration date of the media, and pH of the media.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-797 Microbiology testing: selectivity

In order to ensure identity and traceability, reference cultures used for positive and negative controls shall be obtained from a recognized national collection, organization, or manufacturer. Microorganisms may be single use preparations or cultures maintained by documented procedures that demonstrate the continued purity and viability of the organism.

1. Reference cultures may be revived (if freeze-dried) or transferred from slants and subcultured once to provide reference stocks. The reference stocks shall be preserved by a technique that maintains the characteristics of the strains. Reference stocks shall be used to prepare working stocks for routine work. If reference stocks have been thawed, they shall not be refrozen and reused.

2. Working stocks shall not be sequentially cultured more than five times and shall not be subcultured to replace reference stocks.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-798 Microbiology testing: constant and consistent test conditions

A. Laboratory facilities. Floors and work surfaces shall be nonabsorbent and easy to clean and disinfect. Work surfaces shall be adequately sealed. Laboratories shall provide sufficient storage space, and shall be clean and free from dust accumulation. Plants, food, and drink shall be prohibited from the laboratory work area.

B. Laboratory equipment.

1. Temperature measuring devices. Temperature measuring devices such as liquid-in-glass thermometers, thermocouples, and platinum resistance thermometers used in incubators, autoclaves and other equipment shall be the appropriate quality to meet specifications in the test method. The graduation of the temperature measuring devices shall be appropriate for the required accuracy of measurement and they shall be calibrated to national or international standards for temperature (see 1VAC30-45-740 C). Calibration shall be done at least annually.

2. Autoclaves.

a. The performance of each autoclave shall be initially evaluated by establishing its functional properties and performance, for example, heat distribution characteristics with respect to typical uses. Autoclaves shall meet specified temperature tolerances. Pressure cookers shall not be used for sterilization of growth media.

b. Demonstration of sterilization temperature shall be provided by use of continuous temperature recording device or by use of a maximum registering thermometer with every cycle. Appropriate biological indicators shall be used once per month to determine effective sterilization. Temperature sensitive tape shall be used with the contents of each autoclave run to indicate that the autoclave contents have been processed.

c. Records of autoclave operations shall be maintained for every cycle. Records shall include date, contents, maximum temperature reached, pressure, time in sterilization mode, total run time (may be recorded as time in and time out) and analyst's initials.

d. Autoclave maintenance shall be performed annually, either internally or by service contract, and shall include a pressure check and calibration of temperature device. Records of the maintenance shall be maintained in equipment logs. If the laboratory demonstrates regular monitoring of pressure (e.g., for each autoclaved batch) and annual calibration of the maximum registering thermometer, the annual autoclave pressure and temperature device checks shall not be required.

e. The autoclave mechanical timing device shall be checked quarterly against a stopwatch and the actual time elapsed documented.

3. Volumetric equipment. Volumetric equipment shall be calibrated as follows:

a. Equipment with movable parts such as automatic dispensers, dispensers/diluters, and mechanical hand pipettes shall be verified for accuracy quarterly.

b. Equipment such as filter funnels, bottles, nonclass A glassware, and other marked containers shall be calibrated once per lot prior to first use.

c. The volume of the disposable volumetric equipment such as sample bottles and disposable pipettes shall be checked once per lot.

4. UV instruments. UV instruments used for sanitization shall be tested quarterly for effectiveness with an appropriate UV light meter or by plate count agar spread plates. Replace bulbs if output is less than 70% of original for light tests or if count reduction is less than 99% for a plate containing 200 to 300 organisms.

5. Conductivity meters, oxygen meters, pH meters, hygrometers, and other similar measurement instruments shall be calibrated according to the method specified requirements (see 1VAC30-45-740 D 1 d).

6. Incubators, water baths, and ovens.

a. The uniformity of temperature distribution in incubators and water baths shall be established. Temperature of incubators and water baths shall be documented twice daily, at least four hours apart, on each day of use.

b. Ovens used for sterilization shall be checked for sterilization effectiveness monthly with appropriate biological indicators. Records shall be maintained for each cycle that include date, cycle time, temperature, contents and analyst's initials.

7. Labware (glassware and plasticware).

a. The laboratory shall have a documented procedure for washing labware, if applicable. Detergents designed for laboratory use shall be used.

b. Glassware shall be made of borosilicate or other noncorrosive material, free of chips and cracks, and shall have readable measurement marks.

c. Labware that is washed and reused shall be tested for possible presence of residues that may inhibit or promote growth of microorganisms by performing the Inhibitory Residue Test annually, and each time the lab changes the lot of detergent or washing procedures.

d. Washed labware shall be tested at least once daily, each day of washing, for possible acid or alkaline residue by testing at least one piece of labware with a suitable pH indicator such as bromothymol blue. Records of tests shall be maintained.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-800 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-801 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-802 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-803 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-804 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-805 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-806 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-807 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-808 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-809 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-810 Air testing: general

These standards shall apply to samples that are submitted to a laboratory for the purpose of analysis. They do not apply to field activities such as source air emission measurements or the use of continuous analysis devices.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-811 Air testing: negative and positive controls

A. Negative controls.

1. Method blanks shall be performed at a frequency of at least one per batch of 20 environmental samples or less per sample preparation method. The results of the method blank analysis shall be used to evaluate the contribution of the laboratory provided sampling media and analytical sample preparation procedures to the amount of analyte found in each sample. If the method blank result is greater than the limit of quantitation and contributes greater than 10% of the total amount of analyte found in the sample, the source of the contamination shall be investigated and measures taken to eliminate the source of contamination. If contamination is found, the data shall be qualified in the report.

2. Collection efficiency. Sampling trains consisting of multiple sections (e.g., filters, sorbent tubes, impingers) that are received intact by the laboratory shall be separated into "front" and "back" sections if required by the client. Each section shall be processed and analyzed separately and the analytical results reported separately.

B. Positive controls. Laboratory control sample (LCS) shall be analyzed at a rate of at least one per batch of 20 or fewer samples per sample preparation method for each analyte. If a spiking solution is not available, a calibration solution whose concentration approximates that of the samples shall be included in each batch and with each lot of media. The concentration of the LCS shall be relevant to the intended use of the data and either at a regulatory limit or below it.

C. Surrogates shall be used as required by the test method.

D. Matrix spike shall be used as required by the test method.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-812 Air testing: analytical variability/reproducibility

Matrix spike duplicates (MSDs) or laboratory duplicates shall be analyzed at a minimum of one in 20 samples per sample batch. The laboratory shall document their procedure to select the use of appropriate types of spikes and duplicates. The selected samples(s) shall be rotated among sampling points or sampling locations so that various sample matrix problems may be noted and/or addressed. Poor performance in the spikes and duplicates may indicate a problem with the sample composition and shall be reported to the client.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-813 Air testing: method evaluation

In order to ensure the accuracy of the reported result, the following procedures shall be in place:

1. Demonstration of capability shall be performed prior to the analysis of any samples and with a significant change in instrument type, personnel, quality system matrix, or test method.

2. Calibration. Calibration protocols specified in 1VAC30-45-740 shall be followed.

3. Proficiency test samples. The results of such analyses shall be used by the laboratory to evaluate the ability of the laboratory to produce accurate data.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-814 Air testing: limit of detection

The requirements of 1VAC30-45-771 shall apply.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-815 Air testing: data reduction

The procedures for data reduction, such as use of linear regression, shall be documented.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-816 Air testing: quality of standards and reagents

A. The source of standards shall comply with 1VAC30-45-740 C.

B. The purity of each analyte standard and each reagent shall be documented by the laboratory through certificates of analyses from the manufacturer/vendor, manufacturer/vendor specifications, and/or independent analysis.

C. In methods where the purity of reagents is not specified, analytical reagent grade or higher quality, if available, shall be used.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-817 Air testing: selectivity

The laboratory shall develop and document acceptance criteria for test method selectivity such as absolute and relative retention times, wavelength assignments, mass spectral library quality of match, and mass spectral tuning.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-818 Air testing: constant and consistent test conditions

A. The laboratory shall assure that the test instruments consistently operate within the specifications required of the application for which the equipment is used.

B. The laboratory shall document that all sampling equipment, containers and media used or supplied by the laboratory meet required test method criteria.

C. If supplied or used by the laboratory, procedures for field equipment decontamination shall be developed and their use documented.

D. The laboratory shall have a documented program for the calibration and verification of sampling equipment such as pumps, meter boxes, critical orifices, flow measurement devices and continuous analyzers, if these equipment are used or supplied by the laboratory.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-819 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-820 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-821 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-822 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-823 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-824 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-825 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-826 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-827 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-828 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-829 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; repealed, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-830 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-840 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-850 Sample handling, sample acceptance policy, and sample receipt

While the laboratory may not have control of field sampling activities, the following are essential to ensure the validity of the laboratory's data.

1. Sample tracking. The laboratory shall have a documented system for uniquely identifying the items to be tested to ensure that there can be no confusion regarding the identity of such items at any time. This system shall include identification for all samples, subsamples and subsequent extracts or digestates or both. The use of container shape, size or other physical characteristic, such as amber glass or purple top, is not an acceptable means of identifying the sample. System laboratories shall use a permanent chronological record such as a logbook or electronic database to document receipt of all containers. This sample receipt log shall record the following at a minimum: name of facility where sample was taken, date and time of laboratory receipt, unique laboratory ID code, and signature or initials of the person making the entries.

2. Sample acceptance policy. The laboratory shall have a written sample acceptance policy that clearly outlines the circumstances under which samples shall be accepted or rejected. The policy shall ensure that only properly obtained samples with appropriate sampling records (see 1VAC30-45-640 B) are analyzed and that the samples are handled properly. This sample acceptance policy shall be made available to sample collection personnel. The policy shall include elements such as appropriate documentation of the sample's identification, use of appropriate sample containers, adherence to specified holding times, adequate sample volume to perform necessary tests, and procedures to be used when samples show signs of damage, contamination or inadequate preservation.

3. Sample receipt protocols.

a. Upon receipt, the condition of the sample, including any abnormalities or departures from standard condition as prescribed in the relevant test method, shall be recorded. All items specified by the sample acceptance policy shall be checked.

b. All samples that require thermal preservation shall be considered acceptable if the arrival temperature is either within 2°C of the required temperature or the method specified range. For samples with a specified temperature of 4°C, samples with a temperature of ranging from just above freezing temperature of water to 6°C shall be acceptable. Samples that are hand delivered to the laboratory immediately after collection or on the same day that are collected may not meet these criteria. In these cases, the samples shall be considered acceptable if there is evidence that the chilling process has begun such as arrival on ice. Thermal preservation is not required in the field if the laboratory receives the sample and either begins the analysis or refrigerates the sample within 15 minutes of collection.

c. The laboratory shall implement procedures for checking chemical preservation using readily available techniques, such as pH or free chlorine prior to or during sample preparation or analysis.

d. The results of all checks required by the sample acceptance policy and relevant test method shall be recorded.

4. Storage conditions.

a. The laboratory shall have documented procedures and appropriate facilities to avoid deterioration, contamination or damage to the sample during storage, handling, preparation, and testing. Any relevant instructions provided with the item shall be followed. Where items have to be stored or conditioned under specific environmental conditions, these conditions shall be maintained, monitored and recorded.

b. Samples shall be stored according to the conditions specified by preservation protocols:

(1) Samples that require thermal preservation shall be stored under refrigeration that is within 2°C of the specified preservation temperature unless method specific criteria exist. For samples with a specified storage temperature of 4°C, storage at a temperature above the freezing point of water to 6°C shall be acceptable.

(2) Samples shall be stored away from all standards, reagents, food and other potentially contaminating sources. Samples shall be stored in such a manner to prevent cross contamination.

c. Sample fractions, extracts, leachates and other sample preparation products shall be stored according to subdivision 4 a of this section or according to specifications in the test method.

d. Where a sample or portion of the sample is to be held secure (e.g., for reasons of record, safety or value, or to enable check calibrations or tests to be performed later), the laboratory shall have storage and security arrangements that protect the condition and integrity of the secured items or portions concerned.

5. Sample disposal. The laboratory shall have standard operating procedures for the disposal of samples, digestates, leachates and extracts or other sample preparation products.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

1VAC30-45-860 Laboratory report format and contents

A. The results of each test or series of tests carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively. The results shall normally be reported in a test report required by regulation and shall include all the information necessary for the interpretation of the test results and all information required by the method used.

B. Where the certificate or report contains results of tests performed by subcontractors, these results shall be clearly identified by subcontractor name or applicable certification number.

C. After issuance of the report, the laboratory report shall remain unchanged. Material amendments to a calibration certificate, test report or test certificate after issue shall be made only in the form of a further document, or data transfer including the statement "Supplement to Test Report or Test Certificate, serial number... (or as otherwise identified)," or equivalent form of wording. Such amendments shall meet all the relevant requirements of this article.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

Chapter 46 Accreditation for Commercial Environmental Laboratories

Part I General Provisions

1VAC30-46-10 Purpose

Section 2.2-1105 of the Code of Virginia directs the Division of Consolidated Laboratory Services to establish a program to certify environmental laboratories that perform tests, analyses, measurements or monitoring required pursuant to the Commonwealth's air, waste and water laws and regulations. This chapter sets out the required standards and the process by which owners of commercial environmental laboratories may obtain certification for their laboratories. Certification is referred to as accreditation in this chapter.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 1, eff. November 1, 2015.

1VAC30-46-15 Standards for accreditation transition

A. Commercial environmental laboratories are accredited under the standards of The NELAC Institute (TNI).

B. DCLS shall accredit commercial environmental laboratories under the 2009 TNI Standards as specified by the provisions of this chapter that became effective on November 1, 2015, for the first six months following April 1, 2022.

C. DCLS shall accredit commercial environmental laboratories under the 2016 TNI Standards as specified by the provisions of this chapter effective April 1, 2022, beginning on the first day of the seventh month following April 1, 2022.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 1, eff. November 1, 2015; amended, Virginia Register Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-46-20 Establishment of accreditation program

A. Once the accreditation program has been established, laboratory accreditation shall be required before any environmental analyses performed by a commercial environmental laboratory may be used for the purposes of the Virginia Air Pollution Control Law, the Virginia Waste Management Act or the State Water Control Law (§ 10.1-1300 et seq., § 10.1-1400 et seq., and § 62.1-44.2 et seq., respectively, of the Code of Virginia).

B. The accreditation program shall be established on January 1, 2012.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-46-30 Applicability

A. General applicability. This chapter applies to the following:

1. Any owner of a commercial environmental laboratory.

2. Any owner of an environmental laboratory holding TNI accreditation from a primary accreditation body who wishes to apply for secondary accreditation under 1VAC30-46-140.

B. Acquiring primary TNI accreditation through this chapter.

1. A commercial environmental laboratory located in Virginia shall obtain primary TNI accreditation in Virginia as long as the fields of accreditation for which the laboratory seeks accreditation are offered by DCLS.

2. DCLS shall not provide primary TNI accreditation for environmental laboratories located in other states that offer TNI accreditation.

C. Voluntary accreditation. Any owner of a noncommercial environmental laboratory may apply for accreditation under this chapter.

D. Drinking water laboratory certification. An owner of a laboratory who must meet the requirements of 1VAC30-41 pertaining to drinking water laboratory certification and either 1VAC30-45 or this chapter may meet those requirements by obtaining accreditation under this chapter.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 1, eff. November 1, 2015; Errata, 32:3 VA.R. 447 October 5, 2015.

1VAC30-46-40 Definitions

A. The definitions contained in the 2016 TNI Standards are incorporated by reference into this section. Some of these definitions are included in this section because the terms are used throughout this chapter.

B. The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Acceptance criteria" means specified limits placed on characteristics of an item, process, or service defined in requirement documents.

"Accreditation" means the process by which an agency or organization evaluates and recognizes a laboratory as meeting certain predetermined qualifications or standards, thereby accrediting the laboratory. "Accreditation" is the term used as a substitute for the term "certification" under this chapter.

"Accreditation body" or "AB" means the territorial, state, or federal agency having responsibility and accountability for environmental laboratory accreditation and which grants accreditation.

"Algae" means simple single-celled, colonial, or multicelled, mostly aquatic plants, containing chlorophyll and lacking roots, stems and leaves that are either suspended in water (phytoplankton) or attached to rocks and other substrates (periphyton).

"Analyte" means the substance , organism, physical parameter, or chemical constituent for which an environmental sample is being analyzed.

"Analytical method" means a technical procedure for providing analysis of a sample, defined by a body such as the Environmental Protection Agency or the American Society for Testing and Materials, that may not include the sample preparation method.

"Assessment" means the evaluation process used to measure or establish the performance, effectiveness, and conformance of an organization and its systems or both to defined criteria (i.e., to the standards and requirements of laboratory accreditation).

"Assessor" means the person assigned by DCLS to perform, alone or as part of an assessment team, an assessment of an environmental laboratory.

"Authority" means, in the context of a governmental body or local government, an authority created under the provisions of the Virginia Water and Waste Authorities Act, Chapter 51 (§ 15.2-5100 et seq.) of Title 15.2 of the Code of Virginia.

"Benthic macroinvertebrates" means bottom dwelling animals without backbones that live at least part of their life cycles within or upon available substrates within a body of water.

"Commercial environmental laboratory" means an environmental laboratory where environmental analysis is performed for another person.

"Corrective action" means the action taken to eliminate the causes of an existing nonconformity, defect or other undesirable situation in order to prevent recurrence.

"DCLS" means the Division of Consolidated Laboratory Services of the Department of General Services.

"Environmental analysis" or "environmental analyses" means any test, analysis, measurement, or monitoring used for the purposes of the Virginia Air Pollution Control Law, the Virginia Waste Management Act or the State Water Control Law (§ 10.1-1300 et seq., § 10.1-1400 et seq., and § 62.1-44.2 et seq., respectively, of the Code of Virginia). For the purposes of these regulations, any test, analysis, measurement, or monitoring required pursuant to the regulations promulgated under these three laws, or by any permit or order issued under the authority of any of these laws or regulations is "used for the purposes" of these laws. The term shall not include the following:

1. Sampling of water, solid and chemical materials, biological tissue, or air and emissions.

2. Field testing and measurement of water, solid and chemical materials, biological tissue, or air and emissions, except when performed in an environmental laboratory rather than at the site where the sample was taken.

3. Taxonomic identification of samples for which there is no national accreditation standard such as algae, benthic macroinvertebrates, macrophytes, vertebrates, and zooplankton.

4. Protocols used pursuant to § 10.1-104.2 of the Code of Virginia to determine soil fertility, animal manure nutrient content, or plant tissue nutrient uptake for the purposes of nutrient management.

5. Geochemical and permeability testing for solid waste compliance.

6. Materials specification for air quality compliance when product certifications specify the data required by an air permit such as fuel type, Btu content, sulfur content, or volatile organic chemical (VOC) content.

"Environmental laboratory" or "laboratory" means a facility or a defined area within a facility where environmental analysis is performed. A structure built solely to shelter field personnel and equipment from inclement weather shall not be considered an environmental laboratory.

"Establishment date" means the date set for the accreditation program under this chapter and the certification program under 1VAC30-45 to be established.

"Establishment of accreditation program" or "established program" means that DCLS has completed the initial accreditation of environmental laboratories covered by this chapter and the initial certification of environmental laboratories covered by 1VAC30-45.

"Facility" means something that is built or installed to serve a particular function.

"Field of accreditation" means those matrix, technology/method, and analyte combinations for which DCLS offers accreditation.

"Field of accreditation matrix" means the following when accrediting a laboratory:

1. Drinking water. Any aqueous sample that has been designated a potable or potential potable water source.

2. Nonpotable water. Any aqueous sample excluded from the definition of drinking water matrix. Includes surface water, groundwater, effluents, water treatment chemicals, and TCLP or other extracts.

3. Solid and chemical materials. Includes soils, sediments, sludges, products and byproducts of an industrial process that results in a matrix not previously defined.

4. Biological tissue. Any sample of a biological origin such as fish tissue, shellfish, or plant material. Such samples shall be grouped according to origin (i.e., by species).

5. Air and emissions. Whole gas or vapor samples including those contained in flexible or rigid wall containers and the extracted concentrated analytes of interest from a gas or vapor that are collected with a sorbent tube, impinger solution, filter or other device.

"Field of proficiency testing" or "FoPT" means the matrix, technology/method, and analyte combinations for which the composition spike concentration ranges and acceptance criteria have been established by the Proficiency Testing Program Executive Committee of TNI.

"Field testing and measurement" means any of the following:

1. Any test for parameters under 40 CFR Part 136 for which the holding time indicated for the sample requires immediate analysis; or

2. Any test defined as a field test in federal regulation.

The following is a limited list of currently recognized field tests or measures that is not intended to be inclusive: continuous emissions monitoring; online monitoring; flow monitoring; tests for pH, residual chlorine, temperature and dissolved oxygen; and field analysis for soil gas.

"Finding" means an assessment conclusion referenced to a laboratory accreditation standard incorporated by reference or contained in this chapter and supported by objective evidence that identifies a deviation from a laboratory accreditation standard requirement.

"Governmental body" means any department, agency, bureau, authority, or district of the United States government, of the government of the Commonwealth of Virginia, or of any local government within the Commonwealth of Virginia.

"Holding time" means the maximum time that can elapse between two specified activities.

"Legal entity" means an entity, other than a natural person, who has sufficient existence in legal contemplation that it can function legally, be sued or sue and make decisions through agents as in the case of corporations.

"Local government" means a municipality (city or town), county, sanitation district, or authority.

"Macrophytes" means any aquatic or terrestrial plant species that can be identified and observed with the eye, unaided by magnification.

"Matrix" means the substrate of a test sample.

"National Environmental Laboratory Accreditation Conference" or "NELAC" means a voluntary organization of state and federal environmental officials and interest groups with the primary purpose to establish mutually acceptable standards for accrediting environmental laboratories. NELAC preceded the formation of The NELAC Institute or TNI.

"National Environmental Laboratory Accreditation Program" or "NELAP" means the program under TNI the purpose of which is to establish and implement a program for the accreditation of environmental laboratories. This program is comprised in part of NELAP Accreditation Bodies which are recognized and approved under the program to implement the TNI standards. The NELAP accreditation bodies currently are state programs such as the one in Virginia.

"Noncommercial environmental laboratory" means either of the following:

1. An environmental laboratory where environmental analysis is performed solely for the owner of the laboratory.

2. An environmental laboratory where the only performance of environmental analysis for another person is one of the following:

a. Environmental analysis performed by an environmental laboratory owned by a local government for an owner of a small wastewater treatment system treating domestic sewage at a flow rate of less than or equal to 1,000 gallons per day.

b. Environmental analysis performed by an environmental laboratory operated by a corporation as part of a general contract issued by a local government to operate and maintain a wastewater treatment system or a waterworks.

c. Environmental analysis performed by an environmental laboratory owned by a corporation as part of the prequalification process or to confirm the identity or characteristics of material supplied by a potential or existing customer or generator as required by a hazardous waste management permit under 9VAC20-60.

d. Environmental analysis performed by an environmental laboratory owned by a Publicly Owned Treatment Works (POTW) for an industrial source of wastewater under a permit issued by the POTW to the industrial source as part of the requirements of a pretreatment program under Part VII (9VAC25-31-730 et seq.) of 9VAC25-31.

e. Environmental analysis performed by an environmental laboratory owned by a county authority for any municipality within the county's geographic jurisdiction when the environmental analysis pertains solely to the purpose for which the authority was created.

f. Environmental analysis performed by an environmental laboratory owned by an authority or a sanitation district for any participating local government of the authority or sanitation district when the environmental analysis pertains solely to the purpose for which the authority or sanitation district was created.

"Owner" means any person who owns, operates, leases, or controls an environmental laboratory.

"Person" means an individual, corporation, partnership, association, company, business, trust, joint venture or other legal entity.

"Physical," for the purposes of fee test categories, means the tests to determine the physical properties of a sample. Tests for solids, turbidity, and color are examples of physical tests.

"Pretreatment requirements" means any requirements arising under Part VII (9VAC25-31-730 et seq.) of 9VAC25-31 including the duty to allow or carry out inspections, entry, or monitoring activities; any rules, regulations, or orders issued by the owner of a POTW; or any reporting requirements imposed by the owner of a POTW or by the regulations of the State Water Control Board. Pretreatment requirements do not include the requirements of a national pretreatment standard.

"Primary accreditation body" or "primary AB" means the accreditation body responsible for assessing a laboratory's total quality system, on-site assessment, and PT performance tracking for fields of accreditation.

"Proficiency test," "proficiency testing," or "PT" means a process to evaluate a laboratory's performance under controlled conditions relative to a given set of criteria through analysis of unknown samples provided by an external source.

"Proficiency test sample" or "PT sample" means a sample, the composition of which is unknown to the laboratory and is provided to test whether the laboratory can produce analytical results within specified acceptance criteria.

"Proficiency testing program" or "PT program" means the aggregate of providing rigorously controlled and standardized environmental samples to a laboratory for analysis, reporting of results, statistical evaluation of the results and the collective demographics and results summary of all participating laboratories.

"Publicly Owned Treatment Works" or "POTW" means a treatment works as defined by § 212 of the CWA, which is owned by a state or municipality (as defined by § 502(4) of the CWA). This definition includes any devices and systems used in the storage, treatment, recycling, and reclamation of municipal sewage or industrial wastes of a liquid nature. It also includes sewers, pipes, and other conveyances only if they convey wastewater to a POTW treatment plant. The term also means the municipality as defined in § 502(4) of the CWA, which has jurisdiction over the indirect discharges to and the discharges from such a treatment works.

"Quality assurance" or "QA" means an integrated system of management activities involving planning, implementation, assessment, reporting, and quality improvement to ensure that a process, item, or service is of the type and quality needed and expected by the client.

"Quality assurance officer" means the person who has responsibility for the quality system and its implementation. Where staffing is limited, the quality assurance officer may also be the technical manager.

"Quality control" or "QC" means the (i) overall system of technical activities that measures the attributes and performance of a process, item, or service against defined standards to verify that they meet the stated requirements established by the customer; (ii) operational techniques and activities that are used to fulfill requirements for quality; and (iii) system of activities and checks used to ensure that measurement systems are maintained within prescribed limits, providing protection against "out of control" conditions and ensuring that the results are of acceptable quality.

"Quality manual" means a document stating the management policies, objectives, principles, organizational structure and authority, responsibilities, accountability, and implementation of an agency, organization, or laboratory, to ensure the quality of its product and the utility of its product to its users.

"Quality system" means a structured and documented management system describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services. The quality system provides the framework for planning, implementing, and assessing work performed by the organization and for carrying out required quality assurance and quality control activities.

"Responsible official" means one of the following, as appropriate:

1. If the laboratory is owned or operated by a private corporation, "responsible official" means (i) a president, secretary, treasurer, or a vice-president of the corporation in charge of a principal business function, or any other person who performs similar policy-making or decision-making functions for the corporation or (ii) the manager of one or more manufacturing, production, or operating facilities employing more than 250 persons or having gross annual sales or expenditures exceeding $25 million (in second-quarter 1980 dollars), if authority to sign documents has been assigned or delegated in accordance with corporate procedures.

2. If the laboratory is owned or operated by a partnership, association, or a sole proprietor, "responsible official" means a general partner, officer of the association, or the proprietor, respectively.

3. If the laboratory is owned or operated by a governmental body, "responsible official" means a director or highest official appointed or designated to oversee the operation and performance of the activities of the governmental laboratory.

4. Any person designated as the responsible official by an individual described in subdivision 1, 2, or 3 of this definition provided the designation is in writing, the designation specifies an individual or position with responsibility for the overall operation of the laboratory, and the designation is submitted to DCLS.

"Sampling" means an activity related to obtaining a representative sample of the object of conformity assessment, according to a procedure.

"Sanitation district" means a sanitation district created under the provisions of Chapters 3 (§ 21-141 et seq.) through 5 (§ 21-291 et seq.) of Title 21 of the Code of Virginia.

"Secondary accreditation body" or "secondary AB" means the accreditation body that grants laboratory accreditation for a field of accreditation based on recognition of accreditation from a primary accreditation body for the same field of accreditation.

"Sewage" means the water-carried human wastes from residences, buildings, industrial establishments, or other places together with such industrial wastes and underground, surface, storm, or other water as may be present.

"Standard operating procedure" or "SOP" means a written document that details the method for an operation, analysis, or action with thoroughly prescribed techniques and steps. An SOP is officially approved as the method for performing certain routine or repetitive tasks.

