PROPOSED RULEMAKING
DEPARTMENT
OF AGRICULTURE
[ 7 PA. CODE CHS. 59 AND 59a ]
Milk Sanitation
[39 Pa.B. 4677]
[Saturday, August 1, 2009]The Department of Agriculture (Department) proposes to rescind the current Chapter 59 (relating to milk sanitation) and establish a new Chapter 59a (relating to milk sanitation) to read as set forth in Annex A.
Statutory Authority
The Milk Sanitation Law (law) (31 P. S. §§ 645--660g) and the Food Act (act) (31 P. S. §§ 20.1--20.18) provide the legal authority for this rulemaking.
The law prohibits the sale of milk, milk products or manufactured dairy products within this Commonwealth unless the seller has a Department-issued permit, and authorizes the Department to adopt regulations necessary for the proper enforcement of the act. See 31 P. S. §§ 645 and 660c.
The act includes milk within the definition of a ''potentially hazardous food'' and provides the Department broad authority to regulate as necessary for the proper enforcement of that statute, but limits the circumstances under which the regulations can be inconsistent with Federal acts and regulations addressing the same subject matter. See 31 P. S. §§ 20.2, 20.13 and 20.16.
Purpose
The protection of the health and safety of persons who consume milk, milk products and manufactured dairy products is the primary purpose of the proposed regulations. The secondary purpose is to provide the regulated community--persons who produce milk, milk products and manufactured dairy products within this Commonwealth for sale--with clearer standards that facilitate the production and sale of Pennsylvania-produced dairy products. The regulated community is quite diverse, with the size and sophistication of dairy production and processing operations varying dramatically. The proposed rulemaking would provide the entire regulated community clearer and better guidance on the basic sanitation and safe production practices necessary to protect the health and safety of consumers and preserve the vitality of this Commonwealth's diverse dairy industry.
The proposed rulemaking would update the Department's milk sanitation regulations to reflect developments in food science and food technology since the regulations were last amended. Food safety science is an evolving body of knowledge; and the proposed rulemaking would help bring the Commonwealth's standards into alignment with the current state of the science.
In addition, the proposed rulemaking would bring the Commonwealth's regulatory standards relating to pasteurized milk into closer alignment with those recommended in the current Grade ''A'' Pasteurized Milk Ordinance (Grade ''A'' PMO). The Grade ''A'' PMO is a model document issued and updated by the United States Department of Health and Human Services, Public Health Service, Food and Drug Administration. That agency recommends the Grade ''A'' PMO for adoption by all States '' . . . in order to encourage greater uniformity and a higher level of excellence of milk sanitation practice in the United States'' and to ''facilitate the shipment and acceptance of milk and milk products of high sanitary quality in interstate and intrastate commerce.''
The proposed rulemaking would also bring the Commonwealth's regulatory standards relating to milk for manufacturing (milk that is produced for processing and manufacturing into products for human consumption that is not subject to the same requirements as milk for pasteurization) into closer alignment with those recommended in the current Milk for Manufacturing Purposes and it Production and Processing--Recommended Requirements (USDA Recommended Requirements) document issued by the United States Department of Agriculture, Agricultural Marketing Service, Dairy Program.
The proposed rulemaking would also consolidate and update provisions relating to the production of raw milk for human consumption.
The proposed rulemaking would help the regulated community by providing greater clarity, facilitating interstate commerce in pasteurized milk and bringing the Commonwealth's milk sanitation standards into alignment with well-known and well-regarded Federal standards.
Need for the Proposed Rulemaking
The proposed rulemaking is a much-needed update of the Department's milk sanitation regulations. The ultimate objectives of the proposed rulemaking are to help protect the health and safety of the consumer public, implement regulatory standards that align with National model standards and make the milk sanitation regulations more understandable to the regulated community.
The Department is satisfied there are no reasonable alternatives to proceeding with the proposed rulemaking. The Department is also satisfied the proposed rulemaking meets the requirements of Executive Order No. 1996-1, ''Regulatory Review and Promulgation.''
Overview of the Major Provisions of the Proposed Rulemaking
Proposed Subchapter A (relating to preliminary provisions) would lay the groundwork for the regulatory requirements that follow. Proposed § 59a.2 (relating to definitions) contains various defined terms from the law, the act, the Grade ''A'' PMO, the current regulations in Chapter 59 and other sources. Proposed § 59a.4 (relating to approved inspectors) would establish the process by which a person may become an ''approved inspector'' authorized to conduct dairy farm inspections. Proposed § 59a.5 (relating to standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results) would reference and adopt well-regarded National standards for the testing and examination of dairy products, and for the evaluation of dairy laboratories.
Proposed § 59a.11 (relating to adoption of Grade ''A'' PMO) would establish the standards of the Grade ''A'' PMO as those of the Department, except to the extent they are specifically contradicted by the act, the law or a specific provision in Chapter 59a. Although this single reference would suffice to incorporate the Grade ''A'' PMO standards as those of the Department, a number of other sections in Chapter 59a contain references to specific provisions of the Grade ''A'' PMO as guides to the regulated community.
Proposed § 59a.12 (relating to permits) would provide an overview of the process by which a person may obtain a permit from the Department, authorizing the lawful sale of milk, raw milk or manufactured dairy products.
Proposed § 59a.14 (relating to labeling: bottles, containers and packages of milk, milk products or manufactured dairy products) would provide detailed guidance on the type of product label information that would be helpful to the consumer.
