[54 Pa.B. 3318]
[Saturday, June 15, 2024]

[Continued from previous Web Page]

Annex A

TITLE 7. AGRICULTURE

PART III. BUREAU OF FOOD SAFETY AND LABORATORY SERVICES

Subpart B. LIQUID FOODS

CHAPTER 59a. MILK SANITATION

Subchapter A. PRELIMINARY PROVISIONS

§ 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:

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 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. This includes dairy plant samplers and industry plant samplers as defined in the PMO.

 BTU—[Bulk] bulk tank unit—A specified dairy farm or group of dairy farms from which milk for pasteurization or for manufacturing purposes is collected by a milk tank truck.

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 Certified industry inspector—An approved inspector who has been licensed by the Department in accordance with § 59a.4(h) and (i) 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 inspections described in the Grade ''A'' PMO.]

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 Grade ''A'' PMO or PMO—The most current revision of the Grade ''A'' Pasteurized Milk Ordinance and its appendices, as published by the United States Department of Health and Human Services, Public Health Service and the FDA. The Grade ''A'' Pasteurized Milk Ordinance is a set of minimum standards and requirements for Grade A milk production and processing, established 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] www.agriculture.pa.gov.

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 HTST—High temperature short [term] time.

 Herd—A group of animals or a single animal maintained for purposes related to this chapter.

 ISO/IEC 17025—The 2017 edition of the standard owned by the International Standards Organization entitled General Requirements for the Competence of Testing and Calibration Laboratories. Copies of the standard can be found at www.iso.org.

 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)].

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 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.]

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 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.

 Pasteurization—The process of heating every particle of milk, milk product or the milk used for manufactured dairy product, in properly designed and operated equipment, to one of the temperatures set forth in § 59a.7 (relating to pasteurization standards) and held continuously at or above that temperature for at least the corresponding specified time.

 Pasteurized—Milk, milk products or the milk used for manufactured dairy products that has undergone pasteurization.

 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.

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 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).

 Raw milk butter—Butter made from raw milk, provided it conforms to Subchapter F.

 Retail food facility—As defined in 3 Pa.C.S. § 5702 (relating to definitions) of the Retail Food Facility Safety Act.

 Secretary—The Secretary of the Department, or an authorized representative.

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 Weigher/sampler—A bulk milk pick-up driver [or a milk plant person], certified industry inspector, approved inspector or other authorized designee certified by the Department [or the Pennsylvania Milk Marketing Board] or other Department-approved certifying body 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 all of the following:

 (1) The term ''regulatory agency,'' which means the Department.

 (2) The term ''milk products,'' which means both ''milk'' and ''manufactured dairy products'' as defined in this chapter.

§ 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] Milk Program

 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] www.agriculture.pa.gov/consumer_protection/foodsafety.

§ 59a.4. Approved inspectors and certified industry inspectors.

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 (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] 18 years of age or older.

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 (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] will verify that an applicant has adequate experience by having a Department [personnel conduct one or more] evaluator conduct five joint dairy farm inspections with the applicant.

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 (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] subsection (d), attendance at an educational seminar is a requisite to the Department issuing or renewing a license.

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 (g)  Refusal, revocation or suspension of [certificate] license. The Department may, upon written notice and opportunity for a hearing, refuse, revoke or suspend a license for [cause] a violation of the act or this chapter.

 (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.

 (i) Certification process. A person seeking to become a certified industry inspector must be a licensed approved inspector. To become and remain a certified industry inspector, a person must meet the standards established in section 5 of the Grade ''A'' PMO (relating to inspection of diary farms and milk plants). These standards include the following for initial certification and recertification:

 (1) Initial certification. For initial certification, a person shall conduct 25 joint dairy farm inspections with a Department evaluator and achieve a passing score of 80% agreement with the same inspection completed by the Department's evaluator.

 (2) Renewal certification. For recertification, a certified industry inspector shall conduct ten joint dairy farm inspections, over a period of 3 years, with a Department evaluator and achieve a passing score of 80% agreement with the same inspection completed by the Department's evaluator.

§ 59a.5. Standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results.

 (a) General laboratory standards.

 (1) Pennsylvania-approved, official and other laboratories. 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 found at AOAC.org. 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.

 (2) Laboratories. Each laboratory that conducts sampling or laboratory examinations for purposes of this chapter shall be listed with NCIMS.

 (3) Pathogen testing laboratories. For pathogen-specific testing required by this chapter, laboratories shall have received accreditation to the ISO/IEC 17025 standard, found at ISO.org, from a National third-party laboratory accrediting body to analyze food products. The accreditation body of the laboratory must be a full member of the International Laboratory Accreditation Cooperation (ILAC) and a signatory to the ILAC mutual recognition arrangement.

 (4) Alternate laboratory methods. The Department may evaluate and approve alternative laboratory sampling or testing standards and procedures concerning bacteriological analysis of milk, milk products and manufactured dairy products as necessary and shall publish these approved methods in the Pennsylvania Bulletin.

 (b) [Reports of results] Laboratory reports.

 (1) Pennsylvania-approved laboratories. 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.

 (2) Other laboratories. If another laboratory issues a report of the results of laboratory examinations for the purposes of this chapter, the report shall be signed by the laboratory director, the person designated by the laboratory director or as otherwise specified under the laboratory's ISO/IEC 17025 standard accreditation documents.

 (3) Report timetable. Reports shall be provided to the Department within the time periods established in the NCIMS Grade ''A'' program, or within 30 days of test completion. Laboratories shall report results that are noncompliant under the standards established in the PMO or this chapter within 48 hours. The Department, through publication in the Pennsylvania Bulletin, may specify the format in which laboratories must submit test results.

 (c) Pennsylvania-approved dairy laboratory director.

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 (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] passes an onsite performance and facilities evaluation by a laboratory evaluation officer from the Department 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.

 (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.

 (5) A certified Pennsylvania-approved dairy laboratory director shall continue to participate in the Department-conducted milk split sample proficiency program, and performance shall be satisfactory.

 (6) A certified Pennsylvania-approved dairy laboratory director shall perform their functions and shall operate a Pennsylvania-approved laboratory in compliance with the standards of the act and this chapter.