"TCLP" or "toxicity characteristic leachate procedure" means Test Method 1311 in "Test Methods for Evaluating Solid Waste, Physical/Chemical Methods," EPA Publication SW-846, as incorporated by reference in 40 CFR 260.11. This method is used to determine whether a solid waste exhibits the characteristic of toxicity (see 40 CFR 261.24).

"Technical manager (however named)" means the person who has overall responsibility for the technical operation of the environmental laboratory and who exercises actual day-to-day supervision of laboratory operation for the appropriate fields of testing and reporting of results. The title of this person may include but is not limited to laboratory director, technical manager, laboratory supervisor, or laboratory manager.

"Technology" means a specific arrangement of analytical instruments, detection systems, or preparation techniques, or any combination of these elements.

"Test" means a technical operation that consists of the determination of one or more characteristics or performance of a given product, material, equipment, organism, physical phenomenon, process, or service according to a specified procedure.

"Test, analysis, measurement or monitoring required pursuant to the Virginia Air Pollution Control Law" means any method of analysis required by the Virginia Air Pollution Control Law (§ 10.1-1300 et seq. of the Code of Virginia); by the regulations promulgated under this law (9VAC5), including any method of analysis listed either in the definition of "reference method" in 9VAC5-10-20, or listed or adopted by reference in 9VAC5; or by any permit or order issued under and in accordance with this law and these regulations.

"Test, analysis, measurement or monitoring required pursuant to the Virginia Waste Management Act" means any method of analysis required by the Virginia Waste Management Act (§ 10.1-1400 et seq. of the Code of Virginia); by the regulations promulgated under this law (9VAC20), including any method of analysis listed or adopted by reference in 9VAC20; or by any permit or order issued under and in accordance with this law and these regulations.

"Test, analysis, measurement or monitoring required pursuant to the Virginia Water Control Law" means any method of analysis required by the Virginia Water Control Law (§ 62.1-44.2 et seq. of the Code of Virginia); by the regulations promulgated under this law (9VAC25), including any method of analysis listed or adopted by reference in 9VAC25; or by any permit or order issued under and in accordance with this law and these regulations.

"Test method" means an adoption of a scientific technique for performing a specific measurement, as documented in a laboratory standard operating procedure or as published by a recognized authority.

"The NELAC Institute" or "TNI" means the organization whose standards environmental laboratories must meet to be accredited in Virginia.

"TNI standards" means the 2016 Standards for Environmental Laboratories and Accreditation Bodies approved by TNI.

"Virginia Air Pollution Control Law" means Chapter 13 (§ 10.1-1300 et seq.) of Title 10.1 of the Code of Virginia that is titled "Air Pollution Control Board."

"Virginia Environmental Laboratory Accreditation Program" or "VELAP" means the program DCLS operates to accredit environmental laboratories under this chapter.

"Wastewater" means liquid and water-carried industrial wastes and domestic sewage from residential dwellings, commercial buildings, industrial and manufacturing facilities, and institutions.

"Waterworks" means each system of structures and appliances used in connection with the collection, storage, purification, and treatment of water for drinking or domestic use and the distribution thereof to the public, except distribution piping.

"Zooplankton" means microscopic animals that float freely with voluntary movement in a body of water.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 29, Issue 4, eff. November 21, 2012; Volume 32, Issue 1, eff. November 1, 2015; Errata, 32:3 VA.R. 447 October 5, 2015; Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-46-50 Scope of accreditation

A. Commercial environmental laboratories shall be accredited based on the general laboratory standards set out in Part II (1VAC30-46-200 et seq.) of this chapter and on the specific test methods or analysis, monitoring or measurement required by Virginia Air Pollution Control Law (§ 10.1-1300 et seq. of the Code of Virginia), Virginia Waste Management Act (§ 10.1-1400 et seq. of the Code of Virginia) or Virginia Water Control Law (§ 62.1-44.2 et seq. of the Code of Virginia), the regulations promulgated under these laws, and by permits and orders issued under and in accordance with these laws and regulations.

B. DCLS shall review alternative test methods and procedures for accreditation when these are proposed by the applicant laboratory. The provisions of 1VAC30-46-70 E and 1VAC30-46-90 B govern alternative test methods and procedures.

C. Accreditation shall be granted for one or more fields of accreditation, including the matrix, the technology and methods used by the commercial environmental laboratory, and the individual analytes determined by the particular method.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 1, eff. November 1, 2015.

1VAC30-46-60 General: accreditation requirements

A. Components of accreditation. The components of accreditation include review of personnel qualifications, on-site assessment, proficiency testing and quality assurance and quality control standards. The criteria for these components, specified in Part II (1VAC30-46-200 et seq.) of this chapter, shall be fulfilled for accreditation.

B. Individual laboratory sites and mobile laboratories.

1. Individual laboratory sites are subject to the same application process, assessments, and other requirements as environmental laboratories. Any remote laboratory sites are considered separate sites and subject to separate on-site assessments.

2. Laboratories located at the same physical location shall be considered an individual laboratory site if these laboratories are owned by the same person, and have the same technical manager and quality system.

3. A mobile laboratory, which is configured with equipment to perform environmental analyses, whether associated with a fixed-based laboratory or not, is considered an environmental laboratory and shall require separate accreditation. This accreditation shall remain with the mobile laboratory and be site independent. Moving the configured mobile laboratory to a different site shall not require a new or separate accreditation. Before performing analyses at each new site, the laboratory shall ensure that instruments and equipment have been checked for performance and have been calibrated.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 1, eff. November 1, 2015.

1VAC30-46-70 Process to apply and obtain accreditation

A. Duty to apply. All owners of (i) commercial environmental laboratories and (ii) TNI-accredited commercial environmental laboratories applying for secondary accreditation shall apply for accreditation as specified by the provisions of this section. Applications for accreditation must be obtained from DCLS program staff by email at Lab_Cert@dgs.virginia.gov.

B. Initial applications. Owners of commercial environmental laboratories applying for accreditation under this chapter for the first time shall submit an application to DCLS as specified under subsection F of this section.

C. Renewal and reassessment.

1. DCLS shall renew accreditation annually for the accredited laboratory provided the laboratory does the following:

a. Maintains compliance with this chapter.

b. Attests to this compliance by signing the certificate of compliance provided under subdivision F 3 of this section.

c. Reports acceptable proficiency test values as required by 1VAC30-46-210 B.

d. Pays the fee required by 1VAC30-46-150.

2. DCLS shall reassess the accredited environmental laboratory during an on-site assessment as required by 1VAC30-46-220.

D. Responsibilities of the owner and operator when the laboratory is owned by one person and operated by another person.

1. When an environmental laboratory is owned by one person but is operated by another person, the operator may submit the application for the owner.

2. If the operator fails to submit the application, the owner is not relieved of his responsibility to apply for accreditation.

3. While DCLS may notify environmental laboratories of the date their applications are due, failure of DCLS to notify does not relieve the owner of his obligation to apply under this chapter.

E. Submission of applications for modifications to accreditation. An owner of an accredited environmental laboratory shall follow the process set out in 1VAC30-46-90 B to modify the laboratory's scope of accreditation.

F. Contents of application.

1. Applications shall include but not be limited to the following information and documents:

a. Legal name of laboratory;

b. Name of owner of laboratory;

c. Name of operator of laboratory, if different than owner;

d. Street address and description of location of laboratory;

e. Mailing address of laboratory, if different from street address;

f. Address of owner, if different from laboratory address;

g. Name, address, telephone number, facsimile number, and email, as applicable, of responsible official;

h. Name, address, telephone number, facsimile number, and email, as applicable, of technical manager;

i. Name, address, telephone number, facsimile number, and email, as applicable, of designated quality assurance officer;

j. Name and telephone number of laboratory contact person;

k. Laboratory type (e.g., commercial, public wastewater system, mobile);

l. Laboratory hours of operation;

m. Fields of accreditation for which the laboratory is seeking accreditation;

n. The results of two successful unique TNI-compliant PT studies for each accreditation field of proficiency testing as required by 1VAC30-46-210 B (for primary accreditation only);

o. Quality assurance manual (for primary accreditation only);

p. Copy of the primary certificate of accreditation for secondary accreditation applications; and

q. For mobile laboratories, a unique vehicle identification number, such as a manufacturer's vehicle identification number (VIN #), serial number, or license number.

2. Fee. The application shall include payment of the fee as specified in 1VAC30-46-150.

3. Certification of compliance.

a. The application shall include a "Certification of Compliance" statement signed and dated by (i) the quality assurance officer, and (ii) the responsible official or the technical manager, or both.

b. The certification of compliance shall state: "The applicant understands and acknowledges that the laboratory is required to be continually in compliance with the Virginia environmental laboratory accreditation program regulation (1VAC30 Chapter 46) and is subject to the provisions of 1VAC30-46-100 in the event of noncompliance. Specifically the applicant:

(1) Shall commit to fulfill continually the requirements for accreditation set by DCLS for the areas where accreditation is sought or granted.

(2) When requested, shall afford such accommodation and cooperation as is necessary to enable DCLS to verify fulfillment of requirements for accreditation. This applies to all premises where laboratory services take place.

(3) Shall provide access to information, documents, and records as necessary for the assessment and maintenance of the accreditation.

(4) Shall provide access to those documents that provide insight into the level of independence and impartiality of the laboratory from its related bodies, where applicable.

(5) Shall arrange the witnessing of laboratory services when requested by DCLS.

(6) Shall claim accreditation only with respect to the scope for which it has been granted accreditation.

(7) Shall pay fees as shall be determined by the accreditation body.

(8) Shall have access to a copy of the TNI standards incorporated by reference into this chapter.

I certify under penalty of law that this document and all attachments were prepared under my direction or supervision in accordance with a system designed to assure that qualified personnel properly gather and evaluate the information submitted. Based on my inquiry of the person or persons who manage the laboratory or those persons directly responsible for gathering and evaluating the information, the information submitted is, to the best of my knowledge and belief, true, accurate and complete. Submitting false information or data shall result in denial or withdrawal of accreditation. I further certify that I am authorized to sign this application."

G. Completeness determination.

1. DCLS shall determine whether an application is complete and notify the laboratory of the result of such determination. DCLS shall provide this notice within 90 calendar days of its receipt of the application.

2. An application shall be determined complete if it contains all the information required pursuant to subsection F of this section and is sufficient to evaluate the laboratory prior to the on-site assessment. Designating an application complete does not preclude DCLS from requesting or accepting additional information.

3. If DCLS determines that an application is incomplete, the DCLS notification of such determination shall explain why the application is incomplete and specify the additional information needed to make the application complete.

4. If DCLS makes no determination within 90 calendar days of its receipt of either (i) the application or (ii) additional information, in the case of an application determined to be incomplete, the application shall be determined to be complete.

5. If the laboratory has not submitted the required additional information within 90 days of receiving a notice from DCLS requesting additional information, DCLS may inform the laboratory that the application cannot be processed. The laboratory may then submit a new application.

H. Grant of interim accreditation pending final determination on application.

1. DCLS shall grant interim accreditation status to laboratories applying initially under the following conditions:

a. The laboratory's application is determined to be complete;

b. The laboratory has satisfied all the requirements for accreditation, including all requests for additional information, with the exception of on-site assessment; and

c. DCLS is unable to schedule the on-site assessment within 120 days of its determination that the application is complete.

2. A laboratory with interim accreditation status shall have the same rights and status as a laboratory that has been granted accreditation by DCLS.

3. Interim accreditation status shall not exceed 12 months.

I. On-site assessment. An on-site assessment shall be performed and the follow-up and reporting procedures for such assessments shall be completed in accordance with 1VAC30-46-220 prior to issuance of a final determination on accreditation.

J. Final determination on accreditation. Upon completion of the accreditation review process and corrective action, if any, DCLS shall grant accreditation in accordance with subsection K of this section or deny accreditation in accordance with subsection L of this section.

K. Grant of accreditation.

1. When a laboratory meets the requirements specified for receiving accreditation, DCLS shall issue a certificate to the laboratory. The certificate shall be sent to the technical manager, and the responsible official shall be notified.

2. The director of DCLS or his designee shall sign the certificate.

3. The certificate shall include the following information:

a. Name of owner of laboratory;

b. Name of operator of laboratory, if different from owner;

c. Name of responsible official;

d. Address and location of laboratory;

e. Laboratory identification number;

f. Fields of accreditation (matrix, technology/method, and analyte) for which accreditation is granted;

g. Any addenda or attachments; and

h. Issuance date and expiration date.

4. TNI accreditation status.

a. Laboratories accredited under this chapter are accredited under the standards of TNI.

b. The certificate of accreditation shall contain the TNI insignia.

c. Accredited laboratories shall comply with the provisions of 1VAC30-46-130 with regard to the use of these certificates and their status as TNI-accredited laboratories.

5. The laboratory shall post the most recent certificate of accreditation and any addenda to the certificate issued by DCLS in a prominent place in the laboratory facility.

6. Accreditation shall expire one year after the date on which accreditation is granted.

L. Denial of accreditation.

1. DCLS shall deny accreditation to an environmental laboratory in total if the laboratory is found to be falsifying any data or providing false information to support accreditation.

2. Denial of accreditation in total or in part.

a. DCLS may deny accreditation to an environmental laboratory in total or in part if the laboratory fails to do any of the following:

(1) Pay the required fees;

(2) Employ laboratory staff to meet the personnel qualifications as required by 1VAC30-46-210 A;

(3) Successfully analyze and report proficiency testing samples as required by 1VAC30-46-210 B;

(4) Submit a corrective action plan in accordance with 1VAC30-46-220 in response to a deficiency report from the on-site assessment team within the required 30 calendar days;

(5) Implement the corrective actions detailed in the corrective action plan within the time frame specified by DCLS;

(6) Pass required on-site assessment as specified in 1VAC30-46-220; or

(7) Implement a quality system as defined in 1VAC30-46-210 C.

b. DCLS may deny accreditation to an environmental laboratory in total or in part if the laboratory's application is not determined to be complete within 90 days following notification of incompleteness because the laboratory is delinquent in submitting information required by DCLS in accordance with this chapter.

c. DCLS may deny accreditation to an environmental laboratory in total or in part if the DCLS on-site assessment team is unable to carry out the on-site assessment pursuant to 1VAC30-46-220 because a representative of the environmental laboratory denied the team entry during the laboratory's normal business hours that it specified in the laboratory application.

3. DCLS shall follow the process specified in 1VAC30-46-110 when denying accreditation to an environmental laboratory.

M. Reapplication following denial of accreditation. DCLS shall not waive application fees for a laboratory reapplying for accreditation.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 1, eff. November 1, 2015; Errata, 32:3 VA.R. 447 October 5, 2015; amended, Virginia Register Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-46-80 Maintaining accreditation

A. Accreditation remains in effect until withdrawn by DCLS, withdrawn voluntarily at the written request of the accredited laboratory, or expiration of the accreditation period. To maintain accreditation, the accredited laboratory shall comply with the elements listed in this section and in 1VAC30-46-90.

B. Quality systems. A laboratory seeking to maintain accreditation under this regulation shall assure consistency and promote the use of quality assurance and quality control procedures. 1VAC30-46-210 C specifies the quality assurance and quality control requirements that shall be met to maintain accreditation. The laboratory shall establish and maintain a quality system based on these required elements.

C. Proficiency tests. Laboratories seeking to maintain accreditation under this regulation shall perform proficiency tests as required under 1VAC30-46-210 B.

D. Recordkeeping and retention. All laboratory records associated with accreditation parameters shall be kept as provided by the requirements for records under Part II (1VAC30-46-200 et seq.) of this chapter. These records shall be maintained for a minimum of five years unless designated for a longer period by another regulation or authority. All such records shall be available to DCLS upon request.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 1, eff. November 1, 2015.

1VAC30-46-90 Notifications and changes to accreditation elements and status

A. Changes to key accreditation criteria. The accredited laboratory shall notify DCLS in writing of any changes in key accreditation criteria within 30 calendar days of the change. Key accreditation criteria are laboratory ownership (including legal, commercial, or organizational status), location, resources and premises, key personnel (including top management), major instrumentation, and quality system policies.

B. Changes to scope of accreditation.

1. DCLS may approve a laboratory's application to add a new matrix, technology, analyte, or test method to a laboratory's scope of accreditation or otherwise modify the laboratory's scope of accreditation by performing a data review.

2. To apply, the owner of the accredited laboratory shall submit the following to DCLS:

a. A written request signed by the owner that briefly summarizes the addition to be made to the laboratory's scope of accreditation.

b. Pertinent information demonstrating the laboratory's capability to perform the additional matrix, technology/method, or analyte, such as proficiency testing performance and quality control performance.

c. A written standard operating procedure covering the new matrix, technology/method, or analyte.

3. DCLS may approve a laboratory's application for modification to its scope of accreditation by performing a review of the application materials submitted, without an on-site assessment. The addition of a new technology or test method requiring the use of specific equipment may require an on-site assessment. Other reviews of performance and documentation may be carried out by DCLS, depending on the modification for which the laboratory applies.

4. Within 90 calendar days of the receipt of the application from the accredited environmental laboratory, DCLS shall review and determine whether the proposed modification may be approved.

5. If the proposed modification to the laboratory's scope of accreditation is approved, DCLS shall amend the laboratory's certificate of accreditation.

6. DCLS shall not send the amended certificate of accreditation to the laboratory until DCLS receives the payment of the fee required under 1VAC30-46-150 E 1.

C. Change of ownership or location of laboratory.

1. The accredited laboratory shall submit a written notification to DCLS of the change of ownership or location of the laboratory within 30 calendar days of the change. This requirement pertaining to change of location does not apply to mobile laboratories.

2. Accreditation may be transferred when the legal status or ownership of an accredited laboratory changes as long as the transfer does not affect the laboratory's personnel, equipment, or organization.

3. If the laboratory's personnel, equipment, or organization are affected by the change of legal status or ownership, DCLS may require reaccreditation or reapplication in any or all of the categories for which the laboratory is accredited.

4. DCLS may require an on-site assessment depending on the nature of the change of legal status or ownership. DCLS shall determine the elements of any on-site assessment required.

5. When there is a change in ownership, the new owner of the accredited laboratory shall keep for a minimum of five years all records and analyses performed by the previous owner pertaining to accreditation. These records and analyses are subject to inspection by DCLS during this five-year period. This provision applies regardless of change of ownership, accountability or liability.

D. Voluntary withdrawal. Any environmental laboratory owner who wishes to withdraw the laboratory from its accreditation status or from being accredited, in total or in part, shall submit written notification to DCLS. DCLS shall provide the laboratory with a written notice of withdrawal.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 1, eff. November 1, 2015.

1VAC30-46-95 Suspension of accreditation

A. Before withdrawing accreditation, DCLS may suspend accreditation from an environmental laboratory in total or in part to allow the laboratory time to correct the reason for which DCLS may withdraw accreditation. Suspension is limited to the reasons listed in subsection B of this section.

B. DCLS may suspend accreditation from an environmental laboratory in part or in total when the laboratory has failed to do any of the following:

1. Participate in the proficiency testing program as required by 1VAC30-46-210 B.

2. Complete proficiency testing studies and maintain a history of at least two successful proficiency testing studies for each accredited field of testing out of the three most recent proficiency testing studies as defined in 1VAC30-46-210 B.

3. Submit an acceptable corrective action plan after two opportunities as specified in 1VAC30-46-220 L.

4. Maintain a quality system as defined in 1VAC30-46-210 C.

5. Employ staff that meets the personnel qualifications of 1VAC30-46-210 A.

6. Notify DCLS of any changes in key accreditation criteria as set forth in 1VAC30-46-90.

C. Process to suspend accreditation.

1. When DCLS determines that cause exists to suspend a laboratory, the agency shall send notification to the responsible official and the technical manager stating the agency's determination that the laboratory has failed to meet the 1VAC30-46 standards for one or more of the reasons listed in subsection B of this section. DCLS shall send the notification by certified mail.

2. In its notice, DCLS shall request the laboratory to notify DCLS in writing if the laboratory believes the agency is incorrect in its determination.

3. The notification shall state that the laboratory is required to take corrective action whenever a failure occurs and to document the corrective action. The notification shall require the laboratory to provide DCLS with documentation of the corrective action taken with regard to its failure to meet a standard under this chapter.

4. The notification shall state what the laboratory is required to do to restore its accreditation status and the time allowed to do so.

5. The environmental laboratory may proceed to correct the deficiencies for which DCLS has suspended the laboratory's accreditation.

6. Alternatively the laboratory may state in writing that DCLS is incorrect in its determination regarding suspension, giving specific reasons why the laboratory believes DCLS should not suspend accreditation.

7. With the exception of subdivision B 4 of this section, DCLS may allow the laboratory up to 60 days to correct the problem for which it may have its accreditation suspended.

8. DCLS shall set a date for suspension that follows the period provided under subdivision 7 of this subsection to restore accreditation.

9. If the laboratory does not correct its deficiencies within the time period allowed, DCLS shall suspend a laboratory in part or in total.

10. DCLS shall notify the laboratory by letter of its suspension status. DCLS shall send the notification by certified mail. DCLS shall also notify the pertinent Virginia state agency of the laboratory's suspension status.

11. The laboratory may provide information demonstrating why suspension is not warranted in accordance with the standard referenced in the initial DCLS notification. If such information is not provided prior to the suspension date, the laboratory accepts the DCLS decision to suspend.

12. The laboratory has the right to due process as set forth in 1VAC30-46-110.

D. Responsibilities of the environmental laboratory and DCLS when accreditation has been suspended.

1. The term of suspension shall be limited to six months or the period of accreditation whichever is longer.

2. The environmental laboratory shall not continue to analyze samples or report analysis for the fields of accreditation for which DCLS has suspended accreditation.

3. The environmental laboratory shall retain accreditation for the fields of accreditation, methods, and analytes where it continues to meet the requirements of this chapter.

4. The laboratory's suspended accreditation status shall change to accredited when the laboratory demonstrates to DCLS that the laboratory has corrected the deficiency or deficiencies for which its accreditation was suspended.

5. An environmental laboratory with suspended accreditation shall not have to reapply for accreditation if the cause or causes for suspension are corrected within the term of suspension.

6. An environmental laboratory that DCLS has suspended in total shall pay the cost of any necessary follow-up on-site assessments or data review or both to determine compliance. This cost shall be calculated under the provisions of 1VAC30-46-150 E and F.

7. If the laboratory fails to correct the causes of suspension within the term of suspension, DCLS shall withdraw the laboratory's accreditation in total or in part.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 1, eff. November 1, 2015; amended, Virginia Register Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-46-100 Withdrawal of accreditation

A. DCLS shall withdraw accreditation from an environmental laboratory in total if the laboratory is found to be falsifying any data or providing false information to support accreditation.

B. DCLS may withdraw accreditation from an environmental laboratory in part or in total when the laboratory has failed to do any of the following:

1. Participate in the proficiency testing program as required by 1VAC30-46-210 B.

2. Complete proficiency testing studies and maintain a history of at least two successful proficiency testing studies for each affected accredited field of testing out of the three most recent proficiency testing studies as defined in 1VAC30-46-210 B.

3. Maintain a quality system as defined in 1VAC30-46-210 C.

4. Employ staff that meets the personnel qualifications of 1VAC30-46-210 A.

5. Submit an acceptable corrective action plan after two opportunities as specified in 1VAC30-46-220.

6. Implement corrective action specified in the laboratory's corrective action plan as set out under 1VAC30-46-220.

7. Correct the causes of suspension within the term of suspension.

8. Notify DCLS of any changes in key accreditation criteria as set forth in 1VAC30-46-90.

9. Use correct and authorized references to the laboratory's accreditation status or that of DCLS in the laboratory's documentation and advertising as set forth in 1VAC30-46-130.

10. Allow a DCLS assessment team entry during normal business hours to conduct an on-site assessment required by 1VAC30-46-220.

11. Pay required fees specified in 1VAC30-46-150.

12. Meet the provisions regarding communication with others in Volume 1, Module 1, Section 4.1.5 of the 2016 TNI Standards.

C. DCLS may withdraw accreditation from an environmental laboratory in part or in total when the laboratory has failed three consecutive proficiency testing studies for the same field of accreditation either by failure to participate in the proficiency testing study or by failure to obtain acceptable results.

D. DCLS shall follow the process specified in 1VAC30-46-110 when withdrawing accreditation from an environmental laboratory.

E. Responsibilities of the environmental laboratory and DCLS when accreditation has been withdrawn.

1. Laboratories that lose their accreditation in full shall return their certificate to DCLS.

2. If a laboratory loses accreditation in part, DCLS shall issue a revised certificate to the laboratory.

3. The laboratory shall discontinue the use of all materials that contain either a reference to the environmental laboratory's past accreditation status or that display the TNI logo. These materials may include catalogs, advertising, business solicitations, proposals, quotations, laboratory analytical reports, or other materials.

4. The environmental laboratory shall not continue to analyze samples or report analyses for the fields of accreditation for which DCLS has withdrawn accreditation.

F. After correcting the reason or cause for the withdrawal of accreditation under 1VAC30-46-100 A or B, the laboratory owner may reapply for accreditation under 1VAC30-46-70 B and E.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 1, eff. November 1, 2015; Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-46-110 Procedures to deny or withdraw accreditation, and appeal procedures

A. Notification.

1. If DCLS determines that cause exists to deny accreditation to or withdraw accreditation from an environmental laboratory, DCLS shall notify the environmental laboratory in writing of its determination. DCLS shall send this notification by certified mail to the responsible official and provide a copy to the technical manager of the environmental laboratory.

2. For denial of accreditation, the notice shall state that the laboratory has failed to meet the standards in 1VAC30-46 and shall specify one or more of the reasons for denial of accreditation under 1VAC30-46-70 L, providing a detailed explanation of the basis for the denial of accreditation.

3. For withdrawal of accreditation, the notice shall state that the laboratory has failed to meet the standards in 1VAC30-46 and shall specify one or more of the reasons for withdrawal of accreditation under 1VAC30-46-100 A or B, providing a detailed explanation of the basis for the withdrawal of accreditation.

4. In its notice, DCLS shall request the laboratory to notify DCLS in writing if the laboratory believes the agency is incorrect in its determination.

5. If the laboratory believes DCLS to be incorrect in its determination, the laboratory shall provide DCLS with a detailed written demonstration of why DCLS should not deny or withdraw accreditation.

B. An environmental laboratory may appeal a final decision by DCLS to deny or withdraw accreditation pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

C. The accreditation status of an environmental laboratory appealing withdrawal of accreditation shall not change pending the final decision of the appeals filed under the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) and Part 2A of the Rules of the Supreme Court of Virginia.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 1, eff. November 1, 2015.

1VAC30-46-120 Information about accredited environmental laboratories

DCLS shall make available to the public information identifying the environmental laboratories that it has accredited under this chapter.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 1, eff. November 1, 2015.

1VAC30-46-130 Use of accreditation status by environmental laboratories accredited under this chapter

A. The owner of an environmental laboratory accredited under this chapter shall not misrepresent the laboratory's fields of accreditation or its accreditation status on any document. This includes laboratory reports, catalogs, advertising, business solicitations, proposals, quotations or other materials.

B. Environmental laboratories accredited under this chapter shall comply with all of the following:

1. Post or display their most recent accreditation certificate or their fields of accreditation in a prominent place in the laboratory facility.

2. Make accurate statements concerning their fields of accreditation and accreditation status.

3. Accompany DCLS's name or the TNI logo or both with at least the phrase "TNI-accredited" and the laboratory's identification number or other identifier when DCLS's name is used on general literature such as catalogs, advertising, business solicitations, proposals, quotations, laboratory analytical reports or other materials.

4. Not use their accreditation certificate, their accreditation status or the TNI logo to imply endorsement by DCLS.

C. The owners of laboratories accredited under this chapter who choose to (i) use DCLS's name; (ii) make reference to its TNI accreditation status; or (iii) use the TNI logo in any catalogs, advertising, business solicitations, proposals, quotations, laboratory analytical reports or other materials, shall comply with both of the following:

1. Distinguish between proposed testing for which the laboratory is accredited and the proposed testing for which the laboratory is not accredited.

2. Include the laboratory's identification number or other identifier.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 1, eff. November 1, 2015.

1VAC30-46-140 Secondary accreditation

A. DCLS may grant secondary accreditation to an environmental laboratory that holds a current accreditation from another NELAP-recognized primary accreditation body.

B. The owner of a TNI-accredited environmental laboratory that seeks accreditation under this chapter shall apply as specified in 1VAC30-46-70 with the exception of 1VAC30-46-70 F 1 n and o.

