PROPOSED RULEMAKING

DEPARTMENT OF AGRICULTURE

[ 7 PA. CODE CH. 59a ]

Milk Sanitation

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

 The Department of Agriculture (Department) proposes to amend Chapter 59a (relating to milk sanitation) to read as set forth in Annex A.

Statutory Authority

 This proposed rulemaking is authorized under the act of July 2, 1935 (P.L. 589, No. 210) (31 P.S. §§ 645—660g), referred to as the Milk Sanitation Law (act). Section 19 of the act (31 P.S. § 660c) provides, ''The Secretary of Agriculture is hereby authorized to adopt and promulgate rules and regulations for the proper enforcement of this act.'' In addition, the act of June 30, 2021 (P.L. 333, No. 62) (Act 62 of 2021) added 3 Pa.C.S. §§ 5741—5747 (relating to milk sell-by date and best-by date labeling). Section 5747 of 3 Pa.C.S. authorizes the Department to adopt the regulations necessary to administer the provisions of 3 Pa.C.S. §§ 5741—5747. Under 3 Pa.C.S. §§ 5721—5737 (relating to food safety) (Food Safety Act), the term ''milk'' is included within the definition of a ''potentially hazardous food'' and provides the Department broad authority to regulate ''milk'' as necessary for the proper enforcement of the Food Safety Act. See 3 Pa.C.S. §§ 5722 and 5733 (relating to definitions; and rules and regulations).

Need for the Proposed Rulemaking

 This proposed rulemaking would accomplish several regulatory objectives, including:

 (1) authorization for issuance of an additional raw milk butter permit to raw milk permitholders, in response to the industry-driven initiative to provide more raw milk products. Sections 59a.363(a)(1)(i), 59a.401, 59a.402(b)(2) and (c), 59a.405, 59a.408, 59a.409(e), 59a.411(a)(1) and (2) and (c), 59a.412 and 59a.413(a) and (b) are proposed to be amended to provide standards for raw milk butter.

 (2) implementation of the statutory requirements imposed by Act 62 of 2021. Sections 59a.15(a), (b), (b.1), (c), (d), (e) and (f) and 59a.411(a)(3)(i), (ii) and (iv) (relating to labeling: milk dating and label content review by the Department) are proposed to be amended to provide standards for 3 Pa.C.S. §§ 5741—5747.

 (3) removal of an outdated and extraneous regulatory requirement for label and labeling preapproval by the Department for all permitholders, as preapproval of labels and labeling are not expressly required by the act or by any other act under which milk, milk products, milk for manufacturing or manufactured dairy products may be regulated,¹ and to align with all other food products, which do not require preapproval of labels. The Department retains this requirement, however, for those raw milk permitholders subject to Subchapter F (relating to raw milk for human consumption). The change was prompted by the industry stating that no other product label or labeling requires preapproval of the label or labeling and it was delaying their ability to quickly market new products. Section 59a.14(a), (b) and (c) (relating to labeling: bottles, containers and packages of milk, milk products or manufactured diary products), which provide standards for the label and labeling requirements for milk, milk products, manufactured dairy products or milk for manufacturing purposes which currently establish the parameters for preapproval of labels, are proposed be deleted. Subsection (d) is proposed to be expanded to establish minimum label and labeling requirements for bottles, containers and packages enclosing milk, milk products or manufactured dairy products. While labels must comply with those standards, no preapproval of the labels will be required. The raw milk label content review provisions of § 59a.411 are not amended and are not affected. Raw milk labels must still be submitted to the Department for preapproval.

 (4) regulating sampler, weigher/sampler and milk tanker inspections previously conducted by the Pennsylvania Milk Marketing Board (MMB) in accordance with a Memorandum of Understanding (MOU) with the Department. The MOU was terminated in 2019, and since then, the Department has been tasked with conducting the field certifications and inspection programs required by the Interstate Milk Shippers Grade A Program (a United States Food and Drug Administration (FDA) Federal cooperative program that each state and commonwealth must adopt and conform to for their dairy industry to ship in interstate commerce) and the United States Department of Health and Human Services, Federal Grade ''A'' Pasteurized Milk Ordinance (Grade ''A'' PMO). Appendix B (relating to milk sampling, hauling and transportation) of the Grade ''A'' PMO requires samplers and weigher/samplers to be approved and milk tanker inspections to be done. The Department had established an MOU with the MMB under which the MMB did a large percentage of the sampler and weigher/sampler certification and milk tanker inspections. As set forth previously, the MOU terminated in 2019 and was not renewed. The Department has no certification standards or requirements set forth in regulation. Therefore, it is necessary to establish uniform standards through regulation and to properly inform the regulated community of the requirements to be met. Sections 59a.6(a), (b), (c) and (f), 59a.16(g), (h) and (i), 59a.107(a), 59a.382(g) and 59a.409(d) are affected by standards for regulation of a sampler or weigher/sampler and milk tanker inspections.

 (5) making the regulation more understandable and user-friendly for the regulated community, and more closely aligned with the Federal Grade ''A'' milk standards outlined in the Grade ''A'' PMO. The most current revision of the Grade ''A'' PMO and its appendices, as published by the FDA, may be found on the Department's web site at www.agriculture.pa.gov/consumer_protection/FoodSafety. The web site contains a link to an electronic copy of the document. Many provisions of the current regulations contain references to the Grade ''A'' PMO. Proposed amendments to §§ 59a.2 (relating to definitions) specifically the terms ''approved sampler,'' ''certified industry inspector,'' ''Grade A PMO or PMO'' and ''(c) [a]dditional terms used in the Grade 'A' PMO,'' 59a.4(i), 59a.5(b)(3) and (c)(3), 59a.6(c)(4) and (f), 59a.7, 59a.12(j), 59a.16(g),(i) and (j), 59a.21(a) and (d) and 59a.28(a)(1) and (b) are affected by, contain slight changes to, or provide standards related to the Grade ''A'' PMO.

Summary of this Proposed Rulemaking

Proposed revisions to § 59a.2

 This section is proposed to be amended by adding or refining various defined terms and include citations for various statutes referenced elsewhere in the regulation. These amendments include the following:

 The definition of ''approved inspector'' is proposed to be deleted. The current definition is different from the statutory definition. In addition, the proposed amendments to § 59a.4(b)(3) (relating to approved inspectors and certified industry inspectors) clarify the licensure standards for approved inspectors.

 The definition of ''approved sampler'' is proposed to be amended to make it clear that an approved sampler includes a certified person that obtains milk sampled as a ''dairy plant sampler'' or ''industry plant sampler,'' as those terms are defined under the Grade ''A'' PMO. The rationale for this amendment is to achieve consistency with Federal milk regulations and standards as outlined in the Grade ''A'' PMO.

 The definition of the term ''BTU—bulk tank unit'' is defined in the current regulation. The Department proposes to modify the definition slightly to clarify that it includes both individual dairy farms and groups of dairy farms from which milk is collected. The current definition references only a ''group'' of dairy farms. However, many BTUs are located on individual farms. Therefore, the definition now includes a specified farm in addition to a group of dairy farms. This was done to ensure both accuracy and clarity of the definition. The term ''BTU,'' while not defined in the Grade ''A'' PMO, is used in the Grade ''A'' PMO, which is adopted in the current regulations and is proposed to be amended in this proposed rulemaking, and in § 59a.16(e) (relating to marking, sealing and documentation for vehicles containing milk and milk products) of both the current regulations and this proposed rulemaking.

 The definition of ''certified industry inspector'' is proposed to be added because the term is used in § 59a.4(h) regarding approved inspectors current regulation and proposed subsection (i) regarding the certification process.

 The Department proposes to amend the current definition of ''Grade 'A' PMO'' to set forth information disclosing the Federal agencies that publish it, provide factual information disclosing it, provide the minimum standards for Grade ''A'' milk production and processing as established by the FDA and provide the proper link to the Department's web site.

 The definition of ''HTST'' is proposed to be amended to correct the definition. The current definition is incorrect because it states that HTST stands for ''high temperature short term.'' In actuality, HTST stands for ''high temperature short time,'' as provided in the definition of ''pasteurization'' in section 1 RR of the Grade ''A'' PMO (see definition of pasteurization).