 (7) A certified Pennsylvania-approved dairy laboratory director shall ensure recorded laboratory test results are accurate and in compliance with the act and this chapter.

 (8) Falsification of required records shall be a violation of this chapter.

 (d) Refusal, revocation or suspension of approval or certification. The Department may, upon written notice and opportunity for a hearing, refuse, revoke or suspend a Pennsylvania-approved dairy laboratory approval or a Pennsylvania-approved laboratory director certification for any violation of the act or this chapter.

 (Editor's Note: Sections 59a.6 and 59a.7 are proposed to be added and are printed in regular type to enhance readability.)

§ 59a.6. Approved sampler and weigher/sampler.

 (a) Application for approved sampler. A person may apply to the Department to be certified as an approved sampler for purposes of the act and this chapter. The Department will provide certification application forms and the certification renewal forms described in subsection (e) upon receiving a request sent to the address or web site identified in § 59a.3 (relating to contacting the Department).

 (b) Application for weigher/sampler. A person may apply to the Department to be certified as a weigher/sampler for purposes of the act and this chapter. The Department will provide certification application forms and the certification renewal forms described in subsection (e) upon receiving a request sent to the address or web site identified in § 59a.3.

 (c) Criteria for approval.

 (1) An applicant for certification under subsection (a) or subsection (b) must have training and experience in the area of sampling milk, milk products and manufactured dairy products, such as experience on a dairy farm, taking the Pennsylvania Milk Board's Power Point training, working with a milk cooperative or dairy processor or other dairy or weighing and sampling experience, and shall pass a field test, administered by the Department, or other Department-approved certifying body, verifying appropriate sampling technique. At least one passing inspection score must be obtained.

 (2) An applicant for a weigher/sampler certification must also have training and experience in weighing milk and shall complete a Department or Pennsylvania Milk Board administered written examination and achieve a final score of at least 70%.

 (3) The Department may modify criteria for approval to be consistent with provisions of the Grade ''A'' PMO, in particular Appendix B (relating to milk sampling, hauling and transportation), which specifies the required training and periodic evaluation of samplers and weighers/samplers.

 (d) Certificate. The Department will issue a certificate, verifying certification in the appropriate field, to any applicant meeting the standards established in subsection (c).

 (e) Duration of certificate; renewal. A certificate shall expire as of January 1 of each calendar year. Applicants shall do the following:

 (1) Apply or reapply by December 31 of the calendar year preceding the year for which certification is requested.

 (2) Provide documentation verifying compliance with the continuing education training requirements established in subsection (f)(1).

 (f) Continuing education and recertification requirements.

 (1) As a prerequisite to renewal of certification under subsection (e), the applicant shall attend a Department or Department-approved continuing education training for approved samplers and weigher/samplers that meets the training requirements established in Appendix B of the Grade ''A'' PMO during the period of certification.

 (2) Applicants are required to demonstrate proper sampling techniques every 24 months to the Department as referenced in Appendix B of the Grade ''A'' PMO.

 (g) Refusal, revocation or suspension of certificate. The Department may, upon written notice and opportunity for a hearing, refuse, revoke or suspend a certificate for any violation of the act or this chapter.

§ 59a.7. Pasteurization standards.

 To be considered pasteurized, every particle of milk, milk product or manufactured dairy product must be heated in properly designed and operated equipment to the applicable temperature and maintained at that temperature for the corresponding specified time, as set forth under the definition of ''pasteurization'' in section 1 of the Grade ''A'' PMO (relating to definitions).

Subchapter B. PERMIT REQUIREMENTS

§ 59a.12. Permits.

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 (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,] retail food facility, or any other facility where these products are to be consumed on-premises when the [milk or milk] products have been purchased from a person already in possession of a permit to sell milk [or], milk products or manufactured dairy 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] [Reserved].

 (5) A person producing and selling milk from a single cow[, and exempted from the permit requirement in accordance with the act]. The registration shall be renewed every 2 years.

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 (j) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO, in particular section 3[, regarding permits] (relating to permits), apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO). Section 3 of the Grade ''A'' PMO establishes that to move, including to manufacture, bring into, send into, receive into, sell, offer for sale or store, milk products, as defined in section 1 of the Grade ''A'' PMO (relating to definitions), in interstate commerce a person must possess a permit issued by the appropriate State regulatory agency. The Department will issue a permit upon verifying the person is a Grade A facility regulated by the appropriate State regulatory agency, and receipt of a copy of their most recent inspection report evidencing compliance.

§ 59a.13. Adulterated or misbranded milk, milk products or manufactured dairy products.

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 (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] (relating to adulterated or misbranded milk and/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] [Reserved].

 (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] [Reserved].

 (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)] [Reserved].

 (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] must comply with the labeling provisions of the act, the Food Safety Act, 3 Pa.C.S. §§ 5741—5747 (relating to milk sell-by date and best-by date labeling), the Federal Fair Packaging and Labeling Act (15 U.S.C. §§ 1451—1461) and this section, and contain at minimum the following information:

 (1) The common or standardized name of the food.

 (2) The net quantity of contents, which shall be in accordance with the standards provided in 21 CFR 101.7 (relating to declaration of net quantity of contents) and 16 CFR Parts 500—503.

 (3) The common name of the hooved mammal producing the milk preceding the name of the milk [or], milk product[,] or manufactured dairy product if the milk [or], milk product or manufactured dairy 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 or manufactured dairy product is aseptically processed.

 (5) The words ''keep refrigerated,'' if the [milk or PMO-defined milk product] milk, milk product or manufactured dairy 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 or manufactured dairy 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 the 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] Milk, milk products or manufactured dairy 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, milk product or manufactured dairy product is made by reconstitution or recombination.

 (10) The volume or proportion of water, in both standard and metric units, to be added for reconstitution or recombination, if the milk [or], milk product or manufactured dairy 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 or manufactured dairy 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 or manufactured dairy 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 or manufactured dairy 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 or manufactured dairy 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 or manufactured dairy 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 or manufactured dairy 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 or manufactured dairy 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] The sell by date, best by date or other 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 and inspection requirements 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)] or manufactured dairy products). In addition, these requirements do not apply to cans of raw milk from individual dairy farms, which must be identified by name or number of the producer.