C. The owner of the applicant laboratory shall pay the fee required by 1VAC30-46-150.

D. DCLS shall not require a TNI-accredited environmental laboratory that seeks accreditation under this section to meet any additional proficiency testing, quality assurance, or on-site assessment requirements for the fields of accreditation for which the laboratory holds primary TNI accreditation.

E. DCLS shall consider only the current certificate of accreditation issued by the TNI-recognized primary accreditation body.

F. DCLS shall grant secondary accreditation for only the fields of accreditation offered under this chapter for which the laboratory holds current primary TNI accreditation.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 1, eff. November 1, 2015; Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-46-150 Fees

A. General.

1. Environmental laboratories shall pay a fee with all applications, including reapplications, for accreditation. DCLS shall not designate an application as complete until it receives payment of the fee.

2. Each accredited environmental laboratory shall pay an annual fee to maintain its accreditation. DCLS shall send an invoice to the accredited environmental laboratory.

3. An environmental laboratory applying for secondary accreditation under 1VAC30-46-140 shall pay the same fee as other laboratories subject to this chapter.

4. Fees shall be nonrefundable.

5. DCLS, as part of its regular budgetary review of the program, shall determine whether the fees charged under this section offset the program costs as required under § 2.2-1105 of the Code of Virginia.

B. Fee computation.

1. Fees shall be applied on an annual basis.

2. Environmental laboratories shall pay the total of the base fee and the test category fees set out in subsections C and D of this section.

C. Base fee.

1. DCLS determines the base fee for a laboratory by taking into account both the total number of methods and the total number of field of accreditation matrices for which the laboratory would be accredited.

2. DCLS shall charge the base fees set out in Table 1. The base fee for a laboratory is located by first finding the row for the total number of methods to be accredited and then finding the box on that row located in the column headed by the total number of matrices to be accredited. For example, DCLS charges a base fee of $1625 to a laboratory performing a total of eight methods for one matrix.

| TABLE 1: BASE FEES | | | | | | --- | --- | --- | --- | --- | | Number of Methods | One Matrix | Two Matrices | Three Matrices | Four or more Matrices | | 1 - 9 | $1625 | $1788 | $1969 | $2163 | | 10 - 29 | $1750 | $1969 | $2188 | $2438 | | 30 - 99 | $1938 | $2281 | $2688 | $3188 | | 100 - 149 | $2063 | $2475 | $2969 | $3563 | | 150%2B | $2250 | $2813 | $3531 | $4406 |

D. Test category fees.

1. The test category fees cover the types of testing for which a laboratory may be accredited as specified in the laboratory's application or as accredited at the time of annual billing.

2. Fees shall be charged for each category of tests to be accredited.

3. Fees shall be charged for the total number of field of accreditation matrices to be accredited under the specific test category. For example, if a laboratory is performing inorganic chemistry for both nonpotable water and solid and chemical matrices, the fee for this test category would be found in the column for two matrices.

4. The fee for each category includes one or more analytical methods unless otherwise specified.

5. Test category fees. DCLS shall charge the test category fees set out in Table 2. The test category fees for a laboratory are located by first finding the row with the total number of test methods for the test category to be accredited. The fee to be charged for the test category will be found on that row in the column headed by the total number of matrices to be accredited. A laboratory performing four test methods for bacteriology in both nonpotable and drinking water (two matrices) would be charged a test category fee of $413.

| TABLE 2: TEST CATEGORY FEES | | | | | --- | --- | --- | --- | | | Fees by Number of Matrices | | | | Test Category | One | Two | Three or More | | Aquatic toxicity, acute methods only | $740 | N/A | N/A | | Aquatic toxicity, acute and chronic methods | $990 | N/A | N/A | | Oxygen demand | $281 | $419 | $544 | | Bacteriology, 1 - 3 total methods | $219 | $331 | $431 | | Bacteriology, 4 or more total methods | $275 | $413 | $538 | | Physical, 1 - 5 total methods | $219 | $331 | $431 | | Physical, 6 - 10 total methods | $275 | $413 | $538 | | Physical, 11 or more total methods | $344 | $519 | $675 | | Inorganic chemistry, 1 - 10 total methods | $313 | $469 | $613 | | Inorganic chemistry, 11 - 20 total methods | $394 | $594 | $775 | | Inorganic chemistry, 21 - 49 total methods | $493 | $738 | $959 | | Inorganic chemistry, 50 or more total methods | $615 | $925 | $1203 | | Chemistry metals, 1 - 5 total methods | $406 | $613 | $796 | | Chemistry metals, 6 - 20 total methods | $513 | $769 | $1000 | | Chemistry metals, 21 or more total methods | $640 | $963 | $1250 | | Organic chemistry, 1 - 5 total methods | $1020 | $1270 | $1495 | | Organic chemistry, 6 - 20 total methods | $1145 | $1458 | $1739 | | Organic chemistry, 21 - 40 total methods | $1301 | $1695 | $2048 | | Organic chemistry, 41 or more total methods | $1495 | $1983 | $2420 | | Radiochemical, 1 - 10 total methods | $990 | $1365 | $1703 | | Radiochemical, 11 or more total methods | $1146 | $1603 | $2015 | | Asbestos | $1146 | $1603 | $2015 |

6. Fee examples. Three examples are provided.

a. Example 1:

| Base Fee | One matrix and four test methods | $1625 | | --- | --- | --- | | Test Category Fees | | | | One Matrix | | | | Nonpotable Water | Bacteriology (2 methods) | $219 | | Nonpotable Water | Oxygen demand (1 method) | $281 | | Nonpotable Water | Physical (1 method) | $219 | | TOTAL | | $2344 |

b. Example 2:

| Base Fee | One matrix and 15 test methods | $1750 | | --- | --- | --- | | Test Category Fees | | | | One Matrix | | | | Nonpotable Water | Bacteriology (2 methods) | $219 | | Nonpotable Water | Inorganic chemistry (9 methods) | $313 | | Nonpotable Water | Metals (2 methods) | $406 | | Nonpotable Water | Oxygen demand (1 method) | $281 | | Nonpotable Water | Physical (1 method) | $219 | | TOTAL | | $3188 |

c. Example 3:

| Base Fee | Two matrices and 27 test methods | $1969 | | --- | --- | --- | | Test Category Fees | | | | One Matrix | | | | Nonpotable Water | Bacteriology (4 methods) | $275 | | Nonpotable Water | Oxygen demand (1 method) | $281 | | Solid and Chemical Materials | Metals (1 method) | $406 | | Two Matrices | | | | Nonpotable Water and Solid and Chemical Materials | Inorganic chemistry (13 methods) | $594 | | Nonpotable Water and Solid and Chemical Materials | Physical (7 methods) | $413 | | TOTAL | | $3938 |

E. Additional fees. Additional fees shall be charged to laboratories applying for the following: (i) modification to scope of accreditation under 1VAC30-46-90 B, (ii) transfer of ownership under 1VAC30-46-90 C, (iii) review of compliance following total suspension, or (iv) petition for a variance under 1VAC30-46-160.

1. For any accredited environmental laboratory that applies to modify its scope of accreditation as specified under 1VAC30-46-90 B, DCLS shall assess a fee determined by the method in subsection F of this section.

2. Under 1VAC30-46-90 C, DCLS may charge a transfer fee to a certified laboratory that transfers ownership. A fee shall be charged if DCLS (i) needs to review documentation sent by the laboratory about the transfer of ownership or (ii) determines that an on-site assessment is necessary to evaluate the effect of the transfer of ownership. DCLS shall assess a fee determined by the method in subsection F of this section. If, under 1VAC30-46-90 C, DCLS determines that the change of ownership or location of laboratory requires reaccreditation of or reapplication by the laboratory, the laboratory shall pay the application fee required under this section.

3. Under 1VAC30-46-95 D 6, an environmental laboratory that DCLS has suspended in total shall be charged the cost of any necessary follow-up on-site assessments or data review or both to determine compliance. This charge shall be calculated under the method specified in subsection F of this section.

4. Under 1VAC30-46-160, any person regulated by this chapter may petition the director to grant a variance from any requirement of this chapter. DCLS shall charge a fee for the time needed to review the petition, including any on-site assessment required. The fee shall be determined by the method specified in subsection F of this section.

F. Additional fees determination.

1. The fee shall be the sum of the total hourly charges for all reviewers plus any on-site review costs incurred.

2. An hourly charge per reviewer shall be determined by (i) obtaining a yearly cost by multiplying the reviewer's annual salary by 1.35 (accounts for overhead such as taxes and insurance) and then (ii) dividing the yearly cost by 1,642 (number of annual hours established by Fiscal Services, Department of General Services, for billing purposes).

3. The charge per reviewer shall be determined by multiplying the number of hours expended in the review by the reviewer's hourly charge.

4. If an on-site review is required, travel time and on-site review time shall be charged at the same hourly charge per reviewer, and any travel expenses shall be added.

G. Out-of-state laboratories applying for primary accreditation.

1. The owner of an environmental laboratory located in another state who applies for primary accreditation under this chapter shall pay a surcharge of $5000 plus the labor costs of the on-site assessment and reasonable travel costs associated with conducting an on-site assessment at the laboratory. Reasonable travel costs include transportation, lodging, per diem, and telephone and duplication charges. These charges shall be in addition to the fees charged under subdivision A 1 and subsections B through D of this section.

2. Once the laboratory is accredited, DCLS shall charge the annual fee specified in subdivision A 2 and subsections B through D of this section, the labor costs for the on-site assessment, and reasonable travel costs associated with conducting the on-site assessment.

H. DCLS shall derive the travel costs charged under subsections F and G of this section from the Commonwealth of Virginia reimbursement allowances and rates for lodging, per diem, and mileage.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 1, eff. November 1, 2015; Volume 36, Issue 2, eff. September 1, 2019; Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-46-160 Petitioning for a variance

A. Any person regulated by this chapter may petition the director to grant a variance from any requirement of this chapter. Any person submitting a petition to the director shall meet the provisions of this section. Any petition submitted to the director is subject to the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

B. The petition shall be submitted to the director by certified mail and shall include:

1. The petitioner's name and address;

2. A statement of the petitioner's interest in the proposed action;

3. A description of desired action and a citation of the regulation from which a variance is requested;

4. A description of need and justification for the proposed action, including impact of the proposed action on the laboratory's operation;

5. Information demonstrating that the requested variance will meet the purposes and objectives of the relevant regulatory provision and of § 2.2-1105 of the Code of Virginia (Environmental Laboratory Certification Program);

6. The duration of the variance, if applicable;

7. The potential impact of the variance on public health or the environment;

8. Other information believed by the applicant to be pertinent; and

9. The following statement signed by the petitioner or authorized representative: "I certify that I have personally examined and am familiar with the information submitted in this petition and all attached documents, and that, based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment."

C. Petition processing.

1. After receiving a petition that includes the information required in subsection B of this section, the director will determine whether the information received is sufficient to render the decision. If the information is deemed insufficient, the director will specify additional information needed and request that it be furnished.

2. The petitioner may submit the additional information requested, or may attempt to show that no reasonable basis exists for additional information. If the director agrees that no reasonable basis exists for the request for additional information, he will act in accordance with subsection D of this section. If the director finds that a reasonable basis exists to require the submission of such information, he will proceed with the denial action in accordance with the Administrative Process Act.

D. Public review of tentative decision. The director will evaluate the application and issue a draft notice tentatively denying the petition, granting the variance as requested, or granting a modified or partial variance. Notification of this tentative decision will be published in the Virginia Register of Regulations. The director will accept comment on the tentative decision for 30 days, and shall hold a public hearing if a request is received or at his discretion if there is no request. The director will issue a final decision after receipt of comments and after the hearing (if any).

E. Conditions for granting variance request or a modified variance.

1. The director may grant the variance if the applicant demonstrates to the satisfaction of the director that:

a. The proposed variance will meet the goals and purposes of the provisions from which a variance is sought; and

b. The variance does not conflict with federal or state law or regulations.

2. If the director grants a variance request, the notice to the petitioner shall provide that the variance may be terminated upon a finding by the director that the petitioner has failed to comply with any requirements of the variance.

3. When a modified variance is granted, the director may:

a. Specify the termination date of the variance;

b. Include a schedule for:

(1) Compliance, including increments of progress, by the laboratory with each requirement of the variance; and

(2) Implementation by the laboratory of such measures as the director finds necessary in order that the variance may be granted.

F. Decisions to grant or deny a petition in whole or in part, or to modify or terminate a variance are subject to the provisions of Article 3 (§ 2.2-4018 et seq.) of the Virginia Administrative Process Act.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; Errata, 25:1 VA.R. 96 September 15, 2008.

1VAC30-46-170 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-46-180 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-46-190 (Reserved)

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

Part II Standards

1VAC30-46-200 Incorporation by reference of TNI standards

A. The following TNI standards are incorporated by reference into this chapter: The Standards for Environmental Laboratories and Accreditation Bodies, 2016 (The NELAC Institute (TNI)), Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis, and Volume 2: General Requirements for Accreditation Bodies Accrediting Environmental Laboratories, except for Section 6.6 of Module 3 concerning confidential business information.

B. Environmental laboratories applying for accreditation and accredited under this chapter shall comply with the TNI standards incorporated by reference into subsection A of this section. For convenience these standards are specified by accreditation component in 1VAC30-46-210 and 1VAC30-46-220.

C. The TNI standards are organized by volume and module.

1. Volume 1 - Management and Technical Requirements for Laboratories Performing Environmental Analysis includes the following modules:

a. Proficiency Testing.

b. Quality Systems General Requirements.

c. Quality Systems for Asbestos Testing.

d. Quality Systems for Chemical Testing.

e. Quality Systems for Microbiological Testing.

f. Quality Systems for Radiochemical Testing.

g. Quality Systems for Toxicity Testing.

2. Volume 2 - General Requirements for Accreditation Bodies Accrediting Environmental Laboratories includes the following modules:

a. General Requirements.

b. Proficiency Testing.

c. On-Site Assessment.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 1, eff. November 1, 2015; Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-46-210 Standards for accreditation

A. Standards for personnel. The standards for personnel are found in Section 5.2 of Volume 1, Module 2 of the TNI standards.

B. Standards for proficiency testing.

The standards for proficiency testing are found in (i) Module 1 and (ii) section 4.11 of Module 2 of Volume 1 of the TNI standards.

C. Standards for quality systems.

1. General requirements for all environmental laboratories are found in Volume 1, Module 2 of the TNI standards.

2. Requirements for the specific types of testing that may be performed by an individual environmental laboratory are found in Volume 1, Modules 3 through 7 of the TNI standards.

3. Drinking water laboratories obtaining certification under this chapter shall meet the reporting requirements set out in 1VAC30-41 for compliance with 12VAC5-590-530 and 12VAC5-590-540.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 1, eff. November 1, 2015; Volume 38, Issue 12, eff. April 1, 2022.

1VAC30-46-220 On-site assessment

A. The standards for on-site assessment are found in Volume 2, Module 3 of the TNI standards. The requirements specific to environmental laboratories are set out in this section.

B. DCLS shall conduct a comprehensive on-site assessment of an environmental laboratory prior to granting final primary accreditation to the laboratory.

C. Frequency of on-site assessment.

1. DCLS shall reassess each accredited laboratory every two years starting from the date of the previous assessment plus or minus six months.

2. Other on-site assessments.

a. If DCLS identified a deficiency on a previous on-site assessment, the agency may conduct a follow-up on-site assessment.

b. DCLS may conduct an on-site assessment under the following circumstances:

(1) A laboratory applies to modify its scope of accreditation;

(2) A transfer of ownership occurs that affects personnel, equipment, or the laboratory facilities; or

(3) A laboratory applies for an exemption or a variance.

c. Any other change occurring in a laboratory's operations that might reasonably be expected to alter or impair analytical capability and quality may trigger an on-site assessment.

D. Announced and unannounced on-site assessments. DCLS, at its discretion, may conduct either announced or unannounced on-site assessments. Advance notice of an assessment shall not be necessary.

E. Preparation for the on-site assessment.

1. Prior to the actual site visit, DCLS may request in writing from a laboratory those records required to be maintained by this chapter.

2. DCLS may opt not to proceed with an on-site assessment based on nonconformities found during document and record review.

F. Areas to be assessed.

1. DCLS shall assess the laboratory against the standards incorporated by reference and specified in 1VAC30-46-200 and 1VAC30-46-210.

2. The laboratory shall ensure that its quality manual, analytical methods, quality control data, proficiency test data, laboratory SOPs, and all records needed to verify compliance with the standards specified in 1VAC30-46-200 and 1VAC30-46-210 are available for review during the on-site assessment.

G. National security considerations.

1. Assessments at facilities owned or operated by federal agencies or contractors may require security clearances, appropriate badging, or a security briefing before the assessment begins.

2. The laboratory shall notify DCLS in writing of any information that is controlled for national security reasons and cannot be released to the public.

H. Arrival, admittance, and opening conference.

1. Arrival. DCLS and the laboratory shall agree to the date and schedule for announced on-site assessments.

2. Admittance of assessment personnel. A laboratory's refusal to admit the assessment personnel for an on-site assessment shall result in an automatic failure of the laboratory to receive accreditation or loss of an existing accreditation by the laboratory, unless there are extenuating circumstances that are accepted and documented by DCLS.

3. Health and safety. Under no circumstance, and especially as a precondition to gain access to a laboratory, shall assessment personnel be required or even allowed to sign any waiver of responsibility on the part of the laboratory for injuries incurred during an assessment.

4. Opening conference. An opening conference shall be conducted and shall address the following topics:

a. The purpose of the assessment;

b. The identification of assessment personnel;

c. The test methods that will be examined;

d. Any pertinent records and procedures to be examined during the assessment and the names of the individuals in the laboratory responsible for providing assessment personnel with such records;

e. The roles and responsibilities of laboratory staff and managers;

f. Any special safety procedures that the laboratory may think necessary for the protection of assessment personnel;

g. The standards and criteria that will be used in judging the adequacy of the laboratory operation;

h. Confirmation of the tentative time for the exit conference; and

i. Discussion of any questions the laboratory may have about the assessment process.

I. On-site laboratory records review and collection.

1. Records shall be reviewed by assessment personnel for accuracy, completeness, and the use of proper methodology for each analyte and test method to be evaluated.

2. Records required to be maintained pursuant to this chapter shall be examined as part of an assessment for accreditation.

J. Observations of and interviews with laboratory personnel.

1. As an element of the assessment process, the assessment team shall evaluate an analysis regimen by requesting that the analyst normally conducting the procedure give a step-by-step description of exactly what is done and what equipment and supplies are needed to complete the regimen. Any deficiencies shall be noted and discussed with the analyst. In addition, the deficiencies shall be discussed in the closing conference.

2. Assessment personnel may conduct interviews with appropriate laboratory personnel.

3. Calculations, data transfers, calibration procedures, quality control, and quality assurance practices, adherence to test methods, and report preparation shall be assessed for the complete scope of accreditation with appropriate laboratory analysts.

K. Closing conference.

1. Assessment personnel shall meet with representatives of the laboratory following the assessment for a closing conference.

2. During the closing conference, assessment personnel shall inform the laboratory of the preliminary findings and the basis for such findings. The laboratory shall have an opportunity to provide further explanation or clarification relevant to the preliminary findings. If the laboratory objects to the preliminary findings during the closing conference, all objections shall be documented by the assessment personnel and included in the final report to DCLS.

3. Additional problem areas may be identified in the final report.

L. Follow-up and reporting procedures.

1. DCLS shall provide an on-site assessment report to the laboratory documenting any deficiencies found by DCLS within 30 calendar days of the last day of the on-site assessment.

2. When deficiencies are identified in the assessment report, the laboratory shall have 30 calendar days from the date of its receipt of the on-site assessment report to provide a corrective action plan to DCLS.

3. The laboratory's corrective action plan shall include the following:

a. Any objections that the laboratory has with regard to the on-site assessment report;

b. The action that the laboratory proposes to correct each deficiency identified in the assessment report;

c. The time period required to accomplish the corrective action; and

d. Documentation of corrective action that the laboratory has already completed at the time the corrective action plan is submitted.

4. If the corrective action plan, or a portion of the plan, is determined to be unacceptable to remedy the deficiency, DCLS shall provide written notification to the responsible official and technical manager of the laboratory, including a detailed explanation of the basis for such determination. Following receipt of such notification, the laboratory shall have an additional 30 calendar days to submit a revised corrective action plan acceptable to DCLS.

5. DCLS may suspend accreditation from a laboratory under 1VAC30-46-95 B 3 or withdraw accreditation from a laboratory under 1VAC30-46-100 B 5 if DCLS finds the second revised corrective action plan to be unacceptable.

6. The laboratory shall submit documentation to DCLS that the corrective action set out in its plan has been completed within the time period specified in the plan.

7. DCLS, under 1VAC30-46-100 B 6, may withdraw accreditation from a laboratory if the laboratory fails to implement the corrective actions set out in its corrective action plan.

8. DCLS shall grant final accreditation as specified in 1VAC30-46-70 K upon successful completion of any required corrective action following the on-site assessment.

History

• Statutory Authority: § 2.2-1105 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 1, eff. November 1, 2015; amended, Virginia Register Volume 38, Issue 12, eff. April 1, 2022.

Agency 42 Office of The State Inspector General

Chapter 5 Public Participation Guidelines

Part I Purpose and Definitions

1VAC42-5-10 Purpose

The purpose of this chapter is to promote public involvement in the development, amendment, or repeal of the regulations of the Office of the State Inspector General. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 8, eff. January 29, 2016.

1VAC42-5-20 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§ 2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Office of the State Inspector General, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia).

"Negotiated rulemaking panel" or "NRP" means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending, or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov that has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended, and repealed regulations of state agencies, which is published under the provisions of Article 6 (§ 2.2-4031 et seq.) of the Administrative Process Act.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 8, eff. January 29, 2016.

Part II Notification of Interested Persons

1VAC42-5-30 Notification list

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 8, eff. January 29, 2016.

1VAC42-5-40 Information to be sent to persons on the notification list

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 1VAC42-5-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed or a reproposed regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 8, eff. January 29, 2016.

Part III Public Participation Procedures

1VAC42-5-50 Public comment

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to (i) submit data, views, and arguments, either orally or in writing, to the agency, and (ii) be accompanied by and represented by counsel or other representative. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 8, eff. January 29, 2016.

1VAC42-5-60 Petition for rulemaking

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 8, eff. January 29, 2016.

1VAC42-5-70 Appointment of regulatory advisory panel

A. The agency may appoint a RAP to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 8, eff. January 29, 2016.

1VAC42-5-80 Appointment of negotiated rulemaking panel

A. The agency may appoint an NRP if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 8, eff. January 29, 2016.

1VAC42-5-90 Meetings

Notice of any open meeting, including meetings of a RAP or an NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 8, eff. January 29, 2016.

1VAC42-5-100 Public hearings on regulations

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working days prior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 8, eff. January 29, 2016.

1VAC42-5-110 Periodic review of regulations

A. The agency shall conduct a periodic review of its regulations consistent with the following:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 8, eff. January 29, 2016.

Agency 45 Department of Law

Chapter 5 Public Participation Guidelines

Part I Purpose and Definitions

1VAC45-5-10 Purpose

The purpose of this chapter is to promote public involvement in the development, amendment, or repeal of the regulations of the Department of Law. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 5, eff. December 17, 2015.

1VAC45-5-20 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§ 2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Department of Law, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel" or "NRP" means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending, or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov that has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended, and repealed regulations of state agencies, which is published under the provisions of Article 6 (§ 2.2-4031 et seq.) of the Administrative Process Act.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 5, eff. December 17, 2015.

Part II Notification of Interested Persons

1VAC45-5-30 Notification list

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 5, eff. December 17, 2015.

1VAC45-5-40 Information to be sent to persons on the notification list

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 1VAC45-5-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed or a reproposed regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 5, eff. December 17, 2015.

Part III Public Participation Procedures

1VAC45-5-50 Public comment

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to (i) submit data, views, and arguments, either orally or in writing, to the agency and (ii) be accompanied by and represented by counsel or other representative. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 5, eff. December 17, 2015.

1VAC45-5-60 Petition for rulemaking

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider, and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 5, eff. December 17, 2015.

1VAC45-5-70 Appointment of regulatory advisory panel

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 5, eff. December 17, 2015.

1VAC45-5-80 Appointment of negotiated rulemaking panel

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. A NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 5, eff. December 17, 2015.

1VAC45-5-90 Meetings

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 5, eff. December 17, 2015.

1VAC45-5-100 Public hearings on regulations

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working days prior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 5, eff. December 17, 2015.

1VAC45-5-110 Periodic review of regulations

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

History

• Statutory Authority: § 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 5, eff. December 17, 2015.

Agency 50 Commission On Local Government

Chapter 11 Public Participation Guidelines

Part I Purpose and Definitions

1VAC50-11-10 Purpose

The purpose of this chapter is to promote public involvement in the development, amendment, or repeal of the regulations of the Commission on Local Government. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

History

• Statutory Authority: §§ 2.2-4007.02 and 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008; amended, Virginia Register Volume 34, Issue 12, eff. March 23, 2018.

1VAC50-11-20 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§ 2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Commission on Local Government within the Virginia Department of Housing and Community Development, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Calendar maintained by the Commonwealth" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending, or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§ 2.2-4031 et seq.) of the Administrative Process Act.

History

• Statutory Authority: §§ 2.2-4007.02 and 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008; amended, Virginia Register Volume 34, Issue 12, eff. March 23, 2018.

Part II Notification of Interested Persons

1VAC50-11-30 Notification list

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

History

• Statutory Authority: §§ 2.2-4007.02 and 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

1VAC50-11-40 Information to be sent to persons on the notification list

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 1VAC50-11-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

History

• Statutory Authority: §§ 2.2-4007.02 and 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

Part III Public Participation Procedures

1VAC50-11-50 Public comment

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity (i) to submit data, views, and arguments, either orally or in writing, to the agency, and (ii) be accompanied by and represented by counsel or other representative. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

History

• Statutory Authority: §§ 2.2-4007.02 and 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008; amended, Virginia Register Volume 34, Issue 12, eff. March 23, 2018.

1VAC50-11-60 Petition for rulemaking

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider, and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

History

• Statutory Authority: §§ 2.2-4007.02 and 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008; amended, Virginia Register Volume 34, Issue 12, eff. March 23, 2018.

1VAC50-11-70 Appointment of regulatory advisory panel

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

History

• Statutory Authority: §§ 2.2-4007.02 and 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

1VAC50-11-80 Appointment of negotiated rulemaking panel

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

History

• Statutory Authority: §§ 2.2-4007.02 and 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

1VAC50-11-90 Meetings

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and a calendar maintained by the Commonwealth at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

History

• Statutory Authority: §§ 2.2-4007.02 and 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008; amended, Virginia Register Volume 34, Issue 12, eff. March 23, 2018.

1VAC50-11-100 Public hearings on regulations

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and a calendar maintained by the Commonwealth at least seven working daysprior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

History

• Statutory Authority: §§ 2.2-4007.02 and 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008; amended, Virginia Register Volume 34, Issue 12, eff. March 23, 2018.

1VAC50-11-110 Periodic review of regulations

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

History

• Statutory Authority: §§ 2.2-4007.02 and 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

Chapter 20 Organization and Regulations of Procedure

Part I Commission on Local Government

1VAC50-20-1 Applicability

The Commission on Local Government's regulations are promulgated pursuant to the authority of § 15.2-2903 of the Code of Virginia and are applicable to the proceedings of the Commission on Local Government. When necessary to fulfill its statutory responsibilities, the commission may grant, upon its own initiative, a waiver or modification of any of the provisions of these regulations, except those required by law, under terms and conditions and to the extent it deems appropriate.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 26, eff. October 4, 2006.

1VAC50-20-5 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Chair" means the Chair of the Commission on Local Government.

"Commission" means the Commission on Local Government.

"County" means a county in the Commonwealth of Virginia.

"Local government" means a county, city, or town in the Commonwealth of Virginia.

"Locality" means a county, city, or town in the Commonwealth of Virginia.

"Municipality" means a city or town in the Commonwealth of Virginia.

"Party" means local governments, voters, or property owners initiating a proposed annexation, voters of any community requesting that their community be incorporated as a town, voters petitioning for the transition of a city to town status, or a committee appointed by the circuit court to act for and in lieu of a local government to perfect a consolidation agreement.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 26, eff. October 4, 2006; amended, Virginia Register Volume 35, Issue 1, eff. October 18, 2018.