 The Department proposes the addition of the definition of ''ISO/IEC 17025.'' This term appears in the amended regulations at § 59a.5(a)(3) and (b)(2) (relating to standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results).

 The Department proposes to amend the definition of ''manufactured dairy products'' to ensure it is the same as the statutory definition under section 1 of the act (31 P.S. § 645).

 The Department proposes to amend the definition of ''milk products'' by deleting the last sentence, ''[t]he term includes those foods that are milk products under the Grade 'A' PMO.'' This sentence is inconsistent with the definition of ''milk products'' set forth in section 1 of the act.

 The Department proposes to add the definition of ''pasteurization'' for clarity purposes. It is used in the definitions of ''pasteurized'' and ''Pennsylvania-approved dairy laboratory'' and in §§ 59a.7, 59a.12, 59a.14, 59a.15, 59a.17, 59a.19—59a.21, 59a.309, 59a.363, 59a.373, 59a.382, 59a.402 and 59a.405. The definition of ''pasteurization'' comes from section 1 RR of the Grade ''A'' PMO. The Department proposes to add the phrase ''the milk used for'' when referring to manufactured dairy products to clarify only milk must be pasteurized, and not other ingredients in the manufacture of dairy products.

 The Department proposes to add the definition of ''pasteurized'' for clarity. The definition of pasteurized is combined with the definition of ''pasteurization'' at section 1 RR of the Grade ''A'' PMO. Webster's Dictionary defines ''pasteurize'' as ''to expose to pasteurization.'' Therefore, the Department is proposing to define ''pasteurized'' in a manner that denotes the milk, milk product or milk used in manufactured dairy product has undergone pasteurization. The word pasteurized is used in the definition of ''Grade 'A' PMO or PMO'' and in §§ 59a.7, 59a.14—59a.16, 59a.20, 59a.309, 59a.363, 59a.373 and 59a.382.

 The Department proposes to add the definition of ''raw milk butter'' since it is different from ''butter'' which is made from pasteurized milk and the term is used in §§ 59a.363(a), 59a.401, 59a.402(b)(2) and (c), 59a.408, 59a.409(e), 59a.411(a) and (c), 59a.412 and 59a.413 of this proposed rulemaking, all of which set forth standards for ''raw milk butter.''

 The Department proposes to add the definition of a ''retail food facility'' because that term is used throughout §§ 59a.12(b)(3), 59a.15 and 59a.501 (relating to permits; labeling: milk dating; and interrelatedness with the Retail Food Facility Safety Act and the Food Safety Act).

 The Department proposes to amend the definition of ''weigher/sampler'' by (1) adding the terms ''certified industry inspector,'' ''approved inspector'' and ''other authorized designee,'' and (2) deleting the term ''milk plant person,'' because there is no person specifically defined or set forth in the act or the Grade ''A'' PMO related to weigher and sampler and (3) deleting the ''Pennsylvania Milk Marketing Board'' and replacing it with ''or other Department-approved certifying body.'' The Department had established an MOU with the MMB to do a large percentage of the certification, but the MOU expired in 2019 and the MMB did not approve a renewal. Therefore, the specific reference to the MMB has been replaced with the broader term ''Department-approved certifying body.'' The amendment clarifies that certified inspectors and approved inspectors, as defined in the regulation, and other persons certified by the Department may be a weigher/sampler. In addition, Appendix B of the Grade ''A'' PMO requires weigher/samplers to be approved by the regulatory agency.

 The Department proposes to amend § 59a2(c) which provides for additional terms used in the Grade 'A' PMO by adding paragraphs (1) and (2). Paragraph (1) is simply created from current language for clarity and paragraph (2) clarifies that additional terms used in the Grade ''A'' PMO include ''milk products'' which include both ''milk'' and ''manufactured dairy products.''

Proposed amendments to § 59a.3 (relating to contacting the Department)

 The Department proposes to amend this section by updating the contact and address information.

Proposed amendments to § 59a.4

 The Department proposes to:

 1. Add ''and certified industry inspectors'' to the title.

 2. Reduce the applicant age from 21 years of age to 18 years of age in subsection (b)(1). There is no legal reason to require a person to be 21 years of age to become a licensed approved inspector when the legal age of adulthood in this Commonwealth is 18 years of age—see 23 Pa.C.S. § 5101 (relating to attainment of full age)—and there are no special circumstances to require a person to be 21 years of age prior to licensure.

 3. Amend subsection (b)(3) to establish that the Department will evaluate each applicant and to increase the number of joint dairy farm evaluation inspections to five. The increase in joint dairy farm evaluation inspections is more consistent with the standards established in section 5 of the Grade ''A'' PMO.

 4. Amend subsection (e) by deleting the reference to ''subsections (b) and'' in the second sentence resulting in only subsection (d) being referenced. The reason for the change is that subsection (b) does not apply to continuing education requirements for license renewals. The amendment will correct an error in the current regulation.

 5. Amend the heading in subsection (g) to read ''license'' instead of ''certificate'' as the Department issues licenses.

 6. Add subsection (i), regarding the certification process, to make it consistent with the Grade ''A'' PMO, and current industry practice. The Department established language that clarifies a person must be licensed as an approved inspector prior to seeking certification as a certified industry inspector. In addition, the Department set forth general standards for initial certification and renewal of certification that are established in the Grade ''A'' PMO.

Proposed changes to § 59a.5

 1. The Department proposes to amend the title of subsection (a) by adding ''laboratory'' to clarify these are general standards for all laboratories covered under this section. In addition, the Department proposes to add subsections to break down standards for all laboratories, pathogen testing laboratories and to provide for alternate laboratory methods.

 2. The Department proposes to add subsection (a)(1) regarding Pennsylvania-approved, official and other laboratories. The general laboratory standards for sampling and testing conducted by Pennsylvania-approved laboratories, official laboratories and other laboratories are not substantively changed from those that appear in the current regulations under subsection (a). The Department proposes to add a web site reference, ''found at AOAC.org,'' to allow the regulated community to view any updates or familiarize itself with the standards of the ''Official Methods of Analysis of the Association of Official Analytical Chemists.''

 3. The Department proposes to add subsection (a)(2) which requires all laboratories that conduct sampling or examinations to be listed with the National Conference on Interstate Milk Shippers (NCIMS). That listing identifies the interstate milk shippers who have been certified by Milk Sanitation Rating Officers as having attained the necessary milk sanitation compliance and enforcement ratings. The ratings are based on compliance with the requirements of the latest revision of the USPHS/FDA Grade ''A'' PMO and are made in accordance with the procedures set forth in the latest revision of the Methods of Making Sanitation Rating of Milk Shippers.

 4. The Department proposes to add subsection (a)(3) regarding pathogen testing laboratories. Subsection (a)(3) provides specific standards that must be attained by laboratories that conduct pathogen-specific testing required by the regulations. It requires laboratories conducting pathogen testing to have received accreditation to the ISO/IEC 17025 standard from a National third-party laboratory accrediting body that is a full member of the International Laboratory Accreditation Cooperation (ILAC) and a signatory to the ILAC mutual recognition arrangement. This proposed amendment helps to establish uniform standards across the industry and ensure proper, legally defensible and valid testing.

 5. The Department proposes to add subsection (a)(4) regarding alternate laboratory methods, which provides that the Department may evaluate and approve alternative laboratory sampling and testing standards and procedures concerning bacteriological analysis of milk, milk products and manufactured dairy products. Approved methods would be published in the Pennsylvania Bulletin. This proposed amendment would provide some flexibility for ''alternate laboratory methods'' as new testing standards and techniques, proven to be just as effective as those currently followed, may come available in the future. Section 16 of the act (31 P.S. § 660) provides the Secretary authority to ''. . . make requirements concerning the number and character of bacteria in milk, milk products and manufactured dairy products after hearing. Bacteriological analysis of milk, milk products and manufactured dairy products shall be made under the supervision of a laboratory, the equipment and director of which have been approved by the Secretary of Agriculture. The bacterial analysis of milk, milk products and manufactured dairy products shall be in accordance with. . . unless special permission is given by the secretary for a modification of the above standard methods.''

