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This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and universities.

Chapter 901:11-3 | Ohio Frozen Dessert Rules

 
 
 
Rule
Rule 901:11-3-01 | Definitions.
 

As used in rules 901:11-3-01 to 901:11-3-09 of the Administrative Code:

(A) "21 C.F.R." means Title 21 of the Code of Federal Regulations (April 2023).

(B) "Drug" means:

(1) Articles recognized in the official United States pharmacopoeia, official homeopathic pharmacopoeia of the United States, or official national formulary;

(2) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal;

(3) Articles other than food intended to affect the structure or any function of the body of man or other animals; and

(4) Articles intended for use as a component of any articles specified in paragraph (B)(1), (B)(2), or (B)(3) of this rule, but does not include devices or their components, parts, or accessories.

(C) "Federal Food Drug and Cosmetic Act" means "FFD&CA" (March 2024 edition).

(D) "Nutrition Labeling and Education Act" means "NLEA" (November 2014 edition).

(E) "Official Methods" means the "Official Methods of Analysis of the AOAC International (OMA)" 22nd edition, Dr. William Horsitz, editor, published by AOAC International, Suite 500, 481 North Frederick Ave., Gaithersburg, Maryland 20877-2417 USA.

(F) "Officially Designated Laboratory" has the same meaning as defined in the "Grade A Pasteurized Milk Ordinance."

(G) "PMO" means the "Grade A Pasteurized Milk Ordinance" and its appendices (2019 revision) as adopted in rules 901:11-1-01 to 901:11-1-05 of the Administrative Code.

(H) "Standard Methods" means the "Standard Methods for the Examination of Dairy Products (SMEDP)", 18th edition 2024, edited by H. Michael Wehr, PhD, Jeffrey L. Komacki, PhD, Elliot T. Ryser, PhD and Cynthia M. Mangione, BA, American Public Health Association, 800 I Street, N.W., Washington, DC 02001.

Last updated October 31, 2024 at 8:27 AM

Supplemental Information

Authorized By: 917.02
Amplifies: 917.01
Five Year Review Date: 10/31/2029
Prior Effective Dates: 9/19/2007
Rule 901:11-3-02 | Standard of identity.
 

Frozen dessert means those articles of food denominated in 21 C.F.R. 135 Subpart B and shall conform to the descriptions contained therein, except for 21 C.F.R. 135.160 which is deleted in its entirety.

Last updated December 2, 2024 at 8:32 AM

Supplemental Information

Authorized By: 917.02
Amplifies: 917.02
Five Year Review Date: 11/30/2029
Prior Effective Dates: 9/20/1999
Rule 901:11-3-03 | Frozen dessert labeling.
 

(A) When a frozen dessert is made from the milk of an animal other than a cow, the animal species shall precede or follow the name of the product on the label.

(B) Retail packaged frozen desserts shall be legibly labeled in accordance with the applicable requirements of the Federal Food Drug and Cosmetic Act (FFD&CA), the Nutrition Labeling and Education Act (NLEA), regulations developed there under, and with:

(1) The name of the product;

(2) The net weight or volume;

(3) The name and address of the manufacturer; and

(4) Any other identification that may be required by the director.

(C) All commercial bulk packages of frozen desserts shall be adequately and legibly marked with:

(1) The name of the product;

(2) The net weight;

(3) The production code, date of manufacture or lot number;

(4) The name and address of the manufacturer; and

(5) Any other identification that may be required by the director.

Last updated October 31, 2024 at 8:27 AM

Supplemental Information

Authorized By: 917.02
Amplifies: 917.11
Five Year Review Date: 10/31/2029
Prior Effective Dates: 6/16/2018
Rule 901:11-3-04 | Chemical, bacteriological, and temperature standards.
 

(A) Raw milk or milk products intended for use in the manufacturing of frozen desserts shall not be accepted by the manufacturer of frozen desserts unless the milk and milk products meet the following standards at the time of delivery and are maintained by the manufacturer of frozen desserts through pasteurization:

(1) Temperature at forty-five degrees Fahrenheit (seven degrees Celsius) or less;

(2) Bacterial limits not to exceed three-hundred thousand parts per milliliter and tested in conjunction with the drug residue inhibitory substance test; and

(3) No positive results on a drug residue inhibitory substance test using methods that are analyzed at an officially designated laboratory using examinations in substantial compliance with the "Appendix N of the "PMO."

