Ohio Adm.Code 901:3 | Ohio Administrative Code 901:3 — Department of Agriculture | Food Safety

Chapter 901:3-1 Food Processing Manufacturing Practices, Standards of Identity, and Labeling Requirements

Ohio Adm.Code 901:3-1-11 Food labeling.

(A) All food processing establishments shall utilize and apply the generally recognized federal standards for food labeling in 21 C.F.R. Part 101 (2023). Cottage food production operations and exempt processors as described in division (A) of section 3715.021 of the Revised Code shall comply with the requirements in section 3715.023 of the Revised Code and utilize and apply 21 C.F.R. part 101 (2023) when nutritional labeling is required.

(B) An exempt processor of tree syrup or sorghum, or a beekeeper who jars honey as described in division (A) of section 3715.021 of the Revised Code that produces, processes, or manufactures maple syrup, honey, or sorghum and is in compliance with Chapter 901:3-46 of the Administrative Code may place the director's seal of conformity and inspection on their container.

Last updated February 12, 2024 at 10:45 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-1-12 Standards of identity.

Foods processed in a food processing establishment shall meet the generally recognized federal standards of identity specified in 21 C.F.R. Parts 100 through 169 (2023) as follows:

(A) 21 C.F.R. Part 100.155, salt and iodized salt;

(B) 21 C.F.R. Part 102, common or usual name for non-standardized foods;

(D) 21 C.F.R. Part 133, cheeses and related cheese products;

(E) 21 C.F.R. Part 135, frozen desserts;

(F) 21 C.F.R. Part 136, bakery products;

(G) 21 C.F.R. Part 137, cereal flours and related products;

(H) 21 C.F.R. Part 139, macaroni and noodle products;

(I) 21 C.F.R. Part 145, canned fruits;

(J) 21 C.F.R. Part 146, canned fruit juices;

(K) 21 C.F.R. Part 150, fruit butters, jellies, preserves, and related products;

(L) 21 C.F.R. Part 152, fruit pies;

(M) 21 C.F.R. Part 155, canned vegetables;

(N) 21 C.F.R. Part 156, vegetable juices;

(O) 21 C.F.R. Part 158, frozen vegetables;

(P) 21 C.F.R. Part 160, eggs and egg products;

(Q) 21 C.F.R. Part 161, fish and shellfish;

(R) 21 C.F.R. Part 163, cacao products;

(S) 21 C.F.R. Part 164, tree nut and peanut products;

(T) 21 C.F.R. Part 165, beverages;

(U) 21 C.F.R. Part 166, margarine;

(V) 21 C.F.R. Part 168, sweeteners and table sirups; and

(W) 21 C.F.R. Part 169, food dressings and flavorings;

Last updated February 12, 2024 at 10:45 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-1-13 Food coloring.

All food products shall conform to the following requirements regarding the use of color additives:

(A) 21 C.F.R. Part 73 (2024).

(B) 21 C.F.R. Part 74 (2024).

(D) 21 C.F.R. Part 82 (2024).

Last updated April 1, 2025 at 7:48 AM

History

Effective: April 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 901:3-1-14 Food nutritional labeling.

(A) All food service operations and retail food establishments, as defined in section 3717.01 of the Revised Code, shall comply with the nutritional labeling standards as outlined in 21 C.F.R. 101.11 and 21 C.F.R. 101.8 (2023), as applicable, except the rule does not apply to mobile or temporary food service operations and mobile or temporary retail food establishments.

(B) If the director or the director's designee finds that a person is operating a food service operation or retail food establishment in violation of the standards adopted in paragraph (A) of this rule, the director or the director's designee shall issue a letter of warning to the person giving the person thirty days to come into compliance. If the person fails to come into compliance within the thirty-day time period, the director may assess a civil penalty against the person. If the director assesses a civil penalty, the director shall do so as follows:

(1) If, within five years of the issuance of the letter of warning to the person, the director has not previously assessed a civil penalty against the person under this section, in an amount not exceeding five hundred dollars.

(2) If, within five years of the issuance of the letter of warning to the person, the director has previously assessed one civil penalty against the person under this section, in an amount not exceeding one thousand five hundred dollars.

(3) If, within five years of the issuance of the letter of warning to the person, the director has previously assessed two or more civil penalties against the person under this section, in an amount not exceeding five thousand dollars.

Last updated February 12, 2024 at 10:45 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-1-15 Nutrition labeling of restaurant foods.

Retail food establishments and food service operations as defined in section 3717.01 of the Revised Code shall comply with the nutrition labeling of restaurant foods as outlined in 21 C.F.R. 101.10 (2023), as applicable.

Last updated February 12, 2024 at 10:45 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Chapter 901:3-4 Retail Food Establishments-Licensing

Ohio Adm.Code 901:3-4-01 Definitions.

As used in this chapter:

(A) "Certified in food protection" means an individual has met the certification requirements pursuant to Chapter 3717. of the Revised Code.

(B) "Director" means the director of Ohio department of agriculture or an authorized designee of the director.

(D) "Noncommercial retail food establishment" means a retail food establishment as described in Chapter 3717. of the Revised Code, conducted by any of the following: an agency of government, a church, school, non-profit youth group whose membership consists primarily of persons aged eighteen or younger, or an organization which is described in subsection 501(c)(3) of the Internal Revenue Code of 1986, Pub. L. No. 99-514, 100 Stat. 2085 (1986), U.S.C. 1, et seq., as amended and is tax exempt under subsection 501(a) of the Code.

(E) "Noncommercial temporary retail food establishment" means a temporary retail food establishment as described in Chapter 3717. of the Revised Code conducted by any of the following: an agency of government, a church, school, fraternal organization, service club organization, veterans organization, volunteer fire organization, non-profit youth group whose membership consists primarily of persons aged eighteen or younger, volunteer emergency medical service organization, or an organization which is described in subsection 501(c)(3) of the Internal Revenue Code of 1986 Pub. L. No. 99-514, 100 Stat. 2085 (1986), U.S.C. 1, et seq., as amended and is tax exempt under subsection 501(a) of the Code, or any individual or group raising all of its funds for the benefit of one of these organizations if such operation is operated at an event for no more than five consecutive days, except when operated for more than five consecutive days under division (E)(2) of section 3717.23 of the Revised Code.

(F) "Process review inspection" means an inspection made to determine if a risk level IV processing procedure is in compliance with Chapter 3717. of the Revised Code.

(G) "Standard inspection" means an inspection designed to determine compliance with Chapter 3717. of the Revised Code, section 3715.551 of the Revised Code, and the rules adopted thereunder.

(H) "Temporary retail food establishment" means a retail food establishment that is operated at an event for not more than five consecutive days, except when operated for more than five consecutive days pursuant to division (E)(2) of section 3717.23 of the Revised Code.

(I) "Variance review" means a determination by the licensor of compliance with a food processing variance issued by the Ohio department of agriculture.

Last updated February 12, 2024 at 8:35 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-4-02 License.

(A) During the month of February of each year, except as hereinafter provided, every person that operates a retail food establishment shall apply for a license for that year from the licensor of retail food establishments for the area in which the retail food establishment is located. This provision shall apply to all retail food establishments except seasonal retail food establishments, mobile retail food establishments, temporary retail food establishments, and new retail food establishments opened for business subsequent to March first of each year.

All licenses issued to retail food establishments expire pursuant to division (C) of section 3717.23 of the Revised Code.

(B) An application for a license to operate a new retail food establishment during any part of the year shall be filed as hereinafter provided not less than ten days before the retail food establishment is opened for business. If proper application has been made, the facility layout and equipment specifications have been approved and complied with on the final inspection, and all items are in compliance with Chapter 3717. of the Revised Code, Chapter 3717-1 of the Administrative Code, and this chapter; the ten-day waiting period may be waived and the license issued. The operator of a low risk and high risk mobile retail food establishment shall make application for a license to the board of health of the health district in which the operator's business headquarters are located. The operator of a mobile retail food establishment whose business address is located outside of Ohio shall make application for a license to the board of health having jurisdiction over the operator's first Ohio location in any one licensing year. A retail food establishment license issued to an operator of a mobile retail food establishment by an approved health district, as provided in Chapter 3717. of the Revised Code, shall be recognized by all other licensors in this state.

(C) The operator of a retail food establishment shall make written application for a license to the licensor on an application form prescribed or approved by the director which shall contain all pertinent information related to the premises utilized for the retail food establishment.

(D) Fees for issuing and renewing retail food establishment licenses, determined by the licensor in accordance with section 3717.25 of the Revised Code, may be levied upon each retail food establishment. These fees shall be used solely for paying the expense of the administration and enforcement of Chapter 3717. of the Revised Code, Chapter 3717-1 of the Administrative Code, and this chapter.

(1) In determining the amount of the annual license fee, the licensor shall use the categories established by rule 901:3-4-03 of the Administrative Code and the cost analysis established by rule 901:3-4-04 of the Administrative Code.

(2) If a license fee as prescribed under paragraph (D) of this rule is not filed with the licensor or postmarked on or before the due date, a penalty of twenty-five per cent of any such fee shall be imposed and paid.

(3) Fees authorized or charged under paragraph (D) of this rule shall be in lieu of all retail food establishment license fees required by the licensor on or with respect to the operation of, ownership of, or employment by retail food establishments within this state, except as provided in paragraph (C) of rule 901:3-4-03 of the Administrative Code.

(E) For each retail food establishment license issued the following applicable amount shall be collected and transmitted by the licensor to the director for deposit in the food safety fund created in section 915.24 of the Revised Code and used for administering and enforcing Chapter 3717. of the Revised Code, Chapter 3717-1 of the Administrative Code, and this chapter:

(1) Twenty-eight dollars for each license that the licensor issues under the fee category specified in paragraphs (A)(1), (A)(2), and (A)(4) of rule 901:3-4-03 of the Administrative Code; or

(2) Fourteen dollars for each license that the licensor issues under the fee category specified in paragraph (B)(1) of rule 901:3-4-03 of the Administrative Code.

(F) The licensor shall submit a report of all retail food establishment licenses and temporary retail food establishment licenses issued during the period included in the fee transmittal completed in accordance with paragraph (E) of this rule on a form prescribed or approved by the director.

(G) The operator of a retail food establishment that also plans to cater shall apply for a catering food service operation endorsement to the operator's retail food establishment license. A retail food establishment license with such an endorsement shall be recognized by all other licensors in this state. The operator of such an establishment shall maintain a copy of the license at each catered event.

(H) A license holder shall display the license for that retail food establishment at all times at the licensed location.

(I) Each operator of a mobile retail food establishment shall conspicuously display the name of the operation, the city of origin, area code, and telephone number on the exterior of the mobile unit. The name and city of origin of the mobile retail food establishment shall be displayed with individual lettering measuring at least three inches high and one inch wide.

Last updated February 12, 2024 at 8:36 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-4-03

(A) The license fees established by a licensor pursuant to section 3717.25 of the Revised Code for retail food establishments as described in section 3717.01 of the Revised Code shall be specified for the following categories:

(1) Retail food establishments, including micro markets, in which the interior premises is under twenty-five thousand square feet for each risk level specified in rule 901:3-4-05 of the Administrative Code;

(2) Retail food establishments in which the interior premises is twenty-five thousand square feet or more for each risk level specified in rule 901:3-4-05 of the Administrative Code;

(3) Temporary retail food establishments as a per event fee or as a per day fee; and

(4) Mobile retail food establishments as specified in rule 901:3-4-05 of the Administrative Code and low risk mobile retail food establishments as specified in rule 901:3-4-05 of the Administrative Code which will be fifty per cent of the mobile retail food establishment fee established in this rule.

(B) The licensor may establish a different fee for retail food establishments the licensor classifies as:

(1) Noncommercial retail food establishments in all risk level categories, which shall be fifty per cent of the fee established in paragraphs (A)(1) and (A)(2) of this rule, as applicable; and

(2) Noncommercial temporary retail food establishments, which shall be fifty per cent of the fee established in paragraph (A)(3) of this rule.

(1) Review of facility layout and equipment specifications for retail food establishments, other than mobile and temporary retail food establishments;

(2) Any necessary collection and bacteriological examination of food or water samples, or similar services specified in rules adopted under section 3717.05 of the Revised Code; and

(3) Attendance at a course of study offered by the licensor in food protection if the course is approved under section 3717.09 of the Revised Code.

Last updated February 12, 2024 at 8:36 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-4-04

(A) A cost analysis shall be conducted each fiscal year. The licensor shall use data from the previous fiscal year to calculate the actual cost of administering and enforcing Chapter 3717. of the Revised Code, and the rules adopted thereunder for food service operations and retail food establishments licensed by the licensor. The licensor shall calculate the actual cost of administration and enforcement attributable to each of the following components on forms prescribed or approved by the director:

(1) Risk level I, risk level II, risk level III, and risk level IV food service operations and retail food establishments;

(2) Temporary food service operations and temporary retail food establishments; and

(3) Mobile retail food establishments and mobile food service operations.

(B) Except as specified in paragraph (D) of this rule, the licensor shall calculate the cost attributable to each component listed in paragraph (A) of this rule for administering and enforcing Chapter 3717. of the Revised Code and the rules adopted thereunder for operations licensed by the licensor. Cost shall not exceed all reasonable and necessary direct cost and indirect cost. For the purposes of this rule indirect cost means support cost which includes support staff cost plus overhead cost. The licensor shall use a form prescribed or approved by the director of agriculture and the director of health that includes the following data:

(1) A list of all inspecting sanitarians who worked in the component;

(2) The total hours worked in the component by each inspecting sanitarian;

(3) The total hours that each inspecting sanitarian worked in the last fiscal year;

(4) The total annual wages or salary paid to each inspecting sanitarian;

(5) The total amount for fringe benefits paid on behalf of each inspecting sanitarian;

(6) The total travel costs for each inspecting sanitarian;

(7) The support costs for the component as determined by one of the following methods:

(a) Use of actual support cost not to exceed thirty per cent of the total program cost for items, such as salary and fringe benefits of the health commissioner, the director of environmental health, supervisory staff, clerical staff, utilities, rent, supplies, equipment, liability insurance, and training; or

(b) Use of an indirect cost rate of thirty per cent of the wages or salaries and fringe benefits of inspecting sanitarians attributable to the component.

(8) The sampling and laboratory costs for the component other than those costs specified in paragraph (C) of rule 901:3-4-03 of the Administrative Code;

(9) Funding for the component which includes revenues obtained from license fees and penalty fees.

(C) The licensor shall calculate the license fee for each retail food establishment category listed in rule 901:3-4-03 of the Administrative Code as follows:

(1) For a temporary retail food establishment:

(a) Using fees established on a per event basis, the temporary food service operation and temporary retail food establishment category cost divided by the number of temporary food service operation and temporary retail food establishment licenses issued. If a licensor elects to establish a noncommercial fee for temporary food service operations and temporary retail food establishments, the category cost is divided by the number of licenses issued for commercial temporary food service operations and commercial temporary retail food establishments plus fifty per cent of the number of licenses issued for noncommercial temporary food service operations and noncommercial temporary retail food establishments; or

(b) Using fees established on a per day basis, the temporary food service operation and temporary retail food establishment category cost divided by the total number of days for which temporary food service operation and temporary retail food establishment licenses were issued. If a licensor elects to establish a noncommercial fee for temporary food service operations and temporary retail food establishments, the category cost is divided by the number of days for which commercial licenses were issued plus fifty per cent of the number of days for which temporary licenses were issued for noncommercial temporary food service operations and noncommercial temporary retail food establishments.

(2) For retail food establishments classified as risk level I, risk level II, risk level III, and risk level IV retail food establishments:

(a) Determine support costs in accordance with paragraph (B)(7) of this rule. Equally allocate support costs attributable to the risk level food service operations and retail food establishments component by dividing the support costs of the risk level food service operations and retail food establishments component by the total number of commercial risk level I, risk level II, risk level III, and risk level IV food service operations and retail food establishments plus fifty per cent of the noncommercial operations classified by risk level;

(b) Determine the total number of food service operations and retail food establishments in each risk level category. If the licensor elects to establish noncommercial categories for risk level food service operations and risk level retail food establishments the total number of food service operations and retail food establishments in each risk level category is the number of commercial risk level food service operations and commercial risk level retail food establishments plus fifty per cent of the number of noncommercial risk level food service operations and noncommercial risk level retail food establishments;

(c) Determine the number of standard inspection periods for each risk level category using the inspection time factor. The number of standard inspection periods is the minimum number of inspections required for each risk level category multiplied by the inspection time factor, the product of which is multiplied by the total number of food service operations and retail food establishments in each risk level category. The inspection time factor is the ratio of the average amount of time per inspection for all risk levels relative to the average time per inspection for the risk level I less than twenty-five thousand square feet operations. The inspection time factor for:

(i) Risk level I less than twenty-five thousand square feet is 1.00, and twenty-five thousand square feet or above is 1.88;

(ii) Risk level II less than twenty-five thousand square feet is 1.25, and twenty-five thousand square feet or above is 2.03;

(iii) Risk level III less than twenty-five thousand square feet is 1.64, and twenty-five thousand square feet or above is 4.84; and

(iv) Risk level IV less than twenty-five thousand square feet is 2.21, and twenty-five thousand square feet or above is 5.16.

(d) Determine the total number of standard inspection periods by summing the standard inspection periods for all risk level categories;

(e) Determine the non-support cost per standard inspection period: subtract the support cost from the total actual cost of the component and divide this amount by the total number of standard inspection periods;

(f) Determine the non-support cost for each risk level category by using the following formula:

A B C = The non-support cost for each risk level, where A is equal to the non-support cost per standard inspection period, B is equal to the standard inspection period for the risk level category, and C is equal to the inspection time factor for the risk level category.

(g) Determine the maximum license fee that may be established: add the non-support cost for each risk level category to the support cost per license issued.

(3) The mobile retail food establishment and the mobile food service operation category cost divided by the number of mobile retail food establishments and mobile food service operation licenses issued.

(D) Additional considerations.

(1) The total sanitarian hours that may be accounted for in calculating the cost attributable to the food service operations and retail food establishments identified in paragraph (A)(1) of this rule shall not exceed an average of nine hours per risk classified food service operation and retail food establishment.

(2) Anticipated increases in costs that may be attributable to a component are limited to known increases for which official notification or board action has been documented.

(E) The licensor shall provide a proportional reduction in the fees to be charged in the next license period if a licensor included anticipated costs in the calculation of licensing fees and the total amount of anticipated costs was not incurred.

(F) The licensor shall provide for a proportionate reduction in fees to be charged in the next license period if discovered through an audit by the auditor of state or any other means that the licensor has charged or is charging a license fee that exceeds the amount that should have been charged.

(G) The licensor shall reduce the fees to be charged in the next license period when a reduction is imposed as a penalty under division (C) of section 3717.071 of the Revised Code.

Last updated February 12, 2024 at 8:36 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-4-05

The licensor shall determine the risk level based on the highest risk level activity of the retail food establishment in accordance with the following criteria:

(A) Risk level I poses potential risk to the public in terms of sanitation, food labeling, sources of food, storage practices, or expiration dates.

(1) Examples of risk level I activities include, but are not limited to, an operation that offers for sale or serves:

(a) Coffee, self-service hot beverage dispenser drinks, self-service fountain drinks, prepackaged non-time/temperature controlled for safety food beverages;

(b) Pre-packaged refrigerated or frozen time/temperature controlled for safety food;

(d) Pre-packaged non-time/temperature controlled for safety food; or

(e) Baby food or formula.

(2) A "food delivery operation" as defined in division (H) of section 3717.01 of the Revised Code shall be classified as risk level I.

(3) A "micro market" as defined in paragraph (B) of rule 3717-1-01 of the Administrative Code shall be classified as a risk level I.

(B) Risk level II poses a higher potential risk to the public than risk level I because of hand contact or employee health concerns but minimal possibility of pathogenic growth exists. Examples of risk level II activities include, but are not limited to:

(1) Handling, heat treating, or preparing non-time/temperature controlled for safety food;

(2) Holding for sale or serving time/temperature controlled for safety food at the same proper holding temperature at which it was received;

(3) Heating individually packaged, commercially processed time/temperature controlled for safety food for immediate service; or

(4) Hand dipping of commercially manufactured ice cream.

(C) Risk level III poses a higher potential risk to the public than risk level II because of the following concerns: proper cooking temperatures, proper cooling procedures, proper holding temperatures, contamination issues or improper heat treatment in association with longer holding times before consumption, or processing a raw food product requiring bacterial load reduction procedures in order to sell the product as ready-to-eat. Examples of risk level III activities include, but are not limited to:

(1) Handling, cutting, or grinding raw meat products;

(2) Cutting or slicing ready-to-eat meats and cheeses;

(3) Assembling, partially cooking, or cooking time/temperature controlled for safety food that is immediately served, held hot or cold, or cooled;

(4) Operating a soft serve ice cream or frozen yogurt machine;

(5) Reheating in individual portions only; or

(6) Heating of a product from an intact hermetically sealed package and holding the product hot.

(D) Risk level IV poses a higher potential risk to the public than risk level III because of concerns associated with: handling or preparing food using a procedure with several preparation steps that includes reheating of a product or ingredient of a product where multiple temperature controls are needed to preclude bacterial growth. Examples of risk level IV activities include, but are not limited to:

(1) Reheating bulk quantities of leftover time/temperature controlled for safety food more than once every seven days;

(2) Operating a heat treatment dispensing freezer;

(3) Catering food service operations as defined in division (G) of section 3717.01 of the Revised Code;

(4) Offering as ready-to-eat a raw time/temperature controlled for safety animal food or a food with these raw ingredients;

(5) Using freezing as a means to achieve parasite destruction;

(6) Preparing food for a primarily high risk clientele including immune-compromised or elderly individuals in a facility that provides either health care or assisted living;

(7) Using time as a public health control for time/temperature controlled for safety food;

(8) Non-continuous cooking of raw time/temperature controlled for safety food;

(9) Performing activities requiring a HACCP plan, as defined in paragraph (B)(52) of rule 3717-1-01 of the Administrative Code; or

(10) Activities requiring a variance for the process.

(E) The licensor shall determine the risk level of mobile retail food establishment based on the highest risk level activity of mobile retail food establishments in accordance with the criteria listed in paragraphs (E)(1) to (E)(2) of this rule:

(1) Low risk poses a potential risk to the public in terms of sanitation, food labeling, sources of food, and food storage practices in the mobile. Low risk activities include:

(a) Holding for sale or service pre-packaged refrigerated or frozen time/temperature controlled for safety foods; and

(b) Offering for sale or serving pre-packaged non-time/temperature controlled for safety foods.

(2) High risk poses a higher potential risk to the public than low risk because of concerns associated with: proper receiving, holding, and cooking temperatures; proper cooling procedures; processing a raw food that has undergone parasite or bacterial load reduction procedures in order to sell or serve it as ready-to-eat; handling or preparing food using a procedure with several preparation steps that includes reheating of a product or ingredient of a product where multiple temperature controls are needed to preclude bacterial growth; offering as ready-to-eat a raw time/temperature controlled for safety meat, poultry product, fish, or shellfish; or a food with these raw time/temperature controlled for safety items as ingredients; or using time in lieu of temperature as a public health control for time/temperature controlled for safety food. Examples of high-risk activities include, but are not limited to:

(a) Assembling or cooking time/temperature controlled for safety food that is immediately served, held hot or cold, or cooled;

(b) Operating a heat treatment dispensing freezer;

(d) Heating a food from an intact, hermetically sealed package and holding it hot; or

(e) Operating as a mobile catering food service operation as defined in paragraph (L) of rule 3701-21-01 of the Administrative Code.

Last updated February 12, 2024 at 8:36 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 3717-1-01

[Comment: For publication dates of the Code of Federal Regulations (C.F.R.) referenced in this rule, see paragraph (B)(15)(b) of rule 3717-1-01 of the Administrative Code.]

(A) Chapter 3717-1 of the Administrative Code will also be known as "The State of Ohio Uniform Food Safety Code."

(B) Definitions for the purposes of Chapter 3717-1 of the Administrative Code:

(1) Additive.

(a) "Color additive" has the meaning stated in the Federal Food, Drug, and Cosmetic Act, section 201(t) (as amended on December 29, 2022) and 21 C.F.R. 70.3 (f).

(b) "Food additive" has the meaning stated in the Federal Food, Drug, and Cosmetic Act, section 201(s) (as amended on December 29, 2022) and 21 C.F.R. 170.3 (e)(1).

(2) "Adulterated" has the meaning stated in section 3715.59 of the Revised Code.

(3) "Approved" means acceptable to the appropriate regulatory authority based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.

(4) "Approved source" means a food is from:

(a) A processor that is inspected by a federal food safety regulatory agency or equivalent, the Ohio department of agriculture under Chapter 3715., 911., 913., 915., 917., 918. whether mandatory or voluntary, or 925. of the Revised Code, or other recognized food regulatory agency of another state responsible for food safety; or

(b) A cottage food production operation as defined in division (A) of section 3715.01 of the Revised Code, or an exempt processor of tree syrup, honey, sorghum, apple syrup, or apple butter as specified in division (A) of section 3715.021 of the Revised Code; and that is in compliance with the provisions of Chapter 3715. of the Revised Code and any applicable rules adopted thereunder; or

(c) Provided the processing is not subject to regulations as stated in paragraphs (B)(4)(a) and (B)(4)(b) of this rule, a food service operation or retail food establishment as defined and licensed in accordance with Chapter 3717. of the Revised Code.

(d) Except for mushrooms and sprouts, the term "approved source" is not applicable to fresh unprocessed fruits and vegetables.

(5) "ANSI" means the American national standards institute.

(6) "Asymptomatic" means without obvious symptoms; not showing or producing indications of a disease or other medical condition, such as an individual infected with a pathogen but not exhibiting or producing any signs or symptoms of vomiting, diarrhea, or jaundice. It includes not showing symptoms because symptoms have resolved or subsided.

(7) "aw" means water activity, which is a measure of the free moisture in a food, is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.

(8) "Balut" means an embryo inside a fertile egg that has been incubated for a period sufficient for the embryo to reach a specific stage of development after which it is removed from incubation before hatching.

(9) "Beverage" means a liquid for drinking, including water.

(10) "Board of health" means the board of health of any city or general health district, or the authority having the duties of a board of health as authorized by section 3709.05 of the Revised Code.

(11) "Bottled drinking water" means water that is sealed in bottles, packages, or other containers and offered for sale for human consumption, including bottled mineral water.

(12) "Bulk water machine" means a self-service device used for the filling of containers with water. The device includes a water treatment process which is not replenished after each use and does not need prior payment by the user for activation of the machine.

(13) "Casing" means a tubular container for sausage products made of either natural or artificial (synthetic) material.

(14) "Certification number" means the unique identification number issued by the shellfish control authority to each dealer for each location.