 6. The Department proposes to amend the title of subsection (b) to read ''laboratory reports.'' The intent is to provide clarity that the standards under this section address laboratory reports. In addition, the Department proposes to split subsection (b) into three paragraphs, (1) addressing Pennsylvania-approved laboratory signatories, (2) addressing other laboratories' signatories and (3) addressing reporting timetables for all laboratories.

 7. The Department proposes to add subsection (b)(1), regarding Pennsylvania-approved laboratories, to this section. The standards for reports issued by Pennsylvania-approved laboratories and official laboratories are not changed from those that appear in the current regulations under subsection (b).

 8. The Department proposes to add subsection (b)(2), regarding other laboratories, to address signature standards for laboratories, other than Pennsylvania-approved dairy laboratories or an official laboratory, issuing reports of the results of laboratory examinations. The proposed amendment is intended to provide clarity and to ensure uniform standards across the industry. The language of paragraph (2) establishes substantially the same signatory standards as those established in paragraph (1), allowing the laboratory director or person designated by the laboratory director to sign the laboratory reports. The only difference is that if the laboratory report is signed by someone other than the laboratory director or a designee, the signatory must be a person designated by the laboratory's ISO/IEC standard accreditation documents. The Commonwealth may not specify a higher standard than that accepted by the industry.

 9. The Department proposes to add subsection (b)(3), regarding report timetable, to clarify and establish reporting time periods for all laboratories. The timetables are those required in the NCIMS Grade ''A'' Program, or within 30 days of the test completion. This proposed amendment also addresses the timetable, 48 hours, for reporting results that are noncompliant with the standards of the Grade ''A'' PMO or the regulations. This is intended to provide clarity and a uniform standard for the industry to follow.

 10. The Department proposes to amend subsection (c), regarding the Pennsylvania-approved dairy laboratory director, by deleting subparagraphs (i) and (ii) and adding paragraphs (5)—(8).

 11. The Department proposes to amend subsection (c) by deleting subparagraph (i) standards that required the completion of a written examination as part of the criteria for becoming a provisionally certified dairy laboratory director as that is not required by the statute or the Grade ''A'' PMO. Subparagraph (ii) would no longer be necessary without subparagraph (i) so the language of subparagraph (ii) is proposed to be incorporated into paragraph (3). The language of what was subparagraph (ii) is proposed to be amended by adding language to require an onsite performance and facility evaluation that is ''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.'' The Department's rationale for this amendment is that it is already industry practice and the Bureau of Food Safety and Laboratory Services (Bureau) desires to codify current practice consistent with Federal milk regulations standards including the Grade ''A'' PMO provisions.

 12. The Department proposes to amend subsection (c) by adding paragraphs (5)—(7) which provide additional standards that a certified Pennsylvania-approved dairy laboratory director must follow. The language of paragraph (5) requires the director to continue to participate in the Department-conducted milk split sample proficiency program. Paragraph (6) requires the director to operate the Pennsylvania-approved laboratory in conformance with the standards of the act and the regulation, and paragraph (7) requires the director to ensure all records of laboratory test results are accurate and in compliance with the standards of the act and the regulations. These additions are intended to help ensure compliance and accountability.

 13. The Department proposes to amend subsection (c) by adding paragraph (8) to clarify that any falsification of required records is a violation of the regulation. This will help to ensure compliance and accountability.

 14. The Department proposes to amend this section by adding subsection (d), regarding refusal, revocation or suspension of approval of certification, which provides that upon written notice and opportunity for a hearing the Department may refuse, revoke or suspend a Pennsylvania-approved laboratory approval or a Pennsylvania-approved laboratory director certification for any violation of the act or regulation.

Proposed addition of § 59a.6 (relating to approved sampler and weigher/sampler)

 The Department proposes to add § 59a.6 to the regulation which establishes certification criteria for an individual to be approved as a sampler or weigher/sampler consistent with the requirements established in the Grade ''A'' PMO. This section is more specific in detailing current practices of the Department in fulfilling the standards established in § 59a.104 (relating to certification of bulk milk collectors—weighers/samplers). This amendment would ensure samplers and weigher/samplers are properly and uniformly trained thereby providing better service to the industry and ensuring accountability now that the Department has assumed full responsibility for these certifications. By way of background, the Department had previously established an MOU with the MMB to do a large percentage of the certification, but the MOU expired in 2019 and the MMB did not approve a renewal. The overall purpose of this section is to align the regulation with the standards set forth in the Grade ''A'' PMO, provide for uniform certification standards and provide applicants with a general overview of the requirements for certification as a sampler or weigher/sampler. The proposed amendments require forms that will be provided by the Department. Those forms are attached to this proposed rulemaking. More specifically, the Department proposes to:

 1. Add subsection (a), regarding application for approved sampler, which sets forth the manner by which a person may apply to the Department to be certified as an approved sampler. The Department will provide the certification application forms and the certification renewal forms.

 2. Add subsection (b), regarding application for weigher/sampler, which sets forth the manner by which a person may apply to the Department to be certified as a weigher/sampler. The Department will provide the certification application forms and the certification renewal forms.

 3. Add subsection (c), regarding criteria for approval, which includes three paragraphs. Paragraph (1) establishes the general criteria for certification as a sampler or weigher/sampler. The general criteria includes training and experience in the area of sampling milk, milk products and manufactured dairy products and passing a Department-administered or -approved field test to verify the applicant is utilizing proper sampling techniques. The Department added examples of the basic training or experience a person should have prior to applying for the position. Once the application is accepted the applicant must pass a field test, involving sampling technique, that is administered by the Department, or a Department-approved certifying body. Paragraph (2) sets forth additional criteria for a weigher/sampler certification, including training and experience in weighing milk for approval of the initial application, and once the applicant is accepted, the completion of a Department or MMB-administered written examination with a final score of at least 70%. Paragraph (3) provides language that will allow the Department to modify the training and approval criteria to remain consistent with the particular provisions in Appendix B of the Grade ''A'' PMO. This will help to ensure samplers and weigher/samplers are consistently trained and certified, thereby providing uniformity in sampling and weighing and sampling across the industry.

 4. Add subsection (d), regarding certificate, establishing that the Department will issue a certificate in the appropriate field (sampler or weigher/sampler) to any applicant meeting the standards established in subsection (c).

 5. Add subsection (e), regarding duration of certificate; renewal, which establishes that certificates expire January 1 of each calendar year. Paragraph (1) requires that applicants apply or reapply for a certificate by December 31 of the proceeding calendar year and paragraph (2) requires the applicant to provide verification of compliance with the continuing education requirements of the regulation.

 6. Add subsection (f), regarding continuing education and recertification requirements, which requires continuing education for certified samplers and weigher/samplers. Paragraph (1) establishes that a prerequisite to renewal of certification as a sampler or weigher/sampler is that the applicant attend a Department or Department-approved continuing education training course that meets the requirements established in Appendix B of the Grade ''A'' PMO. Paragraph (2) requires applicants to demonstrate proper sampling techniques to the Department every 24 months. This subsection is intended to help ensure all samplers and weigher/samplers have up-to-date training and remain competent in the necessary skills to carry out their jobs.

 7. Add subsection (g), regarding refusal, revocation or suspension of certificate, which provides that the Department may, upon written notice and opportunity for a hearing, refuse, revoke or suspend a certificate for any violation of the act or the regulation.

Proposed addition of § 59a.7 (relating to pasteurization standards)

 This section provides specific standards for milk, milk products or manufactured dairy products that are sent for pasteurization. This section does not change the regulatory requirements enforced under the Grade ''A'' PMO and will provide clarity and ease of finding the requirements to the regulated community by referencing and providing a citation to the Grade ''A'' PMO pasteurization standard details within the regulation.

Proposed amendments to § 59a.12

 The Department proposes the following amendments to § 59a.12:

 Amend subsection (b), regarding exceptions, by making the following changes to paragraphs (3)—(5):

 1. In paragraph (3) delete the broad reference to ''store'' and add clarity by adding ''retail food facility or any other facility where these products are to be consumed on-premises. . . .'' In addition, delete the redundant and now incorrect phrase ''milk or milk products'' and amend it to read ''. . .when products have been purchased. . .'' with ''products'' referring to the beginning of the sentences which clarifies that this paragraph refers to ''milk, milk products or manufactured dairy products.'' Finally, the words ''manufactured dairy products'' are proposed to be added to the end of the sentence. This creates uniform language throughout the paragraph clarifying it only pertains to ''milk, milk products and manufactured dairy products.''

