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, 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.
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 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.
UHT—Ultra-high temperature.
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.
Cross References This section cited in 7 Pa. Code § 59a.309 (relating to pasteurized, ultrapasteurized or aseptically processed and packaged products).
§ 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.
Cross References This section cited in 7 Pa. Code § 59a.4 (relating to approved inspectors); 7 Pa. Code § 59a.12 (relating to permits); 7 Pa. Code § 59a.14 (relating to 29labeling: bottles, containers and packages of milk, milk products or manufactured dairy products); and 7 Pa. Code § 59a.403 (relating to raw milk permit).
§ 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.
Cross References This section cited in 7 Pa. Code § 59a.2 (relating to definitions).
§ 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:
(i) Sampling.
(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.
Cross References This section cited in 7 Pa. Code § 59a.2 (relating to definitions).
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