(15) "C.F.R." means Code of Federal Regulations which is the compilation of the general and permanent rules published in the federal register by the executive departments and agencies of the federal government which:

(a) Is published annually by the United States government printing office;

(b) Contains FDA rules in 21 C.F.R. (as amended on March 21, 2023), USDA rules in 7 C.F.R. and 9 C.F.R. (as amended on January 1, 2018), EPA rules in 40 C.F.R. (as amended on March 20, 2023), and wildlife and fisheries rules in 50 C.F.R. (as amended on March 16, 2023); and

(c) Citations in this chapter to the C.F.R. refer sequentially to the title, part, and section numbers, such as 40 C.F.R. 180.194 refers to Title 40, Part 180, Section 194.

(16) "CIP" means cleaned in place by the circulation or flowing by mechanical means through a piping system of a detergent solution, water rinse, and sanitizing solution onto or over equipment surfaces that are to be cleaned, such as the method used, in part, to clean and sanitize a frozen dessert machine. "CIP" does not include the cleaning of equipment such as band saws, slicers, or mixers that are subjected to in-place manual cleaning without the use of a CIP system.

(17) "Commingle" means the act of combining different lots of shellfish.

(18) "Comminuted":

(a) Means reduced in size by methods including chopping, flaking, grinding, or mincing; and

(b) Includes fish or meat products that are reduced in size and restructured or reformulated such as gefilte fish, gyros, ground beef, and sausage; and a mixture of two or more types of meat that have been reduced in size and combined, such as sausages made from two or more meats.

(19) "Conditional employee" means a potential food employee to whom a job offer is made, conditional on responses to subsequent medical questions or examinations designed to identify potential food employees who may be suffering from a disease that can be transmitted through food and done in compliance with Title 1 of the Americans with Disabilities Act of 1990.

(20) "Confirmed disease outbreak" means a foodborne disease outbreak in which laboratory analysis of appropriate specimens identifies a causative agent and epidemiological analysis implicates the food as the source of the illness.

(21) "Consumer" means a person who is a member of the public, takes possession of food, is not functioning in the capacity of an operator of a food service operation, retail food establishment or food processing plant, and does not offer the food for resale.

(22) "Corrosion-resistant material" means a material that maintains acceptable surface cleanability characteristics under prolonged influence of the food to be contacted, the normal use of cleaning compounds and sanitizing solutions, and other conditions of the use environment.

(23) "Cottage food production operation" means a person who, in the person's home, produces food items that are not potentially hazardous foods, including bakery products, jams, jellies, candy, fruit butter, and similar products specified in rules adopted pursuant to section 3715.025 of the Revised Code.

(24) "Counter-mounted equipment" means equipment that is not portable and is designed to be mounted off the floor on a table, counter, or shelf.

(25) "Critical control point" means a point or procedure in a specific food system where loss of control may result in an unacceptable health risk.

(26) "Critical limit" means the maximum or minimum value to which a physical, biological, or chemical parameter is to be controlled at a critical control point to minimize the risk that the identified food safety hazard may occur.

(27) "Cut leafy greens" means fresh leafy greens whose leaves have been cut, shredded, sliced, chopped, or torn. The term "leafy greens" includes iceberg lettuce, romaine lettuce, leaf lettuce, butter lettuce, baby leaf lettuce (i.e., immature lettuce or leafy greens), escarole, endive, spring mix, spinach, cabbage, kale, arugula and chard. The term "leafy greens" does not include herbs such as cilantro or parsley.

(28) "Dealer" means a person who is authorized by a shellfish control authority for the activities of shellstock shipper, shucker-packer, repacker, reshipper, or depuration processor of molluscan shellfish according to the provisions of the national shellfish sanitation program.

(29) "Disclosure" means a written statement that clearly identifies the animal-derived foods which are, or can be ordered, raw, undercooked, or without otherwise being processed to eliminate pathogens, or items that contain an ingredient that is raw, undercooked, or without otherwise being processed to eliminate pathogens.

(30) "Drinking water" means water that meets criteria as specified in 40 C.F.R. 141. "Drinking water" is traditionally known as "potable water." "Drinking water" includes the term "water" except where the term used connotes that the water is not potable, such as "boiler water," "mop water," "rainwater," "wastewater," and "nondrinking" water.

(31) "Dry storage area" means a room or area designated for the storage of packaged or containerized bulk food that is not time/temperature controlled for safety and dry goods such as single-service items.

(32) "Easily cleanable":

(a) Means a characteristic of a surface that:

(i) Allows effective removal of soil by normal cleaning methods;

(ii) Is dependent on the material, design, construction, and installation of the surface; and

(iii) Varies with the likelihood of the surface's role in introducing pathogenic or toxigenic agents or other contaminants into food based on the surface's approved placement, purpose, and use.

(b) Includes a tiered application of the criteria that qualify the surface as easily cleanable as specified under paragraph (B)(32)(a) of this rule to different situations in which varying degrees of cleanability are needed such as:

(i) The appropriateness of stainless steel for a food preparation surface as opposed to the lack of need for stainless steel to be used for floors or for tables used for consumer dining; or

(ii) The need for a different degree of cleanability for a utilitarian attachment or accessory in the kitchen as opposed to a decorative attachment or accessory in the consumer dining area.

(33) "Easily movable" means:

(a) Portable; mounted on casters, gliders, or rollers; or provided with a mechanical means to safely tilt a unit of equipment for cleaning; and

(b) Having no utility connection, a utility connection that disconnects quickly, or a flexible utility connection line of sufficient length to allow the equipment to be moved for cleaning of the equipment and adjacent area.

(34) "Egg" means the shell egg of avian species such as chicken, duck, goose, guinea, quail, ratites or turkey. It does not include a balut; the egg of reptile species such as alligator; or an egg product.

(35) "Egg product" means all, or a portion of, the contents found inside eggs separated from the shell and pasteurized in a food processing plant, with or without added ingredients, intended for human consumption, such as dried, frozen or liquid eggs. It does not include food which contains eggs only in a relatively small proportion such as cake mixes.

(36) "Employee" means the license holder, person in charge, food employee, person having supervisory or management duties, person on the payroll, family member, volunteer, person performing work under contractual agreement, or other person working in a food service operation or retail food establishment.

(37) "EPA" means the United States environmental protection agency.

(38) "Equipment" means an article that is used in the operation of a food service operation or retail food establishment such as a freezer, grinder, hood, ice maker, meat block, mixer, oven, reach-in refrigerator, scale, sink, slicer, stove, table, temperature measuring device for ambient air, vending machine, bulk water machine, or warewashing machine. "Equipment" does not include apparatuses used for handling or storing large quantities of packaged foods that are received from a supplier in a cased or overwrapped lot, such as hand trucks, forklifts, dollies, pallets, racks, or skids.

(39) "Exclude" means to prevent a person from working as an employee in a food service operation or retail food establishment, or entering a food service operation or retail food establishment as an employee.

(40) "FDA" means the United States food and drug administration.

(41) "Fish":

(a) Means fresh or saltwater finfish, crustaceans and other forms of aquatic life (including alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of such animals) other than birds or mammals, and all mollusks, if such animal life is intended for human consumption.

(b) Includes an edible human food product derived in whole or in part from fish, including fish that have been processed in any manner.

(42) "Food" means a raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum.

(43) "Foodborne disease outbreak" means the occurrence of two or more cases of a similar illness resulting from the ingestion of a common food.

(44) "Food-contact surface" means:

(a) A surface of equipment or a utensil with which food normally comes into contact; or

(b) A surface of equipment or a utensil from which food may drain, drip, or splash:

(i) Into a food; or

(ii) Onto a surface normally in contact with food.

(45) "Food employee" means an individual working with unpackaged food, food equipment or utensils, or food-contact surfaces.

(46) "Food monitoring device" means a digital pH meter, aw meter, or other device such as a relative humidity meter or wet bulb thermometer, that are used to ensure a critical limit is being met as indicated in a HACCP plan or a variance as specified in paragraph (B)(129) of this rule.

(47) "Food processing plant" means a commercial business or that portion of a business that manufactures, packages, labels, or stores food for human consumption, and is under regulation of the federal government or the Ohio department of agriculture under Chapter 3715., 911., 913., 915., 917., 918., or 925. of the Revised Code.

(48) "Food service operation":

(a) Means a place, location, site, or separate area where food intended to be served in individual portions is prepared or served for a charge or mandatory donation. As used in this definition, "served" means a response made to an order for one or more individual portions of food in a form that is edible without washing, cooking, or additional preparation and "prepared" means any action that affects a food other than receiving or maintaining it at the temperature at which it was received;

(b) Includes a catering food service operation, a food delivery sales operation, a mobile food service operation, temporary food service operation, seasonal food service operation, and a vending machine location; and

(49) "Food service operation sales volume" means the annual sales, minus sales tax, for individual portions of food that are prepared or served by the operation for on premise consumption or individual portions of food served for carry-out or delivery and that are edible without further washing, cooking, or additional preparation.

(50) "Game animal":

(a) Means an animal, the products of which are food, that is not classified as cattle, sheep, swine, goat, horse, mule or other equine in 9 C.F.R. 301.2, or as poultry, or fish.

(b) Includes mammals such as reindeer, elk, deer, antelope, water buffalo, bison, rabbit, squirrel, opossum, raccoon, nutria, or muskrat, and nonaquatic reptiles such as land snakes.

(51) "General use pesticide" means a pesticide that is not classified as a restricted use pesticide under the federal act which, except as provided to avoid immediate harm, may only be applied in a food service operation or retail food establishment under the direct supervision of a commercial applicator licensed as specified under section 921.06 of the Revised Code.

(52) "Grade A standards" means the requirements of the United States public health service/FDA "Grade A Pasteurized Milk Ordinance" with which certain fluid and dry milk and milk products comply.

(53) "HACCP plan" means a written document that delineates the formal procedures for following the hazard analysis and critical control point (HACCP) principles developed by the national advisory committee on microbiological criteria for foods.

(54) "Handwashing sink" means a lavatory, a basin or vessel for washing, a wash basin, or a plumbing fixture especially placed for use in personal hygiene and designed for the washing of the hands. The term includes an automatic handwashing facility.

(55) "Hazard" means a biological, chemical, or physical property that may cause an unacceptable consumer health risk.

(56) "Hermetically sealed container" means a container that is designed and intended to be secure against the entry of microorganisms and, in the case of low acid canned foods, to maintain the commercial sterility of its contents after processing.

(57) "Highly susceptible population" means persons who are more likely than other people in the general population to experience foodborne disease because they are:

(a) Immunocompromised; preschool age children, or older adults; and

(b) Obtaining food at a facility that provides services such as custodial care, health care, or assisted living, such as a child or adult day care center, kidney dialysis center, hospital or nursing home, or nutritional or socialization services such as a senior center.

(58) "Injected" means manipulating meat to which a solution has been introduced into its interior by processes that are referred to as "injecting," "pump marinating," or "stitch pumping."

(59) "In-shell product" means non-living, processed shellfish with one or both shells present.

(60) "Intact meat" means a cut of whole muscle(s) meat that has not undergone comminution, mechanical tenderization, vacuum tumbling with solutions, reconstruction, cubing, or pounding.

(61) "Juice" means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree. Juice includes juice as a whole beverage, an ingredient of a beverage and a puree as an ingredient of a beverage.

(62) "Kitchenware" means food preparation and storage utensils.

(63) "Law" means applicable local, state, and federal statutes, regulations, and ordinances.

(64) "License" means the document issued by the licensor that authorizes a person to operate a food service operation or retail food establishment.

(65) "License holder" means the entity that:

(a) Is legally responsible for the operation of the food service operation or retail food establishment such as the owner, the owner's agent, or other person; and

(b) Possesses a valid license to operate a food service operation or retail food establishment.

(66) "Licensor" means one of the following:

(a) A board of health or the authority having the duties of a board of health approved under section 3717.11 of the Revised Code;

(b) The director of agriculture acting under section 3717.11 of the Revised Code or 3717.111 of the Revised Code with respect to licensing retail food establishments; or

(c) The director of health acting under section 3717.11 of the Revised Code or 3717.111 of the Revised Code with respect to licensing food service operations.

(67) "Linens" means fabric items such as cloth hampers, cloth napkins, table cloths, wiping cloths, and work garments including cloth gloves.

(68) "Major food allergen" means:

(a) Milk, egg, fish (such as bass, flounder, cod, and including crustacean shellfish such as crab, lobster, or shrimp), tree nuts (such as almonds, pecans, or walnuts), wheat, peanuts, soybeans, and sesame; or

(b) A food ingredient that contains protein derived from a food, as specified in paragraph (B)(68)(a) of this rule.

(i) Any highly refined oil derived from a food specified in paragraph (B)(68)(a) of this rule and any ingredient derived from such highly refined oil; or

(ii) Any ingredient that is exempt under the petition or notification process specified in the Food Allergen Labeling and Consumer Protection Act of 2004 (Public Law 108-282).

(69) "Meat" means the flesh of animals used as food including the dressed flesh of cattle, swine, sheep, or goats and other edible animals, except fish and poultry.

(70) "Mechanically tenderized" means manipulating meat by piercing with a set of needles, pins, blades, or any mechanical device, which breaks up muscle fiber and tough connective tissue, to increase tenderness. This includes injection, scoring, and processes which may be referred to as "blade tenderizing," "jaccarding," "pinning," or "needling."

(71) "mg/L" means milligrams per liter, which is the metric equivalent of parts per million (ppm).

(72) "Micro market" means a retail food establishment that offers for sale food items that are allowable in a risk level one operation in displays not more than two hundred and fifty linear feet. All commercially prepackaged refrigerated or frozen time/temperature controlled for safety foods are to be stored in equipment that complies with paragraph (H) of rule 3717-1-03.4, paragraphs (MM) and (NN) of rule 3717-1-04.1 of the Administrative Code.

(73) "Mobile food service operation" means a food service operation that is operated from a movable vehicle, portable structure, or watercraft and that routinely changes location, except that if the operation remains at any one location for more than forty consecutive days, the operation is no longer a mobile food service operation. "Mobile food service operation" includes a food service operation that does not remain at any one location for more than forty consecutive days and serves, in a manner consistent with division (F) of section 3717.01 of the Revised Code.

(74) "Mobile retail food establishment" means a retail food establishment that is operated from a movable vehicle or other portable structure, and that routinely changes location, except that if the establishment operates from any one location for more than forty consecutive days, the establishment is no longer a mobile retail food establishment.

(75) "Molluscan shellfish" means any edible species of fresh or frozen oysters, clams, mussels, and scallops or edible portions thereof, except when the scallop product consists only of the shucked adductor muscle. Molluscan shellfish includes shellstock, shucked shellfish, and in-shell products.

(76) "Non-continuous cooking":

(a) Means the cooking of food in a food service operation or retail food establishment using a process in which the initial heating of the food is intentionally halted so that it may be cooled and held for complete cooking at a later time prior to sale or service.

(b) Does not include cooking procedures that only involve temporarily interrupting or slowing an otherwise continuous cooking process.

(77) "NSF" means the national sanitation foundation or NSF international which contains standard 61, "Drinking Water System Components - Health Effects" (2020).

(78) "Packaged":

(a) Means bottled, canned, cartoned, bagged, or wrapped, whether packaged in a food service operation, retail food establishment, or a food processing plant; and

(b) Does not include wrapped or placed in a carry-out container to protect the food during service or delivery to the consumer, by a food employee, upon consumer request.

(79) "Person" means an association, corporation, individual, partnership, other legal entity, government, or governmental subdivision or agency.

(80) "Person in charge" means the individual present at a food service operation or retail food establishment who is responsible for the operation at any given time .

(81) "Personal care items" means items or substances that may be poisonous, toxic, or a source of contamination and are used to maintain or enhance a person's health, hygiene, or appearance. Personal care items include items such as medicines; first aid supplies; and other items such as cosmetics, and toiletries such as toothpaste and mouthwash.

(82) "pH" is the symbol for the negative logarithm of the hydrogen ion concentration, which is a measure of the degree of acidity or alkalinity of a solution. Values between zero and seven indicate acidity and values between seven and fourteen indicate alkalinity. The value for pure distilled water is seven, which is considered neutral.

(83) "Physical facilities" means the structure and interior surfaces of a food service operation or retail food establishment including accessories such as soap and towel dispensers and attachments such as light fixtures and heating or air conditioning system vents.

(84) "Plumbing fixture" means a receptacle or device that:

(a) Is permanently or temporarily connected to the water distribution system of the premises and demands a supply of water from the system; or

(b) Discharges used water, waste materials, or sewage directly or indirectly to the drainage system of the premises.

(85) "Plumbing system" means the water supply and distribution pipes; plumbing fixtures and traps; soil, waste, and vent pipes; sanitary and storm sewers and building drains, including their respective connections, devices, and appurtenances within the premises; and water-treating equipment.

(86) "Poisonous or toxic materials" means substances that are not intended for ingestion and are included in four categories:

(a) Cleaners and sanitizers, which include cleaning and sanitizing agents and agents such as caustics, acids, drying agents, polishes, and other chemicals;

(b) Pesticides, except sanitizers, which include substances such as insecticides and rodenticides;

(c) Substances necessary for the operation and maintenance of the establishment such as nonfood grade lubricants and personal care items that may be deleterious to health; and

(d) Substances that are not necessary for the operation and maintenance of the establishment and are on the premises for retail sale, such as petroleum products and paints.

(87) "Potentially hazardous food" means time/temperature controlled for safety food as defined in paragraph (B)(125) of this rule.

(88) "Poultry" means:

(a) Any domesticated bird (chickens, ducks, geese, guineas, ratites, squabs or turkeys), whether live or dead, as defined in 9 C.F.R. 381.1; and

(b) Any migratory waterfowl or game bird, pheasant, partridge, quail, grouse, or pigeon, whether live or dead, as defined in 9 C.F.R. 362.1.

(89) "Premises" means:

(a) The physical facility, its contents, and the contiguous land or property under the control of the license holder; or

(b) The physical facility, its contents, and the land or property not described under paragraph (B)(89)(a) of this rule if its facilities and contents are under the control of the license holder and may impact food service operation or retail food establishment personnel, facilities, or operations, and a food service operation or retail food establishment is only one component of a larger operation such as a health care facility, hotel, motel, school, recreational camp, or prison.

(90) "Primal cut" means a basic major cut into which carcasses and sides of meat are separated, such as a beef round, pork loin, lamb flank, or veal breast.

(91) "Public water system" has the meaning stated in Chapter 3745-81 of the Administrative Code.

(92) "Ratite" means a flightless bird such as an emu, ostrich, or rhea.

(93) "Ready-to-eat food":

(a) Means food that:

(i) Is in a form that is edible without additional preparation to achieve food safety, as specified under one of the following paragraph (A)(1) or (A)(4), (B), or (F) of rule 3717-1-03.3 of the Administrative Code or as specified in paragraph (A)(2) of rule 3717-1-03.3 of the Administrative Code; or

(ii) Is a raw or partially cooked animal food and the consumer is advised as specified in paragraphs (A)(3)(a) and (A)(3)(b) of rule 3717-1-03.3 of the Administrative Code; or

(iii) Is prepared in accordance with a variance that is granted as specified in paragraph (A)(3)(c) of rule 3717-1-03.3 of the Administrative Code; and

(iv) May receive additional preparation for palatability or aesthetic, epicurean, gastronomic, or culinary purposes.

(b) Includes:

(i) Raw animal food that is cooked as specified under paragraph (A) or (B) or frozen as specified under paragraph (F) of rule 3717-1-03.3 of the Administrative Code;

(ii) Raw, fruits and vegetables that are washed as specified under paragraph (G) of rule 3717-1-03.2 of the Administrative Code;

(iii) Plant foods that are cooked for hot holding, as specified under paragraph (C) of rule 3717-1-03.3 of the Administrative Code;

(iv) All time/temperature controlled for safety food that is cooked to the temperature and time requirements for the specific food under paragraphs (A) to (D) of rule 3717-1-03.3 of the Administrative Code and cooled as specified under paragraph (D) of rule 3717-1-03.4 of the Administrative Code;

(v) Plant food for which further washing, cooking, or other processing is not necessary for food safety, and from which rinds, peels, husks, or shells, if naturally present are removed;

(vi) Substances derived from plants such as spices, seasonings, and sugar;

(vii) A bakery item such as bread, cakes, pies, fillings, or icing for which further cooking is not necessary for food safety;

(viii) The following products that are produced in accordance with USDA guidelines and that have received a lethality treatment for pathogens: dry fermented sausages, such as dry salami or pepperoni; salt-cured meat and poultry products, such as prosciutto ham, country cured ham, and Parma ham; and dried meat and poultry products, such as jerky or beef sticks; and

(ix) Foods manufactured as specified in 21 C.F.R. 113, thermally processed low-acid foods packaged in hermetically sealed containers.

(i) Commercially packaged food that bears a manufacturer's cooking instructions; and

(ii) Food for which the manufacturer has provided information that it has not been processed to control pathogens.

(94) "Reduced oxygen packaging":

(a) Means the reduction of the amount of oxygen in a package by removing oxygen; displacing oxygen and replacing it with another gas or combination of gases; or otherwise controlling the oxygen content to a level below that normally found in the surrounding atmosphere, which is approximately twenty-one per cent at sea level; and

(b) Is a process as specified in paragraph (B)(94)(a) of this rule that involves a food for which the hazards Clostridium botulinum or Listeria monocytogenes warrant control in the final packaged form.

(i) Vacuum packaging, in which air is removed from a package of food and the package is hermetically sealed so that a vacuum remains inside the package;

(ii) Modified atmosphere packaging, in which the atmosphere of a package of food is modified so that its composition is different from air but the atmosphere may change over time due to the permeability of the packaging material or the respiration of the food. Modified atmosphere packaging includes: reduction in the proportion of oxygen, total replacement of oxygen, or an increase in the proportion of other gases such as carbon dioxide or nitrogen;

(iii) Controlled atmosphere packaging, in which the atmosphere of a package of food is modified so that until the package is opened, its composition is different from air, and continuous control of that atmosphere is maintained, such as by using oxygen scavengers or a combination of total replacement of oxygen, nonrespiring food, and impermeable packaging material;

(iv) Cook chill packaging, in which cooked food is hot filled into impermeable bags that are then sealed or crimped closed. The bagged food is rapidly chilled and refrigerated at temperatures that inhibit the growth of psychrotrophic pathogens; or

(v) Sous vide packaging, in which raw or partially cooked food is vacuum packaged in an impermeable bag, cooked in the bag, rapidly chilled, and refrigerated at temperatures that inhibit the growth of psychrotrophic pathogens.

(95) "Refuse" means solid waste not carried by water through the sewage system.

(96) "Regulatory authority" means the local, state, or federal enforcement body or authorized representative having jurisdiction over the process or facility.

(97) "Reminder" means a written statement concerning the health risk of consuming animal foods raw, undercooked, or without otherwise being processed to eliminate pathogens.

(98) "Re-service" means the transfer of food that is unused and returned by a consumer after being served or sold and in the possession of the consumer, to another person.

(99) "Restrict" means to limit the activities of a food employee so that there is no risk of transmitting a disease that is transmissible through food and the food employee does not work with exposed food; clean equipment, utensils, linens; or unwrapped single-service or single-use articles.

(100) "Restricted egg" means any check, dirty egg, incubator reject, inedible, leaker, or loss as defined in 9 C.F.R. 590.

(101) "Restricted use pesticide" means any pesticide or pesticide use classified by the administrator of the United States environmental protection agency for use only by a certified applicator or by an individual working under the direct supervision of a certified applicator.

(102) "Retail food establishment" means a premises or part of a premises where food is stored, processed, prepared, manufactured, or otherwise held or handled for retail sale. Except when expressly provided otherwise, retail food establishment includes a mobile retail food establishment, seasonal retail food establishment and temporary retail food establishment. It does not include those operations exempted in section 3717.22 of the Revised Code. As used in this definition:

(a) "Retail" means the sale of food to a person who is the ultimate consumer of the food.

(b) "Prepared" means any action that affects a food, including receiving and maintaining it at the temperature at which it was received.

(103) "Retail food establishment sales volume" means the annual sales, minus sales tax, for food, that is sold in bulk or multiple portions by the establishment for off premise consumption that may need further washing, cooking, or additional preparation; or in individual portions that are not consumed on the premise and that either need further washing, cooking or additional preparation before consumption or are ingredient labeled for self service.

(104) "Risk" means the likelihood that an adverse health effect will occur within a population as a result of a hazard in a food.

(105) "Safe material" means:

(a) An article manufactured from or composed of materials that is not expected to result, directly or indirectly, in their becoming a component or otherwise affecting the characteristics of any food;

(b) An additive that is used as specified in section 409 of the Federal Food, Drug, and Cosmetic Act (as amended on August 14, 2018); or

(c) Other materials that are not additives and that are used in conformity with applicable regulations of the food and drug administration.

(106) "Sanitization" means the application of cumulative heat or chemicals on cleaned food-contact surfaces that, when evaluated for efficacy, is sufficient to yield a reduction of five logs, which is equal to a 99.999 per cent reduction, of representative disease microorganisms of public health importance.

(107) "Sealed" means free of cracks or other openings that allow the entry or passage of moisture.

(108) "Seasonal food service operation" means a food service operation, other than a mobile food service operation, that is operated for not more than six months in a licensing period.

(109) "Seasonal retail food establishment" means a retail food establishment, other than a mobile retail food establishment, that is operated for not more than six months in a licensing period.

(110) "Service animal" means an animal such as a guide dog, signal dog, or other animal individually trained to provide assistance to an individual with a disability.

(111) "Servicing area" means an operating base location to which a mobile food service operation, mobile retail food establishment or transportation vehicle returns regularly for such things as vehicle and equipment cleaning, discharging liquid or solid wastes, refilling water tanks and ice bins, and boarding food.

(112) "Sewage" means liquid waste containing animal or vegetable matter in suspension or solution and may include liquids containing chemicals in solution.

(113) "Shellfish control authority" means a state, federal, foreign, tribal, or other government entity legally responsible for administering a program that includes certification of molluscan shellfish harvesters and dealers for interstate commerce.

(114) "Shellstock" means live molluscan shellfish in the shell.

(115) "Shiga toxin-producing Escherichia coli" or STEC means any E. coli capable of producing Shiga toxins (also called verocytotoxins). STEC infections can be asymptomatic or may result in a spectrum of illness ranging from mild non-bloody diarrhea, to hemorrhagic colitis (i.e., bloody diarrhea), to hemolytic uremic syndrome (HUS - a type of kidney failure). Examples of serotypes of STEC include : E. coli 0157:H7; E.coli 0157:NM; E.coli 026:H11; E. coli 0145:NM; E. coli 0103:H2; and E. coli 0111:NM. STEC are sometimes referred to as verocytotoxigenic E. coli (VTEC) or as Enterohemorrhagic E. coli (EHEC). EHEC are a subset of STEC which can cause hemorrhagic colitis or HUS.