 (f) False or misleading material. False or misleading marks, words or endorsements upon the label are prohibited. In determining whether labeling is false or misleading, the Department will take into account not only the specific representations made on the label but also the extent to which the labeling fails to reveal facts that are material in light of [such] these 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.

 (1) Labels containing claims, such as A2A2, organic, kosher, grass-fed and other marks, words or endorsements placed on the label, shall have documentation to support the claims. This documentation shall be provided to the Department upon request.

 (2) Proof of certification issued by a National or third-party accreditation or certification process shall be maintained by the permittee and support the marks, words or endorsements used on the label. This proof of certification shall be provided to the Department upon request.

 (g) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO, in particular section 4[, regarding labeling] (relating to 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 a retail food facility, to include retail food stores, restaurants, schools [or similar food facilities], farmers markets, and roadside stands, for resale shall be conspicuously and legibly marked in a contrasting color with the designation of the [''sell-by'' date—] ''sell by'' or ''best by'' date.

 (1) Sell by date. A ''sell by'' date shall consist of a designation of 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''—], whether expressed in standard fashion (such as ''August 15''), numerically (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.] (such as ''AUG 15 or AU 15'') and either:

 (i) The words ''Sell by'' or ''Not to be sold after'' preceding that designation and appearing legibly on the cap or nonglass container; or

 (ii) The statement ''Not to be sold after the date stamped above'' following that designation and appearing legibly on the cap or nonglass container.

 (2) Best by date. A ''best by'' date shall consist of designation of the month and the day of the month, in the same format as required in paragraph (1), established by the permitholder as a product quality guideline and the words ''Best By,'' ''Best if Consumed By'' or ''Best if Used By'' preceding that designation and appearing legibly on the cap or nonglass container.

 (b) Prominence of [sell-by] sell by or best by date on label. The [sell-by] ''Sell By'' or ''Best By'' date shall be separate and distinct from any other number, letter or intervening material on the cap or nonglass container.

 (b.1) Sell by or best by date limitation. A ''Sell By'' or ''Best By'' date may not exceed 17 days beginning after midnight on the day on which the milk was pasteurized, unless the Department approves a longer interval in accordance with the procedure set forth in subsection (f).

 (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] sell by or best by date designated on the cap or nonglass container.

 (d) Exemption. The following types of pasteurized [dairy products] milk are exempt from the requirements of this section, provided that the cap or nonglass container [of all pasteurized dairy products contains,] 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] milk.

 (2) Cultured [dairy products] milk.

 (3) Aseptically processed [dairy products] milk.

 (4) [Dairy products that have] Milk that has undergone [higher heat shorter time] HTST pasteurization.

 (5) Milk sold or offered for retail sale on the same premises at which it was processed.

 (e) Monitoring by the permitholder and 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.] Permitholder samples. Permitholders shall sample and submit milk for testing in accordance with paragraph (2), and as often as follows:

 (i) Permitholders using sell by or best by dates of 17 days or less. If the permitholder labels milk with a sell by or best by date that is no later than 17 days beginning after midnight on the day on which the milk was pasteurized, the permitholder shall, at intervals of no greater than 12 months and for the highest-selling volume of milk type, and each type and volume of container of that highest-selling volume of milk type bearing that label information, sample and test in accordance with paragraph (2).

 (ii) Permitholders using sell by or best by dates of greater than 17 days. If the permitholder labels milk with a sell by or best by date that is greater than 17 days beginning after midnight on the day on which the milk was pasteurized, and that has been approved by the Department under subsection (f), the permitholder shall, at intervals of no greater than 6 months and for the highest-selling volume of milk type, and each type and volume of container of that highest-selling volume of milk type bearing that label information, sample and test in accordance with paragraph (2).

 (1.1) Department monitoring. The Department may, at its discretion, pull regulatory samples from a permitholder or person required to have a permit, at any time during regular business hours, for testing at an official laboratory.

 (2) Testing methodology. The permitholder shall submit unopened 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,''] for analysis by a laboratory meeting the requirements of § 59a.5 (relating to standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results), applying the methodology established in subsection (f)(1)(ii) or an approved method established under § 59a.5(a)(4) 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] sell by or best by date designated on the retail container.

 (3) Pasteurized milk that exceeds the bacterial limits.

 (i) When a sample pulled under paragraph (1) or paragraph (1.1) exceeds the bacterial limits for pasteurized milk described in § 59a.21 prior to the expiration of the sell by or best by date designated on the retail container, the permitholder shall resample that same product at the next production date, or within 10 days, following receipt of test results, for retesting as established in paragraph (2).

 (ii) When two or more samples [demonstrate a processor] pulled under paragraph (1) or paragraph (1.1) indicate that a permitholder 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] established in § 59a.21 during the sell by or best by date period the Department will calculate [this revised sell-by] a reduced sell by or best by date so that bacterial growth in the milk will not exceed the referenced bacterial limits within that [sell-by] sell by or best by date period if the milk is maintained in accordance with the temperature standards for pasteurized milk in § 59a.21.

 (4) Resumption of use of a sell by or best by date not exceeding 17 days. A processor may submit three samples from different production days to [the Department] a laboratory meeting the requirements of § 59a.5 for analysis to obtain approval to resume a 17-day [sell-by] sell by, or less, period for the product sampled. The Department will approve resumption of a 17-day, or less, [sell-by] 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] sell by period if the milk is maintained in accordance with the temperature standards for pasteurized milk in § 59a.21.

 (5) Reapplying to resume a sell by or best by date period greater than 17 days. A permitholder may reapply to the Department to resume a sell by or best by date period greater than 17 days for the product sampled by following the application process established in subsection (f).

 (6) Reporting test results. The Pennsylvania-approved dairy laboratory conducting tests required under this section shall submit results to the permitholder and the Department as established in § 59a.5.

