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PA Bulletin, Doc. No. 02-1677

PROPOSED RULEMAKING

DEPARTMENT OF AGRICULTURE

[7 PA. CODE CH. 59]

Milk Sanitation

[32 Pa.B. 4717]

   The Department of Agriculture (Department) proposes to amend §§ 59.1 and 59.22 (relating to definitions; and milk dating) to read as set forth in Annex A.

Statutory Authority

   The act of July 2, 1935 (act) (P. L. 589, No. 210) (31 P. S. §§ 645--660g) provides the legal authority for this proposed 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.

Purpose

   The primary purpose of the proposed 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 allows for the production of pasteurized milk that can remain on-the-shelf for longer periods of time without bacterial growth exceeding acceptable limits. The proposed rulemaking will follow the trend among states to extend sell-by dates for pasteurized milk--whether by designating a maximum sell-by period (as the proposed rulemaking would do) 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 proposed rulemaking would also reformat § 59.1. The section is currently divided into two subsections--one containing ''general definitions'' and the other containing definitions related to ''milk and milk products.'' The proposed rulemaking would delete these subsection designations and combine the two sets of terms and definitions into a single, more readable set.

   In addition, proposed § 59.1 would add 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. Proposed § 59.22(d) would exempt milk processed through either of these methods (and several other methods) from the sell-by date requirements described in that section.

   Proposed § 59.22 would also describe the process by which the Department would sample and analyze pasteurized milk to ensure it does not exceed bacterial limits prescribed by regulation.

Background

   The Department has increased the maximum ''sell-by'' date for pasteurized milk several times in recent years, to keep pace with developments in the fluid milk industry. The nature of the fluid milk industry is changing. The number of milk processing plants and milk distributing plants has declined significantly. Where the average plant once distributed its pasteurized milk in a 100-150 mile radius, the average modern plant's distribution radius is between 300 and 400 miles. Although these plants are fewer in number, they tend to be larger, more modern and more efficient. Modern processing, refrigeration and transportation gives pasteurized milk a longer shelf life than it has had in the past.

   The milk ''sell-by'' date that appears on a container of pasteurized milk does not control the time within which the milk may be consumed, only the time within which it may be sold. All pasteurized milk supports bacterial growth that, in time, affects the flavor of the milk. Although the bacteria in milk does not pose a threat to the health of people who drink it, there is a general consumer expectation that milk will have a certain crisp, consistent taste.

   Although the proposed rulemaking would extend the maximum sell-by date for pasteurized milk, a milk plant would have the discretion to use a shorter sell-by period. This exercise of discretion might be driven by a milk plant's desire to meet a particular consumer taste preference, or by the processing, refrigeration and transportation system through which the milk is delivered to the consumer.

Need for the Proposed Rulemaking

   The proposed rulemaking is necessary to keep Commonwealth-produced pasteurized milk competitive in interstate commerce. The proposed increase in the maximum sell-by date for pasteurized milk is justified by advances in processing, packaging and transportation that result in pasteurized milk with a longer shelf life.

   The Department is satisfied of the need for the proposed rulemaking and believes the document is consistent with the principles outlined in Executive Order 1996-1, ''Regulatory Review and Promulgation.''

Overview of the Major Provisions of the Proposed Rulemaking

   Section 59.22 would be amended by extending the maximum sell-by date for pasteurized milk by 3 days. In addition, subsection (c) would be revised to clarify the sell-by date requirement. Subsection (d) would list the types of dairy products that are exempt from the sell-by date requirements. Subsection (e) would describe the sampling and testing that would be undertaken by the Department to ensure the bacterial levels of milk remain within acceptable limits for the duration of the sell-by period set forth on the milk container.

Affected Individuals and Organizations

   The Commonwealth's dairy industry will benefit from this proposed rulemaking in that it will make this Commonwealth's pasteurized milk more competitive in interstate commerce. The milk sell by date also provides processors with a tool by which to insure consistent turnover of their inventories. Milk retailers will also benefit from this proposed rulemaking in that, by extending the sell-by date from 14 days to 17 days, the retailers will have an additional 3 days within which to turn over their milk inventories This proposed rulemaking is not expected to have an adverse affect on any person or entity.