(116) "Shucked shellfish" means molluscan shellfish that have both shells removed.

(117) "Single-service articles" means tableware, carry-out utensils, and other items such as bags, containers, placemats, stirrers, straws, toothpicks, and wrappers that are designed and constructed for one time, one person use after which they are intended for discard.

(118) "Single-use articles":

(a) Means utensils and bulk food containers designed and constructed to be used once and discarded; and

(b) Includes, but are not limited to, items such as wax paper, butcher paper, plastic wrap, formed aluminum food containers, jars, plastic tubs or buckets, bread wrappers, pickle barrels, ketchup bottles, and number ten cans which do not meet the materials, durability, strength, and cleanability specifications under paragraph (A) of rule 3717-1-04 of the Administrative Code, and paragraphs (A) and (C) of rule 3717-1-04.1 of the Administrative Code for multiuse utensils.

(119) "Slacking" means the process of moderating the temperature of a food such as allowing a food to gradually increase from a temperature of minus ten degrees Fahrenheit (minus twenty-three degrees Celsius) to twenty-five degrees Fahrenheit (minus four degrees Celsius) in preparation for deep-fat frying or to facilitate even heat penetration during the cooking of previously block-frozen food such as shrimp.

(120) "Smooth" means:

(a) A food-contact surface having a surface free of pits and inclusions with a cleanability equal to or exceeding that of (one hundred grit) number three stainless steel;

(b) A nonfood-contact surface of equipment having a surface equal to that of commercial grade hot-rolled steel free of visible scale; or

(c) A floor, wall, or ceiling having an even or level surface with no roughness or projections that render it difficult to clean.

(121) "Tableware" means eating, drinking, and serving utensils for table use such as plates; flatware including forks, knives, and spoons; and hollowware including bowls, cups, serving dishes, and tumblers.

(122) "Temperature measuring device" means a thermometer, thermocouple, thermistor, or other device that indicates the temperature of food, air, or water.

(123) "Temporary food service operation" means a food service operation that is operated at an event for no more than five consecutive days, except when operated for more than five consecutive days under division (E)(2) of section 3717.43 of the Revised Code.

(124) "Temporary retail food establishment" means a retail food establishment that is operated at an event for not more than five consecutive days, except when operated for more than five consecutive days pursuant to division (E)(2) of section 3717.23 of the Revised Code.

(125) "Time/temperature controlled for safety food" or "TCS food" means a food that needs time/temperature control for safety to limit pathogenic microorganism growth or toxin formation.

(a) TCS food includes:

(i) An animal food that is raw or heat-treated; a plant food that is heat-treated or consists of raw seed sprouts, cut melons, cut leafy greens, cut tomatoes or mixtures of cut tomatoes that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation, or garlic-in-oil mixtures that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation; and

(ii) Except as specified in paragraph (B)(125)(b)(iv) of this rule, a food that because of the interaction of its aw and pH values is designated as product assessment needed (PA) in table A or B of this rule.

Table A. Interaction of pH and aw for control of spores in food heat-treated to destroy vegetative cells and subsequently packaged.

	pH 4.6 or less	pH greater than 4.6 to 5.6	pH greater than 5.6
aw less than or equal to 0.92	non-TCS food	non-TCS food	non-TCS food
aw greater than 0.92 to 0.95	non-TCS food	non-TCS food	PA
aw greater than 0.95	non-TCS food	PA	PA

Table B. Interaction of pH and aw for control of vegetative cells and spores in food not heat-treated or heat-treated but not packaged.

	pH less than 4.2	pH 4.2 to 4.6	pH greater than 4.6 to 5.0	pH greater than 5.0
aw less than 0.88	non-TCS food	non-TCS food	non-TCS food	non-TCS food
aw 0.88 to 0.90	non-TCS food	non-TCS food	non-TCS food	PA
aw greater than 0.90 to 0.92	non-TCS food	non-TCS food	PA	PA
aw greater than 0.92	non-TCS food	PA	PA	PA

(b) TCS food does not include:

(i) An air-cooled hard-boiled egg with shell intact, or an egg with shell intact that is not hard-boiled, but has been pasteurized to destroy all viable salmonellae;

(ii) A food in an unopened hermetically sealed container that is commercially processed to achieve and maintain commercial sterility under conditions of non-refrigerated storage and distribution;

(iii) A food that because of its pH or aw value, or interaction of aw and pH values, is designated as a non-TCS food in table A or B of paragraph (B)(125)(a) of this rule;

(iv) A food that is designated as product assessment needed (PA) in table A or B of paragraph (B)(125)(a) of this rule and has undergone a product assessment showing that the growth or toxin formation of pathogenic microorganisms that are reasonably likely to occur in that food is precluded due to:

(a) Intrinsic factors including added or natural characteristics of the food such as preservatives, antimicrobials, humectants, acidulants, or nutrients,

(b) Extrinsic factors including environmental or operational factors that affect the food such as packaging, modified atmosphere such as reduced oxygen packaging, shelf life and use, or temperature range of storage and use, or

(v) A food that does not support the growth or toxin formation of pathogenic microorganisms in accordance with either paragraph (B)(125)(b)(i), (B)(125)(b)(ii), (B)(125)(b)(iii), or (B)(125)(b)(iv) of this rule even though the food may contain a pathogenic microorganism or chemical or physical contaminant at a level sufficient to cause illness or injury.

(126) "Tobacco product" has the meaning specified in Chapter 2927. of the Revised Code.

(127) "USDA" means the United States department of agriculture.

(128) "Utensil" means a food-contact implement or container used in the storage, preparation, transportation, dispensing, sale, or service of food, such as kitchenware or tableware that is multiuse, single-service, or single-use; gloves used in contact with food; temperature sensing probes of food temperature measuring devices; and probe-type price or identification tags used in contact with food.

(129) "Variance" means a written document issued by the Ohio department of agriculture or the Ohio department of health that authorizes a modification or waiver of one or more requirements of this chapter if, in the opinion of the Ohio department of agriculture or the Ohio department of health, a health hazard or nuisance will not result from the modification or waiver.

(130) "Vending machine" means a self-service device that automatically dispenses on the insertion of currency, token, card, key, by electronic transaction, or similar means a predetermined unit serving of food, either in bulk or in package, without having to be replenished after each use.

(131) "Vending machine location" means an area or room where one or more vending machines are installed and operated, except that if the machines within an area are separated by more than one hundred fifty feet, each area separated by that distance constitutes a separate vending machine location.

(132) "Warewashing" means the cleaning and sanitizing of utensils and food-contact surfaces of equipment.

(133) "Whole-muscle, intact beef" means whole muscle beef that is not injected, mechanically tenderized, reconstructed, or scored and marinated, from which beef steaks may be cut.

Last updated September 5, 2024 at 11:02 AM

History

Effective: September 5, 2024
Promulgated Under: 119.03

Ohio Adm.Code 3701-21-01

As used in Chapter 3701-21 of the Administrative Code:

(A) "aw" means water activity, which is a measure of the free moisture in a food, is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.

(B) "Board of health" means the board of health of any city or general health district, or the authority having the duties of a board of health as authorized by section 3709.05 of the Revised Code.

(C) "Catering food service operation" means a food service operation, as defined in section 3717.01 of the Revised Code where food is prepared for serving at a function or event held at an off-premise site, for a charge determined on a per-function or per-event basis. The charge is contracted for on the basis of the entire luncheon, banquet, or event and not on the basis of an individual meal or lunch.

(D) "Critical control point inspection" means an inspection designed to identify and prevent food handling procedures that epidemiological data have shown to lead to outbreaks of foodborne disease.

(E) "Director" means the director of health or an authorized designee of the director.

(F) "Employee" means the license holder, person in charge, food employee, person having supervisory or management duties, person on the payroll, family member, volunteer, person performing work under contractual agreement, or other person working in a food service operation.

(G) "Equipment" means an article that is used in the operation of a food service operation such as a freezer, grinder, hood, ice maker, meat block, mixer, oven, reach-in refrigerator, scale, sink, slicer, stove, table, temperature measuring device for ambient air, vending machine, bulk water machine, or warewashing machine. "Equipment" does not include apparatuses used for handling or storing large quantities of packaged foods that are received from a supplier in a cased or overwrapped lot, such as hand trucks, forklifts, dollies, pallets, racks, or skids.

(H) "Food" means a raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum.

(I) "Food service operation" means an operation as defined in section 3717.01 of the Revised Code. Two or more food serving areas, each supplied by separate kitchens, are considered two or more separate food service operations and are to be licensed individually even though located in the same building or structure.

(J) "Health district" means each city and general health district established by section 3709.01 of the Revised Code.

(K) "Licensor" means one of the following:

(1) The board of health of any city or general health district, or the authority having the duties of a board of health as authorized by section 3709.05 of the Revised Code, approved under section 3717.11 of the Revised Code;

(2) The director of agriculture acting under section 3717.11 of the Revised Code or 3717.111 of the Revised Code with respect to the licensing of retail food establishments; or

(3) The director of health acting under section 3717.11 of the Revised Code or 3717.111 of the Revised Code with respect to the licensing of food service operations.

(L) "Mobile catering food service operation" means an operation that prepares food in a licensed high risk mobile food service operation or prepares food in a risk level IV food service operation or risk level IV retail food establishment for serving at a function or event for a charge determined on a per-function or per-event basis. The charge is contracted for on the basis of the entire function or event and not on the basis of an individual meal or serving.

(M) "Mobile food service operation" means an operation as defined in section 3717.01 of the Revised Code.

(N) "Noncommercial food service operation" means a food service operation as described in Chapter 3717. of the Revised Code, conducted by any of the following: an agency of the government, a church, school, non-profit youth group whose membership consists primarily of persons aged eighteen or younger, or an organization which is described in subsection 501(c)(3) of the Internal Revenue Code of 1986 (Pub. L. No. 99-514, 100 Stat. 2085, U.S.C. 1, et seq., as amended) and is tax exempt under subsection 501(a) of the code.

(O) "Noncommercial temporary food service operation" means a temporary food service operation as described in Chapter 3717. of the Revised Code, conducted by any of the following: an agency of the government, a church, school, fraternal organization, service club organization, veterans' organization, volunteer fire organization, non-profit youth group whose membership consists primarily of persons aged eighteen or younger, volunteer emergency medical service organization, or an organization which is described in subsection 501(c)(3) of the Internal Revenue Code of 1986 (Pub. L. No. 99-514, 100 Stat. 2085, U.S.C. 1, et seq.,as amended) and is tax exempt under subsection 501(a) of the code, or any individual or group raising all of its funds for the benefit of one of these organizations if such operation is operated at an event for no more than five consecutive days, except when operated for more than five consecutive days under division (E)(2) of section 3717.43 of the Revised Code.

(P) "Operator" means the person, association, corporation, or governmental operation that is responsible for conducting a food service operation.

(Q) "Person in charge" means the individual present at a food service operation or retail food establishment who is responsible for the operation at any given time.

(R) "Potentially hazardous food": means time/temperature controlled for safety food as defined in paragraph (V) of this rule.

(S) "Premises" means:

(1) The physical facility, its contents, and the contiguous land or property under the control of the license holder; or

(2) The physical facility, its contents, and the land or property not described under paragraph (S)(1) of this rule if its facilities and contents are under the control of the license holder and may impact food service operation or retail food establishment personnel, facilities, or operations, and a food service operation or retail food establishment is only one component of a larger operation such as a health care facility, hotel, motel, school, recreational camp, or prison.

(T) "Seasonal food service operation" means an operation as defined in section 3717.01 of the Revised Code.

(U) "Standard inspection" means an inspection designed to determine compliance with Chapter 3717. of the Revised Code and the rules adopted under it.

(V) "Time/temperature controlled for safety food" or "TCS food" means a food that needs time/temperature control for safety to limit pathogenic microorganism growth or toxin formation.

(1) TCS food includes:

(a) An animal food that is raw or heat-treated; a plant food that is heat-treated or consists of raw seed sprouts, cut melons, cut leafy greens, cut tomatoes or mixtures of cut tomatoes that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation, or garlic-in-oil mixtures that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation; and

(b) Except as specified in paragraph (V)(2)(d) of this rule, a food that because of the interaction of its aw and pH values is designated as product assessment (PA) needed in table A or B of this rule.

Table A. Interaction of pH and aw for control of spores in food heat-treated to destroy vegetative cells and subsequently packaged

	pH of 4.6 or less	pH greater than 4.6 to 5.6	pH greater than 5.6
aw less than or equal to 0.92	non-TCS food	non-TCS food	non-TCS food
aw greater than 0.92 to 0.95	non-TCS food	non-TCS food	PA
aw greater than 0.95	non-TCS food	PA	PA

Table B. Interaction of pH and aw for control of vegetative cells and spores in food not heat-treated or heat-treated but not packaged

	pH less than 4.2	pH 4.2 to 4.6	pH greater than 4.6 to 5.0	pH greater than 5.0
aw less than 0.88	non-TCS food	non-TCS food	non-TCS food	non-TCS food
aw 0.88 to 0.90	non-TCS food	non-TCS food	non-TCS food	PA
aw greater than 0.90 to 0.92	non-TCS food	non-TCS food	PA	PA
aw greater than 0.92	non-TCS food	PA	PA	PA

(2) TCS food does not include:

(a) An air-cooled hard-boiled egg with shell intact, or an egg with shell intact that is not hard-boiled, but has been pasteurized to destroy all viable salmonellae;

(b) A food in an unopened hermetically sealed container that is commercially processed to achieve and maintain commercial sterility under conditions of non-refrigerated storage and distribution;

(c) A food that because of its pH or aw value, or interaction of aw and pH values, is designated as a non-TCS food in table A or B of paragraph (V)(1) of this rule;

(d) A food that is designated as product assessment (PA) needed in table A or B of paragraph (V)(1) of this rule and has undergone a product assessment showing that the growth or toxin formation of pathogenic microorganisms that are reasonably likely to occur in that food is precluded due to:

(i) Intrinsic factors including added or natural characteristics of the food such as preservatives, antimicrobials, humectants, acidulants, or nutrients,

(ii) Extrinsic factors including environmental or operational factors that affect the food such as packaging, modified atmosphere such as reduced oxygen packaging, shelf life and use, or temperature range of storage and use, or

(iii) A combination of intrinsic and extrinsic factors; or

(e) A food that does not support the growth or toxin formation of pathogenic microorganisms in accordance with paragraph (V)(2)(a), (V)(2)(b), (V)(2)(c) or (V)(2)(d) of this rule even though the food may contain a pathogenic microorganism or chemical or physical contaminant at a level sufficient to cause illness or injury.

(W) "Temporary food service operation" means an operation as defined in section 3717.01 of the Revised Code.

(X) "Variance review" means a determination by the licensor of compliance with a food processing variance issued by the Ohio department of health.

Last updated September 3, 2024 at 8:57 AM

History

Effective: September 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-4-06 Retail food establishment inspection frequency.

A licensor shall inspect retail food establishments at least every fifteen months as follows:

(A) Risk level I: at least one standard inspection each licensing period. With the inspection of micro markets, the license holder must be notified prior to inspection and at minimum is to be completed by the end of the next business day after notification.

(B) Risk level II: at least one standard inspection each licensing period.

(D) Risk level IV: at least two standard inspections and if applicable two process review inspections, and if applicable two variance reviews each licensing period. The licensor may conduct process review inspections on the same visits as standard inspections and when applicable verify the terms of any variance that may have been issued.

(E) Temporary retail food establishments: at least one inspection during the period of operation.

(F) New retail food establishments: one standard inspection not later than thirty days after the license has been issued. If less than six months remain in a licensing period, the licensor may elect to eliminate one standard inspection, one process review inspection and one variance review for an establishment classified as risk level III or IV.

(G) Mobile retail food establishments: at least one standard inspection each licensing period.

Last updated February 12, 2024 at 8:37 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-4-07 Approval of facility layout and equipment specifications.

No person, firm, association, organization, corporation, or government operation shall construct, install, provide, equip, or extensively alter a retail food establishment until the facility layout and equipment specifications therefore have been submitted to and approved in writing by the licensor. When the facility layout and equipment specifications are submitted to the licensor, the licensor shall act upon them within thirty calendar days after date of receipt. The facility layout and equipment specifications shall be approved by the licensor in accordance with the rules adopted pursuant to section 3717.05 of the Revised Code stating the criteria for facility layout and equipment specifications.

Last updated March 21, 2024 at 8:34 AM

History

Effective: March 21, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-4-08 Appeal procedures.

(A) This rule prescribes procedures for appealing the proposed denial, suspension, or revocation of a retail food establishment license and appealing the suspension of a license for a violation presenting a clear and present danger to the public health. An appeal of a proposed denial, suspension, or revocation of an endorsement on a retail food establishment license and appeal of the suspension of an endorsement on a license for a violation presenting a clear and present danger to the public health shall be conducted in the same manner.

(B) In the case of a proposal to deny, suspend, or revoke a retail food establishment license, the licensor shall provide the license holder with written notice of the proposed action and the cause for the action. The notice shall describe the procedure for appealing the proposed denial, suspension, or revocation.

(1) The licensor shall provide written notice by certified mail, return receipt requested, or by hand delivery. If the notice is returned because of failure of delivery, the licensor shall send the notice by regular mail to the retail food establishment location listed on the license or conspicuously post the notice at an entrance of the operation, and posting or mailing constitutes notice.

(2) After receiving the notice, to obtain a hearing, the license holder must submit a written request that the licensor receives within fifteen days.

(3) The licensor shall schedule a hearing before the licensor or a hearing officer designated by the licensor. If the licensor provides a hearing officer, the hearing officer shall be licensed to practice law in Ohio and shall not have participated in any manner in the decision to take the action against the license holder.

(4) The licensor shall mail or hand-deliver notice of the date, time, and place of the hearing to the license holder no less than ten days before the scheduled date.

(5) At the hearing, the license holder shall have the opportunity to present the license holder's case orally or in writing and to confront and cross-examine witnesses. The license holder may be represented by counsel and may review the case record before the hearing. If the licensor is a board of health of a city or general health district or the authority having the duties of the board of health under section 3709.05 of the Revised Code, and a hearing officer has been designated, a member of that board does not have to be present at the hearing.

(6) If the hearing is before a hearing officer, the hearing officer shall prepare a written recommendation as to the validity of the licensor's action, which shall rest solely on the evidence presented at the hearing and the statutory and regulatory provisions governing the licensor's action. The hearing officer shall describe the basis for the hearing officer's recommendation, but need not prepare a full opinion or formal findings of fact and conclusions of law. The hearing officer shall mail by certified mail, return receipt requested, or hand-deliver the recommendation to the licensor and the license holder. Either party may file objections to the recommendation provided that the objections are received by the licensor within five days of receiving a copy of the recommendation from the hearing officer.

(7) After reviewing any timely objections, the licensor may by motion take additional evidence or approve, modify, or disapprove the hearing officer's recommendation and shall enter an order in the record of the proceedings.

(8) If the licensor does not receive a timely request for a hearing, the licensor may immediately enter an order as proposed in the notice.

(C) In the case of a suspension of a license issued for a violation presenting clear and present danger to the public health, the licensor shall provide the license holder with written notice of the action, the cause for the action, and the effective date of the action. The written notice shall specify the procedure for appealing the suspension and shall list the address to which a hearing request shall be sent or delivered. The license holder may appeal the suspension by mailing or hand-delivering a written request for a hearing to the address specified in the notice. If a hearing is requested, the hearing shall be heard not later than two business days after the request is received by the licensor. At the hearing, the license holder shall have the opportunity to present the license holder's case orally or in writing and to confront and cross-examine witnesses. The license holder may be represented by counsel and may review the case record before the hearing. At the hearing, the licensor shall determine whether the clear and present danger to the public health continues to exist.

(D) Any determination made or order entered by the licensor pursuant to this rule shall be made as follows:

(1) If the licensor is a board of health of a city or general health district or the authority having the duties of the board of health under section 3709.05 of the Revised Code, by majority vote of the members of the board or authority present at a meeting at which there is a quorum;

(2) If the director is acting as the licensor pursuant to section 3717.11 or 3717.111 of the Revised Code, by decision of the director.

If the licensor conducts the hearing, the licensor may immediately render a decision denying, suspending, or revoking a license, or render a decision removing or continuing a license suspension. If the licensor is a board of health of a city or general health district or the authority having the duties of the board of health under section 3709.05 of the Revised Code, the determination or order may be considered and made at a meeting without publication or advertisement, and may become effective without such publication or advertisement, recording or certifying. An order is not effective until the order is recorded in the licensor's record of the proceedings.

Last updated February 12, 2024 at 8:37 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-4-09 Complaint investigation procedure.

(A) The licensor shall accept all complaints regarding retail food establishments. The complaints shall be investigated in accordance with a written policy of the licensor. The policy shall include at a minimum:

(1) A complaint form or electronic database to be used to document the receipt of all complaints and contains at least the following:

(a) The name and address of the retail food establishment; and

(b) A statement of facts about the complaint including the date and time of any alleged occurence.

(2) The time frame for conducting investigations of complaints according to the potential risk to the public health, and

(3) The criteria for declining to investigate a complaint.

(B) The licensor shall:

(1) Document the results and disposition of the licensor's investigation on a food inspection form prescribed or approved by the director;

(2) Maintain the complaint form, any laboratory results, food inspection form documenting the investigation findings, and any other records pertaining to the complaint in the retail food establishment's file or electric database;

(3) Investigate each complaint in a fair and complete manner; and

(4) If requested, report the results to the complainant orally or in writing upon completion of the investigation.

Last updated February 12, 2024 at 8:37 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-4-10 Dispute mediation procedure.

A licensor or license holder may request mediation by the Ohio department of agriculture to resolve a dispute regarding the application of Chapter 3717. of the Revised Code, Chapter 3717-1 of the Administrative Code, or this chapter pertaining to retail food establishments. The request shall be in writing and contain a detailed description of the dispute including any applicable supporting documentation. The Ohio department of agriculture shall investigate the case and the findings transmitted to all affected entities. A request for mediation does not affect the right of any party to seek any other remedy available by law.

Last updated February 12, 2024 at 8:37 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-4-11 Enforcement support.

(A) For the purpose of this rule "enforcement support" means the provision of any of the following by the Ohio department of agriculture in the license suspension, license revocation, prosecution, or proposed prosecution of a person for a violation of the provisions of Chapter 3717. of the Revised Code, Chapter 3717-1 of the Administrative Code, or this chapter:

(1) Consultation regarding the facts of the case;

(2) Case preparation assistance if the county prosecutor or legal representative requests assistance;

(3) Expert testimony;

(4) Evidence collection; and

(5) Review and comment on case documentation.

(B) To request enforcement support a board of health or the authority having the duties of a board of health must request assistance to the director on a form prescribed by the director.

Last updated February 12, 2024 at 8:38 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-4-12 Articles - requirement to cease use.

(A) Any article such as a utensil, material, or piece of equipment may be removed from use in a retail food establishment or a food service operation by the licensor if the article presents a public health hazard. For the purposes of this rule, a public health hazard is presented by any article whose use can reasonably be expected to result in the contamination or adulteration of a food product based upon its state of repair, cleanliness, location, or construction. The licensor may tag any such article and prohibit the article's use by the license holder.

(B) A tag removing an article from use shall state the reason for the article's removal from use, and either

(1) The provisions for returning the article to use, or

(2) The disposition of the article if the article cannot be satisfactorily reconditioned.

(D) Any action that may be taken by a licensor under paragraphs (A) to (C) of this rule may be taken by a health commissioner or other person employed by the licensor if the person or health commissioner is authorized by the licensor to take the action.

Last updated February 12, 2024 at 8:38 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-4-13 Records.

A license holder of a retail food establishment shall:

(A) For the purpose of any investigation provide the licensor, upon request and within a reasonable time, proof of origination of the foods sold at the retail food establishment.

(B) Maintain records required as a condition of a variance or a required HACCP plan, as defined in paragraph (B)(52) of rule 3717-1-01 of the Administrative Code, for a period of one year.

Last updated February 12, 2024 at 8:38 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-4-14 Collection of food samples for the purposes of identifying adulteration and misbranding.

(A) A licensor may submit a sample for testing to the Ohio department of agriculture consumer protection laboratory when:

(1) A food or food additive is the subject of a consumer complaint;

(2) At the request of a consumer after a physician has isolated an organism from the consumer as the physician's patient;

(3) A food or food additive is suspected of having caused an illness;

(4) A food or food additive is suspected of being adulterated or misbranded;

(5) A food or food additive is subject to verification of food labeling and standards of identity; or

(6) The director considers a sample analysis necessary or the sample is part of an Ohio department of agriculture food sample monitoring program.

(B) Samples taken for any reason specified in paragraph (A) of this rule, should when possible, be from a non-compromised package and of the same lot, code, or production unit as the food or food additive that is of concern. As used in this rule, "non-compromised" means securely wrapped and packaged as purchased, not opened by the complainant, or otherwise handled in a manner that might result in the discrediting of the sample results.

(1) Not contaminated by the sampling or shipping process;

(2) Maintained at a temperature that is appropriate to help minimize additional growth of bacteria, other organisms, and deterioration until received by the laboratory;

(3) Collected, submitted, and shipped in accordance with any guidelines for such sample submission as directed by the consumer protection laboratory; and

(4) For a non-compromised sample a chain of custody is documented. For the purposes of this rule, "chain of custody" means the documentation of the history of the handling of a sample by persons in charge of a sample from the initial sampling to receipt and analysis by the analyzing laboratory.

(D) The Ohio department of agriculture's consumer protection laboratory may charge a licensor a reasonable fee for the analysis of a sample unless the sample is considered to be an official sample as defined in rules promulgated pursuant to section 901.43 of the Revised Code or the fee has been waived by the director.

(E) No person shall refuse to furnish a sample for analysis upon a demand and tender of payment.

Last updated February 12, 2024 at 8:38 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-4-15 Embargo of food.

(A) For the purposes of this rule, "expired" means:

(1) In the case of infant formula, the "use by" date required by 21 C.F.R. 107.20 (as published on April 1, 2021) has passed; or

(2) In the case of baby food, that any expiration date, "use by" date, or sale date established by state or federal law or marked on the container by the manufacturer, processor, or packager has passed.

(B) Whenever a licensor finds or has cause to believe within a retail food establishment or food service operation in the licensor's jurisdiction that any food is adulterated, or so misbranded as to be dangerous or fraudulent, within the meaning of sections 3715.01 and 3715.52 to 3715.72 of the Revised Code, or that infant formula, or baby food is expired, the licensor shall affix to the item a tag giving notice that the item is, or is suspected of being, adulterated, misbranded, or expired and has been embargoed. The tag shall warn all persons not to remove or dispose of the item by sale or otherwise until permission for removal or disposal is given by the licensor or the court. No person may remove or dispose of a detained or embargoed item by sale or otherwise without such permission.

