CHAPTER 59a. MILK SANITATION
Subchap.
A. PRELIMINARY PROVISIONS…59a.1
B. PERMIT REQUIREMENTS…59a.11
C. PRODUCTION AND PROCESSING OF MILK FOR MANUFACTURING PURPOSES…59a.101
D. FARMS PRODUCING MILK FOR MANUFACTURING…59a.201
E. MANUFACTURING PLANTS…59a.301
F. RAW MILK FOR HUMAN CONSUMPTION…59a.401
G. MISCELLANEOUS PROVISIONS…59a.501Authority The provisions of this Chapter 59a issued under the act of July 2, 1935 (P. L. 589, No. 210) (31 P. S. § § 645—660g); and 3 Pa.C.S. Chapter 57, Subchapter B, unless otherwise noted.
Source The provisions of this Chapter 59a adopted May 20, 2011, effective May 21, 2011, 41 Pa.B. 2540, unless otherwise noted.
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).
Subchapter B. PERMIT REQUIREMENTS
Sec.
59a.11. Adoption of Grade ‘‘A’’ PMO.
59a.12. Permits.
59a.13. Adulterated or misbranded milk, milk products or 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’’ 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 Safety 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.
Cross References This section cited in 7 Pa. Code § 59a.12 (relating to permits); 7 Pa. Code § 59a.13 (relating to adulterated or misbranded milk, milk products or manufactured dairy products); 7 Pa. Code § 59a.14 (relating to labeling: bottles, containers and packages of milk, milk products or manufactured dairy products); 7 Pa. Code § 59a.16 (relating to markings, sealing and documentation for vehicles containing milk and milk products); 7 Pa. Code § 59a.17 (relating to inspection of dairy farms and milk plants); 7 Pa. Code § 59a.18 (relating to sampling and examination); 7 Pa. Code § 59a.20 (relating to standards for Grade ‘‘A’’ pasteurized, ultrapasteurized and aseptically processed milk and milk products); 7 Pa. Code § 59a.21 (relating to standards); 7 Pa. Code § 59a.22 (relating to animal health); 7 Pa. Code § 59a.23 (relating to milk and milk products which may be sold); 7 Pa. Code § 59a.24 (relating to transferring; delivery containers; cooling); 7 Pa. Code § 59a.25 (relating to milk, milk products and manufactured dairy products from points outside this Commonwealth); 7 Pa. Code § 59a.26 (relating to plans for construction and reconstruction); 7 Pa. Code § 59a.27 (relating to personnel health); 7 Pa. Code § 59a.28 (relating to procedure when infection or high risk of infection is discovered); 7 Pa. Code § 59a.104 (relating to certification of bulk milk collectors—weighers/samplers); and 7 Pa. Code § 59a.114 (relating to inspection and quality testing of milk from producers).
§ 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, bulk tank unit and milk tank truck cleaning facility, and by every producer of raw milk in accordance with Subchapter F (relating to raw milk for human consumption). Additional permits or licenses may be required for milk haulers and weighers/samplers under regulations established and enforced by the Milk Marketing Board under Part VI (relating to Milk Marketing Board).
(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, milk products or manufactured dairy 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 where milk, milk products or manufactured dairy 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 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, in particular section 3, regarding permits, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ‘‘A’’ PMO).
Cross References This section cited in 7 Pa. Code § 59a.102 (relating to milk permits).
§ 59a.13. Adulterated or misbranded milk, milk products or 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 considers 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, in particular section 2, 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, 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 May 21, 2011, shall have until November 21, 2011, to come into compliance with this registration requirement.
(b) Approval process.
(1) A permitholder seeking the Department’s approval of a milk, 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, 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, milk products or manufactured dairy 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 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), or to raw milk for human consumption, which is addressed in § 59a.411 (relating to label content review by the Department). 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, in particular section 4, 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 facilities 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.
Cross References This section cited in 7 Pa. Code § 59a.14 (relating to labeling: bottles, containers and packages of milk, milk products or manufactured dairy products); and 7 Pa. Code § 59a.15 (relating to labeling: milk dating).
§ 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, in particular section 4, regarding labeling, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ‘‘A’’ PMO).
Cross References This section cited in 7 Pa. Code § 59a.14 (relating to labeling: bottles, containers and packages of milk, milk products or manufactured dairy products).
§ 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 for human consumption 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, in particular section 5, 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).
§ 59a.18. Sampling and examination.
(a) Sampling and testing costs. Sampling and testing required under this section shall be at the expense of the permitholder or permit applicant, and shall be conducted by a Pennsylvania-approved dairy laboratory, an out-of-State dairy laboratory that is listed with the NCIMS or that operates in accordance with the current Evaluation of Milk Laboratories, Recommendations of the United States Public Health Service/Food and Drug Administration and current FDA 2400 Laboratory Series forms, or the Department.
(b) Certified milk plants, receiving stations and transfer stations; milk plants and transfer stations that receive Grade ‘‘A’’ milk. A milk plant, receiving station or transfer station shall comply with Appendix N of the Grade ‘‘A’’ PMO, regarding drug residue testing and farm surveillance, if it is certified under the NCIMS Interstate Milk Shippers Program, or if it receives Grade ‘‘A’’ milk.
(c) Noncertified milk plants and transfer stations. Milk plants that are not certified under the NCIMS Interstate Milk Shippers Program, and which do not receive bulk shipments of Grade ‘‘A’’ milk, shall obtain a representative sample of commingled milk for pasteurization each processing day. The sample shall be collected by a certified industry plant sampler and analyzed for Beta lactam drug residues in a laboratory as described in subsection (a). If a milk plant is not certified under the NCIMS Interstate Milk Shippers Program, does not receive bulk shipments of Grade ‘‘A’’ milk and produces that milk in accordance with a written quality control program addressing the use of animal drugs at that dairy operation, that milk plant may request a variance from the testing requirements in this subsection. The request shall be in writing and include a copy of the written quality control program. The Department may, on the basis of the request, issue a variance with respect to the requirements in this subsection. A variance issued under this subsection will be valid for no more than 1 year and may be renewed for additional periods of up to 1 year following the Department’s review of the quality control program and any onsite inspections the Department deems necessary to determine whether a successor variance should be issued.
(d) Drug residue testing. Drug residue screening test records shall be maintained on file by the permitholder for at least 2 years.
(e) Reference to applicable provisions of the Grade ‘‘A’’ PMO. The provisions of the Grade ‘‘A’’ PMO, in particular section 6 and Appendix N, regarding examination of milk and milk products and drug residue testing and farm surveillance, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ‘‘A’’ PMO).
(f) Interpretation of Grade ‘‘A’’ PMO. When milk is excluded from market under a provision of the Grade ‘‘A’’ PMO on the basis of an accumulation of violative test results and the accelerated sampling testing called for under the Grade ‘‘A’’ PMO results in the provisional or final return of milk to market, the Department will consider tests preceding the date of return to market in determining future accumulations of violative test results.
§ 59a.19. Standards for Grade ‘‘A’’ milk for pasteurization, ultrapasteurization or aseptic processing.
(a) Applicability. The standards prescribed under this section apply to a dairy farm that produces milk for pasteurization, ultrapasteurization or aseptic processing regardless of whether the dairy farm is certified under the NCIMS Interstate Milk Shippers Program.
(b) Reference to applicable provisions of the Grade ‘‘A’’ PMO. The provisions of the Grade ‘‘A’’ PMO, in particular the Standards for Grade ‘‘A’’ Raw Milk for Pasteurization, Ultrapasteurization or Aseptic Processing set forth in that document and section 7, regarding standards for Grade ‘‘A’’ milk and milk products, are incorporated by reference as regulations authorized under the act, to the extent they do not conflict with the act or any provision of this chapter. This includes all of the items listed under the referenced Grade ‘‘A’’ PMO provisions, including the following:
(1) Item 1r. Abnormal milk
(2) Item 2r. Milking Barn, Stable or Parlor—Construction
(3) Item 3r. Milking Barn, Stable or Parlor—Cleanliness
(4) Item 4r. Cowyard
(5) Item 5r. Milkhouse—Construction and Facilities
(6) Item 6r. Milkhouse—Cleanliness
(7) Item 7r. Toilet
(8) Item 8r. Water Supply, with the additional requirement that a plate heat exchanger or tubular cooler installed and in use on a dairy farm shall be equipped with an appropriate backflow prevention device
(9) Item 9r. Utensils and Equipment—Construction
(10) Item 10r. Utensils and Equipment—Cleaning
(11) Item 11r. Utensils and Equipment—Sanitization
(12) Item 12r. Utensils and Equipment—Storage
(13) Item 13r. Milking—Flanks, Udders and Teats
(14) Item 14r. Protection from Contamination
(15) Item 15r. Drug and Chemical Control
(16) Item 16r. Personnel—Handwashing Facilities
(17) Item 17r. Personnel—Cleanliness
(18) Item 18r. Raw Milk Cooling, with the exception that milk for pasteurization shall be cooled to 4° C (40° F) within 2 hours after completion of milking, and shall be delivered to the plant within 72 hours of the initial milking
(19) Item 19r. Insect and Rodent Control
Cross References This section cited in 7 Pa. Code § 59a.405 (relating to sanitation).
§ 59a.20. Standards for Grade ‘‘A’’ pasteurized, ultrapasteurized and aseptically processed milk and milk products.
(a) Applicability. The standards prescribed under this section apply to a milk plant regardless of whether it is certified under the NCIMS Interstate Milk Shippers Program.
(b) Reference to applicable provisions of the Grade ‘‘A’’ PMO. The provisions of the Grade ‘‘A’’ PMO, in particular the Standards for Grade ‘‘A’’ Pasteurized, Ultrapasteurized and Aseptically Processed Milk and Milk Products and section 7, regarding standards for Grade ‘‘A’’ milk and milk products, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ‘‘A’’ PMO). This includes all of the items listed under the referenced Grade ‘‘A’’ PMO provisions, including the following:
(1) Item 1p. Floors—Construction
(2) Item 2p. Walls and Ceilings—Construction
(3) Item 3p. Doors and Windows
(4) Item 4p. Lighting and Ventilation
(5) Item 5p. Separate Rooms
(6) Item 6p. Toilet-Sewage Disposal Facilities
(7) Item 7p. Water Supply
(8) Item 8p. Handwashing Facilities
(9) Item 9p. Milk Plant Cleanliness
(10) Item 10p. Sanitary Piping
(11) Item 11p. Construction and Repair of Containers and Equipment
(12) Item 12p. Cleaning and Sanitizing of Containers and Equipment
(13) Item 13p. Storage of Cleaned Containers and Equipment
(14) Item 14p. Storage of Single-Service Containers, Utensils and Materials
(15) Item 15p. Protection from Contamination
(16) Item 16p. Pasteurization and Aseptic Processing
(17) Item 17p. Cooling of Milk and Milk Products
(18) Item 18p. Bottling, Packaging and Container Filling
(19) Item 19p. Capping, Container Closure and Sealing and Dry Milk Product Storage
(20) Item 20p. Personnel—Cleanliness
(21) Item 21p. Vehicles
§ 59a.21. Standards.
(a) Standards for milk and milk products. The standards that apply to milk and milk products are as set forth in section 7 of the Grade ‘‘A’’ PMO, in Table 1, regarding chemical, physical, bacteriological, and temperature standards.
(b) Standards for milk for manufacturing and manufactured dairy products. The standards that apply to milk for manufacturing and manufactured dairy products are as set forth in Subchapter C (relating to production and processing of milk for manufacturing purposes). Other fluid derivatives of milk, including condensed milk and milk products, nonfat dry milk and milk products, condensed whey and whey products, and buttermilk and buttermilk products, may be processed according to the standards and requirements for manufactured grade milk and milk products provided that they meet all applicable requirements of Subchapter C.
(c) Standards for ice cream and frozen dessert mixes. Frozen desserts—vanilla, chocolate, and one other flavor when applicable—shall be tested at least monthly for the standard plate count and coliform group. Frozen desserts mix shall be tested at least monthly for the standard plate count, coliform group, and phosphatase activity. The following are the specific standards for ice cream and frozen dessert mixes:
(1) Temperature. Cooled to 45° F (7° C) or less and maintained thereat.
(2) Bacterial limits applicable to all but cultured products. 50,000 per gram.
(3) Coliform. Not to exceed 10 per gram. When fruit or nuts and flavoring are added after pasteurization, the count shall not exceed 20 per gram.
(4) Phosphatase. Less than 350 milliunits per liter by approved electronic phosphatase procedures.
(5) Drugs. On test of milk ingredients, no positive results on drug residue detection methods as referenced in section 7 of the Grade ‘‘A’’ PMO, Table 1, regarding chemical, physical, bacteriological and temperature standards.
(d) Reference to applicable provisions of the Grade ‘‘A’’ PMO. The provisions of the Grade ‘‘A’’ PMO and, in particular, section 7 and Appendix N of that document regarding examination of milk and milk products and drug residue testing and farm surveillance, respectively, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ‘‘A’’ PMO).
§ 59a.22. Animal health.
The provisions of the Grade ‘‘A’’ PMO, in particular section 8, regarding animal health, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ‘‘A’’ PMO).
§ 59a.23. Milk and milk products which may be sold.
The provisions of the Grade ‘‘A’’ PMO, in particular section 9, regarding milk and milk products which may be sold, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ‘‘A’’ PMO).
§ 59a.24. Transferring; delivery containers; cooling.
The provisions of the Grade ‘‘A’’ PMO, in particular section 10, regarding transferring; delivery; containers; cooling, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ‘‘A’’ PMO).
§ 59a.25. Milk, milk products and manufactured dairy products from points outside this Commonwealth.
(a) General requirement. Milk, milk products and manufactured dairy products originating from outside this Commonwealth may be sold in this Commonwealth if they are produced and pasteurized, ultrapasteurized, or aseptically processed, concentrated (condensed) or dried under regulations which are substantially equivalent to the Grade ‘‘A’’ PMO and one or more of the following apply:
(1) The products have been awarded acceptable Milk Sanitation Compliance and Enforcement Ratings by a Milk Sanitation Rating Officer certified by FDA.
(2) The products have been awarded a satisfactory HACCP listing, under a HACCP Program as specified in Appendix K of the Grade ‘‘A’’ PMO.
(3) The products originate from a country that the FDA has, following consultation with NCIMS, determined to have in place a public health regulatory program and government oversight of that program that have an equivalent effect on the safety of regulated milk or milk products, or both.
(4) The products are USDA-approved manufactured dairy products.
(5) The products have a Department-issued milk permit.
(b) Reference to applicable provisions of the Grade ‘‘A’’ PMO. The provisions of the Grade ‘‘A’’ PMO, in particular section 11, regarding milk and milk products from points beyond the limits of routine inspection, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ‘‘A’’ PMO).
Cross References This section cited in 7 Pa. Code § 59a.12 (relating to permits).
§ 59a.26. Plans for construction and reconstruction.
(a) Specific requirements. Properly prepared plans for all transfer stations, receiving stations, and milk plants regulated under this chapter which are constructed, reconstructed, or extensively altered shall be submitted to the Secretary for written approval before work is begun. Plans must likewise be approved before construction or extensive modification of a manure storage system; installation of a bulk milk storage tank; installation of a milk transfer system on a dairy farm; or installation of milk handling equipment in a transfer station, receiving station, or milk plant.
(b) Reference to applicable provisions of the Grade ‘‘A’’ PMO. The provisions of the Grade ‘‘A’’ PMO, in particular section 12, regarding plans for construction and reconstruction, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ‘‘A’’ PMO).
§ 59a.27. Personnel health.
The provisions of the Grade ‘‘A’’ PMO, in particular section 13, regarding personnel health, are adopted as the regulatory standards of the Department to the extent described in § 59a.11 (relating to adoption of Grade ‘‘A’’ PMO).
§ 59a.28. Procedure when infection or high risk of infection is discovered.
(a) Specific requirements. When reasonable cause exists to suspect the possibility of transmission of infection from a person concerned with the handling of milk or milk products, the Department is authorized to require one or more of the following measures:
(1) The immediate exclusion of that person from handling milk or milk products, or the handling of related milk or milk-product contact surfaces, subject to release from this exclusion if in accordance with Table 5 of section 15 of the Grade ‘‘A’’ PMO.
(2) The immediate exclusion of the milk supply concerned from distribution and use.
(3) Adequate medical and bacteriological examination of the person and his associates and of their body discharges.
(b) Reference to applicable provisions of the Grade ‘‘A’’ PMO. The provisions of the Grade ‘‘A’’ PMO, in particular section 16, regarding procedure when infection or high risk of infection is discovered, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ‘‘A’’ PMO).
Subchapter C. PRODUCTION AND PROCESSING OF MILK FOR MANUFACTURING PURPOSES
Sec.
59a.101. Adoption of USDA recommended requirements.
59a.102. Milk permits.
59a.103. Plant inspection.
59a.104. Certification of bulk milk collectors-weighers/samplers.
59a.105. Approved milk graders.
59a.106. Basis.
59a.107. Appearance and odor.
59a.108. Sediment content classification.
59a.109. Bacterial estimate classification.
59a.110. Somatic cell count.
59a.111. Drug residue level.
59a.112. Rejected milk.
59a.113. Suspended milk for manufacturing.
59a.114. Inspection and quality testing of milk from producers.
59a.115. Record of tests.
59a.116. Abnormal milk.
59a.117. Animal health.
Cross References This subchapter C cited in 7 Pa. Code § 59a.21 (relating to standards); and 7 Pa. Code § 59a.201 (relating to farm inspection).
§ 59a.101. Adoption of USDA recommended requirements.
The provisions, terms, procedures and standards of the most current version of the publication of the United States Department of Agriculture, Agricultural Marketing Service, Dairy Programs, titled Milk for Manufacturing Purposes and its Production and Processing—Recommended Requirements, 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 Safety Act.
(3) A provision of this subchapter.
§ 59a.102. Milk permits.
Plants, receiving stations, transfer stations and bulk tank units handling or processing milk for manufacturing of dairy products shall apply for a permit in accordance with § 59a.12 (relating to permits) which describes the process and requirements by which permits are acquired and maintained.
(1) Permits are required for the sale of milk for manufacturing purposes and manufactured dairy products. Application shall be made annually on a form secured from the Secretary.
(2) A separate permit shall be obtained for each plant, receiving station, transfer station and bulk tank unit.
(3) The permit year begins September 1 of each year and ends on August 31 of the following year.
Cross References This section cited in 7 Pa. Code § 59a.201 (relating to farm inspection).
§ 59a.103. Plant inspection.
Plants receiving milk or dairy products, for manufacturing or further processing, will be subject to inspection by the Secretary or an agent.
§ 59a.104. Certification of bulk milk collectors—weighers/samplers.
(a) Weighers/samplers will be evaluated and approved by the Department.
(b) The provisions of the Grade ‘‘A’’ PMO, in particular Appendix B, regarding the required training and periodic evaluation of weighers/samplers, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ‘‘A’’ PMO).
§ 59a.105. Approved milk graders.
Milk graders will be approved by the Department based upon the milk grader being capable of determining the quality classification of raw milk for manufacturing purposes in accordance with § § 59a.106—59a.111.
§ 59a.106. Basis.
The quality classification of raw milk for manufacturing purposes shall be based on an organoleptic examination for appearance and odor, a drug residue test and quality control tests for sediment content, bacterial estimate and somatic cell count.