Proposed § 59a.17 (relating to inspection of dairy farms and milk plants) would establish a requirement that dairy farm operations be inspected at least once every 6 months, and that milk plants and receiving stations be inspected at least once every 3 months. These inspection intervals derive from the Grade ''A'' PMO.
Proposed Subchapter C (relating to production and processing of milk for manufacturing purposes) would adopt the USDA Recommended Requirements as the Department's regulatory standards with respect to milk for manufacturing.
Proposed Subchapter D (relating to farms producing milk for manufacturing) would establish on-farm sanitation, equipment and procedural standards for farms that produce milk that is to be processed into manufactured dairy products for human consumption, but that is not subject to the same requirements as milk that is bound for fluid consumption.
Although proposed Subchapter E (relating to manufacturing plants) would supplant current Chapter 59, Subchapter G (relating to manufacturing), the result is basically an updating of current regulatory standards for plants that manufacture dairy products.
Proposed Subchapter F (relating to raw milk for human consumption) is intended to establish clear, reasonable standards for those dairy operations that produce unpasteurized milk for human consumption. The current regulatory provisions addressing the production of raw milk for human consumption are spread throughout Chapter 59, are hard to find, and do not cover all of the subject matter that should be addressed in regulations on this subject. In recent years, the Department has experienced a dramatic rise in the number of dairy operations that produce raw milk for human consumption under authority of Department-issued permits. The Department expects this new subchapter will provide raw milk permitholders a clear set of regulatory standards under which to operate.
Proposed § 59a.501 (relating to interrelatedness with Food Act) would make the important point that the act provides the Department separate-but-related legal authority by which to address matters relating to milk (which is defined as a ''potentially hazardous food'' under the act).
Affected Individuals and Organizations
The proposed rulemaking would benefit nearly all Commonwealth residents, since the majority of this Commonwealth's 12.4 million citizens are consumers of milk and dairy products.
Pennsylvania's 8,500-plus dairy producers and 872-plus milk permitholders will also benefit from the rulemaking. In addition, approximately 120 raw milk producers, and the persons who acquire and consume raw milk from these producers, will benefit from the updated raw milk permit provisions that will clarify the requirements for obtaining and maintaining a raw milk permit and attempt to protect the health of raw milk consumers. Also, approximately 40 Grade ''A'' milk processing plants, approximately 120 Grade ''A'' bulk tank units (permitted farm groups), approximately 80 dairy manufacturing (non-Grade A) facilities, 46 Interstate milk shippers program certified laboratory facilities, 57 drug residue testing facilities, and 26 manufacturers of single service containers and closures will be impacted.
Fiscal Impact
Commonwealth: The proposed rulemaking is expected to impose approximately $180,000 per year in additional costs upon the Department, commencing with the Fiscal Year 2010-2011.
Political Subdivisions: The proposed rulemaking would impose no costs and have no fiscal impact upon political subdivisions.
Private Sector: Most of the impacted regulatory community is familiar with the Grade ''A'' PMO and the USDA Recommended Requirements, and produces milk, milk products and manufactured dairy products to the standards prescribed by those documents. For these entities, the proposed rulemaking will have very little impact on day-to-day operations, and will not impose any appreciable new costs. In addition, the Department plans to help train the regulated community to minimize confusion and costs related to implementing the new regulatory standards. A small section of the regulated community--approximately 40 dairy operations that process milk for in-State sales only--may need to acquire drug residue testing equipment in the initial year after the proposed regulations take effect, or to incur costs related to testing by third-party laboratories. The Department estimates these dairy operations would, in the aggregate, incur total costs of approximately $85,200 in the first year after the proposed regulations take effect, and costs of approximately $55,200 in subsequent years.
General Public: The proposed rulemaking would impose no costs and have no fiscal impact on the general public. The proposal would enhance public safety.
Paperwork Requirements
The proposed rulemaking is not likely to appreciably impact upon the paperwork generated by the Department or the regulated community.
Effective Date
The proposed rulemaking will be effective upon publication in the Pennsylvania Bulletin as final-form rulemaking.
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 regulations within 30 days following publication in the Pennsylvania Bulletin. Comments are to be submitted to the Department of Agriculture, Bureau of Food Safety, Division of Milk Sanitation, 2301 North Cameron Street, Harrisburg, PA 17110-9408, Attention: Paul Hoge.
Regulatory Review
The Department submitted a copy of the proposed regulations to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House and Senate Standing Committees (Committees) on Agriculture and Rural Affairs on July 21, 2009, in accordance with section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)). The Department also provided IRRC and the Committees a detailed Regulatory Analysis Form prepared by the Department in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of this material is available to the public upon request.
If IRRC has an objection to any portion of the proposed regulations, it must so notify the Department within 30 days of the close of the public comment period.
The notification shall specify the regulatory criteria that have not been met by that portion. The Regulatory Review Act sets forth detailed procedures for review of these objections by the Department, the General Assembly and the Governor prior to the final publication of the proposed rulemaking.
DENNIS C WOLFF,
SecretaryFiscal Note: 2-160. (1) General Fund; (2) Implementing Year 2008-09 is $0; (3) 1st Succeeding Year 2009-10 is $0; 2nd Succeeding Year 2010-11 is $180,000; 3rd Succeeding Year 2011-12 is $180,000; 4th Succeeding Year 2012-13 is $180,000; 5th Succeeding Year 2013-14 is $180,000; (4) 2007-08 Program--$29,696,000; 2006-07 Program--$30,042,000; 2005-06 Program--$29,451,000; (7) General Government Operations; (8) recommends adoption.
