The purpose of this rule development is to clarify specific sanitation requirements that apply to facilities that utilize pasteurization and to those that do not utilize pasteurization. The proposed rule implements changes ....

 

DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES

Division of Food Safety

RULE NOS.:RULE TITLES:

5K-10.002Permits, Licenses and Inspections

5K-10.003Dating, Standards for Milk, Milk Products, Manufactured Milk Products and Frozen Desserts

5K-10.005Guidelines for Imposing Administrative Penalties

PURPOSE AND EFFECT: The purpose of this rule development is to clarify specific sanitation requirements that apply to facilities that utilize pasteurization and to those that do not utilize pasteurization. The proposed rule implements changes made to section 502.042, F.S., by removing the requirement that the Department conduct periodic shelf-life studies and periodic sampling of milk. The proposed rule sets out the shelf-life testing procedures and methods to be used by the Department for shelf-life testing when it verifies the shelf-life set by the producer or manufacturer. Additionally, the proposed rule removes an outdated reference to Rule 5D-10.001, Florida Administrative Code, and replaces it with the correct rule reference, Rule 5K-10.001, Florida Administrative Code. References to grade A milk are updated by capitalizing and adding quotation marks for proper terminology description of Grade “A”. The proposed rule also updates established guidelines for administering penalties for violations and institutes a more defined enforcement matrix for common issues found in the dairy industry.

SUMMARY: The proposed rule addresses the use of pasteurization for frozen desserts in accordance statutory changes to chapter 502, F.S., during the 2023 legislative session. The proposed changes clarify that facilities producing frozen desserts utilizing pasteurization are regulated pursuant to the rule and chapter 502, FS, and facilities producing frozen desserts that do not utilize pasteurization are regulated pursuant to chapter 500, FS. The proposed rule provides required updates to implement statutory changes to shelf-life requirements for certain dairy products. Section 581.217, F.S., sets out the state hemp program and the department’s regulatory authority thereof. This rulemaking provides administrative penalties for violations of regulations governing milk, milk products and frozen desserts and the hemp program, and allows the Department to ensure a safe food supply for consumers.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The Agency has determined that this rule will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the agency. The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or, if no SERC is required, the information expressly relied upon and described herein: The department’s proposed rules do not increase fees or otherwise impose any other costs, directly or indirectly, on the regulated industry. Based on this information, the department determined there will be no adverse impact to small businesses and the potential regulatory costs of the proposed rule chapter does not exceed any of the criteria established in section 120.541(2)(a), F.S. Additionally, no interested party submitted additional information regarding the economic impact. Any person who wishes to provide information regarding the statement of estimated regulatory costs or to provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 500.09, 502.014, 502.042, 570.07(23), 570.971(5), 581.217(12) F.S.

LAW IMPLEMENTED: 502.014, 502.042, 502.053, 502.091, 502.121, 502.165, 502.231, 581.217(7) F.S.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Ben Rosson at [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

5K-10.002 Permits, Licenses and Inspections.

(1) through (2) No change.

(3) Licenses for Frozen Dessert Plants, both in state and out-of-state, selling product in Florida.

(a) Frozen dessert plants utilizing pasteurization shall be subject to the requirements outlined in Chapter 502, F.S., and Rule Chapter 5K-10, F.A.C. A Frozen Ddessert Manufacturer as defined by Rule 5K-4.020, F.A.C., plants does that do not utilize pasteurization as outlined in Chapter 502, F.S., and shall be subject to the requirements outlined in Chapter 500, F.S., and Rule Chapter 5K-4, F.A.C.

(b) No change.

(4) through (6) No change.

(7) Routine Inspections and Tests.

(a) through (c) No change.

(d) Frozen Dessert Plants and Manufacturing Milk Plants within the state shall be subject to inspections based upon the criteria and frequency established for milk plant inspections in the PMO. Sampling and testing shall be quarterly, unless test results indicate a more frequent sampling and testing is necessary. Raw milk cheeses shall be tested for pathogens semi-annually.

(e) through (f) No change.

Rulemaking Authority 502.014 FS. Law Implemented 502.014, 502.053, 502.091, 502.165, 502.231 FS. History–New 9-21-67, Amended 1-26-81, 8-31-82, 8-16-84, Formerly 5D-1.03, Amended 10-9-86, 12-29-88, 6-27-90, 8-29-93, 7-2-95, 10-15-03, 4-14-08, Formerly 5D-1.003, Formerly 5K-4.042, Amended 6-20-22,            .

 

5K-10.003 Dating, Standards for Milk, Milk Products, Manufactured Milk Products and Frozen Desserts.

(1) Shelf-Life Dating and Expiration Dating.

(a) All milk and milk products shall be legibly labeled with their shelf-life date. The date or date code for frozen desserts and other manufactured milk products shall be approved by the department and shall indicate the date of manufacture of the product or the last day the product is to be offered for sale. The standards for labeling for all products shall be in accordance with 21 CFR, Part 101, adopted by reference in paragraph 5K-10.001(1)(e)5D-10.001(1)(e), F.A.C.