 (f) Applying to the Department for approval to use a sell by or best by date greater than 17 days. A permitholder may apply to the Department for approval to use a sell by or best by date that exceeds the 17-day period referenced in subsection (b.1). The Department will approve a permitholder's application by type of milk and the type and volume of the milk container.

 (1) Approval process. The permitholder shall apply to the Department for approval to use a specific sell by or best by date that is greater than 17 days using a form provided by the Department.

 (i) The permitholder must specify on the form by milk type and type and volume of container each product for which approval is requested and the specific sell by date or best by date proposed for that product as packaged.

 (ii) For each milk type and type and volume of container for which approval is requested, the permitholder must include a report from a laboratory meeting the requirements of § 59a.5 that confirms the requirements set forth in 3 Pa.C.S. § 5744(b)(3) (relating to sell-by date or best-by date of greater than 17 days from pasteurization). The bacterial count required under 3 Pa.C.S. § 5744(b)(3)(ii) shall conform with the bacteriological standards established in § 59a.21(a).

 (iii) Testing results shall be maintained by the permitholder for a minimum of 2 years.

 (2) Continuation of approval. The Department's approval under this section shall remain in effect as long as the permitholder continues to complete the periodic sampling and testing required in subsection (e).

§ 59a.16. Markings, sealing [and], documentation and inspection requirements for vehicles containing milk [and], milk products or manufactured dairy products.

 (a) Marking requirements. A vehicle or milk tank truck containing milk [or], milk products or manufactured dairy 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 [or], milk products or manufactured dairy 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 or manufactured dairy 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 or manufactured dairy 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)] BTU identification numbers or—for farm groups listed with a milk plant—the IMS Listed Milk Plant Number.

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 (12) Grade [of product] ''A,'' if product is Grade ''A.''

 (d) Cans of raw milk. Cans of raw milk from individual dairy farms shall be identified by the name, producer number or permit number of the individual milk producer.

 (e) Additional documentation. Milk transport tank trucks transporting bulk milk [and] or manufactured 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)] [Reserved].

 (g) Vehicle or milk tank truck inspection. Vehicles and milk tank trucks transporting raw, heat-treated or pasteurized milk, milk products or manufactured dairy products within this Commonwealth shall be inspected at least once every 24 months, or at a lesser interval where violations have occurred, by the Department or other Department authorized official, or a non-Commonwealth State agency participating in the NCIMS program, and shall comply with standards set forth in PMO Appendix B, VIII (relating to milk tank truck permitting and inspection).

 (h) Reporting and inspection. Haulers and milk plants shall cooperate with the Department by:

 (1) Providing an annual report of the vehicles and milk tank trucks described in subsection (g) in their fleet on forms supplied by the Department or as otherwise deemed acceptable by the Department.

 (2) Making those vehicles and milk tanker trucks available for inspection.

 (i) Proof of inspection. Upon compliant inspection, the Department will issue an official sticker indicating compliance and setting forth the expiration date of the current valid inspection. The Department shall apply the sticker to each vehicle and milk tanker truck found to be compliant.

 (j) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO, in particular section 4 (relating to labeling) and Appendix B (relating to milk sampling, hauling and transportation), apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).

§ 59a.17. Inspection of dairy farms and milk plants.

 (a) General inspection requirement. Dairy farms shall be inspected by an approved inspector at intervals of no greater than 6 months[, unless the dairy farm produces raw milk 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] the Department 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]. The milk producer shall have an empty bulk tank for an initial inspection or change of market inspection. An inspection 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 (relating to drug residue testing and farm surveillance) of the Grade ''A'' PMO [regarding drug residue testing and farm surveillance].

 (c) Notification to the Department 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 with 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] (relating to 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] or laboratory compliant with § 59a.5 (relating to standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results).

 (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 (relating to drug residue testing and farm surveillance) 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.

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 (e) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO, in particular section 6 (relating to examination of milk and/or milk products) 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).

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§ 59a.19. Standards for Grade ''A'' milk for pasteurization, ultrapasteurization or aseptic processing.

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 (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] (relating to 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] the provisions of this chapter. This includes all of the items listed under the referenced Grade ''A'' PMO provisions, including the following:

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§ 59a.20. Standards for [Grade ''A''] pasteurized, ultrapasteurized and aseptically processed milk and [milk] manufactured dairy products.

 (a) Applicability. The standards prescribed under this section apply to a milk plant processing milk and manufactured dairy products 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] (relating to 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] Articles, Utensils and Materials

 (15) Item 15p. Protection from Contamination

 (16) Item 16p. Pasteurization and Aseptic Processing and Packaging, Retort Processed after Packaging, and Fermented High Acid, Shelf-Stable Processing and Packaging

 (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 and Practices

 (21) Item 21p. Vehicles

 (22) Item 22p. Surroundings

§ 59a.21. Standards.

 (a) Standards for milk and [milk] manufactured dairy products. The standards that apply to milk and [milk] manufactured dairy products are as set forth in section 7 (relating to standards for Grade ''A'' milk and milk products) of the Grade ''A'' PMO, in Table 1[, regarding] (relating to chemical, physical, bacteriological, and temperature standards) except that the somatic cell count for Grade ''A'' raw milk and manufactured dairy products for pasteurization shall not exceed 500,000 per milliliter.

 (b) Standards for milk for manufacturing, milk products and manufactured dairy products. The standards that apply to milk for manufacturing, milk products 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] manufactured dairy products provided that they meet [all] the applicable requirements of Subchapter C.

 (c) Standards for milk products, including 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 (relating to standards for Grade ''A'' milk and milk products) 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] 6 (relating to the examination of milk and/or milk products) and Appendix N [of that document regarding examination of milk and milk products and drug residue testing and farm surveillance, respectively] (relating to drug residue testing and farm surveillance), 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] (relating to 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 and manufactured dairy products which may be sold.

 The provisions of the Grade ''A'' PMO, in particular section 9[, regarding] (relating to milk [and] and/or 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] (relating to transferring; delivery containers; and 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.

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 (b) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO, in particular section 11[, regarding] (relating to milk [and] and/or 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).

§ 59a.26. Plans for construction and reconstruction.