Annex A
TITLE 7. AGRICULTURE
PART III. BUREAU OF FOOD SAFETY AND LABORATORY SERVICES
CHAPTER 59. MILK SANITATION
Sec. 59.1. [Reserved]. 59.2. [Reserved]. 59.11. [Reserved]. 59.13--59.17. [Reserved]. 59.21. [Reserved]. 59.22. [Reserved]. 59.31--59.34. [Reserved]. 59.51. [Reserved]. 59.52. [Reserved]. 59.101--59.121. [Reserved]. 59.201--59.215. [Reserved]. 59.216a--59.216d. [Reserved]. 59.217--59.222. [Reserved]. 59.251--59.253. [Reserved]. 59.301--59.310. [Reserved]. 59.401--59.406. [Reserved]. 59.501--59.510. [Reserved]. 59.601--59.607. [Reserved]. 59.701--59.716. [Reserved]. 59.721--59.752. [Reserved]. 59.761--59.763. [Reserved]. 59.771--59.773. [Reserved]. 59.781. [Reserved]. 59.782. [Reserved]. 59.791. [Reserved]. 59.792. [Reserved]. (Editor's Note: As part of this proposed rulemaking, the Department of Agriculture is proposing to rescind the text of Chapter 59, which appears in 7 Pa. Code pages 59-1--59-107, serial pages (299227)--(299236), (301719), (301720), (299239), (217609)--(217612), (299241), (219242), (217615)--(217666), (223219), (223220) and (217667)--(217703).)
CHAPTER 59a. MILK SANITATION Subchap.
A. PRELIMINARY PROVISIONS B. PERMIT REQUIREMENTS C. PRODUCTION AND PROCESSING OF MILK FOR MANUFACTURING PURPOSES D. FARMS PRODUCING MILK FOR MANUFACTURING E. MANUFACTURING PLANTS F. RAW MILK FOR HUMAN CONSUMPTION G. MISCELLANEOUS PROVISIONS
Subchapter A. PRELIMINARY PROVISIONS Sec.
59a.1. Scope. 59a.2. Definitions. 59a.3. Contacting the Department. 59a.4. Approved inspectors. 59a.5 Standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results. § 59a.1. Scope.
This chapter establishes the minimum requirements for the following:
(1) The production, transportation, processing, handling, sampling, examination, labeling and sale of milk, milk products and manufactured dairy products.
(2) The inspection of dairy farms, milk plants, receiving stations, transfer stations, milk tank truck cleaning facilities, milk tank trucks and bulk milk haulers/samplers.
(3) The issuing, suspension and revocation of permits to milk plants, receiving stations, transfer stations, milk tank truck cleaning facilities and distributors.
§ 59a.2. Definitions.
(a) Terms. The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
3-A Sanitary Standards--The latest standards for dairy equipment promulgated jointly by the Sanitary Standards Subcommittee of the Dairy Industry Committee, the Committee on Sanitary Procedure of the International Association for Food Protection and the Milk Safety Branch, Center for Food Safety and Applied Nutrition, Food and Drug Administration, Public Health Service, Department of Health and Human Services, or as otherwise defined in the Grade ''A'' PMO.
Act--The act of July 2, 1935 (P. L. 589, No. 210) (31 P. S. §§ 645--660g), known as the Milk Sanitation Law.
Adulterated--As defined in section 8 of the Food Act (31 P. S. § 20.8).
Approved inspector--A person who has been licensed by the Department in accordance with § 59a.4 (relating to approved inspectors) to perform dairy farm inspections required under this chapter in a capable and efficient manner.
Approved sampler--A person certified by the Department to obtain samples of milk or milk products for analysis by a Pennsylvania-approved dairy laboratory.
BTU--Bulk tank unit--A specified group of dairy farms from which milk for pasteurization or for manufacturing purposes is collected by a milk tank truck.
CIP--Cleaned in place--The removal of soil from product contact surfaces in their process position by circulating, spraying or flowing chemical solutions and water rinses onto and over the surfaces to be cleaned, provided that:
(i) Components of the equipment which are not designed to be cleaned-in-place are removed from the equipment to be cleaned out-of-place or manually cleaned.
(ii) Product contact surfaces can either be readily inspected by the Department or, with respect to product contact surfaces that cannot be readily inspected (such as permanently installed pipelines and silo tanks), their cleanability by cleaned-in-place cleaning has been accepted by the Department.
Canned milk--Condensed, evaporated or concentrated milk in hermetically sealed containers or for manufacturing purposes.
Certified industry inspector--An approved inspector who has been licensed by the Department in accordance with § 59a.4(h) to inspect dairy farms on which milk is produced for an interstate milk shipper. A certified industry inspector is the equivalent of a ''certified industry inspector,'' for purposes of conducting certified industry inspections described in the Grade ''A'' PMO.
Classification of farm sanitation compliance---
(i) Passing. A general compliance with sanitary standards established for the production of milk.
(ii) Reinspect. A significant noncompliance with sanitary standards established for the production of milk requiring remedial action and a subsequent review to determine conformity.
(iii) Suspend. Major noncompliance with sanitary standards or evidence of conditions that would render the milk unsafe for human consumption, or if on the reinspection it is found that sufficient progress has not been made on the previously recommended corrections.