 2. Delete current paragraph (4). The same language appears in section 2 of the act (31 P.S. § 646). This is redundant in the regulation because the facilities set forth are all retail food facilities that are addressed in paragraph (3).

 3. In paragraph (5), delete the phrase ''and exempted from permit requirements in accordance with the act.'' That phrase is unnecessary as the act has a specific exemption for a person producing and selling from a single cow. See 31 P.S. § 646.

 4. Amend subsection (j) by adding two sentences: one citing the standards and provisions of the Grade ''A'' PMO that require a permit for the interstate movement of milk products including the movement, manufacture, sale, storage or receipt of milk products, and the second sentence identifying when the Department will issue a permit. The Department proposes to add the information to provide additional clarity for the regulated community.

 Proposed amendments to § 59a.13 (relating to adulterated or misbranded milk, milk products or manufactured dairy products)

 The Department proposes to make a small formatting change to the title of section 2 of the Grade ''A'' PMO (relating to adulterated or misbranded milk and/or milk products) to ensure it matches the title set forth in the Grade ''A'' PMO.

Proposed amendments to § 59a.14

 The Department proposes the following amendments to § 59a.14:

 1. Delete subsections (a)—(c). The requirement for all dairy labels to be approved by the Bureau is not a requirement under the statute and it is extremely time consuming and burdensome on the Bureau. Furthermore, no other food has to have the labeling approved by a regulatory entity at a Federal or state level. The industry has the ultimate responsibility to make sure their labels are compliant with labeling standards established by the Department and at the Federal level. As with every other food under the Food Safety Act, if a label is noncompliant the Department would document that on an inspection and the firm would need to correct it. With regard to raw milk, the requirement for the raw milk permittees to seek label approval before using their labels was maintained. These small processors need guidance, and it will be much easier to work with them prior to them printing large amounts of labels than to force corrections if they are noncompliant. The Bureau will also continue to do ''courtesy reviews'' of labels upon request, as it currently does with any other food processors.

 2. Amendments to the language related to label requirements in subsection (d) are necessary to establish and ensure compliance with the Commonwealth's and Federal' labeling standards, including the act, the Food Safety Act and 3 Pa.C.S. §§ 5741—5747 and the Fair Packaging and Labeling Act (15 U.S.C. §§ 1451—1461). In addition, the Bureau clarified that ''manufactured dairy products'' must also meet the label requirements. Amendments are also proposed to be made to replace any reference to ''product'' with the more specific references to ''milk,'' ''milk product'' or ''manufactured dairy product.''

 3. Amendments to subsection (e) set forth the proper title of § 59a.16 of the regulation and delete the label requirement exclusion for raw milk for human consumption addressed in § 59a.411 of the regulation.

 4. The addition of subsection (f)(1) and (2), regarding false and misleading material, for clarity and the purpose of consumer protection. Paragraph (1) clarifies that labels containing additional claims, such as A2A2, organic, kosher, grass fed or other marks or endorsements, must be accompanied by documentation supporting these claims and the documentation must be provided to the Department upon request. Paragraph (2) provides that certification issued by a National or third-party accreditation or certification process must be maintained by the permittee and must support the marks, words or endorsements used on the label. Proof of certification must be provided to the Department upon request.

 5. Amend subsection (g) by amending the word ''regarding'' to ''relating to'' in the Grade ''A'' PMO section reference.

Proposed amendments to § 59a.15

 The Department proposes the following amendments to § 59a.15:

 1. Clarification of which entities are included under this section by adding the more encompassing ''retail food facility'' and providing additional examples of farmers markets and roadside stands which commonly provide milk to consumers.

 2. Addition of subsection (b.1) that specifies ''sell by'' and ''best by'' date limitations of 17 days which is in accordance with recently passed legislation found in 3 Pa.C.S. §§ 5741—5747.

 3. Provisions for both a ''sell by'' and ''best by'' date. These provisions are proposed to be added to subsections (a)—(c) and are in accordance with recently passed legislation relating to milk sell-by date and best-by date labeling, found in 3 Pa.C.S. §§ 5741—5747, allowing for a ''best by'' date designation.

 4. An additional process, in subsection (f), to petition the Department for approval to utilize a ''sell by'' or ''best by'' date that is greater than the 17-day period, as allowed by 3 Pa.C.S. §§ 5741—5747, established by the regulation. The process contains strict provisions for sampling, testing methodology, bacterial limits and storage, as well as authorizing the Department to take regulatory samples and view results of all testing. These provisions provide for a safe product while at the same time reducing food waste.

 5. An amendment to subsection (e), regarding monitoring by the permitholder and the Department, including adding ''the permitholder and'' to the title to denote the permitholder now has monitoring duties, to require, under paragraph (1), the permit holder to sample and submit milk for routine monitoring testing dependent on whether the permitholder uses sell by or best by dates of 17 days or less or sell by and best by dates of greater than 17 days. Proposed paragraph (1.1) provides the Department discretion to monitor a permitholder through the pulling and testing of samples. Paragraph (2) further clarifies the testing methodology to be used and paragraph (3) establishes the process for sampling and retesting milk that exceeds bacterial limits for pasteurized milk. Paragraph (4) is proposed to be amended by adding a header to distinguish it as providing the process for resumption of a 17-day or less ''sell by'' or ''best by'' date. The language was clarified to require the submission of three samples in accordance with the requirements of 3 Pa.C.S. §§ 5744(b)(3)(i) and 5746(d)(2) (relating to sell-by date or best-by date of greater than 17 days from pasteurization; and monitoring by milk plants and department), and the language is proposed to be amended to be consistent with the provisions of 3 Pa.C.S. § 5746(b), regarding methodology, that require samples to be submitted to a Pennsylvania-approved dairy laboratory. Finally, proposed paragraph (5) establishes sample submission standards for reapplying to reinstate an extended ''sell by'' or ''best by'' date, and proposed paragraph (6) provides that test results must be submitted to the permitholder and the Department.

Proposed amendments to § 59a.16

 The Department proposes the following amendments to § 59a.16:

 1. The section name is proposed to be amended to better reflect the standards set forth in this section and to add manufactured dairy products since the substantive provisions of this section add and thereby clarify that manufactured dairy products are also regulated under these provisions.

 2. Subsection (c)(12) clarifies the product grade must reference ''Grade A'' if the milk, milk products, or manufactured dairy products being transported are Grade ''A'' to clarify that the provisions of that subsection apply to Grade ''A'' and not nongrade ''A'' milk.

 3. Adding subsection (g), regarding vehicle or milk tank truck inspection. The subsection provides clarity for the industry by adding language in accordance with section VIII (relating to milk tank truck permitting and inspection) of Appendix B of the Grade ''A'' PMO, which requires the Department to inspect all vehicles transporting raw, heat-treated or pasteurized milk, milk products or manufactured dairy products at least every 24 months or sooner if violations are found.

 4. Adding subsection (h), regarding reporting and inspection. This provision relates to subsection (g) by requiring haulers and milk plants to provide, on forms supplied by or approved by the Department, an annual report of vehicles and milk trucks in their fleet and making milk trucks and vehicles available for inspection by the Department.

 5. Adding subsection (i), regarding proof of inspection. Again, in accordance with subsection (g), which requires inspections, this subsection provides that upon a compliant inspection the Department will issue and apply a sticker to each vehicle or milk truck passing inspection, indicating compliance and setting forth the expiration date of the valid inspection.

 6. Subsection (f), regarding reference to applicable provisions of the Grade ''A'' PMO, is proposed to be deleted and recodified as subsection (j) because of the other proposed amendments. This allows the regulations to have proper order and clarity. In addition, the provisions of what had been subsection (f) are proposed to be amended to update the applicable provisions of the Grade ''A'' PMO by adding a reference to Appendix B of the Grade ''A'' PMO.

Proposed amendments to § 59a.17 (relating to inspection of dairy farms and milk plants)

 The Department proposes the following amendments to § 59a.17:

 1. Deletion of a sentence related to inspection of raw milk producers in subsection (a). Raw milk is addressed later in this proposed rulemaking.

