RULES AND REGULATIONS
DEPARTMENT OF AGRICULTURE
[ 7 PA. CODE CHS. 59 AND 59a ]
[41 Pa.B. 2540]
[Saturday, May 21, 2011]
The Department of Agriculture (Department) rescinds Chapter 59 and adopts Chapter 59a (relating to milk sanitation) to read as set forth in Annex A.
(Editor's Note: This final-form rulemaking was proposed under the authority of the Food Act (31 P. S. §§ 20.1—20.18). The act of November 23, 2010 (P. L. 1039, No. 106) repealed the Food Act and enacted 57 Pa.C.S. Chapter 57, Subchapter B (relating to Food Safety Act). In the preamble and annex of this final-form rulemaking, references to the Food Act have been updated to the Food Safety Act.)
The act of July 2, 1935 (P. L. 589, No. 210) (31 P. S. §§ 645—660g), known as the Milk Sanitation Law (law), and 3 Pa.C.S. Chapter 57, Subchapter B (relating to Food Safety Act) (act) provide the legal authority for this final-form rulemaking.
Section 2 of the law prohibits (31 P. S. § 646) the sale of milk, milk products or manufactured dairy products within this Commonwealth unless the seller has a Department-issued permit. Section 19 of the law (31 P. S. § 660c) authorizes the Department to adopt regulations necessary for the proper enforcement of the act.
Section 5722 of the act (relating to definitions) includes milk within the definition of a ''potentially hazardous food.'' Section 5733 of the act (relating to rules and regulations) provides the Department broad authority to regulate as necessary for the proper enforcement of the act, but section 5736 of the act (relating to construction of subchapter) limits the circumstances under which the regulations can be inconsistent with Federal acts and regulations addressing the same subject matter.
Purpose of the Final-form Rulemaking
The protection of the health and safety of persons who consume milk, milk products and manufactured dairy products is the primary purpose of the final-form rulemaking. 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 final-form rulemaking provides 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 final-form rulemaking updates 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. The final-form rulemaking helps bring the Commonwealth's standards into alignment with the current state-of-the-science.
In addition, the final-form rulemaking brings the Commonwealth's regulatory standards regarding 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. The 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 final-form rulemaking also brings the Commonwealth's regulatory standards regarding 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 its Production and Processing—Recommended Requirements (USDA Recommended Requirements) document issued by the United States Department of Agriculture, Agricultural Marketing Service, Dairy Program.
The final-form rulemaking also consolidates and updates provisions regarding the production of raw milk for human consumption.
The final-form rulemaking helps 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.
The final-form rulemaking serves the objectives previously set forth. In the extensive Comment and Response Document and Report, the Department details many of the changes and improvements accomplished by the final-form rulemaking. As part of its extensive comments, the Independent Regulatory Review Commission (IRRC) requested an explanation of the Department's rationale for the changes accomplished by the final-form rulemaking. The Department offers this preamble, including the statement of purpose, this summary section and the extensive Comment and Response Document and Report, in support of its position that the final-form rulemaking is in the public interest.
In general, the adoption of Grade ''A'' PMO standards and the references to specific applicable portions of the Grade ''A'' PMO throughout the final-form rulemaking are significant steps forward in that they bring the Commonwealth's milk sanitation standards into alignment with Nationally-used milk sanitation standards that embody the current state of dairy science. The former milk sanitation regulations (which is being supplanted by the final-form rulemaking) were premised on the 1978 version of the Grade ''A'' PMO.
Section 59a.2 (relating to definitions) establishes a common terminology, borrowing language from the former regulations in Chapter 59, the law, the act, the Grade ''A'' PMO and the USDA Recommended Requirements.
Section 59a.4 (relating to approved inspectors) clarifies the requirements that must be met for a person to be eligible to become an approved inspector (authorized to inspect dairy farms).
Section 59a.5 (relating to standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results) adds detailed language as to the standards and procedures by which a person may become a Pennsylvania-approved dairy laboratory director.
Section 59a.12 (relating to permits) provides substantially more detail on milk permit requirements than the former provision in § 59.12. The new provision details exceptions to permit requirements, provides an explanation of the process by which a permit can be obtained and addresses ownership, refusal, suspension and revocation in detail.