Cross References This section cited in 7 Pa. Code § 59a.105 (relating to approved milk graders).
§ 59a.107. Appearance and odor.
The appearance of acceptable raw milk for manufacturing purposes must be normal and free of excessive coarse sediment when examined visually or by the methods described in § 59a.108(a) (relating to sediment content classification). The milk may not show any abnormal condition including curdles, ropy, bloody or mastitic conditions, as indicated by visual examination of the milk. The odor must be fresh and sweet. The milk must be free from objectionable feed and other off-odors that would adversely affect the finished product.
Cross References This section cited in 7 Pa. Code § 59a.105 (relating to approved milk graders); 7 Pa. Code § 59a.108 (relating to sediment content classification); 7 Pa. Code § 59a.112 (relating to rejected milk); and 7 Pa. Code § 59a.114 (relating to inspection and quality testing of milk from producers).
§ 59a.108. Sediment content classification.
(a) Method of testing. Methods for determining the sediment content of the milk of individual producers shall be those described in the Standard Methods for the Examination of Dairy Products. Sediment content must be based on comparison with applicable charts of the United States Sediment Standards for Milk and Milk Products. These charts are available from the Dairy Standardization Branch, Dairy Programs, Agricultural Marketing Service, United States Department of Agriculture, Room 2746-South, 1400 Independence Avenue, S.W., Washington, D.C. 20250-0230.
(b) Classifications. Milk shall be classified for sediment content in accordance with the USDA Sediment Standard, regardless of the results of the appearance and odor examination described in § 59a.107 (relating to appearance and odor), as set forth in this subsection. The USDA Sediment Standard defines the following classifications:
(1) Milk classified as ‘‘No. 1’’ has a tested sediment content that does not exceed 0.50 mg. or equivalent, and is acceptable.
(2) Milk classified as ‘‘No. 2’’ has a tested sediment content that does not exceed 1.50 mg. or equivalent, and is acceptable.
(3) Milk classified as ‘‘No. 3’’ has a tested sediment content that does not exceed 2.50 mg. or equivalent, and is probational for not more than 10 days.
(4) Milk classified as ‘‘No. 4’’ has a tested sediment content that exceeds 2.50 mg. or equivalent, and is rejected.
(c) Frequency of tests. At least once each month, at irregular intervals, the milk from each producer shall be tested as follows:
(1) Milk in cans. A sample shall be taken from one or more cans of milk selected at random from each producer.
(2) Milk in farm bulk tanks. A sample shall be taken from each farm bulk tank.
(d) Acceptance or rejection of milk.
(1) If the sediment disc is classified as No. 1, No. 2 or No. 3, the producer’s milk may be accepted.
(2) If the sediment disc is classified as No. 4, the milk shall be rejected.
(3) If the shipment of milk is commingled with other milk in a transport tank, the next shipment may not be accepted until its quality has been determined at the farm before being picked up. If the person making the test is unable to get to the farm before the next shipment, it may be accepted but no further shipments shall be accepted unless the milk meets the requirements of No. 3 or better. In the case of milk classified as No. 3 or No. 4, if in cans, all cans shall be tested. Producers of No. 3 or No. 4 milk-cans or bulk-shall be notified immediately and shall be furnished applicable sediment discs and the next shipment shall be tested.
(e) Retests. On tests of the next shipment (if in cans, all cans shall be tested) milk classified as No. 1, No. 2 or No. 3, may be accepted, but No. 4 milk shall be rejected. Retests of bulk milk classified as No. 4 shall be made at the farm before pickup. The producers of No. 3 or No. 4 milk shall be notified immediately, furnished applicable sediment discs and the next shipment shall be tested. This procedure of retesting successive shipments and accepting probational (No. 3) milk and rejecting No. 4 milk may be continued for a period not to exceed 10 calendar days. If, at the end of this time, all of the producer’s milk does not meet the acceptable sediment content classification (No. 1 or No. 2), it shall be excluded from market.
Cross References This section cited in 7 Pa. Code § 59a.105 (relating to approved milk graders); 7 Pa. Code § 59a.107 (relating to appearance and odor); 7 Pa. Code § 59a.113 (relating to suspended milk for manufacturing); and 7 Pa. Code § 59a.114 (relating to inspection and quality testing of milk from producers).
§ 59a.109. Bacterial estimate classification.
(a) General testing requirement. A laboratory examination to determine the bacterial estimate shall be made on each producer’s milk at least once each month at irregular intervals. Samples shall be analyzed at a Pennsylvania-approved dairy laboratory. The laboratory must report the results to the permitholder.
(b) Testing methods. Milk shall be tested for bacterial estimate by using one of the following methods or by any other method approved by the Standard Methods for the Examination of Dairy Products, and include the following:
(1) Direct microscopic clump count.
(2) Standard plate count.
(3) Plate loop count.
(4) BactoscanTM count.
(5) Pectin gel plate count.
(6) PetrifilmTM aerobic count.
(7) Spiral plate count.
(8) Hydrophobic grid membrane filter count.
(9) Impedance/conductance count.
(10) Other tests that have been approved by the Department through publication of notice in the Pennsylvania Bulletin.
(c) Excessive bacteria. Whenever the bacterial estimate indicates the presence of more than 500,000 bacteria per milliliter, the result shall be noted as a violation in the permitholder’s records. When two of the last four consecutive bacterial estimates exceed 500,000 per milliliter, the permitholder shall send a written warning notice to the producer in violation. This notice shall be in effect as long as two of the last four consecutive samples exceed the limit of the standard.
(d) Excluding milk with excessive bacteria from the market. If a producer receives the written notice described in subsection (c), the producer shall have an additional sample taken between 3 and 21 days after receiving the notice. If this sample also exceeds 500,000 per milliliter, subsequent milkings shall be excluded from the market until satisfactory compliance is obtained. Shipment may be resumed and a temporary status assigned to the producer by the Department when an additional sample of herd milk is tested and found satisfactory. The producer shall be assigned a full reinstatement status when three out of four consecutive bacterial estimates do not exceed 500,000 per milliliter. The samples shall be taken at a rate of not more than two per week on separate days within a 3-week period.
Cross References This section cited in 7 Pa. Code § 59a.105 (relating to approved milk graders); 7 Pa. Code § 59a.111 (relating to drug residue level); 7 Pa. Code § 59a.113 (relating to suspended milk for manufacturing); and 7 Pa. Code § 59a.114 (relating to inspection and quality testing of milk from producers).
§ 59a.110. Somatic cell count.
(a) General testing requirement. A laboratory examination to determine the level of somatic cells shall be made on each producer’s milk at least once each month. Samples shall be analyzed at a Pennsylvania-approved dairy laboratory. The laboratory must report the results to the permitholder.
(b) Testing methods. Milk shall be tested for somatic cell content by using one of the following procedures:
(1) Direct Microscopic Somatic Cell Count (Single Strip Procedure).
(2) Electronic Somatic Cell Count.
(3) Flow Cytometry/Opto-Electronic Somatic Cell Count.
(4) Membrane Filter DNA Somatic Cell Count.
(c) Excessive somatic cell count. Whenever the official test indicates the presence of more than 750,000 somatic cells per milliliter (1,500,000/ml for goat milk), the result shall be noted as a violation in the permitholder’s records. When two of the last four consecutive bacterial estimates exceed 750,000/ml (1,500,000/ml for goat milk), the permitholder shall send a written warning notice to the producer in violation. This notice shall be in effect as long as two of the last four consecutive samples exceed the limit of the standard.
(d) Excluding milk with an excessive somatic cell count from the market. If a producer receives the written notice described in subsection (c)(2), the producer shall have an additional sample taken between 3 and 21 days after receiving the notice. If this sample also exceeds 750,000 per milliliter, subsequent milkings shall be excluded from the market until satisfactory compliance is obtained. Shipment may be resumed and a temporary status assigned to the producer by the Department when an additional sample of herd milk is tested and found satisfactory. The producer shall be assigned a full reinstatement status when three out of four consecutive somatic cell count tests do not exceed 750,000 per milliliter. The samples shall be taken at a rate of not more than two per week on separate days within a 3-week period.
Cross References This section cited in 7 Pa. Code § 59a.105 (relating to approved milk graders); 7 Pa. Code § 59a.113 (relating to suspended milk for manufacturing); and 7 Pa. Code § 59a.114 (relating to inspection and quality testing of milk from producers).
§ 59a.111. Drug residue level.
(a) Industry responsibilities. Manufactured dairy products permitholders shall meet the requirements of this section to confirm their manufactured dairy products are free of violative drug residues.
(1) Sampling and testing program.
(i) Milk shipped for processing or intended to be processed on the farm where it was produced shall be sampled and tested, prior to processing, for beta lactam drug residue. Collection, handling and testing of samples shall be done according to procedures established by the Department in this section, and in accordance with Appendix N of the Grade ‘‘A’’ PMO, regarding drug residue testing and farm surveillance. If a person processes milk on the farm where it was produced and produces that milk in accordance with a written quality control program addressing the use of animal drugs at that dairy operation, that person may request a variance from the testing requirements of this subparagraph. The request shall be in writing and include a copy of the written quality control program. The Department may, on the basis of the request, issue a variance with respect to the requirements of this subparagraph. A variance issued under this subparagraph will be valid for no more than 1 year and may be renewed for additional periods of up to 1 year following the Department’s review of the quality control program and any on-farm inspections the Department deems necessary to determine whether a successor variance should be issued.
(ii) When so specified by the FDA, milk shipped for processing, or intended to be processed on the farm where it was produced, shall be sampled and tested, prior to processing, for other drug residues under a random drug sampling program. The random drug sampling program must include at least four samples collected in at least 4 separate months during any consecutive 6-month period.
(iii) When the Commissioner of the FDA determines that a potential problem exists with an animal drug residue or other contaminant in the milk supply, a sampling and testing program shall be conducted, as determined by the FDA. The testing shall continue until the Commissioner of the FDA determines with reasonable assurance that the potential problem has been remedied.
(iv) The dairy industry shall analyze samples for beta lactams and other drug residues by methods which have been independently evaluated or evaluated by the FDA and accepted by the FDA as effective to detect drug residues at current safe or tolerance levels. Safe and tolerance levels for particular drugs are established by the FDA.
(v) Sample test results for milk that does not test positive shall be recorded. The test result records shall be retained for 6 months.
(2) Individual producer sampling.
(i) Bulk milk. A milk sample for beta lactam drug residue testing shall be taken at each farm and include milk from each farm bulk tank. The sample shall be tested for beta lactam drug residues on the same monthly schedule as the bacterial estimate testing described in § 59a.109 (relating to bacterial estimate classification).
(ii) Can milk. A milk sample for beta lactam drug residue testing shall be formed separately at the receiving plant for each can milk producer included in a delivery, and shall be representative of all milk received from the producer. The sample shall be tested for beta lactam drug residues on the same monthly schedule as the bacterial estimate testing described in § 59a.109.
(iii) Producer/processor. A milk sample for beta lactam drug residue testing shall be formed separately according to subparagraphs (i) and (ii) for milk produced or received by a producer/processor. The sample shall be tested for beta lactam drug residues on the same monthly schedule as the bacterial estimate testing described in § 59a.109.
(3) Load sampling and testing.
(i) Bulk milk. A load sample shall be taken from the bulk milk pickup tanker and tested for beta lactam residues after its arrival at the plant and prior to further commingling.
(ii) Can milk. A load sample representing all of the milk received on a shipment shall be formed at the plant using a sampling procedure that includes milk from every can on the vehicle and tested for beta lactam residues.
(iii) Producer/processor. A daily load sample shall be formed at the plant using a sampling procedure that includes all milk produced and received at the plant that day and tested for beta lactam residues.
(4) Sample and record retention. A load sample that tests positive for drug residue shall be retained for at least 12 months. The records of all positive sample test results shall be retained for at least 24 months.
(5) Industry follow-up.
(i) When a load sample tests positive for drug residue, an employee or representative of the receiving plant shall notify the Department immediately of the positive test result and of the intended disposition of the shipment of milk containing the drug residue. Milk testing positive for drug residue shall be disposed of in a manner that removes it from the human or animal food chain, except when acceptably reconditioned under FDA compliance policy guidelines.
(ii) Each individual producer sample represented in the positive-testing load sample shall be individually tested as directed by the Department to determine the producer of the milk sample testing positive for drug residue. Identification of the producer responsible for producing the milk testing positive for drug residue, and details of the final disposition of the shipment of milk containing the drug residue, shall be reported immediately to the Department.
(iii) Milk shipment from the producer identified as the source of milk testing positive for drug residue shall cease immediately and may resume only after a sample from a subsequent milking does not test positive for drug residue.
(b) Responsibilities of the Department.
(1) Monitoring and surveillance. The Department will monitor the milk industry’s drug residue program by conducting unannounced onsite inspections to observe testing and sampling procedures and to collect samples for comparison drug residue testing. In addition, the Department will review industry records for compliance with drug residue program requirements. The review will seek to determine that the following conditions are met:
(i) Each producer is included in a routine, effective drug residue milk monitoring program utilizing methods evaluated and found acceptable by FDA to test samples for the presence of drug residue.
(ii) The Department receives prompt notification from industry personnel of each occurrence of a sample testing positive for drug residue, and of the identity of each producer identified as a source of milk testing positive for drug residue.
(iii) The Department receives prompt notification from industry personnel of the intended and final disposition of milk testing positive for drug residue, and that disposal of the load is conducted in a manner that removes it from the human or animal food chain, except when acceptably reconditioned under FDA compliance policy guidelines.
(iv) Milk shipment from a producer identified as a source of milk testing positive for drug residue completely and immediately ceases until a milk sample taken from the dairy herd does not test positive for drug residue.
(2) Enforcement.
(i) Any time milk is found to test positive for drug residue, the Department will immediately take action to suspend the producer’s milk shipping privileges to prevent the sale of milk from the producer shipping milk testing positive for drug residue.
(ii) The producer’s milk shipping privileges may be reinstated when a representative sample taken from the producer’s milk, prior to commingling with any other milk, is no longer positive for drug residue.
(iii) The penalty shall be for the value of all milk on the contaminated load plus any costs associated with the disposition of the contaminated load. The Department may accept certification from the violative producer’s milk marketing cooperative or purchaser of milk as satisfying the penalty requirements.
(iv) Whenever a drug residue test is positive, an investigation shall be made to determine the cause. Action shall be taken to prevent future occurrences.
(v) If a producer ships milk testing positive for drug residue three times within a 12-month period, the producer shall follow best management practices that include testing each shipment for drug residues prior to pick-up.
(vi) The actions and procedures of the Department will be in accordance with this chapter and Appendix N of the Grade ‘‘A’’ PMO, regarding drug residue testing and farm surveillance.
Cross References This section cited in 7 Pa. Code § 59a.105 (relating to approved milk graders); and 7 Pa. Code § 59a.114 (relating to inspection and quality testing of milk from producers).
§ 59a.112. Rejected milk.
(a) Rejection requirement. A plant shall reject specific milk from a producer if it fails to meet the requirements under § 59a.107 (relating to appearance and odor), if it is classified No. 4 for sediment content, or if it tests positive for drug residue.
(b) Tagging and coloring rejected milk. Rejected milk shall be identified with a reject tag and colored with harmless food coloring.
§ 59a.113. Suspended milk for manufacturing.
A plant may not accept milk from a producer if one of the following occurs:
(1) The producer’s initial milk shipment to a plant is classified as No. 3 for sediment content, as described in § 59a.108 (relating to sediment content classification).
(2) The milk has been in a probational (No. 3) sediment content classification for more than 10-calendar days.
(3) Three of the last five milk samples have exceeded the maximum bacterial estimate of 500,000 per milliliter, as described in § 59a.109 (relating to bacterial estimate classification).
(4) Three of the last five milk samples have exceeded the maximum somatic cell count level of 750,000 per milliliter (1,500,000/ml for goat milk), as described in § 59a.110 (relating to somatic cell count).
(5) The producer’s milk shipments to either the Grade ‘‘A’’ milk market or the manufacturing grade milk market are currently prohibited due to a positive drug residue test.
(6) The milk contains added water. For purposes of this requirement, samples analyzed for added water and found to have a freezing point above -0.525° F (0.508° C) shall be considered adulterated unless proven free of added water.
§ 59a.114. Inspection and quality testing of milk from producers.
(a) Inspections. Inspections shall be as follows:
(1) A dairy farm on which milk is produced for manufacturing purposes shall be inspected initially and have a passing score before the first milk is shipped.
(2) The dairy farm of a producer, on a change of market shall be inspected by an approved inspector and have a passing score before the first milk is shipped.
(3) Dairy farms shall be inspected at least once in each 6-month period by an approved inspector.
(b) Testing of first shipment. An examination and tests shall be made on the first shipment of milk from producers shipping milk to a plant for the first time or after a period of nonshipment. The milk must meet the following requirements:
(1) The requirements of § 59a.107 (relating to appearance and odor).
(2) The requirements of § 59a.108 (relating to sediment content classification).
(3) The requirements of § 59a.109 (relating to bacterial estimate classification).
(4) The requirements of § 59a.110 (relating to somatic cell count).
(5) The requirements of § 59a.111 (relating to drug residue level).
(c) Testing of subsequent shipments. For all shipments of milk not described in subsection (b), testing must meet the following requirements:
(1) The requirements of § 59a.107.
(2) The requirements of § 59a.108.
(3) The requirements of § 59a.109.
(4) The requirements of § 59a.110.
(5) The requirements of § 59a.111.
(d) Transfer producers. When a producer discontinues milk delivery to one plant and begins delivery to a different plant, the provisions of the Grade ‘‘A’’ PMO, in particular section 5, regarding certified industry inspection and change-of-market requirements, apply to the extent described in § 59a.11 (relating to adoption of Grade ‘‘A’’ PMO).
§ 59a.115. Record of tests.
Accurate records of the results of the milk quality and drug residue tests for each producer shall be kept on file for 24 months and be available for examination by the Department.
§ 59a.116. Abnormal milk.
(a) Certain milk to be excluded from human consumption. Cows which show evidence of the secretion of abnormal milk in one or more quarters based on bacteriological, chemical or physical examination and cows which have been treated with or have consumed chemical, medicinal or radioactive agents which are capable of being secreted in the milk in excess of any established limits and which may be deleterious to human health shall be milked last or with separate equipment and the milk may not be offered for sale for human consumption.
(b) Medicinal agents. Milk from cows being treated with medicinal agents may not be offered for sale for periods recommended by the attending veterinarian or as indicated on the package label of the medicinal agent.
(c) Pesticides. Milk from cows treated with or exposed to pesticides not approved for use on dairy cattle by the United States Environmental Protection Agency may not be offered for sale until the milk has been tested and found acceptable by the Secretary, in accordance with the procedures and standards set forth in Appendix N of the Grade ‘‘A’’ PMO, regarding drug residue testing and farm surveillance.
(d) Visibly abnormal milk and odorous milk. Bloody, stringy, off-color milk or milk abnormal in sight and odor shall be handled and disposed of to preclude the infection of other cows, and the contamination of the utensils.
(e) Equipment, utensils and containers. Equipment, utensils and containers used for handling of abnormal milk may not be used for the handling of milk to be offered for sale unless they are first effectively cleaned and sanitized.
