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PA Bulletin, Doc. No. 19-1138




[ 7 PA. CODE CH. 59a ]

Milk Sanitation

[49 Pa.B. 3897]
[Saturday, July 27, 2019]

 The Department of Agriculture (Department) amends § 59a.402 (relating to raw milk; prohibitions) to read as set forth in Annex A.

Effective Date

 This final-form rulemaking will be effective upon publication in the Pennsylvania Bulletin.


 This final-form rulemaking is authorized under the act of July 2, 1935 (P.L. 589, No. 210) (31 P.S. §§ 645—660g), known as the Milk Sanitation Law (act), which establishes the powers and duties of the Department with respect to milk sanitation. Section 19 of the act (31 P.S. § 660c) authorizes the Department to adopt the regulations necessary to administer the act. This final-form rulemaking is also authorized under 3 Pa.C.S. §§ 5721—5737 (relating to Food Safety Act), which: 1) authorize the Department to promulgate regulations and food standards necessary for enforcement of 3 Pa.C.S. §§ 5721—5737; 2) defines certain ''Federal acts'' including the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. §§ 301—399i); and 3) encourage consistency among the Department's food safety regulations and the defined Federal acts and their attendant regulations. See 3 Pa.C.S. §§ 5722, 5733(a) and 5736(a) (relating to definitions; rules and regulations; and construction of subchapter).

Background and Summary

 The United States Food and Drug Administration's (FDA) regulations in 21 CFR Part 133, Subpart B (relating to requirements for specific standardized cheese and related products) were promulgated under the authority of the Federal Food, Drug, and Cosmetic Act, and establish standardized definitions and requirements for 72 different kinds of cheese. These same Federal regulations allow for 57 of these standardized cheeses to be produced from raw (unpasteurized) milk.

 Section 59a.402 addresses the types of cheese that can be produced from raw milk and is more restrictive than 21 CFR Part 133, Subpart B. The Department is satisfied that the FDA's raw milk cheese standards are reasonable and represent the current state of food science with respect to the safe production of raw milk cheeses. There is no practical reason for the Department's raw milk cheese standards to be any more stringent than the FDA's raw milk cheese standards. This final-form rulemaking will also further the objective of 3 Pa.C.S. §§ 5721—5737 to make the Department's food regulations consistent with the FDA's food safety regulations.

 This final-form rulemaking will revise § 59a.402 to allow the holder of a raw milk permit to obtain an additional permit from the Department, authorizing the manufacture and sale of cheese from raw milk if: 1) the type of cheese that is being produced is a standardized cheese under the FDA's standards; and 2) the FDA's standards allow that type of standardized cheese to be produced from raw milk. This revision will bring this Commonwealth into alignment with FDA standards and allow the manufacture and sale of cheese from raw milk to the full extent allowed under the FDA standards. It will also allow manufacturers of raw milk cheese to market a greater variety of raw milk cheeses and provide consumers a wider selection of these cheeses.

Response to Comments

 Notice of proposed rulemaking was published at 48 Pa.B. 4761 (August 4, 2018), with a 30-day public comment period.

 The Department received a total of 10 comments from the public. The commentators included the Pennsylvania Cheese Guild, the Pennsylvania Farm Bureau, Oldways Cheese Coalition, the Real Food Consumer Coalition and six individuals. Each of these commentators offered support for the proposed rulemaking as written, without recommending any revisions. Commentators noted the benefits of aligning this Commonwealth's raw milk cheese standards with existing Federal standards of identity for cheese, and believe the rulemaking will bring economic benefits to the raw milk cheese industry and provide consumers a wider variety of raw milk cheeses in the marketplace.

 The Department appreciates these comments and agrees with the sentiments expressed by the commentators.

 The Independent Regulatory Review Commission (IRRC) had no objections, comments or recommendations to offer on the proposed rulemaking.

Fiscal Impact


 This final-form rulemaking will have no fiscal impact on the Commonwealth.

Political Subdivisions

 This final-form rulemaking will have no fiscal impact on political subdivisions.

Private Sector

 This final-form rulemaking will have some fiscal impact on the private sector. Businesses that manufacture raw milk cheese will benefit from being able to market a greater variety of raw milk cheeses. There are approximately 90 of these manufacturers.