Section 59a.16 (relating to markings, sealing and documentation for vehicles containing milk and milk products) provides new regulatory guidance, using standards and language from the Grade ''A'' PMO.
Section 59a.17 (relating to inspection of dairy farms and milk plants) supplants the former provision in § 59.31 and provides clearer regulatory guidance.
Section 59a.18 (relating to sampling and examination) clearly identifies the types of laboratories that may conduct regulatory testing and sampling.
Sections 59a.19—59a.21 (relating to standards for Grade ''A'' milk for pasteurization, ultrapasteurization or aseptic processing; standards for Grade ''A'' pasteurized, ultrapasteurized and aseptically processed milk and milk products; and standards) incorporate specific Grade ''A'' PMO standards. These provisions accomplish a major regulatory change and go a long way toward bringing this Commonwealth's dairy industry into compliance with these well-regarded National milk sanitation standards.
Section 59a.25 (relating to milk, milk products and manufactured dairy products from points outside this Commonwealth) supplants the former provision in § 59.304. The final-form regulation provides more specific guidance as to the standards that must be met by other jurisdictions from which milk is shipped into this Commonwealth and adds applicable references to the Grade ''A'' PMO.
Section 59a.27 (relating to personnel health) supplants vague regulatory language from the former provision in § 59.306 and provides a reference to the provisions of the Grade ''A'' PMO that address this subject matter.
In Subchapter C (relating to production and processing of milk for manufacturing purposes), the Department adopts the USDA Recommended Requirements and restates a number of former regulatory requirements.
Section 59a.109 (relating to bacterial estimate classification) supplants the former provision in § 59.504 and establishes a uniform 500,000 bacteria per milliliter standard as a bacterial count beyond which warnings and exclusion of milk from market may occur. This provision should promote good sanitation practices.
Section 59a.110 (relating to somatic cell count) effectively lowers the acceptable somatic cell count from a maximum of 1,000,000 per milliliter to a maximum of 750,000 per milliliter (with a higher permissible count for goat milk). Somatic cell count is a general indicator of sanitation practices and quality of milk. This change is significant and will help improve the overall quality and safety of the milk supply.
Section 59a.113 (relating to suspended milk for manufacturing) expands upon the list of circumstances under which a milk plant may not accept milk by adding situations when milk has repeated excessively high somatic cell counts or contains added water to that list.
Subchapter D (relating to farms producing milk for manufacturing) restates rescinded regulatory requirements. Section 59a.201 (relating to farm inspection) adds clarification as to how an approved inspector is to determine a particular farm should receive a passing score on required inspections. Section 59a.207 (relating to water supply) provides a specific reference to the Grade ''A'' PMO requirements for water sources.
Subchapter E (relating to manufacturing plants) brings the regulations addressing milk for manufacturing into closer alignment with the USDA Recommended Requirements. This subchapter uses the basic format and language from the former provisions in §§ 59.701—59.792. The former regulations were promulgated in 1985 and much of the language was borrowed directly from the then-current USDA Recommended Requirements. For this reason, there are comparatively fewer changes or new requirements imposed on the regulatory community under Subchapter E.
Section 59a.302(f)(5) (relating to buildings) contains a more specific reference to the appropriate laboratory standards to be followed should a permitholder establish its own testing laboratory. These standards are as prescribed in the current Evaluation of Milk Laboratories, Recommendations of the United States Public Health Service/Food and Drug Administration and FDA 2400 Laboratory Series forms.
Section 59a.311(c) (relating to cleaning and sanitizing treatment) provides better guidance as to how milk transport tanks are to be cleaned and sanitized. This section also adopts a requirement from the USDA Recommended Requirements that a tank that has been cleaned and sanitized be cleaned and sanitized again if 96 hours or more elapse between uses of the tank.
