Update definitions and incorporated materials used in the dairy regulatory program to better align with federal regulations.

 

DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES

Division of Food Safety

RULE NO.:RULE TITLE:

5K-10.001Documents Incorporated by Reference and Definitions

PURPOSE AND EFFECT: Update definitions and incorporated materials used in the dairy regulatory program to better align with federal regulations.

SUMMARY: This rulemaking is to update definitions and adoptions of federal regulatory documents used in the dairy regulatory program for the State of Florida to maintain consistency with regulations at the federal level and as required for Florida’s participation in the National Conference on Interstate Milk Shipments.

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 do 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, 570.07(23), FS.

LAW IMPLEMENTED: 502.012, 502.014, 502.053, 502.091, 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: Zach Conlin by email at [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

“Substantial rewording of Rule 5K-10.001 follows. See Florida Administrative Code for present text.”

5K-10.001 Documents Incorporated by Reference and Definitions.

(1) The following materials are hereby incorporated by reference and shall apply in the interpretation and enforcement of Chapter 502, F.S. Copies of all referenced materials are available at the Florida Department of Agriculture and Consumer Services, Division of Food Safety, Bureau of Dairy Industry, 3125 Conner Boulevard, Suite C, Tallahassee, Florida 32399-1650 and online as indicated.

(a) Grade A Pasteurized Milk Ordinance (“PMO”), 2017 Revision, Public Health Service/Food and Drug Administration, its Appendices and notes available online at http://www.flrules.org/Gateway/reference.asp?No=RefXXXX.

(b) The  Procedures  Governing  the  Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipments, 2017 Revision, available online at http://www.flrules.org/Gateway/reference.asp?No=RefXXXX.

(c) Methods  of  Making  Sanitation  Rating  of Milk Shippers and the Certification/Listings of Single-Service Containers and/or Closures for Milk and/or Milk Products Manufacturers (MMSR), 2017 Revision, available online at http://www.flrules.org/Gateway/reference.asp?No=RefXXXX.

(d) Evaluation of Milk Laboratories, 2017 Revision, available online at http://www.flrules.org/Gateway/reference.asp?No=RefXXXX.

(e) 21 Code of Federal Regulations, Parts 7, 11,101, 108, 110, 113, 114, 117, 130.10, 130.17, 131, 133, 135, 173.10, 174-178, 182.6285, 184.1666, 184,1979, 1240.61, Revised April 1, 2017, available online at http://www.flrules.org/Gateway/reference.asp?No=RefXXXX.

(f) 40  Code  of  Federal  Regulations, Parts 141,  152.500,  156.10, 158, 180.940, Revised July 1, 2017 and available online at http://www.flrules.org/Gateway/reference.asp?No=RefXXXX.

(g) 7 Code of Federal Regulations, Part 58, Subpart B, 58.101(e), (g), (n), (t), (u), (v), (w); 58.125-58.131; 58.142, 58.147; 58-148 (B)-(F); 58.150-58.154; 58.205-58.247; 58.305-58.344; 58.405-58.445; 58.605-58.645; 58.647-58.654; 58.705-58.732; and 58.805-58.811, Revised January 1, 2017, available online at http://www.flrules.org/Gateway/reference.asp?No=RefXXXX.

(h) Frozen Desserts Processing Guidelines, 1st edition, October 1989 published by the Milk Safety Branch, Division of Cooperative Programs, U.S. Food and Drug Administration. Copies are available for inspection during regular business hours at the Florida Administrative Code and Register, R.A. Gray Building, 500 South Bronough Street, Tallahassee, FL 32399-0250 and at the Florida Department of Agriculture and Consumer Services, Division of Food Safety, 3125 Conner Boulevard, Tallahassee, FL 32399-1650. Posting of the aftermentioned materials on the internet for purposes of public examination would violate federal copyright law.

(i) United States Standards for Grades of Nonfat Dry Milk (Spray Process), February 2, 2001. Available online at http://www.flrules.org/Gateway/reference.asp?No=RefXXXX.