(C) When a food, infant formula, or baby food that has been embargoed has been found by the licensor to be adulterated, misbranded, or expired, the licensor shall petition the municipal or county court in whose jurisdiction the item is embargoed for an order for condemnation of the item. When the licensor has not found within ten days that an item embargoed is adulterated, misbranded, or expired, the licensor shall remove the tag or other marking.

(D) If the court finds that an embargoed item is adulterated, misbranded, or expired, the item shall, after entry of the decree, be destroyed at the expense of the claimant thereof, under the supervision of the licensor, and all court costs, fees, storage, and other proper expenses shall be taxed against the claimant of the item or the claimant's agent; provided, that when the adulteration or misbranding can be corrected by proper labeling or processing of the item, the court, after entry of the decree and after such costs, fees, and expenses have been paid and a good and sufficient bond, conditioned that the item shall be so labeled or processed, has been executed, may by order direct that the item be delivered to the claimant thereof for labeling or processing under the supervision of the licensor. The expense of supervision shall be paid by the claimant. The bond shall be returned to the claimant of the item on representation to the court by the licensor that the item is no longer in violation of sections 3715.01 and 3715.52 to 3715.72 of the Revised Code, and that the expenses of supervision have been paid.

(E) Whenever the licensor finds in any retail food establishment or food service operation, any meat, seafood, poultry, vegetable, fruit, or other perishable foods that are unsound, or contain any filthy, decomposed, or putrid substance, or that may be poisonous or deleterious to health or otherwise unsafe, the foods are declared to be a nuisance, and the licensor shall forthwith condemn or destroy the foods, or in any other manner render the items unsalable as human food.

(F) Any action that may be taken by a licensor under paragraphs (A) to (E) of this rule may be taken by a health commissioner or other person employed by the licensor if the person or health commissioner is authorized by the licensor to take the action.

Last updated February 12, 2024 at 8:39 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-4-16 Certification in food protection.

(A) Persons seeking approval for a course of study for persons to be certified in food protection, shall make application to the Ohio department of health in accordance with Chapter 3701-21 of the Administrative Code.

(B) Any person recognized by the Ohio department of health as "certified in food protection" shall also be recognized as such by the Ohio department of agriculture and any other licensor of retail food establishments in Ohio.

(C) The licensor shall mandate person in charge certification for risk level I, II, III, and IV retail food establishments and high risk mobile retail food establishments for the reasons provided in paragraph (K) of rule 3701-21-25 of the Administrative Code. This paragraph does not apply to micro markets as defined by rule 3717-1-01 of the Administrative Code.

Last updated February 29, 2024 at 12:21 PM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 3701-21-25

(A) In accordance with section 3717.09 of the Revised Code, the director of health will approve the following categories of food certification courses:

(1) Person in charge certification covers the principles of food safety and the requirements of paragraph (B) of rule 3717-1-02.4 of the Administrative Code.

(2) Manager certification in food protection is a comprehensive food safety training that provides managers with in-depth knowledge of proper food safety practices for use in their facilities. A manager certification in food protection course approved by the director of health prior to April 1, 2019 will retain its approval until a new or amended course is submitted to the director of health no later than nine months after the effective date of this rule and approved or disapproved by the director of health no later than twelve months after the effective date of this rule. If a new or amended course is not submitted and approved within twelve months of the effective date of this rule, the course will no longer be approved.

(B) Any person desiring to apply to the director of health for approval to conduct a food certification course is obligated to complete an application prescribed by the director and submit the completed application to the director. An application to conduct a person in charge certification course or manager certification in food protection course will contain at least the following criteria:

(1) The applicant's name, address, email address and telephone number;

(2) Name of course to be conducted;

(3) Course agenda that identifies the core content as specified in appendix A of this rule for a person in charge certification course and as specified in appendix B of this rule for a manager certification in food protection course;

(4) A description of any methods of training to be used such as classroom instruction, guest speakers, interactive computer programming, or video;

(5) The names of all course instructors and verification that the instructors possess the following qualifications:

(a) For person in charge certification:

(i) The instructor is a registered environmental health specialist working in food safety; or

(ii) The instructor possesses a valid manager certification in food protection in accordance with this rule.

(b) For manager certification in food protection:

(i) The instructor is a registered environmental health specialist working in food safety; or

(ii) The instructor possesses a valid manager certification in food protection in accordance with this rule; and

(iii) Documentation that confirms the instructors possess approval from the course developer to instruct the course.

(6) The names of all examination proctors and documentation that the proctors possess approval from the examination developer to proctor the examination;

(7) For a manager certification in food protection course, the name of the examination to be administered. The examination will comply with the criteria set by the conference for food protection standards (April 2016) for food safety certification examination;

(8) An example of the certificate issued to individuals who attend a person in charge certification course, which will contain the following:

(a) Name of student;

(b) Statement that student completed "Ohio Person-in-Charge" course;

(d) Name of training provider; and

(e) Course provider approval number assigned by the director of health.

(1) An application for approval of a person in charge certification or manager certification in food protection course will be completed on a form prescribed by the director and will contain at least the following information:

(a) The applicant's name, address, email address and telephone number; and

(b) A copy of all course materials, such as student manuals, written or verbal exercises, access to interactive computer program, videos, handouts or other materials mandated by the director of health;

(2) Amendments to a person in charge or manager certification in food protection course approved by the director of health will be submitted to and approved by the director of health prior to implementation.

(D) Person in charge certification and manager certification in food protection course curriculums.

(1) The core content of a person in charge certification course will address the areas of knowledge and the topics described in appendix A of this rule and contain a verbal or written exercise, without the written exercise containing a passing score.

(2) The core content of a manager certification in food protection course will address the areas of knowledge and the topics described in appendix B of this rule.

(3) A food certification course administered through interactive computer programming will affirm that the course does not enable an individual to fast forward or skip through course content.

(E) Individuals that submit with their applications proof that they are a service member or veteran, or the spouse or surviving spouse of a service member or veteran will receive priority processing.

(1) The acceptable proof of service member/veteran status documents are:

(a) Department of defense identification card (active, retired, temporary disability retirement list (TDRL));

(b) DD214 military discharge certificate indicating disposition of discharge;

(d) Veterans identification card from the department of veterans affairs.

(2) All acceptable proof documents, except veterans identification card, are to show the veteran status as honorable, general, general under honorable conditions, or discharged or released under conditions other than dishonorable.

(F) An approved provider of a person in charge certification course will:

(1) Prior to implementation, submit to the director any changes such as course materials, course agenda, instructors, certificate of completion, or provider contact information;

(2) Provide adequate facilities, equipment and supplies necessary to administer the approved course; and

(3) Provide a certificate of completion to individuals who complete the course.

(G) An approved provider of a manager certification in food protection course will:

(1) Prior to implementation, submit to the director any changes such as course materials, course agenda, instructors, proctors, examination, or provider contact information;

(2) Provide adequate facilities, equipment and supplies necessary to administer the approved course;

(3) Ensure that, prior to administering the examination:

(a) Instructors affirm that students attended the entire course; and

(b) Proctors mandate students to provide documentation of completion of a manager course approved by the director of health. Providers will maintain the documentation until the provider has been audited by the director of health.

(4) Within thirty days of administering the examination, send to the director of health a copy of the examination score report that includes date of examination, each individual's name, passing grade, name of provider, and name of instructor or proctor; and

(5) Distribute the Ohio certification to individuals who successfully complete a certification course and examination within ten business days of receiving the certifications from the director of health.

(H) The director may audit any food certification course or provider to determine compliance with the most current requirements in Chapter 3717-1 of the Administrative Code and this rule.

(I) The director may disapprove a food certification course or provider if the course or provider fails to meet the requirements of this rule. An applicant, course, or course provider may request that the director reconsider the decision and may submit additional materials to the director in support of their request, provided that the director receives the request for reconsideration and any additional materials within thirty days of the date of the director's notice of disapproval. The director will reconsider the disapproval and issue a final decision within thirty days of receiving the request for reconsideration.

(J) An individual desiring manager certification in food protection is obligated to successfully complete a manager certification in food protection course and examination that meet the requirements of this rule. If the course and examination were administered by a course provider not approved by the director of health, the individual may apply for certification in food protection by submitting an application to the director of health on a form prescribed by the director along with the following:

(1) Documentation that the individual has successfully completed a manager certification in food protection course in accordance with this rule; and

(2) A certificate that confirms the individual has successfully completed a course examination that complies with paragraph (B)(7) of this rule within one year of completion of an approved manager certification in food protection course.

(K) Person in charge certification:

(1) The licensor will mandate person in charge certification for at least one person in charge per shift in risk level I, II, III, and IV food service operations and retail food establishments initially licensed after March 1, 2010.

(2) The licensor will mandate person in charge certification for all persons in charge in food service operations and retail food establishments initially licensed prior to March 1, 2010 that have been implicated in a foodborne disease outbreak or the licensor has documented a failure to maintain sanitary conditions as per sections 3717.29 and 3717.49 of the Revised Code.

(3) A person in charge of a food service operation or a retail food establishment not subject to paragraph (K)(2) of this rule that provides documentation to the licensor that the person in charge has obtained manager certification in food protection issued by the director of health is not obligated to obtain person in charge certification.

(4) The licensor will mandate person in charge certification for at least one person in charge per license holder at each individual event in high risk mobile food service operations and high risk mobile retail food establishments initially licensed on or after the effective date of this rule.

(5) The licensor will mandate person in charge certification for all persons in charge in high risk mobile food service operations and high risk mobile retail food establishments initially licensed prior to the effective date of this rule that have been implicated in a foodborne disease outbreak or the licensor has documented a failure to maintain sanitary conditions as per sections 3717.29 and 3717.49 of the Revised Code.

(L) A licensor that is an approved course provider in accordance with this rule may charge a fee as specified in division (B)(3) of section 3717.25 of the Revised Code for retail food establishments and division (B)(3) of section 3717.45 of the Revised Code for food service operations.

View AppendixView Appendix

Last updated September 3, 2024 at 9:00 AM

History

Effective: September 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-4-17 State survey procedures for program evaluation.

(A) Pursuant to section 3717.11 of the Revised Code the director will survey at least once every three years the retail food establishment program of every licensor for retail food establishments. The licensor will provide the director with all requested information to complete the survey.

(B) The director will provide the survey methodology to all licensors. The methodology shall include:

(1) A review of the administrative aspects of the retail food establishment program including applications and licensing, cost analysis and fee adoption, facility layout and equipment specification review, inspections and reports and enforcement;

(2) A written or electronic assessment pursuant to division (H) of section 3717.33 of the Revised Code to be administered in the following manner:

(a) Except as provided in paragraph (B)(2)(b) of this rule, each individual registered as an environmental health specialist or environmental health specialist in training that has conducted food inspections within the last licensing year will be evaluated by the director using the assessment;

(b) Any individual registered as an environmental health specialist or environmental health specialist in training that previously passed the assessment given by the director of health within the same calendar year in which a survey occurs will not be obligated to be assessed again by the director during a survey conducted in the same calendar year;

(d) No smart watches or cellular phones will be permitted during the assessment;

(e) The assessment will consist of not more than fifty questions in length;

(f) The individual will have one hundred twenty minutes to complete the assessment;

(g) In order to pass the assessment, the individual will correctly answer eighty per cent of the assessment questions;

(h) In accordance with division (H) of section 3717.33 of the Revised Code, each licensor will provide the director the most commonly documented violations within the jurisdiction by January thirty-first of each year.

(3) A review of other performance standards relevant to the conduct of the retail food establishment program. Performance standards are outside the scope of the status of compliance.

(C) The director will survey the retail food establishment program in accordance with the survey methodology and determine whether the licensor is qualified to administer and enforce Chapter 3717. of the Revised Code, this chapter and Chapter 3717-1 of the Administrative Code. The licensor will be classified as provisional if any subparagraph of paragraph (C)(1), (C)(2), or (C)(3) of this rule is identified as "needs improvement" during the current survey. The licensor will be classified as provisional if all subparagraphs of paragraph (C)(4) of this rule are identified as "needs improvement" during the current survey.

(1) Fee setting:

(a) Licensing fees exceed the maximum calculated fee; or

(b) Licensing categories do not comply with rule 901:3-4-03 of the Administrative Code; or

(2) Licensing:

(a) Licensor charges additional fees to retail foods establishments not specified in paragraph (C) of rule 901:3-4-03 of the Administrative Code; or

(b) Licensor does not remit state fees to the director as specified in division (C)(2) of section 3717.25 of the Revised Code and paragraph (E) of rule 901:3-4-02 of the Administrative Code.

(3) Inspections:

(a) Inspections are not conducted at the frequency specified in rule 901:3-4-06 of the Administrative Code; or

(b) Inspections are not conducted by a registered environmental health specialist or environmental health specialist in training.

(4) Program administration:

(a) Less than fifty per cent of the registered environmental health specialist or environmental health specialist in training pass the written assessment or electronic assessment; and

(b) The licensor does not administer and enforce Chapter 3717. of the Revised Code, this chapter and Chapter 3717-1 of the Administrative Code; and

(D) After the survey is complete, the director will classify the licensor as approved or provisional and provide a survey report to the licensor within forty-five days of the completion of the survey. The director will transmit the survey report to the licensor by regular U.S. mail or e-mail to the address provided by the licensor on the local health district information form. The survey report will include:

(1) A set time frame for correcting the deficiencies;

(2) Procedures for program disapproval that the department will pursue if the licensor fails to correct the deficiencies identified in paragraph (C)(1), (C)(2), (C)(3) or (C)(4) of this rule or other deficiencies identified by the director, revealed by the survey; and

(3) An opportunity to request a meeting with a representative of the director to discuss the deficiencies.

(E) The director will re-evaluate a licensor's provisional retail food establishment program in the established time frame to determine if the program is in compliance. If in compliance, the director will classify the licensor as approved. If the deficiencies have not been corrected, the director will propose to disapprove the licensor, or will propose to revoke the approval, whichever is appropriate. The director will transmit the determination to the licensor by regular U.S. mail or e-mail to the address provided by the licensor on the local health district information form.

(F) The licensor may request an informal hearing on the director's proposed determination if a written request is received by the director no later than thirty days after the date the proposed determination is mailed or emailed by the director of agriculture to the licensor. The informal hearing will be conducted before the director or the director's authorized representative no later than thirty days after the director received the request for hearing. At the hearing, a representative of the licensor may present information orally and in writing. The director will transmit by regular U.S. mail or e-mail to the address provided by the licensor on the local health district information form a written decision no later than thirty days after the conclusion of the informal hearing.

Last updated January 2, 2025 at 8:15 AM

History

Effective: January 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 901:3-4-18 Reinstatement of a licensor.

The director may reinstate a licensor if all the conditions in division (D) of section 3717.11 of the Revised Code are met. Upon reinstatement, the director shall provide the licensor a set-time frame for survey which shall be no later than one year after reinstatement. The licensor shall be classified as provisional until the licensor has successfully passed the survey. If the director determines that the licensor is qualified to administer and enforce Chapter 3717. of the Revised Code, Chapter 3717-1 of the Administrative Code, and the applicable rules of this chapter, the director shall classify the licensor as approved. If the director determines that the licensor is not qualified, the director may propose to revoke the approval in accordance with paragraph (D) of rule 901:3-4-17 of the Administrative Code.

Last updated February 12, 2024 at 8:39 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Chapter 901:3-5 Processing Acidified Foods

Ohio Adm.Code 901:3-5-01 Criteria and definitions for processing acidified foods.

(A) Food processing establishments processing acidified foods shall comply with Chapter 901:3-5 of the Administrative Code and the applicable provisions of Chapter 901:3-17 of the Administrative Code.

(B) Definitions.

As used in Chapter 901:3-5 of the Administrative Code:

(1) "Acid foods" means foods that have a natural pH of 4.6 or below.

(2) "Acidified foods" means low-acid foods to which acid(s) or acid food(s) are added; these foods include, but are not limited to, beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits and fish, singly or in any combination. They have a water activity greater than 0.85 and have a finished equilibrium pH of 4.6 or below. These foods may be called, or may purport to be, "pickles" or "pickled." Carbonated beverages, jams, jellies, preserves, acid foods (including such foods as standardized and non-standardized food dressings and condiment sauces) that contain small amounts of low-acid food(s) and have a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food, and foods that are stored, distributed and retailed under refrigeration are excluded from the coverage of this part.

(3) "21 CFR 113" means title 21 of the Code of Federal Regulations part 113 (April 2023).

(4) "Lot" means the food product produced during a period indicated by a specific code.

(5) "Low-acid foods" means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85. Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not classed as low-acid foods.

(6) "pH" is the symbol for the negative logarithm of the hydrogen ion concentration which is a measure of degree of acidity or alkalinity of a solution.

(7) "Scheduled process" means the process selected by a processor as adequate for use under the conditions of manufacture for a food in achieving and maintaining a food that will not permit the growth of microorganisms having public health significance. It includes control of pH and other critical factors equivalent to the process established by a processing authority.

(8) Water activity means a measure of the free moisture in a food and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.

Last updated November 22, 2024 at 7:44 AM

History

Effective: November 22, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-5-02 Personnel training.

(A) The operators of processing and packaging systems shall be under the operating supervision of a person who has attended a school for giving instruction in food-handling techniques, food-protection principles, personal hygiene, plant sanitation practices, pH controls, critical factors in acidification, and who has been identified by that school as having satisfactorily completed the prescribed course of instruction.

(B) The supervisor identified in paragraph (A) of this rule shall supply the director, upon request, a copy of their certificate of completion for the prescribed applicable course of instruction.

Last updated October 7, 2024 at 11:47 AM

History

Effective: June 29, 2015
Promulgated Under: 119.03

Ohio Adm.Code 901:3-5-03 Processes and controls.

(A) Processing operations.

The manufacturer shall employ appropriate quality control procedures to ensure that finished foods do not present a health hazard.

(1) Acidified foods shall be so manufactured, processed, and packaged that a finished equilibrium pH value of 4.6 or lower is achieved within the time designated in the scheduled process and maintained in all finished foods. Manufacturing shall be in accordance with the scheduled process filed with the U.S. food and drug administration. Acidified foods shall be thermally processed to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance and those of no health significance capable of reproducing in the food under the conditions in which the food is stored, distributed, retailed and held by the user. In lieu of thermal processing, approved preservatives may be used to inhibit reproduction of microorganisms of no health significance.

(2) Sufficient control, including frequent testing and recording of results, shall be exercised so that the finished equilibrium pH values for acidified foods are not higher than 4.6. If the finished equilibrium pH of the food is above 4.0, the measurement of the finished equilibrium pH shall be by a potentiometric method, and the in-process measurements by titration or colorimetry shall be related to the finished equilibrium pH. If the finished equilibrium pH is 4.0 or below, then the measurement of acidity of the final product may be made by any suitable method.

(3) Procedures for acidification to attain acceptable equilibrium pH levels in the final food include, but are not limited to, the following:

(a) Blanching of the food ingredients in acidified aqueous solutions.

(b) Immersion of the blanched food in acid solutions provided the acid concentration is properly maintained.

(c) Direct batch acidification, which can be achieved by adding a known amount of an acid solution to a specified amount of food during acidification.

(d) Direct addition of a predetermined amount of acid to individual containers during production provided care is taken to ensure that the proper amount of acid is added to each container.

(e) Addition of acid foods to low-acid foods in controlled proportions to conform to specific formulations.

(4) Testing and examinations of containers shall occur often enough to ensure that the container suitably protects the food from leakage or contamination.

(B) Coding.

(1) Each container or product shall be marked with an identifying code permanently visible to the naked eye.

(2) The required identification shall specify in code the establishment where the product was packed, the product contained therein, and the year, day, and period during which it was packed.

(3) The packing period code shall be changed often enough to enable ready identification of lots during their sale and distribution. Codes may be changed periodically on one of the following bases:

(a) Intervals of four to five hours;

(b) Personnel shift changes; or

(c) Batches, as long as the containers constituting the batch do not represent those processed during more than one personnel shift.

Last updated October 7, 2024 at 11:47 AM

History

Effective: June 29, 2015
Promulgated Under: 119.03

Ohio Adm.Code 901:3-5-04 Production and process controls.

(A) Scheduled processes for acidified foods.

(1) Processor shall supply upon request a copy of:

(a) Their FDA food canning establishment number;

(b) The scheduled process filed with the FDA including a list of critical control points; and

(c) An evaluation of the operator's process made by a competent processing authority attesting to the adequacy of such process to ensure a safe product.

(2) Complete records covering all aspects of the establishment of the process and associated incubation test shall be prepared and shall be permanently retained by the person or organization making the determination.

(B) Deviations from scheduled processes.

Whenever any process operation deviates from the scheduled process for any acidified food and/or the equilibrium pH of the finished product is higher than 4.6, the commercial processor of the acidified food shall either:

(1) Fully reprocess that portion of the food in accordance with the scheduled process filed with FDA;

(2) Thermally process it as a low-acid food under 21 CFR 113 thermally processed low-acid foods packaged in hermetically sealed containers; or

(3) Set aside that portion of the food involved for further evaluation as to any potential public health significance.

(a) The evaluation of the deviation shall be made to detect any potential hazard to public health.

(b) Unless the evaluation demonstrates that the food has undergone a process that has rendered it safe, the food set aside shall either be fully reprocessed to render it safe, or be destroyed.

(d) Upon completion of full reprocessing and the attainment of a safe food, or after the determination that no significant potential for public health hazard exists, that portion of the food involved may be shipped in normal distribution.

(e) Food involved that has been determined to present a potential health hazard and not been reprocessed to render it safe shall be destroyed.

(C) A manufacturer shall promptly notify the director of any instance of spoilage, process deviation, or contamination with microorganisms when:

(1) There is a potential health endangering significance; and

(2) Where the lot of such food, in whole or in part, has entered distribution in commerce.

(D) A manufacturer shall prepare and maintain files on procedures which contains plans for the following:

(1) Recalling products;

(2) Identifying, collecting, warehousing and controlling products;

(3) Determining the effectiveness of recalls;

(4) Notifying the director of any recalls; and

(5) Implementing recall programs.

Last updated November 22, 2024 at 7:44 AM

History

Effective: November 22, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-5-05 Records.

(A) Records shall be maintained of examinations of raw materials, packaging materials, finished products, and of suppliers' guarantees or certifications.

(B) Processing and production records showing adherence to scheduled processes, including records of pH measurements and other critical factors intended to ensure a safe product, shall be maintained and shall contain sufficient additional information such as product code, date, container size, and product, to permit a public health hazard evaluation of the processes applied to each lot, batch, or other portion of production.

(C) All departures from scheduled processes having a possible bearing on public health or the safety of the food shall be noted and the affected portion of the product identified; these departures shall be recorded and made the subject of a separate file or log identifying the appropriate data delineating them, the action taken to rectify them, and the disposition of the portion of the product involved.

(D) Records shall be maintained identifying initial distribution of the finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise unfit for their intended use.

(E) Copies of all records provided for in paragraphs (B), (C), and (D) of this rule shall be retained at the processing plant or other reasonably accessible location for a period of three years from the date of manufacture.

Last updated October 7, 2024 at 11:48 AM

History

Effective: June 29, 2015
Promulgated Under: 119.03

Chapter 901:3-6 Farm Markets and Auctions

Ohio Adm.Code 901:3-6-01 Authority of the director of agriculture; Definitions.

(A) Pursuant to section 3717.221 of the Revised Code, the director shall administer the applicable provisions of Chapter 901:3-6 of the Administrative Code to farm markets and farm product auctions that have registered with the Ohio department of agriculture. A farm market, or farm product auction may register with the Ohio department of agriculture on a form prescribed by the director which can be found at https://agri.ohio.gov/divisions/food-safety/resources/farm-market.

Unregistered farm markets and unregistered farm product auctions will be regulated pursuant to Chapter 3717. of the Revised Code as a retail food establishment or a food service operation.

(B) Definitions:

As used in Chapter 901:3-6 of the Administrative Code:

(1) "Adulterated" has the meaning stated in section 3715.59 of the Revised Code.

(2) "C.F.R." means code of federal regulations.

(3) "Cottage food production operation" as defined in section 3715.01 of the Revised Code.

(4) "Director" means the director of the Ohio department of agriculture or designee.

(5) "Registered farm market" means a producer operated facility where only the following food items may be offered for sale:

(a) Fresh unprocessed fruits or vegetables;

(b) Products of a cottage food production operation;

(c) Tree syrup, sorghum, apple syrup, apple butter or honey that is produced by a processor or beekeeper described in division (A) of section 3715.021 of the Revised Code;

(d) Commercially prepackaged food that is not potentially hazardous, on the condition that the food is contained in displays, the total space of which equals less than one hundred cubic feet at the farm market;

(e) Cider and other juices manufactured on site at the farm market;

(f) Raw eggs, raw poultry, and raw nonamenable meat on the condition that those products were produced in accordance with divisions (B)(8) to (B)(10) of section 3717.22 of the Revised Code.

(6) "Farmers' market" means a location where producers congregate to offer food items for sale.

(7) "Registered farm product auction" means a location where only one or more of the following products are offered for sale at auction:

(a) Raw eggs, raw poultry, or raw nonamenable meat on the condition that those products were produced in accordance with divisions (B)(8) to (B)(10) of section 3717.22 of the Revised Code.

(b) Fresh unprocessed fruits or vegetables;

(d) Tree syrup, sorghum, apple syrup, apple butter or honey that is produced by a processor or beekeeper described in division (A) of section 3715.021 of the Revised Code.

(8) "Home" has the meaning stated in section 3715.01 of the Revised Code.

(9) "Misbranded Food" has the meaning stated in section 3715.60 of the Revised Code.

(10) "Nonamenable meat" means any species other than cattle, sheep, swine, goats, horses, mules, other equines, ratites (emu, rhea, and ostrich), and domesticated poultry (turkey, chicken, ducks, geese, and guinea fowl). Examples of nonamenable species includes farm raised mammals such as bison, rabbit, and deer.

(11) "Potentially hazardous food" has the meaning stated in division (A)(18) of section 3715.01 of the Revised Code.

(12) "Producer" means a person who raises agricultural products on land the person owns or leases by themselves.

(13) "Egg" means the shell egg of avian species such as chicken, duck, goose, guinea, quail, ratites, or turkey. It does not include a balut, the egg of reptile species such as alligator; or an egg product.

Last updated July 11, 2024 at 8:22 AM

History

Effective: July 11, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-6-02 Food.

(A) Food shall:

(1) Be obtained from sources that comply with law;

(2) Be labeled as specified in law and be honestly presented in a way that does not mislead or misinform the consumer;

(3) Be discarded if unsafe, adulterated, or not honestly presented. Food or color additives, colored overwraps, or lights may not be used to misrepresent the true appearance, color, or quality of a food;

(4) Be protected from contamination;

(5) Not be displayed or stored on the ground except for whole and intact raw agricultural products.