 2. Addition of a standard requiring the bulk milk tank of the producer to be empty for any initial or change of market inspection.

 3. Other amendments are minor and reflect clarity changes, such as setting forth a ''relating to. . .'' phrase when an Appendix or section of the Grade ''A'' PMO is mentioned.

Proposed amendments to § 59a.18 (relating to sampling and examination)

 The Department proposes the following amendments to § 59a.18: The majority of amendments to this section are minor clarity changes, such as setting forth a ''relating to. . .'' phrase when an Appendix or section of the Grade ''A'' PMO is mentioned. The Department proposes to add language to subsection (a) requiring laboratories to be compliant with the requirements of § 59a.5. Therefore, the Department proposes to delete what would be redundant language in subsection (a), requiring a laboratory to be listed with the NCIMS or to 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, or the Department.''

Proposed amendments to § 59a.19 (relating to standards for grade ''A'' milk for pasteurization, ultrapasteurization or aseptic processing)

 The Department proposes the following amendments to § 59a.19: The one amendment to this section is a minor clarity change setting forth a ''relating to. . .'' phrase when a section of the Grade ''A'' PMO is mentioned.

Proposed amendments to § 59a.20 (relating to standards for grade ''A'' pasteurized, ultrapasteurized and aseptically processed milk and manufactured dairy products)

 The Department proposes the following amendments to § 59a.20:

 1. The title of the section is proposed to be amended to reflect that it covers manufactured dairy products as well as milk and that it covers all milk whether Grade ''A'' or non-grade ''A'' milk. The words ''Grade A'' are proposed to be deleted as the standard applies to all the milk and manufactured dairy products produced in this Commonwealth, whether from Grade ''A'' milk or non-grade ''A'' milk. Non-grade ''A'' milk may be pasteurized, ultrapasteurized or aseptically processed. It may also be utilized for manufactured dairy products. The Department also proposes to amend the title of the section.

 2. Subsection (a) reflects that proposed amendment.

 3. Subsection (b) reflects a proposed amendment to ''(relating to. . .)'' which is a proper formatting amendment.

 4. Amendments to subsection (b)(14), (16) and (20) reflect amendments to the terms of the Grade ''A'' PMO that paragraphs (14), (16) and (20) fall under.

Proposed amendments to § 59a.21 (relating to standards)

 The Department proposes the following amendments to § 59a.21:

 1. The title of subsection (a) is proposed to be amended to reflect it covers manufactured dairy products as well as milk. The term ''milk products'' in the act and in the milk sanitation regulations includes ice cream. The definition of ''milk products'' differs between the act and the Grade ''A'' PMO. The definition under the act and its regulations states, ''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.'' The Grade ''A'' PMO defines ''milk products'' in a manner that excludes ice cream or frozen desserts. Therefore, to include milk products under this subsection would be inconsistent with the Grade ''A'' PMO. The standards for ''milk products'' are established under subsections (b) and (c).

 2. The rest of the amendments, with the exception of the somatic cell count exception in subsection (a), reflect formatting (''relating to. . .'') changes, including manufactured dairy products and changes to reflect amendments to the Grade ''A'' PMO section numbers and titles.

 3. The exception, in subsection (a), to the somatic cell count reflects and is consistent with negotiated changes with the industry. These occur throughout this proposed rulemaking.

Proposed amendments to § 59a.22 (relating to animal health)

 The Department proposes a minor formatting change.

Proposed amendments to § 59a.23 (relating to milk, milk products and manufactured dairy products which may be sold)

 The Department proposes the following amendments:

 1. The title of the section is proposed to be amended to reflect that it covers manufactured dairy products as well as milk and milk products.

 2. The rest of the proposed amendments reflect minor formatting changes and changes to reflect amendments to the title of section 9 of the Grade ''A'' PMO.

Proposed amendments to § 59a.24 (relating to transferring; delivery containers; cooling)

 The Department proposes a minor formatting change and changes to reflect amendments to the title of section 10 of the Grade ''A'' PMO.

Proposed amendments to § 59a.25 (relating to milk, milk products and manufactured dairy products from points outside this Commonwealth)

 The Department proposes a minor formatting change to subsection (b) and changes to reflect amendments to the title of section 11 of the Grade ''A'' PMO.

Proposed amendments to § 59a.26 (relating to plans for construction and reconstruction)

 The Department proposes a minor formatting change to subsection (b).

Proposed amendments to § 59a.27 (relating to plans for personal health)

 The Department proposes a minor formatting change.

Proposed amendments to § 59a.28 (relating to procedure when infection or high risk of infection is discovered)

 The Department proposes the following amendments to § 59a.28:

 1. Clarity to ensure inclusion of ''manufactured dairy products'' in the regulated products throughout.

 2. Subsection (a)(1), an amendment to reflect the actual sections of the Grade ''A'' PMO, specifically sections 13 and 14 (relating to personnel health; and procedure when infection or high risk of infection is discovered) that apply to immediate exclusion of a person from handling milk, milk products or manufactured dairy products, and not section 15, which relates to enforcement.

 3. Subsection (b), an amendment to reflect the actual section of the Grade ''A'' PMO, specifically section 14, and not section 16 (relating to penalty) applies.

Proposed amendments to § 59a.102 (relating to milk permits)

 The Department proposes minor amendments for clarity to ensure milk products and manufactured dairy products are included.

Proposed amendments to § 59a.103 (relating to plant inspection)

 The Department proposes minor amendments for clarity to ensure milk products and manufactured dairy products are included.

Proposed amendments to § 59a.104

 The Department proposes to delete the broad and somewhat vague standard contained in subsections (a) and (b) and instead rely on the new and very specific certification and training provisions for samplers and weigher/samplers which is established in § 59a.6.

Proposed amendments to § 59a.105 (relating to approved milk graders)

 The Department proposes to delete this section. No current approved milk graders exist and the current Grade ''A'' PMO or United States Department of Agriculture (USDA) recommended requirements have no provisions for these graders.

Proposed amendments to § 59a.106 (relating to basis)

 The Department proposes a minor change, deleting ''sediment content'' from the raw milk quality classification, consistent with the deletion of § 59a.108 (relating to sediment content classification), and sets forth §§ 59a.107, 59a.109, 59a.110 and 59a.111, which establish the appearance and odor, bacterial estimate classification, somatic cell count and drug residue level standards.

Proposed amendments to § 59a.107 (relating to appearance and odor)

 The Department proposes to break this section into subsections (a) and (b). Subsection (a) provides that approved samplers shall be responsible for ensuring that raw milk for manufacturing purposes meets the requirements of the section for appearance and odor. Subsection (b) contains the current language of the section, but the Department proposes to delete the reference to § 59a.108 since it is proposed to be deleted because it establishes sediment content classifications which the Department will no longer require. The Department also proposes to delete the word ''excessive'' from the language of subsection (b) as that term is too broad. In practice, if the inspector can visually see any sediment in the milk, then the milk should be rejected.

Proposed amendments to § 59a.108

 The Department proposes to delete this section. The Department proposes, consistent with §§ 59a.106 and 59a.107 amendments, to remove all standards regarding sediment content, other than visual examination under § 59a.107, as sediment content is no longer used to determine quality of milk for manufacturing under the current Grade ''A'' PMO and is only a recommended requirement under the current USDA, Agricultural Marketing Service, Dairy Programs, titled Milk for Manufacturing Purposes and its production and Processing-Recommended Requirements.

Proposed amendments to § 59a.109 (relating to bacterial estimate classification).

 The Department proposes two minor changes. First, the addition of language allowing other laboratories that are compliant with § 59a.5 to analyze milk samples. The proposed compliant laboratory standard has been added throughout this proposed rulemaking and expands the scope, while still requiring the same high standards, of laboratories sanctioned to test milk samples. Second, inserting the word ''producer'' to clarify that any bacterial count in excess of 500,000 bacteria per milliliter will be considered a producer violation.

Proposed amendments to § 59a.110 (relating to somatic cell count)

 The Department proposes the following amendments to § 59a.110:

 1. The Department proposes to add language allowing other laboratories that are compliant with § 59a.5 to analyze milk samples. The compliant laboratory standard is proposed to be added throughout this rulemaking and expands the scope, while still requiring the same high standards, of laboratories sanctioned to test milk samples. This clarifies what is happening in the industry and provides a service to producers that border other states.