Subchapter F (relating to raw milk for human consumption) seeks to present the major provisions that relate to the production of raw milk for human consumption in a single chapter. Under the former milk sanitation regulations, provisions regarding the production of raw milk for human consumption were scattered throughout the chapter. The Department believes this has been inconvenient for the regulated community and has been the cause of some confusion. In 2008, the Department issued a guidance document titled ''Permits allowing the Sale of Raw milk for Human Consumption.'' The guidance document was distributed to all raw milk permitholders with the objective of providing them a single document that referenced those statutory and regulatory provisions that most impacted their raw milk production businesses. This guidance document was used in drafting Subchapter F. Subchapter F also reflects the experience the Department has gained as it has assisted dairy producers through the raw milk permit application process, encountered problems and pathogenic bacteria in raw milk, and been involved in investigations of food borne human illness when raw milk has been implicated as a source.
Section 59a.402 (relating to raw milk; prohibitions) is significant in that it clearly states the extent of a raw milk permitholder's authority. A raw milk permitholder may produce raw milk for human consumption and, under certain circumstances, aged cheese manufactured from raw milk.
Section 59a.404 (relating to requirements for the issuance of a raw milk permit) provides a detailed statement of the standards that shall be met to obtain a raw milk permit and varies these requirements based upon whether the permit sought is a new raw milk permit or a successor permit to a raw milk permit that has expired.
Section 59a.406 (relating to animal health) requires that animals used in the production of raw milk be brucellosis-free, tuberculosis-free and in apparent good general health. Good animal health is essential to the production of safe raw milk for human consumption.
Section 59a.408 (relating to regular testing of raw milk for human consumption) provides a chart explaining the routine testing that shall be performed by raw milk permitholders. This includes a requirement that milk temperatures be monitored and that regular testing for bacterial count, coliform count, somatic cell count and the presence of drugs and specific pathogenic bacteria occur at regular intervals.
As a result of IRRC's October 7, 2010, order disapproving the final-form rulemaking, the Department made revisions to § 59a.410 (relating to raw milk packaging) as part of the report it subsequently filed with IRRC, the House Committee for Agriculture and Rural Affairs and the Senate Committee for Agriculture and Rural Affairs (House and Senate Committees). In summary, the section was revised to require mechanical filling and capping of raw milk containers only when packaging is being done for off-farm sales. It also requires that the mechanical filling and capping of raw milk containers that are being filled for off-farm sale occur ''in a room separate from the milk room'' and that the washing of returnable (reusable) containers occur in a room that is separate from any room that is devoted to bottling or the filling of other containers.
Section 59a.411 (relating to label content review by the Department) requires raw milk permitholders to submit their proposed label information for review by the Department, just as other milk permitholders are required to do. Given that milk is a potentially hazardous food and that raw milk, in particular, presents risks to certain consumers, the provision requires a label statement much as is required with respect to other potentially hazardous foods (such as raw shellfish, raw or undercooked meat, and similar foods).
Sections 59a.412—59a.416 provide the raw milk permitholder with a comprehensive summary of actions the Department or the Office of Attorney General might take with respect to the permit. This includes references to the Department's authority to conduct reasonable inspections, permit suspension or revocation actions, permit denials, suspensions or revocations, summary criminal prosecutions, injunctive relief and the seizure or detention of unsafe raw milk. As previously stated, one of the Department's objectives with respect to Subchapter F is to consolidated provisions regarding raw milk permits in a single subchapter.
Comments and Responses
A notice of proposed rulemaking was published at 39 Pa.B. 4677 (August 1, 2009) affording the public, the House and Senate Committees and IRRC the opportunity to offer comments. The comment period was extended an additional 30 days, through September 30, 2009, by notice published at 39 Pa.B. 5131 (August 29, 2009).
Comments were received from IRRC, the United States Department of Agriculture Agricultural Marketing Service Dairy Grading Branch, QC Laboratories, the Pennsylvania Independent Consumers and Farmers Association, the Pennsylvania Association for Sustainable Agriculture, the Farm-to-Consumer Legal Defense Fund (from Virginia), the Pennsylvania State University Dairy Herd Health Educator for Southeastern Pennsylvania and over 100 additional commentators.
In addition, the Department reviewed and considered, and in its Comment and Response Document offers a response to, approximately 12 comment letters that were submitted after the close of the formal public comment period. The Department appreciates the time and thought that went into these various comments and treated each as it would a timely comment.