(j) United States Standards for Grades of Whole Dry Milk, April 13, 2001. Available online at http://www.flrules.org/Gateway/reference.asp?No=RefXXXX.

(k) United States Standards for Dry Whey, December 14, 2000. Available online at http://www.flrules.org/Gateway/reference.asp?No=RefXXXX.

(l) Milk for Manufacturing Purposes and its Production and Processing (“MMPPP”), July 21, 2011. Available online at http://www.flrules.org/Gateway/reference.asp?No=RefXXXX.

(m)Standard Methods for the Examination of Dairy Products, 17th Edition, June 1, 2004 published by the American Public Health Association. Copies may be obtained from APHA Headquarters, 800 I Street N.W., Washington D.C. 20001or https://secure.apha.org/imis/APHA/Store/Search_Bookstore and are also available for public inspection during regular business hours at the Florida Administrative Code and Register, R.A. Gray Building, 500 South Bronough Street, Tallahassee, FL 32399-0250 and at the Florida Department of Agriculture and Consumer Services, Division of Food Safety, 3125 Conner Boulevard, Tallahassee, FL 32399-1650. Posting of the aftermentioned materials on the internet for purposes of public examination would violate federal copyright law.

(n) Standard Methods for the Examination of Water and Wastewater, 23rd Edition, (2017), published by the American Public Health Association, American Water Works Association, Water Environment Federation. Copies may be obtained from AWWA, 6666 W. Quincy Ave., Denver, CO 80235 or https://www.awwa.org/Store/Product-Details/productId/65266295, and are also available for public inspection during regular business hours at the Florida Administrative Code and Register, R.A. Gray Building, 500 South Bronough Street, Tallahassee, FL 32399-0250 and at the Florida Department of Agriculture and Consumer Services, Division of Food Safety, 3125 Conner Boulevard, Tallahassee, FL 32399-1650. Posting of the aftermentioned materials on the internet for purposes of public examination would violate federal copyright law.

(2) Definitions. In addition to the definitions in Chapter 502, F.S., and the definitions in the materials incorporated by reference, the following definitions shall apply:

(a) “Adulterated” means any milk, milk product or frozen dessert if:

1. It bears or contains any poisonous or deleterious substance in a quantity which may render it injurious to health.

2. It consists, in whole or in part, of any substance unfit for human consumption.

3. It has been produced, processed, prepared, packed, or held under unsanitary conditions.

4. Its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health, or;

5. Any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, reduce its quality or strength, or make it appear better or of greater value than it is.

(b) “Bulky Flavored” means Frozen desserts, Mix or other defined products flavored with a bulky flavor ingredient such as chocolate, fruit, nut, malted milk, confectionery, or cereal.

(c) “Bulk Milk Hauler/Sampler” means any person who collects official samples and may transport raw milk from a farm and/or raw milk products to or from a milk plant, receiving station or transfer station and has in their possession a permit from any Regulatory Agency to sample such products. This term also includes “milk haulers.”

(d) “Bulk Milk Hauling Service” means any person who hauls or causes to be hauled bulk milk or milk products from a dairy farm, transfer station, receiving station or milk and milk products plant to another location and/or a person or entity responsible for a bulk milk pickup tanker.

(e) “Butter” means a food product usually known as butter, and which is made exclusively from milk or cream, or both, with or without common salt, with or without additional coloring matter, and containing not less than 80 percent by weight of milkfat, of which all tolerances having been allowed.

(f) “Certified Direct Load Operator” means any person permitted by the Department and employed by a milk producer to operate a direct load system on a permitted dairy farm. This includes the cleaning and sanitizing of in-line samplers and the preparation of bulk milk tankers to receive raw milk from the dairy farm.

(g) “Cheese” means a fresh or matured product obtained by draining after coagulation of milk, cream, skimmed, or partly skimmed milk or a combination of some or all of these products and including any cheese that conforms to the requirements of the Food and Drug Administration for cheeses and related cheese products in 21 CFR part 133 incorporated by reference in paragraph (1)(e).