1VAC50-20-10 Principal duties

The commission is charged with reviewing proposed annexations, other local boundary change issues, petitions for partial immunity, local government transitions, and interlocal agreements and with assisting other interlocal concerns for the purpose of maintaining the Commonwealth's local governments as viable communities in which their citizens can live.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 1.1, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006.

1VAC50-20-20 (Repealed.)

Historical Notes

Derived from VR445-01-02 §§ 1.2, 1.3, eff. November 1, 1984; repealed, Virginia Register Volume 22, Issue 26, October 4, 2006.

1VAC50-20-40 Officers

The commission shall elect from its membership at the end of its regular November meeting, or as soon thereafter as possible, a chair and a vice chair, who shall serve terms of one year or until successors are elected. In the event of a vacancy occurring in the office of chair or vice chair, for any cause, the commission shall fill the vacancy by election for the unexpired term. The chair shall preside at all meetings, presentations, and public hearings held by the commission unless absent. In the absence of the chair, the vice chair shall preside at any meeting or other assembly of the commission and shall exercise all powers and duties of the chair. In the event that the chair and vice chair are absent for a meeting or other assembly of the commission, the remaining members of the commission shall elect a temporary chair who shall exercise all powers and duties of the chair for the duration of the meeting or assembly.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 1.4, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 35, Issue 1, eff. October 18, 2018; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-50 Powers and duties of chair

In addition to any other powers or duties placed upon the chair by law, this chapter, or other action of the commission, the chair shall be authorized to:

1. Request one or more members of the commission or its staff to represent the commission before local governing bodies, before state agencies and legislative committees, or before any other entity where the representation of the commission is requested or where the chair deems appropriate;

2. Select or change sites for oral presentations and public hearings;

3. Defer and reschedule issues the chair deems appropriate upon consultation with the commission;

4. Act on behalf of the commission in efforts to resolve disputes between the parties to an issue relative to the production and sharing of data, or with respect to related concerns bearing on the commission's review of an issue; and

5. Establish upon consultation with the parties an equitable distribution of time for public presentations and to make other arrangements the chair deems appropriate and consistent with the requirements of law and this chapter for the conduct of the commission's oral presentations and public hearings.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 1.5, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 35, Issue 1, eff. October 18, 2018.

1VAC50-20-60 (Repealed.)

Historical Notes

Derived from VR445-01-02 §§ 1.6 to 1.9, eff. November 1, 1984; repealed, Virginia Register Volume 22, Issue 26, eff. October 4, 2006.

1VAC50-20-100 Canons of conduct

The commission shall adopt, and may from time to time amend, Canons of Conduct regarding members' conduct and their relations with parties and their agents. Officials and agents of parties with issues before the commission shall be expected to obtain and review a copy of the Canons of Conduct.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 1.10, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006.

1VAC50-20-110 Staff

The commission shall have a staff consisting of an executive director, who shall be appointed by the Governor and confirmed by the General Assembly, and other employees as are needed and authorized by law.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 1.11, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006.

1VAC50-20-120 (Repealed.)

Historical Notes

Derived from VR445-01-02 §§ 2.1, 2.2, eff. November 1, 1984; repealed, Virginia Register Volume 22, Issue 26, eff. October 4, 2006.

Part II General Administration

1VAC50-20-140 Regular meetings

The commission shall fix the time and place for holding regular meetings, which shall be held at least once every two months. Changes in the schedule and location of the regular meetings may be made by the commission, but the changes shall be duly announced in the Virginia Register of Regulations published by the Virginia Code Commission and posted on the Virginia Regulatory Town Hall.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 2.3, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 35, Issue 1, eff. October 18, 2018.

1VAC50-20-142 Special meetings

Special meetings of the commission may be called by any member on such occasions as may be reasonably necessary to carry out the duties of the commission. Except in instances where a special meeting is scheduled at a regular meeting, the chair shall send by electronic means to all members, at least five days in advance of a special meeting, a written notice specifying the time, place, and purpose of the special meeting. Notice of special meetings shall be announced appropriately on the Virginia Regulatory Town Hall and on a calendar maintained by the Commonwealth.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 26, eff. October 4, 2006; amended, Virginia Register Volume 35, Issue 1, eff. October 18, 2018; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-150 Minutes of meetings and hearings

Minutes shall be recorded for each public meeting held by the commission. The minutes shall include a brief summary of comments on major issues under consideration and concise and specific statements of all action taken by the commission. The minutes shall be provided to each commission member for reading and editing prior to approval at a subsequent commission meeting. There need be no actual reading of the minutes at the meeting, but a vote shall be taken for the formal approval of the minutes as written or amended. Copies of the minutes of public meetings shall be made available to any interested party in accordance with the Department of Housing and Community Development's Virginia Freedom of Information Act policies.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 2.4, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 35, Issue 1, eff. October 18, 2018; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-160 Closed statutorily mandated proceedings exempt from the Virginia Freedom of Information Act

A. The commission, along with its panels, committees, subcommittees, members, and staff, may hold and conduct closed statutorily mandated proceedings as may be necessary for mediation and negotiations, for deliberations, for meeting with local governing bodies or members thereof, or for other lawful and appropriate purposes allowed by § 15.2-2907 D of the Code of Virginia. Closed statutorily mandated proceedings shall be exempt from the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia) in accordance with § 15.2-2907 D of the Code of Virginia.

B. The following rules shall apply to closed statutorily mandated proceedings:

1. Closed statutorily mandated proceedings may be called with notice given by the chair at the chair's discretion and held in any location, in person or virtually.

2. A quorum of commissioners must be present to conduct a closed statutorily mandated proceeding.

3. No action of the commission taken during a closed statutorily mandated proceeding that would be considered at a regular meeting or would otherwise require a public vote shall be binding unless the commission takes a vote on such action at a subsequent regular meeting of the commission.

4. The commission may permit a nonmember to attend a closed statutorily mandated proceeding if such person is deemed necessary by the commission, if the person's presence will reasonably aid the commission in its consideration of a topic that is a subject of the proceeding, or as required by law.

5. Minutes and recordings may be taken during a closed statutorily mandated proceeding but shall not be required. Pursuant to 1VAC50-20-170 and other applicable laws, such minutes and recordings shall be confidential.

C. The commission reserves the right to meet in a closed meeting as allowed by §§ 2.2-3711 and 2.2-3712 of the Code of Virginia.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 2.5, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-170 Confidentiality of proceedings and submissions

All testimony, statements, exhibits, documents, or other evidence submitted to the commission by the parties in conjunction with the commission's legally prescribed public meetings, presentations, or hearings shall be subject to disclosure by the commission under the provisions of the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia). All other materials, including the testimony, statements, exhibits, documents, or other evidence submitted to the commission during closed statutorily mandated proceedings allowed under 1VAC50-20-160, along with other deliberations, negotiations, or mediation that the commission is authorized by law to conduct under § 15.2-2907 D of the Code of Virginia shall be treated as confidential and shall neither be subject to disclosure by the commission nor by the parties involved in closed statutorily mandated proceedings, except by agreement of the commission and all parties to the proceedings.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 2.6, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 42, Issue 8, eff. December 31, 2025.

Part III Mandatory Commission Reviews

1VAC50-20-180 Notice to commission of proposed action as required by § 15.2-2907 of the Code of Virginia

A. Notice of a proposed action to the commission as required by § 15.2-2907 of the Code of Virginia shall be accompanied by resolution of the governing body of the locality providing the notice evidencing its support of such action. Notice to the commission shall indicate the name, title, telephone number, and email address of the individual who shall serve as designated contact with the commission regarding the issue presented.

1. Notice of a proposed annexation initiated by voters or property owners shall be accompanied by the original or certified petition signed by 51% of the voters of any territory adjacent to any municipality or 51% of the owners of real estate in number and land area in a designated area. Notice to the commission shall indicate the name, title, telephone number, and email address of the individual who shall serve as designated contact with the commission regarding the issue presented.

2. Notice of a petition for the proposed transition of a city to town status that has been referred to the commission pursuant to § 15.2-4102 of the Code of Virginia shall indicate the name, title, telephone number, and email address of the individual who shall serve as designated contact with the commission regarding the issue referred.

3. Notice to the commission by a committee of citizens that has been appointed by the circuit court to act for and in lieu of a governing body to perfect a consolidation agreement pursuant to § 15.2-3531 of the Code of Virginia shall indicate the name, title, telephone number, and email address of the individual who shall serve as designated contact with the commission regarding the proposed consolidation.

B. Any party giving notice to the commission of a proposed action pursuant to § 15.2-2907 of the Code of Virginia may submit with the notice as much data, exhibits, documents, or other supporting materials as it deems appropriate; however, the submissions should be fully responsive to all relevant elements of the applicable section of Part IV (1VAC50-20-540 et seq.) of this chapter.

C. Any party giving notice to the commission of a proposed action as required by § 15.2-2907 of the Code of Virginia shall also give notice to each Virginia local government located within or contiguous to or sharing functions, revenue, or tax sources with the local government proposing the action. All notices to the local governments shall include contact information for the commission's staff with instructions to contact the commission or the locality's Freedom of Information Act (FOIA) officer, as applicable, for copies of additional documents and exhibits submitted to the commission.

1. Any voters or property owners giving notice to the commission of a proposed annexation as required by § 15.2-2907 of the Code of Virginia shall also give notice to each Virginia local government located within or contiguous to or sharing functions, revenue, or tax sources with the municipality to which annexation is sought. All notices to the immediately affected local governments shall include contact information for the commission's staff with instructions to contact the commission for copies of additional documents and exhibits submitted to the commission.

2. Any voters whose petition for the proposed transition of a city to town status that has been referred to the commission pursuant to § 15.2-4102 of the Code of Virginia shall also give notice to each Virginia local government located within or contiguous to or sharing functions, revenue, or tax sources with the city proposed for town status. All notices to the immediately affected local governments shall include contact information for the commission's staff with instructions to contact the commission for copies of additional documents and exhibits submitted to the commission.

3. A committee of citizens that has been appointed by the circuit court to act for and in lieu of a governing body to perfect a consolidation agreement pursuant to § 15.2-3531 of the Code of Virginia shall also give notice to each Virginia local government located within or contiguous to or sharing functions, revenue, or tax sources with the local governments that are proposed to be consolidated. All notices to the immediately affected local governments shall include contact information for the commission's staff with instructions to contact the commission for copies of additional documents and exhibits submitted to the commission.

D. Any local government receiving notice pursuant to subsection C of this section or any other affected party may submit data, exhibits, documents, or other material for commission review and consideration as it deems appropriate. The submissions should, however, be responsive to all relevant elements of the applicable section of Part IV (1VAC50-20-540 et seq.) of this chapter. Any party submitting material to the commission for review pursuant to this section shall also designate an individual as principal contact for the commission and shall furnish the individual's name, title, telephone number, and email address. The submitting party shall notify the party initiating the proceeding before the commission. Such notification shall include contact information for the commission's staff with instructions to contact the commission for copies of the documents submitted to the commission. The commission may establish a time by which all submissions by respondent parties must be received.

E. Upon its receipt of notice of a proposed action pursuant to subsection A of this section, the commission shall, subsequent to discussion with representatives of the party submitting the notice and other appropriate parties, schedule a review of the proposed action. The commission shall also concurrently extend the services of its office to the parties in an endeavor to promote a negotiated settlement of the issue and, further, may designate, with the agreement of the parties, an independent mediator to assist in the negotiations.

The commission's review of a notice of a proposed annexation as required by § 15.2-2907 of the Code of Virginia filed by voters or property owners shall be terminated upon receipt of an ordinance, duly adopted by a majority of the elected members of the governing body of the affected city or town, rejecting the annexation proposed by the notice.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 3.1, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 35, Issue 1, eff. October 18, 2018; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-190 (Repealed.)

Historical Notes

Derived from VR445-01-02 §§ 3.2 to 3.5, eff. November 1, 1984; repealed, Virginia Register Volume 22, Issue 26, eff. October 4, 2006.

1VAC50-20-230 Referral to commission of proposed voluntary settlement agreements

A. Referral of a proposed voluntary settlement agreement to the commission under the provisions of § 15.2-3400 of the Code of Virginia shall be accompanied by resolutions, joint or separate, of the governing bodies of the localities that are parties to the proposed agreement requesting the commission to review the agreement. The resolutions shall also state the intention of the governing bodies to adopt the agreement subsequent to the commission's review and shall indicate the name, title, telephone number, and email address of the individual who shall serve as each locality's principal contact with the commission during the period of the commission's review.

B. Any party referring a proposed voluntary settlement agreement to the commission for review pursuant to § 15.2-3400 of the Code of Virginia may submit with the proposed agreement as much data, exhibits, documents, or other supporting materials as deemed appropriate; however, the submissions should be fully responsive to all relevant elements of 1VAC50-20-610.

C. Whenever a proposed voluntary settlement agreement is referred to the commission for review pursuant to subsection A of this section, the parties to the proposed agreement shall concurrently give notice of the referral to each Virginia local government with which any of the parties is contiguous or with which any of the parties shares any function, revenue, or tax source. All such notices of referral shall be accompanied by contact information for the commission's staff with instructions to contact the commission for copies of the documents submitted to the commission.

D. Any local government receiving notice of referral pursuant to subsection C of this section or any other party may submit data, exhibits, documents, or other supporting materials relevant to the commission's review as it deems appropriate; however, the submissions should be responsive to all relevant elements of 1VAC50-20-610. Any party submitting materials to the commission pursuant to this chapter shall also designate an individual who shall serve as principal contact with the commission during the period of the commission's review and shall furnish the individual's name, title, telephone number, and email address. The commission may establish a time by which all submissions by respondent parties must be received. Any party submitting materials to the commission pursuant to this chapter shall also notify the parties to the voluntary settlement agreement of the submission. Such notification shall include contact information for the commission's staff with instructions to contact the commission for copies of the documents submitted to the commission.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 3.6, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 35, Issue 1, eff. October 18, 2018; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-240 (Repealed.)

Historical Notes

Derived from VR445-01-02 §§ 3.7 to 3.9, eff. November 1, 1984; repealed, Virginia Register Volume 22, Issue 26, eff. October 4, 2006.

1VAC50-20-270 Referral to commission of proposed town-county agreement defining annexation rights

A. Referral to the commission of a proposed town-county agreement defining annexation rights pursuant to § 15.2-3231 of the Code of Virginia shall be accompanied by resolutions, joint or separate, of the governing bodies of the town and county requesting the commission to review the agreement. The resolutions shall also state the intention of the governing bodies to adopt the agreement subsequent to the commission's review and shall indicate the name, title, telephone number, and email address of the individual who shall serve as each locality's principal contact with the commission during the period of its review.

B. Any affidavit made pursuant to § 15.2-3232 B of the Code of Virginia shall be filed with the commission within five business days of execution.

C. Any notice given under § 15.2-3232 B of the Code of Virginia shall include contact information for the commission's staff with instructions to contact the commission for copies of the documents submitted to the commission.

D. Any party referring a proposed agreement to the commission for review pursuant to § 15.2-3231 of the Code of Virginia may submit with the proposed agreement as much data, exhibits, documents, or other supporting materials as deemed appropriate; however, submissions should be fully responsive to all relevant elements of 1VAC50-20-560.

E. Any person or local government may submit data, exhibits, documents, or other supporting materials relevant to the commission's review as the person or local government deems appropriate; however, the submissions should be responsive to all relevant elements of 1VAC50-20-560. Any party submitting materials to the commission pursuant to this chapter shall also designate an individual who shall serve as principal contact with the commission during the period of the commission's review and shall furnish the individual's name, title, telephone number, and email address. The commission may establish a time by which all submissions by respondent parties must be received. Any party submitting materials to the commission pursuant to this chapter shall also notify the parties to the agreement defining annexation rights of the submission. Such notification shall include contact information for the commission's staff with instructions to contact the commission for copies of the documents submitted to the commission.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 3.10, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 35, Issue 1, eff. October 18, 2018; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-280 (Repealed.)

Historical Notes

Derived from VR445-01-02 §§ 3.11 to 3.13, eff. November 1, 1984; repealed, Virginia Register Volume 22, Issue 26, eff. October 4, 2006.

1VAC50-20-310 Referral to commission of town petition for order establishing annexation rights

A. Any town unable to reach an agreement with its county as to future annexation rights may, pursuant to § 15.2-3234 of the Code of Virginia, adopt an ordinance petitioning the commission for an order establishing its rights to annex territory in such county. The petition to the commission shall include the terms of a proposed order establishing the town's annexation rights and shall indicate the name, title, telephone number, and email address of the individual who shall serve as the town's principal contact with the commission. Petitions to the commission pursuant to § 15.2-3234 of the Code of Virginia shall also be accompanied by a copy of the ordinance.

B. Any town petitioning the commission under the authority of § 15.2-3234 of the Code of Virginia may submit with the petition as much data, exhibits, documents, or other supporting materials as deemed appropriate; however, the submissions should be fully responsive to all relevant elements of 1VAC50-20-616.

C. Any town petitioning for an order establishing its annexation rights under the authority of § 15.2-3234 of the Code of Virginia shall serve a copy of the petition and ordinance on the Commonwealth's attorney, or the county attorney if there is one, and on the chair of the board of supervisors of the county whose territory would be affected by the town's proposed annexation order. The service must include contact information for the commission's staff with instructions to contact the commission for copies of additional documents and exhibits submitted to the commission.

D. A county served with a copy of a town's petition pursuant to subsection C of this section shall file its response to such petition with the commission within 60 days after receipt of the service. Any other party with an interest in the proceedings may also submit materials to the commission for consideration with respect to the town's petition. The commission may establish a time by which all submissions by respondent parties must be received, so long as the time is no earlier than the county's response date. Responses and submissions to the commission pursuant to this chapter may include data, exhibits, documents, or other materials as the submitting party deems appropriate; however, such responses and submissions should be responsive to all relevant elements of 1VAC50-20-616. Any party submitting materials to the commission for review pursuant to this chapter shall also designate an individual who shall serve as principal contact with the commission and shall furnish the individual's name, title, telephone number, and email address. Any party submitting materials to the commission pursuant to this chapter shall also notify the town that they have submitted materials to the commission.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 3.14, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 35, Issue 1, eff. October 18, 2018; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-320 (Repealed.)

Historical Notes

Derived from VR445-01-02 §§ 3.15 to 3.17, eff. November 1, 1984; repealed, Virginia Register Volume 22, Issue 26, eff. October 4, 2006.

1VAC50-20-350 Referral to commission of boundary line adjustment

A. Whenever a court refers a proposed boundary line adjustment to the commission pursuant to § 15.2-3109 of the Code of Virginia, the localities proposing the boundary line adjustment shall, upon receipt of notification of the referral, provide the commission with a copy of the petition to the court and shall designate an individual for each locality who shall serve as principal contact with the commission and shall furnish the individual's name, title, telephone number, and email address.

B. The two localities proposing a boundary line adjustment pursuant to § 15.2-3109 of the Code of Virginia may, jointly or independently, submit to the commission with the petition as much data, exhibits, documents, or other supporting materials as the localities deem appropriate; however, such submissions should be fully responsive to all relevant elements of 1VAC50-20-600.

C. Any person or local government may submit data, exhibits, documents, or other supporting materials relevant to the commission's review as the person or local government deems appropriate; however, such submissions should be responsive to all relevant elements of 1VAC50-20-600. Any party submitting materials to the commission pursuant to this chapter shall also designate an individual who shall serve as principal contact with the commission during the period of the commission's review and shall furnish the individual's name, title, telephone number, and email address. The commission may establish a time by which all submissions by respondent parties must be received. Any party submitting materials to the commission pursuant to this chapter shall also notify the localities proposing the boundary line adjustment that the party has submitted evidence to the commission.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 3.18, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 35, Issue 1, eff. October 18, 2018; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-360 (Repealed.)

Historical Notes

Derived from VR445-01-02 §§ 3.19 to 3.21, eff. November 1, 1984; repealed, Virginia Register Volume 22, Issue 26, eff. October 4, 2006.

1VAC50-20-382 Referral to commission of proposed economic growth-sharing agreements

A. Referral of a proposed economic growth-sharing agreement to the commission under the provisions of § 15.2-1301 of the Code of Virginia shall be accompanied by resolution, joint or separate, of the governing bodies of the localities that are parties to the proposed agreement requesting the commission to review the agreement. The resolutions shall also state the intention of the governing bodies to adopt the agreement subsequent to the commission's review and shall indicate the name, title, telephone number, and email address of the individual who shall serve as each locality's principal contact with the commission during the period of the commission's review.

B. Any party referring a proposed economic growth-sharing agreement to the commission for review pursuant to § 15.2-1301 of the Code of Virginia may submit with the proposed agreement as much data, exhibits, documents, or other supporting materials as deemed appropriate; however, the submissions should be fully responsive to all relevant elements of 1VAC50-20-612.

C. Whenever a proposed economic growth-sharing agreement is referred to the commission for review pursuant to subsection A of this section, the parties to the proposed agreement shall concurrently give notice of the referral to each Virginia local government with which any of the parties shares any function, revenue, or tax source. All notices of referral shall include contact information for the commission's staff with instructions to contact the commission for copies of the additional documents and exhibits submitted to the commission.

D. Any local government receiving notice of referral pursuant to subsection C of this section or any other party may submit data, exhibits, documents, or other supporting materials relevant to the commission's review as it deems appropriate; however, the submissions should be responsive to all relevant elements of 1VAC50-20-612. Any party submitting materials to the commission pursuant to this chapter shall also designate an individual who shall serve as principal contact with the commission during the period of the commission's review and shall furnish the individual's name, title, telephone number, and email address. Any party submitting materials to the commission pursuant to this chapter shall notify the parties to the economic growth-sharing agreement that they have submitted materials to the commission. The commission may establish a time by which all submissions by respondent parties must be received.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 26, eff. October 4, 2006; amended, Virginia Register Volume 35, Issue 1, eff. October 18, 2018; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-384 Determination of continued eligibility for city status

A. The commission shall review each decennial census of population released by the United States Bureau of the Census to determine whether any city has failed to meet the criteria for city status established by Article VII, Section 1 of the Constitution of Virginia. In any instance where the census indicates that a city may not meet the constitutional criteria, the commission shall conduct an investigation of the city's population, assets, liabilities, rights, and obligations and shall certify its findings to the governing body of such city.

B. In the conduct of its investigation, the commission shall request the assistance of the city in the provision of relevant data and information. The city may submit as much data, exhibits, documents, or other material as it deems appropriate; however, the submissions should be responsive to all relevant elements of 1VAC50-20-614.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 26, eff. October 4, 2006; amended, Virginia Register Volume 35, Issue 1, eff. October 18, 2018.

1VAC50-20-390 General provisions applicable to mandatory commission reviews

A. Any local government or other party appearing before the commission relative to any mandatory review may be represented by counsel.

B. The commission shall generally schedule for consideration issues in the order in which received; however, the commission reserves the right to consider issues in other sequence where it deems appropriate. Where notices are received of related or competitive actions affecting the same localities, the commission may, where appropriate, consider the issues and render the reports or a consolidated report concurrently.

C. Subsequent to its receipt of an issue for a mandatory review, the commission or the commission's staff shall meet, or otherwise converse, with representatives of the principally affected parties for purposes of establishing a schedule for its review of the issue. The schedule shall include dates for (i) the submission of responsive materials from affected jurisdictions, (ii) tours of affected areas and oral presentations if any are desired by the commission, (iii) a public hearing, and (iv) the issuance of the commission's report, as well as other dates the commission deems appropriate.

D. The commission may continue or defer its proceedings with respect to an issue at any time it deems appropriate; however, no continuance or deferral shall result in an extension of the commission's reporting deadline beyond any time limit imposed by law, except by agreement of the parties or in accordance with other statutory procedures. The commission shall also accept requests for continuances or deferrals from any party at any time during its proceedings but shall not grant or deny any such requests until all parties have had an opportunity to comment on the requests. In any instance where the commission grants a continuance or a deferral, the continuance or deferral may be conditioned upon an appropriate extension of the commission's reporting deadline with respect to the issue under review.

E. The commission may confront the necessity of continuing or deferring its proceedings as a result of statutory requirement or court order. In such instances, the commission shall reschedule its proceedings, upon consultation with the parties, in a manner that permits an expeditious conclusion of its review. The parties should anticipate, however, that the duration of the continuance or stay shall result in a commensurate delay in the issuance of the commission's report.

F. In addition to any meeting, presentation, public hearing, or other gathering of the parties specified by this chapter, the commission may, where it deems necessary for an analysis of material or for a discussion or clarification of the issues before it, schedule other meetings of appropriate parties.

G. No party to a proceeding before the commission for mandatory review shall communicate in any manner with any member of the commission with respect to the merits of the issue under review except as is authorized by this chapter or as may be otherwise authorized by the commission or its chair.

H. In addition to the submissions authorized by 1VAC50-20-180 through 1VAC50-20-384, the commission may allow supplemental submissions deemed necessary or appropriate by the commission for the provision of current and complete data. Where supplemental submissions are authorized pursuant to this subsection, copies of all submissions shall be provided by the submitting party to all principal parties. The commission shall endeavor to establish dates for the filing of all supplemental submissions that will allow an opportunity for review and critical analysis by other affected parties. However, the commission may accept supplemental submissions filed after any established dates if, in the commission's judgment, the submissions assist the commission in the discharge of its statutory responsibilities.

I. Any material submitted to the commission by the parties in conjunction with or relative to any notice filed pursuant to any mandatory review covered by 1VAC50-20-180 through 1VAC50-20-384, except materials presented in the context of negotiations or mediation of a confidential nature as authorized by law, shall be considered public documents and made available by the commission for review by any other interested party or by the public. Any interested party or member of the public may request copies of any such material from the commission or its staff in accordance with the Department of Housing and Community Development's Freedom of Information Act policies. In addition, the commission will post all public documents, as defined in this subsection, on its website.

J. Each document, exhibit, or other material submitted to the commission shall bear a title, the date of preparation, a detailed citation of the sources from which all data are obtained, and the name of the entity that submitted the document, exhibit, or other material. All material submitted to the commission by a local government shall be, as nearly as practicable, in the same form as the material would subsequently be submitted to the courts. The commission may refuse to accept for review and consideration any exhibit, document, or other material unless the person preparing it or a representative of the entity responsible for its submission is willing to appear before the commission for purposes of answering questions concerning the material.

K. Unless otherwise requested, wherever the regulations of the commission call for the projection of data, the projections should be made for a 10-year period. In each instance where projections are given, the method and bases of the projections should be indicated.

L. All data, exhibits, documents, or other material submitted to the commission on the initiative of a party or pursuant to a request from the commission shall be certified by the submitting party as to (i) source and (ii) the fact that the material is correct within the knowledge of the submitting party.

M. Any party filing notice or making submissions to the commission shall provide at least eight copies of all submissions, unless the commission agrees that a lesser number would be sufficient for its review and analysis. The commission may make provisions for the electronic filing of submissions, including facsimile.

N. At any time during the course of the commission's review of any issue, the commission's staff may solicit additional data, documents, records, or other materials from the parties as is deemed necessary for proper analysis of any issue. Where such materials are solicited from a party, the commission's staff, where practicable, shall make the request in writing, with copies of the request being provided to other principal parties. Copies of all materials submitted to the commission pursuant to this chapter shall concurrently be provided to each principal party or shall be made available to the parties in a manner acceptable to the commission.

O. The commission shall not be limited in its analysis of any issue to the materials submitted by the parties but shall undertake independent research as it deems appropriate in order to ensure a full and complete investigation of each issue.

P. The commission shall request all parties to cooperate fully in the development and timely sharing of data relative to the issue under review. The commission considers the cooperation among parties vital to the discharge of its responsibilities.

Q. The commission may allow the parties to correct the data, exhibits, documents, or other material submitted to the commission prior to the date established for the closing of the record pursuant to 1VAC50-20-640 B. Where corrections are authorized pursuant to this chapter, copies of all corrections shall be provided by the submitting party to all principal parties. If, in the commission's judgment, the corrections are of a substantive nature as to significantly alter the scope or character of the issue under review, the commission may delay its proceedings for an appropriate amount of time to provide an opportunity for other parties to respond to the corrected data, exhibits, documents, or other material.