 2. In accordance with changes requested by the regulated community, the Department proposes to reduce the somatic cells per millimeter from 750,000 to 500,000. The industry is already requiring these lower counts from their producers: the lower somatic cell counts make the milk easier to pasteurize and process and help to ensure a safer raw milk product.

 3. For clarity, the Department proposes to add ''sheep'' to the somatic cell count standards that previously only included ''goat'' milk.

 4. For clarity, the Department proposes to insert the word ''producer'' to clarify that any excess somatic count violations will be considered a producer violation.

Proposed amendments to § 59a.111 (relating to drug residue level)

 The Department proposes a minor formatting change and to insert ''Milk products. . . '' in subsection (a) to clarify milk products are regulated under this section. The Department proposes a change to paragraph (1)(v) to clarify that all sample results, positive and negative, are to be reported.

Proposed amendments to § 59a.112 (relating to rejected milk)

 The Department proposes to delete language referencing sediment content. The Department proposes, consistent with proposed amendments to §§ 59a.106—59a.108, to remove all standards regarding sediment content.

Proposed amendments to § 59a.113 (relating to suspended milk for manufacturing)

 The Department proposes the following amendments to § 59a.113:

 1. The Department proposes to delete the language in paragraphs (1) and (2) referencing deleted § 59a.108 and sediment content.

 2. The Department proposes, consistent with proposed amendments to §§ 59a.106, 59a.107, 59a.108 and 59a.112, to delete all standards regarding sediment content.

 3. The Department proposes to make amendments consistent with the proposed reductions to somatic cell counts and the addition of sheep in other sections of the proposed regulation.

Proposed amendments to § 59a.114 (relating to inspection and quality testing of milk from producers)

 The Department proposes the following amendments to § 59a.114:

 1. Consistent with proposed amendments to § 59a.17, in § 59a.114(a)(1) the Department proposes to add the requirement that initial and change market inspections be done with an empty bulk milk tank.

 2. The Department proposes to delete subsections (b)(2) and (c)(2) referencing § 59a.108.

 3. The Department proposes, consistent with proposed amendments to §§ 59a.106—59a.108, 59a.112 and 59a.113, to delete all standards regarding sediment content.

 4. The Department proposes a minor formatting change to subsections (c) and (d).

Proposed amendments to § 59a.116 (relating to abnormal milk)

 The Department proposes the following amendments to § 59a.116:

 1. The Department proposes that all references to ''cows'' or ''dairy cattle'' be changed to ''dairy animals'' for clarity and consistency.

 2. The Department proposes a minor formatting change to subsection (c).

Proposed amendments to § 59a.201 (relating to farm inspection)

 The Department proposes the following amendments to § 59a.201:

 1. The Department proposes, consistent with proposed amendments to § 59a.17, to amend paragraph (1) by adding the requirement that initial and change-of-market inspections be done with an empty bulk milk tank.

 2. The Department proposes to delete the language in paragraph (2) referencing sediment content. The Department proposes, consistent with §§ 59a.106—59a.108 and 59a.112—59a.114 amendments, to delete all standards regarding sediment content.

 3. The Department proposes to amend paragraph (3) by adding ''e-mail'' as an accepted means of notification.

Proposed amendment to § 59a.202 (relating to milking facilities and housing)

 The Department proposes to delete the word ''pools'' from subsection (e), as it is redundant and is covered by the ''standing water'' standard.

Proposed amendments to § 59a.205 (relating to milkhouse and milkroom)

 The Department proposes to amend subsection (b) to add insects to the list of contaminants that must be controlled.

Proposed amendments to § 59a.207 (relating to water supply)

 The Department proposes a minor formatting change to this section.

Proposed amendments to § 59a.302 (relating to buildings)

 The Department proposes the following amendments to § 59a.302:

 1. The Department proposes to amend subsection (b) by adding self-closing to the requirements for outside doors opening into processing rooms and adding insects to the list of contaminants that must be controlled.

 2. The Department proposes to amend subsection (f)(5) by deleting the language, ''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,'' as the required standard and replacing it with the updated standards established in § 59a.5. This is consistent with the changes made to other sections related to laboratory standards.

Proposed amendments to § 59a.303 (relating to facilities)

 The Department proposes to amend subsection (a) by deleting the language ''twice a year'' and replacing it with ''every 6 months.'' This adds clarity to the standard and ensures the bacteriological examinations are spread out over the year.

Proposed amendments to § 59a.307 (relating to protection and transport of raw milk and cream)

 The Department proposes to delete the word ''milkstone'' from subsection (a) and replace it with ''milk residue'' for clarity.

Proposed amendment to § 59a.308 (relating to raw product storage)

 The Department proposes to amend subsection (e)(4) by replacing the word ''license'' with the word ''permit'' since a plant holds a ''permit'' under the act and that is what would be affected.

Proposed amendments to § 59a.309 (relating to pasteurized, ultrapasteurized or aseptically processed and packaged products)

 The Department proposes to amend § 59a.309 to cite to the pasteurization standards that are now set forth in the substantive provisions of the regulation in § 59a.7, instead of citing a definition in § 59a.2, and to change the word ''insure'' to ''ensure'' for proper grammar purposes.

Proposed amendments to § 59a.310 (relating to composition and wholesomeness)

 The Department proposes to amend § 59a.310, to ensure consistency and clarity by adding ''milk,'' ''milk products'' and ''manufactured'' dairy products throughout, adding a citation to applicable Federal regulations in 21 CFR, Chapter I, Subchapter B (relating to food for human consumption) and adding the requirement of adherence to Commonwealth regulations and statutes.

Proposed amendments to § 59a.313 (relating to plant records)

 The Department proposes to amend § 59a.313 by deleting language in paragraph (1) referring to ''sediment.'' This proposed change is consistent with proposed amendments to §§ 59a.106—59a.108, 59a.112—59a.114 and 59a.201 which remove all standards regarding sediment content.

Proposed amendments to § 59a.314 (relating to packaging and general identification)

 The Department proposes to amend § 59a.314, to ensure consistency and clarity by adding ''milk,'' ''milk products'' and ''manufactured'' dairy products throughout.

Proposed amendments to § 59a.315 (relating to storage of finished product)

 The Department proposes to amend § 59a.315, to ensure consistency and clarity by adding ''milk,'' ''milk products'' and ''manufactured'' dairy products throughout and amending the structure of the sentence for ease of reading and clarity.

Proposed amendments to § 59a.317 (relating to Federal Food Safety regulations)

 The Department proposes to add § 59a.317. The purpose of the proposed amendment is to add clarity for the regulated community related to applicable statutory and regulatory standards. The Food Safety Act requires the Department to adopt all Federal regulations related to food. This proposed section sets forth those regulatory requirements.

Proposed amendments to § 59a.348 (relating to operations and operating procedures: packaging, repackaging and storage)

 The Department proposes the following amendments to § 59a.348:

 1. The Department proposes to amend this section by adding ''manufactured'' dairy products to subsection (a).

 2. The Department proposes to correct the wording of subsection (b) to reference ''palletizing'' not ''palleting.''

 3. The Department proposes to correct subsection (d)(1) by deleting the reference to ''milk'' products. It now refers to all packaged dry products.

Proposed amendments to § 59a.350 (relating to operations and operating procedures: checking quality)

 The Department proposes to amend this section by adding the term ''milk products'' to ensure dried milk products, such as dried ice cream mix, are included in the products regulated under this section. In addition, the Department replaces ''and'' with ''to include'' related to dry milk products because those products are part of milk or manufactured dairy products and the ''and'' made it sound like it was a separate product to be regulated.

Proposed amendments to § 59a.351 (relating to operations and operating procedures: requirements for instant nonfat dry milk)

 The Department proposes to amend subsection (a) by adding language allowing other laboratories that are compliant with § 59a.5 to sample and test nonfat dry milk samples. This proposed compliant laboratory standard is proposed to be added throughout this proposed rulemaking and expands the scope while still requiring the same high standards of laboratories sanctioned to test milk samples.