(B) Eggs shall be clean, sound and maintained in an ambient air temperature of forty-five degrees Fahrenheit or less.

(D) Poultry and nonamenable meats shall be maintained frozen or at an internal temperature of forty-one degrees Fahrenheit or less.

(E) Cider and other juices manufactured on site of a farm market shall be processed in accordance with the good manufacturing practices established in Chapter 901:3-17 of the Administrative Code.

Last updated July 11, 2024 at 8:22 AM

History

Effective: July 11, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-6-06

(A) Except as provided in paragraph (B) of this rule, water provided for hand washing and cleaning pursuant to this chapter shall be from a municipal water supply.

(B) Water from a non-municipal supply, provided for hand washing and cleaning, may be used in this chapter however it shall be tested annually to determine that the water is negative for total coliform.

Last updated May 6, 2024 at 9:40 AM

History

Effective: March 20, 2017
Promulgated Under: 119.03

Ohio Adm.Code 901:3-6-03 Equipment and facilities.

(A) Except as specified in paragraphs (A)(1), (A)(2), and (A)(3) of this rule, foods requiring refrigeration or freezing shall be held in mechanical refrigeration or freezer units at temperatures specified in rule 901:3-6-02 of the Administrative Code.

(1) At a farm product auction fresh dressed poultry may be held for auction by submersion in crushed ice.

(2) At a farm product auction frozen nonamenable meats may be held frozen by the use of adequate amounts of dry ice.

(3) At a farm product auction eggs may be held for auction in a cooler with adequate amounts of bagged ice or gel packs.

(B) Toilet facilities shall be readily accessible to farm market and farm product auction personnel.

Last updated July 11, 2024 at 8:22 AM

History

Effective: July 11, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-6-04 Wash, rinse, and bactericidal treatment.

(A) Each farm market or farm product auction that offers raw poultry, nonamenable meats or both for sale shall clean and sanitize utensils and food contact surfaces of equipment used in the preparation, display, and sale of the raw poultry and nonamenable meats in one of the following:

(1) A three-compartment sink;

(2) A two-compartment sink;

(3) If approved by the director, receptacles that substitute for compartments of a multi-compartment sink; or

(4) Another method approved by the director.

(B) The following procedure shall be used to manually wash, rinse, and sanitize utensils and food contact surfaces of equipment in a three-step process:

(1) In the first compartment, equipment and utensils shall be thoroughly washed in a detergent solution that is kept clean;

(2) In the second compartment, equipment and utensils shall be rinsed free of detergent and abrasives with clean water;

(3) In the third compartment, equipment and utensils shall be sanitized by either immersion for:

(a) At least one half minute in clean hot water at a temperature of at least one hundred seventy degrees Fahrenheit; or

(b) At least thirty seconds in a cleaning solution containing at least fifty parts per million of available chlorine; or

(4) Equipment too large to sanitize by immersion may be rinsed, sprayed, or swabbed with a solution of one hundred parts per million chlorine or at the approved concentration of another sanitizer approved for food contact surfaces.

(C) The following procedure shall be used to manually wash and sanitize utensils and food contact surfaces of equipment in a two step process:

(1) In the first compartment, equipment and utensils shall be immersed and thoroughly washed with an approved detergent-sanitizer solution that is kept clean;

(2) In the second compartment, equipment and utensils shall be immersed and thoroughly sanitized with an approved detergent-sanitizer solution used according to the manufacturer's label that is kept clean.

(3) The same approved detergent-sanitizer product used in paragraphs (C)(1) and (C)(2) of this rule shall be used for both the cleaning and sanitizing steps.

Last updated July 11, 2024 at 8:23 AM

History

Effective: July 11, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-6-05 Hand washing.

(A) Personnel shall wash their hands to prevent the contamination of food, food contact surfaces and food packaging material, especially after using the toilet facilities or handling raw meat or poultry.

(B) Except as permitted in paragraph (C) of this rule, handwashing facilities shall consist of water as defined in rule 901:3-6-06 of the Administrative Code, soap, and disposable towels.

(C) Based upon the types of food products being offered for sale and the amount of food handling at the facility, the director may approve an alternative method of handwashing, such as the use of a non-permanent handwashing facility.

Last updated July 11, 2024 at 8:23 AM

History

Effective: July 11, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-6-07 Right of entry.

A person or government entity operating a farm market or a farm product auction shall permit the director to inspect, for the purpose of determining compliance with this chapter or investigating a complaint. On request of the director, the operator of the farm market or farm product auction shall permit the director to examine the operator's records to obtain information about the purchase, receipt, or use of food, supplies, and equipment.

Last updated July 11, 2024 at 8:23 AM

History

Effective: July 11, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-6-08 Retail food establishment referral.

When a farm market or farm product auction is offering food products for sale that are of a type or that exceed the scope of those permitted in rule 901:3-6-01 of the Administrative Code, the director shall refer the licensing and regulation of such facility to the local board of health with jurisdiction. Such facilities will be assessed and regulated under Chapter 3717. of the Revised Code.

Last updated July 11, 2024 at 8:23 AM

History

Effective: July 11, 2024
Promulgated Under: 119.03

Chapter 901:3-7 Fish and Fishery Products

Ohio Adm.Code 901:3-7-01 Incorporated by reference- fish and fishery products.

The federal food safety regulations located at 21 C.F.R. chapter 1, subchapter b, part 123 (2015), are adopted in their entirety with the exception of those provisions amended or deleted by this chapter. A copy is available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=123.

All food processing establishments as defined in section 3715.021 of the Revised Code shall comply with the rules of this chapter to determine that food has been manufactured under such conditions that render the food safe, unadulterated, and not misbranded.

Last updated June 10, 2024 at 8:27 AM

History

Effective: June 10, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-7-02 Amended definitions.

As adopted in rule 901:3-7-01 of the Administrative Code, as used in 21 C.F.R. chapter 1, subchapter b, part 123, the following definitions are modified as follows:

(A) "Corrective action plan" means a plan that describes the steps to be taken and assigns responsibility for those steps as they pertain to a particular deviation from the hazard analysis and critical control plan (HACCP).

(B) Processing

(1) "Processing" means, with respect to fish or fishery products: handling, storing, preparing, heading, eviscerating, shucking, freezing, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading, or holding.

(2) The regulations in this part do not apply to:

(a) Harvesting or transporting fish or fishery products, without otherwise engaging in processing.

(b) Practices such as heading, eviscerating, or freezing intended solely to prepare a fish for holding on board a harvest vessel.

(d) A non-profit organization exempt from federal income taxation pursuant to section 501 (c)(3) of the Internal Revenue Code, 26 U.S.C.A. (2017), or senior centers created under section 173.11 of the Revised Code, that do both of the following:

(i) Moves fish or fishery products from a food processing establishment to another location under their control; and

(ii) Serves the food to the end consumer, without charge.

Last updated June 10, 2024 at 8:27 AM

History

Effective: June 10, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-7-03 Deleted regulations.

Pursuant to rule 901:3-07-01 of the Administrative Code, the following sections of 21 C.F.R. 123 are deleted in their entirety and shall not become rules of the Ohio department of agriculture:

(A) 21 C.F.R. 123.9(d); and

(B) 21 C.F.R. 123.12.

Last updated June 10, 2024 at 8:28 AM

History

Effective: June 10, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-7-04 Modifications.

Pursuant to rule 901:3-7-01 of the Administrative Code, the following section of the 21 C.F.R. 123 is modified to read as follows:

"Section 21 C.F.R. 123.6(g)" shall read as "Legal basis. Failure of a processor to have and implement a hazard analysis and critical control plan (HACCP) that complies with this section whenever a HACCP plan is necessary, otherwise operate in accordance with the requirements of this part, shall render the fish or fishery products of that processor adulterated under section 3715.59 of the Revised Code. Whether a processor's actions are consistent with ensuring the safety of food will be determined through an evaluation of the processors overall implementation of its HACCP plan, if one is required."

Last updated June 10, 2024 at 8:28 AM

History

Effective: June 10, 2024
Promulgated Under: 119.03

Chapter 901:3-8 Shellfish Processing

Ohio Adm.Code 901:3-8-01 Incorporation by reference - shellfish processing.

The federal food safety standards contained in the "National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish" (2019 revision) published by the United States food and drug administration is adopted in its entirety. A copy is available at https://www.fda.gov/food/federalstate-food-programs/national-shellfish-sanitation-program-nssp.

All food processing establishments as defined in section 3715.021 of the Revised Code shall comply with this rule and Chapter 901:3-17 of the Administrative Code to determine that food has been manufactured under such conditions that render the food safe, unadulterated, and not misbranded.

Last updated July 29, 2026 at 10:46 AM

History

Effective: September 28, 2023
Promulgated Under: 119.03

Chapter 901:3-12 Produce Safety

Ohio Adm.Code 901:3-12-01 Produce safety.

The standards for growing, harvesting, packing and holding of produce for human consumption which are housed in Title 21 of the Code of Federal Regulations part 112 (April, 2023) are adopted in their entirety with the exception of those provisions amended or deleted by this chapter.

Last updated August 15, 2024 at 9:26 AM

History

Effective: August 15, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-12-02 Amended definitions.

As adopted in rule 901:3-12-01 of the Administrative Code, where ever used in 21 C.F.R. part 112, the following definitions are modified as follows:

(A) "Food" means:

(1) Articles used for food or drink for humans or animals;

(2) Chewing gum; or

(3) Articles used for components of any such articles.

(B) "FDA" shall be read as "Ohio department of agriculture."

(D) "Section 403(w) of the Federal Food, Drug, and Cosmetic Act" shall be read as "section 3715.60 of the Revised Code."

Last updated August 15, 2024 at 9:26 AM

History

Effective: August 15, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-12-03 Deleted regulations.

Pursuant to rule 901:3-12-01 of the Administrative Code, following sections of the 21 C.F.R. 112 are deleted in their entirety and shall not become rules of the Ohio department of agriculture:

(A) 21 C.F.R. 112.171

(B) 21 C.F.R. 112.172

(D) 21 C.F.R. 112.174

(E) 21 C.F.R. 112.175

(F) 21 C.F.R. 112.176

(G) 21 C.F.R. 112.177

(H) 21 C.F.R. 112.178

(I) 21 C.F.R. 112.179

(J) 21 C.F.R. 112.180

(K) 21 C.F.R. 112.181

(L) 21 C.F.R. 112.182

(M) 21 C.F.R. 112.193

(N) 21 C.F.R. 112.201

(O) 21 C.F.R. 112.202

(P) 21 C.F.R. 112.203

(Q) 21 C.F.R. 112.204

(R) 21 C.F.R. 112.205

(S) 21 C.F.R. 112.206

(T) 21 C.F.R. 112.207

(U) 21 C.F.R. 112.208

(V) 21 C.F.R. 112.209

(W) 21 C.F.R. 112.210

(X) 21 C.F.R. 112.211

(Y) 21 C.F.R. 112.213

Last updated August 20, 2024 at 8:19 AM

History

Effective: August 15, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-12-04 Modifications.

Pursuant to rule 901:3-12-01 of the Administrative Code, the following sections of the 21 C.F.R. 112 are amended to read as follows:

(A) 21 C.F.R. 112.166(a) delete existing language and insert:

"You must have all records required under this part readily available and accessible during the retention period for inspection and copying by the Ohio department of agriculture upon oral or written request, except that you have 24 hours to obtain records you keep offsite and make them available and accessible to the Ohio department of agriculture for inspection and copying."

(B) 21 C.F.R. 112.167 delete existing language and insert:

"Records obtained by the Ohio department of agriculture in accordance with this part are subject to the disclosure requirements under Chapter 149. of the Revised Code."

"The failure to comply with the requirements of this part will result in the determination that the food produced is adulterated pursuant to section 3715.59 of the Revised Code."

(D) 21 C.F.R. 112.201 delete existing language and insert:

"The process and procedure for the withdrawal of a qualified exemption will be handled and administered by the Food and Drug Administration."

Last updated August 20, 2024 at 8:19 AM

History

Effective: August 15, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-12-06 Voluntary registration.

(A) Farms that are exempt from the rules of this chapter may request to be voluntarily regulated by the Ohio department of agriculture.

(1) Farms who request to be voluntarily regulated shall annually register with the Ohio department of agriculture.

(2) The annual registration is from the first day of March to the last day of February annually.

(3) All interested farms must renew annually in order to be voluntarily regulated.

(4) Once registered farms may not withdraw their voluntary registration unless specifically permitted by the Ohio department of agriculture.

(B) Pursuant to rule 901:3-12-01 of the Administrative Code all voluntary registered farms shall be subject to the laws and rules applicable to very small businesses as defined in 21 C.F.R. 112.3.

Last updated August 20, 2024 at 8:19 AM

History

Effective: August 15, 2024
Promulgated Under: 119.03

Chapter 901:3-17 Federal Food Safety Regulations

Ohio Adm.Code 901:3-17-01 Incorporation by reference.

The federal food safety regulations housed in Title 21 of the Code of Federal Regulations part 117 (2022) are adopted in their entirety with the exception of those provisions amended or deleted by this chapter.

All food processing establishments as defined in section 3715.021 of the Revised Code, including processors of intoxicating beverages, shall comply with the rules of this chapter to determine that food has been manufactured under such conditions that render the food safe, unadulterated, and not misbranded.

Last updated April 19, 2024 at 7:40 AM

History

Effective: April 19, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-17-02 Amended definitions.

As adopted in rule 901:3-17-01 of the Administrative Code, where ever used in 21 C.F.R. part 117, the following definitions are modified as follows:

(A) The definitions found in 21 C.F.R. 117.3 are amended as follows:

(1) "Audit" means "the systematic, independent, and documented examination (through observation, investigation, records review, discussions with employees of the audited entity, and, as appropriate, sampling and laboratory analysis) to assess a food suppliers' food safety processes and procedures.

(2) "Facility" means a food processing establishment as defined in section 3715.021 of the Revised Code.

(3) "Food" means:

(a) Articles used for food or drink for humans or animals;

(b) Chewing gum; or

(4) "Lot' means

(B) The following terms found in 21 C.F.R. 117 are hereby replaced as indicated:

(1) "Establishment", with the exception of the term "retail food establishment," shall be read as "facility."

(2) "FDA" shall be read as "Ohio department of agriculture."

(3) "Section 402 of the Federal Food, Drug, and Cosmetic Act" shall be read as "section 3715.59 of the Revised Code."

(4) "Section 403(w) of the Federal Food, Drug, and Cosmetic Act" shall be read as "section 3715.60 of the Revised Code."

Last updated February 6, 2024 at 9:35 AM

History

Effective: October 29, 2017
Promulgated Under: 119.03

Ohio Adm.Code 901:3-17-03 Deleted regulations.

Pursuant to rule 901:3-17-01 of the Administrative Code, following sections of the 21 C.F.R. 117 are deleted in their entirety and shall not become rules of the Ohio department of agriculture:

(A) 21 C.F.R. 117.1

(B) 21 C.F.R. 117.254

(D) 21 C.F.R. 117.260

(E) 21 C.F.R. 117.264

(F) 21 C.F.R. 117.267

(G) 21 C.F.R. 117.270

(H) 21 C.F.R. 117.274

(I) 21 C.F.R. 117.277

(J) 21 C.F.R. 117.280

(K) 21 C.F.R. 117.284

(L) 21 C.F.R. 117.287

Last updated February 6, 2024 at 9:36 AM

History

Effective: October 29, 2017
Promulgated Under: 119.03

Ohio Adm.Code 901:3-17-04 Modifications.

Pursuant to rule 901:3-17-01 of the Administrative Code, the following sections of the 21 C.F.R. 117 are amended to read as follows:

(A) 21 C.F.R. 117.5(a) delete existing language and insert:

"Subparts C and G of this part do not apply to a qualified facility unless the FDA has withdrawn the qualified facility exemption. Qualified facilities are subject to the modified requirements in 21 C.F.R. part 117.201."

(B) 21 C.F.R. 117.201 is amended to add the following language:

"(g) Ohio department of agriculture. All records required by this part must be made promptly available to a duly authorized representative of the director of the Ohio department of agriculture for official review and copying upon oral or written request."

"The process and procedure for the withdrawl of a qualified exemption will be handled and administered by the Food and Drug Administration."

(D) 21 C.F.R. 117.320 delete existing language and insert:

"All records required by this part must be made promptly available to a duly authorized representative of the director of the Ohio department of agriculture for official review and copying upon oral or written request."

(E) 21 C.F.R. 117.325 delete existing language and insert:

"Records obtained by the Ohio department of agriculture in accordance with this part are subject to disclosure pursuant to Chapter 149. of the Revised Code.

Last updated February 6, 2024 at 9:36 AM

History

Effective: October 29, 2017
Promulgated Under: 119.03

Chapter 901:3-18 Intentional Adulteration

Ohio Adm.Code 901:3-18-01 Incorporation by reference.

The federal food safety regulations located at 21 C.F.R. Part 121 (2023) are adopted in their entirety with the exception of those provisions amended or deleted by this chapter.

Last updated February 12, 2024 at 8:41 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-18-02 Amended definitions.

As adopted in rule 901:3-18-01 of the Administrative Code, as used in 21 C.F.R. Part 121, the following definitions are modified as follows:

(A) The definitions found in 21 C.F.R. 121.3 are amended as follows:

(1) "Facility" means a food processing establishment as defined in section 3715.021 of the Revised Code.

(2) "Food" means:

(a) Articles used for food or drink for humans or animals;

(b) Chewing gum; or

(B) The following terms found in 21 C.F.R. Part 121 shall be replaced as indicated:

(1) "FDA" replace with "Ohio department of agriculture";

(2) "Secretary of health and human services" replace with "the director of the Ohio department of agriculture."

Last updated February 12, 2024 at 8:42 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-18-03 Deleted regulations.

Pursuant to rule 901:3-18-01 of the Administrative Code, 21 C.F.R. 121.325 and 21 C.F.R 121.401 are deleted in their entirety and shall not become rules of the Ohio department of agriculture.

Last updated February 12, 2024 at 8:42 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-18-04 Modifications.

Pursuant to rule 901:3-18-01 of the Administrative Code, the following section of 21 C.F.R. Part 121 is amended to read as follows:

21 C.F.R. 121.1 delete existing language and insert, "This part applies to a food processing establishment as defined in section 3715.021 of the Revised Code."

Last updated February 12, 2024 at 8:42 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Chapter 901:3-20 Cottage Food Production

Ohio Adm.Code 901:3-20-01 Criteria and definitions for cottage food operations.

(A) Pursuant to division (B) of section 3715.025 of the Revised Code, cottage food production operations shall comply with the provisions of Chapter 901:3-20 of the Administrative Code.

(B) Definitions:

As used in Chapter 901:3-20 of the Administrative Code:

(1) "Adulterated" has the meaning stated in section 3715.59 of the Revised Code.

(2) "CFR" means Code of Federal Regulations.

(3) "Cottage food production operation" has the same meaning stated in section 3715.01 of the Revised Code.

(4) "Director" means the director of the Ohio department of agriculture.

(5) "Misbranded" has the meaning stated in section 3715.60 of the Revised Code.

(6) "Reduced oxygen packaging" means the reduction of the amount of oxygen in a package by removing oxygen; displacing oxygen and replacing it with another gas or combination of gases; or otherwise controlling the oxygen content to a level below that normally found in the surrounding atmosphere, which is approximately twenty-four per cent at sea level. It includes:

(a) Vacuum packaging, in which air is removed from a package of food and the package is hermetically sealed so that a vacuum remains inside the package; and

(b) Modified atmosphere packaging, in which the atmosphere of a package is modified so that its composition is different from air but the atmosphere may change over time due to the permeability of the packaging material or the respiration of the food. Modified atmosphere packaging includes: reduction in the proportion of oxygen, total replacement of oxygen, or an increase in the proportion of other gases such as carbon dioxide or nitrogen.

(7) All other technical definitions are the same as those found in section 3715.01 of the Revised Code.

Last updated December 5, 2023 at 11:30 AM

History

Effective: January 22, 2016
Promulgated Under: 119.03

Ohio Adm.Code 901:3-20-02 Labeling.

(A) A cottage food production operation shall label each food product and include on the label the information mandated by section 3715.023 of the Revised Code, in addition to the food labeling requirements of 21 CFR Part 101 (April 1, 2014).

(B) Food products identified and labeled in accordance with paragraph (A) of this rule are acceptable food products that a retail food establishment or food service operation licensed under Chapter 3717. of the Revised Code may offer for sale or use in preparing and serving food.

Last updated December 5, 2023 at 11:30 AM

History

Effective: January 22, 2016
Promulgated Under: 119.03

Ohio Adm.Code 901:3-20-03 Cottage food products sampling.

All cottage food products as outlined in rule 901:3-20-04 of the Administrative Code are subject to food sampling conducted by the director of agriculture, or representative the director authorizes, to determine if a food product is misbranded or adulterated. A component of the food sampling conducted under this section may include the performance of sample analyses in accordance with Chapter 3715. of the Revised Code.

Last updated December 5, 2023 at 11:30 AM

History

Effective: January 22, 2016
Promulgated Under: 119.03

Ohio Adm.Code 901:3-20-04

(A) The food items listed below are approved as cottage food products:

(1) Non-potentially hazardous bakery products;

(2) Jams;

(3) Jellies;

(4) Candy, not including fresh fruit dipped, covered, or otherwise incorporated with candy;

(5) Flavored honey which has been produced by a beekeeper exempt under division (A) of section 3715.021 of the Revised Code;

(6) Fruit chutneys;

(7) Fruit butters;

(8) Granola, granola bars, granola bars dipped in candy, if fruit is used in any of these products it must be commercially dried;

(9) Maple sugar produced by a maple syrup producer exempt under division (A) of section 3715.021 of the Revised Code;

(10) Popcorn, flavored popcorn, kettle corn, popcorn balls, caramel corn, not including popping corn;

(11) Unfilled baked donuts;

(12) Waffle cones and waffle cones dipped in candy;

(13) Pizzelles;

(14) Dry cereal and nut snack mixes with seasonings;

(15) Roasted coffee, whole beans or ground;

(16) Dry baking mixes in a jar, including cookie mix in a jar;

(17) Dry herbs and herb blends;

(18) Dry soup mixes containing commercially dried vegetables, beans, grains, and seasonings;

(19) Dry seasoning blends; and

(20) Dry tea blends.

(B) Cottage food products may not be packed using reduced oxygen packaging.

Last updated December 5, 2023 at 11:30 AM

History

Effective: January 22, 2016
Promulgated Under: 119.03

Ohio Adm.Code 901:3-20-05 Prohibitions.

A cottage food operation may not do any of the following:

(A) Process potentially hazardous foods;

(B) Process acidified and low acid canned food;

(D) Refuse the taking of samples as authorized by rule 901:3-20-03 of the Administrative Code;

(E) Produce food items not expressly listed in paragraph (A) of rule 901:3-20-04 of the Administrative Code; or

(F) Sell cottage food products outside the state of Ohio.

Last updated December 5, 2023 at 11:30 AM

History

Effective: January 22, 2016
Promulgated Under: 119.03

Chapter 901:3-21 Food Processing Establishments

Ohio Adm.Code 901:3-21-01 Registration and fees.

(A) Pursuant to section 3715.041 of the Revised Code, the director shall administer the applicable provisions of Chapter 901:3-21 of the Administrative Code to food processing establishments as defined in section 3715.021 of the Revised Code.

(B) Registration:

(1) A food processing establishment that is currently inspected by the Ohio department of agriculture and has not been put on notice pursuant to section 913.41 of the Revised Code will receive the application of registration automatically from the Ohio department of agriculture. The application must be returned to the Ohio department of agriculture and postmarked on or before the thirty-first of January in order to be considered timely.

(2) A new food processing establishment (a firm not actively inspected by the division of food safety) shall be inspected to determine if the firm is in compliance with this chapter and Chapter 925. of the Revised Code and all applicable rules adopted under those chapters. Upon inspection the firm will be given an application of registration if the firm is determined to be in compliance with applicable statutes and rules.

(3) A food processing establishment currently inspected by the Ohio department of agriculture and on notice pursuant to section 913.41 of the Revised Code must come into compliance before an application for registration is provided.

Fees

Size in square feet	Annual fee
0- 4,999	$50
5,000- 9,999	$75
10,000- 49,999	$125
50,000- 99,999	$175
100,000 and up	$300

(D) The late fee as provided in division (C)(2) of section 3715.041 of the Revised Code shall be up to fifty dollars for registrations not postmarked on or prior to the thirty-first of January. The director shall not renew the registration until the applicant pays the registration and late fee. The late fees are as follows:

Late Fees

Size in square feet	Late fee
0- 4,999	$25.00
5,000- 9,999	$30.00
10,000- 49,999	$35.00
50,000- 99,999	$40.00
100,000 and up	$50.00

Last updated December 5, 2023 at 11:31 AM

History

Effective: June 3, 2016
Promulgated Under: 119.03

Chapter 901:3-23 Juice Product Processors

Ohio Adm.Code 901:3-23-01 Criteria and definitions for juice products.

(A) Except for as specified in paragraph (B) of this rule, all food processing establishments processing juice, including juice products to be used as an ingredient, shall comply with Chapter 901:3-23 and the applicable provisions found in Chapter 901:3-17 of the Administrative Code.

(B) Entities which produce juice that has not undergone a five-log reduction are exempt from the rules of this chapter provided that they are either:

(1) A food processing establishment that is also a licensed food service operation or retail food establishment who moves juice, including juice products, to a separate food service operation or retail food establishment which is licensed under the same name; or

(2) A food processing establishment who moves juice, including juice products, to a farmers market stand operated by them where only non-TCS (temperature control for safety) juices are sold; or

(3) A farm market that moves their product to a separate farm market provided both are registered under the same name or to a farmers market stand operated by the registered farm market.

As used in Chapter 901:3-23 of the Administrative Code:

(1) "Cleaned" means washed with water of adequate sanitary quality.

(2) "Control" means to prevent, eliminate, or reduce.

(3) "Control measure" means any action or activity to prevent, reduce to acceptable levels, or eliminate a hazard.

(4) "Corrective action plan" means a plan that describes the steps to be taken and assigns responsibility for those steps as they pertain to a particular deviation from the HACCP plan.

(5) "Critical control point" means a point, step, or procedure in a food process at which a control measure can be applied and at which control is essential to reduce an identified food hazard to an acceptable level.

(6) "Critical limit" means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food hazard.

(7) "Culled" means the separation of damaged fruit from undamaged fruit. For processors of citrus juices using treatments to fruit surfaces to comply with rule 901:3-23-09 of the Administrative Code, culled means undamaged, tree-picked fruit that is U.S. department of agriculture choice or higher quality.

(8) "Food hazard" means any biological, chemical, or physical property that is reasonably likely to cause illness or injury in the absence of its control.

(9) "HACCP" means hazard analysis and critical control point.