(f) Poultry litter and recycled animal body discharges. Poultry litter and recycled animal body discharges may not be fed to lactating dairy animals.
Cross References This section cited in 7 Pa. Code § 59a.203 (relating to milking procedures).
§ 59a.117. Animal health.
(a) General health. Animals in the herd shall be maintained in a healthy condition, and shall be properly fed and kept.
(b) Tuberculin test. The lactating animals shall be located in a modified accredited state or zone, an accredited free state or zone, or an accredited free herd as determined by the United States Department of Agriculture under 9 CFR Part 77 (relating to tuberculosis). If the animals are not located in those areas or zones, they shall be tested annually in accordance with that United States Department of Agriculture program. Additions to the herd shall be from an area or from herds meeting those same requirements.
(c) Brucellosis test. The lactating animals shall be located in states or areas meeting Class B status, or Certified Brucellosis-Free Herds, as determined by the United States Department of Agriculture under 9 CFR Part 78 (relating to brucellosis) or shall be involved in a milk ring test program or blood testing program under the current USDA Brucellosis Eradication Uniform Methods and Rules. Additions to the herd shall be from a State, area or herd meeting these same requirements.
(d) Prohibition. Brucellosis and tuberculosis reactors disclosed shall be separated immediately from the milking herd. Milk from brucellosis or tuberculosis reactors may not be sold.
Subchapter D. FARMS PRODUCING MILK FOR MANUFACTURING
Sec.
59a.201. Farm inspection.
59a.202. Milking facilities and housing.
59a.203. Milking procedures.
59a.204. Cooling and storage.
59a.205. Milkhouse or milkroom.
59a.206. Utensils and equipment.
59a.207. Water supply.
59a.208. Sewage disposal.§ 59a.201. Farm inspection.
Farms producing and selling milk for manufacturing purposes shall comply with the following inspection provisions:
(1) Each dairy farm operated by a producer of milk for manufacturing purposes shall 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. To attain a passing score, there may not be deficiencies in areas of major significance to the sanitary quality of the farm’s milk supply unless these deficiencies are immediately corrected during the inspection. These areas of major significance include toilet, water supply, construction of utensils and equipment, cleaning and sanitizing of equipment, cow cleanliness and proper storage and labeling of medications. Dairy farms producing milk for manufacturing purposes shall be inspected every 6 months by an approved inspector, and an accurate record of inspections shall be maintained by each permitholder for 24 months.
(2) Producers who cannot produce milk of a wholesome sanitary quality will be suspended. Producers who are not in substantial compliance with this section or § 59a.102 (relating to milk permits) will be reinspected after an appropriate time for correction of deficiencies. Milk for manufacturing is of wholesome sanitary quality if it meets the applicable requirements of Subchapter C (relating to production and processing of milk for manufacturing purposes), including those relating to appearance and odor, drug residue, sediment content, bacterial estimate and somatic cell count, and § 59a.202 (relating to milking facilities and housing).
(3) A permitholder shall promptly notify the Department of initial instatement, suspension or reinstatement of a producer from which milk for manufacturing is or was received. Identification of the producer, including name and address, shall be provided orally or by mail within 24 hours of the action.
§ 59a.202. Milking facilities and housing.
(a) General requirements. A milking barn or milking parlor of adequate size and arrangement shall be provided to permit normal sanitary milking operations. It shall be well lighted and ventilated, and the floors and gutters in the milking area shall be constructed of concrete or other impervious material. The facility shall be kept clean, the manure removed daily and stored to prevent access of lactating animals to accumulation thereof. Swine or fowl may not be permitted in the milking area. When a milking barn is used and horses are present, the horses shall be stalled in a separate area a sufficient distance from the milking area or separated by tight partitions.
(b) Platforms and ramps. If a milking barn or milking parlor has ramps and platforms that are used to elevate lactating animals, these ramps and platforms must be constructed of an impervious material such as steel. Wooden platforms and ramps are prohibited. Rubber mats may be used as long as they are not placed over a wooden platform.
(c) Concentrates and feed storage. Concentrates and feed, if stored in the building, shall be stored in a tightly covered box, bin or container.
(d) Protection of exposed milk. If milk is exposed during straining or transferring in the milking area, it shall be protected from falling particles from areas above the milk facility.
(e) Yard requirements. The yard or loafing area must be of ample size to prevent overcrowding, be drained to prevent forming of standing water pools, insofar as practicable, and kept clean.
Cross References This section cited in 7 Pa. Code § 59a.201 (relating to farm inspection).
§ 59a.203. Milking procedures.
(a) Cleanliness of udders and flanks. The udders and flanks of all lactating animals shall be kept clean. The udders and teats shall be washed or wiped immediately before milking with a clean, damp cloth or paper towel moistened with a sanitizing solution and wiped dry or by another sanitary method approved in writing by the Department.
(b) Milker. The milker’s outer clothing must be clean and his hands clean and dry. A person with an infected cut or open sores on the person’s hands or arms may not milk lactating animals, or handle milk or milk containers, utensils or equipment.
(c) Equipment. Milk stools, surcingles or antikickers shall be kept clean and properly stored. Dusty operations may not be conducted immediately before or during milking. Strong flavored feeds may not be fed immediately before or during milking.
(d) Abnormal milk. In addition to the requirements of § 59a.116 (relating to abnormal milk), abnormal milk may not be squirted on the floor, on the platform or in the producer’s hand. Producers shall also wash their hands after handling equipment and handling the teats and udders of animals producing abnormal milk.
§ 59a.204. Cooling and storage.
(a) Milk in cans. Milk in cans shall be cooled immediately after milking to 50° F or lower at the farm, and not exceed 55° F upon delivery to the plant, unless delivered to the plant within 2 hours after milking. The cooler, tank or refrigerated unit shall be kept clean. Maximum time of delivery of milk to a milk plant shall be within 48 hours of initial milking.
(b) Milk in farm bulk tanks. Milk in farm bulk tanks shall be cooled to 40° F within 2 hours after milking. Cooled milk may not be allowed to rise above a temperature of 50° F by subsequent addition of milk to the bulk tank and shall be cooled at 45° F or lower at time of pick-up, and not exceed 50° F upon delivery to the plant. Maximum time of delivery of milk to a milk plant may not exceed 72 hours of initial milking.
§ 59a.205. Milkhouse or milkroom.
(a) General requirements. A milkhouse or milkroom shall be provided for handling and cooling milk and for washing, handling and storing the utensils and equipment. The milkhouse or milkroom must be conveniently located and properly constructed, lighted and ventilated. Other products may not be handled in the milkroom which would be likely to contaminate milk, or otherwise create a public health hazard.
(b) Equipment and construction. The milkroom must be equipped with a wash and rinse vat, utensil rack, milk cooling facilities and an adequate supply of hot water available for cleaning milking equipment. If a part of the barn or other building, it must be partitioned, screened and sealed to prevent the entrance of dust, flies or other contamination. The floor of the building must be of concrete or other impervious material and graded to provide proper drainage. The walls and ceilings must be constructed of smooth easily cleaned material. Outside doors must open outward and be self-closing, unless they are provided with tight-fitting screen doors that open outward or unless other effective means are provided to prevent the entrance of flies.
(c) Farm bulk tanks. If a farm bulk tank is used, the following requirements apply:
(1) The farm bulk tank shall be properly located in the milkhouse or milkroom for access to all areas for cleaning and servicing. It may not be located over a floor drain or under a ventilator.
(2) A small platform or slab constructed of concrete or other impervious material shall be provided outside the milkhouse, properly centered under a suitable port opening in the wall of the milkhouse. The opening shall be fitted with a tight, self-closing door. The truck approach to the milkhouse or milkroom must be properly graded and surfaced to prevent mud or pooling of water at the point of loading.
(d) Trash, animals and fowl. The milkhouse or milkroom and appurtenances shall be kept clean and free of trash, animals and fowl.
(e) Farm chemicals and animal drugs.
(1) Animal biologics and other drugs intended for treatment of animals, and insecticides approved for use in dairy operations, must be clearly labeled and used in accordance with label instructions, and stored in a manner which will prevent accidental contact with milk and milk contact surfaces.
(2) Only drugs that are approved by the FDA or biologics approved by the United States Department of Agriculture (USDA) for use in dairy animals that are properly labeled according to FDA or USDA regulations shall be administered to the animals.
(3) When drug storage is located in the milkroom, milkhouse or milking area, the drugs shall be stored in a closed, tight-fitting storage unit. The drugs shall further be segregated so that drugs labeled for use in lactating dairy animals are separated from drugs labeled for use in nonlactating dairy animals.
(4) Drugs labeled for use in nondairy animals may not be stored with drugs labeled for use in dairy animals. When drugs labeled for use in nondairy animals are stored in the barn, the drugs shall be located in an area of the barn separate from the milking area.
(5) Herbicides, fertilizers, pesticides and insecticides that are not approved for use in dairy operations may not be stored in the milkhouse, milkroom or milking area.
§ 59a.206. Utensils and equipment.
(a) General requirements. Utensils, milk cans, milking machines—including pipeline systems—rubber and rubber-like parts and other equipment used in the handling of milk shall be maintained in good condition, be free from rust, open seams, milkstone or any unsanitary condition, and shall be washed, rinsed and drained after each milking, stored in suitable facilities and sanitized immediately before use with a dairy equipment sanitizer that has been approved by the United States Environmental Protection Agency for use with dairy or food processing equipment, and that is used according to the label directions. New or replacement can lids must be umbrella type. New utensils and equipment must comply with applicable 3-A Sanitary Standards.
(b) Farm bulk tanks. Farm bulk tanks must meet 3-A Sanitary Standards for construction at the time of installation and be installed under § 59a.26 (relating to plans for construction and reconstruction).
(c) Single service articles. Single service articles shall be properly stored and may not be reused.
§ 59a.207. Water supply.
A dairy farm water supply shall be properly located, protected and operated, and shall be easily accessible, ample, and of safe, sanitary quality for the cleaning of dairy utensils and equipment. The water supply must come from a source which complies with the water supply provisions of the Grade ‘‘A’’ PMO, including Appendix D, regarding standards for water sources, and is approved by the Department.
§ 59a.208. Sewage disposal.
House, milkhouse or milkroom and toilet wastes shall be disposed of in a manner that does not pollute the soil surface, contaminate the water supply or be conducive to the breeding of insects.
Subchapter E. MANUFACTURING PLANTS
GENERAL REQUIREMENTS Sec.
59a.301. Premises.
59a.302. Buildings.
59a.303. Facilities.
59a.304. Equipment and utensils.
59a.305. Personnel cleanliness.
59a.306. Personnel health.
59a.307. Protection and transport of raw milk and cream.
59a.308. Raw product storage.
59a.309. Pasteurized, ultrapasteurized or aseptically processed and packaged products.
59a.310. Composition and wholesomeness.
59a.311. Cleaning and sanitizing treatment.
59a.312. Insect and rodent control program.
59a.313. Plant records.
59a.314. Packaging and general identification.
59a.315. Storage of finished product.
59a.316. Permits.
SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING AND PACKAGING INSTANT NONFAT DRY MILK, NONFAT DRY MILK, DRY WHOLE MILK, DRY BUTTERMILK, DRY WHEY AND OTHER DRY MILK PRODUCTS
59a.321. Requirements for rooms and compartments.
59a.322. Dry storage.
59a.323. Packaging room for bulk products.
59a.324. Hopper or dump room.
59a.325. Repackaging room.
59a.326. Equipment and utensils.
59a.327. Preheaters.
59a.328. Hotwells.
59a.329. Evaporators or vacuum pans, or both.
59a.330. Surge tanks.
59a.331. High pressure pumps and lines.
59a.332. Dryers.
59a.333. Collectors and conveyors.
59a.334. Dry dairy product cooling equipment.
59a.335. Special treatment equipment.
59a.336. Sifters.
59a.337. Portable and stationary bulk bins.
59a.338. Automatic sampling device.
59a.339. Dump hoppers, screens and mixers.
59a.340. Filler and packaging equipment.
59a.341. Heavy duty vacuum cleaners.
59a.342. Clothing and shoe covers.
59a.343. Operations and operating procedures: Pasteurization.
59a.344. Operations and operating procedures: Condensed surge supply.
59a.345. Operations and operating procedures: Condensed storage tanks.
59a.346. Operations and operating procedures: Drying.
59a.347. Operations and operating procedures: Cooling dry products.
59a.348. Operations and operating procedures: Packaging, repackaging and storage.
59a.349. Operations and operating procedures: Product adulteration.
59a.350. Operations and operating procedures: Checking quality.
59a.351. Operations and operating procedures: Requirements for instant nonfat dry milk.
59a.352. Operations and operating procedures: Cleaning of dryers, conveyors, sifters and storage bins.
59a.353. Operations and operating procedures: Insect and rodent control program.
SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING AND PACKAGING BUTTER AND RELATED PRODUCTS
59a.361. Rooms and compartments.
59a.362. Equipment and utensils.
59a.363. Operations and operating procedures.
SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING AND PACKAGING CHEESE
59a.371. Rooms and compartments.
59a.372. Equipment and utensils.
59a.373. Operations and operating procedures.
SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING AND PACKAGING PASTEURIZED PROCESS CHEESE AND RELATED PRODUCTS
59a.381. Equipment and utensils.
59a.382. Operations and operating procedures.
SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING AND PACKAGING EVAPORATED, CONDENSED OR STERILIZED MILK PRODUCTS
59a.391. Equipment and utensils.
59a.392. Operations and operating procedures.
Cross References This subchapter E cited in 7 Pa. Code § 59a.2 (relating to definitions).
GENERAL REQUIREMENTS
§ 59a.301. Premises.
(a) General. The exterior premises of a manufacturing plant shall be kept in a clean and orderly condition, and be free from strong or foul odors, smoke or excessive air pollution. Construction and maintenance of driveways and adjacent plant traffic areas must be of concrete, asphalt or similar material to keep dust and mud to a minimum.
(b) Surroundings. The adjacent surroundings of a manufacturing plant must be free from refuse, rubbish and waste materials to prevent harborage of rodents, insects and other vermin.
(c) Drainage. A suitable drainage system shall be provided which will allow rapid drainage of all water from manufacturing plant buildings and driveways, including surface water around the plant and on the premises. The water shall be disposed of in a manner that prevents a nuisance or health hazard.
§ 59a.302. Buildings.
(a) General. Manufacturing plant buildings must be of sound construction and kept in good repair to prevent the entrance or harboring of rodents, birds, insects, vermin, dogs and cats. Service pipe openings through outside walls shall be effectively sealed around the opening or provided with tight metal collars.
(b) Outside doors, windows and openings. Openings to the outer air, including doors, windows, skylights and transoms, shall be effectively protected or screened against the entrance of flies and other insects, rodents, birds, dust and dirt. Outside doors opening into processing rooms must be in good condition and fit properly. Hinged, outside screen doors must open outward. Doors and windows shall be kept clean and in good repair. Outside conveyor openings and other special-type outside openings shall be effectively protected to prevent the entrance of flies and rodents, by the use of doors, screens, flaps, fans or tunnels. Outside openings for sanitary pipelines shall be covered when not in use. On new construction, window sills should be slanted downward at a 45° angle.
(c) Walls, ceilings, partitions and posts. The walls, ceilings, partitions, posts of rooms in which milk or dairy products are processed, manufactured, handled, packaged or stored (except dry storage of packaged finished products and supplies) or in which utensils are washed and stored, must be smoothly finished with a suitable material of light color, which is substantially impervious to moisture and kept clean. They shall be refined as often as necessary to maintain a neat, clean surface.
(d) Floors.
(1) The floors of all rooms in which milk or dairy products are processed, manufactured, packaged or stored or in which utensils are washed must be constructed of tile properly laid with impervious joint material, concrete or other equally impervious material. The floors must be smooth, kept in good repair, graded so that there will be no pools of standing water or milk products after flushing, and the openings to the drains must be equipped with traps properly constructed and kept in good repair. On new construction, bell-type traps may not be used. The plumbing shall be installed to prevent the backup of sewage into the drain lines and to the floor of the plant.
(2) Sound, smooth wood floors which can be kept clean, may be used in rooms where new containers and supplies and certain packaged finished products are stored.
(e) Lighting and ventilation. Lighting and ventilation must comply with the following:
(1) Light must be ample, natural or artificial, or both, of good quality and well distributed. Rooms in which dairy products are manufactured or packaged or where utensils are washed must have at least 30 foot-candles of light intensity on all working surfaces and at least 50 foot-candles of light intensity in areas where dairy products are graded or examined for condition and quality. In other rooms, there must be at least 5 foot-candles of light intensity when measured at a distance of 30 inches from the floor. Where contamination of a product by broken glass is possible, light bulbs, fluorescent tubes, fixtures, skylight or other glass suspended over the product must be protected against breakage.
(2) There must be adequate heating, ventilation or air conditioning for all rooms and compartments to permit maintenance of sanitary conditions. Exhaust or inlet fans, vents, hoods or temperature and humidity control facilities shall be provided where and when needed to minimize or eliminate undesirable room temperatures, objectionable odors, moisture condensation or mold. Inlet fans shall be provided with an adequate air filtering device to eliminate dirt and dust from the incoming air. Ventilation systems shall be cleaned periodically as needed and maintained in good repair. Exhaust outlets must be screened or provided with self-closing louvers to prevent the entrance of insects when not in use.
(f) Certain rooms and compartments. Rooms and compartments in which raw material, packaging, ingredient supplies or dairy products are handled, manufactured, packaged or stored shall be designed, constructed and maintained to assure desirable room temperatures and clean and orderly operating conditions free from objectionable odors and vapors. Enclosed bulk milk receiving rooms must be separated from the processing rooms by a partition. Rooms for receiving can milk must be separated from the processing rooms by a partition—partial or complete—by suitable arrangement of equipment or by allowing enough distance between receiving and processing operations to avoid possible contamination of milk or dairy products during manufacturing and handling. Processing rooms shall be kept free from equipment and materials not regularly used. Rooms and compartments must comply with the following:
(1) Coolers and freezers. Coolers and freezers where dairy products are stored must be clean, reasonably dry and maintained at the proper uniform temperature and humidity to adequately protect the product and minimize the growth of mold. Adequate circulation of air must be maintained at all times. Coolers and freezers must be free from rodents, insects and pests. Shelves shall be kept clean and dry. Refrigeration units must have provisions for collecting and disposing of condensate.
(2) Supply room. The supply rooms used for the storing of packaging materials, containers and miscellaneous ingredients shall be kept clean, dry, orderly, free from insects, rodents and mold and maintained in good repair. Items stored in supply rooms shall be adequately protected from dust, dirt or other extraneous matter and arranged on racks, shelves or pallets to permit access to the supplies and cleaning and inspection of the room. Insecticides, rodenticides, cleaning compounds and other nonfood products must be properly labeled and segregated, and stored in a separate room or cabinet away from milk, dairy products, ingredients or packaging supplies.
(3) Boiler rooms, shop room and service areas. The boiler rooms, shop room and service areas must be separated from other rooms where milk and dairy products are processed, manufactured, packaged, handled or stored. The rooms shall be kept orderly and reasonably free from dust and dirt.
(4) Toilet and dressing rooms. Adequate toilet and dressing rooms facilities must be conveniently located.
