ENVIRONMENTAL LABORATORY ACCREDITATION ACT - REPEALED — 2002 Pa. Act 25 (historical enacted text)

Historical Act text

HOUSE AMENDED
PRIOR PRINTER'S NOS. 1395, 1573, 1675, PRINTER'S NO. 1719
1702
INTRODUCED BY M. WHITE, MUSTO, EARLL, TOMLINSON, LAVALLE, BELL,
BODACK, COSTA, HOLL, D. WHITE, ERICKSON, MOWERY, THOMPSON,
LEMMOND, SCHWARTZ, WAUGH, BOSCOLA AND ROBBINS,
OCTOBER 9, 2001
AS REPORTED FROM COMMITTEE ON ENVIRONMENTAL RESOURCES AND
ENERGY, HOUSE OF REPRESENTATIVES, AS AMENDED,
FEBRUARY 12, 2002
AN ACT
1 Establishing within the Department of Environmental Protection
2 an accreditation program for environmental laboratories.
3 TABLE OF CONTENTS
4 Section 1. Short title.
5 Section 2. Definitions.
6 Section 3. Establishment of program.
7 Section 4. Powers and duties.
8 Section 5. Powers and duties of Environmental Quality Board.
9 Section 6. Requirements of certificate of accreditation.
10 Section 7. Interim requirements.
11 Section 8. Advisory committee.
12 Section 9. Unlawful conduct.
13 Section 10. Penalties.
14 Section 11. Records.
15 Section 12. Continuation of existing rules and regulations. <--
1 Section 13. Repeals.
2 Section 14. Effective date.
3 SECTION 12. WHISTLEBLOWER PROTECTION. <--
4 SECTION 13. CONTINUATION OF EXISTING RULES AND REGULATIONS.
5 SECTION 14. REPEALS.
6 SECTION 15. EFFECTIVE DATE.
7 The General Assembly of the Commonwealth of Pennsylvania
8 hereby enacts as follows:
9 Section 1. Short title.
10 This act shall be known and may be cited as the Environmental
11 Laboratory Accreditation Act.
12 Section 2. Definitions.
13 The following words and phrases when used in this act shall
14 have the meanings given to them in this section unless the
15 context clearly indicates otherwise:
16 "Accreditation." A determination by the Department of
17 Environmental Protection that an environmental laboratory is
18 capable of performing one or more classes of testing or analysis
19 of environmental samples in accordance with this act.
20 "Certificate of accreditation." A document issued by the
21 Department of Environmental Protection certifying that an
22 environmental laboratory has met standards for accreditation.
23 "Department." The Department of Environmental Protection of
24 the Commonwealth.
25 "Environmental Hearing Board." The board established under
26 the act of July 13, 1988 (P.L.530, No.94), known as the
27 Environmental Hearing Board Act.
28 "Environmental laboratory." A facility engaged in the
29 testing or analysis of environmental samples.
30 "Environmental Quality Board." The board established under
20010S1115B1719 - 2 -
1 section 1920-A of the act of April 9, 1929 (P.L.177, No.175),
2 known as The Administrative Code of 1929.
3 "Environmental sample." A solid, liquid, gas or other
4 specimen taken for the purpose of testing or analysis as
5 required by an environmental statute.
6 "Environmental statute." A statute administered by the
7 Department of Environmental Protection relating to the
8 protection of the environment or of public health, safety and
9 welfare.
10 "Laboratory supervisor." A technical supervisor of an
11 environmental laboratory who supervises laboratory procedures
12 and reporting of analytical data.
13 "NELAC." The National Environmental Laboratory Accreditation
14 Conference.
15 "NELAP." The National Environmental Laboratory Accreditation
16 Program.
17 "Secretary." The Secretary of Environmental Protection of
18 the Commonwealth.
19 Section 3. Establishment of program.
20 (a) Establishment.--The department shall establish an
21 accreditation program for environmental laboratories.
22 (b) Accreditation.--An environmental laboratory must be
23 accredited under this act and be in compliance with all the
24 provisions of this act in order to generate data or perform
25 analyses to be used to comply with an environmental statute.
26 (c) Testing and analysis.--All testing and analysis
27 requirements of an environmental statute shall be performed by
28 an environmental laboratory accredited under this act. Testing
29 and analysis shall be performed in accordance with the
30 requirements of this act, the environmental statutes and any
20010S1115B1719 - 3 -
1 conditions imposed by the department.