(b) through (d) No change.

(e) No milk or milk products shall be offered for sale as a Grade “A” grade A product after the shelf-life expiration date shown on the container. All milk and milk products offered for sale after the shelf-life expiration date will be deemed to be misbranded and subject to be impounded and made unsalable or otherwise disposed of by the department, under the provisions of Section 502.231, F.S.

(f) No change.

(g) Each processor shall establish certify to the department the maximum shelf-life of each product in the hands of the consumer under normal storage conditions. Provided, however, the maximum shelf-life of fluid uncultured milk pasteurized at less than 270 F shall not exceed ten days from date of packaging unless technical supporting justification has been supplied to the department, the department has confirmed such shelf-life claims, and specific authority to use a longer shelf-life has been granted by the department.

(2) Department Shelf – Life Testing and Testing Procedures.

When the Department tests shelf-life, the following testing procedures apply:

(a) Milk product samples shall not exceed the microbial count limits specified in this subsection when tested be held at 43 F (plus or minus 2 F) for the shelf life period plus four (4) days and analyzed to determine that shelf-life expiration dates stated on the containers assure the consumer of acceptable quality milk and milk products when kept under normal storage conditions. The temperature at the time of collection shall be officially recorded by the collector. Nothing herein contained shall be construed to prohibit the department from taking special samples for analysis and making special tests in order to assure all milk and milk products comply with the minimum standards of freshness, quality and palatability. In the event the department determines a processor’s or a manufacturer’s shelf-life for a given product is improper, the department shall immediately take such samples as are necessary for full and complete recheck of the shelf-life of the product. If the full and complete recheck confirms that the shelf-life of the product is improper, the department shall serve written notice on the processor or manufacturer and the processor or manufacturer immediately upon receipt of such notice shall alter the shelf-life expiration date of the product to comply with the department tests. Compliance shall be with the next processing of the product after receipt of such department notice. Failure of the processor or manufacturer to timely correct the shelf-life expiration date of the product will result in a stop-sale order pursuant to section 502.231(4), F.S.

(b) To extend the shelf-life expiration date of a qualifying product, the processor shall submit a written request to the Bureau of Dairy Industry specifying the product to be tested and supplying test results which indicate that the product is acceptable for at least ten (10) days or for an additional two (2) days over the current code period. This information must be compiled from current records that cover a period of at least thirty (30) days. The department will collect in Florida two series of duplicate samples of the product during a four week period. The first duplicate sample will be used for routine analysis, the second will be stored at 43° F plus or minus 2° F until six (6) days past the expiration date and then evaluated as acceptable or unacceptable. Both series of samples must be acceptable for six (6) days past the expiration date for the extension request to be granted. If acceptable, the processor will be notified in writing and the product must remain at this new code level for at least six (6) months before any additional code is requested. If unacceptable, the processor will be notified in writing and at least six (6) months must pass before another request is initiated for the product. Milk product samples tested by the department shall be tested in accordance with the method adopted in Rule 5K-10.001(1)(m), Florida Administrative Code. The microbial counts for milk products shall not exceed 30 million colony forming units (CFU)/ml.

(3) Chemical, bacteriological and temperature standards for manufacture of Grade “A” grade A products:

Grade “A” A raw milk for pasteurization, ultra pasteurization or aseptic processing.

Temperature, Bacterial Limits, Drugs, and Somatic	Standards shall be the same as those listed in Section 7 of the PMO.
Cell Count
Added Water	Freezing point not to exceed -0.526º H.

Grade “A” A pasteurized or ultra pasteurized milk and milk products and bulk shipment heat treated milk products.

Temperature, Bacterial Limits, Coliform, Phosphatase, and Drugs	Standards shall be the same as those listed in Section 7 of the PMO.
Added Water	Freezing point not to exceed -0.526º H.

Grade “A” A aseptically processed milk and milk products.

Temperature, Bacterial Limits and Limits and Drugs	Standards shall be the same as those listed in Section 7 of the PMO.
Added Water	Freezing point not to exceed -0.526º H.

(4)-(5) No change.

Rulemaking Authority 502.014, 502.042 FS. Law Implemented 502.014, 502.042, 502.091 FS. History–New 9-21-67, Amended 9-26-69, 12-24-71, 1-26-81, 8-31-82, 8-16-84, Formerly 5D-1.07, Amended 10-9-86, 5-19-87, 12-29-88, 6-27-90, 8-29-93, 12-4-94, 7-2-95, 10-15-03, 4-14-08, Formerly 5D-1.007, Formerly 5K-4.043, Amended 6-20-22,              .

 

5K-10.005 Guidelines for Imposing Administrative Penalties.