(10) "Juice" means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.

(11) "mL" means milliliter.

(12) "Monitor" means to conduct a planned sequence of observations or measurements to assess whether a process, point, or procedure is under control and to produce an accurate record for use in verification.

(13) "Processing" means activities that are directly related to the production of juice products. Processing does not include harvesting, picking, or transporting raw agricultural ingredients of juice products without otherwise engaging in processing.

(14) "Processor" means any person engaged in commercial, custom, or institutional processing of juice products. A processor includes any person engaged in the processing of juice products that are to be used in market or consumer tests.

(15) "Shelf-stable product" means a product that is hermetically sealed in accordance with 21 C.F.R. 113 and when stored at room temperature should not demonstrate any microbial growth.

(16) "Validation" means that element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP plan, when properly implemented, will effectively control the identified food hazards.

(17) "Verification" means those activities, other than monitoring, that establish the validity of the HACCP plan and that the system is operating according to the plan.

(18) "21 C.F.R. 113" means title 21 of the Code of Federal Regulations part 113 (edition April 2024).

Last updated April 1, 2025 at 7:49 AM

History

Effective: April 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 901:3-23-09

(A) In order to meet the requirements of rules 901:3-23-01 to 901:3-23-09 of the Administrative Code, processors of juice products shall include in their hazard analysis and critical control point plans control measures that will consistently produce, at a minimum, a five-log reduction of the pertinent microorganism, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions. For the purposes of this rule, the "pertinent microorganism'' is the most resistant microorganism of public health significance that is likely to occur in the juice. The following juice processors are exempt from this paragraph:

(1) A juice processor that is subject to the requirements of Chapter 901:3-5 of the Administrative Code or 21 C.F.R. 113; and

(2) A juice processor using a single thermal processing step sufficient to achieve shelf-stability of the juice or a thermal concentration process that includes thermal treatment of all ingredients, provided that the processor includes a copy of the thermal process used to achieve shelf-stability or concentration in its written hazard analysis required by rule 901:3-23-03 of the Administrative Code.

(B) All juice processors shall meet the requirements of paragraph (A) of this rule through treatments that are applied directly to the juice, except that citrus juice processors may use treatments to fruit surfaces, provided that the 5-log reduction process begins after culling and cleaning as defined in paragraphs (C)(1) and (C)(7) of rule 901:3-23-01 of the Administrative Code and the reduction is accomplished within a single production facility.

(C) All juice processors shall meet the requirements of paragraphs (A) and (B) of this rule and perform final product packaging within a single production facility operating under the applicable provisions found in Chapter 901:3-17 of the Administrative Code. Processors claiming an exemption under paragraph (A)(1) or (A)(2) of this rule shall also process and perform final product packaging of all juice subject to the claimed exemption within a single production facility operating under the applicable provisions found in Chapter 901:3-17 of the Administrative Code.

(D) Each juice processor that relies on treatments that do not come into direct contact with all parts of the juice to achieve the requirements of this rule shall analyze the finished product for biotype I Escherichia coli at an accredited laboratory at the following frequency and sample sizes:

(1) One twenty mL sample (consisting of two ten mL subsamples) for each one-thousand gallons of juice produced shall be sampled each production day. If less than one thousand gallons of juice is produced per day, the sample must be taken for each one-thousand gallons produced but not less than once every five working days that the facility is producing that juice. Each subsample shall be taken by randomly selecting a package of juice ready for distribution to consumers.

(2) If the facility is producing more than one type of juice covered by this rule, processors shall take subsamples according to paragraph (D)(1) of this rule for each of the covered juice products produced.

(3) Processors shall analyze each subsample for the presence of E. coli by a method designed to detect the presence or absence of E. coli in a twenty mL sample of juice (consisting of two ten mL subsamples).

(4) If either ten mL subsample is positive for E. coli, the twenty mL sample is recorded as positive and the processor shall:

(a) Review monitoring records for the control measures to attain the five-log reduction standard and correct those conditions and practices that are not met.

(b) If the review of monitoring records or the additional testing indicates that the five-log reduction standard was not achieved, the processor shall take corrective action as set forth in rule 901:3-23-05 of the Administrative Code.

(5) If two samples in a series of seven tests are positive for E. coli, the control measures to attain the five-log reduction standard shall be deemed to be inadequate and the processor shall immediately:

(a) Use an alternative process or processes that achieve the five-log reduction after the juice has been expressed until corrective actions are completed;

(b) Perform a review of the monitoring records for control measures to attain the five-log reduction standard. The review shall be sufficiently extensive to determine if there are trends towards loss of control:

(i) If the conditions and practices are not being met, correct those that do not conform to the HACCP plan; or

(ii) If the conditions and practices are being met, the processor shall validate the HACCP plan in relation to the five-log reduction standard.

Last updated April 1, 2025 at 7:51 AM

History

Effective: April 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 901:3-23-02 Sanitation standard operating procedures.

(A) Sanitation controls.

Each processor shall have and implement a sanitation standard operating procedure that addresses sanitation conditions and practices before, during, and after processing. The sanitation standard operating procedure shall address:

(1) Safety of the water that comes into contact with food or food contact surfaces or that is used in the manufacture of ice;

(2) Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;

(3) Prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to processed product;

(4) Maintenance of hand washing, hand sanitizing, and toilet facilities;

(5) Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants;

(6) Proper labeling, storage, and use of toxic compounds;

(7) Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and

(8) Exclusion of pests from the food plant.

(B) Monitoring.

The processor shall monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with those conditions and practices specified Chapter 901:3-17 of the Administrative Code that are appropriate both to the plant and to the food being processed. Each processor shall correct, in a timely manner, those conditions and practices that are not met.

Each processor shall maintain sanitation standard operating procedure records that, at a minimum, document the monitoring and corrections prescribed by paragraph (B) of this rule. These records are subject to the record keeping requirements of rule 901:3-23-07 of the Administrative Code.

Last updated April 1, 2025 at 7:49 AM

History

Effective: April 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 901:3-23-07

(A) Required records.

Each processor shall maintain the following records documenting the processor's hazard analysis and critical control point plan:

(1) Records documenting the implementation of the sanitation standard operating procedures;

(2) The hazard analysis required by rule 901:3-23-03 of the Administrative Code;

(3) The HACCP plan required by rule 901:3-23-04 of the Administrative Code;

(4) Records documenting the ongoing application of the HACCP plan that include:

(a) Monitoring of critical control points and their critical limits, including the recording of actual times, temperatures, or other measurements, as prescribed in the HACCP plan; and

(b) Corrective actions, including all actions taken in response to a deviation.

(5) Records documenting verification and validation of the HACCP plan or hazard analysis, as appropriate.

(B) General requirements.

All records required by this chapter shall include:

(1) The name of the processor and the location of the processor, if the processor has more than one location;

(2) The date and time of the activity that the record reflects, except that records required by paragraphs (A)(2), (A)(3), and (A)(5) of this rule need not include the time;

(3) The signature or initials of the person performing the operation or creating the record; and

(4) The identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed. The records shall contain the actual values and observations obtained during monitoring.

(1) The records in paragraphs (A)(2) and (A)(3) of this rule shall be signed and dated by the most responsible individual onsite at the processing facility or by a higher level official of the processor. These signatures shall signify that these records have been accepted by the firm.

(2) The records in paragraphs (A)(2) and (A)(3) of this rule shall be signed and dated:

(a) Upon initial acceptance;

(b) Upon any modification; and

(D) Record retention

(1) All records required by this chapter shall be retained at the processing facility as follows:

(a) Perishable or refrigerated juices, at least one year after the date that such products were prepared,

(b) Frozen, preserved, or shelf stable juice products, two years or the shelf life of the product, whichever is greater, after the date that the products were prepared.

(2) Offsite storage of processing records required by paragraphs (A)(1) and (A)(4) of this rule is permitted after six months following the date that the monitoring occurred, if such records can be retrieved and provided onsite within twenty-four hours of request for official review. Electronic records are considered to be onsite if they are accessible from an onsite location and comply with this rule.

(3) If the processing facility is closed for a prolonged period between seasonal packs, the records may be transferred to some other reasonably accessible location at the end of the seasonal pack but shall be immediately returned to the processing facility for official review upon request.

(E) Official review.

All records required by this chapter shall be available for review and copying at reasonable times.

(F) Records maintained on computers.

The maintenance of computerized records is acceptable.

Last updated April 1, 2025 at 7:50 AM

History

Effective: April 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 901:3-23-03 Hazard analysis.

(A) Each processor shall develop, or have developed for it, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for each type of juice processed by that processor and to identify control measures that the processor can apply to control those hazards. The written hazard analysis shall consist of at least the following:

(1) Identification of food hazards;

(2) An evaluation of each food hazard identified to determine if the hazard is reasonably likely to occur and thus, constitutes a food hazard that must be addressed in the HACCP plan. A food hazard that is reasonably likely to occur is one for which a processor would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that, in the absence of those controls, the food hazard will occur in the particular type of product being processed. This evaluation shall include an assessment of the severity of the illness or injury if the food hazard occurs;

(3) Identification of the control measures that the processor can apply to control the food hazards identified as reasonably likely to occur in paragraph (A)(2) of this rule;

(4) Review of the current process to determine whether modifications are necessary; and

(5) Identification of critical control points.

(B) The hazard analysis shall include food hazards that can be introduced both within and outside the processing plant environment, including food safety hazards that can occur before, during, and after harvest. The hazard analysis shall be conducted by an individual or individuals who have been trained in accordance with rule 901:3-23-08 of the Administrative Code and shall be subject to the record keeping requirements of rule 901:3-23-07 of the Administrative Code.

(C) HACCP plans for juice need not address the food hazards associated with microorganisms and microbial toxins that are controlled by the requirements of Chapter 901:3-5 of the Administrative Code and 21 C.F.R. 113. A HACCP plan for such juice shall address any other food hazards that are reasonably likely to occur.

Last updated April 1, 2025 at 7:49 AM

History

Effective: April 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 901:3-23-08

(A) At a minimum, the following functions shall be performed by an individual who has successfully completed training in the application of HACCP principles to juice processing:

(1) Conducting the hazard analysis, including delineating control measures, as required by rule 901:3-23-03 of the Administrative Code;

(2) Developing a hazard analysis and critical control point plan that is appropriate for a specific processor, in order to meet the requirements of rule 901:3-23-04 of the Administrative Code;

(3) Verifying and modifying the HACCP plan in accordance with the corrective action procedures specified in paragraph (C)(5) of rule 901:3-23-05 of the Administrative Code and the validation activities specified in paragraphs (B) and (C) of rule 901:3-23-06 of the Administrative Code; and rule 901:3-23-03 of the Administrative Code;

(4) Performing the record review required in paragraph (A)(1)(d) of rule 901:3-23-06 of the Administrative Code.

(B) An individual described in paragraph (A) of this rule shall provide the director, upon request, a copy of their certificate of completion for the application of HACCP principles to juice processing.

(C) Job experience may qualify an individual to perform the functions specified in paragraph (A) of this rule. The trained individual need not be an employee of the processor.

Last updated April 1, 2025 at 7:51 AM

History

Effective: April 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 901:3-23-04 Hazard analysis and critical control point (HACCP) plan.

(A) HACCP plan.

Each processor shall have and implement a written HACCP plan whenever a hazard analysis reveals one or more food hazards that are reasonably likely to occur during processing, as described in rule 901:3-23-03 of the Administrative Code. The HACCP plan shall be developed by an individual or individuals who have been trained in accordance with rule 901:3-23-08 of the Administrative Code and shall be subject to the record keeping requirements of rule 901:3-23-07 of the Administrative Code. A HACCP plan shall be specific to:

(1) Each location where juice is processed by that processor; and

(2) Each type of juice processed by the processor. The plan may group types of juice products together, or group types of production methods together, if the food hazards, critical control points, critical limits, and procedures required to be identified and performed by paragraph (B) of this rule are essentially identical, provided that any required features of the plan that are unique to a specific product or method are clearly delineated in the plan and are observed in practice.

(B) The contents of the HACCP plan. The HACCP plan shall, at a minimum:

(1) List all food hazards that are reasonably likely to occur as identified in accordance with rule 901:3-23-03 of the Administrative Code;

(2) List the critical control points for each of the identified food hazards that is reasonably likely to occur, including as appropriate:

(a) Critical control points designed to control food hazards that are reasonably likely to occur and could be introduced inside the processing plant environment; and

(b) Critical control points designed to control food hazards introduced outside the processing plant environment, including food hazards that occur before, during, and after harvest;

(3) List the critical limits that shall be met at each of the critical control points;

(4) List the procedures, and the frequency with which they are to be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;

(5) Include any corrective action plans that have been developed in accordance with paragraph (A) of rule 901:3-23-05 of the Administrative Code, and that are to be followed in response to deviations from critical limits at critical control points;

(6) List the validation and verification procedures, and the frequency with which they are to be performed by the processor in accordance with rule 901:3-23-06 of the Administrative Code; and

(7) Provide for a record keeping system that documents the monitoring of the critical control points in accordance with rule 901:3-23-07 of the Administrative Code. The records shall contain the actual values and observations obtained during monitoring.

Sanitation controls that are monitored in accordance with paragraph (B) of rule 901:3-23-02 of the Administrative Code need not be included in the HACCP plan.

Last updated April 1, 2025 at 7:50 AM

History

Effective: April 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 901:3-23-05

(A) Whenever a deviation from a critical limit occurs, a processor shall take corrective action either by:

(1) Following a corrective action plan that is appropriate for the particular deviation, or

(2) Following the procedures in paragraph (C) of this rule.

(B) If a written corrective action plan is developed, it shall become part of the HACCP plans in accordance with paragraph (B)(5) of rule 901:3-23-04 of the Administrative Code, by which they predetermine the corrective actions that they will take whenever there is a deviation form a critical limit. A corrective action plan shall ensure that:

(1) No product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and

(2) The cause of the deviation is corrected.

(C) When a deviation from a critical limit occurs and the processor does not have a corrective action plan that is appropriate for that deviation, the processor shall:

(1) Segregate and hold the affected product, at least until the requirements of paragraphs (C)(2) and (C)(3) of this rule are met;

(2) Perform or obtain a review to determine the acceptability of the affected product for distribution;

(3) Take corrective action, when necessary, with respect to the affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation;

(4) Take corrective action, when necessary, to correct the cause of the deviation;

(5) Perform or obtain timely reassessment by an individual or individuals who have been trained in accordance with rule 901:3-23-08 of the Administrative Code, to determine whether the HACCP plan needs to be modified to reduce the risk of recurrence of the deviation, and modify the HACCP plan as necessary.

(D) All corrective actions taken in accordance with this rule shall be fully documented in records that are subject to verification in accordance with rule 901:3-23-06 of the Administrative Code and the record keeping requirements of rule 901:3-23-07 of the Administrative Code.

Last updated April 1, 2025 at 7:50 AM

History

Effective: April 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 901:3-23-06

(A) Verification.

Each processor shall verify that the hazard analysis and critical control point plan is being implemented according to design.

(1) Verification activities shall include:

(a) A review of any consumer complaints that have been received by the processor to determine whether such complaints relate to the performance of the HACCP plan or reveal previously unidentified critical control points;

(b) The calibration of process monitoring instruments;

(c) At the option of the processor, the performance of periodic end-product or in-process testing; except that processors of citrus juice that rely in whole or in part on surface treatment of fruit shall perform end-product testing in accordance with rule 901:3-23-09 of the Administrative Code.

(d) A review, including signing and dating, by an individual who has been trained in accordance with rule 901:3-23-08 of the Administrative Code, of the records that document:

(i) The monitoring of critical control points to ensure that the records are complete and to verify that the records document values that are within the critical limits. This review shall occur within seven days of the day that the records are made;

(ii) The taking of corrective actions to ensure that the records are complete and to verify that appropriate corrective actions were taken in accordance with rule 901:3-23-05 of the Administrative Code. This review shall occur within seven days of the day that the records are made; and

(iii) The calibrating of any process monitoring instruments used at critical control points and the performance of any periodic end-product or in-process testing that is part of the processor's verification activities. The purpose of these reviews shall be to ensure that the records are complete and that these activities occurred in accordance with the processor's written procedures. These reviews shall occur within a reasonable time after the records are made.

(e) Following procedures in rule 901:3-23-05 of the Administrative Code whenever any verification procedure, including the review of consumer complaints, establishes the need to take a corrective action; and

(f) Additional process verification if required by rule 901:3-23-09 of the Administrative Code.

(2) Records that document the calibration of process monitoring instruments, and the performance of any periodic end-product and in-process testing, in accordance with this rule, are subject to the record keeping requirements of rule 901:3-23-07 of the Administrative Code.

(B) Validation of the HACCP plan.

Each processor shall validate that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur; this validation shall occur at least once within twelve months after implementation and at least annually thereafter or whenever any changes in the process occur that could affect the hazard analysis or alter the HACCP plan in any way. The validation shall be performed by an individual or individuals who have been trained in accordance with rule 901:3-23-08 of the Administrative Code and, shall be subject to record keeping requirements of rule 901:3-23-07 of the Administrative Code. The HACCP plan shall be modified immediately whenever a validation reveals that the plan is no longer adequate to fully meet the requirements of this chapter.

Whenever a juice processor has no HACCP plan because a hazard analysis has revealed no food hazards that are reasonably likely to occur, the processor shall reassess the adequacy of that hazard analysis whenever there are any changes in the process that could reasonably affect whether a food hazard exists. The validation of the hazard analysis shall be performed by an individual or individuals who have been trained in accordance with rule 901:3-23-08 of the Administrative Code and records documenting the validation shall be subject to the record keeping requirements of rule 901:3-23-07 of the Administrative Code.

Last updated April 1, 2025 at 7:50 AM

History

Effective: April 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 901:3-23-10 Adulteration.

Failure of a processor to have and to implement a hazard analysis and critical control point plan that complies with rules 901:3-23-02, 901:3-23-03 and 901:3-23-04 of the Administrative Code, or otherwise to operate in accordance with the requirements of this chapter, shall render the juice products of that processor adulterated under section 3715.59 of the Revised Code. Whether a processor's actions are consistent with ensuring the safety of juice will be determined through an evaluation of the processor's overall implementation of its HACCP plan.

Last updated February 10, 2025 at 12:58 PM

History

Effective: April 28, 2003
Promulgated Under: 119.03

Chapter 901:3-24 Sanitary Transportation of Human and Animal Food

Ohio Adm.Code 901:3-24-01 Incorporation by reference.

The federal food safety regulations located at 21 C.F.R. Chapter 1, Subchapter A, Part 1, Subpart O (2023) are adopted in their entirety with the exception of those provisions amended or deleted by this chapter.

Last updated February 12, 2024 at 10:30 PM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-24-02 Amended Definitions.

As adopted in rule 901:3-24-01 of the Administrative Code, as used in 21 C.F.R. Chapter 1, Subchapter A, Part 1, Subpart O, the following definition is modified as follows:

"Food" means:

(A) Articles used for food or drink for humans or animals;

(B) Chewing gum; or

Last updated February 12, 2024 at 10:30 PM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-24-03 Deleted regulations.

Pursuant to rule 901:3-24-01 of the Administrative Code, 21 C.F.R. 1.914 to 21 C.F.R. 1.934 are deleted in their entirety and shall not become rules of the Ohio department of agriculture.

Last updated February 12, 2024 at 10:30 PM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-24-04 Modifications.

Pursuant to rule 901:3-24-01 of the Administrative Code, the following section of 21 C.F.R. Chapter 1, Subchapter A, Part 1, Subpart O is amended as follows:

(A) "Section 402 of the Federal Food Drug and Cosmetic Act" shall read as "section 3715.59 of the Ohio Revised Code."

(B) "Section 1.900 Who is subject to this subpart? (a)"shall read as "Except for non-covered businesses as defined in 1.904, businesses who have a current FDA waiver and as provided for in paragraph (b) of this section, the requirements of this subpart apply to shippers, receivers, loaders, and carriers engaged in transportation operations whether or not the food is being offered for or enters interstate commerce. The requirements of this subpart apply in addition to any other requirements of this chapter that are applicable to the transportation of food, e.g., in 21 CFR parts 1, 117, 118, 225, 507, and 589."

Last updated February 12, 2024 at 10:30 PM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Chapter 901:3-44 Tolerance Level Standards and Action Steps for Maple Syrup, Sorghum, and Honey

Ohio Adm.Code 901:3-44-01 Mandatory food sampling tolerance level standards and action steps for maple syrup, sorghum, and honey.

(A) The following tolerance levels and action steps are adopted by the Ohio department of agriculture for evaluating the level of lead to determine whether tree syrup or sorghum produced, processed, or offered for sale in the state of Ohio is adulterated as per section 3715.59 of the Revised Code:

Tolerance level standards and action steps

Lead tolerance level for tree syrup and sorghum	Action step
0 - 499 Parts per billion	Acceptable. A warning letter shall be issued by the director to any producer or processor whose tree syrup or sorghum lead levels are greater than two hundred fifty parts per billion but less than five hundred parts per billion.
500 Parts per billion and greater	Tree syrup and sorghum is considered adulterated in accordance with section 3715.59 of the Revised Code.

(B) The following tolerance levels and action steps are adopted by the Ohio department of agriculture for evaluating the levels of coumaphos and antibiotics to determine whether or not honey or the components thereof produced, processed, or offered for sale in the state of Ohio is considered to be adulterated as per section 3715.59 of the Revised Code:

(1) There shall be no antibiotics detected in any sample of honey or the beeswax of honey. The detection of antibiotics in any amount shall render the honey or the beeswax of honey as adulterated as per section 3715.59 of the Revised Code.

(2) Coumaphos shall not exceed one hundred parts per billion in any sample of honey and shall not exceed one hundred parts per million in any sample of the beeswax of honey, otherwise, the honey or beeswax will be considered adulterated as per section 3715.59 of the Revised Code.

Last updated April 19, 2024 at 9:40 AM

History

Effective: April 19, 2024
Promulgated Under: 119.03

Chapter 901:3-45 Maple Syrup

Ohio Adm.Code 901:3-45-01 Grades and Color Classes.

(A) Grades. The following grades shall be used in classifying maple syrup:

(1) U.S. grade A is the quality of maple syrup that:

(a) Not more than 68.9 per cent solids content by weight (Brix);

(b) Has good uniform color;

(d) Is free from off flavors and odors considered as damage;

(e) Is free from cloudiness, turbidity, sediment, and is clean; and

(f) No deviants for damage shall be allowed in grade A.

(2) Maple syrup for processing (processing grade) means any maple syrup that fails to meet the requirements of U.S. grade A, but possess good characteristic maple taste and may contain off-flavors, but is fairly free of damage, turbidity, cloudiness, and is fairly clean.

(3) Substandard is the quality of maple syrup that fails to meet the requirements of processing grade maple syrup.

(B) Color classes.

(1) The color class of maple syrup is determined by:

(a) The per cent of light transmission through the syrup as measured with a spectrophotometer using matched square optical cells having a ten mm light path at a wavelength of five hundred sixty nm. The color value is expressed as percent of light transmission as compared to analytical reagent glycerol fixed at one hundred per cent. Per cent transmission is symbolized by "%Tc."

(b) Any method that provides equivalent results. When certifying the color of a sample that has been officially drawn and which represents a specific lot of maple syrup, if the number of color deviants exceeds the acceptance number in the appropriate sampling plan, the lot should be designated as mixed color.

(c) Any commercial color determining kit that provides an analysis of clarity and color comparable to that obtained by a spectrophotometer may be used to determine the grade listed on a label; however, in any dispute over the accuracy of a grade claim, a spectrophotometer shall be used to determine grade.

(2) Color classes are associated with specific "%Tc" values as follows:

Grade A Color Classes	Taste	Light Transmittance (%Tc)
U.S. Grade A Golden	Delicate	>75.0
U.S. Grade A Amber	Rich	50.0-74.9
U.S. Grade A Dark	Robust	25.0-49.9
U.S. Grade A Very Dark	Strong	<25.0

Last updated February 6, 2024 at 9:36 AM

History

Effective: September 2, 2017
Promulgated Under: 119.03

Ohio Adm.Code 901:3-45-02 Optional ingredients.

The following ingredients may be added to maple products:

(A) Salt;

(B) Chemical preservatives; and

Last updated February 6, 2024 at 9:36 AM

History

Effective: September 2, 2017
Promulgated Under: 119.03

Ohio Adm.Code 901:3-45-03 Labeling.

(A) Any producer or processor whose maple syrup conforms to a standard for a grade other than commercial or substandard may place the grade name on the package label. The legend shall be stylized: "U.S. Grade _______," and include the full grade name listed in rule 901:3-45-01 of the Administrative Code.

(B) No grade may be placed on a package label unless the maple syrup has first been tested by one of the methods in paragraph (B)(1) of rule 901:3-45-01 of the Administrative Code.

(C) Any optional ingredients permitted under rule 901:3-45-02 of the Administrative Code, when used, shall be listed on the package label, except for those not required by 21 CFR 101.100 (2017).

Last updated February 6, 2024 at 9:36 AM

History

Effective: September 2, 2017
Promulgated Under: 119.03

Ohio Adm.Code 901:3-45-04 Packaging and fill.

(A) Except as specified in paragraph (B) of this rule, all packaging shall be:

(1) Made of food grade materials;

(2) Clean prior to filling and free of water at the time of filling;

(3) Free from rust on food contact surfaces and not contain any substances or be constructed from any material which could damage either the color or flavor of maple syrup;

(4) Constructed with an air tight closing mechanism;

(5) Filled with not less than ninety per cent of their capacity.

(B) Canning containers designed for reuse shall be washed and sanitized prior to refilling. Closures shall not be reused.

Last updated February 6, 2024 at 9:36 AM

History

Effective: September 2, 2017
Promulgated Under: 119.03

Ohio Adm.Code 901:3-45-05 Bulk containers.

Barrels, drums, and other similar bulk containers used to store or ship maple syrup shall:

(A) Be made of food grade materials;

(B) Be in good condition and constructed to provide an easily cleanable surface;

(D) Not be used if it has:

(1) Previously contained a chemical or other hazardous material including lead or lead-based paint;

(2) A food-contact surface that is rusted; or

(3) Lead solder on the food-contact surface.

Last updated February 6, 2024 at 9:36 AM

History

Effective: September 2, 2017
Promulgated Under: 119.03

Chapter 901:3-46 Exempt Maple Syrup and Sorghum Processors and Beekeepers: Standards and Rules

Ohio Adm.Code 901:3-46-01 Definitions.

As used in rules 901:3-46-02 to 901:3-46-09 of the Administrative Code:

(A) "Department" means the Ohio department of agriculture.

(B) "Director" means the director of the Ohio department of agriculture.

(C) "Food grade material" means a material that when in contact with food will remain safe, durable, free of rust, non-absorbent; and, will not allow the migration of deleterious substances, impart color, odor, or taste to food under normal use.