Commingled milk--
(i) Milk from two or more producers.
(ii) In a milk plant, a representative sample of all daily sources of milk prior to pasteurization.
Dairy farm--A place or premise where one or more cows are kept, and a part of all the milk from which is sold or delivered to any person.
Department--The Department of Agriculture of the Commonwealth.
FDA--The Food and Drug Administration of the United States Department of Health and Human Services, Public Health Service.
Food Act--31 P. S. §§ 20.1--20.18.
Food establishment--
(i) A retail food store and a room, building or place or portion thereof or vehicle maintained, used or operated for the purpose of commercially storing, packaging, making, cooking, mixing, processing, bottling, baking, canning, freezing, packing or otherwise preparing or transporting or handling food.
(ii) The term includes those portions of public eating and drinking licensees which offer food for sale for off-premises consumption, except those portions of establishments operating exclusively under milk or milk products permits.
Grade ''A'' PMO--The most current revision of the Grade ''A'' Pasteurized Milk Ordinance and its appendices, as published by the United States Department of Health and Human Services, Public Health Service/Food and Drug Administration. The Department maintains a link to an electronic copy of this document on its web site: www.agriculture.state.pa.us.
Growth inhibitor--A antimicrobial adulterant, including but not limited to, antibiotics.
HACCP or Hazard Analysis Critical Control Point--The systematic approach to the identification, evaluation and control of significant milk or milk product safety hazards, as described in the Grade ''A'' PMO.
HTST--High temperature short time.
Manufactured dairy products--Butter, cheese (natural or processed), dry whole milk, nonfat dry milk, dry buttermilk, dry whey, evaporated milk (whole or skim), condensed whole and condensed skim (plain or sweetened), and other products for human consumption, as may be designated by the Secretary.
Milk--Milk, skimmed milk, cream, sour milk, sourcream, buttermilk and all other fluid derivatives of milk.
Milk for manufacturing purposes--Milk produced for processing and manufacturing into products for human consumption but not subject to requirements of milk for pasteurization.
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 plant or plant--A place or premise or establishment where milk, milk for manufacturing purposes or milk for pasteurization is collected, separated, processed, stored, bottled, pasteurized, or prepared in any manner for sale as milk, milk products or manufactured dairy products.
Milk products--Ice cream, ice cream mix, custard ice cream, french ice cream, frozen custard, and other similar frozen products, and all dairy products used in the manufacture thereof.
Misbranded--As defined in section 9 of the Food Act (31 P. S. § 20.9).
Municipality--Any city, borough, town or township in this Commonwealth.
NCIMS--The National Conference of Interstate Milk Shippers.
Official laboratory--A biological, chemical or physical laboratory which is under the direct supervision of the Department.
PMO-defined milk products--
(i) Milk products that fit within the following description, or as otherwise defined in the Grade ''A'' PMO.
(ii) The term includes the following:
(A) Milk products including cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated (condensed) milk, concentrated (condensed) milk products, concentrated (condensed) and dry milk products, nonfat (skim) milk, reduced fat or lowfat milk, frozen milk concentrate, eggnog, buttermilk, buttermilk products, whey, whey products, cultured milk, cultured reduced fat or lowfat milk, cultured nonfat (skim) milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified reduced fat or lowfat milk, acidified nonfat (skim) milk, low-sodium milk, low-sodium reduced fat or lowfat milk, low-sodium nonfat (skim) milk, lactose-reduced milk, lactose-reduced reduced fat or lowfat milk, lactose-reduced nonfat (skim) milk, aseptically processed and packaged milk products as defined in the Grade ''A'' PMO, milk, reduced fat, lowfat milk or nonfat (skim) milk with added safe and suitable microbial organisms and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin or mineral fortification of milk products described in this definition.
(B) Those dairy foods made by modifying the Federally standardized products described in this definition, in accordance with 21 CFR 130.10 (relating to requirements for foods named by use of a nutrient content claim and a standardized term).
(C) Milk and milk products described in this definition, which have been aseptically processed and then packaged.
(D) Milk and milk products which have been retort processed after packaging or which have been concentrated (condensed) or dried if they are either:
(I) Used as an ingredient to produce any milk or milk product described in this definition.
(II) Labeled as Grade ''A'' as described in the Grade ''A'' PMO.
(E) Powdered dairy blends may be labeled Grade ''A'' and used as ingredients in Grade ''A'' dairy products, such as cottage cheese dressing mixes or starter media for cultures used to produce various Grade ''A'' cultured products if they meet the requirements of the Grade ''A'' PMO. If used as an ingredient in Grade ''A'' products, such as those listed in this clause, blends of dairy powders must be blended under conditions, which meet all applicable Grade ''A'' requirements. Grade ''A'' powder blends must be made from Grade ''A'' powdered dairy products, except that small amounts of functional ingredients, (total of all ingredients may not exceed 5% by weight of the finished blend) which are not Grade ''A'' are allowed in Grade ''A'' blends when the finished ingredient is not available in Grade ''A'' form, that is, sodium caseinate. This is similar to the existing FDA position that the dairy ingredient in small cans of freeze-dried starter culture need not be Grade ''A.''
(III) The term is not intended to include dietary products other than as described in the Grade ''A'' PMO, infant formula, ice cream or other frozen desserts, butter or cheese.
Pennsylvania-approved dairy laboratory--
(i) A commercial or regulatory laboratory approved and certified by the Department within the preceding 2 years to do official analyses of milk and milk products.