(1) This rule sets forth the guidelines the Department will follow in imposing the penalties authorized under Chapter 502, F.S., for violations of Chapter 502, section 581.217, F.S., and this rule chapter. The purpose of these guidelines is to give notice of the range of penalties that will be imposed for a single violation within a three-year period. The three-year period shall be based on the date of the last administrative enforcement action imposed against the violator. These guidelines list aggravating and mitigating factors that, if present, will increase or reduce penalties to be imposed. No aggravating factors will be applied to increase a fine imposed for a single violation above the statutory maximum as follows:

(a) In the case of a frozen dessert plant licensee, the fine imposed for each violation shall not exceed $5,000 as provided in Section 570.971, F.S., for Class II category;

(b) In the case of failure to report the information described in Section 502.053(3)(d), F.S., the fine imposed shall not exceed ten percent of the license fee or $100, whichever is greater; and

(b)(c) In the case of any other violation, the fine imposed shall not exceed $1000 for each occurrence as provided in Section 570.971, F.S., for a Class I category.

(2) No change.

(3) The Department will enforce compliance with Chapter 502, section 581.217(7), F.S., and this rule chapter by issuing an administrative complaint, a stop-sale order, or stop-use order, notice of non-compliance, permit suspension or revocation for violations of Chapter 502, section 581.217(7), F.S., and this rule chapter.

(4) through (5) No change.

(6) Aggravating and Mitigating Factors. The Department will consider aggravating and mitigating factors in determining penalties for violations of Chapter 502, F.S., and this rule chapter. The factors shall be applied against each single count of the listed violation.

(a) Aggravating Factors:

1. through 2. No change.

3. Previous violations for the same or a similar offense that resulted in enforcement action, defined as follows:

a. First Offense. A violation of any law subject to penalty under Chapter 502 or section 581.217(7), F.S., when no disciplinary administrative complaints involving the same permitholder have been filed with the Agency Clerk within the three years preceding the date the current administrative complaint is issued.

b. Second Offense. A violation of any law subject to penalty under Chapter 502, or section 581.217(7), F.S., after one disciplinary administrative complaint involving the same permitholder has been filed with the Agency Clerk within the three years preceding the date the current administrative complaint is issued, even if the current violation is not the same as the previous violation.

c. Third and Any Subsequent Offense. A violation of any law subject to penalty under Chapter 502, or section 581.217(7), F.S., after two disciplinary administrative complaints involving the same permitholder has been filed with the Agency Clerk within the three years preceding the date the current administrative complaint is issued, even if the current violation is not the same as the previous violation.

4. through 10. No change.

(b) Mitigating Factors:

1. through 2. No change.

3. Acts of God or nature that impaired the ability of the violator to comply with Chapter 502, section 581.217, F.S., or this rule chapter.

4. through 7. No change.

(7) through (8) No change.

(9) Penalties.

(a) No change.

(b) Major Violations. Any violation of Chapter 502, section 581.217, F.S., or this rule chapter that may result in economic or physical harm to a person or may adversely affect the public health, safety, or welfare or creates a significant threat of such harm shall be considered a major violation.

1. Tier I major violations. Tier 1 Major major violations shall result in the issuance of a stop-sale order, or stop-use order, permit suspension and an administrative fine of $500 up to the statutory maximum, or any combination thereof. Aggravating factors, as defined in paragraph (6)(a) of this rule, shall warrant the adjustment of the fine upward per violation per aggravating factor and mitigating factors, as defined in paragraph (6)(b) of this rule, shall warrant the adjustment of the fine downward per violation per mitigating factor, but no fine shall exceed the statutory maximum as outlined in section 570.971, F.S., as applicable. If, three years after the day of the last violation under Chapter 502, F.S., or this rule chapter, no new violation has occurred, all previous fines shall be disregarded when administering a fine for the next violation.   For the purposes of this rule, the following violations shall be considered majorTier I violations:

a. through m. renumbered 1. through 13. No change.

2. Tier II Major Violations. Tier II violations shall result in the issuance of a stop-sale or stop-use order and an administrative fine of $500 up to the statutory maximum. Aggravating factors, as defined in paragraph (6)(a) of this rule, shall warrant the adjustment of the fine upward per violation per aggravating factor and mitigating factors, as defined in paragraph (7)(b) of this rule, shall warrant the adjustment of the fine downward per violation per mitigating factor, but no fine shall exceed the statutory maximum as outlined in Section 570.971, F.S., as applicable. If, three years after the day of the last violation under Chapter 502, F.S., or this rule chapter, no new violation has occurred, all previous fines shall be disregarded when administering a fine for the next violation. For the purposes of this rule, the following violations shall be considered Tier II violations:

a. through b. renumbered 14. through 15. No change.

16.c. Operating as a dairy establishment or frozen dessert plant establishment without a valid dairy permit, as provided in Section 502.053, F.S.

d. through f. renumbered 17. Through 19. No change.

3. renumbered (c) No change.

a. through 1. renumbered 1. through 12. No change.

(10) No change.

Rulemaking Authority 500.09, 502.014, 570.07(23), 570.971(5), 581.217(12) FS. Law Implemented  500.172, 502.014, 502.053, 502.091, 502.121, 502.231, 581.217(7) FS. History–New 6-29-22,            .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Jennifer Lester, Bureau Chief

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Commissioner of Agriculture Wilton Simpson

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: 07/10/2024

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 07/14/2023