The Department has compiled an extensive Comment and Response Document to address each comment previously referenced. The document addresses approximately 210 different comments that were received with respect to the proposed rulemaking. A copy of this lengthy Comment and Response Document can be downloaded from the Department's website at www.agriculture.state.pa.us. The Comment and Response Document will be provided by the Department upon request through the contact person listed as follows.
IRRC Disapproval and Subsequent Approval
By order of October 7, 2010, IRRC disapproved this final-form regulation. See 40 Pa.B. 6367 (October 30, 2010). In response, on November 19, 2010, the Department filed a report with IRRC and the House and Senate Committees in accordance with section 7(c) of the Regulatory Review Act (71 P. S. § 745.7(c)). The referenced report provided the Department's response to IRRC's October 7, 2010 disapproval order and made several revisions to the final-form rulemaking in response to concerns raised by IRRC in that order. On December 16, 2010, IRRC issued an order approving the final-form rulemaking with the revisions described in the referenced report. See 41 Pa.B. 118 (January 1, 2011).
A copy of the report described in the previous paragraph can be downloaded from the Department's website at www.agriculture.state.pa.us. The report will be provided by the Department upon request through the contact person listed as follows.
Affected Individuals and Organizations
The final-form rulemaking will benefit nearly all residents in this Commonwealth since the majority of the 12.4 million citizens are consumers of milk and dairy products.
The 8,500-plus dairy producers and 872-plus milk permitholders in this Commonwealth will also benefit from the final-form rulemaking. In addition, approximately 132 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 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.
Commonwealth. The final-form rulemaking is expected to impose approximately $180,000 per year in additional costs upon the Department beginning with the 2010-2011 fiscal year.
Political subdivisions. The final-form rulemaking will not impose costs and will have not 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 final-form 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 regarding 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 final-form rulemaking takes effect or to incur costs regarding testing by third party laboratories. The Department estimates these dairy operations will, in the aggregate, incur total costs of approximately $85,200 in the first year after the final-form rulemaking becomes effective and costs of approximately $55,200 in subsequent years.
Persons who hold milk permits that authorize the sale of raw milk for human consumption will incur approximately $740 in additional testing costs under the final-form rulemaking. These permitholders will incur approximately $300 in additional somatic cell count test costs (12 additional tests, costing approximately $25 each) and $440 in pathogen testing costs (2 tests annually, costing between $120 and $220 each). There are approximately 132 of these permitholders. The total annual cost increase for these permitholders will be approximately $97,680 each year.
General public. The final-form rulemaking is not expected to impose any appreciable new costs or have any appreciable financial impact on the general public. The final-form rulemaking will enhance public safety. It is possible that some portion of the additional testing costs imposed on the private sector will be passed-along to the consumer. The Department expects any cost increases would be minimal.
The final-form rulemaking will not affect the paperwork generated by the Department or the regulated communities.
The final-form rulemaking will become effective upon publication in the Pennsylvania Bulletin.
Individuals who need information about the final-form rulemaking should contact the Department of Agriculture, Bureau of Food Safety, Division of Milk Sanitation, 2301 North Cameron Street, Harrisburg, PA 17110-9408, Attention: Paul Hoge.
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on July 21, 2009, the Department submitted a copy of the notice of proposed rulemaking, published at 39 Pa.B. 4677, to IRRC and the Chairpersons of the House and Senate Committees for review and comment.
IRRC disapproved the final-form rulemaking by order of October 7, 2010. Under section 7(c) of the Regulatory Review Act, on November 19, 2010, the Department filed a report with IRRC and the Chairpersons of the House and Senate Committees setting forth the Department's responses and recommendations with respect to the final-form rulemaking.
Under section 5(c) of the Regulatory Review Act, IRRC and the House and Senate Committees were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Department has considered all comments from IRRC, the House and Senate Committees and the public.
Under section 7(c.1) of the Regulatory Review Act, IRRC approved the Department's report by order of December 16, 2010. Under section 7(d) of the Regulatory Review Act, the final-form rulemaking, as revised in the Department's report, was deemed approved by the House and Senate Standing Committees on Agriculture and Rural Affairs as of March 2, 2011.