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 (b) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO, in particular section 12[, regarding] (relating to 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] (relating to 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 or manufactured dairy 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 manufactured dairy products, or the handling of related [milk or milk-product] product contact surfaces, subject to release from this exclusion if in accordance with [Table 5 of section 15] sections 13 and 14 (relating to personnel health; and procedure when infection or high risk of infection is discovered) 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] 14, 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

§ 59a.102. Milk permits.

 Plants, receiving stations, transfer stations and [bulk tank units] BTUs handling or processing milk for manufacturing of milk products or manufactured 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, manufactured milk products 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.

§ 59a.103. Plant inspection.

 Plants receiving milk, milk products or manufactured 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] [Reserved].

 [(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] [Reserved].

 [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, as set forth in §§ 59a.107, 59a.109, 59a.110 and 59a.111.

§ 59a.107. Appearance and odor.

 (a) Industry responsibilities. Approved samplers shall be responsible for ensuring that raw milk for manufacturing purposes meets the requirements of this section.

 (b) Examination for 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.

§ 59a.108. [Sediment content classification] [Reserved].

 [(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.]

§ 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 or other laboratory compliant with § 59a.5 (relating to standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results). The laboratory must report the results to the permitholder.

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 (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 producer 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.

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§ 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 or other laboratory compliant with § 59a.5 (relating to standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results). The laboratory must report the results to the permitholder.

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 (c) Excessive somatic cell count. Whenever the official test indicates the presence of more than [750,000] 500,000 somatic cells per milliliter (1,500,000/ml for [goat] goat/sheep milk), the result shall be noted as a producer violation in the permitholder's records. When two of the last four consecutive bacterial estimates exceed [750,000/ml] 500,000/ml (1,500,000/ml for [goat] goat/sheep 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)] (c), the producer shall have an additional sample taken between 3 and 21 days after receiving the notice. If this sample also exceeds [750,000] 500,000 per milliliter (1,500,000/ml for goat/sheep milk), 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] 500,000 per milliliter (1,500,000/ml for goat/sheep milk). The samples shall be taken at a rate of not more than two per week on separate days within a 3-week period.

§ 59a.111. Drug residue level.

 (a) Industry responsibilities. [Manufactured] Milk products and manufactured dairy products permitholders shall meet the requirements of this section to confirm their milk products and 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] (relating to 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.

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 (v) [Sample test results for milk] A sample test result, including negative and positive test results, shall be recorded. The test result records shall be retained for 6 months.

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 (b) Responsibilities of the Department.

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 (2) Enforcement.

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 (vi) The actions and procedures of the Department will be in accordance with this chapter and Appendix N of the Grade ''A'' PMO[, regarding] (relating to drug residue testing and farm surveillance).

§ 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)] [Reserved].

 (2) [The milk has been in a probational (No. 3) sediment content classification for more than 10-calendar days] [Reserved].

 (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] 500,000 per milliliter (1,500,000/ml for [goat] goat/sheep 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] Hortvet (0.508° [C] Celsius) 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 with an empty bulk milk tank 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] have an empty bulk milk tank inspected by an approved inspector and have a passing score before the first milk is shipped.

*  *  *  *  *

 (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)] [Reserved].

 (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] [Reserved].

 (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] (relating to inspection of dairy farms and milk plants), apply to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).

§ 59a.116. Abnormal milk.

 (a) Certain milk to be excluded from human consumption. [Cows] Dairy animals which show evidence of the secretion of abnormal milk in one or more quarters or halves based on bacteriological, chemical or physical examination and [cows] dairy animals 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] dairy animals 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] dairy animals treated with or exposed to pesticides not approved for use on dairy [cattle] animals 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] (relating to 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] dairy animals, and the contamination of the utensils.

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Subchapter D. FARMS PRODUCING MILK FOR MANUFACTURING

§ 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. The dairy farm shall have an empty bulk tank for inspection 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 or e-mail within 24 hours of the action.

§ 59a.202. Milking facilities and housing.

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 (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.

§ 59a.205. Milkhouse or milkroom.

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 (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, insects 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 or insects.

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§ 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] (relating to standards for water sources), and is approved by the Department.

Subchapter E. MANUFACTURING PLANTS

GENERAL REQUIREMENTS

§ 59a.302. Buildings.

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 (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, self-closing, 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, insects 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.

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 (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] ensure 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:

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 (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] § 59a.5 (relating to standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results). If the permitholder does not establish its own laboratory, an existing [approved laboratory] Pennsylvania-approved dairy laboratory or other laboratory compliant with § 59a.5 is acceptable if services are conveniently available so that samples and results can be transmitted without delay.

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§ 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] an 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] every 6 months, 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.

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§ 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] milk residue or any unsanitary condition.

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§ 59a.308. Raw product storage.

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 (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:

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 (4) If a plant remains in temporary status in excess of 60 days, administrative procedures to suspend the plant's [license] permit will be taken by the Department until the plant complies with the bacteriological requirements.

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§ 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)] the pasteurization standards established in § 59a.7 (relating to pasteurization standards). 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] ensure proper pasteurization or sterilization of the product. The heat treatment by either process must be sufficient to [insure] ensure public health safety and [to assure] adequate keeping quality, [yet] while 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, milk products or manufactured dairy products during manufacturing. Substances and ingredients used in the processing or manufacturing of a milk, milk product or manufactured 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—399i) [and] , applicable regulations under 21 CFR Chapter I, Subchapter B (relating to food for human consumption), and applicable Commonwealth statutes and regulations as to their composition and wholesomeness.

§ 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] 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] [Reserved].

 (2) Positive drug residue tests: retain for 12 months.

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§ 59a.314. Packaging and general identification.

 (a) Containers. Containers must meet the following standards:

 (1) The size, style and type of packaging used for milk, milk products and 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 milk, milk products and manufactured 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 a special type of 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 milk, milk products or manufactured 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 milk, milk products or manufactured 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 other products [foreign to] and items in the same room with milk, milk products and manufactured dairy products [in the same room], to prevent impairment or damage to the milk, milk products or manufactured 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.