Proposed amendments to § 59a.363 (relating to operations and operating procedures)

 The Department proposes to amend § 59a.363 by adding language exempting cream used for the production of raw milk butter from the pasteurization standards, established in subsection (a)(1)(i), for the production of butter since pasteurization standards do not apply to raw milk.

Proposed amendments to § 59a.371 (relating to rooms and compartments)

 The Department proposes to amend § 59a.371 by deleting the random text at the end of subsection (c).

Proposed amendments to § 59a.372 (relating to equipment and utensils)

 The Department proposes to amend § 59a.372 by adding subsections (m)—(p), which establish construction and cleaning standards for conveyors, grinders and shredders, cookers and fillers used in the manufacturing of cheese and related products. These standards are already included in the current regulation in § 59a.381(b)—(e) (relating to equipment and utensils). The standards are being deleted from § 59a.381(b)—(e) and added to § 59a.372(m)—(p) because the purpose and regulatory requirements of the subchapter are proposed to be amended from addressing pasteurized processed cheese to addressing milk products, to include ice cream, frozen desserts and related products. In addition, currently § 59a.372(a) states, ''[g]eneral construction, repair and installation. Equipment and utensils necessary to the manufacture of cheese and related products must meet the requirements of § 59a.304 (relating to equipment and utensils). In addition, for other equipment the following requirements in this section shall be met.'' Therefore, the additions are intended to provide standards for other equipment and utensils that are utilized in the manufacture of cheese that currently are not covered or set forth in § 59a.372. This is to help to guarantee public safety by establishing standards for all equipment and utensils utilized and guaranteeing they can be properly cleaned and sanitized, just as the equipment and utensils were covered previously under § 59a.381.

Proposed amendments to § 59a.373 (relating to operations and operating procedures)

 The Department proposes the following amendments to § 59a.373:

 1. The Department proposes to amend subsection (a)(1) by deleting the reference to specific temperature and time standards and replacing it with language referencing the pasteurization standards established in § 59a.7.

 2. The Department proposes to amend subsection (a)(2) by deleting the reference to HTST pasteurization units and instead broadly referring to any type of pasteurization unit since there are multiple types of pasteurization units and all must be properly equipped to ensure pasteurization.

 3. The Department proposes to amend subsection (b) by breaking it into separate paragraphs for clarity and regulatory purposes and adding paragraph (3) creating standards for the labeling of ''raw aged'' cheese.

 4. The Department proposes to add subsections (c.1), (c.2) and (d.1), creating standards for forming containers, filling containers and trimming and cleaning cheese. The addition of subsection (c.1), regarding forming containers, is proposed to be added for clarity and to address sanitation in the handling and storage of these containers. The addition of subsection (c.2), regarding filling containers, is proposed to be added for clarity and to address sanitation and proper weight controls during the filling of the containers, and the addition of subsection (d.1), regarding trimming and cleaning, is proposed to be added for clarity and to address sanitation and cleaning of natural cheese.

 5. The Department proposes to amend subsection (e), regarding general identification, by adding language requiring each consumer-sized container of cheese to include the wording ''raw milk,'' ''made with raw milk'' or similar identifying language and add the number of days the cheese was aged to the labeling requirements.

Proposed amendments to § 59a.381

 The Department proposes the following amendments to § 59a.381:

 1. The standards for ''Supplemental Requirements For Plants Manufacturing and Packaging Cheese'' are addressed in §§ 59a.371—59a.373. The Department has chosen to amend the undesignated heading of this subchapter to include milk products and no longer addresses pasteurized processed cheese. The undesignated heading is proposed to be amended to ''SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING AND PACKAGING MILK PRODUCTS, TO INCLUDE ICE CREAM, FROZEN DESSERTS AND RELATED PRODUCTS.'' The Department proposes to delete the reference to ''cheese'' in subsection (a) and add a reference to ''milk.'' Section 59a.381 already references § 59a.304, which is the proper section of the regulations concerning standards for equipment and utensils used for milk and manufacture of dairy products.

 2. The Department proposes to delete subsections (b)—(e) regarding specific construction and cleaning requirements for conveyors, grinders or shredders, cooker and fillers utilized for handling and processing ''milk'' products, as those standards are already addressed in § 59a.304, which relates to equipment and utensils utilized for milk and manufacture of dairy products.

Proposed amendments to § 59a.382 (relating to operations and operating procedures)

 The Department proposes the following changes to § 59a.382:

 1. The Department proposes to delete subsections (a)—(d), as they reference standards for cheese, which are covered earlier in the regulations, so these provisions are redundant. In addition, they no longer apply since this section now covers milk products.

 2. The Department proposes to add subsections (d.1), (d.2), (d.3), (f), (g) and (h) establishing standards for milk products regarding pasteurization of milk products, purchase of pasteurized mixes for production of milk products, filling containers, freezer storage, sampling and inspections.

 3. The Department proposes to keep subsection (e) regarding closing and sealing containers, as its provisions may be applied to milk products.

Proposed amendments to § 59a.401 (relating to raw milk; general)

 The Department proposes to amend § 59a.401 by adding ''raw milk butter'' to the permitting, testing and inspection requirements as new provisions related to raw milk butter are proposed to be established later in Subchapter F (relating to raw milk for human consumption).

Proposed amendments to § 59a.402 (relating to raw milk; prohibitions)

 The Department proposes the following amendments to § 59a.402:

 1. The Department proposes to add language to subsection (a) clarifying that the term ''sell'' applies to selling, exchanging or delivering to consumers that are members of a ''buyer's club,'' cow share herd agreement or other type of membership purchasing group. These types of groups and entities have arisen since the passage of the current regulation and need to be addressed to add clarity.

 2. The Department proposes to amend subsection (b) by breaking a long paragraph down into separate paragraphs of regulatory areas covered and add clarifying language related to the actions authorized by a raw milk permit. The Department also proposes to delete the provisions related to obtaining an additional raw milk permit for cheese and related cheese products. Raw milk aged cheeses are addressed under § 59a.373 and are allowed under the provisions in 21 CFR Part 133 (relating to cheeses and related cheese products) to be manufactured and sold in interstate commerce if the cheese has been aged at least 60 days. Therefore, the sale of raw milk aged cheeses is not unique to producers in this Commonwealth. However, cheese manufacturers are still required to hold a milk permit under 21 CFR Part 133, Subpart B (relating to requirements for specific standardized cheese and related products), because they are producing a manufactured dairy product but would not be required to hold a special raw milk permit.

 3. The Department proposes to establish a new provision in subsection (b)(2) to allow a raw milk permitholder to obtain an additional permit authorizing the production and sale of raw milk butter manufactured from raw milk and setting standards for the manufacturing, processing, packaging, storage and equipment and utensils used and operating procedures applicable to raw milk butter.

 4. The Department proposes to add the term ''raw milk butter'' to subsection (c), regarding compliance with testing and documentation requirements, to ensure compliance with those standards.

Proposed amendments to § 59a.404 (relating to requirements for the issuance of a raw milk permit)

 The Department proposes to amend § 59a.404(e)(1)(ii) by clarifying the submission, testing and analyzing process for new raw milk permit applicants and deleting ''or the Department for analysis'' since the new language provides the type of laboratories that may be used.

Proposed amendments to § 59a.405 (relating to sanitation)

 The Department proposes a minor formatting change to § 59a.405.

Proposed amendments to § 59a.408 (relating to regular testing of raw milk and raw milk butter for human consumption)

 The Department proposes the following amendments to § 59a.408:

 1. The Department proposes to amend the title of this section to clarify it includes standards for raw milk butter.

 2. The Department proposes to amend subsection (a) by adding the term ''raw milk butter.''

 3. The Department proposes to amend subsection (b) by adding the term ''raw milk butter'' and adding the standards for analysis set forth in § 59a.5.

 4. The Department proposes to make minor changes to the chart ''Raw Milk Testing Schedule and Standards,'' including adding ''cfu'' to ''per milliliter'' as the unit of measurement, throughout, reducing the somatic cell count to 500,000 per milliliter consistent with changes made throughout the regulation and adding ''sheep'' to the somatic cell count requirement for goats to be consistent with changes made throughout the rest of this proposed rulemaking. Reducing the somatic cell count is in the interest of the general public because it lowers the bacteria count and enhances the quality of the milk.