(ii) A milk industry laboratory approved and certified by the Department within the preceding 2 years for the examination of producer samples of raw milk for pasteurization or of commingled raw milk for pasteurization for the detection of drug residues, bacterial limits and somatic cell count.
Pennsylvania-approved dairy laboratory director--An individual who has satisfactorily demonstrated competency by achieving a minimum score of 80% on the written examinations and has demonstrated the necessary experience to direct the analytical and administrative activities of a Pennsylvania-approved dairy laboratory in accordance with the methods and procedures adopted by the Department in § 59a.5 (relating to standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results).
Permitholder--A person holding a permit issued by the Department to sell milk, PMO-defined milk products, milk products or manufactured dairy products.
Person--Includes singular and plural, masculine and feminine, and any individual, firm, copartnership, institution, association or corporation thereof.
Producer--The persons who exercise control over the production of the milk delivered to a plant, and who receive payment for this product. A new producer is one who is initiating the shipment of milk from a farm.
Raw milk--Milk that is not pasteurized and may be sold to consumers without further treatment or processing, provided that it conforms to the relevant provisions of this chapter.
Secretary--The Secretary of the Department, or an authorized representative.
Standard Methods for the Examination of Dairy Products--The current edition of the Standard Methods for the Examination of Dairy Products, a publication of the American Public Health Association, 1015 Fifteenth Street, NW, Washington, D.C. 20005.
''To sell,'' ''for sale'' or ''sold'' and similar terms--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.
UHT--Ultra-heat treated.
UHTST--Ultra-high temperature short time.
USDA Recommended requirements--The most current revision of the Milk for Manufacturing Purposes and its Production and Processing--Recommended Requirements, as published by the United States Department of Agriculture, Agricultural Marketing Service, Dairy Program.
Weigher/sampler--A bulk milk pick-up driver or a milk plant person certified by the Department or the Pennsylvania Milk Marketing Board to take official samples of producers' milk for chemical, antibiotic, somatic cell and bacteriological analyses.
(b) Additional terms used in this chapter and defined in the Grade ''A'' PMO. Any word or term used in this chapter and not otherwise defined in subsection (a) has the meaning ascribed to it in the Grade ''A'' PMO.
(c) Additional terms used in the Grade ''A'' PMO. Any applicable word or term used in the Grade ''A'' PMO has the meaning ascribed to it in the Grade ''A'' PMO, the exception of the term ''regulatory agency,'' which means the Department.
§ 59a.3. Contacting the Department.
For purposes of this chapter, the Department may be contacted as follows:
(a) By mail, at the following address:
Pennsylvania Department of Agriculture
Bureau of Food Safety and Laboratory Services
ATTN: Division of Milk Sanitation
2301 North Cameron Street
Harrisburg, PA 17110-9408(b) By telephone, as follows: (717) 787-4315
(c) Through the following web site address: www. agriculture.state.pa.us.
§ 59a.4. Approved inspectors.
(a) Application. A person may apply to the Department to be licensed as an approved inspector for purposes of the act and this chapter. The Department will provide application forms, or the renewal forms described in subsection (d), upon request to the address or web site identified in § 59a.3 (relating to contacting the Department). An application fee of $50 (or as otherwise prescribed by statute) must accompany the application.
(b) Criteria for approval. An applicant shall be at least 18 years of age, have attended a PDA-approved seminar as described in subsection (e) within 12 months preceding the date of the application and demonstrate to the satisfaction of the Department to be of good character and to have adequate education or experience, or both, to carry-out dairy farm and milk plant inspection in a capable and efficient manner.
(c) License. The Department will issue a license to a person who follows the application process described in this section and meets the criteria for approval in subsection (b).
(d) Duration of license; renewal. A license will expire each year, as of January 1. Applications for renewal of a license must be accompanied by a fee of $20 (or as otherwise prescribed by statute), and confirmation that the applicant for renewal has attended a Department-approved seminar as described in subsection (e) within 12 months preceding the date of the application, and shall be returned to the Department by December 31st of each year.
(e) Education requirement. The Department will convene an approved inspector educational seminar on at least two separate dates each calendar year, and provide current approved inspectors written notice of the dates, times and locations of these seminars. As described in subsections (b) and (d), attendance at an educational seminar is a requisite to the Department issuing or renewing a license.
(f) Status of approved inspectors. An approved inspector is not an employee, agent or authorized representative of the Department, and may not represent himself to be any of these.
(g) Refusal, revocation or suspension of certificate. The Department may, upon written notice and opportunity for a hearing, refuse, revoke or suspend a license for cause.
(h) Certified industry inspectors. The Department may designate on the license of an approved inspector that the approved inspector is a certified industry inspector who may, in addition to conducting the inspection activities of an approved inspector, inspect dairy farms on which milk is produced for an interstate milk shipper under the NCIMS Interstate Milk Shippers Program and the Grade ''A'' PMO.
§ 59a.5. Standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results.
(a) General standards. A Pennsylvania-approved dairy laboratory, an official laboratory or another laboratory that conducts sampling or laboratory examinations for purposes of this chapter shall conform that sampling or testing to the applicable standards and procedures set forth in the Standard Methods for the Examination of Dairy Products, the current edition of the Official Methods of Analysis of the Association of Official Analytical Chemists, or other methods approved by the Secretary. Procedures, including laboratory examination procedures and the certification of sample collectors, shall be evaluated in accordance with the current Evaluation of Milk Laboratories, Recommendations of the United States Public Health Service/Food and Drug Administration.
