RULES AND REGULATIONS
Title 7--AGRICULTURE
DEPARTMENT OF AGRICULTURE
[7 PA. CODE CH. 59]
Milk Sanitation
[33 Pa.B. 4445] The Department of Agriculture (Department) amends Chapter 59 (relating to milk sanitation). The revisions: (1) reformat and add several new defined terms to § 59.1 (relating to definitions); and (2) revise § 59.22 (relating to milk dating) to extend the current 14-day maximum ''sell-by'' period for pasteurized milk to 17 days, clarify the exceptions to that sell-by date requirement and describe the milk quality sampling and testing that will be performed by the Department.
Statutory Authority
The act of July 2, 1935 (P. L. 589, No. 210) (31 P. S. §§ 645--660g) (act) provides the legal authority for this final-form rulemaking. In particular, section 21 of the act (31 P. S. § 660e) makes the Department generally responsible for the safety and wholesomeness of the milk supply and allows the Department to exclude milk from commerce if it fails to meet the requirements of the act, and section 19 of the act (31 P. S. § 660c) authorizes the Department to regulate for the proper enforcement of the act.
Need for the Final-Form Rulemaking
The primary purpose of the final-form rulemaking is to amend § 59.22 to extend the maximum sell-by date for pasteurized milk by 3 days. The current maximum sell-by date is 14 days beginning after midnight of the date of pasteurization. Modern processing and refrigeration allow for the production of pasteurized milk that can remain on-the-shelf for longer periods of time without bacterial growth exceeding acceptable limits. The final-form rulemaking follows the trend among states to extend sell-by dates for pasteurized milk, whether by designating a maximum sell-by period (as the final-form rulemaking does) or allowing individual producers to demonstrate their pasteurization and refrigeration processes result in dairy products that remain within acceptable bacterial limits for the period in which they are marketed to consumers.
The final-form rulemaking also reformats § 59.1. The section was divided into two subsections, one containing ''general definitions'' and the other containing definitions related to ''milk and milk products.'' The final-form rulemaking deletes these subsection designations and combines the two sets of terms and definitions into a single, more readable set.
The final-form rulemaking also revises § 59.1 by adding definitions of ''aseptically processed dairy products'' and ''higher heat shorter time pasteurization,'' two terms describing relatively recent advances in the processing of dairy products. These processes result in milk with a longer shelf life than milk processed through typical pasteurization processes. Section 59.22(d) exempts milk processed through either of these methods (and several other methods) from the sell-by date requirements described in that section.
Section 59.22 describes the process by which the Department will sample and analyze pasteurized milk to ensure it does not exceed bacterial limits prescribed by regulation.
In summary, the Department is satisfied there is a need for the revisions accomplished by this final-form rulemaking.
Comments
Notice of proposed rulemaking was published at 32 Pa.B. 4717 (September 28, 2002), and provided for a 30-day public comment period. Comments were received from the Pennsylvania Association of Milk Dealers (Dealers) and the Independent Regulatory Review Commission (IRRC).
Comment: The Dealers represent the substantial majority of companies which process beverage milk sold in this Commonwealth, and offered its strong support for the increase in the maximum milk sell-by date to 17 days from date of pasteurization. The commentator believes the change will '' . . . help the industry adapt to the changing marketplace and grow stronger.''
Response: The Department accepts the comment without further response.
Comment: IRRC noted that proposed § 59.22(e) made reference to the Department ''periodically'' sampling containers of pasteurized milk, and suggested the final-form regulation include a specific time frame for this ''periodic'' sampling.
Response: The Department accepts this suggestion, and has implemented it in § 59.22(e)(1) of the final-form regulation by specifying this ''periodic'' sampling shall be at least one product from each processor or distributor each year. As a result of this comment and the other comments offered by IRRC, the Department divided § 59.22(e) into four paragraphs dealing with: (1) sampling requirements; (2) testing requirements; (3) the imposition of maximum sell-by dates of less than 17 days; and (4) resumption of 17-day maximum sell-by periods. This reformatting adds clarity to the section.
Comment: Proposed § 59.22(e) provided that the Department might require a milk processor to use a maximum sell-by date of something less than 17 days if two or more samples demonstrated the processor could not produce pasteurized milk that remained consistently within acceptable bacterial limits during a 17-day sell-by period. IRRC recommended the final-form rulemaking describe the procedure by which a milk processor could reestablish a 17-day sell-by date for its pasteurized milk.
Response: The Department accepts IRRC's recommendation and has implemented it in § 59.22(e)(2) and (3). The new language also clarifies that the analysis of samples is to be conducted by a ''Pennsylvania approved dairy laboratory''--a term defined in § 59.1.
Comment: On a subject closely related to the previous comment, IRRC requested the final-form rulemaking specify how the Department will establish a specific maximum sell-by date for a milk processor that cannot produce pasteurized milk that merits a 17-day maximum sell-by date.
Response: The Department has revised the final-form regulation to implement this request, in § 59.22(e)(3) and (4), to reflect that predicted bacterial growth shall determine the appropriate sell-by date.
Fiscal Impact
The final-form rulemaking does not impose any costs and has no fiscal impact upon the Commonwealth, political subdivisions or the general public.
The final-form rulemaking has no adverse fiscal impact upon the private sector. The extension of the maximum sell-by date for pasteurized milk is expected to have a favorable economic impact upon milk processors and milk retailers. These economic impacts cannot be readily quantified.
Paperwork Requirements
The final-form rulemaking does not appreciably increase the paperwork burden of the Department, local government units, milk producers, milk distributors or other affected entities.