 5. The Department proposes to add subsection (d), regarding raw milk butter testing schedule and standards, to set forth the Commonwealth regulatory requirements for testing intervals and bacterial coliform and yeast and mold standards per gram. The proposed standards are consistent with Federal CFR standards for butter from pasteurized milk.

Proposed amendments to § 59a.409 (relating to violations of raw milk testing standards)

 The Department proposes the following changes to § 59a.409:

 1. The Department proposes to amend subsection (d)(3) and (4) to reference § 59.5.

 2. The Department proposes to amend subsection (d)(4) and (5) to provide language consistent with other provisions of the regulation requiring an empty tank between samples being taken.

 3. The Department proposes to add subsection (e), regarding raw milk butter not meeting testing standards, for purposes of clarity and to provide a standard and procedure to be followed by the producer that has not met microbiological limits for the raw milk butter. This also helps to guarantee consumer health.

Proposed amendments to § 59a.411

 The Department proposes the following amendments to § 59a.411:

 1. The Department proposes to add raw milk butter labeling standards and requirements to this section.

 2. The Department proposes to add a reference to what laboratories meet the testing standards of the regulations in § 59.5.

 3. The Department proposes to add ''best by'' language to this section.

 4. The Department proposes to amend subsection (a)(3)(i) by adding clauses (A) and (B) for ease of reading and clarity and adding clarifying language and standards regarding both a ''sell by'' and ''best by'' date.

 5. Consistent with previous proposed amendments to § 59a.15, the Department proposes to amend subsection (a)(3)(iv) to require the permitholder to submit samples and have them tested in accordance with the standards established in § 59a.15 and at a laboratory meeting the requirements of § 59a.5. In addition, the Department proposes to delete the provision that requires it to take at least one raw milk sample from each permitholder each year. The language requiring periodic testing remains. The language that provides discretion to periodically take samples and have them tested addresses both raw milk and raw milk butter and establishes a standard and procedure that a permitholder must follow for re-sampling and retesting when a product fails to meet bacterial and coliform standards.

 6. The Department proposes to add subsection (c) establishing specific label standards for raw milk butter.

Proposed amendments to § 59a.412 (relating to inspection, sampling and testing by the Department)

 The Department proposes to amend § 59a.412 by adding raw milk butter to the inspection, sampling and testing standards of this section.

Proposed amendments to § 59a.413 (relating to enforcement: suspension or revocation of a raw milk or raw milk butter permit).

 1. The Department proposes to amend § 59a.413 by adding raw milk butter standards to all provisions of this section and changing the title of this section to reflect that change.

 2. The Department proposes to amend subsection (b)(2)(i) to address initial enforcement procedures when a raw milk permitholder or raw milk butter permitholder, or both, voluntarily complies with a request from the Department to cease sales. It establishes that the Department will consider this action as a mitigating factor in determining any penalty or sanction issues.

 3. The Department proposes to amend subsection (b)(2)(ii) to establish the enforcement measures that the Department will follow when a raw milk permit holder or a raw milk butter permit holder, or both, does not choose to comply with a request from the Department to voluntarily cease the sale of raw milk or raw milk butter, or both. It provides the regulated community with clarity related to potential Department enforcement actions.

 4. The Department proposes to amend subsection (c) to make it clear to the regulated entity that the Department owns the raw milk permit or raw milk butter permit that was issued, and that the permit must be returned to the Department after the permitholder has been afforded written notice and opportunity for a hearing upon a proposed suspension or revocation of the raw milk permit or raw butter permit issued to the regulated entity. Where a suspension has been imposed, 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.

Proposed amendments to § 59a.501

 The Department proposes to amend § 59a.501 by adding provisions and citations referencing 3 Pa.C.S. §§ 5701—5714 (relating to retail food facility safety) and the Food Safety Act and their applicable regulations.

Persons Likely to be Affected

 The number of people directly involved with this Commonwealth's dairy industry is difficult to quantify, but the following provides an estimate: Businesses include approximately 8,500 dairy farms that produce milk within this Commonwealth, approximately 35 Grade ''A'' milk processing plants, approximately 150 Grade ''A'' BTUs (permitted farm groups), approximately 120 permitted raw milk facilities, approximately 125 dairy manufacturing (non-Grade ''A'') facilities, 35 Interstate Milk Shippers Program-certified laboratory facilities, 120 drug residue testing facilities, 32 manufacturers of single service containers and closures and 100 milk hauling companies. Individuals include approximately 1,500 approved milk samplers/weighers, 100 approved farm inspectors, 70 approved dairy laboratory directors and 750 certified laboratory analysts.

Fiscal Impact

Commonwealth

 This proposed rulemaking would have some minor positive fiscal impact upon the Commonwealth. However, for the most part, the proposed changes to the regulations are to provide consistency with the Federal standards and clarity. This proposed rulemaking will enhance public health and safety, maintain modern state-of-the-science milk sanitation standards in this Commonwealth and provide clarity to the dairy industry where ambiguity exists. The proposed regulatory amendments will not substantially affect the ongoing business practices or regulatory standards of the industry.

Political subdivisions

 This proposed rulemaking would not have any appreciable fiscal impact on political subdivisions.

Private sector

 This proposed rulemaking would have some appreciable fiscal impact on the private sector. This Commonwealth's 800-plus milk permit holders will benefit from the regulation, as well as the 35 approved dairy laboratories. Other businesses will also benefit through the increased availability of desired dairy products. This proposed rulemaking will provide for further economic opportunities for the regulated industry by providing a path for extending shelf life dating on pasteurized milk and allowing for production of raw milk butter. Approved dairy testing laboratories will benefit from increased revenue from shelf-life testing requirements and elimination of laboratory director exam requirements.

General public

 This proposed rulemaking will benefit nearly all Commonwealth residents, since the majority of this Commonwealth's 12.8 million citizens are consumers of milk and dairy products, by protecting the public health, while expanding the availability of milk and raw milk products available to the consumer. This proposed rulemaking will enhance public health and safety by maintaining modern state-of-the-science milk sanitation standards in this Commonwealth.

Paperwork Requirements

 This proposed rulemaking will not add to paperwork requirements for the regulated community. The various documents that comprise licensing and label applications and review will remain constant, with perhaps slight changes such as allowing for raw milk butter production. This proposed rulemaking does not add to those documents.

Regulatory Review

 Under section 5(a) of the Regulatory Review Act (71 P.S. § 745.5(a)), on May 28, 2024, the Department submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the chairperson of the standing committee on Agriculture and Rural Affairs of the Senate and to the chairperson of the standing committee on Agriculture and Rural Affairs of the House of Representatives. A copy of this material is available to the public upon request.

 Under section 5(g) of the Regulatory Review Act, IRRC may convey comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria in section 5.2 of the Regulatory Review Act (71 P.S. § 745.5b) which have not been met. The Regulatory Review Act specifies detailed procedures for review prior to final publication of the rulemaking by the Department, the General Assembly and the Governor.

Effective Date

 This proposed rulemaking will be effective upon final-form publication in the Pennsylvania Bulletin.

Public Comments

 Interested persons are invited to submit written comments, suggestions or objections regarding this proposed rulemaking to Stefanie Smith, Chief, Division of Policy and Programs, Bureau of Food Safety and Laboratory Services, Department of Agriculture, 2301 North Cameron Street, Harrisburg, PA 17110-9408, (717) 787-5108, within 30 days of the publication of this proposed rulemaking in the Pennsylvania Bulletin.

Contact Person

 The contact person for technical questions regarding this proposed rulemaking is Sheri Morris, Assistant Director, Bureau of Food Safety and Laboratory Services, Department of Agriculture, 2301 North Cameron Street, Harrisburg, PA 17110-9408, (717) 787-5289.

RUSSELL C. REDDING, 
Secretary

 Fiscal Note: 2-194. No fiscal impact; recommends adoption.

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¹  The act of July 2, 1935 (P.L. 589, No. 210) (31 P.S. §§ 645—660g); the act of August 8, 1961 (P.L. 975, No. 436) (31 P.S. §§ 520-1.1—520-9) referred to as the Milk Adulteration and Labeling Act, specifically section 520-6 (31 P.S. § 520-6); the Food Safety Act; and Act 62 of 2021.

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