2 Section 4. Powers and duties.
3 The department shall have the following powers and duties:
4 (1) Establish, administer and enforce an environmental
5 laboratory accreditation program which shall include
6 accreditation standards necessary for a State certification
7 program. The program shall also include a NELAP accreditation
8 program for those laboratories seeking this certification.
9 The program may also include any other specific broad-based
10 Federal or State accreditation program for certification.
11 (2) Issue, renew, deny, revoke, suspend or modify
12 certificates of accreditation to environmental laboratories
13 in accordance with regulations adopted by the Environmental
14 Quality Board.
15 (3) Impose terms or conditions on accreditation as
16 necessary to implement and enforce this act.
17 (4) Conduct inspections and tests or samplings,
18 including the examination and copying of records and data
19 pertinent to a matter under investigation. Duly authorized
20 agents and employees of the department may, at reasonable
21 times, enter and examine property, facilities, operations and
22 activities subject to regulation under this act.
23 (5) Issue orders and initiate proceedings as necessary
24 to implement and enforce this act.
25 (6) Require a fee for the processing of an application
26 for a certificate of accreditation, including the issuance,
27 renewal, modification or other action relating to the
28 certificate in an amount sufficient to pay the department's
29 cost of implementing and administering the accreditation
30 program.
20010S1115B1719 - 4 -
1 (7) Provide technical assistance and advice to persons
2 and environmental laboratories subject to this act.
3 (8) Contract with third parties to inspect and monitor
4 environmental laboratories.
5 (9) Cooperate with appropriate Federal, State,
6 interstate and local government units and private
7 organizations to implement this act.
8 (10) Allow the use of experimental procedures, on a
9 case-by-case basis, to satisfy the testing or analysis
10 requirements established under an environmental statute.
11 (11) Seek approval as an accrediting authority from
12 NELAP.
13 Section 5. Powers and duties of Environmental Quality Board.
14 (a) General rule.--The Environmental Quality Board shall
15 adopt regulations as necessary to implement this act, to include
16 the establishment of:
17 (1) Testing or analysis to be conducted by an
18 environmental laboratory.
19 (2) Allowable fees for environmental laboratories.
20 (3) Requirements for education, training and experience
21 of laboratory supervisors.
22 (4) Criteria and procedures to be used by the department
23 to accredit environmental laboratories, which may include
24 proficiency test samples and onsite audits.
25 (b) Accreditation.--An environmental laboratory shall be
26 accredited pursuant to this act and in compliance with the
27 provisions of this act in order to generate the data and perform
28 analysis to be used to comply with an environmental statute.
29 (c) General certificate program.--The Environmental Quality
30 Board may adopt regulations that establish a general certificate
20010S1115B1719 - 5 -
1 of accreditation program or certificates of accreditation-by-
2 rule.
3 (d) Unique needs.--To the extent possible, the Environmental
4 Quality Board shall establish requirements and procedures that
5 address the unique needs of small businesses, municipalities,
6 municipal authorities and in-house laboratories.
7 Section 6. Requirements of certificate of accreditation.
8 (a) Forms.--Applications, certificates and other documents
9 shall be in a form prescribed by the department.
10 (b) General requirements.--An environmental laboratory shall
11 have the staff, management structure, equipment, quality
12 assurance and quality control procedures and recordkeeping
13 procedures necessary to ensure that the environmental laboratory
14 generates valid and accurate test results in accordance with all
15 conditions of accreditation and this act.
16 (c) Laboratory supervisor.--Testing, analysis and reporting
17 of data by an accredited laboratory shall be under the direct
18 supervision of a laboratory supervisor. The laboratory
19 supervisor shall certify that each test or analysis is accurate
20 and valid and that the test or analysis was performed in
21 accordance with all conditions of accreditation. The department
22 may disqualify a laboratory supervisor who is responsible for
23 the submission of inaccurate test or analysis results.
24 (d) Access to records and data.--An accredited laboratory
25 shall provide the department with access to inspect records and
26 data maintained under this act and to conduct tests and sampling
27 related to inspections.
28 Section 7. Interim requirements.
29 (a) Registration.--All environmental laboratories shall
30 register with the department within six months of the effective
20010S1115B1719 - 6 -
1 date of this act, on a registration form prepared by the
2 department. An environmental laboratory which begins operations <--
3 in this Commonwealth TESTING OR ANALYSIS OF ENVIRONMENTAL <--
4 SAMPLES after this date shall register with the department
5 before beginning operations.