Contact Person
Further information is available by contacting the Department of Agriculture, Bureau of Food Safety and Laboratory Services, 2301 North Cameron Street, Harrisburg, PA 17110-9408, Attention: James Dell, (717) 787-4316.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a), on September 18, 2002, the Department submitted a copy of the notice of proposed rulemaking published at 32 Pa.B. 4717 to IRRC and to the Chairpersons of the House and Senate Standing Committees on Agriculture and Rural Affairs for review and comment.
In compliance with section 5(c) of the Regulatory Review Act, the Department also provided IRRC and the Committees with copies of all comments received, as well as other documentation. In preparing this final-form rulemaking, the Department has considered all comments received from IRRC, the Committees and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on July 23, 2003, the House and Senate Committees deemed approved the final-form rulemaking. Under section 5.1(e) of the Regulatory Review Act, IRRC met on August 14, 2003, and approved the final-form rulemaking.
Findings
The Department finds that:
(1) Public notice of its intention to adopt the regulations encompassed by this order has been given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments received were considered.
(3) The modifications that were made to this final-form rulemaking in response to comments received do not enlarge the purpose of the proposed rulemaking published at 32 Pa.B. 4717.
(4) The adoption of the regulations in the manner provided in this order is necessary and appropriate for the administration of the authorizing statute.
Order
The Department, acting under authority of the authorizing statute, orders that:
(a) The regulations of the Department, 7 Pa. Code Chapter 59, are amended by amending § 59.1 to read as set forth at 32 Pa.B. 4717 and by amending § 59.22 to read as set forth in Annex A.
(b) The Secretary of Agriculture shall submit this order, 32 Pa.B. 4717 and Annex A to the Office of General Counsel and to the Office of Attorney General for approval as required by law.
(c) The Secretary of Agriculture shall certify this order, 32 Pa.B. 4717 and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) This order shall take effect upon publication in the Pennsylvania Bulletin.
DENNIS C. WOLFF,
Secretary(Editor's Note: For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 33 Pa.B. 4372 (August 30, 2003).)
Fiscal Note: Fiscal Note 2-141 remains valid for the final adoption of the subject regulations.
Annex A
TITLE 7. AGRICULTURE
PART III. BUREAU OF FOOD SAFETY AND LABORATORY SERVICES
Subpart B. LIQUID FOODS
CHAPTER 59. MILK SANITATION
Subchapter A. PRELIMINARY PROVISIONS
LABELING § 59.22. Milk dating.
(a) Label requirement. The cap or nonglass container of pasteurized milk held in retail food stores, restaurants, schools or similar food establishments for resale shall be conspicuously and legibly marked in a contrasting color with the designation of the ''sell-by'' date--the month and day of the month after which the product may not be sold or offered for sale. The designation may be numerical--such as ''8-15''--or with the use of an abbreviation for the month, such as ''AUG 15 or AU 15.'' The words ''Sell by'' or ''Not to be sold after'' shall precede the designation of the date, or the statement ''Not to be sold after the date stamped above'' shall appear legibly on the container. This designation of the date may not exceed 17 days beginning after midnight on the day on which the milk was pasteurized.
(b) Prominence of sell-by date on label. The sell-by date shall be separate and distinct from any other number, letter or intervening material on the cap or nonglass container.
(c) Prohibition. Pasteurized milk may not be sold or offered for sale if either of the following occurs:
(1) The milk is sold or offered for sale after the sell-by date designated on the container.
(2) Without regard to the sell-by date designated on the container, the milk exceeds the bacterial limits for pasteurized milk described in § 59.52 (relating to table).
(d) Exemption. The following pasteurized dairy products are exempt from the requirements of this section:
(1) Ultra-pasteurized dairy products.
(2) Cultured dairy products.
(3) Aseptically processed dairy products.
(4) Dairy products that have undergone higher heat shorter time pasteurization.
(5) Milk sold or offered for retail sale on the same premises at which it was processed.
(e) Monitoring by the Department.
(1) The Department will periodically sample containers of pasteurized milk in the possession of the processor or distributor. This sampling may occur at any time before the pasteurized milk is delivered to the store or the customer. The Department will sample at least one milk product from each processor each calendar year.
(2) The samples described in paragraph (1) shall be analyzed by a Pennsylvania-approved dairy laboratory, applying a methodology set forth in the most current edition of Dairy Practices Council Guideline No. 10, entitled ''Guidelines for Maintaining and Testing Fluid Milk Shelf Life,'' to determine whether the bacterial test results exceed the bacterial limits for pasteurized milk described in § 59.52 prior to the expiration of the sell-by date designated on the retail container.
(3) When two or more samples demonstrate a processor cannot produce pasteurized milk that remains consistently within the bacterial limits referenced in paragraph (2) during a 17-day sell-by period, the Department will require a processor to use a sell-by date of something less than the 17-day period described in subsection (a). The Department will calculate this revised sell-by date so that bacterial growth in the milk will not exceed the referenced bacterial limits within that sell-by period if the milk is maintained in accordance with the temperature standards for pasteurized milk in § 59.52.
(4) A processor may submit samples to the Department for analysis to obtain approval to resume a 17-day sell-by period for the product sampled. The Department will approve resumption of a 17-day sell-by period when analysis of a sample demonstrates that bacterial growth in the milk will not exceed the referenced bacterial limits within that sell-by period if the milk is maintained in accordance with the temperature standards for pasteurized milk in § 59.52.
[Pa.B. Doc. No. 03-1742. Filed for public inspection September 5, 2003, 9:00 a.m.]
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