General Public

 This final-form rulemaking will have no appreciable impact on the general public, other than to make a greater variety of Pennsylvania-made raw milk cheeses available to consumers.

Paperwork Requirements

 This final-form rulemaking will not add to paperwork requirements for any entity or the Department. The persons who are currently making raw milk cheese under authority of Department-issued permits are the same group that will be producing the expanded variety of standardized raw milk cheeses when the final-form regulation is promulgated. New permits or paperwork will not be necessary.

Regulatory Review

 Under section 5(a) of the Regulatory Review Act (71 P.S. § 745.5(a)), on July 25, 2018, the Department submitted a copy of proposed rulemaking, published at 48 Pa.B. 4761, to IRRC and the Chairpersons of the House and Senate Agriculture and Rural Affairs Committees for review and comment.

 Under section 5(c) of the Regulatory Review Act, the Department is required to submit to IRRC and the referenced Legislative Standing Committees copies of comments received during the public comment period, as well as other documents when requested. The Department provided the required copies of comments it received. No other documents were requested by the Legislative Standing Committees.

 Under section 5.1(j.2) of the Regulatory Review Act (71 P.S. § 745.5a(j.2)), on June 19, 2019, this final-form rulemaking was deemed approved by the House and Senate Agriculture and Rural Affairs Committees. IRRC did not comment on, make recommendations regarding or object to any portion of the proposed rulemaking, and the Department did not make any changes to the proposed rulemaking. Thus, under section 5.1(e) of the Regulatory Review Act (71 P.S. § 745.5a(e)), IRRC met on June 20, 2019, and this final-form rulemaking was deemed approved under section 5(g) of the Regulatory Review Act.

Additional Information

 Additional information may be obtained from Lydia Johnson, Ph.D., Director, Bureau of Food Safety and Laboratory Services, Department of Agriculture, 2301 North Cameron Street, Harrisburg, PA 17110-9408, (717) 787-4315.


 The Department finds that:

 (1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P.L. 769, No. 240) and regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2.

 (2) A public comment period was provided as required by law.

 (3) The amendments to the regulations of the Department are necessary and appropriate for the administration of the authorizing statute.


 The Department, acting under its authorizing statute, orders that:

 (a) The regulations of the Department, 7 Pa. Code Chapter 59a are amended by amending § 59a.402 to read as set forth in Annex A.

 (b) The Department shall submit a copy of this final-form regulation to the Office of the Attorney General and the Office of General Counsel for approval as required by law.

 (c) The Department shall submit this final-form regulation to IRRC and the committees as required by law.

 (d) The Department shall certify this final-form regulation and deposit it with the Legislative Reference Bureau as required by law.

 (e) This final-form regulation shall take effect immediately upon publication in the Pennsylvania Bulletin.


 (Editor's Note: See 49 Pa.B. 3546 (July 6, 2019) for IRRC's approval order.)

Fiscal Note: Fiscal Note 2-191 remains valid for the final adoption of the subject regulation.

Annex A






§ 59a.402. Raw milk; prohibitions.

 (a) Sale of raw milk without permit. A person may not sell raw milk for human consumption without having a current raw milk permit issued by the Department. The term ''sell'' includes the selling, exchanging, delivering or having in possession, care, control or custody with intent to sell, exchange, or deliver or to offer or to expose for sale.

 (b) Actions authorized under a raw milk permit. A raw milk permit authorizes the permitholder to lawfully produce and sell (within this Commonwealth) raw whole milk for human consumption. It also authorizes the permitholder to obtain an additional permit, issued by the Department under authority of 21 CFR Part 133 (relating to cheese and related cheese products), authorizing the sale of cheese manufactured from raw milk if all of the following apply:

 (1) The cheese is a standardized cheese identified in 21 CFR Part 133, Subpart B (relating to requirements for specific standardized cheese and related products).

 (2) The standards for that cheese allow for it to be manufactured from raw milk.

 (c) Compliance with testing and documentation requirements. A person may not sell raw milk for human consumption without being in compliance with the testing and documentation requirements of this section.

[Pa.B. Doc. No. 19-1138. Filed for public inspection July 26, 2019, 9:00 a.m.]

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