R. Following the receipt of a notice, the commission may request the party initiating the proposed action to prepare and file testimony in support of the proposed action. The testimony of the party initiating the proposed action may refer to all data, exhibits, documents, or other material previously submitted to the commission or filed with the testimony. In all proceedings in which the initiating party files testimony, the affected party shall be permitted and may be requested by the commission to file, on or before a date established by the commission, testimony in response to the proposed action. The testimony of the affected party may refer to all data, exhibits, documents, or other material previously submitted to the commission or filed with the testimony. Any affected party that chooses not to file testimony by the date established by the commission may not thereafter present testimony except by permission of the commission, but may otherwise fully participate in the proceeding and engage only in cross-examination of the testimony of other parties. Failure to comply with the directions of the commission without good cause shown may result in rejection of the testimony by the commission. The commission may permit the parties to correct or supplement any prepared testimony before or during the oral presentations as called for in 1VAC50-20-620. Eight copies of prepared testimony shall be filed unless otherwise specified by the commission.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 3.22, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 35, Issue 1, eff. October 18, 2018; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-400 (Repealed.)

Historical Notes

Derived from VR445-01-02 §§ 3.23 to 3.36, eff. November 1, 1984; repealed, Virginia Register Volume 22, Issue 26, eff. October 4, 2006.

Part IV Information, Data, and Factors Relative to Mandatory Commission Reviews

1VAC50-20-540 Annexation

In developing its findings of fact and recommendations with respect to a proposed annexation, the commission shall consider the relevant information, data, and factors listed in this section. Any city or town filing notice with the commission that it proposes to annex territory shall submit with the notice data and other evidence responsive to each element listed in this section that the city or town deems relevant to the proposed annexation. Any voters or property owners filing notice pursuant to § 15.2-2907 of the Code of Virginia with the commission seeking annexation to a municipality shall submit with the notice data and other evidence responsive to each element listed in this section that those parties deem relevant to the proposed annexation, except that subdivision 1 of this section is required to be included in the notice filed with the commission.

1. A written metes and bounds description of the boundaries of the area proposed for annexation having, as a minimum, sufficient certainty to enable a layperson to identify the proposed new boundary. The description may make reference to readily identifiable monuments, such as public roads, rivers, streams, railroad rights of way, and similar discernible physical features.

2. A map showing (i) the boundaries of the area proposed for annexation and their geographic relationship to existing political boundaries; (ii) identifiable unincorporated communities; (iii) major streets, highways, schools, and other major public facilities; (iv) significant geographic features, including mountains and bodies of water; (v) existing uses of the land, including residential, commercial, industrial, and agricultural; and (vi) information deemed relevant as to the possible future use of the property within the area sought for annexation.

3. A land-use table showing both the acreage and percentage of land currently devoted to the various categories of land use in the municipality, the county, and the area proposed for annexation.

4. The past, the estimated current, and the projected population of the municipality, the county affected by the proposed annexation, and the area of the county proposed for annexation.

5. The past, the estimated current, and the projected future number of public school students enrolled in the public schools and the number of school-age children living in the municipality, the county affected by the proposed annexation, and the area of the county proposed for annexation.

6. The assessed property values, by major classification, and if appropriate, the ratios of assessed values to true values for real property, personal property, machinery and tools, merchants' capital, and public service corporation property for the current year and the preceding 10 years for the municipality and the county affected by the proposed annexation, and similar data for the current year for the area of the county proposed for annexation.

7. The current local property and nonproperty tax rates and the tax rates for the preceding 10 years, applicable within the municipality, the county affected by the proposed annexation, and the area of the county proposed for annexation.

8. The estimated current local revenue collections and intergovernmental aid, the collections and aid for the previous 10 years, and projections of the collections and aid (including tax receipts from real property, personal property, machinery and tools, merchants' capital, business and professional license, consumer utility, and sales taxes) within the municipality and the county affected by the proposed annexation, and similar data for the past year for the area of the county proposed for annexation.

9. The amount of long-term indebtedness and the purposes for which all long-term debt has been incurred by the municipality and the county affected by the proposed annexation.

10. The need in the area proposed for annexation for urban services, including those listed in this subdivision, the level of services provided by the municipality and by the county affected by the proposed annexation, and the ability of the municipality and the county to provide the services in the area proposed for annexation:

a. Sewage treatment;

b. Water;

c. Solid waste collection and disposal;

d. Public planning;

e. Subdivision regulation and zoning;

f. Crime prevention and detection;

g. Fire prevention and protection;

h. Public recreational facilities;

i. Library facilities;

j. Curbs, gutters, and sidewalks;

k. Storm drains;

l. Street lighting;

m. Snow removal;

n. Street maintenance;

o. Schools;

p. Housing; and

q. Public transportation.

11. Efforts made by the municipality and the county affected by the proposed annexation to comply with applicable state policies with respect to environmental protection, public planning, education, public transportation, housing, and other state service policies promulgated by the General Assembly.

12. The community of interest that may exist (i) between the municipality and the area proposed for annexation and its citizens or (ii) between that area and its citizens and the rest of the county. The term "community of interest" may include consideration of natural neighborhoods, natural and manmade boundaries, the similarity of service needs, and economic and social bonds.

13. Any arbitrary prior refusal to cooperate by the governing body of the municipality or of the county affected by the proposed annexation, if such has occurred, to enter into cooperative agreements providing for joint activities that would have benefited citizens of both localities.

14. The need for the municipality to expand its tax resources, including its real estate and personal property tax base.

15. The need of the municipality to obtain land for industrial, commercial, and residential development.

16. The adverse effect on the county affected by the proposed annexation resulting from the loss of areas suitable and developable for industrial, commercial, or residential use.

17. The adverse effect on the county of the loss of tax resources and public facilities necessary to provide services to those persons in the remaining areas of the county after the proposed annexation.

18. The adverse impact of the proposed annexation on agricultural operations located in the area proposed for annexation.

19. The terms and conditions upon which the municipality proposes to annex, its plans for the improvement of the annexed territory during the 10-year period following annexation, including the extension of public utilities and other services, and the means by which the municipality shall finance the improvements and extension of services.

20. Data pertinent to a determination of the appropriate financial settlement between the municipality and the affected county as required by § 15.2-3211 of the Code of Virginia and other applicable provisions of the Code of Virginia.

21. The commission's staff shall endeavor to assist parties contemplating or involved in annexation proceedings by identifying additional data elements considered by the commission to be relevant in the disposition of annexation issues.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 4.1, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 35, Issue 1, eff. October 18, 2018; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-550 Partial county immunity

In developing its findings of fact and recommendations with respect to a proposed petition for partial immunity, the commission shall consider the relevant information, data, and factors listed in this section. Any county filing notice with the commission that it proposes to seek immunity for a portion of its territory shall submit with the notice data and other evidence responsive to each element listed in this section that the county deems relevant to the proposed petition for partial immunity.

1. A written metes and bounds description of the area for which immunity is sought having, as a minimum, sufficient certainty to enable a layperson to identify the proposed immunity areas. The description may make reference to readily identifiable monuments, such as public roads, rivers, streams, railroad rights of way, and similar discernible physical features.

2. A map showing: (i) the boundaries of the area proposed for immunity and their geographic relationship to existing political boundaries; (ii) identifiable unincorporated communities; (iii) major streets, highways, schools, and other major public facilities; (iv) significant geographic features, including mountains and bodies of water; (v) existing uses of the land, including residential, commercial, industrial, and agricultural; and (vi) information deemed relevant as to the possible future use of the property within the area for which immunity is sought.

3. A land-use table showing both the acreage and percentage of land currently devoted to the various categories of land use in the county, the affected city, and the area proposed for immunity.

4. The estimated current and projected population and population density of the areas for which immunity is sought.

5. The urban services, including those listed in this subdivision, provided in the area for which immunity is sought and the type and level of services in relation to those furnished by the city from which immunity is sought:

a. Sewage treatment;

b. Water;

c. Solid waste collection and disposal;

d. Public planning;

e. Subdivision regulation and zoning;

f. Crime prevention and detection;

g. Fire prevention and protection;

h. Public recreational facilities;

i. Library facilities;

j. Curbs, gutters, sidewalks;

k. Storm drains;

l. Street lighting;

m. Snow removal;

n. Street maintenance;

o. Schools;

p. Housing; and

q. Public transportation.

6. Efforts made by the county to comply with applicable state policies with respect to environmental protection, public planning, education, public transportation, housing, and other state service policies promulgated by the General Assembly.

7. The community of interest that (i) may exist between the area for which immunity is sought and the remainder of the county; (ii) the community of interest that may exist between that area and the city from which immunity is sought; and (iii) the relative strength of the community of interests.

8. Any instance in which either the county or the affected city has arbitrarily refused to cooperate in the joint provision of services.

9. Whether the proposed grant of immunity would substantially foreclose a city of 100,000 population or less from expanding its boundaries by annexation.

10. The commission's staff shall endeavor to assist localities contemplating or involved in partial immunity proceedings by identifying the additional data elements considered by the commission to be relevant in the disposition of partial immunity issues.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 4.2, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-560 Town-county agreements defining annexation rights

In developing its findings of fact and recommendations with respect to a proposed town-county annexation agreement, the commission shall consider the relevant information, data, and factors listed in this section. Any town or county presenting proposed annexation agreements to the commission under the provisions of § 15.2-3231 of the Code of Virginia shall submit with the proposed agreement data and other evidence responsive to each element listed in this section that the town or county deems relevant.

1. A written metes and bounds description of those areas of the county made eligible for annexation under the proposed agreement having as a minimum, sufficient certainty to enable a layperson to identify those areas. The description may make reference to readily identifiable monuments such as public roads, rivers, streams, railroad rights of way, and similar discernible physical features.

2. A map showing (i) the boundaries of the various areas eligible for annexation under the proposed agreement and their relationship to existing political boundaries; (ii) identifiable unincorporated communities; (iii) major streets, highways, schools, and other major public facilities; (iv) significant geographic features, including mountains and bodies of water; (v) existing uses of the land, including residential, commercial, industrial, and agricultural; and (vi) information deemed relevant as to the possible future use of the property in the areas affected by the proposed agreement.

3. A land-use table showing both the acreage and percentage of land currently devoted to the various categories of land use in the town, the county, and the areas of the county affected by the agreement.

4. The past, the estimated current, and the projected population of the town, the county, and those areas of the county affected by the proposed agreement.

5. The past, the estimated current, and the projected number of public school students enrolled in the public schools and the number of school-age children living in the town, the county, and those areas of the county affected by the proposed agreement.

6. The assessed property values by major classification and, if appropriate, the ratios of assessed values to true values for real property, personal property, machinery and tools, merchants' capital, and public service corporation property for the current and preceding 10 years for the town, and the county, and similar data for the current year in those areas of the county affected by the proposed agreement.

7. The need of the municipality to expand its tax resources, including its real estate and personal property tax base.

8. The need of the municipality to obtain land for industrial, commercial, and residential development.

9. The current and prospective need for additional urban services in the areas of its county subject to annexation under the agreement.

10. Plans for the immediate and future improvement of areas annexed under the terms of the agreement, including the extension of public utilities and other services.

11. The commission's staff shall endeavor to assist localities contemplating or involved in town-county agreements defining annexation rights by identifying additional data elements considered by the commission to be relevant in the disposition of the issues.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 4.3, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 35, Issue 1, eff. October 18, 2018; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-570 Town incorporation

In developing its findings of fact and recommendations with respect to a proposed town incorporation, the commission shall consider the relevant information, data, and factors listed in this section. Any party filing notice with the commission that the party proposes to have a community incorporated as a town, or whose petition for incorporation has been referred to the commission by the court pursuant to § 15.2-3601 of the Code of Virginia, shall submit with such notice or subsequent to the court referral data and other evidence responsive to each element listed in this section that the party deems relevant to the proposed incorporation.

1. A petition signed by not fewer than 100 duly qualified voters residing within the boundaries of the proposed town supporting the proposed incorporation.

2. A written metes and bounds description of the area proposed for incorporation as a town having, as a minimum, sufficient certainty to enable a layperson to identify the proposed town boundary. The description may make reference to readily identifiable monuments, such as public roads, rivers, streams, railroad rights of way, and similar discernible physical features.

3. A map showing (i) the boundaries of the proposed town and their relationship to existing political boundaries; (ii) identifiable unincorporated communities; (iii) major streets, highways, schools, and other major public facilities; (iv) significant geographic features, including mountains and bodies of water; and (v) existing uses of the land, including residential, commercial, industrial, and agricultural.

4. A land-use table showing both the acreage and percentage of land currently devoted to the various categories of land use in the area proposed for incorporation.

5. The past, the estimated current, and the projected population of the area proposed for incorporation and the county within which the town would be situated.

6. Information indicating (i) why the proposed incorporation is desired and in the interest of the inhabitants; (ii) how the general good of the community is served by the incorporation; and (iii) why the services needed within the proposed town cannot be provided by the establishment of a sanitary district, through the extension of existing county services, or by other arrangements provided by law.

7. The commission shall endeavor to assist communities contemplating or involved in proposed town incorporations by identifying additional data elements considered by the commission to be relevant in the disposition of incorporation issues.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 4.4, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 35, Issue 1, eff. October 18, 2018; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-580 Town-city transitions

In developing its findings of fact and recommendations with respect to a proposed town to city transition, the commission shall consider the relevant information, data, and factors listed in this section. Any town filing notice with the commission that it proposes to become a city shall submit with the notice data and other evidence responsive to each element listed in this section that the town deems relevant to the proposed transition.

1. A written metes and bounds description of the boundaries of the proposed city having, as a minimum, sufficient certainty to enable a layperson to identify the proposed city boundary. The description may make reference to readily identifiable monuments, such as public roads, rivers, streams, railroad rights of way, and similar discernible physical features.

2. A map showing: (i) the boundaries of the proposed city and their geographic relationship to existing political boundaries; (ii) identifiable unincorporated communities; (iii) major streets, highways, schools, and other major public facilities; (iv) significant geographic features, including mountains and bodies of water; (v) existing uses of the land, including residential, commercial, industrial, and agricultural; and (vi) information deemed relevant as to the possible future use of the property within the proposed city.

3. A land-use table showing both the acreage and percentage of land currently devoted to the various categories of land use in the proposed city.

4. The past, the estimated current, and the projected population of the proposed city and the county affected by the proposed transition.

5. The past, the estimated current, and the projected future number of public school students enrolled in the public schools and the number of school-age children living in the proposed city and the county affected by the proposed transition.

6. The assessed values by major classification and, if appropriate, the ratios of assessed values to true values for real property, personal property, machinery and tools, merchants' capital, and public service corporation property for the current year and the preceding 10 years for the county and within the proposed city.

7. The current local property and nonproperty tax rates and the tax rates for the preceding 10 years applicable within the county and the proposed city.

8. The estimated current local revenue collections and intergovernmental aid, the collections and aid for the previous 10 years, and projections of the collections and aid, including tax receipts from real property, personal property, machinery and tools, merchants' capital, business and professional license, consumer utility, and sales taxes, within the county and the proposed city.

9. The amount of long-term indebtedness and the purposes for which that long-term debt has been incurred by the municipality and the county affected by the proposed transition.

10. The current type and level of urban services provided by the town, the additional services to be provided and the additional costs to be borne by the proposed city, and the means by which the proposed city shall finance the additional services and costs.

11. The fiscal capacity of the town to function as an independent city and to provide appropriate urban services.

12. The effect and impact of the proposed transition on the ability of the county to meet the service needs of its remaining population and the means by which any substantial impairment of the county's ability to meet those needs shall be offset.

13. The effect of the proposed transition on compliance with and the promotion of applicable state policies with respect to environmental protection, public planning, education, public transportation, housing, and other state service policies declared by the General Assembly.

14. Data pertinent to a determination of the appropriate financial settlement as required by § 15.2-3829 and other applicable provisions of the Code of Virginia.

15. The commission's staff shall endeavor to assist localities contemplating or involved in town-city transition proceedings by identifying additional data elements considered by the commission to be relevant in disposition of town to city transition issues.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 4.5, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-590 County-city transitions

In developing its findings of fact and recommendations with respect to a proposed county to city transition, the commission shall consider the relevant information, data, and factors listed in this section. Any county filing notice with the commission that it proposes to become a city shall submit with the notice data and other evidence responsive to each element listed in this section that the county deems relevant to the proposed transition.

1. A map showing (i) the location of all towns situated within the county; (ii) all adjoining and adjacent localities; (iii) identifiable unincorporated communities within the county; (iv) the population density of the various areas of the county; (v) the areas of the county served by urban services; (vi) major streets, highways, schools, and other major public facilities; (vii) significant geographic features, including mountains and bodies of water; (viii) existing uses of the land, including residential, commercial, industrial, and agricultural; and (ix) information deemed relevant as to the possible future use of the property within the county.

2. A land-use table showing both the acreage and percentage of land currently devoted to the various categories of land use in the county.

3. The past, the estimated current, and the projected future population of the county, each town within the county, and of the major densely populated unincorporated communities within the county.

4. The past, the estimated current, and the projected future number of public school students enrolled in the public schools and the number of school-age children living in the county and in each town within the county.

5. The assessed values by major classification and, if appropriate, the ratios of assessed values to true values for real property, personal property, machinery and tools, merchants' capital, and public service corporation property for the current year and the preceding 10 years for the county and each town within the county.

6. The current local property and nonproperty tax rates and the tax rates for the preceding 10 years within the county and all towns within the county.

7. The estimated current local revenue collections and intergovernmental aid, the collections and aid for the previous 10 years, and projections of the collections and aid (including tax receipts from real property, personal property, machinery and tools, merchants' capital, business and professional license, consumer utility, and sales taxes) within the county and within each town within the county.

8. The amount of long-term indebtedness of the county and each town within the county and the amount and purpose for which that debt has been incurred.

9. Data regarding (i) the urban-type services presently provided by the county; (ii) the level of those services; (iii) the areas of the county served by those services; (iv) the additional services to be provided and the additional cost to be borne by the proposed city; and (v) the means by which the proposed city shall finance the additional services and costs.

10. The fiscal capacity of the county to function as an independent city and to provide appropriate services.

11. The impact of the proposed transition on compliance with and the promotion of applicable state policies with respect to environmental protection, public planning, education, public transportation, housing, and other state service policies declared by the General Assembly.

12. The commission's staff shall endeavor to assist localities contemplating or involved in proposed county-city transitions by identifying additional data elements considered by the commission to be relevant in the disposition of county to city transition issues.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 4.6, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 35, Issue 1, eff. October 18, 2018; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-600 Boundary line adjustment

In developing its findings of fact and recommendations with respect to a proposed boundary line adjustment, the commission shall consider the relevant information, data, and factors listed in this section. The localities petitioning for a boundary line adjustment under the provisions of § 15.2-3109 of the Code of Virginia shall, separately or jointly, at the time the localities initiate such petition to the court, submit to the commission data and other evidence responsive to each element listed in this section that is relevant to the boundary line adjustment.

1. A written metes and bounds description of the precise segment of the boundary for which an adjustment is sought having, as a minimum, sufficient certainty to enable a layperson to identify the boundary segment in question. The description may make reference to readily identifiable monuments, such as public roads, rivers, streams, railroad rights of way, and similar discernible physical features.

2. A map showing (i) the precise segment of the boundary that the parties agree should be adjusted; (ii) identifiable unincorporated communities; (iii) major streets, highways, schools, and other major public facilities; (iv) significant geographic features, including mountains and bodies of water; (v) existing uses of the land, including residential, commercial, industrial, and agricultural; and (vi) information deemed relevant as to the possible future use of the land.

3. The estimated past, the estimated current, and the projected future population and population density of all areas adjacent to the segment of the boundary proposed for adjustment and of other areas possibly affected by the proposed boundary line adjustment.

4. A land-use table showing both the acreage and percentage of land currently devoted to the various categories of land use in all areas adjacent to the segment of the boundary proposed for adjustment and in other areas possibly affected by the proposed boundary line adjustment.

5. The past, the estimated current, and the projected future number of public school students enrolled in the public schools and the number of school-age children living in all areas adjacent to the segment of the boundary proposed for adjustment and in other areas possibly affected by the proposed boundary line adjustment.

6. The assessed and true real property values, by major classification of those areas adjacent to the segment of the boundary proposed for adjustment and of any other area possibly affected by the proposed adjustment and other fiscal data relative to the issue.

7. Maps indicating the principal alternative boundary line adjustments that have been considered by the parties and a brief statement as to how each alternative adjustment would promote the effective and efficient provision of public services.

8. Information as to why the proposed boundary line adjustment is sought by the parties.

9. The commission's staff shall endeavor to assist localities contemplating or involved in proposed boundary line adjustments by identifying additional data elements considered by the commission to be relevant in the disposition of boundary line adjustment issues.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 4.7, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-601 City-town transitions

In developing its findings of fact and recommendations with respect to a proposed transition of a city to town status, the commission shall consider the relevant information, data, and factors listed in this section. Any city filing notice with the commission that it proposes to become a town or any petition for the transition of a city to town status that has been referred to the commission by the court pursuant to § 15.2-4104 of the Code of Virginia should be accompanied by data and other evidence responsive to each element listed in this section that is relevant to the proposed transition.

1. A map showing (i) the boundaries of the city proposed for transition and their geographic relationship to other political boundaries; (ii) identifiable unincorporated communities; (iii) major streets, highways, schools, and other major public facilities; (iv) significant geographic features, including mountains and bodies of water; (v) existing uses of the land within the city, including residential, commercial, industrial, and agricultural; and (vi) information deemed relevant as to the possible future use of the land within the city.

2. The past, the estimated current, and the projected future population and population of the city and the county affected by the proposed transition, and the estimated density of the city and the affected county.

3. A land-use table showing both the acreage and percentage of land currently devoted to the various categories of land use in the city and the county affected by the proposed transition.

4. The past, the estimated current, and a five-year projection of the future number of public school students enrolled in the public schools and the number of school-age children living in the city and the county affected by the proposed transition.

5. The assessed values by major classification for real property, personal property, machinery and tools, merchants' capital, and public service corporation property for the current year and the preceding 10 years for the city and for the county affected by the proposed transition.

6. The current local property and nonproperty tax rates and the rates for the preceding 10 years applicable within the city and the county affected by the proposed transition.

7. The estimated current local revenue collections (including receipts from real property, personal property, machinery and tools, consumer utility, sales taxes, etc., and receipts from nontax sources) and intergovernmental aid, and the collections and aid for the preceding 10 years, for the city and the county affected by the proposed transition.

8. The identification of those services performed by the city that are proposed for assumption by the county as a result of the proposed transition, the number of customers or recipients of each service within the city that would be served by the county subsequent to the transition, and the aggregate annual cost to the county for the provision of services within the city.

9. The identification of those services that would be provided by the town subsequent to the proposed reversion, the number of recipients of each service within the municipality, and the aggregate annual cost to the proposed town for the provision of services.

10. The identification of those city-owned facilities that are proposed for transfer to the county, the identification of those that would be retained by the proposed town, and the current fair market value and the outstanding city debt attributable to each facility.

11. The current outstanding debt of the city, the applicable portion of debt stated as a percentage of the city's constitutional debt limit, and the current schedule for the retirement of all municipal debt.

12. The identification of that portion of the city's indebtedness that is proposed for transfer to the county and the purposes for which the debt has been incurred.

13. Estimates of the annual amount of tax and nontax revenues to be collected by the county within the municipality subsequent to the proposed transition.

14. Estimates of the annual additional amount of intergovernmental aid to be received by the county as a result of the proposed transition.

15. An estimate of the net aggregate fiscal impact of the proposed transition on the county during the initial year subsequent to the transition and during each of the ensuing five years.

16. An estimate of the adjustment required in the county's real property tax rate, assuming that the net aggregate fiscal impact on the county resulting from the transition is addressed solely by an adjustment in the rate.

17. An estimate of the net aggregate fiscal impact of the proposed transition on the city during the initial year subsequent to the transition and during each of the ensuing five years.

18. An estimate of the adjustment required in the municipality's real property tax rate, assuming that the net aggregate fiscal impact on the city resulting from the transition is addressed solely by an adjustment in the rate.

19. The effect of the proposed transition on compliance with and the promotion of applicable state policies with respect to environmental protection, public planning, education, public transportation, housing, and other state service policies declared by the General Assembly.

20. Specification of the terms and conditions that should be established by the court to balance the equities between the city and the county; protect the best interests of the affected localities, their residents, and the Commonwealth; and ensure an orderly transition of the city to town status.

21. The commission's staff shall endeavor to assist the parties involved in proceedings for the transition of a city to town status by identifying additional data elements considered by the commission to be relevant in the disposition of city to town transition issues.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 26, eff. October 4, 2006; amended, Virginia Register Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-605 County-city consolidations

In developing its findings of fact and recommendations with respect to a proposed consolidation of a county and a city that would establish an independent city, the commission shall consider the relevant information, data, and factors listed in this section. Any local government filing notice proposing the consolidation of a city and a county to establish an independent city, or any committee of citizens that has been appointed by the circuit court to act for and in lieu of a governing body to perfect a consolidation agreement pursuant to § 15.2-3531 of the Code of Virginia shall, separately or jointly, submit to the commission data and other evidence responsive to each element listed in this section that the local government or committee deems relevant to the proposed consolidation.

1. Copy of the consolidation agreement.

2. A map showing (i) the location of all municipalities situated within the proposed consolidated city; (ii) all adjoining and adjacent localities; (iii) identifiable unincorporated communities within the proposed consolidated city; (iv) major streets, highways, schools, and other major public facilities; (v) significant geographic features, including mountains and bodies of water; (vi) existing uses of the land, including residential, commercial, industrial, and agricultural; and (vii) information deemed relevant as to the possible future use of the property within the proposed consolidated city and as to its future viability.

3. The past, the estimated current, and the projected population of each locality proposing to consolidate.

4. The population density of the proposed consolidated city based on the most recent United States decennial census or as estimated by the Weldon Cooper Center for Public Service at the University of Virginia.

5. A land-use table showing both the acreage and percentage of land currently devoted to the various categories of land use in the proposed consolidated city.

6. The estimated current and a five-year projection of the future number of public school students enrolled in the public schools in each locality proposing to consolidate and the number of school-age children living in the proposed consolidated city.

7. The assessed values by major classification for real property, personal property, machinery and tools, merchants' capital, and public service corporation property for the current year and the preceding 10 years for the county and the city proposing to consolidate and the proposed consolidated city.

8. The estimated local property and nonproperty tax rates that will be applicable within the proposed consolidated city.

9. The estimated local revenue collections, including tax receipts from real property, personal property, machinery and tools, merchants' capital, business and professional license, consumer utility, and sales taxes and intergovernmental aid, such collections and aid for the preceding 10 years, and projections of the collections and aid within each of the localities proposing to consolidate.

10. The amount of long-term indebtedness of each of the localities proposing to consolidate and the amount and purpose for which that debt has been incurred.

11. Data regarding (i) the urban-type services presently provided by each of the localities proposing to consolidate, (ii) the level of those services to be provided in the proposed consolidated city, (iii) the additional services to be provided and the additional cost to be borne by the proposed consolidated city, and (iv) the means by which the proposed consolidated city shall finance the additional services and costs.

12. The fiscal capacity of the proposed consolidated city to function as an independent city and to provide appropriate services.

13. The impact of the proposed consolidation on compliance with and the promotion of applicable state policies with respect to environmental protection, public planning, education, public transportation, housing, and other state service policies declared by the General Assembly.

14. The impact of the proposed consolidation on the interest of the Commonwealth in promoting strong and viable units of government in the area.

15. The commission's staff shall endeavor to assist the parties involved in proceedings for the consolidation of a county and a city that would establish an independent city by identifying additional data elements considered by the commission to be relevant in the disposition of city-county consolidation issues.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 26, eff. October 4, 2006; amended, Virginia Register Volume 35, Issue 1, eff. October 18, 2018; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-610 Voluntary settlement agreements

In developing its findings of fact and recommendations with respect to a proposed agreement developed under the authority of § 15.2-3400 of the Code of Virginia, the commission shall consider the relevant information, data, and factors listed in this section. Local governments submitting a proposed agreement for review shall, separately or jointly, submit to the commission data and other evidence responsive to each element listed in this section that the local governments deem relevant to the proposed voluntary settlement agreement.

1. If the agreement proposes a municipal boundary expansion, submissions should include data and evidence responsive to the relevant provisions of 1VAC50-20-540.

2. If the agreement proposes the immunization of areas of a county from annexation or the incorporation of new cities, submissions should include data and evidence responsive to the relevant provisions of 1VAC50-20-550.

3. If the agreement proposes the incorporation of a town, submissions should include data and evidence responsive to the relevant provisions of 1VAC50-20-570.

4. If the agreement proposes the transition of a town to city status, submissions should include data and evidence responsive to the relevant provisions of 1VAC50-20-580.