(i) Toilet rooms may not open directly into a room where milk or dairy products are processed, manufactured, packaged or stored. Doors must be self-closing. Ventilation must be provided by mechanical means or screened openings to the outer air. Fixtures shall be kept clean and in good repair.
(ii) Employees shall be furnished with a locker, or other suitable facility, and the lockers and dressing rooms shall be kept clean and orderly. Adequate handwashing facilities shall be provided and durable, legible signs shall be posted conspicuously in each toilet or dressing room directing employees to wash their hands before returning to work.
(5) Laboratory. The permitholder may establish its own laboratory to perform required tests on milk received as milk for manufacturing purposes. The laboratory shall be adequately equipped and maintained and be properly staffed with qualified, trained personnel and operate in accordance with the current Evaluation of Milk Laboratories, Recommendations of the United States Public Health Service/Food and Drug Administration and current FDA 2400 Laboratory Series forms. If the permitholder does not establish its own laboratory, an existing approved laboratory is acceptable if services are conveniently available so that samples and results can be transmitted without delay.
(6) Starter facilities. Adequate sanitary facilities shall be provided for the handling of starter cultures.
(7) Lunch rooms and eating areas. When eating areas are provided, they shall be kept clean and orderly and not open directly into a room in which milk or dairy products are processed, manufactured or packaged. Signs shall be posted directing employees to wash their hands before returning to work.
Cross References This section cited in 7 Pa. Code § 59a.321 (relating to requirements for rooms and compartments); and 7 Pa. Code § 59a.323 (relating to packaging room for bulk products).
§ 59a.303. Facilities.
(a) Water supply. There must be an ample supply of both hot and cold water of safe and sanitary quality, with adequate facilities for its proper distribution throughout the plant, and protection against contamination and pollution. Water from other facilities, when approved in writing by the Department, may be used for boiler feed water and condenser water provided that the waterlines are completely separated from the waterlines carrying the sanitary water supply, and the equipment is so constructed and controlled to preclude contamination of product contact surfaces. There may not be cross connection between the safe water supply and any unsafe or questionable water supply, or any other source of pollution through which contamination of the safe water supply is possible. Bacteriological examination shall be made of the sanitary water supply at least twice a year, or as often as necessary to determine purity and suitability for use in manufacturing dairy products. The tests shall be made in a laboratory that is approved by the Department. The results of all water tests shall be kept on file at the plant for which the test was performed.
(b) Drinking water. Sanitary drinking water facilities shall be provided in the plant and be conveniently located.
(c) Hand-washing facilities. Convenient hand-washing facilities shall be provided, including hot and cold running water, soap or other detergents, and sanitary single-service towels or air dryers. The accommodations must be located in or adjacent to toilet and dressing rooms and also at other places in the plant that may be essential to the cleanliness of all personnel handling products. Vats for washing equipment or utensils may not be used as handwashing facilities. Self-closing metal or plastic containers shall be provided for used towels and other wastes.
(d) Steam. Steam shall be supplied in sufficient volume and pressure for satisfactory operation of each applicable piece of equipment. Culinary steam used in direct contact with milk or dairy products must be free from harmful substances or extraneous material and only nontoxic boiler compounds shall be used, or a secondary steam generator shall be used in which soft water is converted to steam and no boiler compounds are used. Steam traps, strainers and condensate traps shall be used wherever applicable to insure a satisfactory and safe steam supply. Culinary steam must comply with the current 3-A Accepted Practices for a Method of Producing Culinary Steam.
(e) Air under pressure. The method for supplying air under pressure which comes in contact with milk or dairy products or any product contact surface must comply with the current 3-A Accepted Practices for Supplying Air Under Pressure. The air used at the point of application must be free from volatile substances, volatiles which may impart any flavor or odor to the products, and extraneous or harmful substances.
(f) Dairy waste. Dairy wastes shall be properly disposed of from the plant and premises. The sewer system must have sufficient slope and capacity to readily remove all waste from the various processing operations. When a public sewer is not available, wastes shall be properly disposed of so as not to contaminate milk equipment or to create a nuisance or public health hazard. Containers used for the collection and holding of wastes shall be constructed of metal, plastic or other equally impervious material and kept covered with tight fitting lids and placed outside the plant on a concrete slab or on a rack raised at least 12 inches. Waste containers may be kept inside a suitably enclosed, clean and flyproof room. Solid wastes shall be disposed of regularly and the containers cleaned before reuse. Accumulation of dry wastepaper and cardboard shall be kept to a minimum.
§ 59a.304. Equipment and utensils.
(a) General construction, repair and installation.
(1) The equipment and utensils used for the processing of milk and manufacture of dairy products must be constructed to be readily demountable when necessary for cleaning and sanitizing. The product contact surfaces of all utensils and equipment such as holding tanks, pasteurizers, coolers, vats, agitators, pumps, sanitary piping and fittings or any specialized equipment must be constructed of stainless steel or other equally corrosion-resistant material. Nonmetallic parts other than glass having product contact surfaces must meet the current 3-A Standards for Multiple-Use Plastic Materials or the current 3-A Sanitary Standards for Multiple-Use Rubber, and Rubber-Like Materials Used as Product Contact Surfaces in Dairy Equipment.
(2) Equipment and piping shall be designed and installed to be easily accessible for cleaning, and be kept in good repair, free from cracks and corroded surfaces. New or rearranged equipment must be set away from any wall or spaced in a manner that facilitates proper cleaning and good housekeeping. Parts or interior surfaces of equipment, pipes (except certain piping cleaned in place) or fittings, including valves and connections, must be accessible for inspection.
(3) CIP systems must comply with the current 3-A Sanitary Practices for Permanently Installed Sanitary Product, Pipelines, and Cleaning Systems Used in Milk and Milk Processing Plants.
(b) Weigh cans and receiving tanks. Weigh cans and receiving tanks must meet the general requirements of this section, be easily accessible for cleaning both inside and outside and elevated above the floor and protected sufficiently with the necessary covers or baffles to prevent contamination from splash, condensate and drippage. When necessary to provide easy access for cleaning of floors and adjacent wall areas, the receiving tank must be equipped with wheels or casters to allow easy removal.
(c) Can washers. Can washers must have sufficient capacity and ability to discharge a clean, dry can and cover and shall be kept properly timed in accordance with the instructions of the manufacturer. The water and steam lines supplying the washer must maintain a reasonably uniform pressure and if necessary be equipped with pressure regulating valves.
(d) Product storage tanks or vats. Storage tanks or vats must be fully enclosed or tightly covered and well insulated. The entire interior surface, agitator and all appurtenances must be accessible for thorough cleaning and inspection. Any opening at the top of the tank or vat including the entrance of the shaft must be suitably protected against the entrance of dust, moisture, insects, oil or grease. The sight glasses, if used, must be sound, clean and in good repair. Vats which have hinged covers must be designed so that moisture or dust on the surface cannot enter the vat when the covers are raised. If the storage tanks or vats are equipped with air agitation, the system must be of an approved type and properly installed in accordance with the current 3-A Accepted Practices for Supplying Air Under Pressure. Storage tanks or vats intended to hold product for longer than approximately 8 hours must be equipped with adequate refrigeration or have adequate insulation, or both. New storage tanks or vats must meet the appropriate 3-A Sanitary Standards and be equipped with thermometers in good operating order.
(e) Separators. Product contact surfaces of separators must be free from rust and pits and insofar as practicable be of stainless steel or other equally noncorrosive metals. New separators must meet the current 3-A Sanitary Standards for Centrifugal Separators and Clarifiers.
(f) Coil or dome-type batch pasteurizers. Coil or dome-type batch pasteurizers must be stainless steel lined and if the coil is not stainless steel or other equally noncorrosive metal it must be properly tinned over the entire surface. Sanitary seal assemblies at the shaft ends of coil vats must be of the removable type, except that existing equipment not provided with this type gland will be acceptable if the packing glands are maintained and operated without adverse effects. New or replacement units must be provided with removable packing glands. Dome-type pasteurizer agitators must be stainless steel except that any nonmetallic parts must meet the current 3-A Sanitary Standards for Plastic and Rubber or Rubber-Like Materials, as applicable. Each pasteurizer used for heating product at 165° F or lower for 30 minutes or less must be equipped with space heating equipment and the necessary thermometers to insure a temperature at least 5° F above that required for pasteurization of the product. There must be adequate means of controlling the temperature of the heating medium. Batch pasteurizers must have temperature indicating and recording devices, and meet the current 3-A Sanitary Standards for Non-Coil Type Batch Pasteurizers.
(g) HTST pasteurizers. When pasteurization is intended or required, an approved timing pump or device recorder-controller, automatic flow diversion valve and holding tube or its equivalent, if not a part of the existing equipment, shall be installed on all HTST equipment used for pasteurization, to assure complete pasteurization. The entire facility must meet the current 3-A Accepted Practices for the Sanitary Construction, Installation, Testing, and Operation of High-Temperature, Short-Time Pasteurizers. After the HTST unit has been tested according to the 3-A Accepted Practices, the timing pump or device and the recorder controller shall be sealed at the correct setting to assure pasteurization. Sealing of the HTST unit shall be performed by the control authority having jurisdiction. The HTST pasteurizer shall be tested initially upon installation, and whenever any alteration or replacement is made which affects the proper operation of the instrument or device. When direct steam pasteurizers are used, the steam, prior to entering the product, must be conducted through a steam strainer and a steam purifier equipped with a steam trap and only steam meeting the requirements for culinary steam shall be used.
(h) Indicating thermometers.
(1) Long-stem indicating thermometers which are accurate within 0.5° F, plus or minus, for the applicable temperature range, shall be provided for checking the temperature of pasteurization and cooling of products in vats and checking the accuracy of recording thermometers.
(2) Short-stem indicating thermometers, which are accurate within 0.5° F, plus or minus, for the applicable temperature range, shall be installed in the proper stationary position in all HTST and dome-type pasteurizers. Storage tanks where temperature readings are required must have thermometers which are accurate within 2.0° F, plus or minus.
(3) Air-space indicating thermometers, when applicable, which are accurate within 1.0° F, plus or minus, for the proper temperature range shall also be installed above the surface of the products pasteurized in vats, to make certain that the temperature of the foam or air above the products pasteurized, or both, also received the required minimum temperature treatment.
(i) Recording thermometers.
(1) HTST recording thermometers that are accurate within 1° F, plus or minus, for the applicable temperature range, shall be used on each heat treating, pasteurizing or sterilizing unit to record the heating process.
(2) Additional use of recording thermometers accurate within 2° F, plus or minus, may be required where a record of temperature or time of cooling and holding is of significant importance. A record of temperature or time of cooling and holding is of significant importance when made in accordance with § § 59a.328, 59a.344, 59a.373(b), 59a.381(d), 59a.382(b) and 59a.392(b)(1).
(j) Surface coolers. Surface coolers must be equipped with hinged or removable covers for the protection of the product. The edges of the fins must be designed to divert condensate on nonproduct contact surfaces away from product contact surfaces. Gaskets or swivel connections must be leak proof.
(k) Plate-type heat exchangers. Plate-type heat exchangers must meet the current 3-A Sanitary Standards for Construction and Installation. Gaskets must be tight and kept in good operating order. Plates shall be opened for inspection by the operator at sufficiently frequent intervals to determine if the equipment is clean and in satisfactory condition. A cleaning regimen shall be posted to insure proper cleaning procedures between inspection periods.
(l) Internal return tubular heat exchangers. Internal return tubular heat exchangers must meet the current 3-A Sanitary Standards for Construction and Installation.
(m) Pumps. Pumps used for milk and dairy products must be of the sanitary type and constructed to meet 3-A Sanitary Standards. Unless pumps are specifically designed for effective cleaning in place, they shall be disassembled and thoroughly cleaned after use.
(n) Homogenizers. Homogenizers and high pressure pumps of the plunger type must meet the 3-A Sanitary Standards.
(o) New equipment and replacements. New equipment and replacements, including all plastic parts and rubber and rubber-like materials for parts and gaskets having product contact surfaces, must meet the current 3-A Sanitary Standards or 3-A Accepted Practices. If 3-A Sanitary Standards or 3-A Accepted Practices are not available, the equipment and replacements must meet the general requirements of this section.
(p) Certain vacuum chambers. A vacuum chamber, as used for flavor control, must be made of stainless steel or other equally noncorrosive metal. The unit must be constructed to facilitate cleaning and product contact surfaces must be accessible for inspection. The chamber must be equipped with a vacuum breaker and a check valve at the product discharge line. Only steam which meets the requirements for culinary steam may be used. The incoming steam supply shall be regulated by an automatic solenoid valve which will cut off the steam supply in the event the flow diversion valve of the HTST pasteurizer is not in the forward flow position. Condensers when used must be equipped with a water level control and an automatic safety shutoff valve.
Cross References This section cited in 7 Pa. Code § 59a.326 (relating to equipment and utensils); 7 Pa. Code § 59a.362 (relating to equipment and utensils); 7 Pa. Code § 59a.372 (relating to equipment and utensils); 7 Pa. Code § 59a.382 (relating ti equipment and utensils); 7 Pa. Code § 59a.391 (relating to equipment and utensils); and 7 Pa. Code § 59a.392 (relating to operations and operating procedures).
§ 59a.305. Personnel cleanliness.
Employees shall wash their hands before beginning work and upon returning to work after using toilet facilities, eating, smoking or otherwise soiling their hands. Employees shall keep their hands clean and follow good hygienic practices while on duty. Expectorating or use of tobacco in any form shall be prohibited in each room and compartment where any milk, dairy product or supplies are prepared, stored or otherwise handled. Clean white or light-colored washable outer garments, hair nets and adequate hair covering shall be worn by all persons engaged in receiving, testing, processing milk, manufacturing, packaging or handling dairy products.
§ 59a.306. Personnel health.
A person affected with any disease in a communicable form or while a carrier of the disease may not be permitted in any room or compartment where milk and dairy products are prepared, manufactured or otherwise handled. A person who has a discharging or infected wound, sore or lesion on hands, arms or other exposed portion of the body may not work in any dairy processing rooms or in any capacity resulting in contact with milk or dairy products. Each employee whose work brings him in contact with the processing or handling of dairy products, containers or equipment shall have a medical and physical examination by a registered physician or by the local department of health at the time of employment. In addition, an employee returning to work following illness from a communicable disease shall have a certificate from the attending physician to establish proof of complete recovery. Medical certificates attesting the fact that the employee when last examined was free from communicable disease shall be kept on file at the plant office.
§ 59a.307. Protection and transport of raw milk and cream.
(a) Equipment and facilities.
(1) Milk cans. Cans used in transporting milk from dairy farm to plant must be constructed to be easily cleaned, and shall be inspected, repaired and replaced as necessary to exclude substantially the use of cans and lids with open seams, cracks, rust, milkstone or any unsanitary condition.
(2) Farm bulk tanks. New farm bulk tanks must meet current 3-A Sanitary Standards for construction and be installed in accordance with the requirements of the Grade ‘‘A’’ PMO.
(b) Transporting milk or cream.
(1) Vehicles. Vehicles used for the transportation of can milk or cream must be of the enclosed type, constructed and operated to protect the product from extreme temperature, dust or other adverse conditions and kept clean. Decking boards or racks shall be provided when more than one tier of cans is carried. Cans, or bulk tanks on vehicles, used for the transportation of milk from the farm to the plant may not be used for any other purpose.
(2) Transport tanks. The exterior shell of transport tanks must be clean and free from open seams or cracks which would permit liquid to enter the jacket. The interior shell must be stainless steel and constructed so it will not buckle, sag or prevent complete drainage. Product contact surfaces must be smooth, easily cleaned and maintained in good repair. The pump and hose cabinet must be fully enclosed with tight fitting doors and the inlet and outlet must be provided with dust covers to give adequate protection from road dust. New and replacement transport tanks must meet the current 3-A Sanitary Standards for Stainless Steel Automotive Transportation Tanks for Bulk Delivery and/or Farm Pick-Up Service.
(c) Cleaning and sanitizing facilities. Enclosed facilities shall be available for washing and sanitizing of transport tanks, piping and accessories, at central locations or at all plants that receive or ship milk or milk products in transport tanks.
(d) Transfer of milk. Milk shall be transferred under sanitary conditions from farm bulk tanks through stainless steel piping or approved tubing. The sanitary piping and tubing must be capped when not in use.
§ 59a.308. Raw product storage.
(a) General. Milk shall be held and processed under conditions and at temperatures that will avoid contamination and rapid deterioration. Drip milk from can washers or another source may not be used for the manufacture of dairy products. Bulk milk in storage tanks within the plant shall be handled to minimize bacterial increase and shall be maintained at 45° F or lower until processing begins. This does not preclude holding milk at higher temperatures for a period of time, when applicable to particular manufacturing or processing practices.
(b) Bacteriological quality. The bacteriological quality of commingled milk in storage tanks must be 1 million/ml or lower.
(c) Sampling. During any consecutive 6 months, at least four samples of commingled raw milk for processing will be taken by the Department, or a designated representative, from each plant. The designated representative shall be an approved sampler who is either an employee of the plant or an employee or representative of a Pennsylvania-approved dairy laboratory.
(d) Testing of samples. A laboratory test of the samples described in subsection (c) shall be performed at a Pennsylvania-approved dairy laboratory to determine the bacterial estimate.
(e) Procedures if bacterial counts are high. Whenever a bacterial estimate of commingled milk in a plant indicates the presence of more than 1 million per milliliter, the following procedures shall be applied:
(1) The Department will notify plant management with a warning of excessive bacterial estimate, and recommend that appropriate action be taken to eliminate the bacterial problem.
(2) Whenever two of the last four consecutive commingled milk bacterial estimates exceed 1 million per milliliter, the Department will notify plant management with a written warning notice. The notice will be in effect so long as two of the last four consecutive samples exceed 1 million per milliliter. Plant management should continue to work to eliminate the problem.
(3) An additional sample will be taken by the Department after a lapse of 3 days but within 21 days of the notice required in paragraph (1). If this sample also exceeds 1 million per milliliter, the Department may take action (such as permit suspension or acting to keep the milk from the market place) until an additional sample of commingled milk is tested and found satisfactory. A temporary status may be assigned to the plant by the Department when an additional sample of commingled milk is tested and found in conformance with the 1,000,000-per-milliliter or lower bacterial classification standard for commingled raw milk for manufacturing. The plant will be assigned a full reinstatement status when three out of four consecutive commingled bacterial estimates do not exceed 1 million per milliliter. The samples will be taken at a rate of not more than two per week on separate days within a 3-week period.
(4) If a plant remains in temporary status in excess of 60 days, administrative procedures to suspend the plant’s license will be taken by the Department until the plant complies with the bacteriological requirements.
(f) Heat treated cream. Heat treated cream is derived from the heating of raw milk, one time, to temperatures greater than 125° F but less than 161° F for separation purposes. When enzyme deactivation is necessary for a functional reason, the cream may be further heated to less than 166° F in a continuing heating process. The resulting bulk shipment of cream shall be cooled to 45° F or less, and labeled as heat treated with bacterial limits of 20,000 per ml or gm for dairy products which are weighed.
§ 59a.309. Pasteurized, ultrapasteurized or aseptically processed and packaged products.