(D) "Honey" means the nectar and saccharine exudation of plants that has been gathered, modified, and stored in a honeycomb by honey bees.

(E) "Tree syrup" means the unadulterated liquid food derived by concentration and heat treatment of pure tree sap or by reconstituting tree sugar or tree concrete with water to a density of not less than sixty-six degrees on the brix scale at sixty-eight degrees Fahrenheit.

(F) "Seal of conformity and inspection" means the Ohio department of agriculture certification logo illustrated in paragraph (D) of rule 901:3-46-04 of the Administrative Code.

(G) "Sorghum" means the unadulterated liquid food derived by concentration and heat treatment of the juice of pure sorghum cane.

Last updated April 19, 2024 at 7:41 AM

History

Effective: April 19, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-46-02

A tree syrup processor, sorghum processor, and beekeeper exempt from mandatory inspection under division (A) of section 3715.021 of the Revised Code may voluntarily request that the department conduct an inspection of the processor's or beekeeper's processing facilities.

Last updated April 19, 2024 at 7:41 AM

History

Effective: April 19, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-46-09

Water used for handwashing and the cleaning and sanitizing of food equipment and utensils shall be potable. A non-municipal water supply shall be sampled annually and a copy of the sample results shall be made available to the department for verification during inspection. Alternative water supplies, such as on an enclosed vehicular water tank, an on premises water storage tank, or the use of piping, tubing, or hoses composed of materials that meet national sanitation foundation standard 61 which can be found at www.nsf.org or an equivalent standard connected to an adjacent approved water source, may be used.

Last updated February 6, 2024 at 9:37 AM

History

Effective: September 2, 2017
Promulgated Under: 119.03

Ohio Adm.Code 901:3-46-04

(A) Each tree syrup processor, sorghum processor, and beekeeper exempt from mandatory inspection under division (A) of section 3715.021 of the Revised Code that has registered for voluntary inspection shall be inspected annually by the department.

(B) Tree syrup processors, sorghum processors, or honey processors may place the ODA seal of conformity and inspection on the label of the product that they process if either:

(1) They are a food processing establishment pursuant to division (A) of section 3715.021 of the Revised Code which is not currently placed on notice by the department; or,

(2) They are exempt under division (A) of section 3715.021 of the Revised Code and are in compliance with the rules of this chapter.

(C) The ODA seals of conformity and inspection logos shall only be used on labels and in advertising and promotion of tree syrup, honey, and sorghum products that are produced and processed in compliance with the provisions of this chapter by persons listed in paragraph (B) of this rule.

(D) The ODA seals of conformity and inspection logos are configured as follows:

(E) Prior to incorporating the ODA seals of conformity and inspection logos as a part of their label, each registered and approved tree syrup, sorghum, and honey processor shall submit a sample of their proposed label to the director for approval. A sticker meeting the configuration of the ODA seals of conformity and inspection logos in paragraph (D) of this rule may be used in lieu of incorporating an ODA seal of conformity and inspection as a part of a label.

(F) Tree syrup, sorghum, and honey products bearing the ODA seals of conformity and inspection logos on a package that has been produced by a person who is not in compliance with the provisions of this chapter, and has not registered or renewed their registration, shall be considered misbranded as per section 3715.60 of the Revised Code.

Last updated August 21, 2026 at 2:50 PM

History

Effective: April 19, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-46-03 Registration.

A tree syrup processor, sorghum processor, and beekeeper exempt from mandatory inspection under division (A) of section 3715.021 of the Revised Code who requests voluntary inspection shall register with the department. This registration shall expire annually on May first and may be renewed.

Last updated April 19, 2024 at 7:41 AM

History

Effective: April 19, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-46-05 Collection equipment.

(A) Buckets, plastic transport tubing, reusable plastic bags, extractors, bottling tanks, and other similar equipment used for the collection of tree sap, sorghum juice, or honey shall be clean, constructed of food grade materials, and shall not be used for any other purpose. Any container that has contained a chemical or other hazardous material including lead or lead based paint, or has lead solder shall not be used.

(B) Prior to use, buckets, plastic transport tubing, reusable plastic bags, extractors, bottling tanks, and other similar equipment shall be thoroughly washed with potable water, sanitized with a chemical sanitizer used in accordance with the United States environmental protection agency approved manufacturer's label, and thoroughly rinsed with potable water.

(C) At the end of the collection season, buckets, reusable plastic bags, extractors, bottling tanks, and other similar equipment shall be thoroughly washed with potable water. After rinsing, buckets, bags, and other similar equipment shall be drained, air-dried, and stacked for storage.

Last updated April 19, 2024 at 7:42 AM

History

Effective: April 19, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-46-06 Packaging and fill.

(A) Except as specified in paragraph (B) of this rule, all packaging shall be:

(1) Made of food grade materials;

(2) Clean prior to filling and free of water at the time of filling;

(3) Free from rust on food-contact surfaces and not contain any substances or be constructed from any material which could damage either the color or flavor of the contents;

(4) Constructed with an air tight closing mechanism;

(5) Filled with not less than ninety per cent of their capacity.

(B) Canning containers designed for reuse shall be washed and sanitized prior to refilling. Closures shall not be reused.

Last updated February 6, 2024 at 9:37 AM

History

Effective: September 2, 2017
Promulgated Under: 119.03

Ohio Adm.Code 901:3-46-07 Bulk containers.

Barrels, drums, and other similar bulk containers used to store or ship tree syrup, honey, or sorghum shall:

(A) Be made of food grade materials;

(B) Be in good condition and constructed to provide an easily cleanable surface;

(D) Not be used if it has:

(1) Previously contained a chemical or other hazardous material including lead or lead based paint;

(2) A food-contact surface that is rusted; or,

(3) Lead solder on the food-contact surface.

Last updated April 19, 2024 at 7:43 AM

History

Effective: April 19, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-46-08 Production/processing areas.

(A) Perimeter walls and roofs shall effectively protect the premises of the production and processing areas from the weather and the entry of rodents, birds, insects, other vermin and animals, except those involved in the production of the product.

(B) Floors in the production and processing areas shall be constructed of concrete, wood, or well maintained gravel. A dirt floor shall not be used except in those areas where insects are maintained for the production of the product.

(D) Soap, disposable paper towels, and a method to adequately wash hands shall be provided and used.

(E) All food-contact equipment, including hoses, shall be stored off the ground.

(F) Food-contact surfaces of equipment used for processing shall be maintained in good repair, be easily cleanable, and shall not contain any chemicals or other hazardous materials including lead, lead based paint, or lead solder.

(G) Food-contact surfaces shall be cleaned and sanitized prior to use and after any interruption during which food contact surfaces may have become contaminated.

(H) Non food-contact surfaces of equipment used in operation shall be cleaned as frequently as necessary to protect against the contamination of food.

(I) There shall be no storage or handling of gasoline, oil, pesticides, and other hazardous materials with food, food grade equipment, or in the area used to process food.

Last updated February 6, 2024 at 9:37 AM

History

Effective: September 2, 2017
Promulgated Under: 119.03

Chapter 901:3-57 Perishable Foods

Ohio Adm.Code 901:3-57-01 Definitions.

(A) "Quality assurance period" means the period of time following the completion of normal manufacturing, processing, and packaging procedures during which a food product subjected to normal conditions of exposure will maintain conformity with all of the characteristics normally associated with the food product and will provide the benefits for which the food product is normally purchased. Food product characteristics include, but are not limited to, taste, texture, smell, nutritional value, and reaction value with other food products if used as an ingredient with other food products.

(B) "Sale date" means the date by which the manufacturer, processor, or packager of a packaged food product recommends that the food product be sold for consumption based on the food product's quality assurance period.

(D) "Perishable food product" means a food product, determined by the manufacturer to have a quality assurance period of thirty days or less.

(E) "Consumer package" means a packaged food commodity that is customarily produced or distributed for sale through retail sales agencies or instrumentalities for consumption by individuals or use by individuals for the purposes of personal care or in the performance of services ordinarily rendered in or about the household or in connection with personal possessions.

(F) "Nonconsumer package" means any packaged food commodity other than a consumer package, and particularly a package intended solely for industrial or institutional use or for wholesale distribution.

Last updated February 6, 2024 at 9:37 AM

History

Effective: September 16, 2016
Promulgated Under: 119.03

Ohio Adm.Code 901:3-57-02 Food products considered perishable.

The manufacturer, processor, or packager shall determine which food products manufactured, processed, or packaged shall be considered perishable.

Last updated February 6, 2024 at 9:37 AM

History

Effective: September 16, 2016
Promulgated Under: 119.03

Ohio Adm.Code 901:3-57-03 Establishing sale dates for perishable foods.

(A) The manufacturer, processor, or packager shall establish the sale date for perishable food products.

(B) Sale dates established by the original manufacturer, processor, or packager shall not be increased by a repacker unless the product has been reprocessed in a manner which would enhance or lengthen the quality assurance period.

Last updated February 6, 2024 at 9:37 AM

History

Effective: September 16, 2016
Promulgated Under: 119.03

Ohio Adm.Code 901:3-57-04 Sale date; information and location.

(A) No person shall knowingly sell a perishable food product in a consumer package unless the package is clearly marked with a sale date by the packager. No other similarly stated date may appear on the package. However, nothing in this regulation shall prohibit a coded date, such as a Julian date, which may be required by federal law.

(B) The sale date markings shall be legible to the average consumer under normal conditions of purchase.

(C) The sale date may be indicated by appropriate descriptive terms such as "sell before," "sell by," etc. Terminology used to describe the sale date of a perishable food product shall be easily understood by the average consumer.

(D) Except as provided in paragraph (E) of this rule, the combination of words, numbers and/or abbreviations used to designate the sale date shall be easily understood by the average consumer. Words, numbers or abbreviations or a combination of words, numbers or abbreviations such as "Nov. 23, 11-23, November 23, etc." are acceptable.

(E) Bakery products with a sale date of less than seven days from the date of packaging may be dated with the days of the week or their abbreviations as follows:

Day of the Week	Acceptable Abbreviations
Sunday	SU, SUN
Monday	MO, MON
Tuesday	TU, TUE
Wednesday	WE, WED
Thursday	TH, THU, THUR
Friday	FR, FRI
Saturday	SA, SAT

Last updated February 6, 2024 at 9:37 AM

History

Effective: September 16, 2016
Promulgated Under: 119.03

Ohio Adm.Code 901:3-57-06 Exemptions.

The provisions of this regulation do not apply to the following:

(A) Fresh fruits or vegetables.

(B) Meat and meat products including poultry and poultry meat products whether packaged or unpackaged.

(C) Packaged perishable food products when sold or offered for sale at a place of business where less than one hundred thousand dollars of all products were sold during the preceding year.

(D) Food products in nonconsumer packages.

Last updated February 6, 2024 at 9:37 AM

History

Effective: September 16, 2016
Promulgated Under: 119.03

Ohio Adm.Code 901:3-57-08 Penalties.

Pursuant to section 3715.99 of the Revised Code, whoever violates section 3715.171 of the Revised Code or the rules of this chapter is guilty of a minor misdemeanor.

Last updated February 6, 2024 at 9:38 AM

History

Effective: September 16, 2016
Promulgated Under: 119.03

Chapter 901:3-62 Bottled Water

Ohio Adm.Code 901:3-62-01 Criteria and definitions for processing bottled water.

(A) Food processing establishments processing and bottling drinking water shall comply with Chapter 901:3-62 and the applicable provisions of Chapter 901:3-17 of the Administrative Code.

(B) Definitions.

As used in Chapter 901:3-62 of the Administrative Code:

(1) "Approved source" means:

(a) A public water system, as defined in division (A) of section 6109.01 of the Revised Code, with a current license issued by the director of the E.P.A. under authority of section 6109.21 of the Revised Code;

(b) A private water system, as defined in division (A) of section 3701.344 of the Revised Code, for which a permit has been issued under authority of paragraph (A) of rule 3701-28-03 of the Administrative Code and which is operating in compliance with the requirements of Chapter 3701. of the Revised Code and the rules adopted thereunder;

(c) A source of water which is not required by law to be licensed either as a public water system; or to be operated as a private water system in compliance with the requirements of Chapter 3701. of the Revised Code, but for which:

(i) A written opinion from either a geologist or hydrologist has been obtained stating that the location and geological characteristics of the source do not expose water from the source to contamination by a chemical, biological and radiological pollutants injurious to human health, and

(ii) An analysis of the water from the source, done by a United States environmental protection agency certified laboratory, a state E.P.A. laboratory or a state certified laboratory, has been obtained verifying that the water from the source meets the chemical, biological and radiological quality requirements for bottled water and bottled water packaged in the United States contained in 21 C.F.R. 165.110(b).

(2) "Board of health" means a board of health of a city or general health district or the authority having the duties of a board of health under Chapter 3709. of the Revised Code.

(3) "Bottled water" means all water, that is intended for human consumption, including artesian water, mineral water, purified water, sparkling bottled water, and spring water, and that is sealed in bottles, packages, or other containers with no added ingredients except that it may optionally contain safe and suitable antimicrobial agents. Floride may be optionally added within the limitations established in 21 C.F.R. Part 165.110 (b)(4)(ii).

(4) "C.F.R." means Code of Federal Regulations.

(5) "21 C.F.R. 113" means title 21 of the Code of Federal Regulations part 113 (April 2024).

(6) "21 C.F.R. 165" means title 21 of the Code of Federal Regulations part 165 (April 2024).

(7) "21 C.F.R. 178" means title 21 of the Code of Federal Regulations part 178 (April 2024).

(8) "40 C.F.R. 141" means title 40 of the Code of Federal Regulations part 141 (July 2023).

(9) "Director" means the director of the Ohio department of agriculture.

(10) "E.P.A." means the Ohio environmental protection agency.

(11) "Lot" means a collection of primary containers or unit packages of the same size, type, and style produced under conditions as nearly uniform as possible and designated by a common container code or marking.

(12) "Multi-service containers" means containers intended for use more than one time.

(13) "Nontoxic materials" means materials for product water contact surfaces utilized in the transporting, processing, storing, and packaging of bottled water, which are free of substances which may render the water injurious to health or which may adversely affect the flavor, color, odor, or bacteriological quality of the water.

(14) "Operations water" means water that is delivered under pressure to a plant for container washing, hand washing, plant and equipment cleanup and for other sanitary purposes.

(15) "ppm" means parts per million.

(16) "Primary container" means the immediate container in which the product water is packaged.

(17) "Product water" means processed water used by a plant for bottled water.

(18) "Shipping case" means a container in which one or more primary containers of the product are held.

(19) "Single-service container" means a container intended for one time usage only.

(20) "TDS" means total dissolved solids.

(21) "Unit package" means a standard commercial package of bottled water, which may consist of one or more containers.

(22) "World Health Organization's Guidelines for Drinking Water Quality" means the fourth edition of the world health organization's guidelines for drinking water quality.

Last updated April 1, 2025 at 7:52 AM

History

Effective: April 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 3701-28-03

(A) No person shall construct, alter or seal a private water system, test well or part thereof, unless a valid permit for the system has been issued by the board of health pursuant to this rule.

(1) Any person intending to construct a private water system, convert a well to a private water system, alter a private water system or install a test well or component thereof, shall, either in person or through a designated agent, make application to the board of health for a permit. Permits may be completed in person, sent by mail, or submitted by fax or electronically where the board of health accepts electronic payment. Except as provided in paragraphs (A)(2) and (J) of this rule, no work shall commence until a valid permit has been issued and approved. Each application shall be accompanied by the appropriate permit fee established under this chapter, all information required under this rule, and the fee for at least one water sample for any private water system alteration, conversion, or new construction permit. The applicant shall sign the application form, and shall indicate the name of any registered contractor intending to do the work, if known. An application becomes a permit upon validation by the local health district.

(2) Any person intending to seal a well, or decommission any other type of private water system that is not being sealed or decommissioned due to the replacement of an existing well or other private water system, shall apply for a permit not later than five business days after the well or other private water system has been sealed or decommissioned.

(3) If a plan is not required to be submitted under paragraph (F) of this rule the board of health shall determine whether the proposed construction, alteration, sealing, or decommissioning is in compliance with the provisions of this chapter within ten business days of receipt of a complete application and the appropriate fee. If a plan is required to be submitted under paragraph (F) of this rule the board of health shall determine whether the proposed work is in compliance with the provisions of this chapter within fifteen business days of receipt of a complete application and the appropriate fee.

(a) Except for emergency work conducted under paragraph (J) of this rule, the board of health shall work with the applicant and the private water systems contractor to review the site conditions to ensure that all isolation distances are met in accordance with rule 3701-28-07 of the Administrative Code prior to the construction or alteration of the private water system.

(b) If the board of health determines that the proposed construction, alteration, decommissioning, or sealing of a private water system or test hole is in compliance with this chapter, the board of health shall issue a permit to the applicant. If a registered contractor was not indicated at the time of application, the applicant shall notify the board of health prior to the commencement of work on the private water system of the name of any registered contractor who intends to do the work.

(c) If the board of health determines that the proposed construction, alteration, decommissioning, or sealing does not comply with this chapter, the board of health shall deny the application. The applicant and the registered contractor, if known, shall be notified of the denial in writing by the board of health.

(d) Within thirty days after the denial of an application to construct, alter, decommission, or seal a private water system, the property owner or his designated agent shall be provided with an opportunity to appeal the decision and a hearing shall be provided if requested.

(B) Each application to construct a private water system shall contain information about the location, design, construction, installation and development of the private water system or installation of test holes. The application shall include a site plan designating the location or area of the proposed or existing private water system or test hole, and distances from roadways, road rights-of-way, buildings, driveways, sewage treatment systems, sewers, existing or properly sealed water supply wells, oil and gas wells, above ground or underground fuel oil, liquid petroleum, chemical or gasoline storage tanks, streams, lakes, ponds, ditches, leaching pits, privies, manure ponds, manure lagoons, manure piles, lot lines, easements and any other information required by the department or board of health.

(C) Each application for the alteration of a private water system shall contain all pertinent information required by the department or board of health about the alteration of the private water system.

(D) Each application for a permit to seal or decommission a private water system shall contain all information required by the department or board of health about the sealing or decommissioning of the private water system.

(1) A person intending to seal or decommission a private water system and construct a new private water system on the same premises to replace the sealed or decommissioned private water system shall only be required to obtain a construction permit.

(2) Only one sealing permit is required per property for sealing or decommissioning multiple private water systems.

(E) An alteration permit can be converted into a new construction permit, if during the commencement of an alteration it is determined by a registered contractor or the board of health that the construction of a new water source will be required.

(1) A contractor shall immediately notify the board of health of a request to change the alteration permit into a new replacement private water system construction permit and submit all necessary site plans and detailed plans, as required, for new construction;

(2) A contractor shall immediately cease work on the private water system until the board of health has performed a site review and approved the request to modify the permit; and

(3) The board of health shall collect the additional state portion of the fee and may collect any difference in the amount between an alteration permit fee and a new construction permit fee.

(F) In addition to the requirements of this rule,

(1) An owner or their designated agent proposing to construct, or alter a private water system that meets one of the following criteria shall submit plans relating to the construction, work and equipment of the water system to the board of health:

(a) A private water system servicing a building as defined in section 3781.06 of the Revised Code;

(b) A private water system servicing other than one- two-, or three- family dwelling;

(d) A well drilled in an area of known flowing well conditions as designated by the department or by the board of health at the time the initial permit application is reviewed;

(e) A private water system source that will be located within three hundred feet of a land application area as defined in paragraph (EEE) of rule 3701-28-01 of the Administrative Code;

(f) The installation of a drive point well;

(g) The installation of a buried pressure tank;

(h) The installation of a gasoline powered pump and pressurization system;

(i) The installation of a continuous disinfection and/or filtration system;

(j) The installation of a point of entry water treatment system intended to remove or reduce a contaminant to below a health based standard; or

(2) When plans are not submitted electronically the board of health may require the plans be submitted in duplicate.

(G) Plans required under paragraph (F) of this rule shall:

(1) For a multi-family dwelling or building, include relevant information as to the number of individuals to be served;

(2) Be legible and accurately drawn with a north directional arrow;

(3) Include relevant elevations for ponds and springs;

(4) Show the locations, layout, and type of all water system equipment, including but not limited to any disinfection and filtration equipment and components required for compliance with this chapter. Plans shall include the make and model of devices, storage tank capacities, and any operation and maintenance requirements;

(5) Include a listing of all materials to be used in construction, installation, or alteration of the water system;

(6) For a drive point well, include relevant information to document to the board of health what geologic or site conditions exist at the property to preclude the use of or access to the property by conventional drilling equipment and methods;

(7) Show the layout of the water distribution piping from the source to the service connections; and

(8) Include any other information required by the department or board of health.

(H) Any modification or deviation from the approved permit site plan or additional detailed plans including, but not limited to, a change in the type of system, locations shown on the site plan, or changes in the location or the treatment equipment shown on the detailed plans must be reported to the board of health within three business days. The private water system's owner and contractor are not guaranteed approval of the system by the local board of health when changes are made to the approved permit site plan or additional detailed plans prior to board of health review and approval of the changes.

(I) The board of health shall not approve any plan that does not conform to the requirements of this chapter. No permit shall be issued until the plans have been approved by the board of health.

(J) When an emergency exists, work may be commenced on the construction or alteration of a private water system prior to obtaining a permit, provided the private water systems contractor notifies the board of health the next business day by phone or e-mail, and a permit is applied for within three business days after commencement of the construction or alteration. The private water system's owner and contractor are not guaranteed approval of the system by the board of health under emergency construction.

(1) For purposes of this rule "emergency" means that the existing private water system fails to produce an adequate amount of potable water which poses an immediate threat to health and safety and no alternative potable water source exists, and the work will commence during non-business hours of operation of the board of health, or prior to the end of the board of health's ten business days to review the application.

(2) Emergency alteration or construction work shall not commence prior to application being made during open business hours of the board of health.

(3) Emergency alteration or construction shall not occur at locations where there are currently no existing or partially constructed structures, homes, or buildings.

(4) Except for a private water system servicing a multi-family dwelling or building, emergency alteration or construction shall not occur at locations which require additional plans in accordance with paragraph (F) of this rule.

(K) If a private water system is constructed or altered as an emergency under this rule and it is later determined by the board of health that no emergency existed as defined in paragraph (J)(1) of this rule, the private water system contractor shall be assessed the additional fee amount established in accordance with paragraph (E)(17) of rule 3701-28-06 of the Administrative Code.

(L) A temporary hauled water storage tank may be installed to address extreme situations such as construction dewatering, drought, or flood conditions under a temporary hauled water storage tank permit issued from the board of health and shall include the specified time restrictions for the operation and dismantling of the temporary hauled water storage tank. If a temporary hauled water storage tank is part of a permitted emergency construction, replacement construction or alteration of a private water system, a separate permit for the temporary hauled water storage tank shall not be required. The application for the construction or alteration permit shall contain the required information related to the temporary hauled water storage tank.

(1) Temporary plastic or fiberglass water storage tanks constructed of approved materials that meets NSF 61-2016 and the specifications of paragraph (A) of rule 3701-28-12 of the Administrative Code may be installed above grade.

(2) Temporary plastic or fiberglass water storage tanks may be set at locations on a property that may not meet all of the distance requirements specified in rule 3701-28-07 of the Administrative Code, as allowed by the board of health.

(3) Temporary hauled water storage tanks that do not meet the minimum capacity specified in paragraph (C) of rule 3701-28-12 of the Administrative Code may be permitted.

(4) A temporary hauled water tank shall not become a permanent private water system and shall be removed at the time specified on the installation permit. An additional alteration permit may be applied for to retain the existing temporary hauled water storage tank for an additional specified time period if the emergency conditions continue.

(M) If a permit has been issued for the construction of a well to be used for a new private water system, and the first attempt to drill the well is unsuccessful, then additional wells may be drilled within the area designated on the permit or the drilling site without obtaining additional permits, provided the original permit has not expired. The well sealing report or well log required by section 1521.05 of the Revised Code for each dry hole shall be filed with the Ohio department of natural resources, division of geological survey and the board of health. A copy of the report or log shall be provided to the private water system owner, and the registered contractor who performed the sealing shall retain a copy.

(1) All boreholes left without casing, a properly grouted annular space and a vermin proof well cap, all dry holes, and all test wells and test holes which are not to be converted to private water systems or geothermal wells within ten days of completion, shall be sealed in accordance with rule 3701-28-17 of the Administrative Code.

(2) If a dry hole, test well or test hole is going to be converted into a geothermal well, it shall be done in accordance with the requirements of paragraph (C) of rule 3701-28-17 of the Administrative Code.

(3) A completion form shall be submitted to the board of health for any dry hole, test well or test hole indicating that it is to be converted to a geothermal well instead of being sealed.

(4) An alteration permit shall be obtained for any approved test well or test hole that is to be converted into a private water system.

(N) An additional new construction permit is not required to be issued when there is a change in the type of private water system source.

(1) If the private water system type is changed, the application permit information which needs to be modified shall be submitted by the applicant to the board of health which shall record the changes to the permit. When required, additional plans must be submitted in accordance with paragraph (F) of this rule. Plans must be approved prior to any work being performed.

(2) If the permit category for the other private water system has a higher fee than the original permit fee, then the board of health may charge the difference between the fees for the same permit.

(O) Permit applications, permits and completion forms shall be on forms prescribed or approved by the department. The board of health shall specify within such permits the date upon which the permit expires and that the issuance of the permit is conditioned upon the right of the board of health or the department to enter upon the premises of the private water system identified in the permit at any reasonable time prior to, during, or after completion of the work specified in the permit for the purpose of determining compliance with this chapter.

(P) A permit shall be obtained for any non-potable well, agricultural well, public water system or geothermal system that is to be converted into a private water system and shall be regarded as a new construction. A non-potable well is a well where the water is not used for human consumption, or other potable uses. The converted system shall be reviewed by the board of health prior to issuance of the permit to ensure the well meets all requirements of this chapter. The board of health shall review a well log or downhole camera survey to ensure compliance, and may also review dye test, water sample data, or other information presented by the well owner or a private water systems contractor.

(Q) If the private water system has not been constructed, sealed or altered within one year from the date of permit issuance, the permit shall automatically expire. The board of health may extend the permit period for an additional six months. If a private water system is under orders by the board of health for correction of a construction violation, the permit may be reopened or extended beyond the six month extension for an additional period of time at the discretion of the board of health so that the required work can be performed.

(R) For purposes of this rule, "date of completion" means:

(1) The date on which the well, spring, pond, hauled water storage tank, or cistern is installed;

(2) The date on which the installation of the pump, pumping equipment, or other component of the private water system is completed;

(3) The date on which the other components of the private water system are completed if a pump or pumping equipment will be installed by a person other than the contractor identified on the permit;

(4) If no completion form is filed with the local health district, the date the well log is filed with the department of natural resources by the private water systems contractor;

(5) The date the disinfection, filtration or other treatment equipment to remove contaminants is installed;

(6) When more than one private water systems contractor performs work on a private water system, the date of completion for each private water systems contractor is the date that person completes their portion of the work on the private water system; or

(7) The date that a private water system is sealed or decommissioned.