5. If the agreement proposes the transition of a county to city status, submissions should include data and evidence responsive to the relevant provisions of 1VAC50-20-590.

6. If the agreement proposes the transition of a city to town status, submissions should include data and evidence responsive to the relevant provisions of 1VAC50-20-601.

7. If the agreement proposes a revenue-sharing plan or similar arrangement by which jurisdictions will share the tax or revenue sources of an area, submissions should include:

a. A description of the plan;

b. Calculations indicating for each locality the projected future contributions to the plan for the next five-year period;

c. Each locality's projected net annual receipts or net annual contributions to the plan for the next five-year period;

d. Each locality's annual expenditures for the past five years and its projected annual expenditures for the next five years by general operating, school, and debt service categories;

e. Each locality's real estate and public service corporation property assessed values for the past five years and projected for the next five-year period;

f. Each locality's annual revenue for the past five years and projected for the next five-year period (exclusive of receipts from or payments to the economic growth sharing plan) by source and type;

g. Each locality's anticipated major capital needs for the next five-year period; and

h. Other information indicating the general equity of the proposed plan for each participating locality.

8. The commission's staff shall endeavor to assist localities contemplating or involved in the development of voluntary settlement agreements under the authority of § 15.2-3400 of the Code of Virginia by identifying additional data elements considered by the commission to be relevant to the commission's review of such agreements.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 4.8, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-612 Voluntary economic growth-sharing agreements

In developing its findings of fact and recommendations with respect to a proposed voluntary economic growth-sharing agreement developed under the authority of § 15.2-1301 of the Code of Virginia, the commission shall consider the relevant information, data, and factors listed in this section. Local governments submitting such a proposed agreement for review shall, separately or jointly, submit to the commission data and other evidence responsive to each element listed in this section that the local governments deem relevant to the proposed agreement.

1. A copy of the proposed agreement and a description of the economic growth-sharing plan.

2. A description of the financial investment or other contributions that each participating locality will make to the project envisaged under the agreement.

3. Projections of each participating locality's net annual receipts or net annual contributions to the project specified in the agreement for the next 10-year period, or for a lesser or greater period as deemed appropriate.

4. A description of any dedication or restriction on the use of funds generated by the project specified in the agreement for the participating localities.

5. Calculations indicating the estimated impact of the project proposed in the agreement on the annual operating expenditures of each participating jurisdiction for the next 10-year period, or for a lesser or greater period as deemed appropriate.

6. Calculations indicating the estimated impact of the project proposed in the agreement on the current and prospective capital expenditures of each participating jurisdiction over the course of the next 10-year period, or over a lesser or greater period as deemed appropriate.

7. Calculations indicating the estimated impact of the project proposed in the agreement on the debt and annual debt service of each participating jurisdiction over the course of the next 10-year period, or over the course of a lesser or greater period as deemed appropriate.

8. Information indicating the general equity of the proposed plan for each participating locality.

9. Other information that would assist the commission in analyzing the "probable effect on the people" in the participating jurisdictions of the proposed agreement.

10. The commission's staff shall endeavor to assist localities contemplating or involved in the development of voluntary economic growth-sharing agreements under the authority of § 15.2-1301 of the Code of Virginia by identifying additional data elements considered by the commission to be relevant to the commission's review of such agreements.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 26, eff. October 4, 2006; amended, Virginia Register Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-614 Determination of continued eligibility for city status

In undertaking its investigation with respect to whether a city continues to meet the requirements for city status as prescribed by Article VII, Section 1 of the Constitution of Virginia, the commission shall consider the information and data listed in this section. Any city subject to investigation as prescribed by Chapter 40 (§ 15.2-4000 et seq.) of Title 15.2 of the Code of Virginia shall be requested to submit information and data responsive to each element listed in this section and any other information and data as the city deems relevant to the continued eligibility for city status.

1. Any official correspondence with the United States Bureau of the Census regarding the accuracy of the most recent United States decennial census of the population of the city under investigation.

2. Any data or other evidence produced by the city under investigation or any other entity bearing on the accuracy of the most recent United States decennial census of the population of the city under investigation.

3. Any data or other evidence produced by the city under investigation or any other entity indicating the current population and projected future population of the city under investigation.

4. Contingent upon the commission's findings with respect to the population of the city under investigation, a listing of all of the city's assets, liabilities, rights, and obligations.

5. The commission's staff shall endeavor to assist the city under investigation by identifying additional data elements considered by the commission to be relevant to the continued eligibility for city status.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 26, eff. October 4, 2006; amended, Virginia Register Volume 35, Issue 1, eff. October 18, 2018.

1VAC50-20-616 Order defining a town's future annexation rights

In developing its order defining the future annexation rights of a town pursuant to § 15.2-3234 of the Code of Virginia, the commission shall consider the relevant information, data, and factors listed in this section. Any petition referred to the commission requesting an order establishing a town's future annexation rights should be accompanied by data and other evidence responsive to each element listed in this section that the town deems relevant to the issue.

1. Information regarding the inability of the town and the county to reach a voluntary agreement as to the future annexation rights of the town.

2. Terms and conditions of a proposed order establishing the town's future annexation rights.

3. Data and evidence responsive to the relevant provisions of 1VAC50-20-540.

4. The commission's staff shall endeavor to assist localities involved in proceedings concerning an order defining a town's future annexation rights by identifying additional data elements considered by the commission to be relevant in the disposition of such issues.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 26, eff. October 4, 2006; amended, Virginia Register Volume 42, Issue 8, eff. December 31, 2025.

Part V Formal Commission Reviews

1VAC50-20-620 Oral presentations by parties

A. In the course of its analysis of any issue, the commission may schedule oral presentations for purposes of permitting the parties to amplify submissions, to critique and to offer comment upon the submissions and evidence offered by other parties, and to respond to questions relative to the issue from the commission. The presentations, if scheduled, shall extend for a period of time as the commission may deem appropriate.

B. If oral presentations are scheduled by the commission, the chair shall select, subsequent to the receipt of recommendations from the parties, an appropriate site for the presentations. Recommendations by the parties regarding the sites should be based upon the adequacy of space for the display and movement of exhibits; the adequacy of seating arrangements for the commission, the commission's staff, representatives of the parties, a court reporter, and the public; the adequacy of security at the site to permit materials to be left unattended during recesses; and the adequacy of the acoustic characteristics of the site to facilitate communications or the availability of a public address system.

C. Local governments or other parties desiring to present exhibits or data requiring special equipment should be prepared to provide such special equipment.

D. The commission may, where it deems appropriate, consolidate two or more interlocal issues before it for purpose of oral presentations.

E. The commission shall, within the requirements of law, conduct the oral presentations in the manner it considers best suited for reaching a decision in the best interest of the parties and in the best interest of the Commonwealth.

F. The chair or other member the commission designated to preside during any oral presentations may allocate time to the various parties as the chair or presiding member deems appropriate. The allocation of time shall be based upon the needs of the commission to review data, examine witnesses, and obtain an understanding of the relevant factors affecting the issue under review.

G. The sequence in which testimony will be received by the commission during any oral presentations shall be established by the chair or presiding member, but shall generally be as follows:

1. A brief opening statement by each party, if desired;

2. Presentation by the party initiating the issue before the commission;

3. Presentations by the local governments immediately affected by the action proposed by the initiating party, in an order established by the chair or presiding member;

4. Presentations by other parties in an order established by the chair or presiding member;

5. Rebuttal where requested by a party and agreed to by the chair or presiding member.

H. The chair or presiding member may, to the extent the chair or presiding member deems appropriate, permit parties to question witnesses regarding submissions, testimony, or other facts relevant to the issues before the commission. Where a party is represented by counsel, such questioning may be conducted by counsel.

Where the parties have prefiled testimony at the commission's request pursuant to 1VAC50-20-390 R, the questioning of individuals whose testimony has been prefiled shall be limited to a cross-examination of such testimony. The commission may accept additional oral testimony from individuals whose testimony has been prefiled during the presentations where good cause is shown. Where additional oral testimony is accepted by the commission, the commission shall provide an opportunity for other parties to respond to the testimony and to cross-examine the individual offering such testimony.

I. The chair or presiding member may, during or at the conclusion of the oral presentations, permit or request oral argument on the issues before the commission.

J. The commission and its staff may question any witness or representative of any party during the oral presentations regarding any submission, testimony, or other fact that the commission considers relevant to the issues before it. The chair or presiding member shall endeavor to call for commission questioning in a manner designed to expedite the presentations.

K. The commission may accept depositions from persons unable to attend an oral presentation. Depositions shall only be accepted under conditions deemed acceptable by the commission, including conditions ensuring an opportunity for all affected local governments to be present and to adequately examine the witness during the taking of depositions.

L. The parties or their counsel shall be expected to confer in advance of the time and date set for presentations in order to inform one another of prospective witnesses and the order of the anticipated appearance of the witnesses. All material, data, or exhibits proposed for presentation to the commission during the oral presentations will be made available to the other parties and the public and on the commission's website whenever possible.

M. The commission requires that all materials, data, and exhibits be presented to it and made available to other parties in advance of the commencement of the onsite component of the commission's review. The commission may accept additional materials, data, and exhibits during the onsite component of its review upon unanimous consent of the members present. Where late submissions are accepted by the commission, the commission shall provide an opportunity for other parties to respond to the filings.

N. The commission may record by mechanical device, unless other recording arrangements are made by the parties, all testimony given during the oral presentations, but shall prepare a transcript of the recording only when deemed appropriate. The commission shall provide, upon request, any party a duplicate copy of the transcript or recording, if made, in accordance with the Department of Housing and Community Development's Freedom of Information Act policies. In lieu of recording by the commission, the parties may arrange to provide a court reporter at the expense of the parties. Where a court reporter is utilized, the commission shall receive one copy of the transcript.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 5.1, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 35, Issue 1, eff. October 18, 2018; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-630 Public hearing

A. In all cases where a public hearing is required by law, the commission shall conduct the public hearing at which any interested person or party may testify. The commission shall generally schedule the public hearing in conjunction with the oral presentations held, if any, with respect to the issue; however, public hearings regarding proposed town incorporations required pursuant to § 15.2-3601 of the Code of Virginia shall be held no sooner than 30 days after receipt of the court request for commission review.

B. Prior to holding the public hearing, the commission shall publish notice of the pending hearing as required by law.

In addition to the notice of public hearing required by this subsection, a town that is a party to an agreement defining annexation rights negotiated pursuant to § 15.2-3231 of the Code of Virginia shall give written notice of the commission's hearing at least 10 days before the hearing to the owner or the owner's agent of each parcel of land included in the area proposed for annexation under the terms of the agreement. One notice sent by first-class mail to the last known address of the owner or the owner's agent as shown on the current county real estate tax assessment books or current county real estate tax assessment records shall be deemed adequate compliance with this requirement, provided that the clerk of the town shall make an affidavit that the mailings have been made and file the affidavit with the commission.

C. The commission shall request the party initiating the issue before it and the other principally affected parties to place on public display in or adjacent to the office of the chief administrative officer of each principally affected local government copies of all materials that are available to the party and that have been submitted to the commission for consideration with respect to the issue. The material should be made conveniently available to the public during normal working hours. The commission also encourages the parties to make copies of the material available on their websites or at other public places in order that the public might have ample opportunity to study the material prior to the public hearing. The commission's advertisements published under subsection B of this section shall announce the availability of the material at the offices of the administrators.

D. The commission shall request the chief administrative officer or other official of each jurisdiction principally affected by the issue before the commission to make suitable arrangements in or adjacent to the official's office for the registration of speakers at the public hearing. The commission shall furnish appropriate registration forms for that purpose. The commission's advertisements under subsection B of this section shall advise the public that registration to speak at the public hearing may be accomplished at the offices of the local administrators or, alternatively, through the offices of the commission in Richmond. The commission may also permit speakers to register at the site and at the time of the public hearing and shall request the assistance of the local administrative officers in making suitable arrangements for such registration.

E. The chair or other member of the commission designated to preside over the proceedings shall select the site for the public hearing subsequent to the receipt of recommendations from the parties. Recommendations from the parties should be based upon a site's accessibility to residents of the areas and jurisdictions principally affected, its seating capacity, the adequacy of parking facilities, the availability of a public address system, and seating arrangements permitting the commission to have proper visual contact with the public.

F. The commission shall request the parties to cooperate in the preparation of the site for the public hearing and shall request that a minimum number of maps and exhibits be placed on display at the site in order that any person testifying may identify that person's residences, property, businesses, or other concerns in relation to the proposed issue.

G. The commission shall request the local jurisdiction within which the site for the public hearing is situated to make appropriate arrangements in order to ensure the security and the orderliness of the proceedings.

H. The chair or the presiding member shall determine the sequence of speakers at a public hearing, but the sequence shall ordinarily conform to the sequence of the registration of speakers. The chair or presiding member may, however, vary the sequence of speakers in order that persons from all affected jurisdictions and areas, and those representing different perspectives, might have equal opportunity for the timely presentation of comments.

I. The commission shall endeavor to allow any person or party wishing to speak at a public hearing an opportunity to do so. The chair or presiding member may establish time limits for the presentation of testimony as the chair or presiding member deems appropriate. The chair or presiding member may also rule testimony irrelevant, immaterial, or unduly repetitious. Proponents and opponents of a proposed action are encouraged to designate a chief spokesman for economy of time and for the avoidance of repetitious comment.

J. Any person or party testifying before the commission at the public hearing may extend their remarks in written form for subsequent submission. During the course of the public hearing, the commission shall establish a date by which the extended written comment must be received for consideration.

K. The commission may record by mechanical device, unless other arrangements are made, all testimony given during the public hearing but shall prepare a transcript of the recording only when it deems appropriate. The commission shall provide any person or party with a copy of the transcript or recording, if made, in accordance with the Department of Housing and Community Development's Freedom of Information Act policies. The parties may arrange to provide a court reporter, at their expense. Where a court reporter is utilized, the commission shall receive one copy of the transcript.

L. The commission may, where it deems appropriate, consolidate two or more interlocal issues for purposes of a public hearing.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 5.2, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 35, Issue 1, eff. October 18, 2018; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-640 Conclusion of mandatory reviews

A. The commission may request or authorize the parties to an issue to submit, at a time established by the commission, a written concluding argument with proposed findings and recommendations.

B. The commission shall not accept for consideration or for inclusion in the record of a case any document, exhibit, or other material submitted after the date established by it for the close of the record. This regulation shall not preclude the commission's acceptance of data or information from any party at any time that has been solicited by the commission or its staff.

C. The commission shall submit a written report on the issues presented to it in the manner and at such time as provided by law. The reports shall set forth findings of fact and recommendations on both the merits of a proposed action and, where appropriate and feasible, the financial aspects thereof. Copies of reports shall be made available to the parties and to members of the public that request a copy. The commission may charge a fee for copies of its reports in accordance with the Department of Housing and Community Development's Freedom of Information Act policies and applicable law.

D. Subsequent to its review of a petition submitted by a town under the authority of § 15.2-3234 of the Code of Virginia, and based upon the applicable statutory standards, the commission shall enter an order granting annexation rights to the town. The order may grant the town annexation rights upon the terms proposed by the town in its petition or upon some other basis as the commission deems appropriate and consistent with law. The order shall in no event grant the town the right to annex county territory by ordinance more frequently than once every five years.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 5.3, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 42, Issue 8, eff. December 31, 2025.

Part VI Investigations and Mediation

1VAC50-20-650 Statutorily invoked mediation in annexation immunity issues

A. For purposes of this section, as the requirements in this section pertain to § 15.2-2907 E of the Code of Virginia, the following definitions shall apply:

"Initial notice" means the notice sent to the commission by a locality proposing an action pursuant to § 15.2-2907 A of the Code of Virginia.

"Annexation or partial immunity suit" or "suit" means a court proceeding intended to resolve an annexation or partial immunity dispute that is filed after the commission has issued its advisory report pursuant to § 15.2-2907 of the Code of Virginia.

B. When any county, city, or town seeks to negotiate an agreement with one or more localities relative to annexation or partial immunity under the authority granted by § 15.2-2907 E of the Code of Virginia, it shall notify the commission, and copies of the notice shall be served on all adjacent localities. The notice to the commission shall be accompanied by satisfactory evidence that the governing body of the locality giving notice supports the negotiation. Local governments negotiating under § 15.2-2907 E of the Code of Virginia shall keep the commission advised of progress in the negotiations. If, after a hearing, the commission finds that none of the parties is willing to continue to negotiate, or if it finds, based on progress reports and with or without a hearing, that three months have elapsed with no substantial progress, it shall declare the negotiations to be terminated. Unless the parties agree otherwise, negotiations shall in any event terminate 12 months from the date the initial notice was given to the commission. Once the commission has declared negotiations terminated, or 12 months after the commission's receipt of the initial notice, or upon any extension of the 12-month deadline agreed to by both parties, whichever comes first, no new notice to negotiate shall be filed by any party. Upon the request of the local governments negotiating under the authority of § 15.2-2907 E of the Code of Virginia, the commission or its designee may be requested to serve as mediator, and, in addition, the commission's staff and resources shall be available to assist the negotiating local governments. All expenses incurred by the commission and its staff in assisting with negotiations shall be borne by the parties initiating the negotiations unless otherwise agreed.

C. The commission will neither accept a notice filed under the authority granted by § 15.2-2907 E of the Code of Virginia before the initial notice is filed nor accept a notice after 12 months has passed since receipt of the initial notice, unless both parties agree to an extension.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 6.1, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 42, Issue 8, eff. December 31, 2025.

1VAC50-20-660 Mediation of other interlocal issues

The commission shall, at its discretion, accept for mediation interlocal issues presented to it by mutual agreement of the affected localities. Requests for commission mediation under this section should be made to the commission's offices in Richmond and should be accompanied by satisfactory evidence that the governing bodies of the affected localities agree to the request for mediation assistance. The requests should include a statement indicating the issue for which mediation is sought and any other information as would enable the commission to determine whether its mediation effort would be timely and appropriate. Where the requests for mediation are presented to the commission prior to the submission of formal notice of pending action as required by § 15.2-2907 of the Code of Virginia, the requests need not be accompanied by any of the statistical data or material required under Part IV (1VAC50-20-540 et seq.) of this chapter. However, if the commission agrees to mediate interlocal issues under this section, the local governments requesting the mediation shall assist the commission by providing data, material, and other information as the commission or the parties deem necessary.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 6.2, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006.

1VAC50-20-670 Requested investigations and analyses

The commission may, if it deems appropriate and within the capability of its resources, accept requests from local governments for the undertaking of investigations and analyses. Requests for investigations and analyses should be addressed to the commission's offices in Richmond and should include satisfactory evidence that the governing body of the locality initiating the request supports the proposed study. The request should also include a detailed statement of the issue giving rise to the request for the study, a statement of the extent to which the issue is of general interest to local governments in Virginia, a statement concerning the prospective benefits of a study, and other information as would aid the commission in its determination as to whether or not to undertake the requested study. Where the commission agrees to undertake a study under this section, the locality or localities requesting the study shall assist the commission and provide, to the extent possible, the data and material the commission or the parties deem necessary for the study. The commission shall render reports on such studies at such a time and in such a manner as it deems appropriate.

History

• Statutory Authority: § 15.2-2903 of the Code of Virginia.
• Historical Notes: Derived from VR445-01-02 § 6.3, eff. November 1, 1984; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006.

1VAC50-20-680 (Repealed.)

Historical Notes

Derived from VR445-01-02 §§ 7.1 to 7.3, eff. November 1, 1984; repealed, Virginia Register Volume 22, Issue 26, eff. October 4, 2006.

Agency 55 Department of Human Resource Management

Chapter 11 Public Participation Guidelines

Part I Purpose and Definitions

1VAC55-11-10 Purpose

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the Department of Human Resource Management. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

History

• Statutory Authority: §§ 2.2-4007.02 and 2.2-1201 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

1VAC55-11-20 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§ 2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Department of Human Resource Management, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§ 2.2-4031 et seq.) of the Administrative Process Act.

History

• Statutory Authority: §§ 2.2-4007.02 and 2.2-1201 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

Part II Notification of Interested Persons

1VAC55-11-30 Notification list

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

History

• Statutory Authority: §§ 2.2-4007.02 and 2.2-1201 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

1VAC55-11-40 Information to be sent to persons on the notification list

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 1VAC55-11-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

History

• Statutory Authority: §§ 2.2-4007.02 and 2.2-1201 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

Part III Public Participation Procedures

1VAC55-11-50 Public comment

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to submit data, views, and arguments, either orally or in writing, to the agency. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

History

• Statutory Authority: §§ 2.2-4007.02 and 2.2-1201 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

1VAC55-11-60 Petition for rulemaking

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

History

• Statutory Authority: §§ 2.2-4007.02 and 2.2-1201 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

1VAC55-11-70 Appointment of regulatory advisory panel

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

History

• Statutory Authority: §§ 2.2-4007.02 and 2.2-1201 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

1VAC55-11-80 Appointment of negotiated rulemaking panel

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

History

• Statutory Authority: §§ 2.2-4007.02 and 2.2-1201 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

1VAC55-11-90 Meetings

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

History

• Statutory Authority: §§ 2.2-4007.02 and 2.2-1201 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

1VAC55-11-100 Public hearings on regulations

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working daysprior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

History

• Statutory Authority: §§ 2.2-4007.02 and 2.2-1201 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

1VAC55-11-110 Periodic review of regulations

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

History

• Statutory Authority: §§ 2.2-4007.02 and 2.2-1201 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

Chapter 20 Commonwealth of Virginia Health Benefits Program

Part I General

1VAC55-20-20 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Accident or health plan" means a plan described in the Internal Revenue Code § 105.

"Administrative services arrangement" means an arrangement whereby a third party administrator agrees to administer all or part of the health benefits program.

"Adoption agreement" means an agreement executed between a local employer and the department specifying the terms and conditions of the local employer's participation in the health benefits program.

"Adverse experience adjustment" means the adjustment determined by the department, consistent with its actuarial practices, to premiums for the year in which a local employer withdraws from the plan.

"Alternative health benefits plans" means optional medical benefits plans, inclusive of but not limited to HMOs and PPOs, which are offered pursuant to the health benefits program in addition to the basic statewide plan.

"Basic statewide plan" means the statewide health benefits plan for state employees offered at a uniform rate to all state employees pursuant to § 2.2-2818 of the Code of Virginia.

"Benefits administrator" or "group benefits administrator" means the person or office designated in the application and adoption agreement to be responsible for the day-to-day administration of the health benefits program at the local level. The benefits administrator is an employee of the agency or local employer that employs the benefits administrator. The benefits administrator is not an agent of the health insurance plan or the Department of Human Resource Management.

"Coordinated service" means a health care service or supply covered under both the program and another health plan. The coordinated service will be provided under the program only to the extent it is not excluded or limited under the program.

"Coordination of benefits" means the establishment of a priority between two or more underwriters that provide health benefits protection covering the same claims incident.

"Department" means the Department of Human Resource Management.

"Dependent" means any person who is determined to be an eligible family member of an employee pursuant to subsection E of 1VAC55-20-320.

"Director" means the Director of the Department of Human Resource Management.

"Dual membership" means the coverage in the health benefits program of the employee and either the spouse or one dependent. This definition does not include coverage of retirees or employees or their spouses who are otherwise covered by Medicare.

"Effective date of coverage" means the date on which a participant is enrolled for benefits under a plan or plans elected under the health benefits program.

"Employee" means a person employed by an employer participating in the health benefits program or, where demanded by the context of this chapter, a retired employee of such an employer. The term "employee" shall include state employees and employees of local employers.

"Employee health insurance fund" or "health insurance funds" means accounts established by the state treasury and maintained by the department within which contributions to the plan shall be deposited.

"Employer" means the entity with whom a person maintains a common law employee-employer relationship. The term "employer" is inclusive of each state agency and of a local employer.

"Employer application" or "application" means the form, to be provided by the department, to be used by the local employer for applying to participate in the health benefits program.

"Enrollment action" means providing the information, which would otherwise be contained on an enrollment form, through an alternative means such as the Internet or an interactive voice response system, for the purpose of securing or changing membership or coverage in the employee health benefits program. Submitting a properly completed enrollment form and taking an enrollment action through an employee self-service system are used interchangeably to indicate equivalent actions.

"Enrollment form" means the form, to be provided by the department, to be used by participants to enroll in a plan or to indicate a change in coverage.

"Family membership" means the coverage in the health benefits program of the employee and two or more eligible dependents.

"Health benefits program" or "program" means, individually or collectively, the plan or plans the department may establish pursuant to §§ 2.2-1204 and 2.2-2818 of the Code of Virginia.

"Health Maintenance Organization" or "HMO" means an entity created under federal law, "The Health Maintenance Organization Act of 1973" (Title XIII of the Public Health Service Act), as amended, or one defined under state law.

"Health plan" means:

1. A plan or program offering benefits for, or as a result of, any type of health care service when it is:

a. Group or blanket insurance (including school insurance programs); or

b. Blue Cross, Blue Shield, group practice (including HMOs and PPOs), individual practice (including IPAs), or any other prepayment arrangement (including this program) when:

(1) An employer contributes any portion of the premium;

(2) An employer contracts for the group coverage on behalf of employees; or

(3) It is any labor-management trustee plan, union welfare plan, employer organization plan, or employee benefit organization plan.

2. The term "health plan" refers to each plan or program separately. It also refers to any portion of a plan or program that reserves the right to take into account benefits of other health plans when determining its own benefits. If a health plan has a coordination of benefits provision that applies to only part of its services, the terms of this section will be applied separately to that part and to any other part.

3. A prepaid health care services contract or accident or health plan meeting all the following conditions is not a health plan:

a. One that is individually underwritten;

b. One that is individually issued;

c. One that provides only for accident and sickness benefits; and

d. One that is paid for entirely by the subscriber.

A contract or policy of the type described in subdivision 3 of this definition is not subject to coordination of benefits.

"Independent hearing officer" means an individual requested by the director of the department from a list maintained by the Executive Secretary of the Supreme Court of Virginia to arbitrate disputes that may arise in conjunction with these regulations or the health benefits program.

"Independent review organization" means an organization that, upon written request from the Department of Human Resource Management, examines the adverse health benefits claim decision made by the Commonwealth's Third Party Administrator (TPA). The independent review organization should determine whether the TPA's decision is objective, clinically valid, compatible with established principles of health care, and appropriate under the terms of the contractual obligations to the covered person.

"Insured arrangement" means an accident or health plan underwritten by an insurance company wherein the department's only obligation as it may relate to claims is the payment of insurance company premiums.

"Local employees" or "employees of local governments" means all officers and employees of the governing body of any county, city, or town, and the directing or governing body of any political entity, subdivision, branch, or unit of the Commonwealth or of any commission or public authority or body corporate created by or under an act of the General Assembly specifying the power or powers, privileges or authority capable of exercise by the commission or public authority or body corporate, as distinguished from § 15.2-1300 or 15.2-1303 of the Code of Virginia, or similar statutes, provided that the officers and employees of a social services department, welfare board, community services board, or behavioral health authority, or library board of a county, city, or town shall be deemed to be the employees of local government.

"Local employer" means any county, city, or town, school board, and the directing or governing body of any political entity, subdivision, branch or unit of the Commonwealth or of any commission or public authority or body corporate created by or under an act of the General Assembly specifying the power or powers, privileges or authority capable of exercise by the commission or public authority or body corporate, as distinguished from § 15.2-1300 or 15.2-1303 of the Code of Virginia, or similar statutes.

"Local officer" means the treasurer, registrar, commissioner of revenue, attorney for the Commonwealth, clerk of a circuit court, sheriff, or constable of any county or city or deputies or employees of any of the preceding local officers.

"Local retiree" means a former local employee who has met the terms and conditions for early, normal, or late retirement from a local employer.

"Open enrollment" means the period during which an employee may elect to commence, waive, or change membership or plans offered pursuant to the health benefits program.

"Part-time employee," as defined by each local employer, means an employee working less than full time but more than 20 hours per week whom a local employer has determined to be eligible to participate in the program. The conditions of participation for these employees shall be decided by the local employer in a nondiscriminatory manner.

"Participants" means individuals covered by the plan due to their relationship with the employer. They are not covered as dependents under the plan.

"Plan administrator" means the department.

"Preexisting condition" means a condition that, in the opinion of the plan's medical advisors, displayed signs or symptoms before the participant's effective date of coverage. These signs or symptoms must be ones of which the participant was aware or should reasonably have been aware. The condition is considered preexisting whether or not the participant was seen or treated for the condition. It is also considered preexisting whether or not the signs and symptoms of the condition were correctly diagnosed.