6 (b) Time for application.--All environmental laboratories
7 shall apply for accreditation within six months after the
8 Environmental Quality Board establishes an accreditation
9 requirement by regulation for a type of laboratory. The
10 submission of an application shall provide interim authorization
11 to continue operations until the department takes final action
12 on the application.
13 (c) NELAP accreditation.--An environmental laboratory may
14 apply to the department for NELAP accreditation after the
15 department is approved as an accrediting authority by NELAP. The
16 department may grant NELAP accreditation to a laboratory that
17 meets the requirements of this act and the most current version
18 of the NELAC standards that are hereby incorporated by
19 reference.
20 (d) Temporary fees.--Until regulations are promulgated under
21 this act, the following fees shall be charged:
22 (1) Five thousand dollars for the processing of an
23 application for NELAP accreditation.
24 (2) Fifty dollars for the processing of an application
25 for registration.
26 Section 8. Advisory committee.
27 The secretary shall appoint a Laboratory Accreditation
28 Advisory Committee to provide technical assistance under this
29 act. The committee shall consist of 11 members, including the
30 following:
20010S1115B1719 - 7 -
1 (1) One representative of a municipal authority.
2 (2) One representative from a commercial environmental
3 laboratory.
4 (3) One representative from an industrial environmental
5 laboratory.
6 (4) One representative from an academic laboratory.
7 (5) One representative from a small environmental
8 laboratory.
9 (6) One environmental engineer.
10 (7) One member of an association of community water
11 supply systems.
12 (8) One member of an association of wastewater systems.
13 (9) One member with technical expertise in the testing
14 and analysis of environmental samples.
15 (10) Two members of the general public.
16 Section 9. Unlawful conduct.
17 (a) General rule--It shall be unlawful for a person to
18 violate or to cause or assist in the violation of this act, to
19 fail to comply with an order or condition of accreditation
20 within the time specified by the department or to hinder,
21 obstruct, prevent or interfere with the department in the
22 performance of its duties under this act.
23 (b) Refusal of accreditation.--The department may refuse to
24 issue a certificate of accreditation to an environmental
25 laboratory which has demonstrated a lack of intention or ability
26 to comply with this act or engaged in unlawful conduct or which
27 has an employee, officer, contractor, agent or other person set
28 forth in regulation who has engaged in unlawful activity under
29 this act unless the applicant demonstrates to the satisfaction
30 of the department that the unlawful conduct is being or has been
20010S1115B1719 - 8 -
1 corrected.
2 (c) Denial of access.--It shall be unlawful for an
3 accredited laboratory or other person subject to regulation
4 under this act to deny the department access to make inspections
5 and conduct tests or sampling, including the examination and
6 copying of books, papers, records and data pertinent to any
7 matter under investigation pursuant to this act. Failure to
8 provide the department with access shall result in the immediate
9 suspension of any accreditation of the laboratory. Upon notice
10 from the department, the laboratory shall immediately cease
11 testing or analysis of environmental samples. The department may
12 revoke an accreditation for failure to provide the department
13 with access to make inspections and conduct tests or sampling,
14 including the examination and copying of books, papers, records
15 and data pertinent to any matter under investigation pursuant to
16 this act.
17 (d) Notice.--The environmental laboratory shall notify each
18 of its customers in writing within 72 hours of receipt of the
19 department's notice if the department suspends or revokes in
20 whole or in part a certificate of accreditation. The notice
21 shall be on a form and in a manner approved by the department.
22 Section 10. Penalties.
23 (a) Criminal penalties.--
24 (1) A person who knowingly, willfully or recklessly
25 misrepresents that a test or an environmental sample is
26 accurate or was performed in accordance with procedures
27 authorized pursuant to this act commits a misdemeanor of the
28 third degree and, upon conviction, shall be subject to a fine
29 of not less than $1,250 nor more than $12,500 or to
30 imprisonment for a period of not more than one year, or both,
20010S1115B1719 - 9 -
1 for each separate offense.
2 (2) A person who knowingly, willfully or recklessly
3 performs or reports an inaccurate test or analysis of an
4 environmental sample commits a misdemeanor of the third
5 degree and, upon conviction, shall be subject to a fine of
6 not less than $1,250 nor more than $12,500, or to
7 imprisonment for a period of not more than one year, or both,
8 for each separate offense.