(b) Reports of results. If a Pennsylvania-approved dairy laboratory issues a report of the results of laboratory examinations for purposes of this chapter, the report shall be signed by the laboratory director or a person designated by the laboratory director to sign these reports.
Subchapter B. PERMIT REQUIREMENTS Sec.
59a.11. Adoption of Grade ''A'' PMO. 59a.12. Permits. 59a.13. Adulterated or misbranded milk, milk products of manufactured dairy products. 59a.14. Labeling: Bottles, containers and packages of milk, milk products or manufactured dairy products. 59a.15. Labeling: Milk dating. 59a.16. Markings, sealing and documentation for vehicles containing milk and milk products. 59a.17. Inspection of dairy farms and milk plants. 59a.18. Sampling and examination. 59a.19. Standards for grade ''A'' raw milk for pasteurization, ultrapasteurization or aseptic processing. 59a.20. Standards for grade ''A'' pasteurized, ultrapasteurized and aseptically processed milk and milk products. 59a.21. Standards. 59a.22. Animal health. 59a.23. Milk and milk products which may be sold. 59a.24. Transferring; delivery containers; cooling. 59a.25. Milk, milk products and manufactured dairy products from points outside this Commonwealth. 59a.26. Plans for construction and reconstruction. 59a.27. Personnel health. 59a.28. Procedure when infection or high risk of infection is discovered. § 59a.11. Adoption of Grade ''A'' PMO.
(a) General adoption of the Grade ''A'' PMO. The provisions, terms, procedures, appendices and standards of the Grade ''A'' PMO are adopted as the regulatory standards of the Department to the extent they do not conflict with one or more of the following:
(1) The act.
(2) The Food Act.
(3) A provision of this chapter.
(b) Specific references to applicable provisions of the Grade ''A'' PMO. The provisions of this chapter contain, as guidance, references to the applicable provisions of the Grade ''A'' PMO.
§ 59a.12. Permits.
(a) Permit required. A person may not sell milk, milk products or manufactured dairy products within this Commonwealth without having a current, valid permit from the Secretary, unless the person is exempt from this permit requirement under subsection (b). A separate permit shall be obtained for each milk plant, milk distributor, receiving station, transfer station and bulk tank unit, and by every producer of raw milk in accordance with Subchapter F (relating to raw milk for human consumption).
(b) Exceptions. The permit requirement of subsection (a) does not apply to the following:
(1) A person selling or delivering milk directly from a dairy farm to a milk plant.
(2) A dairy farm producing and selling milk for pasteurization or milk for manufacturing.
(3) A person selling milk or milk products from a store, when the milk or milk products have been purchased from a person already in possession of a permit to sell milk or milk products.
(4) A hotel, restaurant, soda fountain, boarding house or other place when milk or milk products are to be consumed on-premises, and have been purchased from a person already in possession of a permit to sell milk or milk products.
(5) A person producing and selling milk from a single cow, and exempted from the permit requirement in accordance with the act.
(c) Obtaining a permit. A person seeking a permit may obtain a permit application and additional information by contacting the Department as described in § 59a.3 (relating to contacting the Department). An entity that meets the requirements of § 59a.25 (relating to milk, milk products and manufactured dairy products from points outside this Commonwealth) will be issued a permit.
(d) Requirements for initial issuance of permit. Within 30 days of receiving a complete application for an initial permit, the Department will inspect the applicant's operation to determine whether it is in compliance with the standards of the act and this chapter that would be applicable if the applicant received the permit applied for. These standards shall be met for the Department to issue the permit.
(e) Requirements for issuance of a successor permit. If an applicant seeks a permit that is to take effect upon the expiration of a predecessor permit, the Department will approve the permit application if the dairy operation and the milk, milk products or manufactured dairy products produced from that dairy operation meet the requirements of the act and this chapter.
(f) Duration of permit. A permit will be valid for no more than 1 year. Each permit will expire as of September 1 each year, unless revoked or suspended earlier by the Department.
(g) Ownership of milk permit. A permit is and remains the property of the Department--even when it is in the physical custody of the permitholder. If a milk permit is suspended or revoked, the person in possession of the milk permit shall immediately return or surrender that permit to the Department. In the case of a permit suspension, the Department will promptly return the permit to the permitholder at the end of the suspension period.
(h) Refusal, revocation or suspension of a permit.
(1) Authority. The Department may refuse, revoke or suspend a permit issued under the act or this section upon a finding that the applicant or permitholder has violated a provision of the act or this chapter.
(2) Notice and opportunity for a hearing. The Department will notify an applicant or permitholder of a proposed refusal, revocation or suspension of a permit by written notification, and will deliver it by personal service or certified mail. The notice will afford the recipient at least 5 days within which to request an administrative hearing on the proposed action. If no hearing is requested, the Department may enter its final order refusing, suspending or revoking the permit. If a hearing is requested, the Department will conduct the hearing within 30 days of receipt of the request.
(i) Reinstatement of a suspended permit. A person whose permit has been suspended by the Department may make written application to the Department for reinstatement of the permit. The permitholder shall coordinate with the Department to address and resolve the basis for the suspension.
(j) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO and, in particular, section 3 of that document, regarding permits, apply to this section, to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
§ 59a.13. Adulterated or misbranded milk, milk products of manufactured dairy products.