(B) Bulk loads of raw milk and milk products shall be pasteurized in accordance with rule 901:11-3-05 of the Administrative Code at the receiving plant prior to use in the manufacturing of finished products.

(C) Bulk loads of pasteurized milk or milk products shall be re-pasteurized in accordance with rule 901:11-3-05 of the Administrative Code at the receiving plant prior to use in the manufacturing of finished products.

(D) Frozen desserts made from pasteurized milk or milk products shall meet the following standards after pasteurization:

(1) Temperature at forty-five degrees Fahrenheit (seven degrees Celsius) or less;

(2) Bacterial limits not to exceed thirty thousand parts per milliliter; and

(3) Coliform not to exceed ten parts per milliliter.

(E) During at least four separate months within any consecutive six-month period, samples of each type of product produced will be collected for examination to determine the bacterial and/or coliform counts of the samples, in addition to determining the presence of drug residues.

(1) Whenever two of the last four bacteria or coliform counts exceed the standards established in paragraphs (A)(2), (D)(2) and (D)(3) of this rule, the director will send a written warning notice to the processor. The notice will be in effect so long as two of the last four consecutive samples exceed the bacterial or coliform standard.

(2) An additional sample will be taken no sooner than three days and no later than twenty-one days after sending of the warning notice required in paragraph (E)(1) of this rule. If this sample also exceeds the bacteria or coliform standards established in paragraphs (A)(2), (D)(2) and (D)(3) of this rule, the processor license shall be suspended until satisfactory compliance is obtained. The license may be reinstated by the director when an additional sample of the product(s) in violation is tested and found satisfactory.

(3) Whenever a drug residue test is positive following the standards established in paragraph (A)(3) of this rule, the procedures of the "Appendix N of the PMO" will be followed to identify the source of the positive result.

Last updated October 31, 2024 at 8:27 AM

Supplemental Information

Authorized By: 917.02
Amplifies: 917.02
Five Year Review Date: 10/31/2029
Prior Effective Dates: 9/20/2004, 6/16/2018, 6/7/2021
Rule 901:11-3-05 | Pasteurization.
 

(A) Frozen desserts shall be pasteurized by holding the mixture continuously at or above the following temperatures for not less than the corresponding time:

TemperatureTime
155 degrees F (69 degrees C)30 minutes
175 degrees F (80 degrees C)25 seconds
180 degrees F (83 degrees C)15 seconds
191 degrees F (89 degrees C)1.0 second
194 degrees F (90 degrees C)0.5 second
201 degrees F (94 degrees C)0.1 second
204 degrees F (96 degrees C)0.05 second
212 degrees F (100 degrees C)0.01 second

The equipment used and the operation of the equipment shall comply with section 7, item 16p and "Appendix H of the PMO," as adopted in Chapter 901:11-1of the Administrative Code.

(B) All milk and milk products, eggs, egg products, cocoa, cocoa products, emulsifiers, stabilizers, vitamins, and liquid sweeteners shall be added to the frozen dessert before it is pasteurized except in cases where:

(1) The processor demonstrates to the director's satisfaction that the addition of these ingredients prior to pasteurization will negatively impact the ability to produce the product or the quality of the product; and

(2) Records are maintained to the director's satisfaction showing the science proving the ingredients which are added after pasteurization are safe and suitable; and

(3) The ingredients are safely and sanitarily added to the frozen dessert product.

(C) Flavoring and coloring ingredients may be added after pasteurization when:

(1) The ingredient has been subjected to a prior heat treatment sufficient to destroy pathogenic microorganisms; or

(2) The ingredient has 0.85 per cent water activity or less when the water activity is calculated by dividing the water vapor pressure of the ingredient by the vapor pressure of pure water when at the same temperature as the ingredient; or

(3) The ingredient has a high acid content (pH level of 4.6 or below when measured at seventy-five degrees Fahrenheit (twenty-four degrees Celsius)) or high alkalinity (pH level greater than eleven when measured at seventy-five degrees Fahrenheit (twenty-four degrees Celsius)); or

(4) There is an alcohol content in the ingredient sufficient to assure that pathogenic microorganisms will not be transferred to the final product; or

(5) The ingredients consist of safe and suitable bacterial cultures; or enzymes; or

(6) The ingredients are dry sugars and salts; or

(7) The ingredients are subjected to any process acceptable to the director which will assure that the ingredient is free of pathogenic microorganisms.