 (Editor's Note: Section 59a.317 is proposed to be added and is printed in regular type to enhance readability.)

§ 59a.317. Federal food safety regulations.

 (a) The Department adopts all Federal regulations related to food as dictated by 3 Pa.C.S. § 5733(f) (relating to rules and regulations), including all applicable enforcement provisions.

 (b) Permitholders shall comply with food facility registration requirements established in 21 CFR Chapter II, Subchapter A, Part 1, Subpart H (relating to registration of food facilities).

 (c) Permitholders shall comply with the requirements of 21 CFR Chapter I, Subchapter B, Part 117 (relating to current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food).

 (d) Permitholders shall comply with applicable provisions and requirements under 7 CFR Subtitle B, Chapter I, Subchapter C, Part 58 (relating to grading and inspection, general specifications for approved plants and standards for grades of dairy products).

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.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 manufactured dairy product may not be used for the bulk handling of [dairy] these 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] palletizing or dry storage areas.

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 (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 the 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.350. Operations and operating procedures: Checking quality.

 Milk, milk products and manufactured dairy products [and], to include dry milk products shall be subject to inspection an 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 dairy laboratory meeting standards established in § 59a.5 (relating to standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results) 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.

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SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING AND PACKAGING BUTTER AND RELATED PRODUCTS

§ 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, other than the cream for production of raw milk butter as described in § 59a.402 (relating to raw milk; prohibitions), with respect to which pasteurization requirements are not applicable, 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] ensure improved keeping quality characteristics.

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SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING AND PACKAGING CHEESE, PASTEURIZED PROCESS CHEESE AND RELATED PRODUCTS

§ 59a.371. Rooms and compartments.

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 (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.]

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§ 59a.372. Equipment and utensils.

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 (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. [tion.]

 (m) Conveyors. Conveyors shall be constructed of material which can be properly cleaned, will not rust, or otherwise contaminate the cheese, and shall be maintained in good repair.

 (n) Grinders or shredders. Product contact surfaces shall 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, and shall be kept in good repair.

 (o) Cookers. Cookers shall meet the following standards:

 (1) The cookers shall be the steam jacketed or direct steam type.

 (2) The cookers shall be constructed of stainless steel or other equally corrosion resistant material.

 (3) The product contact surface shall be readily and easily accessible for cleaning.

 (4) The cooker shall be equipped with an indicating thermometer and a temperature recording device.

 (5) Steam check valves on direct steam type cookers shall be mounted flush with the cooker wall, constructed of stainless steel and designed to prevent the backup of product into the steam line, or the steam line shall be constructed of stainless steel pipes and fittings which can be readily and easily cleaned.

 (6) If direct steam is applied to the product, only culinary steam shall be used.

 (p) Fillers. The filler valves and head shall be kept in good repair and be capable of accurate measurements. The hoppers of a filler shall meet the following standards:

 (1) Be covered, but these covers may have sight ports.

 (2) May, where necessary, have an agitator to prevent buildup on the side wall.

§ 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] in accordance with the standards established in § 59a.7 (relating to pasteurization standards).

 (2) [HTST pasteurization] Pasteurization units must be equipped with the proper controls and equipment to [assure] ensure 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.

 (1) When the cheese is labeled as ''heat treated,'' ''unpasteurized,'' ''raw milk'' or ''for manufacturing,'' the milk may be raw or heated at a temperature below pasteurization.

 (2) 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.

 (3) Cheese to be labeled as ''raw aged'' shall meet the following requirements:

 (i) The cheese is a standardized cheese identified in 21 CFR Chapter I, Subchapter B, Part 133, Subpart B (relating to requirements for specific standardized cheese and related products).

 (ii) The standards set forth in 21 CFR Chapter I, Subchapter B, Part 133, Subpart B, must allow that type of cheese to be manufactured from raw milk.

 (iii) Laboratory test results verifying the cheese conforms with all applicable CFR standards shall be made available to the Department.

 (c) Whey disposal. Disposal of whey shall be as follows:

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 (c.1) Forming containers.

 (1) When lined or unlined containers are assembled and stored, it shall be done in a sanitary manner to prevent contamination.

 (2) Procedures must be in place for the handling of containers between forming and filling that prevent contamination of the product contact surfaces.

 (3) Preforming and assembling of pouch liners and containers shall be based on production needs and the supply rotated to limit the length of time exposed to possible contamination prior to filling.

 (c.2) Filling containers. Hot fluid cheese from the cookers may be held in hotwells or hoppers to ensure 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.

 (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.

 (d.1) Trimming and cleaning. The natural cheese shall be cleaned so that it is free of all nonedible portions. Paraffin and bandages as well as rind surfaces, mold or other unclean areas deemed unwholesome shall be removed.

 (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, to include the wording ''raw milk'' ''made with raw milk,'' or similar identifying language, the number of days the cheese aged, and other information that may be required.

SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING AND PACKAGING [PASTEURIZED PROCESS CHEESE] MILK PRODUCTS, TO INCLUDE ICE CREAM, FROZEN DESSERTS 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] milk 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] [Reserved].

 (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] [Reserved].

 (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] [Reserved].

 (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] [Reserved].

§ 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] [Reserved].

 (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] [Reserved].

 (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] [Reserved].

 (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] [Reserved].

 (d.1) Pasteurization of milk products.

 (1) Milk products shall be pasteurized.

 (2) HTST, UHT and BATCH pasteurization units shall be equipped with the proper controls and equipment to complete the pasteurization process. Where milk is held more than 2 hours between time of receipt or heat treatment and setting, it shall be cooled to 45° Fahrenheit or lower during the entire time period.

 (d.2) Purchase of pasteurized mixes for production of milk products. Permitholders may purchase a pasteurized frozen dessert or ice cream mix from a permitted facility for further production of a milk product.

 (d.3) Filling Containers.

 (1) Mechanical fillers. Both gravity and vacuum type fillers shall be of sanitary design and all product contact surfaces, if metal, shall 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 shall be designed in a manner to ensure they will not contaminate or detract from the quality of the product in any way.