Pasteurized, ultrapasteurized or aseptically processed and packaged products must conform with § 59a.2 (relating to definitions). When pasteurization or sterilization is intended or required, or when a product is designated ‘‘pasteurized’’ or ‘‘sterilized,’’ every particle of the product shall be subjected to temperatures and holding periods that assure proper pasteurization or sterilization of the product. The heat treatment by either process must be sufficient to insure public health safety and to assure adequate keeping quality, yet retaining the most desirable flavor and body characteristics of the finished product. The phenol value of test samples of pasteurized finished product may be no greater than the maximum specified for the particular product as determined and specified by the phosphatase test method prescribed in the latest edition of ‘‘Official Methods of Analysis of the Association of Official Agricultural Chemists’’ (a publication of the Association of Official Analytical Chemists International, 481 North Frederick Avenue, Suite 500, Gaithersburg, MD 20877-2417).
§ 59a.310. Composition and wholesomeness.
Necessary precautions shall be taken to prevent contamination or adulteration of the milk or dairy products during manufacturing. Substances and ingredients used in the processing or manufacturing of a dairy product will be subject to inspection and must be wholesome and practically free from impurities. The finished product must comply with the Food, Drug, and Cosmetic Act (21 U.S.C.A. § § 301—399a) and applicable Commonwealth statutes as to their composition and wholesomeness.
§ 59a.311. Cleaning and sanitizing treatment.
(a) Equipment and utensils.
(1) The equipment, sanitary piping and utensils used in receiving and processing of the milk, and manufacturing and handling of the product shall be maintained in a sanitary condition. Sanitary seal assemblies must be removable on all agitators, pumps and vats, and shall be inspected at regular intervals and kept clean. Unless other provisions are recommended in the following supplemental sections, equipment not designed for CIP cleaning shall be disassembled after each day of use for thorough cleaning. Cleaning and sanitizing chemicals that are utilized for this cleaning must be labeled and shall be used in accordance with label directions. Steel wool or metal sponges may not be used in the cleaning of any dairy equipment or utensils. Utensils and portable equipment used in processing and manufacturing operations shall be stored above the floor in clean, dry locations and in a self draining position on racks constructed of impervious corrosion resistant material. All product contact surfaces shall be subjected to an effective sanitizing treatment immediately prior to use, except when dry cleaning is permitted. This sanitizing treatment shall entail subjection of a clean surface to steam, hot water, hot air, or an acceptable sanitizing solution for the destruction of most human pathogens and other vegetative microorganisms to a level considered safe for product production, without adversely affecting the equipment, the milk, the milk product or the health of consumers. Sanitizing solutions must comply with 21 CFR 178.1010 (relating to sanitizing solutions).
(2) CIP cleaning, including sprayball systems, shall be used only on equipment and pipeline systems which have been designed and engineered for that purpose. When that cleaning is used, careful attention shall be given to the proper procedures to assure satisfactory cleaning. CIP installations and cleaning procedures shall be in accordance with the current 3-A Accepted Practices for Permanently Installed Product and Solution Pipelines and Cleaning Systems Used in Milk and Milk Product Processing Plants. The established cleaning procedure shall be posted and followed. Following the circulation of the cleaning solution, the equipment and lines shall be thoroughly rinsed and checked for effectiveness of cleaning. Caps, plugs, special fittings, valve seats, cross ends and tee ends shall be opened or removed and brushed clean. Immediately prior to starting the product flow, the product contact surfaces shall be properly sanitized.
(b) Milk cans and can washers. Milk cans and can washers must meet the following requirements:
(1) Milk cans and lids shall be cleaned, sanitized and dried before they are returned to producers. Inspection, repair or replacement of cans and lids shall be adequate to substantially exclude from use cans and lids showing open seams, cracks, rust condition, milkstone or an unsanitary condition.
(2) Washers shall be maintained in a clean and satisfactory operating condition and kept free from accumulation of scale or debris which will adversely affect the efficiency of the washer.
(c) Transport tanks. An enclosed wash dock and cleaning and sanitizing facilities shall be available to all plants that receive or ship milk in tanks. Milk transport tanks, sanitary piping, fittings and pumps shall be cleaned and sanitized at least once each day, after use. If milk transport tanks, sanitary piping, fittings or pumps are not to be used immediately after emptying a load of milk, they shall be washed promptly after use and given bactericidal treatment immediately before use. The following provisions also apply:
(1) A milk transport tank shall be cleaned and sanitized at least once each day after use.
(2) If a milk transport tank has been cleaned and sanitized in accordance with paragraph (1) and 96 hours or more have elapsed from that cleaning and sanitizing without the tank being used, the tank shall be cleaned and sanitized again before use.
(3) When a milk transport tank has been cleaned and sanitized, it must bear a tag or be accompanied by a written document showing the date, time and place of cleaning and sanitizing and bear the signature or initials of the person who performed the cleaning and sanitizing. This tagging or written document requirement is not applicable if the milk transport tank delivers to only one receiving facility and that receiving facility is solely responsible for cleaning and sanitizing and retains records at that receiving facility to confirm date, time and place of cleaning.
(4) A tag or written document as described in paragraph (3) shall be removed at the location where the milk tank truck is next cleaned and sanitized and retained on file at that location for 15 days.
(d) Buildings. Windows, glass, partitions and skylights shall be washed as often as necessary to keep them clean. Cracked or broken glass shall be replaced promptly. The walls, ceilings and doors shall be washed periodically and kept free from soil and unsightly conditions. The shelves and ledges shall be wiped or vacuumed as often as necessary to keep them free from dust and debris. The material picked up by the vacuum cleaners shall be disposed of by burning or other proper methods to destroy any insects that might be present.
§ 59a.312. Insect and rodent control program.
In addition to any commercial pest control service, if one is utilized, a specifically designated employee shall be made responsible for the performance of a regularly scheduled insect and rodent control program. Poisonous substances, insecticides and rodenticides must be properly labeled, and shall be handled, stored and used so that they do not create a public health hazard.
§ 59a.313. Plant records.
A milk plant shall retain adequate records of required tests on raw milk receipts. Records shall be available for examination at reasonable times by the Department. The following records shall be maintained for examination at the plant or receiving station where performed:
(1) Sediment, drug residue and bacterial test results on raw milk from each producer: retain for 12 months.
(i) Routine tests and monthly summary of all producers showing number and percent of total in each class.
(ii) Retests, if initial test places milk in probationary status.
(iii) Rejection of raw milk over No. 3 in quality.
(2) Positive drug residue tests: retain for 12 months.
(3) Pasteurization recorder charts: retain for 6 months.
(4) Water test reports: retain copies for 6 months.
(5) Employee health certificate: retain most recent copy until employee is no longer employed by plant.
(6) Drug residue test results for milk samples that do not test positive: retain for 6 months.
§ 59a.314. Packaging and general identification.
(a) Containers. Containers must meet the following standards:
(1) The size, style and type of packaging used for manufactured dairy products shall be commercially acceptable containers and packaging materials which satisfactorily cover and protect the quality of the contents during storage and regular channels of trade and under normal conditions of handling. The weights and shape within each size and style shall be as nearly uniform as is practical.
(2) Packaging materials for dairy products shall be selected which provide sufficiently low permeability to air and vapor to prevent the formation of mold growth and surface oxidation. The wrapper must be resistant to puncturing, tearing, cracking or breaking under normal conditions of handling, shipping and storage. When special type packaging is used, the instructions of the manufacturers shall be followed closely as to its application and methods of closure.
(b) Packaging and repackaging. Packaging dairy products or cutting and repackaging dairy products require a high level of sanitation to prevent the contamination of exposed product. The atmosphere of the packaging rooms, the equipment and packaging material must be practically free from mold and bacterial contamination. The method for checking the level of contamination shall be as prescribed by the Standard Methods for the Examination of Dairy Products.
(c) General identification. Commercial bulk packages containing dairy products manufactured under this subchapter must be adequately and legibly marked with the name of the product, net weight, name and address of processor or manufacturer or other assigned plant identification, lot number and other identification that may be required. Consumer packaged products must be legibly marked with the name of the product, net weight, name and address of packer, manufacturer or distributor and other identification required by the Department.
§ 59a.315. Storage of finished product.
(a) Dry storage. The finished product must be stored at least 18 inches from the wall in aisles, rows or sections and lots, so it is orderly and easily accessible for inspection. Rooms shall be cleaned regularly. Care shall be taken in the storage of products foreign to dairy products in the same room, to prevent impairment or damage to the dairy product from mold, absorbed odors, vermin or insect infestation. Control of humidity and temperature shall be maintained at all times, consistent with good commercial practices, to prevent conditions detrimental to the product and container.
(b) Refrigerated storage. The finished product must be placed on shelves, dunnage or pallets and properly identified. It must be stored under temperatures that will best maintain the initial quality. The product may not be exposed to anything from which it might absorb foreign odors or be contaminated by drippage or condensation.
Cross References This section cited in 7 Pa. Code § 59a.322 (relating to dry storage).
§ 59a.316. Permits.
Plant permitting requires compliance with the applicable requirements in this subchapter.
SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING AND PACKAGING INSTANT NONFAT DRY MILK, NONFAT DRY MILK, DRY WHOLE MILK, DRY BUTTERMILK, DRY WHEY AND OTHER
DRY MILK PRODUCTS
§ 59a.321. Requirements for rooms and compartments.
Rooms and compartments must conform to § 59a.302(f) (relating to buildings).
§ 59a.322. Dry storage.
(a) General requirement. Dry storage of instant nonfat dry milk, nonfat dry milk, dry whole milk, dry buttermilk, dry whey and other dry milk products must conform with § 59a.315 (relating to storage of finished product).
(b) Storage rooms. Storage rooms for the dry storage of product must be adequate in size, kept clean, orderly, free from rodents, insects and mold, and maintained in good repair. The rooms must be adequately lighted and ventilated. The ceilings, walls, beams and floors shall be free from structural defects and inaccessible false areas which may harbor insects.
§ 59a.323. Packaging room for bulk products.
A separate room or area shall be provided for filling bulk bins, drums, bags or other bulk containers and be constructed to conform to § 59a.302 (relating to buildings). The number of control panels and switchboxes in this area shall be kept to a minimum. Control panels must be mounted a sufficient distance from the walls to facilitate cleaning or be mounted in the wall and provided with tight-fitting removable doors to facilitate cleaning. An adequate exhaust system shall be provided to minimize the accumulation of product dust within the packaging room and, where needed, a dust collector shall be provided and properly maintained to keep roofs and outside areas free of dry product. Only packaging materials that are used within a day’s operation may be kept in the packaging area. These materials shall be kept on metal racks or tables at least 6 inches off the floor. Unnecessary fixtures, equipment or false areas which may collect dust and harbor insects, may not be allowed in the packaging room.
§ 59a.324. Hopper or dump room.
A separate room shall be provided for the transfer of bulk dry dairy products from bags or drums to the hoppers and conveyors which lead to the fillers. The room must meet the same requirements for construction and facilities as the bulk packaging operation. Areas and facilities providing for the transfer of dry dairy products from portable bulk bins will be acceptable if gasketed surfaces or direct connections are used that essentially eliminate the escape of product into the area.
§ 59a.325. Repackaging room.
A separate room shall be provided for the filling of small packages and must meet the same requirements for construction and facilities as the bulk packaging operation.
§ 59a.326. Equipment and utensils.
Equipment and utensils must conform with § 59a.304 (relating to equipment and utensils). Additional, more specific requirements are applicable to the items of equipment listed in § § 59a.327—59a.341.
§ 59a.327. Preheaters.
Preheaters must be of stainless steel or other equally corrosion-resistant material, cleanable, accessible for inspection and equipped with suitable automatic temperature controls.
Cross References This section cited in 7 Pa. Code § 59a.326 (relating to equipment and utensils).
§ 59a.328. Hotwells.
Hotwells must be enclosed or covered and equipped with indicating thermometers either in the hotwell or in the hot milk inlet line to the hotwell and if used for holding high heat products must also have recorders.
Cross References This section cited in 7 Pa. Code § 59a.304 (relating to equipment and utensils); and 7 Pa. Code § 59a.326 (relating to equipment and utensils).
§ 59a.329. Evaporators or vacuum pans, or both.
Open-type evaporators or vacuum pans, or both, must be equipped with an automatic condenser water level control, barometric leg, or constructed to prevent water from entering the product, and meet the applicable 3-A Sanitary Standards. When enclosed-type condensers are used, special controls are not needed to prevent water from entering the product.
Cross References This section cited in 7 Pa. Code § 59a.326 (relating to equipment and utensils).
§ 59a.330. Surge tanks.
If surge tanks are used for hot milk and temperatures of products including foam being held in the surge tank during processing is not maintained at a minimum of 150° F, two or more surge tanks shall be installed with cross connections to permit flushing and cleaning during operation. Covers easily removable for cleaning shall be provided and used at all times.
Cross References This section cited in 7 Pa. Code § 59a.326 (relating to equipment and utensils).
§ 59a.331. High pressure pumps and lines.
High pressure lines may be cleaned in place and must be constructed so that deadends, valves and the high pressure pumps can be disassembled for hand cleaning. New high pressure pumps must meet the current 3-A Sanitary Standard Covering Homogenizers and High Pressure Pumps of the Plunger Type.
Cross References This section cited in 7 Pa. Code § 59a.326 (relating to equipment and utensils).
§ 59a.332. Dryers.
(a) Spray dryers. Spray dryers must conform to the current 3-A Accepted Practices for Spray Drying Systems. The filtering system shall be cleaned or component parts replaced as often as necessary to maintain a clean and adequate air supply. In gas-fired dryers, precautions shall be taken to assure complete combustion. Air must be drawn into the dryer from sources free from objectionable odors and smoke, dust or dirt.
(b) Roller dryers. Roller dryers must comply with the following:
(1) The drums of a roller dryer must be smooth, readily cleanable and free of pits and rusts. The knives shall be maintained in a condition so they do not cause scoring of the drums.
(2) The end boards must have an impervious surface and be readily cleanable. The end boards shall be provided with a means of adjustment to prevent leakage and accumulation of milk solids. The stack, hood, drip pan inside of the hood and related shields must be constructed of stainless steel and be readily cleanable. The lower edge of the hood must be constructed to prevent condensate from entering the product zone. The hood must be properly located and the stack of adequate capacity to remove the vapors. The stack must be closed when the dryer is not in operation. The augers must be of stainless steel or properly plated and be readily cleanable. The auger troughs and related shields must be of stainless steel and be readily cleanable. Air entering the dryer room shall be filtered to eliminate dust and dirt. The filter system must consist of a filtering media or device that will effectively, and in accordance with good commercial practices, prevent the entrance of foreign substances into the drying room. The filtering system must be cleaned or component parts replaced as often as necessary to maintain a clean and adequate air supply. Dryer adjustments must be made and the dryer operating normally before food grade powder can be collected from the dryer.
Cross References This section cited in 7 Pa. Code § 59a.326 (relating to equipment and utensils).
§ 59a.333. Collectors and conveyors.
Collectors must be made of stainless steel or equally noncorrosive material and constructed to facilitate cleaning and inspection. Filter sack collectors, if used, must comply with the current 3-A Sanitary Standards for Bag Collectors. Conveyors must comply with the current 3-A Sanitary Standards for Pneumatic Conveyors for Dry Milk and Dry Milk Products or the current 3-A Sanitary Standards for Mechanical Conveyors for Dry Products.
Cross References This section cited in 7 Pa. Code § 59a.326 (relating to equipment and utensils).
§ 59a.334. Dry dairy product cooling equipment.
Cooling equipment shall be provided with sufficient capacity to cool the products to 110° F or lower immediately after removal from dryer and prior to packaging. If bulk bins are used, the product should be cooled to approximately 90° F, but may not be more than 110° F. A suitable dry air supply with effective filtering shall be provided where air cooling and conveying is used.
Cross References This section cited in 7 Pa. Code § 59a.326 (relating to equipment and utensils).
§ 59a.335. Special treatment equipment.
Special equipment, such as flakers, pulverizers or hammer mills, used to further process dry milk products must be of sanitary construction and parts must be accessible for cleaning and inspection. Instantizing systems must comply with the current 3-A Accepted Practices for Instantizing Systems.
Cross References This section cited in 7 Pa. Code § 59a.326 (relating to equipment and utensils).
§ 59a.336. Sifters.
Newly installed sifters used for dry milk and dry milk products must meet the current 3-A Sanitary Standards for Sifters for Dry Products. Other sifters must be constructed of stainless steel or other equally noncorrosive material and must be of sanitary construction and accessible for cleaning and inspection. The mesh size of sifter screen used for various dry dairy products must be those recommended in the appendix of the referenced 3-A Sanitary Standard.
Cross References This section cited in 7 Pa. Code § 59a.326 (relating to equipment and utensils).
§ 59a.337. Portable and stationary bulk bins.
Bulk bins must be constructed of stainless steel, aluminum or other equally corrosion-resistant materials, free from cracks and seams and have an interior surface that is relatively smooth and easily cleanable. Product contact surfaces must be easily accessible for cleaning. Portable bins must comply with the current 3-A Sanitary Standards for Portable Bins for Dry Milk and Dry Milk Products.
Cross References This section cited in 7 Pa. Code § 59a.326 (relating to equipment and utensils).
§ 59a.338. Automatic sampling device.
When automatic sampling devices are used, they must be constructed to prevent contamination of the product, and parts must be readily accessible for cleaning.
Cross References This section cited in 7 Pa. Code § 59a.326 (relating to equipment and utensils).
§ 59a.339. Dump hoppers, screens and mixers.
The product contact surfaces of dump hoppers, screens and mixers which are used in the process of transferring dry products from bulk containers to fillers for small packages or containers must be of stainless steel or equally corrosion resistant material and designed to prevent contamination. Parts must be accessible for cleaning. The dump hoppers must be of a height above floor level to prevent foreign material or spilled product from entering the hopper.
Cross References This section cited in 7 Pa. Code § 59a.326 (relating to equipment and utensils).
§ 59a.340. Filler and packaging equipment.
Filling and packaging equipment must comply with the current 3-A Sanitary Standards for Equipment for Packaging Dry Milk and Dry Milk Products.
Cross References This section cited in 7 Pa. Code § 59a.326 (relating to equipment and utensils).
§ 59a.341. Heavy duty vacuum cleaners.
Each plant handling dry milk products must be equipped with a heavy duty industrial vacuum cleaner. Regular scheduling shall be established for its use in vacuuming applicable areas.
Cross References This section cited in 7 Pa. Code § 59a.326 (relating to equipment and utensils).
§ 59a.342. Clothing and shoe covers.
Clean clothing and shoe covers must be provided exclusively for the purpose of cleaning the interior of the dryer when it is necessary to enter the dryer to perform the cleaning operation.
§ 59a.343. Operations and operating procedures: Pasteurization.
(a) Pasteurization. Milk, buttermilk and whey used in the manufacture of dry dairy products shall be pasteurized at the plant where dried, except that condensed whey and acidified buttermilk containing 40% or more solids may be transported to another plant for drying without repasteurization. Milk or skim milk to be used in the manufacture of nonfat dry milk shall be heated prior to condensing to at least the minimum pasteurization temperature of 161° F for at least 15 seconds or its equivalent in bacterial destruction. Condensed skim made from pasteurized skim milk may be transported to a drying plant. The skim shall be effectively repasteurized at the drying plant, prior to drying, at a minimum temperature of 166° F for at least 15 seconds or its equivalent.
