PROPOSED RULEMAKING
DEPARTMENT OF AGRICULTURE
[ 7 PA. CODE CH. 59a ]
Milk Sanitation
[48 Pa.B. 4761]
[Saturday, August 4, 2018]The Department of Agriculture (Department) proposes to amend § 59a.402 (relating to raw milk; prohibitions) to read as set forth in Annex A.
Authority
This proposed 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 proposed 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) define certain ''Federal acts'' as 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).
Need for this Proposed Rulemaking
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 authority of the Federal Food, Drug, and Cosmetic Act, and establish standardized definitions and requirements for 72 different kinds of cheese. These Federal regulations allow for 57 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. The proposed 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 proposed rulemaking would bring the 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 would 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.
Summary of this Proposed Rulemaking
Section 59a.402 is proposed to be amended 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.
Persons Likely to be Affected
The beneficiaries of this proposed rulemaking will be cheese manufacturers in this Commonwealth who produce cheese from raw milk. There are approximately 90 manufacturers. These manufacturers will be able to market a greater variety of raw milk cheeses and able to better compete with counterparts from other states. This proposed rulemaking will also benefit consumers to the extent there will be a wider variety of Pennsylvania-produced raw milk cheeses in the marketplace.
Fiscal Impact
Commonwealth
This proposed rulemaking would not have fiscal impact on this Commonwealth.
Political subdivisions
This proposed rulemaking would not have fiscal impact on political subdivisions.
Private sector
This proposed rulemaking would have some fiscal impact on the private sector. In particular, businesses that manufacture raw milk cheese (of which there are approximately 90 businesses) would benefit from being able to market a greater variety of raw milk cheeses.
General public
This proposed rulemaking would not have 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 proposed 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 rulemaking 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 this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House and Senate Standing Committees on Agriculture and Rural Affairs. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria in section 5.2 of the Regulatory Review Act (71 P.S. § 745.5b) which have not been met. The Regulatory Review Act specifies detailed procedures for review prior to final publication of the rulemaking by the Department, the General Assembly and the Governor.
Effective Date
This proposed rulemaking will be effective upon final-form publication in the Pennsylvania Bulletin.
Public Comments
Interested persons are invited to submit written comments, suggestions or objections regarding this proposed rulemaking to 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 within 30 days of the publication of this proposed rulemaking in the Pennsylvania Bulletin.
Contact Person
The contact person for technical questions regarding this proposed rulemaking is 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.
RUSSELL C. REDDING,
SecretaryFiscal Note: 2-191. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 7. AGRICULTURE
PART III. BUREAU OF FOOD SAFETY AND LABORATORY SERVICES
Subpart B. LIQUID FOODS
CHAPTER 59a. MILK SANITATION
Subchapter F. RAW MILK FOR HUMAN CONSUMPTION § 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 133.150 (relating to hard cheeses), authorizing the sale of aged cheese manufactured from raw milk.] 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. 18-1221. Filed for public inspection August 3, 2018, 9:00 a.m.]
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