(a) Sales of adulterated or misbranded milk prohibited. A person may not sell adulterated or misbranded milk, milk products or manufactured dairy products.
(b) Seizure, condemnation, denaturing or destruction of milk, milk products or manufactured dairy products. Adulterated or misbranded milk may be seized, condemned, denatured and destroyed by the Department if the Secretary considered the substance unsafe or a menace to public health.
(c) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO and, in particular, section 2 of that document, regarding adulterated or misbranded milk or milk products, apply to this section, to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
§ 59a.14. Labeling: Bottles, containers and packages of milk, milk products or manufactured dairy products.
(a) Department approval required. A permitholder shall, before using a milk, PMO-defined milk product, milk product or manufactured dairy product label in commerce, apply for and obtain the approval of the Department for the use of that label. Labels in commercial use as of _____ (Editor's Note: The blank refers to the effective date of the adoption of this proposed rulemaking.) shall have until _____ (Editor's Note: The blank refers to a date 6 months after the effective date of adoption of this proposed rulemaking.) within which to come into compliance with this registration requirement.
(b) Approval process.
(1) A permitholder seeking the Department's approval of a milk, PMO-defined milk product, milk product or manufactured dairy product label shall apply to the Department at the address provided in § 59a.3 (relating to contacting the Department). The applicant may use an application form that the Department will provide upon request, or may apply by letter requesting label approval. The application must include clear, accurate copies of all labels for which approval is sought.
(2) The Department will approve the use of a milk, PMO-defined milk product, milk product or manufactured dairy product label if it meets the requirements of the act and this chapter, including the specific requirements of this section.
(3) The Department will, within 10 business days of receiving a complete application, mail the applicant its written approval or denial of the application.
(i) If the application is denied, the written denial will set forth the basis for denial, and afford the applicant notice and opportunity for an administrative hearing on the denial.
(ii) If the application is granted, the written approval will contain a copy of the label and assign a unique serial number to each label approved under the application. The Department will retain copies of these approvals.
(c) Changes of approved labels. If a label is approved under this section, colors and graphics may be changed without requiring reapproval of the label. If the text, type size or wording is to be changed, the label shall be submitted to the Department for approval in accordance with subsection (b).
(d) Label requirements. Bottles, containers and packages enclosing milk or milk products offered for sale shall be labeled. The label shall be approved by the Department in accordance with this section, and contain the following information:
(1) The name of the food.
(2) The net contents.
(3) The common name of the hooved mammal producing the milk preceding the name of the milk or milk product, if the milk or milk product is or is made from milk other than cow's milk.
(4) The words ''keep refrigerated after opening,'' if the milk or milk product is aseptically processed.
(5) The words ''keep refrigerated,'' if the milk or PMO- defined milk product is conventionally pasteurized or ultra-high temperature (UHT) pasteurized.
(6) The words ''Grade 'A' '' on the exterior surface, except for bottles, containers and packages of milk and milk products that are not eligible for certification as Grade ''A'' or that are eligible for certification but are not currently certified. Type size may not be larger than letters in basic product name.
(7) The identity of the milk plant where pasteurized, ultrapasteurized, aseptically processed, condensed or dried. When the name and address of a distributor appears in lieu of that of the processor, words such as ''Mfg. for,'' ''Dist. by'' or ''Packed for'' must also appear on the label. Milk or milk products showing a general address or the name and address of a distributor shall be further labeled to identify the processing plant by assigned numerical code or the plant name and address.
(8) The identity of the plant where processed.
(9) The word ''reconstituted'' or ''recombined,'' immediately preceding or immediately following the name of the product, in type at least half the size of name of the product which has been reconstituted, if the milk product is made by reconstitution or recombination.
(10) The volume or proportion of water to be added for reconstitution or recombination, if the milk or milk product is concentrated milk or milk product.
(11) In descending order of predominance, a listing of additives, such as flavors, sweeteners, milk solids, lactose, stabilizers, emulsifiers, vitamins and minerals if used.
(12) The quantity or percentage of United States Recommended Daily Allowance (U.S. RDA) per serving, if vitamins, minerals or milk solids have been added to the milk or milk product.
(13) The word ''pasteurized,'' in type at least one-fourth the height of the letters in the basic product name, if the milk or milk product has been pasteurized. If desired, letters used in modifying terms and ''pasteurized'' may be the same size, but never larger than the product name. Printing must be readily legible.
(14) The word ''homogenized,'' if the milk or milk product has been homogenized.
(15) The words ''protein fortified'' immediately preceding or immediately following the name of the product which has been fortified, in type at least half the size of name of the product which has been fortified, if the milk or milk product is a protein fortified dairy product. The label must include the percentage of milk solids not fat added or the percentage of U.S. RDA of protein, vitamins and minerals per serving on the information panel of the container.
(16) The words ''artificially colored,'' if an artificial color is used for a flavored milk other than chocolate.
(17) The words ''artificially (name of flavor imitated) flavored milk'' in type at least half the size of the name of the product imitated, if an artificial flavor is used for artificially flavored milk.
(18) If the milk or milk product has been cultured or acidulated after pasteurization it may, at the applicant's option, be labeled ''made from pasteurized dairy products.''
(19) If a milk product contains an ''artificial dairy product'' as defined in § 57.1 (relating to definitions) as an ingredient which replaces portions of basic compositional ingredients in the milk product, the phrase ''contains artificial _____ ,'' with the blank filled in with names of the basic compositional ingredients being simulated, immediately following the name of the food.