(b) Buttermilk. Buttermilk shall be pasteurized prior to condensing at a temperature of 161° F for 15 seconds or its equivalent in bacterial destruction.
(c) Cheese whey. Cheese whey or milk from which it is derived shall be pasteurized prior to condensing at a temperature of 161° F for 15 seconds or its equivalent in bacterial destruction.
(d) Cream derived from buttermilk. Cream derived from buttermilk shall be pasteurized prior to condensing at a temperature of 166° F for 15 seconds or its equivalent in bacterial destruction.
§ 59a.344. Operations and operating procedures: Condensed surge supply.
Surge tanks or balance tanks if used between the evaporators and dryer shall be used to hold the minimum amount of condensed product necessary for a uniform flow to the dryers. The tanks holding products at temperatures below 150° F shall be completely emptied and washed after each 4 hours of operation or less. Alternate tanks shall be provided to permit continuous operation during washing of tanks.
Cross References This section cited in 7 Pa. Code § 59a.304 (relating to equipment and utensils).
§ 59a.345. Operations and operating procedures: Condensed storage tanks.
(a) Excess production. Excess production of condensed products over that which the dryer will take continuously from the evaporator or pans should be by-passed through a cooler into a storage tank at 50° F or lower and held at this temperature until used.
(b) Regular cleaning and sanitizing. Product cut-off points shall be made at least every 24 hours and the tank completely emptied, washed and sanitized before reuse.
§ 59a.346. Operations and operating procedures: Drying.
Each dryer shall be operated at not more than the manufacturer’s rated capacity for the highest quality dry product consistent with the most efficient operation. This does not preclude the remodeling or redesigning of dryers after installation when properly engineered and designed. The dry products shall be removed from the drying chamber continuously during the drying process.
§ 59a.347. Operations and operating procedures: Cooling dry products.
Prior to packaging and immediately following removal from the drying chamber, the dry product shall be cooled to a temperature not exceeding 110° F.
§ 59a.348. Operations and operating procedures: Packaging, repackaging and storage.
(a) Containers. Packages or containers used for the packaging of nonfat dry milk or other dry milk products must be any clean, sound, commercially accepted container or packaging material which satisfactorily protects the contents through the regular channels of trade, without significant impairment of quality with respect to flavor, wholesomeness or moisture content under the normal conditions of handling. Packages or containers that comply with 21 CFR 177.1520 (relating to olefin polymers) are among the packages that meet the requirements of this subsection. Containers which have previously been used for nonfood items or food which would be deleterious to the dairy product may not be used for the bulk handling of dairy products.
(b) Filling. Empty containers shall be protected from possible contamination and containers which are to be lined may not be prepared more than 1 hour in advance of filling. Every precaution shall be taken during the filling operation to minimize product dust and spillage. When necessary, a mechanical shaker shall be provided. The tapping or pounding of containers shall be prohibited. The containers shall be closed immediately after filling and the exteriors shall be vacuumed or brushed when necessary to render them practically free of product remnants before being transferred from the filling room to the palleting or dry storage areas.
(c) Repackaging. The entire repackaging operation shall be conducted in a sanitary manner with all precautions taken to prevent contamination and to minimize dust. Exterior surfaces of individual containers must be practically free of product before overwrapping or packing in shipping containers. The flow shall be kept free of dust accumulation, waste, cartons, liners or other refuse. Conveyors, packaging and carton making equipment shall be vacuumed frequently during the operating day to prevent the accumulation of dust. Bottles or glass materials may not be permitted in the repackaging or hopper room. The inlet openings of hoppers and bins must be of minimum size, screened and placed well above the floor level. The room and all packaging equipment shall be cleaned as often as necessary to maintain a sanitary operation. Close attention shall be given to cleaning points of equipment where residues of the dry product may accumulate. A thorough clean-up, including windows, doors, walls, light fixtures and ledges, shall be performed as frequently as is necessary to maintain a high standard of cleanliness and sanitation. Waste dry dairy products including dribble product at the fillers shall be properly identified and disposed of as animal feed.
(d) Storage. Storage shall be as follows:
(1) Product. The packaged dry milk product must be stored or arranged in aisles, rows or sections and lots at least 18 inches from a wall and in an orderly, easily accessible manner for inspection or for cleaning of the room. Bags and small containers of products must be placed on pallets elevated approximately 6 inches from the floor. The storage room shall be kept clean and dry and all openings protected against entrance of insects and rodents.
(2) Supplies. Supplies must be placed on dunnage or pallets and arranged in an orderly manner for accessibility and cleaning of the room. Supplies must be kept enclosed in their original wrapping material until used. After removal of supplies from their original containers, they must be kept in an enclosed metal cabinet, bins or on shelving, and if not enclosed shall be protected from powder and dust or other contamination. The room shall be vacuumed as often as necessary and kept clean and orderly.
§ 59a.349. Operations and operating procedures: Product adulteration.
Necessary precautions shall be taken throughout the entire operation to prevent the adulteration of one product with another. The commingling of one type of liquid or dry product with another shall be considered as an adulteration of the product. This does not prohibit the normal standardization of like products in accordance with good commercial practices or the production of specific products for special uses, if applicable labeling requirements are met.
§ 59a.350. Operations and operating procedures: Checking quality.
Milk, manufactured dairy products and dry milk products shall be subject to inspection and analysis by the plant for quality and condition throughout each processing operation. Line samples shall be taken periodically as an aid to quality control in addition to the regular routine analysis made on the finished products.
§ 59a.351. Operations and operating procedures: Requirements for instant nonfat dry milk.
(a) Sampling and testing. Instant nonfat dry milk offered for sale shall be sampled and tested by an approved laboratory at least once each month for the purpose of assuring that the product meets the requirements of subsection (b). The dry milk plant shall have each sublot of approximately 4,000 pounds tested and analyzed prior to being packaged or offered for sale. Products which do not meet the requirements of subsection (b) may not be offered as Extra Grade.
(b) Requirements for Extra Grade instant nonfat dry milk. Requirements are as follows:
(1) Flavor and odor. The flavor and odor must be sweet, pleasing and desirable but may possess the following flavors to a slight degree: chalky, cooked, feed or flat.
(2) Physical appearance. The physical appearance must possess a uniform white to light cream natural color and be reasonably free-flowing and free from lumps except those that readily break up with very slight pressure.
(3) Bacterial estimate. The standard plate count may not be more than 10,000 per gram.
(4) Coliform count. The coliform count may not be more than 10 per gram.
(5) Milkfat content. The milkfat may not be more than 1.25%.
(6) Moisture count. The moisture may not be more than 4.5%.
(7) Scorched particle content. Scorched particles may not be more than 15 mg.
(8) Solubility index. The solubility index may not be more than 1 milliliter.
(9) Titratable acidity. The titratable acidity may not be more than 0.15%.
(10) Dispersibility. The dispersibility may not be less than 85% by the Modified Moats-Dabbah Method, as recommended by the United States Department of Agriculture.
(11) Direct microscopic clump count. The direct microscopic clump count may not be more than 40 million per gram.
(12) USDA grading. The product must be graded as Extra Grade instant nonfat dry milk by the Dairy Grading Branch, United States Department of Agriculture.
§ 59a.352. Operations and operating procedures: Cleaning of dryers, conveyors, sifters and storage bins.
Dryers, conveyors, sifters and storage bins shall be cleaned as often as necessary to maintain the equipment in a clean and sanitary condition. The kind of cleaning procedure—either wet or dry—and the frequency of cleaning, shall be based upon observation of actual operating results and conditions.
§ 59a.353. Operations and operating procedures: Insect and rodent control program.
In addition to any commercial pest control service, if one is utilized, a specifically designated employee shall be made responsible for the performance of a regularly scheduled insect and rodent control program.
SUPPLEMENTAL REQUIREMENTS FOR
PLANTS MANUFACTURING, PROCESSING
AND PACKAGING BUTTER AND
RELATED PRODUCTS
§ 59a.361. Rooms and compartments.
(a) Coolers and freezers. The coolers and freezers must be equipped with facilities for maintaining proper temperature and humidity conditions, to protect the quality and condition of the products during storage or during tempering prior to further processing. Coolers and freezers shall be kept clean, orderly, free from insects, rodents and mold, and maintained in good repair. They must be adequately lighted and proper circulation of air shall be maintained at all times. The floors, walls and ceilings must be of a construction that permits thorough cleaning.
(b) Churn rooms. Churn rooms, in addition to proper construction and sanitation, must be equipped so the air is kept free from objectionable odors and vapors and extreme temperatures by means of adequate ventilation and exhaust systems or air conditioning and heating facilities.
(c) Print and bulk packaging rooms. Rooms used for packaging print or bulk butter and related products must, in addition to proper construction and sanitation, provide an atmosphere relatively free from mold (no more than 10 mold colonies per cubic foot of air), dust or other airborne contamination and be maintained at a reasonable room temperature.
§ 59a.362. Equipment and utensils.
(a) General construction, repair and installation. Equipment and utensils necessary to the manufacture of butter and related products must meet requirements in § 59a.304 (relating to equipment and utensils).
(b) Continuous churn. Product contact surfaces must be of noncorrosive material. Nonmetallic product contact surfaces must comply with the current 3-A Standards for Multiple-Use Plastic Materials or the current 3-A Sanitary Standards for Multiple-Use Rubber, and Rubber-Like Materials. Product contact surfaces must be readily accessible for cleaning and inspection.
(c) Conventional churn. Churns must be constructed of aluminum, stainless steel or equally corrosion resistant metal, free from cracks and in good repair. Gasket material must be fat resistant, nontoxic and reasonably durable. Seals around the doors must be tight.
(d) Bulk butter trucks, boats and packers. Bulk butter trucks, boats and packers must be constructed of aluminum, stainless steel or equally corrosion resistant metal free from cracks, seams and have a surface that is relatively smooth and easily cleanable.
(e) Butter, frozen or plastic cream melting machines. Shavers, shredders or melting machines used for rapid melting of butter, frozen or plastic cream must be of stainless steel or equally corrosion resistant metal, sanitary construction and easily cleanable.
(f) Printing equipment. Printing equipment must comply with the current 3-A Sanitary Standards for Equipment for Packaging Viscous Products.
(g) Brine tanks. Brine tanks used for the treating of parchment liners must be constructed of noncorrosive material and have an adequate and safe means of heating the salt solution for the treatment of the liners. The tank must also be provided with a satisfactory drainage outlet.
(h) Starter vats. Bulk starter vats must be of stainless steel or equally corrosion resistant metal and constructed according to applicable 3-A Sanitary Standards. The vats must be in good repair, equipped with tight-fitting lids and have effective temperature controls.
§ 59a.363. Operations and operating procedures.
(a) Pasteurization. The milk or cream shall be pasteurized at the plant where the milk or cream is processed into the finished product.
(1) Cream for buttermaking. Requirements are as follows:
(i) The cream for buttermaking shall be pasteurized at a temperature of at least 165° F and held continuously in a vat at that temperature at least than 30 minutes, pasteurized by the HTST method at a minimum time and temperature of at least 185° F for at least 15 seconds or by another equivalent time and temperature combination that is approved by the Department. Additional heat treatment above the minimum pasteurization requirement is advisable to insure improved keeping quality characteristics.
(ii) Adequate pasteurization control shall be used and the diversion valve shall be set to divert at less than 185° F with a 15 second holding time or its equivalent in time and temperature to assure pasteurization. If the vat or holding method of pasteurization is used, vat covers shall be closed prior to the holding period to assure temperature of air space reaching the minimum temperature before holding time starts. Covers shall also be kept closed during the holding and cooling period.
(2) Cream for plastic or frozen cream. The pasteurization of cream for plastic or frozen cream shall be accomplished in the same manner as in paragraph (1)(i) except that the temperature for the vat method shall be at least 170° F for at least 30 minutes, at least 190° F for at least 15 seconds or by another temperature and holding time which will assure adequate pasteurization and comparable keeping quality characteristics.
(b) Composition and wholesomeness. Ingredients used in the manufacture of butter and related products shall be subject to inspection and must be wholesome and practically free from impurities. Chlorinating facilities shall be provided for butter wash water if needed and other necessary precautions shall be taken to prevent contamination of products. Finished products must comply with the Food, Drug, and Cosmetic Act (21 U.S.C.A. § § 301—399a), as to composition and wholesomeness.
(c) Containers. Containers must comply with the following:
(1) Containers used for the packaging of butter and related products must satisfactorily protect the quality of the contents in regular channels of trade. Caps or covers which extend over the lip of the container shall be used on all cups or tubs containing 2 pounds or less to protect the product from contamination during subsequent handling.
(2) Liners and wrappers must comply with the following:
(i) Supplies of parchment liners, wrappers and other packaging material must be protected against dust, mold and other possible contamination.
(ii) Prior to use, parchment liners for bulk butter packages shall be completely immersed in a boiling salt solution in a suitable container constructed of stainless steel or other equally noncorrosive material. The liners shall be maintained in the solution for at least 30 minutes. The solution must consist of at least 15 pounds of salt for every 85 pounds of water and shall be strengthened or changed as frequently as necessary to keep the solution full strength and in good condition.
(iii) Other liners, such as polyethylene, shall be treated or handled to prevent contamination of the liner prior to filling.
(3) The lined butter containers shall be protected from possible contamination prior to filling.
(d) Printing and packaging. Printing and packaging of consumer size containers of butter shall be conducted under sanitary conditions.
(e) General identification. Commercial bulk shipping containers must be legibly marked with the name of the product, net weight, name and address of manufacturer, processor or distributor or other assigned plant identification—manufacturer’s lot number, churn number, and the like—and other identification that may be required. Packages of plastic or frozen cream must be marked with the percent of milkfat.
(f) Storage of finished product in coolers. Products must be kept under refrigeration at temperatures of 40° F or lower after packaging and until ready for distribution or shipment. The products may not be placed directly on floors or exposed to foreign odors or conditions such as drippage due to condensation which might cause package or product damage.
(g) Storage of finished product in freezer.
(1) Sharp freezers. Plastic cream or frozen cream intended for storage shall be placed in quick freezer rooms immediately after packaging for rapid and complete freezing within 24 hours. The packages must be piled or spaced so that air can freely circulate between and around the packages. The rooms shall be maintained at -10° F or lower and shall be equipped to provide sufficient high-velocity air circulation for rapid freezing. After the products have been completely frozen, they may be transferred to a freezer storage room for continued storage.
(2) Freezer storage. Freezer storage must comply with the following:
(i) The room shall be maintained at a temperature of 0° F or lower. Air circulation must be sufficient to preclude odors and maintain uniform storage temperatures throughout the freezer.
(ii) Butter intended to be held more than 30 days shall be placed in a freezer room as soon as possible after packaging. If not frozen before being placed in the freezer, the packages shall be spaced to permit rapid freezing and repiled, if necessary, at a later time.
SUPPLEMENTAL REQUIREMENTS FOR
PLANTS MANUFACTURING AND
PACKAGING CHEESE
§ 59a.371. Rooms and compartments.
(a) Starter room. Starter rooms or areas shall be properly equipped and maintained for the propagation and handling of starter cultures. Necessary precautions shall be taken to prevent contamination of the starter, the room, equipment and the air therein.
(b) Make room. The room in which the cheese is manufactured must be of adequate size, and the vats adequately spaced to permit movement around the vats and presses for proper cleaning and satisfactory working conditions. Adequate ventilation shall be provided.
(c) Drying room. If cheese is to be paraffined, a drying room of adequate size shall be provided to accommodate the maximum production of cheese during the flush period. Adequate shelving and air circulation shall be provided for proper drying. Suitable temperature and humidity control facilities shall be provided. tion.
(d) Paraffining room or area. For rind cheese, a separate room or area shall be provided for paraffining and boxing the cheese. The room or area must be of adequate size and the temperature maintained near the temperature of the drying room to avoid sweating of the cheese prior to paraffining.
(e) Rindless block wrapping area. For rindless blocks, a suitable space shall be provided for proper wrapping and boxing of the cheese. The area must be free from dust, condensation, mold or other conditions which may contaminate the surface of the cheese or contribute to the unsatisfactory packaging of the cheese.
(f) Coolers or curing rooms. Coolers or curing rooms where cheese is held for curing or storage must be clean and maintained at the proper uniform temperature and humidity to adequately protect the cheese. Proper circulation of air shall be maintained at all times. The rooms must be free from rodents, insects and pests. The shelves shall be kept clean and dry.
(g) Cutting and packaging rooms. When small packages of cheese are cut and wrapped, separate rooms shall be provided for the cleaning and preparation of the bulk cheese and a separate room shall be provided for the cutting and wrapping operation. The rooms must be well lighted, ventilated and provided with filtered air. Air movement must be outward to minimize the entrance of unfiltered air into the cutting and packaging room.
§ 59a.372. Equipment and utensils.
(a) General construction, repair and installation. Equipment and utensils necessary to the manufacture of cheese and related products must meet the requirements of § 59a.304 (relating to equipment and utensils). In addition, for other equipment the following requirements in this section shall be met.
(b) Starter vats. Bulk starter vats must be of stainless steel or equally corrosion resistant metal and must be in good repair, equipped with tight-fitting lids and have adequate temperature controls, such as valves, indicating or recording thermometers. New vats shall be constructed according to the applicable 3-A Sanitary Standards.
(c) Cheese vats. Requirements are as follows:
(1) Open vats used for making cheese must be of metal construction with adequate jacket capacity for uniform heating. The inner liner must be minimum 16-gauge stainless steel, properly pitched from side to center and from rear to front for adequate drainage. The liner must be smooth, free from excessive dents or creases and extend over the edge of the outer jacket. The outer jacket must be constructed of stainless steel or other equally corrosion resistant metal which can be kept clean and sanitary. The junction of the liner and outer jackets must be constructed to prevent milk or cheese from entering the inner jacket.
(2) The vat must be equipped with a suitable sanitary outlet valve. Effective valves must be provided and properly maintained to control the application of heat to the vat.
(3) Enclosed cheese vats must meet the requirements of the current 3-A Sanitary Standards for Enclosed Cheese Vats and Tables.
(d) Mechanical agitators. The mechanical agitators must be of sanitary construction. The carriage and track must be constructed to prevent the dropping of dirt or grease into the vat. Metal blades, forks or stirrers must be constructed of stainless steel, and be free from rough or sharp edges which might scratch the equipment or remove metal particles.
(e) Curd mill and miscellaneous equipment. Knives, hand rakes, shovels, paddles, strainers and miscellaneous equipment must be stainless steel or of material approved in the 3-A Sanitary Standards. The product contact surfaces of the curd mill must be of stainless steel. Pieces of equipment must be constructed so they can be kept clean. The wires in the curd knives must be stainless steel or other suitable metal, kept tight and replaced when necessary.
(f) Hoops and followers. The hoops, forms and followers must be constructed of stainless steel or heavy tinned steel. If tinned, they shall be kept tinned and free from rust. Hoops, forms and followers shall be kept in good repair. Drums or other special forms used to press and store cheese must be clean and sanitary.
(g) Press. The cheese press must be constructed of stainless steel with all joints welded and all surfaces, seams and openings readily cleanable. The pressure device must be the continuous type. Press cloths shall be maintained in good repair and in a sanitary condition. Single-service press cloths shall be used only once.