(h) “Degraded milk” means milk that fails to meet the minimum requirements of subsection 5K-10.003(3), F.A.C.

(i) “Department” means the Department of Agriculture and Consumer Services.

(j) “Depot” means any place, premise or establishment in which Mix, Frozen desserts, defined products, ingredients, containers, or supplies are stored for further distribution.

(k) “Frozen Yogurt” means food which is prepared by freezing, while stirring, a Mix composed of one or more of the optional dairy ingredients provided for in ice cream and frozen custard and which may contain other safe and suitable ingredients. Its dairy ingredients, with or without other ingredients, is (are) pasteurized and subsequently cultured with bacteria, Lactobacillus bulgaricus and Streptococcus thermophilus. The titratable acidity of the cultured frozen yogurt may not be less than 0.5 percent, calculated as lactic acid, except if the frozen yogurt is flavored by the addition of a non-fruit characterizing ingredient(s). Its milkfat content may not be less than 3.25 percent by weight, except that when bulky characterizing ingredients are used the percentage milkfat may not be less than 2.5 percent. The finished frozen yogurt shall weigh not less than 5 pounds per gallon.

(l) “Interstate Milk Shippers (IMS) List” means a list of facilities certified by Milk Sanitation Rating Officers as having attained a score of 90% or greater for sanitation and enforcement compliance rating based on the USPHS/FDA Grade “A” Pasteurized Milk Ordinance, 2017 Revision incorporated by reference in paragraph (1)(a) and produce products in accordance with the procedures set forth in the Methods of Making Sanitation Rating of Milk Shippers and the Certifications/Listing of Single Service Containers and/or Closures for Milk and/or Milk Products Manufacturers (MMSR), 2015 Revision incorporated by reference in paragraph (1)(c).

(m) “Manufacturing Milk Plant” means any place, premises, or establishment where milk is received, collected and used for the production of non-Grade “A” dairy products, such as cheese and butter.

(n) “Manufactured Milk Products” include cheese, butter, non-Grade “A” milk powder, evaporated and condensed milk and such other products, for human consumption, as may be otherwise designated.

(o) “Mix” means a blend of milk, cream, sugar, and stabilizers that could have flavoring packaged for commercial use to be made into ice cream.

(p) “Sealed” means to secure or fasten an opening, connection, or device to prevent intentional and/or unintentional adulteration or tampering of the device or product within.

(q) “Single-Service Container Manufacturer” means any place, premises, or establishment that produces containers and closures used for packaging milk and/or milk products intended for only one (1) use.

(r) “Sold” means a transfer of milk or milk products that involves any direct or indirect form of compensation in exchange for the right to acquire such milk or milk products.

(s) “Temporary Seal Applicator” means any person permitted by the Department and employed by a manufacturing milk plant, wholesale manufacturer of Frozen dessert and/or Mix or milk plant, to test and replace public health seals on pasteurization equipment.

(t) “Wholesale Manufacturer of Frozen Dessert and/or Mix” means any place, premises or establishment that produces for wholesale distribution, Frozen dessert as defined in section 502.012, F.S., 21 CFR 135, and/or Mix as defined in paragraph (2)(o) of this rule. This term includes facilities within the State of Florida and facilities selling Frozen Dessert and/or Mix in Florida.

Rulemaking Authority 502.014, 570.07(23) 503.031 FS. Law Implemented 502.012, 502.014, 503.031 502.053, 502.091 FS. History–New 7-24-70, Amended 1-26-81, 8-31-82, 10-9-86, Formerly 5D-1.01, Amended 12-29-88, 6-27-90, 8-29-93, 12-4-94, 7-2-95, 11-29-95, 10-15-03, 4-14-08, Formerly 5D-1.001, Formerly 5K-4.041, Amended                             .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Zach Conlin

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 08, 2020

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: November 26, 2019