9 (3) A person who knowingly, willfully or recklessly
10 misrepresents that an environmental laboratory holds a
11 certificate of accreditation under this act commits a
12 misdemeanor of the third degree and, upon conviction, shall
13 be subject to a fine of not less than $1,250 nor more than
14 $12,500, or to imprisonment for a period of not more than one
15 year, or both, for each separate offense.
16 (b) Administrative penalties.--
17 (1) In addition to any other remedy available at law or
18 equity, the department may assess an administrative penalty
19 for a violation of this act. The penalty may be assessed
20 whether or not the violation was willful or negligent. When
21 determining the amount of the penalty, the department shall
22 consider the willfulness of the violation, the damage or
23 injury, or threat of damage or injury, to public health or
24 the environment, the costs to the department for
25 investigation and enforcement, the economic benefit of the
26 violation to the person and other related factors. The
27 department shall inform the person of the amount of the
28 penalty. The administrative penalty shall not exceed $5,000
29 per day per violation.
30 (2) Every day a violation continues shall be a separate
20010S1115B1719 - 10 -
1 violation.
2 (3) The amount of the penalty assessed after a hearing
3 before the Environmental Hearing Board, or after waiver of
4 the right to appeal the assessment, shall be payable to the
5 Commonwealth and collectable in any manner provided at law
6 for collection of debts. If any person liable to pay any such
7 penalty neglects or refuses to pay the penalty after demand,
8 the amount of the penalty, together with interest and cost
9 that may accrue, shall constitute a judgment in favor of the
10 department upon the property of such person from the date it
11 has been entered and docketed of record by the prothonotary
12 of the county in which the property is situated. The
13 department may, at any time, transmit to the prothonotaries
14 of any county in which the person holds property, certified
15 copies of all such judgments, and it shall be the duty of
16 each prothonotary to enter and docket the judgment of record
17 in his or her office and to index the judgment as judgments
18 are indexed, without requiring the payment of costs by the
19 department.
20 (c) Concurrent penalties.--Penalties and other remedies
21 under this act shall be concurrent and shall not prevent the
22 department from exercising any other available remedy at law or
23 equity.
24 (d) Rebuttable presumption.--Failure of an environmental
25 laboratory or laboratory supervisor to maintain adequate records
26 or proficiency test samples as required creates a rebuttable
27 presumption that the test or analysis was not conducted as
28 required.
29 (e) Falsifying results.--It shall be unlawful to falsify the
30 results of testing or analysis of environmental samples or to
20010S1115B1719 - 11 -
1 violate the provisions of 18 Pa.C.S. § 4903 (relating to false
2 swearing) or 4904 (relating to unsworn falsification to
3 authorities) in the context of the submission of the results of
4 testing and analysis of environmental samples under an
5 environmental statute.
6 Section 11. Records.
7 Records required under this act shall be maintained for five
8 years unless otherwise specified in regulation.
9 SECTION 12. WHISTLEBLOWER PROTECTION. <--
10 AN EMPLOYEE OF AN ENVIRONMENTAL LABORATORY COVERED BY THIS
11 ACT SHALL BE DEEMED TO BE AN EMPLOYEE UNDER THE ACT OF DECEMBER
12 12, 1986 (P.L.1559, NO.169), KNOWN AS THE WHISTLEBLOWER LAW, IN
13 REGARD TO GOOD FAITH REPORTS OF POTENTIAL VIOLATIONS OF THIS
14 ACT. ENVIRONMENTAL LABORATORIES COVERED BY THIS ACT SHALL BE
15 DEEMED TO BE AN EMPLOYER UNDER THE WHISTLEBLOWER LAW IN REGARD
16 TO GOOD FAITH REPORTS OF POTENTIAL VIOLATIONS OF THIS ACT.
17 Section 12 13. Continuation of existing rules and regulations. <--
18 All existing rules and regulations promulgated pursuant to
19 any environmental statute remain in full force and effect until
20 superseded and repealed by the rules and regulations promulgated
21 pursuant to this act.
22 Section 13 14. Repeals. <--
23 All acts and parts of acts are repealed insofar as they are
24 inconsistent with this act.
25 Section 14 15. Effective date. <--
26 This act shall take effect immediately.
F29L27RLE/20010S1115B1719 - 12 -