Fiscal Impact

   The proposed rulemaking would impose no costs and have no fiscal impact on the Commonwealth, political subdivisions or the general public.

   The proposed rulemaking would impose no costs and have 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. None of these favorable economic impacts can be readily quantified, though.

Paperwork Requirements

   The proposed rulemaking would not appreciably increase the paperwork burden of the Department, local government units, milk producers, milk distributors or other affected entities.

Effective Date

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

Sunset Date

   There is no sunset date for the proposed rulemaking. The Department will review the efficacy of these regulations on an ongoing basis.

Public Comment Period/Contact Person

   Interested persons are invited to submit written comments regarding the proposed rulemaking within 30 days following publication in the Pennsylvania Bulletin. Comments shall be submitted to the Department of Agriculture, Bureau of Food Safety and Laboratory Services, 2301 North Cameron Street, Harrisburg, PA 17110-9408, Attention: James C. Dell.

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 this proposed rulemaking to the Independent Regulatory Review Commission (IRRC) and the Chairpersons of the House and Senate Standing Committees on Agriculture and Rural Affairs. In addition to submitting the proposed rulemaking, the Department has provided IRRC and the Committees with a copy of a detailed Regulatory Analysis Form prepared by the Department in compliance with Executive Order 1996-1. A copy of this material is available to the public upon request.

   Under section 5(g) of the Regulatory Review Act, if IRRC has objections to any portion of the proposed rulemaking, it will notify the Department within 10 days of the close of the Committees' review period. The notification shall specify the regulatory review criteria that have not been met by the portion of the proposed rulemaking to which an objection is made. 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 of objections raised.

SAMUEL E. HAYES, Jr.,   
Secretary

   Fiscal Note: 2-141. 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 59.  MILK SANITATION

Subchapter A.  PRELIMINARY PROVISIONS

TERMS AND APPLICATION

§ 59.1.  Definitions.

   [(a)  General definitions.] The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:

*      *      *      *      *

   Aseptically processed dairy products--Milk and milk products which are packaged in hermetically sealed containers allowing storage for long periods of time without refrigeration.

*      *      *      *      *

   Certified milk--Milk from dairy farms operated in accordance with ''Methods and Standards for the Production and Distribution of Certified Milk,'' last adopted by the American Association of Medical Milk Commissioners, Inc., the production and handling of which shall be certified by a commission instituted in compliance therewith.

*      *      *      *      *

   Commingled milk--Milk from two or more producers; in a milk plant, a representative sample of all daily sources of milk prior to pasteurization.

*      *      *      *      *

   Dry milk and whey products--Products which have been produced for use in pasteurized milk or milk products and which have been manufactured under this chapter.

*      *      *      *      *

   Higher heat shorter time pasteurization--A process through which every particle of a dairy product is heated to between 191°F and 212°F at holding times between 1.0 and 0.1 seconds before packaging, so as to produce a product which has an extended shelf life under refrigerated conditions.

*      *      *      *      *

   Lactose-reduced milk or lactose-reduced lowfat milk or lactose-reduced skim milk--The product resulting from the treatment of milk, lowfat milk or skim milk by the addition of safe and suitable enzymes to convert sufficient amounts of lactose to glucose or galactose, or both, so that the remaining lactose is less than 30% of the lactose in milk, lowfat milk or skim milk.

*      *      *      *      *

   Milk--The natural lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows or goats.

*      *      *      *      *

   Milk for pasteurization--Milk which conforms with relevant provisions of this chapter and is used in the preparation of pasteurized milk and milk products.

*      *      *      *      *

   Milk products--Ice cream, ice cream mix, custard ice cream, French ice cream, frozen custard, ice milk, sherbet, and other similar frozen and semifrozen products and all dairy products used in the manufacture thereof.

*      *      *      *      *

   Pasteurized concentrated dairy products--Includes homogenized concentrated milk, concentrated skim milk, concentrated lowfat milk, and similar concentrated products made from concentrated milk or concentrated skim milk, which, when combined with potable water in accordance with instructions printed on the container, conform with the definitions of the corresponding dairy products in this section.