"Preferred provider organization" or "PPO" means an entity through which a group of health care providers, such as doctors, hospitals, and others, agree to provide specific medical and hospital care and some related services at a negotiated price.

"Primary coverage" means the health plan that will provide benefits first. It does not matter whether or not a claim has been filed for benefits with the primary health plan.

"Retiree" means any person who meets the definition of either a state retiree or a local retiree.

"Secondary coverage" means the health plan under which the benefits may be reduced to prevent duplicate or overlapping coverage.

"Self-funded arrangement" means a facility through which the plan sponsor agrees to assume the risk associated with the type of benefit provided without using an insurance company.

"Single membership" means coverage of the employee only under the health benefits program.

"State" means the Commonwealth of Virginia.

"State agency" means a court, department, institution, office, board, council, or other unit of state government located in the legislative, judicial, or executive departments or group of independent agencies, as shown in the Appropriation Act, and which is designated in the Appropriation Act by title and a three-digit agency code.

"State employee" means any person who is regularly employed full time on a salaried basis, whose tenure is not restricted as to temporary or provisional appointment, in the service of, and whose compensation is payable, no more often than biweekly, in whole or in part, by the Commonwealth or any department, institution, or agency thereof. "State employee" shall include the Governor, Lieutenant Governor, Attorney General, and members of the General Assembly. It includes "judge" as defined in § 51.1-301 of the Code of Virginia and judges, clerks, and deputy clerks of regional juvenile and domestic relations, county juvenile and domestic relations, and district courts of the Commonwealth.

"State retiree" means a former state employee who has met the terms and conditions for early, normal or late retirement from the Commonwealth.

"Teacher" means any employee of a county, city, or other local public school board.

History

• Statutory Authority: § 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 1.2, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; Volume 26, Issue 25, eff. September 16, 2010; Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-30 Designee and delegations of authority

Pursuant to § 2.2-2818 of the Code of Virginia, the Department of Human Resource Management shall establish a health benefits program (the "program"), subject to the approval of the Governor, for providing accident or health benefit protection, including but not limited to chiropractic treatment, hospitalization, medical, surgical and major medical coverage for state employees and the employees of participating local employers.

The Director of the Department of Human Resource Management hereby delegates to the Director of the Office of Health Benefits the authority to:

1. Propose, design, and administer one or more accident or health plans, or both. All such approved plans will, in the aggregate, constitute the health benefits program. Any plan or plans proposed by the Office of Health Benefits shall be subject to the approval of the Director of the Department of Human Resource Management.

2. Propose regulations at any time for the purpose of the implementation, communication, funding, and administration of the health benefits program.

3. Enter into one or more contracts for the purpose of implementing, communicating, funding or administering the health benefits program. To this end, but not exclusively, such contract or contracts may be for the underwriting, the funding, and administration, including claims processing and claims adjudication, of the program. Such contracts may be for the legal, accounting and actuarial services as well as communication, statistical analysis and any other item that may be needed to effectively review and maintain the health benefits program.

4. Evaluate the effectiveness of the health benefits program or any plan which may constitute a component part, as it might relate to the objectives of such program or such component plan and make recommendations regarding the effectiveness of such program or plan in meeting such stated objectives.

History

• Statutory Authority: §§ 2.2-1204 and 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 1.3, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004.

1VAC55-20-40 (Repealed.)

History

• Historical Notes: Derived from VR525-01-02 § 1.4, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; repealed, Virginia Register Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-50 (Repealed.)

Historical Notes

Derived from VR525-01-02 § 1.5, eff. November 21, 1990; repealed, Virginia Register Volume 20, Issue 20, eff. July 16, 2004.

1VAC55-20-60 Types of plans

A. The administration and underwriting of the plans shall be at the discretion of the department and may include but not be limited to self-funded arrangements, insured arrangements, administrative services arrangements, health maintenance organizations, and preferred provider organizations. The department is authorized to exercise judgment and discretion in the establishment, procurement and implementation of all underwriting and other services necessary for the establishment, maintenance, and administration of such plans and will be deemed to do so in good faith.

B. The department, as it deems necessary or prudent, may contract for outside services, including but not limited to actuarial, consulting, and legal counsel. The department may contract such services on an individual basis or in conjunction with other services.

History

• Statutory Authority: §§ 2.2-1204 and 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 1.6, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004.

1VAC55-20-70 Procurement

The department shall comply with the Virginia Public Procurement Act, Chapter 43 (§ 2.2-4300 et seq.) of Title 2.2 of the Code of Virginia, as it may relate to any services to which such Act shall apply.

In an effort to stabilize the administration and maintenance of the health benefits program, the department may contract for services applicable to such program for a period of time not exceeding 10 years, with the department reserving the right, in its sole discretion, to cancel such contracts annually upon 90 days written notice to the contractor.

History

• Statutory Authority: §§ 2.2-1204 and 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 1.7, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004.

1VAC55-20-80 Plan assets

A. The assets of the health benefits program, together with all appropriations, contributions and other payments, shall be deposited in the employee health insurance fund(s) (the "health insurance fund(s)") from which payments for claims, premiums or other contributions, cost containment and administrative expenses shall be withdrawn from time to time.

B. The health insurance fund for state employees shall be maintained separate and apart from the health insurance fund for retirees of the state eligible for Medicare and from the health insurance fund for local employees. All such funds shall be maintained for the exclusive benefit of the employees participating currently in the respective health insurance plans.

C. The department may designate with the approval of the Department of the Treasury one or more insurance companies, banks or any such similar institution as a direct recipient of premiums or other contributions for part or all coverage under the health benefits program from local and state employers.

D. The assets of the fund shall be held for the sole benefit of the employee health insurance fund and to that end, employees participating in the health benefits program.

Any interest on unused balances in the fund shall revert back to the credit of the fund. The State Treasurer shall charge reasonable fees to recover the actual costs of investing the assets held in the fund.

History

• Statutory Authority: §§ 2.2-1204 and 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 1.8, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004.

1VAC55-20-90 Appeals

A. The director of the department shall be the final arbiter of any disputes arising under this chapter. The director may not redelegate this authority other than to an independent hearing officer except as provided under subsection C of this section.

All disputes arising under this chapter shall be submitted to the department, which shall have the responsibility for interpreting and administering this chapter. All disputes shall be made in writing in such manner as may be reasonably required by the department and shall set forth the facts that the applicant believes to be sufficient to entitlement to relief hereunder. The department may adopt forms for such submissions in which case all appeals shall be filed on such forms.

B. Appeals not filed within the time frames established herein shall be denied.

Requests for review of procurements under the provisions of the Virginia Public Procurement Act (§ 2.2-4300 et seq. of the Code of Virginia) shall be filed within 10 days of the department's notice of intent to award a contract.

Requests for relief from local employers or state agencies with respect to any action of the department other than a procurement shall be filed within 30 days of the action grieving the applicant. Requests for relief from state or local employees with respect to any action of the department other than a procurement shall be filed within 60 days of the action grieving the employee.

C. Upon receipt by the department for a request for review under this section, it shall determine all facts that are necessary to establish the right of an applicant for relief. The department shall approve, deny, or investigate any and all disputes arising hereunder. Upon request, the department will afford the applicant the right of a hearing with respect to any finding of fact or determination related to any claim under this section. In the event of an adverse decision by the department, the applicant shall be notified of such decision as provided in this section. Reviews for treatment authorizations or medical claims that have been denied will be sent to an independent review organization. The independent review organization shall examine the final denial of claims or treatment authorizations to determine whether the decision is objective, clinically valid, and compatible with established principles of health care. The decision of the independent review organization shall (i) be in writing, (ii) contain findings of fact as to the material issues in the case and the basis for those findings, and (iii) be final and binding if consistent with law and policy.

D. The applicant shall be notified in writing of any adverse decision with respect to his claim within 90 days after its submission. The notice shall be written in a manner calculated to be understood by the applicant and shall include:

1. The specific reason or reasons for the denial;

2. Specific references to law, this chapter, contracts awarded pursuant to this chapter, or the Health Insurance Manual/Local Administrative Manual and related instructions on which the denial is based;

3. A description of any additional material or information necessary to the applicant to perfect the claim and an explanation why such material or information is necessary; and

4. An explanation of the review process.

If special circumstances require an extension of time for processing an initial application, the department shall furnish written notice of the extension and the reason therefore to the applicant before the end of the initial 90-day period. In no event shall such extension exceed 90 days.

E. Standards, credentials, and qualifications of the independent review organization.

1. In order to qualify to perform either standard or expedited external reviews pursuant to this chapter or the Code of Virginia, an independent review organization shall have and maintain written policies and procedures that govern all aspects of the standard and expedited external review processes that include, at a minimum, a quality assurance mechanism in place that ensures that:

a. External reviews are conducted within the specified time frames and required notices are provided in a timely manner;

b. Qualified and impartial clinical peer reviewers are selected to conduct external reviews on behalf of the impartial health entity and reviewers are suitably matched to specific cases; and

c. The confidentiality of medical records is maintained in accordance with the confidentiality and disclosure laws of the Commonwealth or the Health Insurance Portability and Accountability Act.

2. All clinical peer reviewers assigned by an independent review organization to conduct external reviews shall be physicians or other appropriate health care providers who meet the following minimum qualifications:

a. Are expert in the treatment of the covered person's medical condition that is the subject of the external review;

b. Are knowledgeable about the recommended health care service or treatment through recent or current actual clinical experience treating patients with the same or similar medical conditions as the covered person's;

c. Hold a nonrestricted license in a state of the United States and, for physicians, a current certification by a recognized American medical specialty board in the area or areas appropriate to the subject of the external review; and

d. Have no history of disciplinary actions or sanctions, including loss of staff privileges or participation restrictions, that have been taken or are pending by any hospital, governmental agency or unit, or regulatory body that raise a substantial question as to the clinical peer reviewer's physical, mental, or professional competence or moral character.

3. An independent review organization shall not be affiliated with or a subsidiary of nor be owned or controlled by a health plan, a trade association of health plans, or a professional association of health care providers.

4. In determining whether an independent review organization or a clinical peer reviewer of the independent review organization has a material, professional, familial, or financial conflict of interest, the director may take into consideration situations where the characteristics of that relationship or connection are such that they are not materially sufficient to disqualify the independent review organization or the clinical peer reviewer from conducting the external review.

History

• Statutory Authority: § 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 1.9, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-100 No presumption of right

These regulations and the health benefits program herein established shall not be deemed to constitute a contract of employment between any participating employer and any participant. No participant in the program shall acquire any right to be retained in the employer's employ by virtue of the program, nor, upon the participant's dismissal or voluntary termination of employment, shall the participant have any interest in any assets of the program other than as may be specifically provided herein.

Furthermore, these regulations and the health benefits program herein established shall in no event confer upon any participant any rights, duties or responsibilities other than those granted herein. The Commonwealth of Virginia specifically reserves the right to amend, modify or terminate, inclusive of eligibility, coverage and contributions provisions, the health benefits program or any plan or plans comprising all or part of the program, as they may relate to any active or retired participant.

History

• Statutory Authority: §§ 2.1-20.1 and 2.1-20.1:02 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 1.10, eff. November 21, 1990.

1VAC55-20-110 Authority to withhold revenues

In the event of default by any employer participating in the health insurance program authorized by § 2.2-1204 of the Code of Virginia in the remittance of premiums or other fees and costs of the program, the State Comptroller is hereby authorized to pay such premiums and costs and to recover such payments from any funds appropriated and payable by the Commonwealth to the employer for any purpose. The State Comptroller shall make such payments, and recover an equivalent amount if possible, from an employer's appropriated funds upon receipt of notice from the director of the department that such payments are due and unpaid from the employer.

History

• Statutory Authority: §§ 2.2-1204 and 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 1.11, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004.

1VAC55-20-120 (Repealed.)

Historical Notes

Derived from VR525-01-02 § 1.12, eff. November 21, 1990; repealed, Virginia Register Volume 20, Issue 20, eff. July 16, 2004.

Part II Rights and Duties of the Department

1VAC55-20-130 Develop health benefits program

A. The department shall develop a health benefits program which shall be flexible in its form and content so as to accommodate a structure which permits the creation of multiple accident and health plans. The department, however, may offer a single health insurance plan if it determines that that is the most effective use of plan resources. The department has full authority to make changes in plan terms including, but not limited to, benefits and contributions, or to change underwriters and administrators as it deems appropriate.

B. The department shall supplement these regulations by providing administrative guidance through the Health Insurance Manual, Local Administrative Manual, Flexible Benefits Administrative Manual, memoranda, and other communications.

History

• Statutory Authority: §§ 2.2-1204 and 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 2.1, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004.

1VAC55-20-140 Underwriting

At the department's discretion, the program may either be created and maintained on a self-funded basis or procured from an insurance company licensed to do business in the Commonwealth of Virginia, or a combination of both. In addition, the department is authorized to contract with any third party providers for any and all services which may be necessary to design, administer, communicate or fund the health benefits program.

History

• Statutory Authority: §§ 2.1-20.1 and 2.1-20.1:02 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 2.2, eff. November 21, 1990.

1VAC55-20-150 Employer application

The department shall develop a form on which local employers may apply for participation in the health benefits program and make available such form to local employers joining such program. The department will advise local employers on questions pertaining to the application. Among other items the department may deem necessary, the application may include:

1. Information regarding the political subdivision such as the governing body, individuals or offices responsible to provide, receive and remit information to the department and the method by which information can or will be transmitted.

2. Information regarding the total number of employees and those employees currently covered, those who will immediately become eligible, and those whose participation is anticipated. This information can include but is not limited to demographic data such as the age and sex of employees, geographic location of residence and employment, dependent status, and information concerning employment responsibilities.

3. Information regarding past premiums, claims and enrollment experience, contribution history, financial arrangements with prior underwriters and the types of plans or benefits provided being offered within the five years prior to making the application.

History

• Statutory Authority: §§ 2.1-20.1 and 2.1-20.1:02 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 2.3, eff. November 21, 1990.

1VAC55-20-160 Establishing contribution rates and accounting for contributions and claims

A. The department shall establish one or more pools for establishing contribution rates and for accounting for claims and contributions for state employees and participating local employers. The plan for local employers shall be rated separately from the plan established for state employees. There are hereby authorized pools based on geographic and demographic characteristics and employment relationships. Such pools may include but shall not be limited to:

1. Active state employees, including retirees under age 65 and not eligible for Medicare;

2. Active local employees (excluding separately rated employees of public school systems);

3. Active employees of public school systems;

4. Retired state employees over age 65 and retired state employees eligible for Medicare;

5. Retired local employees (excluding separately rated employees of public school systems);

6. Retired employees of public school systems; and

7. Active employees whose employer does not sponsor a health insurance plan.

Participating employers shall make applicable contributions to the employee health insurance fund.

B. Such contributions may take into account the characteristics of the group, such as the demographics of employees, inclusive of age, sex, and dependent status of the employees of an employer; the geographic location of the employer or employees; claims experience of the employer; and the pool of the employers (for example, see subdivisions A 1 through 6 of this section). Additionally, any such contributions may further be determined by spreading large losses, as determined by the department, across pools. Further, the department reserves the right to recognize, in its sole discretion, the claims experience of groups of sufficient size, regardless of their pool, where future claim levels can be predicted with an acceptable degree of credibility. The application of this rule by the department shall be exercised in a uniform and consistent manner.

C. The contribution rate in the aggregate will be composed of two factors; first, the current contribution and second, the amortization of experience adjustments. The current contributions will reflect the anticipated incurred claims and administrative expenses for the period; an experience adjustment will reflect gains and losses determined in accordance with an actuarial estimate. An experience adjustment will be part of the contributions for the succeeding year; however, the department may authorize the amortization of the experience adjustment for a period not to exceed three years.

D. The department will notify a terminating local employer of any adverse experience adjustment within six-calendar months of the end of the plan year in which the local employer terminates participation in the program. Further the department reserves the right to modify the amount of the experience adjustment applicable to a terminating local employer for a period not to exceed 12 months from the end of the plan year in which such termination occurred. The experience adjustment shall be payable by the local employer in 12 equal monthly installments beginning 30 days after the date of notification by the department. In the event that a terminating local employer requests in writing an extension beyond a period of 12 months, the department may approve an extension up to 36 months provided the local employer agrees to pay interest at the statutory rate on any extended payments.

History

• Statutory Authority: § 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 2.4, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-170 Information to local employers

The department will provide guidance and support to local administrators in the adoption, implementation and administration of the health benefits program.

The department shall furnish local employers with any and all information necessary for any reports the local employer is required to file with any federal or state agency as well as any information necessary for meeting the qualification or nondiscrimination rules under the Internal Revenue Code which may be applicable to such plans.

History

• Statutory Authority: §§ 2.1-20.1 and 2.1-20.1:02 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 2.5, eff. November 21, 1990.

1VAC55-20-180 Information to local employees

The department shall inform local employees when their coverage terminates by reason of nonpayment of premiums for the local employee group by the local employer. The form of the first notice shall be a notice in a newspaper of general circulation in the locality of the local employer. Such notice shall be prospective with respect to the date of termination. The form of the second notice shall be a letter to each contract holder at the contract holder's address of record.

History

• Statutory Authority: §§ 2.1-20.1 and 2.1-20.1:02 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 2.6, eff. November 21, 1990.

1VAC55-20-190 Confidentiality

The department will not disclose identifiable individual health data without the consent of the individual being provided coverage. The department may rely on the representations of any parent or guardian regarding such parent's or guardian's consent to the release of information regarding a child of such parent or any other person to which such guardianship shall apply. Data may be compiled into statistical reports provided that the identity of individual persons is not ascertainable by the reader or disclosed by the department.

History

• Statutory Authority: §§ 2.1-20.1 and 2.1-20.1:02 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 2.7, eff. November 21, 1990.

1VAC55-20-200 Reports

The department, on an annual basis, shall provide a report to the General Assembly. Such report shall discuss the overall objectives of the health benefits program, including enrollment, income and expense, participation by local employers and additional matters of general concern.

History

• Statutory Authority: §§ 2.1-20.1 and 2.1-20.1:02 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 2.8, eff. November 21, 1990.

1VAC55-20-210 Oversight

The department has the responsibility and authority to maintain the health benefits program and take any action it deems necessary to maintain the financial and administrative integrity of the program.

A. The department shall review local administration, including state agency administration of the health benefits program to determine compliance with this chapter, law, and administrative directives. Deficiencies shall be reported to the governing body or agency administrator, who shall take prompt action to remedy the noted deficiencies. To this end, the department shall provide guidance to responsible parties regarding their duties and responsibilities in the administration of the program. Failure to correct noted deficiencies may result in the unilateral termination of participation (in the case of a local employer) in the health benefits program, or a revocation of the agency's administrative responsibility for the health benefits program (in the case of a state agency) and the imposition of a special employer contribution on the state agency to pay for the cost of direct administration of the program by the department. The cost of direct administration shall be determined by the department.

B. The department may exclude from coverage any person who is not eligible for coverage notwithstanding the participation of the state agency or local employer in the health benefits program or the payment of contributions or the previous payment of claims on behalf of such person.

If a person is determined to be ineligible for coverage, claims paid by the program during this period of ineligibility shall be recouped by the program from providers of care and from the ineligible employee to the extent practicable as determined by the department.

Employer contributions on behalf of ineligible persons shall not be returned to the participating employer in as much as the employer agrees by participating in the health benefits program that the amount of such contributions constitute liquidated damages for enrolling ineligible employees and/or their dependents. Employee contributions will not be refunded, and the membership level and contributions rate will be maintained, at the level they had been prior to the removal of the ineligible dependent, until such time as the employee makes a membership change due to a consistent qualifying midyear event, or during open enrollment.

C. The department may exclude from coverage for a period of three years any employee (and dependent) who is found by the department to have enrolled in the health benefits program through fraud, deceit, or misrepresentation of a dependent who is not eligible for the program. A signed enrollment form or equivalent enrollment action shall be deemed prima facie evidence of misrepresentation.

D. The department may refuse, notwithstanding any agreement or assignment from a participant or third party, to make a payment on behalf of a participant for covered services to a provider of care who has been determined by the department to be abusing or defrauding the program. A pattern of billing for services not rendered, misrepresenting the complexity or length of the procedures or services actually rendered, or similar abuses shall compel the department to make such a determination. For the purposes of this section, a "pattern" constitutes a number of instances over a period of at least three months which are so similar as to suggest that the abuse is present in 5.0% or more of the services or procedures billed.

History

• Statutory Authority: §§ 2.2-1204 and 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 2.9, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004.

Part III Local Employer Participation

1VAC55-20-220 Eligible employers

Pursuant to § 2.1-20.1:02 of the Code of Virginia, local employers may, by making proper application and complying with this chapter, participate in the health benefits program.

History

• Statutory Authority: §§ 2.1-20.1 and 2.1-20.1:02 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 3.1, eff. November 21, 1990.

1VAC55-20-230 Entrance into the health benefits program

A. Any local employer desiring to participate in the health benefits program shall complete an employer application provided by the department and execute an adoption agreement acknowledging the rights, duties, and responsibilities of the department and the local employer.

As a condition of participation, the department may require the local employer to complete the application in its entirety and deliver it to the department no less than 120 days prior to the effective date of coverage under the health benefits program. The application shall include the designation of a local administrator and include a list of other individuals whose responsibilities may be such that the department may have cause to contact them.

The application of a local employer may be withdrawn without penalty any time within the first 30 days after the department's delivery of rates to the employer. A 15-day extension will be available upon written request by the employer. Thereafter, the department may levy a processing charge not to exceed $500 to cover the cost of processing the application.

B. Except in unusual circumstances to be determined by the department, the completion of any waiting periods will not be required of employees of local employers joining the program at the time of a local employer's initial participation.

C. Local employers may include in the program their active employees, or their active employees and their retirees. Local employers may not elect to cover only retirees. If the local employer wishes to provide benefits to their Medicare-eligible retirees it must also provide coverage for non-Medicare retirees. The local employer's beneficiaries qualified under the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA) or similar legislation may also participate in the program.

History

• Statutory Authority: § 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 3.2, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-240 Payment of contributions

A. Contributions due. It is the sole responsibility of the local employer to remit local employer and local employee contributions to the department or its designee. The local employer may be responsible for remitting such contributions for active, retired, and COBRA-participating employees. Health benefits program contributions are to be made monthly, in advance, and are due at the department on the first of each month. If the first day of the month falls on a weekend or holiday, the payment is due at the department on the first business day of the month.

B. Nonpayment of contributions. A 10-day grace period for the nonpayment of contributions is hereby provided. If the full and complete payment of contributions is not received by the 10th of the month, a notice will be sent to the local employer by the department or its designee. Additionally, there shall be imposed an interest penalty of 12% per annum of the outstanding balance unpaid as of the 10th.

In the event that payment is not received by the 20th of the month, the department shall place a notice of nonpayment of contributions in a newspaper of general circulation in the locality of the local employer notifying the employees of such local employer that claims incurred after the end of the current month will not be paid until all outstanding contributions and interest have been paid.

Furthermore, the department reserves the right to collect from a local employer the greater of the monthly contribution or any amounts incurred for claims during a period of nonpayment as well as any other costs related thereto.

C. Nonpayment as breach. The nonpayment of contributions by a local employer shall constitute a breach of the adoption agreement and the local employer may be obligated to pay damages. In the event that the local employer terminates participation, such termination can only be prospective, and the employer shall be obligated to pay the greater of past contributions or actual claims incurred during such period and any interest and damages that may be associated with such nonpayment.

D. Coverage and contribution period. Except as noted here, coverage elections including those made by new employees are made on a prospective basis, that is, effective the first of the month coinciding with or following the receipt of the election form. However, if an election form is received from a new employee on the first business day of the month, coverage for the employee will commence on the first day of that month, (see 1VAC55-20-370). Coverage elections made for newborns, adoption, or placement for adoptions are effective the date the child is born, adopted, or placed for adoption, so long as the employee makes the coverage election within 60 days of the event. Coverage terminations are effective the end of the month following receipt of an election notice, except for terminations that are required by the plan. Coverage terminations required by the plan are effective the end of the month that the event takes place. Examples of coverage terminations required by the plan are such things as a divorce, termination of employment, or a dependent child losing eligibility.

Contributions shall always be for full calendar months. Local employees who terminate employment within a calendar month shall have coverage through the end of the month in which they terminate. In the event that a terminating local employee becomes covered under an accident or health plan of another employer prior to the end of the month in which the local employee terminates, this health benefits program shall be a secondary payor to the former local employee's new coverage.

History

• Statutory Authority: § 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 3.3, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-250 Enrollment

The local employer is responsible for providing local employees with enrollment forms for participation in the health benefits program. Such forms shall be provided to the local employer by the department or its designee. It is the responsibility of the local employer to provide information to local employees concerning the benefits offered in each of the plans comprising the health benefits program at such time and in such manner that it can be expected that the local employee can make an informed decision regarding the types of coverage that are being offered.

The local employer is responsible for ensuring that enrollment forms for participation made by local employees are fully completed on a timely basis, signed and certified. No later than 30 days prior to the effective date of coverage, the local employer shall forward the enrollment forms to the department or its designee, as may be appropriate. The department shall be responsible for notifying the local employer as to the location and manner of delivery of all such local employee enrollment forms. Further, the local employer shall be responsible for reporting any changes in benefit coverage in a manner similar to the reporting of an initial application with the department having the ability to waive the 30-day notice requirement.

History

• Statutory Authority: §§ 2.2-1204 and 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 3.4, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004.

1VAC55-20-260 Minimum local employer contributions

A. The department shall require, as a condition of local employer participation in the health benefits program, that a local employer pay a minimum portion of the plan contribution attributable to an active local employee's coverage. Contributions toward the cost of retiree coverage are permitted but not required. Unless otherwise specified in a local employer's adoption agreement, participating local employers shall contribute, at a minimum, 80% of the cost of single coverage, and 20% of the cost of dependent coverage as a condition of participation. In the event that an employer enrolls 75% or more of all eligible employees, the employer will not be required to contribute the above amounts towards the cost of dependent coverage.

B. Local employers allowing part-time employees to participate in the program must contribute a minimum of 50% of the amount they contribute toward active employee coverage (at all membership levels) on behalf of their participating part-time employees.

For purposes of this section, amounts contributed on behalf of an employee who has requested a reduction in salary pursuant to a plan qualified under § 125 of the Internal Revenue Code (Tax Treatment of Cafeteria Plans) will not be counted as an employer contribution.

History

• Statutory Authority: §§ 2.2-1204 and 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 3.5, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004.

1VAC55-20-270 Selection of plans

Local employers electing to participate in the health benefits program must, as a condition of participation, agree to offer exclusively one or more plans constituting such program. Notwithstanding the above, a local employer, with the approval of the department may offer another accident or health plan provided that such other plan does not duplicate the coverage offered by the health benefits program. Such permission shall not be unreasonably withheld.

Local employers participating in the health benefits program who desire to offer a health maintenance organization (HMO) must offer the HMOs included in the health benefits program and only those HMOs.

History

• Statutory Authority: §§ 2.1-20.1 and 2.1-20.1:02 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 3.6, eff. November 21, 1990.

1VAC55-20-280 Commencement of local employer participation

Local employers may join initially at any time upon the timely submission of an employer application, but, thereafter, renewals must be as of July 1 of each year. Local school boards may have an October 1 renewal if they so elect. Initial participation by a local employer at any time other than on July 1 (October 1) may be for the short plan year ending on the June 30 (September 30) following initial participation.

There shall be no specified time for local employee enrollment coincident with the local employer's initial participation in the health benefits program provided the department or its designee shall have knowledge of the local employee elections at least 30 days prior to the effective date of coverage. Thereafter the open enrollment period for local employees shall take place during the month of April or May of each year with the effective date of coverage then being July 1 of such year. Certain school groups may conduct their open enrollment in August and September.

History

• Statutory Authority: § 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 3.7, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-290 Reparticipation of local employers

Local employers having withdrawn from the health benefits program may reenter the program only with the consent of the department, and only on the July 1 (October 1 for school boards) following the timely submission of an employer application. The July 1 (October 1) effective date may be waived for local employers who have been away from the program for more than three years. Local employers seeking reparticipation may be required to serve a waiting period.

Department consent shall not be granted until all pending contributions, penalties, and other assessments have been paid by a local employer and there is no outstanding litigation pending between the department and the local employer. A pending appeal will not prohibit a local employer from reparticipating in the health benefits program.