(S) Within thirty days of the date of completing any portion of the work on a private water system as described in paragraph (R) of this rule, a complete and accurate completion form shall be submitted to the board of health by the person completing the work. Submission of the form may be done by walk-in, fax, electronically, or mail.

(T) Within thirty days of the drilling, alteration or sealing of a well, dry hole, or test hole, or the date of completion of a well, a copy of the well log or sealing report required to be filed with the Ohio department of natural resources, division of geological survey, as required under section 1521.05 of the Revised Code, shall also be submitted to the board of health, to the private water system owner, and the registered contractor shall retain a copy. Submission of the form may be done by walk-in, fax, electronically, or mail.

(U) Within thirty days of the date of completion of an alteration that does not require a well log to be filed under section 1521.05 of the Revised Code, the person who performs the alteration shall file a complete and accurate completion form with the board of health. Submission of the form may be done by walk-in, fax, electronically, or mail.

(V) Upon receipt of all required forms, the board of health shall contact the applicant and/or owner to conduct an inspection and collect a water sample(s) in accordance with rule 3701-28-04 of the Administrative Code and the following requirements:

(1) The initial water sample shall be tested for nitrates, escherichia coli and a coliform CFU or MPN count. Repeat water samples collected for a system after the first sample shall be tested for escherichia coli and a coliform CFU or MPN count, or pathogenic microorganisms as applicable. Repeat sampling may include additional parameters, as required for an investigation.

(2) The board of health may prescreen the water sample for nitrates using test kits or strips capable of reading nitrate concentrations in water down to 1 milligram per liter.

(3) The board of health shall provide the water sample results, in writing, to the private water system owner, agent, applicant, and each private water systems contractor who has performed work on the private water system.

(4) The board of health shall report the findings of water tests which indicate a presence of escherichia coli, pathogenic microorganisms or nitrates in excess of maximum contaminant levels, as set forth in rule 3701-28-04 of the Administrative Code, to the department.

(W) If the sample obtained from the private water system exceeds the maximum contaminant levels for microbiological contaminants specified in paragraph (K) of rule 3701-28-04 of the Administrative Code, the private water system shall not be approved, unless effective remediation measures to reduce the total coliform, and eliminate any escherichia coli, or any primary pathogenic organism are implemented for the private water system. For a private water system well with casing that extends twenty-five feet or more below the ground surface which is exceeding maximum contaminant levels for microbiological contaminants, continuous disinfection of the system may be installed in accordance with rule 3701-28-15 of the Administrative Code only after:

(1) Enhanced disinfection of the entire private water system is performed by a registered private water systems contractor as specified in paragraph (H) of rule 3701-28-11 of the Administrative Code; and

(2) An investigation has been performed by the board of health as specified in paragraph (AA)(1) of this rule and upon determination by the board of health that the private water system well is constructed in compliance with this chapter.

(X) If the sample obtained from the private water system indicates that the maximum contaminant level for nitrates has been exceeded the board of health shall provide information to the private water system owner on the health risks of nitrates, and options for the treatment of the private water system to reduce the nitrates to acceptable levels. If additional sampling is performed on the private water systems for any of the contaminants referenced in paragraph (K) of rule 3701-28-04 of the Administrative Code and listed in Chapter 3745-81 of the Administrative Code, and levels exceeding the maximum contaminant level are identified in the water sample from the private water system, the board of health shall provide information to the private water systems owner on the health risks of that contaminant, and options for treatment of the private water system. The department shall also post health risk information and options for treatment on the department's website.

(Y) After the receipt of the results of the water samples, and upon the basis of the board of health's inspection(s) and review of all completion, job status, alteration or well log forms as applicable, the water sample results, and all other pertinent data relative to the private water system, the board of health shall approve the private water system if the system is in compliance with the provisions of this chapter.

(1) A private water system shall not be approved that is not in compliance with this chapter and the board of health shall order the private water system into compliance for any construction and administrative violation of this chapter in accordance with paragraph (L) of rule 3701-28-02 and paragraph (F) of rule 3701-28-04 of the Administrative Code.

(2) The private water system shall not be used for human consumption until it has been approved by the board of health.

(Z) If repeated total coliform, escherichia coli or other primary pathogenic organisms are found in samples from the well that exceeds the maximum contaminant levels specified in paragraph (K) of rule 3701-28-04 of the Administrative Code after using the disinfection procedure in paragraph (H) of rule 3701-28-11 of the Administrative Code, the board of health shall notify the department and shall undertake a joint investigation with the private water systems contractor of the private water system to determine the source of contamination and approve possible remediation measures, including continuous disinfection as described in rule 3701-28-15 of the Administrative Code.

(1) The investigation may include, but not be limited to:

(a) A dye test;

(b) A down-hole camera recording of the constructed well;

(AA) A private water system shall not be approved unless a water sample from the private water system meets the standards specified in paragraph (K) of rule 3701-28-04 of the Administrative Code.

(BB) Once the board of health approves the private water system the permit is invalid unless the permit is reopened for corrections of construction violations due to a bond claim investigation or board of health orders in accordance with paragraph (Q) of this rule.

(CC) Except for one-, two-, and three-family dwellings, all new and existing private water systems providing water for human consumption or potable uses shall have a water sample collected annually from the private water system by either the board of health, a person holding a current Class A, I, II, III, or IV public water systems operator certification from the Ohio environmental protection agency as authorized under Chapter 3745-7 of the Administrative Code, a person employed by a laboratory holding a current drinking water laboratory certification from the Ohio environmental protection agency as authorized under Chapter 3745-89 of the Administrative Code or equivalent national certification for the analysis of drinking water, or other certification programs developed or authorized by the director. Private water systems covered by this paragraph include, but are not limited to, those serving:

(1) Foster homes as required under rule 5101:2-7-12 of the Administrative Code;

(2) An residential facility as required by rule 5122-30-11 of the Administrative Code;

(3) A licensed child care center as required by rule 5101:2-12-13 of the Administrative Code;

(4) Residential facilities as required under rule 5101:2-9-04 of the Administrative Code;

(5) A resident day camp as required by rule 3701-25-05 of the Administrative Code;

(6) Children's residential centers, group homes, and residential parenting facilities as required under rule 5101:2-9-04 of the Administrative Code;

(7) Licensed type A homes as required under rule 5101:2-13-12 of the Administrative Code;

(8) A campground as defined in paragraph (C) of rule 3701-26-01 of the Administrative Code;

(9) A manufactured home park as defined by division (D) of section 4781.01 of the Revised Code;

(10) A food service operation or retail food establishment as required by rule 3717-1-05 of the Administrative Code;

(11) Private water systems used by registered private water systems contractors to provide water for drilling purposes;

(12) Private homes operated as a bed-and-breakfast that prepares and offers food and water to guests; and,

(13) A hotel, transient hotel, extended stay hotel or residential hotel as defined by section 3731.01 of the Revised Code.

(DD) The sample collected under paragraph (CC) of this rule shall be analyzed for the presence of total coliform, escherichia coli or other primary pathogenic organisms as specified in paragraph (K) of rule 3701-28-04 of the Administrative Code;

(1) The sample results shall be reported to the board of health, along with information about the number of individuals served by the private water system within one business day of the result being returned from the lab; and

(2) The board of health shall maintain these records.

(EE) If the water sample collected under paragraph (CC) of this rule exceeds the maximum contaminant level for bacterial or primary pathogenic organisms under paragraph (K) of rule 3701-28-04 of the Administrative Code, the private water system owner shall:

(1) Have a registered private water system contractor disinfect the private water system in accordance with rule 3701-28-11 of the Administrative Code.

(a) The private water system shall be re sampled after disinfection; and,

(b) The results shall be reported by the system owner or their agent to the board of health within one business day of the result being returned from the lab.

(2) If the water sample collected after disinfection exceeds the bacterial standard under paragraph (K) of rule 3701-28-04 of the Administrative Code, the owner of the private water system shall:

(a) Notify all end users, in writing, of any restrictions of water usage as determined by the department and provided to the private water system owner by the board of health. A copy of this notice and the method of end user notification shall be provided to the board of health the same day of issuance to the end users; and

(b) Implement corrective actions, as needed, to obtain a bacteriologically safe water supply.

(3) If the corrective action implemented under this paragraph is the installation of a continuous disinfection water treatment system as required under rule 3701-28-15 of the Administrative Code, then in addition to the annual sampling, an annual operation and maintenance inspection shall be performed by a registered private water systems contractor and the results reported to the board of health to ensure the continued performance of the disinfection system.

(FF) Any private water system constructed, altered or sealed by a person who has not obtained a registration, as required under rule 3701-28-18 of the Administrative Code, or is not exempt from registration pursuant to paragraph (A)(2) of rule 3701-28-18 of the Administrative Code shall not be approved.

(1) If the entire portion of the system constructed by an unregistered contractor is reconstructed by a registered private water systems contractor, the board of health shall not require a variance to this rule, but shall evaluate the new construction for compliance with this chapter.

(2) The board of health shall not grant a variance to this rule unless the portion of the private water system constructed is assessed and deemed acceptable by a registered private water systems contractor.

(3) The unregistered contractor who performed work on the private water system may complete the work on the private water system provided that the following have occured prior to additional work occuring:

(a) The property owner has obtained a variance from the board of health to paragraph (FF)(1) of this rule and to rule 3701-28-18 of the Administrative Code for the work performed on the private water system by an unregistered contractor. If the surety bond does not cover the work performed, the variance shall require a notarized statement from the unregistered private water systems contractor that they assume financial liability for costs associated with corrective actions which may be required to bring portion(s) of the system constructed without surety bond coverage into compliance with this chapter; and

(b) The contractor makes application to the department for registration as a private water systems contractor in accordance with paragraph (B) of rule 3701-28-18 of the Administrative Code. This application shall include the five hundred dollar registration fee for registrations submitted after work which requires registration has been performed on a private water system; and

History

Effective: January 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 901:3-62-02 License.

(A) No person shall manufacture or bottle for sale within the state bottled water unless the person has a license as prescribed in section 913.23 of the Revised Code. Applicants shall apply for a license on a form provided by the director.

(B) Prior to licensing, the director shall determine if the source and operations water originates from an approved source, inspect the bottled water plant to determine compliance with this chapter and the applicable good manufacturing practices of Chapter 901:3-17 of the Administrative Code, and that any label shall be in conformance with the provisions of this chapter and rule 901:3-1-11 of the Administrative Code.

Last updated April 1, 2025 at 7:52 AM

History

Effective: April 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 901:3-1-11

Last updated February 12, 2024 at 10:45 AM

History

Effective: February 12, 2024
Promulgated Under: 119.03

Ohio Adm.Code 901:3-62-03 Nomenclature and labeling.

(A) The name of the food is bottled water or alternatively one or more of the following terms as appropriate:

(1) Artesian water or artesian well water is the name of the water from a well tapping a confined aquifer in which the water level stands at some height above the top of the aquifer. Artesian water or artesian well water may be collected with the assistance of external force to enhance the natural underground pressure. On request, plants shall demonstrate to appropriate regulatory officials that the water level stands at some height above the top of the aquifer.

(2) Ground water is the name of the water from a subsurface saturated zone that is under a pressure equal to or greater than atmospheric pressure. Ground water must not be under the direct influence of surface water as defined in 40 C.F.R. Part 141.2.

(3) Mineral water is the name of the water containing not less than two hundred fifty ppm total dissolved solids. Mineral water must come from a source tapped at one or more bore holes or springs, originating from a geologically and physically protected underground water source. Mineral water shall be distinguished from other types of water by its constant level and relative proportions of minerals and trace elements at the point of emergence from the source, due account being taken of the cycles of natural fluctuations. No minerals may be added to this water.

(4) Purified water is the name of the water from an approved source, that has been produced by distillation, deionization, reverse osmosis, or other suitable processes and contains no added substance. Purified water is prepared from water complying with 40 C.F.R. Part 141 or the "World Health Organization's Guidelines for Drinking Water Quality." Purified water may be called "deionized water" if the water has been processed by deionization, "distilled water" if it is produced by distillation, "reverse osmosis water" if the water has been processed by reverse osmosis, and " drinking water" with the blank being filled in with one of the defined terms describing the water in this paragraph (e.g., "purified drinking water" or "deionized drinking water"). Purified water must not contain more than ten parts per million of total dissolved solids.

(5) Sparkling bottled water is the name of the water that, after treatment and possible replacement of carbon dioxide, contains the same amount of carbon dioxide from the source that it had at emergence from the source.

(6) Spring water is the name of the water derived from an underground formation from which water flows naturally to the surface of the earth. Spring water shall be collected only at the spring or through a bore hole tapping the underground formation feeding the spring. There shall be a natural force causing the water to flow to the surface through a natural orifice. The location of the spring shall be identified. Spring water collected with the use of an external force shall be from the same underground stratum as the spring, as shown by a measurable hydraulic connection using a hydrogeologically valid method between the bore hole and the natural spring, and shall have all the physical properties, before treatment, and be of the same composition and quality, as the water that flows naturally to the surface of the earth. If spring water is collected with the use of an external force, water must continue to flow naturally to the surface of the earth through the spring's natural orifice. Plants shall demonstrate using a hydrogeologically valid method, that an appropriate hydraulic connection exists between the natural orifice of the spring and the bore hole.

(7) Well water is the name of the water from a hole bored, drilled, or otherwise constructed in the ground which taps the water of an aquifer.

(B) Labeling.

In addition to labeling standards set forth in paragraph (A) of this rule and rule 901:3-1-11 of the Administrative Code, the following standards shall also apply:

(1) If the TDS content of mineral water is below five hundred ppm, or if it is greater than one thousand five hundred ppm, the statement "low mineral content'' or the statement "high mineral content'', respectively, shall appear on the principal display panel following the statement of identity in type size at least one-half the size of the statement of identity but in no case of less than one-sixteenth of an inch. If the TDS of mineral water is between five hundred and one thousand five hundred ppm, no additional statement need appear.

(2) When bottled water comes from a community water system, as defined in 40 C.F.R. Part 141.2, except when it has been treated to meet the definition of purified water in paragraph (A)(4) of this rule and is labeled as such, the label shall state "from a community water system'' or, alternatively, "from a municipal source'' as appropriate, on the principal display panel or panels. This statement shall immediately and conspicuously precede or follow the name of the food without intervening written, printed, or graphic matter, other than statements required by paragraph (B)(3) of this rule, in type size at least one-half the size of the statement of identity but in no case of less than one-sixteenth of an inch.

(3) When the label or labeling of a bottled water product states or implies that the bottled water is for use in feeding infants, and the product is not commercially sterile as defined in 21 C.F.R. Part 113.3(e), the product's label shall bear conspicuously and on the principal display panel the statement "Not sterile. Use as directed by physician or by labeling directions for use of infant formula.''

(4) For the purposes of this rule, the standard of quality for bottled water, including water for use as an ingredient in beverages as prescribed in 21 C.F.R., Part 165.110(b). When the microbiological, physical, chemical, or radiological quality of bottled water is below that prescribed in 21 C.F.R. Part 165.110(b), the label shall bear the statement of substandard quality as applicable:

(a) "Contains Excessive Bacteria."

(b) "Excessively Turbid", "Abnormal Color," or "Abnormal Odor."

(c) "Contains Excessive ________," with the blank filled in with the name of the chemical for which a maximum contaminant level is exceeded. Except that "Contains Excessive Chemical Substances" may be used if the bottled water is not mineral water.

(d) "Excessively Radioactive."

Last updated April 1, 2025 at 7:52 AM

History

Effective: April 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 901:3-62-04 Plant construction, design, and equipment.

(A) The bottling room shall be separated from other plant operations or storage areas by tight walls, ceilings, and self-closing doors to protect against contamination. Conveyor openings shall not exceed the size required to permit passage of containers.

(B) If processing operations are conducted in other than a sealed system under pressure, adequate protection shall be provided to preclude contamination of the water and the system.

(C) Adequate ventilation shall be provided to minimize condensation in processing rooms, bottling rooms, and in container washing and sanitizing areas.

(D) The washing and sanitizing of containers for bottled water shall be performed in an enclosed room. The washing and sanitizing operation shall be positioned within the room so as to minimize any possible post-sanitizing contamination of the containers before they enter the bottling room.

(E) Rooms in which product water is handled, processed, or held or in which containers, utensils, or equipment are washed or held shall not open directly into any room used for domestic household purposes.

(F) When employee locker and lunchrooms are provided, they shall be separate from plant operations and storage areas and shall be equipped with self-closing doors. The rooms shall be maintained in a clean and sanitary condition. Packaging or wrapping material or other processing supplies shall not be stored in locker or lunchrooms.

(G) Suitability.

(1) All plant equipment and utensils shall be suitable for their intended use. This includes all collection and storage tanks, piping, fittings, connections, bottle washers, fillers, cappers, and other equipment which may be used to store, handle, process, package, or transport product water.

(2) All product water contact surfaces shall be constructed of nontoxic and nonabsorbent material which can be adequately cleaned or sanitized and is in compliance with section 3715.62 of the Revised Code.

(H) Storage tanks shall be of the type that can be closed to exclude all foreign matter and shall be adequately vented.

Last updated April 1, 2025 at 7:53 AM

History

Effective: April 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 901:3-62-05 Sanitary facilities.

(A) Product water and operations water.

(1) The product water supply for each bottled water plant shall be from an approved source properly located, protected, and operated; and shall be easily accessible, adequate, and of a safe, sanitary quality.

(2) If different from the product water supply, the operations water supply shall be obtained from an approved source properly located, protected, and operated; and shall be easily accessible, adequate, and of a safe, sanitary quality.

(3) Product water and operations water from approved sources.

(a) Samples of source water are to be taken and analyzed by the plant as often as necessary, but at a minimum frequency of once each year for chemical contaminants and once every four years for radiological contaminants. Additionally, source water obtained from other than a public water system is to be sampled and analyzed for total coliform at least once each week. If any coliform organisms are detected, follow-up testing must be conducted to determine whether any of the coliform organisms are Escherichia coli (E. Coli). This sampling is in addition to any monitoring performed to comply with the E.P.A. or the local board of health requirements, as applicable. Records of approval of the source water by the E.P.A. or the local board of health, as applicable, and of sampling and analyses for which the plant is responsible are to be maintained on file at the plant.

(i) Source water found to contain E. Coli is not considered water of a safe, sanitary quality as required for use in bottled water by paragraph (A)(1) of this rule.

(ii) Before a bottler can use source water from a source that has tested positive for E. Coli, the bottler must take appropriate measures to rectify or otherwise eliminate the cause of E. Coli contamination of that source in manner sufficient to prevent its recurrence.

(iii) A source previously found to contain E. Coli will be considered negative for E. Coli after five samples collected over a twenty-four hour period from the same sampling site that originally tested positive for E. Coli are tested and found to be E. Coli negative.

(b) Test and sample methods shall be those recognized and approved by the E.P.A. or the local board of health, or the director, as applicable, over the approval of the water source and shall be consistent with the minimum requirements set forth in 21 C.F.R. Part 165.110(b).

(c) Samples of source water shall be tested by a United States environmental protection agency certified laboratory, a state E.P.A. laboratory, or a state certified laboratory.

(d) Finished product water must comply with the bottled water quality standards in 21 C.F.R. Part 165.110(b) and section 3715.59 of the Revised Code dealing with adulterated foods.

(B) Air under pressure.

Whenever air under pressure is directed at product water or a product water-contact surface, it shall be free of oil, dust, rust, excessive moisture, and extraneous materials; and shall not affect the bacteriological quality of the water.

Last updated April 1, 2025 at 7:53 AM

History

Effective: April 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 901:3-62-06 Sanitary operations.

(A) The product water-contact surfaces of all multiservice containers, utensils, pipes, and equipment used in the transportation, processing, handling, and storage of product water shall be clean and adequately sanitized. All product water-contact surfaces shall be inspected by plant personnel as often as necessary to maintain the sanitary condition of such surfaces and to assure they are kept free of scale, evidence of oxidation, and other residue. The presence of any unsanitary condition, scale, residue, or oxidation shall be immediately remedied by adequate cleaning and sanitizing of that product water-contact surface prior to use.

(B) After cleaning, all multiservice containers, utensils, and disassembled piping and equipment shall be transported and stored in such a manner as to assure drainage and shall be protected from contamination.

(C) Single-service containers and caps or seals shall be purchased and stored in sanitary closures and kept clean therein in a clean, dry place until used. Prior to use they shall be examined, and as necessary, washed, rinsed, and sanitized and shall be handled in a sanitary manner.

(D) Filling, capping, closing, sealing, and packaging of containers shall be done in a sanitary manner so as to preclude contamination of the bottled water.

Last updated April 1, 2025 at 7:53 AM

History

Effective: April 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 901:3-62-07 Processes and controls.

(A) Treatment of product water.

All treatment of product water by distillation, ion-exchanging, filtration, ultraviolet treatment, reverse osmosis, carbonation, mineral addition, or any other process shall be done in a manner so as to be effective in accomplishing its intended purpose and in accordance with section 3715.62 of the Revised Code. All such processes shall be performed in and by equipment and with substances which will not adulterate the bottled product. A record of the type and date of physical inspections of such equipment, conditions found, and the performance and effectiveness of such equipment shall be maintained by the plant. Product water samples shall be taken after processing and prior to bottling by the plant and analyzed as often as is necessary to assure uniformity and effectiveness of the processes performed by the plant.

(B) Containers.

(1) Multiservice primary containers shall be adequately cleaned, sanitized, and inspected just prior to being filled, capped, and sealed. Containers found to be unsanitary or defective by the inspection shall be reprocessed or discarded. All multiservice primary containers shall be washed, rinsed, and sanitized by mechanical washers or by any other method giving adequate sanitary results.

Mechanical washers shall be inspected as often as is necessary to assure adequate performance. Records of physical maintenance, inspections and conditions found, and performance of the mechanical washer shall be maintained by the plant.

(2) Multiservice shipping cases shall be maintained in such condition as to assure they will not contaminate the primary container or the product water. Adequate dry or wet cleaning procedures shall be performed as often as necessary to maintain the cases in satisfactory condition.

Cleaning and sanitizing solutions utilized by the plant shall be sampled and tested by the plant as often as is necessary to assure adequate performance in the cleaning and sanitizing operations. Records of these tests shall be maintained by the plant.

(D) Sanitizing operations.

Sanitizing operations, including those performed by chemical means or by any other means such as circulation of live steam or hot water, shall be adequate to effect sanitization of the intended product water-contact surfaces and any other critical area. The following times and intensities shall be considered a minimum:

(1) Steam in enclosed system: At least one-hundred-seventy degrees Fahrenheit for at least fifteen minutes or at least two-hundred degrees Fahrenheit for at least five minutes.

(2) Hot water in enclosed system: At least one-hundred-seventy degrees Fahrenheit for at least fifteen minutes or at least two-hundred degrees Fahrenheit for at least five minutes.

(3) Chemical sanitizers shall be equivalent in bactericidal action to a two-minute exposure of fifty ppm of available chlorine at fifty-seven degrees Fahrenheit when used as an immersion or circulating solution. Chemical sanitizers applied as a spray or fog shall have as a minimum one-hundred ppm of available chlorine at fifty-seven degrees Fahrenheit or its equivalent in bactericidal action.

(4) One-tenth ppm ozone water solution in an enclosed system for at least five minutes.

(5) When containers are sanitized using a substance other than one provided for in 21 C.F.R. Part 178.1010, such substance shall be removed from the surface of the container by a rinsing procedure. The final rinse, prior to filling the container with product water, shall be performed with a disinfected water rinse free of pathogenic bacterial or by an additional sanitizing procedure equivalent in bactericidal action to that required in paragraph (D)(3) of this rule.

(E) Unit package production code.

Each unit package from a batch or segment of a continuous production run of bottled water shall be identified by a production code. The production code shall identify a particular batch or segment of a continuous production run and the day produced. The plant shall record and maintain information as to the kind of product, volume produced, date produced, lot code used, and the distribution of the finished product to wholesale and retail outlets.

(F) Filling, capping, or sealing.

(1) During the process of filling, capping or sealing either single-service or multiservice containers, the performance of the filler, capper or sealer shall be monitored and the filled containers visually or electronically inspected to assure they are sound, properly capped or sealed, and coded; and labeled.

(2) Containers which are not satisfactory shall be reprocessed or rejected.

(3) Only nontoxic containers and closures shall be used.

(4) All containers and closures shall be sampled and inspected to ascertain that they are free from contamination.

(5) At least once each three months, a bacteriological swab or rinse count or both shall be made from at least four containers and closures selected just prior to filling and sealing. No more than one of the four samples may exceed more than one bacteria per milliliter of capacity or one colony per square centimeter of surface area. All samples shall be free of coliform organisms.

Tests shall be performed either by personnel at the plant or an approved laboratory.

(G) Compliance procedures.

To assure that the plant's production of bottled water complies with this chapter, the plant will analyze product samples as follows:

(1) For bacteriological purposes, take and analyze at least once a week for total coliform a representative sample from a batch or segment of a continuous production run for each type of bottled water produced during a day's production. The representative sample shall consist of primary containers of product or unit packages of product.

(2) For chemical, physical, and radiological purposes, take and analyze at least annually a representative sample from a batch or segment of a continuous production run for each type of bottled water produced during a day's production. The representative sample(s) consists of primary containers of product of unit packages of product. If any coliform organisms are detected, follow-up testing must be conducted to determine whether any of the coliform organisms are E. coli. If the finished product is positive for E. Coli it is considered adulterated under section 3715.59 of the Revised Code.

(3) Analyze such samples by methods prescribed in 21 C.F.R. Part 165.110(b). The plant shall maintain records of date of sampling, type of product sampled, production code, and results of the analysis.

(H) Record retention.

All records required by rules 901:3-62-05 and 901:3-62-07 of the Administrative Code shall be maintained at the plant for not less than two years. Plants shall also retain, on file at the plant, current certificates or notifications of approval issued by the E.P.A. or the local board of health, or an engineer or hydrologist, as applicable, approving the plant's source and supply of product water and operations water. All required documents shall be available for official review at reasonable times.

(I) Quality.

Bottled water shall meet the standards of microbiological, physical, chemical, and radiological quality set forth in 21 C.F.R. Part 165.110.

(J) Bottled water containing a substance at a level considered injurious to health shall be considered adulterated under section 3715.59 of the Revised Code, regardless of whether or not the bottled water bears a label statement of substandard quality prescribed in paragraph (I) of this rule.

Last updated April 1, 2025 at 7:53 AM

History

Effective: April 1, 2025
Promulgated Under: 119.03