(D) Frozen desserts may be pasteurized at a milk plant other than the milk plant where it is packaged for retail sale provided it is transported to the packaging milk plant in a tote using a single service liner which complies with the following specifications:

(1) Totes used to transport frozen dessert mix shall be:

(a) Constructed and managed to protect their contents from sun, freezing, and contamination;

(b) Constructed for ease of cleaning;

(c) Constructed of smooth, impervious, corrosion-resistant, nontoxic material;

(d) Kept in good repair;

(e) Kept clean; and

(f) Constructed to be fully enclosed when in transport. Provided, totes or containers of five gallon capacity or less are not required to be fully enclosed.

(2) The single service liner used to transport frozen dessert mix shall:

(a) Be fabricated from material complying with 21 C.F.R. parts 175 to 178;

(b) Be nontoxic;

(c) Be free from deleterious substances;

(d) Be free of coliform organisms; and

(e) Have a residual bacteria count not to exceed fifty per container, when the rinse test is used, or not over fifty colonies per eight square inches (one per square centimeter) of product contact surface, when the swab test is used. Testing procedures shall be in substantial compliance with the standard methods as defined in rule 901:11-3-01 of the Administrative Code.

(3) No substance capable of contaminating the frozen dessert mix shall be transported with the product.

Last updated October 31, 2024 at 8:27 AM

Supplemental Information

Authorized By: 917.02
Amplifies: 917.02
Five Year Review Date: 10/31/2029
Prior Effective Dates: 10/15/2007
Rule 901:11-3-06 | Incorporation by reference - good manufacturing practice, hazard analysis and risk-based preventive controls for human food.
 

The federal food safety regulations housed in 21 C.F.R. part 117 are adopted in their entirety with the exception of those provisions amended or deleted by this chapter.

All manufacturers of frozen desserts, as defined in division (M) of section 917.01 of the Revised Code, shall comply with the rules of this chapter to determine if the frozen dessert has been manufactured under such conditions that render the frozen dessert safe, unadulterated, and not misbranded, and shall be inspected at least once in a twelve-month period by the director.

Last updated October 31, 2024 at 8:27 AM

Supplemental Information

Authorized By: 917.02
Amplifies: 917.02
Five Year Review Date: 10/31/2029
Prior Effective Dates: 1/10/2013
Rule 901:11-3-07 | Amended definitions - good manufacturing practice, hazard analysis and risk-based preventive controls for human food.
 

As adopted in rule 901:11-3-06 of the Administrative Code, wherever used in 21 C.F.R. part 117, the following definitions are amended or replaced:

(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 the food safety processes and procedures of a manufacturer of frozen desserts.

(2) "Facility" means a manufacturer frozen desserts as defined in division (M) of section 917.01 of the Revised Code.

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

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

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

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

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

Last updated October 31, 2024 at 8:29 AM

Supplemental Information

Authorized By: 917.02
Amplifies: 917.02
Five Year Review Date: 10/31/2029
Prior Effective Dates: 9/20/2004
Rule 901:11-3-08 | Deleted regulations - good manufacturing practice, hazard analysis and risk-based preventive controls for human food.
 

Pursuant to rule 901:11-3-06 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;

(C) 21 C.F.R. 117.257;

(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; and

(L) 21 C.F.R. 117.287.

Last updated October 31, 2024 at 8:29 AM

Supplemental Information

Authorized By: 917.02
Amplifies: 917.02
Five Year Review Date: 10/31/2029
Prior Effective Dates: 6/6/2005, 10/15/2007
Rule 901:11-3-09 | Modifications - good manufacturing practice, hazard analysis and risk-based preventive controls for human food.
 

Pursuant to rule 901:11-3-06 of the Administrative Code, the following sections of the 21 C.F.R. 117 shall be amended to read as follows:

(A) 21 C.F.R. 117.5(a) will read as:

"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."

(C) 21 C.F.R. 117.251 will read as:

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

(D) 21 C.F.R. 117.320 will read as:

"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 will read as:

"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 and section 917.17 of the Revised Code."

Last updated October 31, 2024 at 8:29 AM

Supplemental Information

Authorized By: 917.02
Amplifies: 917.02
Five Year Review Date: 10/31/2029
Prior Effective Dates: 9/20/2004, 10/15/2007