Under section 7(d) of the Regulatory Review Act, on December 6, 2010, the final-form rulemaking, as revised in the Department's report, was deemed approved by the House and Senate Committees. Under section 7(c.1) of the Regulatory Review Act, IRRC met on December 16, 2010, and approved the final-form rulemaking, as revised in the Department's report.
The Department finds that:
(1) Public notice of intention to adopt this final-form regulation 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 that were received were considered.
(3) The amendments that were made to this final-form rulemaking in response to comments received do not enlarge the purpose of the proposed rulemaking published at 39 Pa.B. 4677.
(4) The adoption of the final-form rulemaking in the manner provided in this order is necessary and appropriate for the administration of the law and the act.
The Department, acting under the law and the act, orders the following:
(1) The regulations of the Department, 7 Pa. Code, are amended by deleting §§ 59.1, 59.2, 59.11, 59.13—59.17, 59.21, 59.22, 59.31—59.34, 59.51, 59.52, 59.101—59.121, 59.201—59.216, 59.216a—59.216d, 59.217—59.222, 59.251—59.253, 59.301—59.310, 59.401—59.406, 59.501—59.510, 59.601—59.607, 59.701—59.716, 59.721—59.752, 59.761—59.763, 59.771—59.773, 59.781, 59.782, 59.791 and 59.792 and by adding §§ 59a.1—59a.5, 59a.11—59a.28, 59a.101—59a.117, 59a.201—59a.208, 59a.301—59a.316, 59a.321—59a.353, 59a.361—59a.363, 59a.371—59a.373, 59a.381, 59a.382, 59a.391, 59a.392, 59a.401—59a.416 and 59a.501 to read as set forth in Annex A.
(2) The Secretary of Agriculture shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for approval as required by law.
(3) The Secretary of Agriculture shall certify and deposit this order and Annex A with the Legislative Reference Bureau as required by law.
(4) This order shall take effect upon publication in the Pennsylvania Bulletin.
GEORGE D. GREIG,
(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 41 Pa.B. 118 (January 1, 2011).)
Fiscal Note: Fiscal Note 2-160 remains valid for the final adoption of the subject regulations.
TITLE 7. AGRICULTURE
PART III. BUREAU OF FOOD SAFETY AND LABORATORY SERVICES
Subpart B. LIQUID FOODS
CHAPTER 59. (Reserved)
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—59.216. (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).
CHAPTER 59a. MILK SANITATION
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
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, raw 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.
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 5728 of the Food Safety Act (relating to adulteration of food).
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.
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 ''designated 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.
(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 or other lactating hooved mammals are kept, and a part or all the milk from which is sold or delivered to any person.
Department—The Department of Agriculture of the Commonwealth.
Easily cleanable—As defined in § 46.3 (relating to definitions).
FDA—The Food and Drug Administration of the United States Department of Health and Human Services.
Food Safety Act—3 Pa.C.S. Chapter 57, Subchapter B.
Grade ''A'' PMO—The most current revision of the Grade ''A'' Pasteurized Milk Ordinance and its appendices, as published by the FDA. The Department maintains a link to an electronic copy of this document on its web site at www.agriculture.state.pa.us.
Growth inhibitor—An antimicrobial adulterant including, but not limited to, antibiotics.
HACCP or Hazard Analysis Critical Control Point—
(i) The systematic approach to the identification, evaluation and control of significant milk or milk product safety hazards, as described in the Grade ''A'' PMO.
(ii) The Grade ''A'' PMO provisions further defining or describing HACCP include Section 1 and Appendix K, regarding definitions and HACCP Program.
HTST—High temperature short term.
Herd—A group of animals or a single animal maintained for purposes related to this chapter.
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 including:
(i) Instant nonfat dry milk and other dry milk products.
(ii) Pasteurized process cheese and related products.
(iii) Sterilized milk products.
(iv) Butter-related products.
(v) Other products that must be produced at plants in accordance with supplemental requirements established under Subchapter E (relating to manufacturing plants).
Milk—Milk, skimmed milk, cream, sour milk, sour cream, buttermilk and all other fluid derivatives of milk. The term includes milk from any hooved mammal species.