(20) Any sell-by date information required under § 59a.15 (relating to labeling: milk dating).
(e) Exception. The label requirements prescribed under this section do not apply to milk tank trucks and storage tanks, which are addressed in § 59a.16 (relating to markings, sealing and documentation for vehicles containing milk and milk products). In addition, these requirements do not apply to cans of raw milk from individual dairy farms, which must be identified by name or number of the producer.
(f) False or misleading material. False or misleading marks, words or endorsements upon the label are prohibited. In determining whether labeling is false or misleading, the Department will take into account not only the specific representations made on the label but also the extent to which the labeling fails to reveal facts that are material in light of such representations. The Department may issue guidance documents addressing false or misleading label statements or any other aspect of labeling under this section. Registered trade designs or terms may be permitted on the container cap or label provided they are not misleading and do not obscure the required labeling.
(g) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO and, in particular, section 4 of that document, regarding labeling, apply to this section, to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
§ 59a.15. Labeling: 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'' must precede the designation of the date, or the statement ''Not to be sold after the date stamped above'' must 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 the milk is sold or offered for sale after the sell-by date designated on the container.
(d) Exemption. The following pasteurized dairy products are exempt from the requirements of this section, provided that the cap or container of all pasteurized dairy products contains, a lot number or manufacturing date code that is acceptable to the Department and can be used for product traceability in the marketplace.
(1) Ultrapasteurized 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) will be analyzed by the Department or a Pennsylvania-approved dairy laboratory, applying a methodology 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 § 59a.21 (relating to standards) 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 § 59a.21.
(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 § 59a.21.
§ 59a.16. Markings, sealing and documentation for vehicles containing milk and milk products.
(a) Marking requirements. A vehicle or milk tank truck containing milk or milk products shall be legibly marked with the name and address of the milk plant or hauler in possession of the contents.
(b) Seal requirement. A vehicle or milk tank truck transporting raw, heat-treated or pasteurized milk and milk products to a milk plant from another milk plant, receiving station or transfer station shall be marked with the name and address of the milk plant from which the milk or milk products are transported, and shall be sealed.
(c) Documentation requirements. A vehicle or milk tank truck transporting raw, heat-treated or pasteurized milk or milk products to a milk plant from another milk plant, receiving station or transfer station shall be accompanied by a legible shipping statement containing the following information:
(1) Shipper's name, address and permit number. A milk tank truck containing milk must include on the weigh ticket or manifest the IMS Bulk Tank Unit (BTU) identification numbers or--for farm groups listed with a milk plant--the IMS Listed Milk Plant Number.
(2) Permit identification of the hauler, if not an employee of the shipper.
(3) Point of origin of shipment.
(4) Tanker identification number.
(5) Name of product.
(6) Weight of product.
(7) Temperature of product when loaded.
(8) Date of shipment.
(9) Name of supervisory regulatory agency at point of origin of shipment.
(10) Whether the contents are raw, pasteurized or in the case of cream, lowfat milk or skim milk-whether it has been heat--treated.
(11) Seal number on inlet, outlet, wash connections and vents.
(12) Grade of product.
(d) Cans of raw milk. All cans of raw milk from individual dairy farms shall be identified by the name or permit number of the individual milk producer.
(e) Additional documentation. Milk transport tank trucks transporting bulk milk and dairy products must be accompanied by documentation, such as a weigh ticket or manifest, which includes the NCIMS BTU Identification Number or the NCIMS Listed Milk Plant Number, for farm groups listed with a milk plant.
(f) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO and, in particular, section 4 of that document, regarding labeling, apply to this section, to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
§ 59a.17. Inspection of dairy farms and milk plants.
(a) General inspection requirement. Dairy farms shall be inspected by an approved inspector at intervals of no greater than 6 months, unless the dairy farm produces raw milk under a raw milk permit, in which case the inspection shall be as prescribed in Subchapter F (relating to raw milk for human consumption). Grade ''A'' dairy farms shall be inspected by a certified industry inspector. Milk plants shall be inspected by an approved inspector at intervals of no greater than 3 months, or as otherwise prescribed by the Grade ''A'' PMO, as referenced in subsection (d).
(b) Inspection frequency. Each producer of milk for pasteurization will be inspected initially and on any change of market by an approved inspector, and shall have a passing score before the first milk is shipped. Producers shall be inspected at least once in each 6-month period by an approved inspector, and an accurate record of farm inspections and quality control testing shall be maintained on forms acceptable to the Department. The records of farm inspections must include the date of inspection, any noted deficiencies, whether the inspection resulted in a passing score, suspension or reinspection. The records of quality control testing must include bacterial count, somatic cell count, drug residue screening results, temperature results, records of water supply testing, copies of warning letters and suspension letters and information required under Appendix N of the Grade ''A'' PMO regarding drug residue testing and farm surveillance.
(c) Notification of producer status. A permitholder shall, within 24 hours of its initial instatement of a producer, its suspension of a producer or its reinstatement of a producer, provide the Department the name and address of the producer and the specific action taken by the permitholder.
(d) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO and, in particular, section 5 of that document, regarding inspection of dairy farms and milk plants, apply to this section, to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
[Continued on next Web Page]
No part of the information on this site may be reproduced for profit or sold for profit.This material has been drawn directly from the official Pennsylvania Bulletin full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.