(h) Rindless cheese press. The press used to heat seal the wrapper applied to rindless cheese must have square interior corners, reasonably smooth interior surface and have controls that provide uniform pressure and heat equally to all surfaces.
(i) Paraffin tanks. The metal tank must be adequate in size, have parafinned wood or metal racks to support the cheese, heat controls and an indicating thermometer. The cheese wax shall be kept clean.
(j) Automatic curd conveyors. When the salted curd is moved to a hooping station for blocks or barrels by means of an air conveying system, the nonproduct contact surfaces of the system must be constructed of suitable nontoxic material which is corrosion resistant. Product contact surfaces must be constructed of stainless steel with all joints welded or properly gasketed, and all surfaces readily accessible and cleanable. The air shall be filtered and of sufficient quality for the intended use. Air compressors or vacuum pumps may not be located in the processing or packaging areas.
(k) Whey probes. Vacuum equipment used to withdraw whey from cheese must be constructed of stainless steel tubes and be readily accessible and removable for cleaning and inspection.
(l) Cheese vacuumizer. Bulk cheese vacuum chambers, if used, must be installed so that floor surfaces underneath are effectively sealed or have enough clearance so they can be cleaned. Interior surfaces of the vacuum chamber must be constructed and maintained so that the product is not contaminated with rust or flaking paint. An inner liner of stainless steel or other corrosion resistant material shall be provided.
§ 59a.373. Operations and operating procedures.
(a) Cheese from pasteurized milk.
(1) When the cheese is labeled as pasteurized, the milk shall be pasteurized by subjecting every particle of milk to a minimum temperature of 161° F for at least 15 seconds.
(2) HTST pasteurization units must be equipped with the proper controls and equipment to assure pasteurization. If the milk is held more than 2 hours between time of receipt or heat treatment and setting, it shall be cooled to 45° F or lower until time of setting.
(b) Cheese from unpasteurized milk. When the cheese is labeled as ‘‘heat treated,’’ ‘‘unpasteurized,’’ ‘‘raw milk’’ or ‘‘for manufacturing,’’ the milk may be raw or heated at temperature below pasteurization. If the milk is held more than 2 hours between time of receipt or heat treatment and setting, it shall be cooled to 45° F or lower until time of setting.
(c) Whey disposal. Disposal of whey shall be as follows:
(1) Adequate sanitary facilities shall be provided for the disposal of whey. If outside, necessary precautions shall be taken to minimize flies, insects and development of objectionable odors.
(2) Whey or whey products intended for human food shall at all times be handled in a sanitary manner under this subpart as specified for handling milk and dairy products. Equipment operated on a batch or vat basis shall be cleaned or thoroughly rinsed between batches or vats. If equipment is operated on a continuous basis, the whey collection pans shall be rinsed at least once every 2 hours of operation with potable water.
(d) Packaging and repackaging. Packaging rindless cheese or cutting and repackaging all styles of bulk cheese requires a high level of sanitation to prevent the contamination of exposed product. The atmosphere of the packaging rooms, the equipment and the packaging material must be practically free from mold and bacterial contamination.
(e) General identification. Each bulk cheese must be legibly marked with the name of the product, code or date of manufacture, vat number, officially designated code number or name and address of manufacturer. Each consumer sized container must be plainly marked with the name and address of the manufacturer, packer, or distributor, net weight of the contents, name of the product and other information that may be required.
Cross References This ssection cited in 7 Pa. Code § 59a.304 (relating to equipment and utensils).
SUPPLEMENTAL REQUIREMENTS FOR
PLANTS MANUFACTURING, PROCESSING
AND PACKAGING PASTEURIZED PROCESS CHEESE AND RELATED PRODUCTS
§ 59a.381. Equipment and utensils.
(a) General construction, repair and installation. The equipment and utensils used for the handling and processing of cheese products must be as specified in § 59a.304 (relating to equipment and utensils). In addition, for certain other equipment the requirements in this section shall be met.
(b) Conveyors. Conveyors must be constructed of material which can be properly cleaned, will not rust, or otherwise contaminate the cheese, and shall be maintained in good repair.
(c) Grinders or shredders. The grinders or shredders used in the preparation of the trimmed and cleaned natural cheese for the cookers must be adequate in size. Product contact surfaces must be of corrosion resistant material, and of a construction to prevent contamination of the cheese and to allow thorough cleaning of all parts and product contact surfaces.
(d) Cookers. The cookers must be the steam jacketed or direct steam type. The cookers must be constructed of stainless steel or other equally corrosion resistant material. Product contact surfaces must be readily accessible for cleaning. Each cooker must be equipped with an indicating thermometer and a temperature recording device. Steam check valves on direct steam type cookers must be mounted flush with cooker wall, constructed of stainless steel and designed to prevent the backup of product into the steam line, or the steam line must be constructed of stainless steel pipes and fittings which can be readily cleaned. If direct steam is applied to the product, only culinary steam shall be used.
(e) Fillers. The hoppers of all fillers must be covered but the cover may have sight ports. If necessary, the hopper may have an agitator to prevent buildup on side wall. The filler valves and head shall be kept in good repair, capable of accurate measurements.
Cross References This section cited in 7 Pa. Code § 59a.304 (relating to equipment and utensils).
§ 59a.382. Operations and operating procedures.
(a) Trimming and cleaning. The natural cheese shall be cleaned free of all nonedible portions. Paraffin and bandages as well as rind surfaces, mold or unclean areas of another part which is unwholesome or unappetizing shall be removed.
(b) Cooking the batch. Each batch of cheese within the cooker, including the optional ingredients, shall be thoroughly commingled, the contents pasteurized at a temperature of at least 158° F and held at that temperature for at least 30 seconds. Care shall be taken to prevent the entrance of cheese particles or ingredients after the cooker batch of cheese has reached the final heating temperature. After holding for the required period of time, the hot cheese shall be emptied from the cooker as quickly as possible.
(c) Forming containers. Containers either lined or unlined shall be assembled and stored in a sanitary manner to prevent contamination. Procedures must be in place for the handling of containers between forming and filling that prevent contamination of the product contact surfaces. Preforming and assembling of pouch liners and containers shall be kept to a minimum and the supply rotated to limit the length of time exposed to possible contamination prior to filling.
(d) Filling containers. Hot fluid cheese from the cookers may be held in hotwells or hoppers to assure a constant and even supply of processed cheese to the filler or slice former. Filler valves must effectively measure the desired amount of product into the pouch or container in a sanitary manner and cut off sharply without drip or drag of cheese across the opening. An effective system shall be used to maintain accurate and precise weight control. Damaged or unsatisfactory packages shall be removed from production, and the cheese may be salvaged into sanitary containers and added back to cookers.
(e) Closing and sealing containers. Pouches, liners or containers having product contact surfaces after filling shall be folded or closed and sealed in a sanitary manner, preferably by mechanical means, to assure against contamination. Each container in addition to other required labeling must be coded in a manner that is easily identifiable as to date of manufacture by lot or sublot number.
Cross References This section cited in 7 Pa. Code § 59a.304 (relating to equipment and utensils).
SUPPLEMENTAL REQUIREMENTS FOR
PLANTS MANUFACTURING, PROCESSING AND PACKAGING EVAPORATED, CONDENSED OR STERILIZED MILK PRODUCTS
§ 59a.391. Equipment and utensils.
(a) General construction, repair and installation. The equipment and utensils used for processing and packaging evaporated and condensed milk shall be as specified in § 59a.304 (relating to equipment and utensils).
(b) Evaporators and vacuum pans. Equipment used in the removal of moisture from milk or milk products for the purpose of concentrating the solids must meet the requirements of the current 3-A Sanitary Standards for Milk and Milk Products Evaporators and Vacuum Pans. New or used replacements for this type of equipment must meet the appropriate 3-A Sanitary Standards.
(c) Fillers. Both gravity and vacuum type fillers must be of sanitary design and all product contact surfaces, if metal, must be made of stainless steel or equally corrosion resistant material. Certain evaporated milk fillers having brass parts may be approved if free from corroded surfaces and kept in good repair. Fillers must be designed so that they in no way will contaminate or detract from the quality of the product being packaged.
(d) Batch or continuous in-container sterilizers. Batch or continuous in-container sterilizers must be equipped with accurate temperature controls and effective valves for regulating the sterilization process. The equipment shall be maintained to assure control of the length of time of processing and to minimize the number of damaged containers.
(e) Homogenizers. Homogenizers, where applicable, shall be used to reduce the size of the fat particles and to evenly disperse them in the product. New homogenizers must meet the applicable 3-A Sanitary Standards.
§ 59a.392. Operations and operating procedures.
(a) Preheat, pasteurization. When pasteurization is intended or required by either the vat method, HTST method, or by the UHT method it shall be accomplished by systems and equipment meeting the requirements of § 59a.304 (relating to equipment and utensils).
(b) Sterilization. The complete destruction of all living organisms shall be performed in one of the following methods:
(1) The complete in-container method, by heating the container and contents to a range of 212° F to 280° F for a sufficient time.
(2) By a continuous flow UHTST process at high temperature of 280° F and above for a sufficient time, then packaged aseptically.
(3) The product is first sterilized according to UHTST methods as in paragraph (2), then packaged and given further heat treatment to complete the sterilization process.
(c) Filling containers.
(1) The filling of small containers with products shall be done in a sanitary manner. The containers may not contaminate or detract from the quality of the product in any way. After filling, the container shall be hermetically sealed.
(2) Bulk containers for unsterilized products must be suitable and adequate to protect the product in storage or transit. The bulk container, including bulk tankers, shall be cleaned and sanitized before filling, and filled and closed in a sanitary manner.
(d) Aseptic filling. A previously sterilized product shall be filled under conditions which prevent contamination of the product by living organisms or spores. The containers prior to being filled shall be sterilized and maintained in a sterile condition. The containers shall be sealed in a manner that prevents contamination of the product.
(e) Storage. Proper facilities shall be provided for the storage and handling of finished product.
Cross References This section cited in 7 Pa. Code § 59a.304 (relating to equipment and utensils).
Subchapter F. RAW MILK FOR HUMAN CONSUMPTION
Sec.
59a.401. Raw milk; general.
59a.402. Raw milk; prohibitions.
59a.403. Raw milk permit.
59a.404. Requirements for the issuance of a raw milk permit.
59a.405. Sanitation.
59a.406. Animal health.
59a.407. Regular testing of water supply.
59a.408. Regular testing of raw milk for human consumption.
59a.409. Violations of raw milk testing standards.
59a.410. Raw milk packaging.
59a.411. Label content review by the Department.
59a.412. Inspection, sampling and testing by the Department.
59a.413. Enforcement: Suspension or revocation of a raw milk permit.
59a.414. Enforcement: Summary criminal prosecution.
59a.415. Enforcement: Injunctions.
59a.416. Enforcement: Seizure, condemnation, denaturing or destruction of raw milk; exclusion from sale.
Cross References This subchapter cited in 7 Pa. Code § 59a.2 (relating to definitions); and 7 Pa. Code § 59a.17 (relating to inspection of dairy farms and milk plants).
§ 59a.401. Raw milk; general.
This subchapter prescribes the permitting, testing and inspection requirements that are applicable to persons seeking to sell raw milk for human consumption.
§ 59a.402. Raw milk; prohibitions.
(a) Sale of raw milk without permit. A person may not sell raw milk for human consumption without having a current raw milk permit issued by the Department. The term ‘‘sell’’ includes 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.
(b) Actions authorized under a raw milk permit. A raw milk permit authorizes the permitholder to lawfully produce and sell (within this Commonwealth) raw whole milk for human consumption. It also authorizes the permitholder to obtain an additional permit, issued by the Department under authority of 21 CFR Part 133 (relating to cheese and related cheese products), authorizing the sale of cheese manufactured from raw milk if all of the following apply:
(1) The cheese is a standardized cheese identified in 21 CFR Part 133, Subpart B (relating to requirements for specific standardized cheese and related products).
(2) The standards for that cheese allow for it to be manufactured from raw milk.
(c) Compliance with testing and documentation requirements. A person may not sell raw milk for human consumption without being in compliance with the testing and documentation requirements of this section.
Authority The provisions of this § 59a.402 amended under section 19 of the Milk Sanitation Law (31 P.S. § 660c) and 3 Pa.C.S. § § 5721—5737.
Source The provisions of this § 59a.402 amended July 26, 2019, effective July 27, 2019, 49 Pa.B. 3897. Immediately preceding text appears at serial pages (356861) to (356862).
§ 59a.403. Raw milk permit.
(a) Application. A raw milk permit application may be obtained by contacting the Department at the address in § 59a.3 (relating to contacting the Department).
(b) Duration. A raw milk permit will be valid for no more than 1 year. Each raw milk permit will expire as of September 1 each year, unless revoked or suspended earlier by the Department.
(c) Timing of filing to ensure Department review of an application for a successor raw milk permit. If a raw milk permitholder wishes to obtain a raw milk permit to replace an expiring raw milk permit, the permitholder is encouraged, but is not required, to file an application for this successor raw milk permit with the Department by July 1 of the year in which the current raw milk permit is to expire. Compliance with this recommendation may help to prevent a lapse between the expiring raw milk permit and the effective date of the successor raw milk permit.
§ 59a.404. Requirements for the issuance of a raw milk permit.
(a) Preissuance inspection.
(1) New raw milk permits. Prior to issuing a raw milk permit, the Department will inspect the dairy farm that is the subject of a new raw milk permit application to determine whether the dairy farm is in compliance with the act and this chapter. The dairy farm must be in compliance with the applicable provisions of the act, the Food Safety Act and this chapter to be eligible for a raw milk permit.
(2) Successor raw milk permits. If a raw milk permitholder applies to the Department for a successor raw milk permit, the Department may issue the raw milk permit without conducting the dairy farm inspection described in paragraph (1).
(b) Confirmation of tuberculosis-free and brucellosis-free status.
(1) New raw milk permits. An applicant for a new raw milk permit shall provide the Department confirmation that the animal or herd from which the raw milk for human consumption is to be produced has been determined to be free from brucellosis and free from tuberculosis, in accordance with the process in § 59a.406 (relating to animal health). This confirmation shall be provided for the subject dairy farm to be eligible for a raw milk permit.
(2) Successor raw milk permits. An applicant for a successor raw milk permit shall, at intervals of no greater than 13 months, provide the Department confirmation that the animal or herd from which the raw milk for human consumption is to be produced has been determined to be free from brucellosis and tuberculosis by annual tests in accordance with the process in § 59a.406.
(c) General herd health.
(1) New raw milk permits. An applicant for a new raw milk permit shall have a licensed veterinarian examine the animal or herd and provide the Department a written report of this examination. The report must reflect that, upon physical examination, the subject animals are in apparent good health and free from evidence of communicable disease. This shall be done in accordance with § 59a.406.
(2) Successor raw milk permits. An applicant for a successor raw milk permit shall provide the Department a copy of a veterinary examination report as described in paragraph (1). The report must be dated within 1 year preceding the date of the application, and reflect that the herd is in general good health and free from communicable disease. The applicant shall continue to have this veterinary examination conducted on an annual basis, in accordance with § 59a.406.
(d) Confirmation of safe water supply.
(1) New raw milk permits. An applicant for a new raw milk permit shall have the dairy farm water supply tested and provide the Department with confirmation that the water is bacteriologically safe, in accordance with § 59a.407 (relating to regular testing of water supply). Water is bacteriologically safe if it meets the requirements in § 59a.405(8) (relating to sanitation) and § 59a.407. The requirement of a bacteriologically safe water supply is also applicable to recirculated cooling water if the dairy farm uses a recirculated cooling water system for milk cooling. Confirmation that the water supply is bacteriologically safe shall be provided for the subject dairy farm to be eligible for a raw milk permit. If the water supply is through a public or municipal water system, this testing requirement does not apply.
(2) Successor raw milk permits. An applicant for a successor raw milk permit shall provide the Department with a copy of a written laboratory report as described in paragraph (1). The report must be dated no earlier than 6 months preceding the date of the application, done in accordance with § 59a.407 and reflect that the dairy farm water supply is bacteriologically safe. Water is bacteriologically safe if it meets the requirements in § § 59a.405(8) and 59a.407.
(e) Sampling and testing.
(1) New raw milk permits. An applicant for a new raw milk permit shall demonstrate its ability to produce raw milk for human consumption through the following process:
(i) The applicant shall have an approved sampler draw three separate samples of commingled milk from the bulk tank. The samples shall be drawn at least 7 days apart, and be taken on an unannounced basis.
(ii) Each of these three samples described in subparagraph (i) shall be submitted to a Pennsylvania-approved dairy laboratory or the Department for analysis.
(iii) The analysis described in subparagraph (ii) will determine whether the sample meets the standards in § 59a.408 (relating to regular testing of raw milk for human consumption).
(iv) If any of the three analyzed samples described in subparagraph (iii) violates or exceeds a standard in § 59.408, the three-sample process shall repeat itself until three successive samples are in compliance with the referenced standards.
(v) If the first of the three required samples is tested as described in subparagraph (iii), and concludes that no pathogenic bacteria are present, the second and third samples need not be tested for the presence of pathogenic bacteria. If a sample test concludes that pathogenic bacteria are present, a raw milk permit will not be issued until two separate consecutive tests, from samples drawn at least 7 days apart, conclude that no pathogenic bacteria are present.
(2) Successor raw milk permits. An applicant for a successor raw milk permit shall demonstrate its ability to produce raw milk for human consumption through the regular sampling and testing process described in § 59.408.
§ 59a.405. Sanitation.
A raw milk permitholder shall maintain and operate the subject dairy operation in compliance with the same sanitation and handling standards that are applicable to the production of milk for pasteurization, as set forth in § 59a.19 (relating to standards for Grade ‘‘A’’ milk for pasteurization, ultra-pasteurization or aseptic processing) except to the extent any of those provisions are inconsistent with this subchapter. The provisions of the Grade ‘‘A’’ PMO, in particular the Standards for Grade ‘‘A’’ Raw Milk for Pasteurization, Ultrapasteurization or Aseptic Processing and section 7, regarding standards for Grade ‘‘A’’ milk and milk products, are incorporated by reference as regulations authorized under the act, to the extent they do not conflict with the act or this subchapter. This includes the items listed under the referenced Grade ‘‘A’’ PMO provisions, including the following:
(1) Item 1r. Abnormal milk.
(2) Item 2r. Milking Barn, Stable or Parlor—Construction.
(3) Item 3r. Milking Barn, Stable or Parlor—Cleanliness.
(4) Item 4r. Cowyard.
(5) Item 5r. Milkhouse—Construction and Facilities.
(6) Item 6r. Milkhouse—Cleanliness.
(7) Item 7r. Toilet.
(8) Item 8r. Water Supply, with the additional requirement that a plate heat exchanger or tubular cooler installed and in use on a dairy farm shall be equipped with a backflow prevention device.
(9) Item 9r. Utensils and Equipment—Construction.
(10) Item 10r. Utensils and Equipment—Cleaning.
(11) Item 11r. Utensils and Equipment—Sanitization.
(12) Item 12r. Utensils and Equipment—Storage.
(13) Item 13r. Milking—Flanks, Udders and Teats.
(14) Item 14r. Protection from Contamination.
(15) Item 15r. Drug and Chemical Control.
(16) Item 16r. Personnel—Handwashing Facilities.