History

• Statutory Authority: § 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 3.8, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-300 Ceasing participation in the health benefits program

A local employer who desires to terminate participation in the health benefits program may do so at any time, as of the last day of any calendar month, with three months notice to the department. The local employer shall be obligated to pay any and all contributions otherwise required through the date of termination of participation and interest related thereto. Additionally, a terminating local employer shall be responsible for any adverse experience adjustment which may apply with respect to the year termination occurred and any prior year within which the terminating local employer participated in the program.

Upon the local employer's cessation of participation in the program, all of the local employers' participants, including retirees, dependents of retirees and COBRA beneficiaries will cease to be covered under the program.

History

• Statutory Authority: §§ 2.2-1204 and 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 3.9, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004.

1VAC55-20-310 Compliance

The department shall oversee the local employers and state agencies and shall assist the employees thereof in the pursuit of all rights and benefits. The department shall hold the employee harmless for any errors made by local employers and state agencies. The cost of any such errors, where applicable, shall be borne by the local employer or state agency, and not the employee.

Nothing in this chapter shall affect the rights of any local employee to bring a cause of action against a local employer for action taken hereunder with respect to such local employer's willful disregard of this chapter. In the event a local employee brings a cause of action against the department due to a local employer's willful disregard for the requirements of this chapter, the local employer as a condition of initial participation in the program shall reimburse the department for any such settlement required by a court of law.

History

• Statutory Authority: §§ 2.1-20.1 and 2.1-20.1:02 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 3.10, eff. November 21, 1990.

Part IV Employee Participation

1VAC55-20-320 Eligible employees

A. State employees.

1. Full-time salaried, classified employees as defined in 1VAC55-20-20 and faculty are eligible for membership in the health benefits program.

2. Certain full-time employees in auxiliary enterprises (such as food services, bookstores, laundry services, etc.) at the University of Virginia, Virginia Military Institute, and the College of William and Mary as well as other state institutions of higher learning are also considered state employees even though they do not receive a salaried state paycheck. The Athletic Department of Virginia Polytechnic Institute and State University is an example of a local auxiliary whose members are eligible for the program.

3. Certain full-time employees of the Medical College of Virginia Hospital Authority are eligible for the program as long as they are on the authority's payroll and were enrolled in the program on November 1, 1996. They may have payroll deductions for health benefits premiums even if they rotate to the Veterans' Administration Hospital or other acute care facility.

4. Other employees identified in the Code of Virginia as eligible for the program.

5. Classified positions include employees who are fully covered by the Virginia Personnel Act, employees excluded from the Virginia Personnel Act by subdivision 16 of § 2.2-2905 of the Code of Virginia, and employees on a restricted appointment. A restricted appointment is a classified appointment to a position that is funded at least 10% from gifts, grants, donations, or other sources that are not identifiable as continuing in nature. An employee on a restricted appointment must receive a state paycheck in order to be eligible.

B. Local employees.

1. Full-time employees of participating local employers are eligible to participate in the program. A full-time employee is one who meets the definition set forth by the local employer in the employer application.

2. Part-time employees of local employers may participate in the plan if the local employer elects and the election does not discriminate among part-time employees. In order for the local employer to cover part-time employees, the local employer must provide to the department a definition of what constitutes a part-time employee.

The department reserves the right to establish a separate plan for part-time employees.

C. Unavailability of employer-sponsored coverage.

1. Employees, officers, and teachers without access to employer-sponsored health care coverage may participate in the plan. The employers of such employees, officers, and teachers must apply for participation and certify that other employer-sponsored health care coverage is not available. The employers shall collect contributions from such individuals and timely remit them to the department or its designee, act as a channel of communication with the covered employee and otherwise assist the department as may be necessary. The employer shall act as fiduciary with respect to such contributions and shall be responsible for any interest or other charges imposed by the department in accordance with these regulations.

2. Local employees living outside the service area of the plan offered by their local employer shall not be considered as local employees whose local employers do not offer a health benefits plan. For example, a local employee who lives in North Carolina and works in Virginia may live outside the service area of the HMO offered by his employer; however, he may not join the program individually.

3. Employer sponsorship of a health benefits plan will be broadly construed. For example, an employer will be deemed to sponsor health care coverage for purposes of this section and 1VAC55-20-260 if it utilizes § 125 of the Internal Revenue Code or any similar provision to allow employees, officers, or teachers to contribute their portion of the health care contribution on a pretax basis.

4. Individual employees and dependents who are eligible to join the program under the provisions of this subsection must meet all of the eligibility requirements pertaining to state employees except the identity of the employer.

D. Retirees.

1. Retirees are not eligible to enroll in the state retiree health benefits group outside of the opportunities provided in this section.

2. Retirees are eligible for membership in the state retiree group if a completed enrollment form is received within 31 days of separation for retirement. Retirees who remain in the health benefits group through a spouse's state employee membership may enroll in the retiree group at one of three later times: (i) future open enrollment, (ii) within 31 days of a qualifying mid-year event, or (iii) within 31 days of being removed from the active state employee spouse's membership.

3. Membership in the retiree group may be provided to an employee's spouse or dependents who were covered in the active employee group at the time of the employee's death in service.

4. Retirees who have attained the age of 65 or are otherwise covered or eligible for Medicare may enroll in certain plans as determined by the department provided that they apply for such coverage within 31 days of their separation from active service for retirement. Medicare will be the primary payor and the program shall serve as a supplement to Medicare's coverage.

5. Retirees who are ineligible for Medicare must apply for coverage within 31 days of their separation from active service for retirement. In order to receive coverage, the individual must meet the retirement requirements of his employer and receive an immediate annuity. For local employers, the immediate annuity requirement is not applicable as long as the retiree meets the age and service requirements imposed by the plan.

6. Local employers may offer retiree coverage at their option.

E. Dependents. The following family members may be covered if the employee elects:

1. The employee's spouse. The marriage must be recognized as legal in the Commonwealth of Virginia.

2. Children. Under the health benefits program, the following eligible children may be covered to the end of the year in which they turn age 26 (age requirement is waived for adult incapacitated children):

a. Natural children, adopted children, or children placed for adoption.

b. Stepchildren. A stepchild is the natural or legally adopted child of the participant's legal spouse. Such marriage must be recognized by the Commonwealth of Virginia.

c. Incapacitated children.

(1) Adult children who are incapacitated due to a physical or mental health condition, as long as the child was covered by the plan and the incapacitation existed prior to the termination of coverage due to the child attaining the limiting age. The employee must make written application, along with proof of incapacitation, prior to the child reaching the limiting age. Such extension of coverage must be approved by the plan and is subject to periodic review. Should the plan find that the child no longer meets the criteria for coverage as an incapacitated child, the child's coverage will be terminated at the end of the month following notification from the plan to the enrollee. The child must live with the employee as a member of the employee's household, be unmarried, and be dependent upon the employee for financial support. In the case of a divorce, living with the spouse will satisfy the condition of living with the employee. Furthermore, the support test is met if either the employee or spouse or combination of the employee and spouse provide over one half of the child's financial support.

(2) Adult incapacitated children of new employees may also be covered, provided that:

(a) The enrollment form is submitted within 30 days of hire;

(b) The child has been covered continuously by group employer coverage since the disability first occurred; and

(c) The disability commenced prior to the child attaining the limiting age of the plan.

The enrollment form must be accompanied by a letter from a physician explaining the nature of the incapacitation, providing the date of onset, and certifying that the dependent is not capable of self-support. This extension of coverage must be approved by the plan in which the employee is enrolled.

d. Other children. A child for whom a court has ordered the employee to assume sole permanent custody.

Additionally, if the employee or spouse shares custody with the minor child who is the parent of the "other child," then the other child may be covered.

When a child loses eligibility, coverage terminates at the end of the month in which the event that causes the loss of eligibility occurs.

There are certain categories of persons who may not be covered as dependents under the program. These include dependent siblings, grandchildren, nieces, and nephews except where the criteria for "other children" are satisfied. Parents, grandparents, aunts, and uncles are not eligible for coverage regardless of dependency status.

History

• Statutory Authority: § 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 4.1, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; Volume 22, Issue 8, eff. March 15, 2006; Volume 26, Issue 25, eff. September 16, 2010; Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-330 Enrollment form or enrollment action

A. No coverage is available unless an employee files an enrollment form or takes an equivalent enrollment action. No changes in coverage are effective unless an employee files an enrollment form or takes an equivalent enrollment action. Employees alone are responsible for knowing when an enrollment action is required, for taking the action, and for certifying that the information conveyed is complete and true.

B. The employer is responsible for checking that the employee fills in the form completely and accurately. The employer will certify each enrollment form in the space provided on the form.

C. The effective date of coverage shall be determined from the date the enrollment form is stamped as received by a designee of the department or the date of the equivalent enrollment action. This is generally the first of the month following receipt.

Except as noted here, coverage elections including those made by new employees are made on a prospective basis, that is, effective the first of the month following the receipt of the election form or enrollment action. However, if the receipt of the form or the date of the enrollment action is the first of the month, then the effective date will be the first of the month. Additionally, if an election form or enrollment action is received from a new employee on the first business day of the month, coverage for the new employee will commence on the first day of that month (see 1VAC55-20-370). Coverage elections made on account of a newborn, adoption, or placement for adoption are effective the date the child is born, adopted, or placed for adoption, as long as the employee makes the coverage election within 60 days of the event. Coverage terminations are effective the end of the month following receipt of an election notice, except for terminations that are required by the plan. Coverage terminations required by the plan are effective the end of the month that the event takes place. Examples of coverage terminations required by the plan are such things as a divorce, termination of employment, or a dependent child losing eligibility.

History

• Statutory Authority: § 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 4.2, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-340 Payment of contributions

A. Active employees shall pay their portion, if any, of contributions through payroll deduction.

B. State retirees will have their contributions deducted from VRS or other retirement system. If the retirement payment is not sufficient to pay the entire contribution, they may pay their contributions directly to the department's designee. There may be an administrative fee for direct payment. Such fee may be waived by the department if payment is made monthly by bank draft.

A credit toward the cost of coverage is made by the Commonwealth on behalf of retired state employees as provided in § 51.1-1400 of the Code of Virginia.

C. Retired employees of local employers shall pay contributions by either of two methods. The retired employee may authorize contributions to be deducted from the retiree's pension payment, whether it be through the VRS or otherwise. Alternatively, if the employer so provides, the retiree may pay his contribution to the employer who shall be responsible for remitting the contributions to the department or its designee. In either case the employer is responsible for collecting and submitting the premium to the plan at the time that the active premium is submitted.

History

• Statutory Authority: §§ 2.2-1204 and 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 4.3, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004.

1VAC55-20-350 Membership

A. Type of membership. Participants have a choice of three types of membership under the program:

1. Single (employee only). If a participant chooses employee only membership, the health benefits program does not cover the employee's dependents (spouse or children).

2. Dual (employee and one eligible dependent).

3. Family membership (employee and two or more eligible dependents).

B. Changing type of membership.

1. Employees may change membership subject to 1VAC55-20-370.

a. During open enrollment.

b. Within no more than 60 days of a qualifying mid-year event. Any such change in membership must be on account of and consistent with the event.

c. Within no more than 60 days of a cost and coverage change, as acknowledged by the department.

2. All changes in membership must be made on a prospective basis except for the birth, adoption, or placement for adoption of a child.

3. If the change is from single to dual or family membership or vice versa because of a qualifying mid-year event, the employee must certify in the enrollment action the type of event and the date of the event.

History

• Statutory Authority: § 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 4.4, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-360 Choice of plans

A. During the annual open enrollment period, state employees and non-Medicare retirees eligible to participate in the health benefits program have a choice of enrolling in any plan offered by their employer, which may often include an alternative health benefits plan offered by the department. To be eligible for membership in the health benefits program, the employee or retiree must live or work within the service area of the particular plan.

B. Employees of participating local employers have a choice of enrolling in the plans offered by their respective employers. Local employers have the option of requiring that employees live within the service area of the plan the employee chooses to join or of allowing employees to join a plan if they live or work in the service area.

C. An enrollment action will not be accepted outside of open enrollment except for an employee who experiences a qualifying mid-year event.

D. The employer's contribution toward coverage, if any, shall be determined by the employer except with respect to the minimum contribution rate applicable to local employers.

History

• Statutory Authority: §§ 2.2-1204 and 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 4.5, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004.

1VAC55-20-370 Effective date of coverage

A. Newly eligible employees. Newly eligible employees (new hires) have up to 30 calendar days to enroll in a health plan or flexible spending account offered by the state. The 30-day countdown period begins on the first day of employment and ends 30 calendar days later. If the enrollment action is received within the 30-calendar-day time frame, coverage will be effective the first of the month coinciding with or following the date of employment. There is no discretion allowed in this area. Coverage will always be effective in this manner. In no case will coverage begin before the eligible employee's first day of employment.

B. Qualifying mid-year events. Employees who experience a qualifying mid-year event have 60 calendar days to make a consistent election change. The 60-day countdown period begins on the day of the event. Normally changes will be effective the first of the month following receipt of the enrollment action.

C. Terminations required by the plan. Employees can only provide coverage for family members who meet the health plans' eligibility definition.

History

• Statutory Authority: § 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 4.6, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-380 Leave of absence

Note: This section addresses various aspects of employee leave and may or may not be applicable to a local employer.

A. Leave of absence with full pay. As long as an employee is still receiving full pay, health benefits coverage continues with the employer making its contribution. No action is required.

Local employers are not required to contribute toward coverage for any part-time employee granted any type of leave of absence.

B. Virginia Sickness and Disability Program, Long-Term Disability (VSDP-LTD).

1. LTD-working employees continue in active coverage until the end of the month in which the employee transitions to LTD-not working.

2. Coverage with the employer contribution continues to the end of the month in which the LTD benefits begin, unless benefits begin on the first day of the month, in which case the employer contribution will end on the last day of the preceding month. Thereafter, employees may continue coverage by paying the entire cost of the coverage.

3. Employees receiving LTD benefits may enroll in the State Retiree Health Benefits Program upon service retirement regardless of whether they have maintained health coverage in the state program provided that the individuals have been continuously covered and have had no break in long-term disability benefits prior to service retirement. The LTD participant has 31 days from the date of retirement to enroll in the State Retiree Health Benefits Program. Coverage in the retiree group begins on the first day of the first full month of retirement.

C. Educational leave -- full or partial pay. An official educational leave is a leave for educational reasons with partial or full pay maintained for the leave, not for work rendered. It is possible to maintain health coverage on an educational leave even when less than full pay is given provided that at least half pay is given. Coverage may continue for the duration of the leave up to 24 months.

D. Leave of absence without pay.

1. Coverage with the employer contribution continues to the end of the month in which the leave without pay begins provided the first day of the leave is after the first work day of the month. If the person returns from leave the following month and works at least half of the workdays in the month, coverage will be continuous. If the leave without pay begins on or before the first work day of the month, coverage and the employer contribution ceases on the last calendar day of the previous month.

2. Employees who do not want to continue coverage will be asked to sign a waiver.

E. Changing coverage while on leave. Coverage changes may be made while on leave in the same manner that changes may be made while actively employed. The same procedures and rules apply.

An employee enrolled in an alternative health benefits plan who moves out of the plan's service area while on a leave of absence may change to another plan offered by the department in his new location by taking an enrollment action within 60 days of the date of the move.

F. Returning from leave without pay.

1. Employees who have maintained coverage while on leave without pay. If the employee has maintained coverage while on leave, the employee's coverage in the health benefits program (with the employer making its contribution) will begin on the first of the month following the date the employee returns to full-time employment. However, if the return to work falls on the first day of the month then the employer contributions may begin immediately. It is not necessary for the employee to take a new enrollment action.

Employees may change from single to dual or family membership within 60 days of returning from leave without pay if the employee dropped dual or family membership during the leave or if there was a qualifying mid-year event during the leave. A new enrollment action must be taken. In the case of a qualifying mid-year event, the effective date would follow the rule on initiating dual or family membership at the time of the particular qualifying mid-year event.

2. Employees who have not maintained coverage while on leave will be treated in the same manner as new employees, unless they have exercised their rights under the Family Medical Leave Act. If these rights are exercised, they will have all rights that are required by law.

a. It shall be necessary to take a new enrollment action to receive coverage. The enrollment action shall indicate the date the employee returned to work as the date that the employee's continuous full-time employment commenced.

b. The employee has a choice of type of membership and plan.

c. The usual deadlines for filing apply. Coverage begins according to the rules and procedures for new employees.

3. Employees returning from military leave for active service. Employees returning from military leave of 30 days or more have the same choice of coverage as a new employee. If the employee returning from a military leave applies for coverage within 31 days of discharge, the coverage will begin on either the first day of the month of discharge or the first of the following month, whichever is necessary to effect continuous coverage.

4. Taking a second leave without pay. If an employee returns from a leave without pay and is employed full-time on every scheduled work day for at least one full calendar month before taking another leave without pay, the second leave will be treated as a new leave. If there is less than one calendar month of full-time employment between leaves without pay, the leaves will be treated as one, regardless of the types of leave. The length of time that coverage may be continued will depend on the current type of leave.

History

• Statutory Authority: § 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 4.7, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-390 Termination of coverage

A. Coverage ends at the end of the month in which an employee terminates the employment relationship, otherwise loses group eligibility, or on the last day of the month for which premiums are paid.

B. Coverage ends on the date of a participant's death. Coverage for family members of state employees continues until the end of the month following the month in which the participant died.

1. A surviving state beneficiary may enroll in the state retiree group if:

a. The state dependent is eligible for an annuity under the Virginia Retirement System (VRS) death-in-service provision;

b. The employee had submitted a disability retirement application naming the dependent under the survivor option before his death and the employee died prior to achieving the retirement date; or

c. The death was job related.

To continue coverage, the family member must apply within 60 days of the date the coverage would otherwise end due to the death.

2. Survivors of deceased state employees who are not eligible for an annuity from VRS can nonetheless be covered under the State Health Benefits Program if they had coverage at the time the employee died. To continue coverage, the state family member must apply within 60 days of the employee's death.

C. In the event that an employee on leave without pay notifies the employer that he is terminating employment, coverage ends on the last day of the month in which the leave without pay ceases.

History

• Statutory Authority: § 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 4.8, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-400 Termination of employment

A. Coverage continues to the end of the month in which an employee terminates. Each terminating employee may elect continuation of coverage pursuant to Internal Revenue Code section 4980B and accompanying regulations.

B. All terminating employees will be given certificates of coverage as required by the Health Insurance Portability and Accountability Act.

History

• Statutory Authority: § 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 4.9, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-410 Suspension and reinstatement of state employees

A. General.

1. Coverage generally continues with the state contribution through the end of the month in which the suspension began. However, if the suspension was effective on or before the first work day of the month, there will be no coverage for that month unless the employee is reinstated in time to work half of the work days in the month. For example, if a suspension is effective on April 19, the employee will have coverage with the state contribution through the end of April. If the suspension is effective April 1, the employee must pay the entire cost of coverage for the month of April. By the same token, if the suspension is effective April 2 and the employee's first workday in April is April 3, the employee will not have the state contribution in April.

2. If the employee is suspended pending court action or pending an official investigation, the suspension may go beyond one pay period. In these cases, coverage will continue with the state contribution to the end of the month in which the suspension began. If the employee is reinstated in time to work half of the workdays of the month following the month in which the suspension began, there would be no break in coverage. Suspension beyond that period should be handled in the same way as a leave without pay with no employer contribution. The employee may waive coverage or remain in the group by paying the full monthly contribution to the employer in advance. Group coverage may continue until a court decision is issued or the official investigation is completed, or up to a period of 12 months, whichever is less.

3. If the employee is reinstated with back benefits, the employer should refund the employee the amount of the employer contribution during the period the employee paid the full premium. Appropriate contributions must be made to cover the retroactive period. Alternatively, the family membership may begin the first full month of reinstatement if the employee applies within 31 days of reinstatement. Previous coverage elections, including dual and family memberships, will be reinstated retroactively.

B. Termination and grievance reinstatement.

1. Employees who are terminated and file a grievance shall be treated as terminated employees and may elect extended coverage or nongroup coverage. In the event such an employee is reinstated with back pay, previous health and flexible spending account elections will be reinstated retroactively. Appropriate contributions must be made to cover the period.

2. If the employee is reinstated without full back pay, no retroactive coverage is available.

History

• Statutory Authority: § 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 4.10, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-420 (Repealed.)

Historical Notes

Derived from VR525-01-02 § 4.11, eff. November 21, 1990; repealed, Virginia Register Volume 20, Issue 20, eff. July 16, 2004.

1VAC55-20-430 Coordination of benefits

A. New employees will receive and be required to respond to a coordination of benefits (COB) inquiry letter following enrollment in the health plan. Employees should notify the plan administrator if coverage changes during employment for them or a covered dependent. If a plan participant is eligible for coverage under two or more plans, the plans involved will share the responsibility for the participant's benefits according to these rules.

1. If the other coverage does not have COB rules substantially similar to the participant's health plan's rules, the other coverage will be primary.

2. If a covered person is enrolled as the employee under one coverage and as a dependent under another, generally the one that covers him as the employee will be primary. The plan that covers a person as an active employee, that is an employee who is neither laid off nor retired, or as a dependent of an active employee is the primary plan. The plan covering that same person as a retired or laid-off employee or as a dependent of a retired or laid-off employee is the secondary plan.

3. If a covered person is the employee under both coverages, generally the one that covers him for the longer period of time will be primary.

4. If the dependent is covered as a dependent on his parent's or parents' plan and is also covered as a dependent on his spouse's plan, the spouse's plan is primary.

5. If the covered person is enrolled as a dependent child under both coverages (for example, when both parents cover their child), typically the coverage of the parent whose birthday falls earliest in the calendar year will be primary.

6. Special rules apply when a covered person is enrolled as a dependent child under two coverages and the child's parents are living apart. Generally, the coverage of the parent or step-parent with custody will be primary. However, if there is a court order that requires one parent to provide health care for the child, that parent's coverage will be primary. If there is a court order that states the parents share joint custody without designating that one parent is responsible for medical expenses, the parent whose birthday falls earliest in the plan year will be primary.

7. If a covered active employee or employee's dependent is also covered by Medicare, the coverage provided by the employer is primary, unless Medicare eligibility is due to end stage renal disease and the coordination period has been exhausted.

8. If a covered retiree, survivor, or long-term disability participant, or a covered dependent of any of these, is eligible for Medicare, the Medicare-eligible member is not eligible for active employee coverage under the member's health plan, except during an end stage renal disease coordination period.

B. When the participant's health plan is the primary coverage, it pays first. When the participant's health plan is the secondary coverage, it pays second as follows:

1. The plan administrator calculates the amount the participant's health plan would have paid if it had been primary coverage, then coordinates this amount with the primary plan's payment. The participant's health plan's payment in combination with the other plan's payment will never exceed the amount the participant's health plan would have paid if it had been the participant's primary coverage.

2. Some plans provide services rather than making a payment (i.e., a group model HMO). When such a plan is the primary coverage, the participant's health plan will assign a reasonable cash value for the services and that will be considered the plan's primary payment. The participant's health plan will then coordinate with the primary plan based on that value.

3. In no event will the participant's health plan pay more in benefits as secondary coverage than it would have paid as primary coverage.

C. If the administrator provided primary coverage and discovers later that it should have provided secondary coverage, the administrator has the right to recover the excess payment from the employee or any other person or organization. If excess benefit payments are made on behalf of the employee, the employee must cooperate with the administrator in exercising its right of recovery.

D. Employees are obligated to supply the plan administrator all information needed to administer this coordination of benefits provision. This must be done before an employee is entitled to receive benefits under this plan. Further, the employees must agree that the administrator has the right to obtain or release information about covered services or benefits received. This right will be used only when working with another person or organization to settle payments for coordinated services. The employee's prior consent is not required.

History

• Statutory Authority: § 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 4.12, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-440 Claims

Claims must be filed no later than the end of the calendar year after the year in which the claim is incurred. Claims not filed in a timely fashion will not be considered.

History

• Statutory Authority: §§ 2.1-20.1 and 2.1-20.1:02 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 4.13, eff. November 21, 1990.

Part V Benefits Plans

1VAC55-20-450 Basic plan

The department may provide self-funded plan(s) administered by a third party administrator including, but not limited to, an exclusive provider organization (EPO) and a point of service plan (POS). These plans are described in the employee handbooks, which are distributed to employees upon enrollment. The department shall denote a self-funded plan as the "basic plan," which is required by code to be available throughout the state and shall provide the basis for all employer contributions.

History

• Statutory Authority: §§ 2.2-1204 and 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 5.1, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004.

1VAC55-20-460 Alternative health benefit plans

The department also offers several health maintenance organization and preferred provider organization plans that are available to participants residing in the service area of the HMO or PPO. A list of these plans is available upon request to the department.

Non-Medicare-eligible retirees have the same enrollment options as active employees.

Retirees must enroll in a plan within 31 days of separation for retirement. A separating state employee who defers retirement will not be eligible to enroll in a retiree medical plan when the former employee seeks retirement benefits.

History

• Statutory Authority: § 2.2-2818 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 5.2, eff. November 21, 1990; amended, Virginia Register Volume 20, Issue 20, eff. July 16, 2004; Volume 30, Issue 14, eff. April 24, 2014.

1VAC55-20-470 Benefits coverage

A. Interpretations of covered services will be made in the following manner, listed in order of priority:

1. The contract documents, including the request for proposal;

2. Member handbooks or contract booklets;

3. The interpretation of the department;

4. The interpretation of the department's contractors.

B. The benefit provisions of the contract documents are contained in the contract booklets or member handbooks distributed to employees by their benefits administrators.

C. The benefits administrators have copies of the contract booklets and member handbooks for all plans offered by that employer. By appointment, any employee or citizen may inspect the entire contract or contracts at the offices of the department.

History

• Statutory Authority: §§ 2.1-20.1 and 2.1-20.1:02 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 5.3, eff. November 21, 1990.

1VAC55-20-480 Department discretion

The department reserves the right to change the plans offered and benefits provided thereunder at its sole discretion based upon market and department considerations.

History

• Statutory Authority: §§ 2.1-20.1 and 2.1-20.1:02 of the Code of Virginia.
• Historical Notes: Derived from VR525-01-02 § 5.4, eff. November 21, 1990.

Agency 75 Department of The Treasury

Chapter 11 Public Participation Guidelines

Part I Purpose and Definitions

1VAC75-11-10 Purpose

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the Department of the Treasury and the Treasury Board. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

History

• Statutory Authority: §§ 2.2-2416 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 25, eff. September 17, 2008.

1VAC75-11-20 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§ 2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Department of the Treasury or the Treasury Board (as appropriate), which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§ 2.2-4031 et seq.) of the Administrative Process Act.

History

• Statutory Authority: §§ 2.2-2416 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 25, eff. September 17, 2008.

Part II Notification of Interested Persons

1VAC75-11-30 Notification list

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

History

• Statutory Authority: §§ 2.2-2416 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 25, eff. September 17, 2008.

1VAC75-11-40 Information to be sent to persons on the notification list

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 1VAC75-11-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

History

• Statutory Authority: §§ 2.2-2416 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 25, eff. September 17, 2008.

Part III Public Participation Procedures

1VAC75-11-50 Public comment

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to (i) submit data, views, and arguments, either orally or in writing, to the agency; and (ii) be accompanied by and represented by counsel or other representative. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

History

• Statutory Authority: §§ 2.2-2416 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 25, eff. September 17, 2008; amended, Virginia Register Volume 37, Issue 18, eff. June 11, 2021.

1VAC75-11-60 Petition for rulemaking

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

History

• Statutory Authority: §§ 2.2-2416 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 25, eff. September 17, 2008.

1VAC75-11-70 Appointment of regulatory advisory panel

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

History

• Statutory Authority: §§ 2.2-2416 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 25, eff. September 17, 2008.

1VAC75-11-80 Appointment of negotiated rulemaking panel

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

History

• Statutory Authority: §§ 2.2-2416 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 25, eff. September 17, 2008.

1VAC75-11-90 Meetings

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

History

• Statutory Authority: §§ 2.2-2416 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 25, eff. September 17, 2008.

1VAC75-11-100 Public hearings on regulations

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working daysprior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

History

• Statutory Authority: §§ 2.2-2416 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 25, eff. September 17, 2008.

1VAC75-11-110 Periodic review of regulations

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

History

• Statutory Authority: §§ 2.2-2416 and 2.2-4007.02 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 25, eff. September 17, 2008.