   Pasteurized frozen milk concentrate--A frozen dairy product with a composition of milkfat and milk solids not fat in proportions so that, when a given volume of concentrate is mixed with a given volume of water, the reconstituted product conforms to the milkfat and milk solids not fat requirements of whole milk. In the manufacturing process, water may be used to adjust the primary concentrate to the final desired concentration. The adjusted primary concentrate is pasteurized, packaged, and immediately frozen. This product is stored, transported and sold in the frozen state.

   Pasteurized low-sodium milk or low-sodium lowfat milk or low-sodium skim milk--The product resulting from the treatment of milk, lowfat milk or skim milk by a process of passing the milk, lowfat milk or skim milk through an ion exchange resin process or by any process which has been recognized by the Food and Drug Administration that effectively reduces the sodium content of the product to less than 10 milligrams in 100 milliliters.

*      *      *      *      *

   Raw milk--Raw milk is milk which conforms with the relevant provisions of this chapter and may be sold to consumers without further treatment or processing.

*      *      *      *      *

   [(b)  Milk and milk products. The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:

   Certified milk--Milk from dairy farms operated in accordance with ''Methods and Standards for the Production and Distribution of Certified Milk,'' last adopted by the American Association of Medical Milk Commissioners, Inc., the production and handling of which shall be certified by a commission instituted in compliance therewith.

   Commingled milk--Milk from two or more producers; in a milk plant, a representative sample of all daily sources of milk prior to pasteurization.

   Dry milk and whey products--Products which have been produced for use in pasteurized milk or milk products and which have been manufactured under the provision of this chapter.

   Lactose-reduced milk or lactose-reduced lowfat milk or lactose-reduced skim milk--The product resulting from the treatment of milk, lowfat milk, or skim milk by the addition of safe and suitable enzymes to convert sufficient amounts of lactose to glucose or galactose, or both, so that the remaining lactose is less than 30% of the lactose in milk, lowfat milk, or skim milk.

   Milk--The natural lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows or goats.

   Milk for pasteurization--Milk which conforms with relevant provisions of this chapter and is used in the preparation of pasteurized milk and milk products.

   Milk products--Ice cream, ice cream mix, custard ice cream, French ice cream, frozen custard, ice milk, sherbet, and other similar frozen and semifrozen products and all dairy products used in the manufacture thereof.

   Pasteurized concentrated dairy products--Includes homogenized concentrated milk, concentrated skim milk, concentrated lowfat milk, and similar concentrated products made from concentrated milk or concentrated skim milk, which, when combined with potable water in accordance with instructions printed on the container, conform with the definitions of the corresponding dairy products in this section.

   Pasteurized frozen milk concentrate--A frozen dairy product with a composition of milkfat and milk solids not fat in such proportions that, when a given volume of concentrate is mixed with a given volume of water, the reconstituted product conforms to the milkfat and milk solids not fat requirements of whole milk. In the manufacturing process, water may be used to adjust the primary concentrate to the final desired concentration. The adjusted primary concentrate is pasteurized, packaged, and immediately frozen. This product is stored, transported, and sold in the frozen state.

   Pasteurized low-sodium milk or low-sodium lowfat milk or low-sodium skim milk--The product resulting from the treatment of milk, lowfat milk, or skim milk by a process of passing the milk, lowfat milk, or skim milk through an ion exchange resin process or by any process which has been recognized by the Food and Drug Administration that effectively reduces the sodium content of the product to less than 10 milligrams in 100 milliliters.

   Raw milk--Raw milk is milk which conforms with the relevant provisions of this chapter and may be sold to consumers without further treatment or processing.]

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 [14] 17 days beginning after midnight on the day on which the [dairy products were] milk was pasteurized. [Stores, as used in this subsection, include mercantile establishments which offer milk for sale except on premises where processed.]

   (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 [after the date designated on the container.] 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. [Sterile, ultra-pasteurized and cultured dairy products are exempt from the dating requirements.] 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. 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 samples shall be analyzed to determine whether the bacterial test results exceed the bacterial limits for pasteurized milk described in § 59.52 (relating to table) prior to the expiration of the sell-by date designated on the retail container. When two or more samples demonstrate a processor cannot produce pasteurized milk that remains consistently within the referenced bacterial limits 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).

[Pa.B. Doc. No. 02-1677. Filed for public inspection September 27, 2002, 9:00 a.m.]



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