 (2) Manual fillers. Manual filling shall be done in a sanitary manner to prevent contamination of the product contact surfaces of containers. The containers shall be kept sanitary and may not contaminate or detract from the quality of the product in any way.

 (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] ensure 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.

 (f) Freezer storage. Freezer storage shall comply with the following:

 (1) The room shall be maintained at a temperature of 0° Fahrenheit or lower.

 (2) Air circulation must be sufficient to preclude odors and maintain uniform storage temperatures throughout the freezer.

 (g) Sampling. Milk products shall be sampled by an approved sampler and tested in accordance with § 59a.21(c) (relating to standards).

 (h) Inspections. Milk product manufacturers will be inspected by the Department every 6 months.

Subchapter F. RAW MILK FOR HUMAN CONSUMPTION

§ 59a.401.  Raw milk; general.

 This subchapter prescribes the permitting, testing and inspection requirements that are applicable to persons seeking to sell raw milk and raw milk butter 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. The term ''sell'' also includes selling, exchanging or delivering to a consumer who is a member of a ''buyer's club,'' cow herd share agreement or other type of membership purchasing group.

 (b) Actions authorized under a raw milk permit.

 (1) 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.] The permit only authorizes the sale of raw milk that has been produced by the permitholder.

 (2) A raw milk permitholder may obtain an additional permit, issued by the Department, authorizing the production and sale of raw milk butter manufactured from raw milk if that raw milk butter is produced in compliance with the supplemental requirements for plants manufacturing, processing and packaging butter and related products presented in §§ 59a.361, 59a.362 and 59a.363 (relating to rooms and compartments; equipment and utensils; and operations and operating procedures) and any other provision of this chapter relating to the production of butter, other than a provision or requirement relating to pasteurization under § 59a.7 (relating to pasteurization standards). The additional permit only authorizes the sale of raw milk butter that has been manufactured by the permitholder from raw milk that has been produced by the permitholder.

 (c) Compliance with testing and documentation requirements. A person may not sell raw milk or raw milk butter for human consumption without being in compliance with the testing and documentation requirements of this section.

§ 59a.404. Requirements for the issuance of a raw milk permit.

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 (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 and tested and analyzed by a Pennsylvania-approved dairy laboratory [or the Department for analysis], official laboratory, or other laboratory meeting the requirements of § 59a.5 (relating to Standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results).

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§ 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] (relating to 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:

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§ 59a.408. Regular testing of raw milk and raw milk butter for human consumption.

 (a) Responsibility. A raw milk or raw milk butter permitholder shall be responsible to arrange for the regular sampling and testing required with respect to the raw milk and raw milk butter permit, and to pay for this testing.

 (b) Testing laboratories. Raw milk or raw milk butter samples submitted for testing shall be analyzed at [an official laboratory or] a Pennsylvania-approved dairy laboratory, official laboratory, or other laboratory meeting the requirements of § 59a.5 (relating to standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results).

 (c) [Testing] Raw milk and raw milk butter testing schedule and standards. A person holding a raw milk [permitholder] permit or raw milk butter permit, or both, shall coordinate the testing of raw milk and raw milk butter for human consumption on the following schedule, and the raw milk and raw milk butter samples must meet the following standards:

Raw Milk Testing Schedule and Standards

Required Action Interval	Type of Action or Test Required	Standard
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 cfu 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 cfu per milliliter. Note: Tested in conjunction with a drug residue/inhibitory substance test.
At least twice each month	Somatic cell count	The somatic cell count may not exceed [750,000/milliliter] 500,000/milliliter (1,500,000/ml for [goat] goat/sheep 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] PMO 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.

 (d) Raw milk butter testing schedule and standards. In addition to the raw milk used for raw milk butter meeting the requirements of the testing schedule and standards in subsection (c), a raw milk butter permitholder shall coordinate and ensure the testing of raw milk butter every 6 months for bacterial count, coliform, and yeast and mold count. The product shall meet the most current microbiological standards outlined in 7 CFR 58.345 (relating to butter). Current standards include:

 (1) Bacterial count not exceeding 100 cfu per gram.

 (2) Coliform count not exceeding 10 cfu per gram.

 (3) Yeast and mold count not exceeding 20 cfu per gram.

§ 59a.409. Violations of raw milk testing standards.

*  *  *  *  *

 (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, official laboratory, or other laboratory meeting the requirements of § 59a.5 (relating to standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results) 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 with an empty tank between samples, and submit it to a Pennsylvania-approved dairy laboratory, official laboratory, or other laboratory meeting the requirements of § 59a.5 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 and with an empty tank between samples, 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.

 (e) Raw milk butter not meeting testing standards. When two or more raw milk butter samples exceed the microbiological limits referenced in § 59a.408(d), the permitholder must cease production of the raw milk butter until the permitholder can demonstrate, through additional sample testing on two different production dates, that the raw milk butter meets the microbiological standards referenced in § 59a.408.

§ 59a.411. Label content review by the Department.

 (a) Raw milk and packaged raw milk butter in containers owned by the raw milk permitholder.

 (1) General label statements. If raw milk or raw milk butter for human consumption is prepackaged for sale in containers that are owned by the raw milk permitholder, and where applicable the raw milk butter 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 or raw milk butter, comply with § 59a.14 (relating to labeling: bottles, containers and packages of milk, milk products or manufactured dairy products), and at a minimum include the fluid volume, for raw milk, or the net weight, for raw milk butter, as well as the name and address of the distributor or producer, the raw milk permit number under which the raw milk was produced, and for raw milk butter, the additional raw milk butter permit number under which the raw milk butter was produced, 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] and raw milk butter have not been processed to remove pathogens that can cause illness. The consumption of raw milk or raw milk butter 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: raw 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—] ''sell by'' or ''best by'' date.

 (A) Sell by date. A ''sell by'' date shall consist of a designation of 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], whether expressed in standard fashion (such as ''August 15''), numerically (such as ''8-15'') or with use of an abbreviation (such as ''AUG 15'' or ''AU 15'') and either 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.

 (B) Best by date. A ''best by'' date shall consist of designation of the month and the day of the month, in the same format as required in clause (A), established by the permitholder as a product quality guideline and the words ''Best By,'' ''Best if Consumed By'' or ''Best if Used By'' preceding that designation.