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 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. The term includes those foods that are milk products under the Grade ''A'' PMO.
Misbranded—As defined in section 5729 of the Food Safety Act (relating to misbranding of food).
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. The term includes a dairy laboratory controlled and operated by the Department, a dairy laboratory that performs dairy testing and analysis under contract with the Department and a dairy laboratory at which Department personnel perform dairy testing and analysis.
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 milk for pasteurization, commingled milk for pasteurization or of raw milk for human consumption for the detection of drug residues, bacterial limits and somatic cell count.
Pennsylvania-approved dairy laboratory director—An individual who has satisfactorily demonstrated competency and 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, 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 Subchapter F (relating to raw milk for human consumption).
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.
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 Programs.
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, with 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:
(1) 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
(2) By telephone, as follows: (717) 787-4315
(3) Through the following web site: 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 meet the following criteria to be eligible for licensure as an approved inspector:
(1) The applicant shall be 21 years of age or older.
(2) The applicant may not have been convicted of a felony criminal offense within the 10 years preceding the date of application.
(3) The applicant shall have at least 2 years of academic training or experience in the area of milk production and milk sanitation. The Department may verify that an applicant has adequate experience by having Department personnel conduct one or more joint dairy farm inspections with the applicant.
(4) The applicant shall complete a Department-administered approved inspector examination and achieve a final score of at least 80%.
(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 or the current edition of the Official Methods of Analysis of the Association of Official Analytical Chemists. 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 and the Grade ''A'' PMO and operate in accordance with current FDA 2400 Laboratory Series forms.
(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 a Pennsylvania-approved dairy laboratory director or a person designated by a laboratory director to sign these reports. If an official laboratory issues a report of the results of laboratory examinations for purposes of this chapter, the report shall be signed by the laboratory director, a person designated by the laboratory director, the person who performed the tests described in the report or the Director of the Department's Bureau of Food Safety and Laboratory Services.
(c) Pennsylvania-approved dairy laboratory director.
(1) A person may apply to the Department to be certified as a Pennsylvania-approved dairy laboratory director. This approval may be sought for one or more of the following categories of dairy testing procedures:
(ii) Cultural procedures.
(iii) Coliform count (media or PetrifilmTM).
(iv) Standard plate count (media or PetrifilmTM Count).
(v) Drug Residue Testing/Appendix N of the Grade ''A'' PMO.
(vi) Direct microscopic somatic cell count or electronic somatic cell count, or both.
(vii) Phosphatase: Electronic Fluorophos or Charm methodologies, or both.
(2) The Department will consider the written application of a dairy laboratory director to be certified as a Pennsylvania-approved dairy laboratory director. The application may be made by letter or on a form the Department will provide upon request. A prospective applicant shall meet two or more of the following requirements to be eligible to apply:
(i) The applicant shall have at least 1 year of experience or the equivalent of that experience conducting analysis at a dairy laboratory.
(ii) The performance of the applicant with respect to the category for which certification is sought has been evaluated onsite by Department personnel and been satisfactory.
(iii) The performance of the applicant in a Department-conducted milk split sample proficiency program with respect to the category for which certification is sought has been satisfactory.
(iv) The applicant has attended and completed a training session offered by the Department or the FDA addressing the category for which certification is sought.
(3) The Department will provisionally certify a dairy laboratory director to be a Pennsylvania-approved dairy laboratory director with respect to one or more specific categories of testing procedures if the applicant meets the qualification standards in paragraph (2), submits an application and does the following:
(i) Completes a Department-administered written examination and attains a score of at least 80%. The examination must have the following parts:
(A) A general section addressing sampling and culturing procedures.
(B) A section addressing the specific categories of dairy testing procedures with respect to which the applicant seeks certification.
(ii) Passes an onsite performance and facilities evaluation by a laboratory evaluation officer from the Department.
(4) After the provisional certification in paragraph (3), the Department will certify a dairy laboratory director to be a Pennsylvania-approved dairy laboratory director with respect to one or more specific categories of testing procedures if the provisionally-certified person submits a split sample to the Department for analysis, retains and analyzes the other portion of the split sample, and the results of analysis are consistent between the Department and the provisionally-certified person.
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