The purpose of this rulemaking is to align sanitation requirements between facilities that use pasteurizations that those that do not; update the methodology used for conducting periodic shelf life studies required pursuant ....

 

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

PURPOSE AND EFFECT: The purpose of this rulemaking is to align sanitation requirements between facilities that use pasteurizations that those that do not; update the methodology used for conducting periodic shelf life studies required pursuant to section 502.042, F.S. (replaces the organoleptic method in favor of a microbial count method).

SUMMARY: 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. Frozen dessert plants that do not utilize pasteurization as outlined in Chapter 502, F.S., shall be subject to the requirements outlined in Chapter 500, F.S., and Rule Chapter 5K-4, F.A.C. Replace the organoleptic only shelf-life study with a microbiological enumeration shelf-life study in order to utilize a more consistent and objective method to conduct shelf-life studies.

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 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 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: 502.014, 502.042, FS.

LAW IMPLEMENTED: 502.014, 502.032, 502.042, 502.053, 502.091, 502.165, 502.231 FS.

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: Jennifer Lester by email 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 local 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. Frozen dessert plants that do not utilize pasteurization as outlined in Chapter 502, F.S., shall be subject to the requirements outlined in Chapter 500, F.S., and Rule Chapter 5K-4, F.A.C. Every frozen dessert plant that manufactures “frozen desserts” and other foods as defined in Section 503.011, F.S., 21 CFR Part 135, and this chapter, which is produced or offered for sale within the State of Florida, shall hold a valid State of Florida license.

(b) Frozen dessert plants shall meet the following requirements in order to secure and maintain said license:

1. Submit, with the appropriate fee, a properly completed application on Form DACS-05016 an Application for License as a Wholesale Manufacturer of Frozen Desserts and/or Mix FDACS 05016 (Rev. 10/07), hereby incorporated by reference and available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX with the required fee. The initial $200.00 application fee shall be paid in full with the initial permit application. The renewal $100.00 application fee shall be paid in full with the annual renewal permit application. A Wholesale Manufacturer of Frozen Dessert and/or Mix license for in-state and out-of-state plants shall expire on June 30 of each year. Copies may be obtained from the Department of Agriculture and Consumer Services, Division of Dairy Industry, 3125 Conner Boulevard, Tallahassee, Florida 32399-1650.

2. In-State Frozen Dessert Plant must also:

a. Submit facility plans for approval.

b. Submit a label for each product produced for review.

c. Pass a sanitiation inspection.

d. Make available all products being produced for sampling. Samples collected shall be analyzed for compliance with Rule 5K-10.003, F.A.C.

3. Out-of-State Frozen Dessert Plant must also submit.

a. A valid permit to produce “frozen desserts” from the responsible food or health regulatory agency.

b. A list of distribution points in Florida during initial permitting and during annual renewal.

c. Documentation evincing that samples taken within the previous six (6) months meet local, state, or federal food safety or health standards from the jurisdiction of origin. The sample results shall meet the requirements of Rule 5K-10.003, F.A.C.

2. Submit labels for approval.

a. In-State Plant must submit, for approval, a label for each product produced.

b. Out-of-State Plant must submit, for approval, a label for each product distributed in Florida.

3. Appropriate Facility Inspection.

a. In-State Plant must pass a sanitation inspection. Inspection criteria is that of the PMO.

b. Out-of-State Plant must submit its most recent inspection report from its local regulatory agency and provide a list of its distribution points in Florida.

(4) through (5) No change.

(6) Penalties for Enforcement and Reinstatement of Permits and Licenses.

(a) through (b) No change.

(c) Frozen Dessert Plant License.

1. When any requirement of Chapter 502, F.S., Chapter 503, F.S., or rule under this chapter is violated, the license holder is subject to the suspension of his license. The department shall forego suspension of the license if the product or products in violation are not sold or offered for sale.

2. Any frozen desserts plant whose license has been suspended may make written application for the reinstatement of its license. The standards for reinstatement are those set forth in the PMO for a milk plant.

(d) No change.

(7) No change.

Rulemaking Authority 502.014, 503.031 FS. Law Implemented 502.014, 502.032, 502.053, 502.091, 502.165, 502.231, 503.031, 503.041, 503.051 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_______.

 

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-1.001(1)(b), F.A.C.

(b) The microbial counts methods for the determination of the shelf-life of milk and milk products shall not exceed 30 million colony forming units (CFU)/mL be microbiological and organoleptical.

(c) through (g) No change.

(2) Shelf – Life Testing and Testing Procedures.

(a) No change.

(b) To extend the shelf-life expiration date of a qualifying product, the processor shall submit a written request to the Bureau Division 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.

(3) through (5) No change.

Rulemaking Authority 502.014, 502.042, 503.031 FS. Law Implemented 502.014, 502.042, 502.091, 503.031 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________.

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

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Nicole "Nikki" Fried, Commissioner

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: January 28, 2022

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: February 1, 2022