 (ii) Prominence of [sell-by] sell by or best by date on label. The [sell-by] sell by or best 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] sell by or best by date designated on the container.

 (iv) Monitoring by the permitholder and the Department.

 (A) Department. The Department will periodically sample containers of raw milk and raw milk butter for human consumption that is in the possession of the raw milk permitholder or a distributor. This sampling may occur at any time before the raw milk, or raw milk butter is delivered to the customer. [The Department will take at least one sample of raw milk from each raw milk permitholder each calendar year.]

 (A.1) Permitholders. The permitholder shall, at intervals of no greater than 12 months, sample and test in accordance with § 59a.15(e)(2) (relating to labeling: milk dating).

 (B) The samples described in [clause (A)] clauses (A) and (A.1) shall be analyzed by [the Department or] a Pennsylvania-approved dairy laboratory, official laboratory, or other laboratory meeting the requirements of § 59a.5 (relating to standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results), to determine whether bacterial and coliform 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 and raw milk butter for human consumption) prior to the expiration of the [sell-by] sell by or best by date designated on the raw milk container.

 (B.1.) When any sample pulled under clause (A.1) exceeds the bacterial or coliform limits for raw milk described in § 59a.408, the permitholder shall resample at the next production date, or within 10 days, following receipt of test results, for retesting as described in clause (B).

 (C) When two or more samples, pulled under clause (A) or clause (A.1), demonstrate a raw milk permitholder cannot produce raw milk for human consumption that remains consistently within the bacterial and coliform limits referenced in clause (B) through the [sell-by] sell by or best by date marked on the container, the Department will require a raw milk permitholder to use a shorter [sell-by] sell by or best by date specified by the Department. The Department will calculate this revised [sell-by] sell by or best by date so that bacterial growth in the raw milk will not exceed the referenced bacterial limits within that [sell-by] sell by or best 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] a Pennsylvania-approved dairy laboratory, official laboratory, or other laboratory meeting the requirements of § 59a.5 for analysis to obtain approval to resume a specific [sell-by] sell by or best by period for the raw milk sampled. The Department will approve resumption of a specific [sell-by] sell by or best by period when analysis of [a sample] at least three samples from 3 different production days demonstrates that bacterial growth in the raw milk will not exceed the referenced bacterial and coliform limits within that [sell-by] sell by or best 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).

 (c) Label statements for raw milk butter. Raw milk butter shall be packaged or wrapped prior to sale with a label identifying the name and address of the distributor or producer, date of manufacture code, and the raw milk and raw milk butter permit number under which the raw milk butter was produced and shall conform with the labeling requirements of subsection (a)(1) and (2).

§ 59a.412. Inspection, sampling and testing by the Department.

 A raw milk permitholder, and a raw milk butter additional 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 or raw milk butter permitholder fails to allow this inspection and sampling by the Department, the Department may take steps to revoke or suspend the raw milk permit or the raw milk butter permit, or both.

§ 59a.413. Enforcement: Suspension or revocation of a raw milk or raw milk butter permit.

 (a) General. The Department may take action to suspend or revoke a raw milk permit or raw milk butter permit, or both, 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 or raw milk butter permitholder with at least 5 days advance written notice of a [raw milk permit] revocation or suspension of their raw milk permit or raw milk butter permit, or both. 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 of the raw milk permit or raw milk butter permit, or both, is that pathogenic bacteria have been detected in the raw milk or raw milk butter, or foreign substances are present in the raw milk or raw milk butter, or any condition exists when consumption of raw milk or raw milk butter produced and sold prior to revocation or suspension of the raw milk or raw milk butter permit may pose a threat to the health or safety of those persons who consume it, the Department will immediately notify the raw milk or raw milk butter permitholder, or both, and request that it voluntarily cease all sales of raw milk, raw milk butter, or both—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 or raw milk butter permitholder to cease sales of raw milk or raw milk butter, or both, for human consumption if required under § 59a.409 (relating to violations of raw milk testing standards).

 (i) If a raw milk permitholder or raw milk butter permitholder, or both, 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 or raw milk butter permitholder, or both, does not choose to comply with a request that it voluntarily cease [raw milk sales,] the sale of raw milk or raw milk butter, or both, 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 or raw milk butter, or both, 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 of raw milk or raw milk butter, or both.

 (C) Arrange for an administrative hearing before a hearing examiner, if the raw milk permitholder or raw milk butter 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 or raw milk butter permitholder, or both, does not request a hearing on the proposed permit suspension or revocation.

 (E) Recommend to the raw milk permitholder or raw milk butter permitholder, or both, that it inform its customers that it has been asked by the Department to voluntarily cease [raw milk sales] the sale of raw milk or raw milk butter, or both, and provide these customers the basis for the Department's request.

 (c) Ownership of raw milk permit or raw milk butter permit. A raw milk permit or a raw milk butter 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 or a raw milk butter permit, or both, 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 or raw milk butter permit, or both, shall immediately return or surrender that raw milk permit or raw milk butter permit, or both, to the Department. In the case of a permit suspension, the Department will promptly return the raw milk permit or raw milk butter permit, or both, to the permitholder at the end of the suspension period.

Subchapter G. MISCELLANEOUS PROVISIONS

§ 59a.501. Interrelatedness with the Retail Food Facility Safety Act and the Food Safety Act.

 The subject matter of the act and this chapter overlaps with the subject matter of 3 Pa.C.S. §§ 5701—5714 (relating to retail food facility safety) and the Food Safety Act [(repealed)] and the applicable regulations promulgated under the authority of [that] each statute which is codified in [Chapter 46 (relating to food code)] Chapters 37—57 and this chapter. This chapter does not restrict, prevent or limit the Department or any other government entity from exercising authority under 3 Pa.C.S. §§ 5701—5714 or the Food Safety Act or [its] their attendant regulations with respect to milk, milk products, manufactured dairy products or any other foods.

[Pa.B. Doc. No. 24-821. Filed for public inspection June 14, 2024, 9:00 a.m.]

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