(17) Item 17r. Personnel—Cleanliness.
(18) Item 18r. Raw Milk Cooling, with the exception that milk for pasteurization shall be cooled to 4° C (40° F) within 2 hours after the completion of milking.
(19) Item 19r. Insect and Rodent Control.
Cross References This section cited in 7 Pa. Code § 59a.404 (relating to requirements for the issuance of a raw milk permit); and 7 Pa. Code § 59a.407 (relating to regular testing of water supply).
§ 59a.406. Animal health.
(a) General. A raw milk permitholder shall monitor the health of the animals from which the raw milk for human consumption is produced to ensure that they are in general good health and free of tuberculosis and brucellosis.
(b) Confirmation of brucellosis-free status. A raw milk permitholder shall, at intervals of no greater than 13 months, provide the Department confirmation from a licensed veterinarian that the animal or herd from which the raw milk for human consumption is produced has been determined to be free from brucellosis by annual blood tests conducted in accordance with Chapter 7 (relating to brucellosis regulations).
(c) Annual confirmation of tuberculosis-free status. A raw milk permitholder shall, at intervals of no greater than 13 months, provide the Department confirmation from a licensed veterinarian that the animal or herd from which the raw milk for human consumption is produced has been determined to be free from tuberculosis by annual tests conducted in accordance with Chapter 9 (relating to control and eradication of tuberculosis of livestock).
(d) Annual veterinary examination. A raw milk permitholder shall, at intervals of no more than 1 year, have a licensed veterinarian examine the herd and issue a written report of this examination. The report must reflect that, upon physical examination, the herd is in apparent good health and free from evidence of communicable disease. The raw milk permitholder shall retain a copy of the written veterinarian’s report for at least 3 years and, upon request of the Department, make the report available for inspection.
Cross References This section cited in 7 Pa. Code § 59a.404 (relating to requirements for the issuance of a raw milk permit).
§ 59a.407. Regular testing of water supply.
(a) General requirement of safe and sanitary water. The water supply for a dairy operation that produces raw milk for human consumption under a raw milk permit must be safe and sanitary.
(b) Testing frequency. The water supply for a dairy operation that produces raw milk for human consumption under a raw milk permit shall be tested at least once every 6 months, and whenever any repair or alteration is made to the water supply system. This testing shall be at the raw milk permitholder’s expense. If the water supply is through a public or municipal water system, this testing requirement does not apply.
(c) Testing standards. The water tests described in this section shall be conducted at a qualified laboratory. The testing must include bacteriological examinations to determine whether the water is bacteriologically safe. Water is bacteriologically safe if it meets the requirements in § § 59a.405(8) and 59a.407 (relating to sanitation; and regular testing of water supply). The requirement of a bacteriologically safe water supply is also applicable to recirculated cooling water if the dairy farm uses a recirculated cooling water system for milk cooling. The water supply must contain a Most Probable Number of Coliform Organisms (MPN) of less than 2.2-per-100-milliliters by the multiple tube fermentation method or less than 1-per-100-milliliters by the membrane filter technique or the chromogenic substrate technique. The water must otherwise be safe and sanitary.
(d) Water test records. The raw milk permitholder shall retain all records of required water tests for 1 year and make these available for inspection upon request of the Department.
Cross References This section cited in 7 Pa. Code § 59a.404 (relating to requirements for the issuance of a raw milk permit); and 7 Pa. Code § 59a.407 (relating to regular testing of water supply).
§ 59a.408. Regular testing of raw milk for human consumption.
(a) Responsibility. A raw milk permitholder shall be responsible to arrange for the regular sampling and testing required with respect to the raw milk permit, and to pay for this testing.
(b) Testing laboratories. Raw milk samples submitted for testing shall be analyzed at an official laboratory or a Pennsylvania-approved dairy laboratory.
(c) Testing schedule and standards. A raw milk permitholder shall coordinate the testing of raw milk for human consumption on the following schedule, and the raw milk samples must meet the following standards:
Raw Milk Testing Schedule and Standards
Required Action
IntervalType of Action or
Test RequiredStandard At all times Maintain raw milk temperature in accordance with raw milk temperature standards. Raw milk shall be cooled to 40° F (4° C) or less within 2 hours after milking, provided that the blend temperature after the first and subsequent milking does not exceed 50° F (10° C). At least twice each month, in conjunction with the tests for coliform count and for the presence of drugs (including growth inhibitors), described in this subsection Bacterial count Bacteria may not be present in excess of 20,000 per milliliter. Note: Tested in conjunction with a drug residue/ inhibitory substance test. At least twice each month, in conjunction with the tests for bacterial count and for the presence of drugs (including growth inhibitors), described in this subsection Coliform count Coliform may not exceed 10 per milliliter. Note: Tested in conjunction with a drug residue/ inhibitory substance test. At least twice each
monthSomatic cell count The somatic cell count may not exceed 750,000/milliliter (1,500,000/ml for goat milk). At least twice each month, in conjunction with the tests for bacterial count and for coliform count, described in this subsection Test for presence of drugs (including growth inhibitors) There may be no positive results for drug residue, using drug residue detection laboratory techniques referenced in the current Grade ‘‘A’’ Pasteurized Milk Ordinance developed by the United States Department of Health and Human Services, Food and Drug Administration. Once every 6 months From a sample drawn from the bulk tank, test for presence of the following pathogenic bacteria: Salmonellae, Listeria monocytogenes, Camphylobacter and E. Coli 0157:H7 There may be no pathogenic bacteria present.
Cross References This section cited in 7 Pa. Code § 59a.404 (relating to requirements for the issuance of a raw milk permit); 7 Pa. Code § 59a.409 (relating to violations of raw milk testing standards); and 7 Pa. Code § 59a.411 (relating to label content review by the department).
§ 59a.409. Violations of raw milk testing standards.
(a) Bacterial count, somatic cell count, coliform count or cooling temperature tests.
(1) If two of the last four tested raw milk samples exceed the bacterial count, somatic cell count or coliform count standards or cooling temperature requirements described in § 59a.408 (relating to regular testing of raw milk for human consumption), the Department will provide the raw milk permitholder with written notice that it is in violation of the act and this chapter.
(2) If three of the last five tested raw milk samples exceed the bacterial count, somatic cell count or coliform count standards or cooling temperature requirements in § 59a.408, the Department will proceed to revoke or suspend the raw milk permit, and the raw milk permitholder may be subject to summary criminal prosecution under the act.
(b) Pesticides. If a raw milk sample tests positive for the presence of a pesticide at or above actionable levels established for the pesticide the United States Environmental Protection Agency, the raw milk permitholder shall:
(1) Immediately cease the sale of raw milk for human consumption.
(2) Take a second sample and submit it for testing for pesticide residue.
(3) Investigate and determine the cause of the contamination, report the result of that investigation to the Department, and correct that cause of contamination.
(4) Refrain from selling raw milk for human consumption until and unless the second test shows the sample to be free of pesticide residue, or to be below the actionable levels established for the residue by the United States Environmental Protection Agency, and the Department reviews these test results and approves the resumption of raw milk sales.
(c) Drugs. If a raw milk sample tests positive for the presence of a drug, the raw milk permitholder shall:
(1) Immediately cease the sale of raw milk for human consumption.
(2) Investigate and determine the cause of the contamination, report the result of the investigation to the Department and correct the cause of contamination.
(3) Have a second sample collected by an approved sampler and tested at a Pennsylvania-approved dairy laboratory.
(4) Refrain from selling raw milk for human consumption until the second test shows the sample to be free of drug residue, and the Department reviews these test results and approves the resumption of raw milk sales.
(d) Disease-producing organisms. If a raw milk sample tests positive for the presence of pathogenic bacteria or other disease-producing organisms such as Salmonellae, Listeria monocytogenes, Camphylobacter or E. Coli 0157:H7, the raw milk permitholder shall do the following:
(1) Immediately cease the sale of raw milk for human consumption.
(2) Investigate and determine the cause of the contamination, report the result of that investigation to the Department, and correct that cause of contamination.
(3) Wait at least 2 days from the cessation of raw milk sales, and then have an approved sampler collect a sample and submit it to a Pennsylvania-approved dairy laboratory to be tested for the presence of pathogenic bacteria.
(4) Following the initial sampling described in the preceding requirement, have an approved sampler collect an additional sample, at least 1 day after the previous sample, and submit it to a Pennsylvania-approved dairy laboratory for testing for the presence of pathogenic bacteria.
(5) Refrain from selling raw milk for human consumption until and unless two consecutive tests, from samples drawn at least 1 day apart, show that raw milk produced at the dairy operation that is the subject of the raw milk permit is free from disease-producing organisms, and the Department reviews these test results and approves the resumption of raw milk sales.
Cross References This section cited in 7 Pa. Code § 59a.413 (relating to enforcement: suspension or revocation of a raw milk permit).
§ 59a.410. Raw milk packaging.
(a) Sales or delivery on premises other than the farm where the raw milk for human consumption is produced. When raw milk for human consumption is packaged for sale or delivery at a location other than the farm where the raw milk for human consumption is produced, bottling and capping, or the filling and closure of containers other than bottles, shall be conducted in a room separate from the milk room by a mechanical means of filling and capping bottles or by a mechanical means of filling and closure of containers other than bottles. The closure must protect the pouring lip to its largest diameter.
(b) Sales or delivery on premises where the raw milk for human consumption is produced. When raw milk for human consumption is packaged for sale or delivery at the location where the raw milk for human consumption is produced, the Department will consider a milk room facility as being adequate for bottling and capping, or the filling and closure of containers other than bottles. This activity shall be completed in a sanitary manner using easily cleanable equipment that has been cleaned and sanitized.
(c) Additional sanitation requirements. Containers shall be filled and closed without any part of the hand coming in contact with the inner surface of the bottle or container or in contact with bottle caps. Containers may not be filled by the customer. Caps shall be obtained from sanitary containers and kept in sanitary containers until used. Containers shall be stored in a clean and dry area off the floor and protected from any source of contamination. Washing of returnable bottles or containers shall be conducted in a room that is separate from any room that is devoted to bottling and capping or the filling and closure of containers other than bottles.
§ 59a.411. Label content review by the Department.
(a) Raw milk in containers owned by the raw milk permitholder.
(1) General label statements. If raw milk for human consumption is prepackaged for sale in containers that are owned by the raw milk permitholder, the labeling on these containers and caps shall be submitted to the Department and approved by the Department prior to use in commerce. The container must be labeled as raw milk, and include the fluid volume as well as the name and address of the distributor or producer and the words ‘‘Keep Refrigerated.’’ It may not be misbranded or contain any false or misleading statements. The Department will, within 10 business days of receiving a complete application for label approval, mail the applicant its written approval or denial of the label.
(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.
(2) Consumer advisory for raw animal-derived foods that have not been processed to remove pathogens. In addition to the information in paragraph (1), the label must contain a consumer advisory statement to notify consumers of the increased risks (particularly to certain highly susceptible populations) associated with the consumption of raw animal-derived foods that have not been processed to remove pathogens. An acceptable notice would be as follows:
Raw milk has not been processed to remove pathogens that can cause illness. The consumption of raw milk may significantly increase the risk of foodborne illness in persons who consume it—particularly with respect to certain highly-susceptible populations such as preschool-age children, older adults, pregnant women, persons experiencing illness, and other people with weakened immune systems.
(3) Label requirement: milk dating.
(i) Requirement. The cap of the raw milk container, or the container itself, must 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 raw milk 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 raw milk was produced.
(ii) Prominence of sell-by date on label. The sell-by date must be separate and distinct from any other number, letter or intervening material on the cap or container.
(iii) Prohibition. Raw milk may not be sold or offered for sale for human consumption if the raw milk is sold or offered for sale after the sell-by date designated on the container.
(iv) Monitoring by the Department.
(A) The Department will periodically sample containers of raw milk for human consumption in the possession of the raw milk permitholder or a distributor. This sampling may occur at any time before the raw milk is delivered to the customer. The Department will take at least one sample of raw milk from each raw milk permitholder each calendar year.
(B) The samples described in clause (A) shall be analyzed by the Department or a Pennsylvania-approved dairy laboratory, to determine whether bacterial test results exceed the bacterial limits for raw milk described in the Raw Milk Testing Schedule and Standards in § 59a.408 (relating to regular testing of raw milk for human consumption) prior to the expiration of the sell-by date designated on the raw milk container.
(C) When two or more samples demonstrate a raw milk permitholder cannot produce raw milk for human consumption that remains consistently within the bacterial limits referenced in clause (B) through the sell-by date marked on the container, the Department will require a raw milk permitholder to use a shorter sell-by date specified by the Department. The Department will calculate this revised sell-by date so that bacterial growth in the raw milk will not exceed the referenced bacterial limits within that sell-by period if the raw milk is maintained in accordance with the temperature requirements for raw milk in the Raw Milk Testing Schedule and Standards in § 59a.408.
(D) A raw milk permitholder may submit samples to the Department for analysis to obtain approval to resume a specific sell-by period for the raw milk sampled. The Department will approve resumption of a specific sell-by period when analysis of a sample demonstrates that bacterial growth in the raw milk will not exceed the referenced bacterial limits within that sell-by period if the raw milk is maintained in accordance with the temperature requirements for raw milk in the Raw Milk Testing Schedule and Standards in § 59a.408.
(b) Raw milk in customer-owned containers.
(1) Container labeling and caps. If raw milk for human consumption is packed for sale in containers that are owned by the consumer, Departmental review of the labeling on the container or caps is not required. The Department recommends, but does not require, that customer owned containers be clean, food-grade containers of 1 gallon or smaller capacity.
(2) Consumer advisory. If raw milk for human consumption is packed for sale in containers that are owned by the consumer, the raw milk permitholder shall post a consumer advisory at the location where the customer owned containers are filled, or in close proximity to that location, to provide consumers notice of increased risks associated with the consumption of raw animal-derived foods that have not been processed to remove pathogens by certain highly susceptible populations. An acceptable notice would be as described in subsection (a)(2).
Cross References This section cited in 7 Pa. Code § 59a.14 (relating to labeling: bottles, containers and packages of milk, milk products or manufactured dairy products).
§ 59a.412. Inspection, sampling and testing by the Department.
A raw milk permitholder shall allow the Department and its personnel to inspect the dairy operation that is the subject of the permit, review records, draw samples, conduct tests and take other actions necessary to the Department’s performance of its responsibilities under the act, the Food Safety Act or any other applicable statute or regulation. If a raw milk permitholder fails to allow this inspection and sampling by the Department, the Department may take steps to revoke or suspend the raw milk permit.
§ 59a.413. Enforcement: Suspension or revocation of a raw milk permit.
(a) General. The Department may take action to suspend or revoke a raw milk permit if a permitholder does not comply with the act or this chapter.
(b) Procedure.
(1) The act requires that the Department provide a raw milk permitholder with at least 5 days advance written notice of a raw milk permit revocation or suspension. This written notice will be sent by certified mail. The Department may supplement the notice by providing the permitholder the written notice by personal service or other means. The written notice must specify the procedure by which the permitholder may request an administrative hearing and the 5-day window within which a written request for an administrative hearing shall be submitted to the Department.
(2) If the basis for a proposed raw milk permit suspension or revocation is that pathogenic bacteria have been detected in the raw milk, or foreign substances are present in the raw milk, or any condition exists when consumption of raw milk produced and sold prior to revocation or suspension of the raw milk permit may pose a threat to the health or safety of those persons who consume it, the Department will immediately notify the raw milk permitholder and request that it voluntarily cease all sales of raw milk—without regard to whether the raw milk permitholder has received the 5 days advance written notice required under the act. The requirements of this paragraph do not alter the obligation of a raw milk permitholder to cease sales of raw milk for human consumption if required under § 59a.409 (relating to violations of raw milk testing standards).
(i) If a raw milk permitholder complies with a request that it voluntarily cease raw milk sales, the Department will consider this cooperation a mitigating factor as it determines any penalty or sanction relating to the violation.
(ii) If a raw milk permitholder does not choose to comply with a request that it voluntarily cease raw milk sales, the Department will do the following:
(A) Apprise the Department of Health and any local health department having jurisdiction of the situation, and recommend these entities take lawful action to ensure that sales of raw milk cease.
(B) Consult with the Office of Attorney General regarding whether it should institute legal action to obtain an injunction to prohibit the raw milk sales.
(C) Arrange for an administrative hearing before a hearing examiner, if the raw milk permitholder has been afforded written notice and opportunity for a hearing on the proposed suspension or revocation and requests a hearing on the proposed permit suspension or revocation.
(D) Issue a final adjudication, ordering the suspension or revocation, if the raw milk permitholder does not request a hearing on the proposed permit suspension or revocation.
(E) Recommend to the raw milk permitholder that it inform its customers that it has been asked by the Department to voluntarily cease raw milk sales and provide these customers the basis for the Department’s request.
(c) Ownership of raw milk permit. A raw milk permit is and remains the property of the Department even when it is in the physical custody of the permitholder. If a raw milk permit is suspended or revoked, and the permitholder has been afforded written notice and opportunity for a hearing on the proposed suspension or revocation, the person in possession of the raw milk permit shall immediately return or surrender that raw milk permit to the Department. In the case of a permit suspension, the Department will promptly return the raw milk permit to the permitholder at the end of the suspension period.
§ 59a.414. Enforcement: Summary criminal prosecution.
If a raw milk permitholder violates any provision of the act or this chapter, the Department may file a summary prosecution against a raw milk permitholder for the violation. The violation is graded as a summary offense.
§ 59a.415. Enforcement: Injunctions.
The Department may ask the Attorney General to initiate legal action to enjoin a person from selling raw milk for human consumption without the required raw milk permit or from violating the act or this chapter. Violations of an injunction can result in fines or imprisonment, or both.
§ 59a.416. Enforcement: Seizure, condemnation, denaturing or destruction of raw milk; exclusion from sale.
(a) Seizure, condemnation, denaturing or destruction of raw milk. Whenever, in the opinion of the Secretary, a given supply of raw milk or raw milk products is considered unsafe or a menace to public health, the Secretary may seize, condemn, denature or destroy the milk or milk products, without compensation to the owner of the milk or milk products. Examples of circumstances under which raw milk or raw milk products may be unsafe or a menace to public health include situations when raw milk or raw milk products have been produced in violation of the act, the Food Safety Act or this chapter and these violations relate to handling and sanitation, when herd health conditions risk the transmittal of disease through the milk or milk products or when pathogenic bacteria are present in the raw milk permitholder’s raw milk supply,
(b) Excluding milk from sale. The Department may exclude raw milk or raw milk products from sale in either of the following circumstances:
(1) The Secretary considers the raw milk or raw milk products to be unsafe or a menace to public health.
(2) If a raw milk permitholder violates a provision of the act or this chapter.
Subchapter G. MISCELLANEOUS PROVISIONS
Sec.
59a.501. Interrelatedness with Food Safety Act.§ 59a.501. Interrelatedness with Food Safety Act.
The subject matter of the act and this chapter overlaps with the subject matter of the Food Act (repealed) and the regulations promulgated under authority of that statute in Chapter 46 (relating to food code). This chapter does not restrict, prevent or limit the Department or any other government entity from exercising authority under the Food Safety Act or its attendant regulations with respect to milk, milk products, manufactured dairy products or any other foods.
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