Explanation of Statutory Authority
The Department has broad general authority, under s. 93.07 (1), Stats., to adopt rules to implement programs under its jurisdiction. The Department also has general authority under s. 97.09 (4), Stats., to adopt rules specifying standards to protect the public from the sale of adulterated or misbranded foods. The Department has specific authority, under s. 97.20 (4), Stats., to establish rules to regulate dairy plants and under s. 97.22 (8) to promulgate rules to regulate the operation of dairy farms by milk producers. The Department also has authority under 97.24 (3), Stats., to adopt rules ensuring compliance with the PMO. Related Statutes and Rules
Wisconsin’s dairy farms, dairy plants, and dairy products are governed by ch. 97, Stats. Section 97.20, Stats., “Dairy plants” and s. 97.22, Stats., “Milk producers,” contain requirements related to milk producer and dairy plant licensing, milk procurement and reinspection fees, and Grade “A” permits. Section 97.23, Stats., “Drug residues in milk,” allows a dairy plant to recover, from a milk producer, the monetary loss incurred when the plant rejects a milk shipment because it is adulterated with drug residues in milk from the producer’s farm. Finally, s. 97.24, Stats., “Milk and milk products,” includes Grade “A” requirements for milk and milk products and authorizes the Department to conduct surveys to verify conformance with the PMO’s Grade “A” standards. Administrative rules spell out the requirements that must be met to ensure compliance with statutes. Dairy farm requirements are currently found in ch. ATCP 60 (Dairy Farms) and dairy plant requirements are currently found in ch. ATCP 80 (Dairy Plants.) These two chapters are consolidated in the proposed rule. Other chapters of administrative rules, governing milk and milk products, include ch. ATCP 77 (Laboratory Certification), ch. ATCP 81 (Cheese Grading, Packaging and Labeling), ch. ATCP 82 (Bulk Milk Collection, Sampling, and Transportation), ch. ATCP 83 (Dairy Product Advertising and Labeling), and ch. ATCP 85 (Butter Grading and Labeling.)
Plain Language Analysis
Wisconsin operates the nation’s largest state dairy inspection program. As of November 27, 2015, Wisconsin had 9,976 licensed milk producers and ranked second nationally in milk production. Milk is shipped from each dairy farm to one of more than 400 licensed dairy plants in the state or to a licensed dairy plant in another state.
About 98% of the milk produced in Wisconsin is Grade “A.” Grade “A” unpasteurized milk, along with pasteurized milk and certain other dairy products made from Grade “A” milk, can only be shipped across state and international boundaries if the production, transportation, processing, and regulatory oversight are in accordance with the PMO. Wisconsin does not adopt the PMO directly, but has its own regulations for the dairy industry. These regulations must be at least as stringent as, and consistent with, the PMO. The FDA revises the PMO every two years and the version of the PMO, to which Wisconsin regulations are compared for compliance, must be within two prior editions. This rule revision, which reflects changes found in the 2013 revision of the PMO, is essential for maintaining compliance with the PMO and for allowing Wisconsin farmers and dairy plant owners to ship their Grade “A” milk and milk products in interstate commerce.
Wisconsin’s regulations also establish standards to ensure the quality of Grade “B” milk, which is milk used only to process non-Grade “A” milk products, such as butter, cheese, and ice cream. Wisconsin had 1,488 Grade “B” licensed milk producers, or 13% of its total, on November 27, 2015. Recommended standards for Grade “B” dairy farms are published by the United States Department of Agriculture (USDA). Wisconsin’s regulations must be at least as stringent as the USDA standards to ensure access of Wisconsin Grade “B” milk products to international markets.
The majority of Grade “A” and Grade “B” dairy plants in Wisconsin will be subject to new federal regulations implementing FSMA and known as the Preventive Controls−Human Food rule. It is possible that future FDA policy will consider compliance with the PMO to be equivalent to compliance with the Preventive Controls−Human Food rule. Grade “B” dairy plants will be expected by the FDA to directly comply with the Preventive Controls−Human Foods rules. Wisconsin regulators operate within a nationally integrated system of food safety regulation. A key part of this integration is functional equivalence between state and federal regulations. In order to maintain state-federal integration and reduce confusion for industry over which rules must be followed, the proposed rule specifies the federal rules that must be followed by Wisconsin-licensed dairy plants.
Wisconsin dairy farm and dairy plant regulations are currently found in chs. ATCP 60 (Dairy Farms) and ATCP 80 (Dairy Plants.) The proposed rule repeals chs. ATCP 60 and 80 and consolidates and reorganizes these chapters into a new ch. ATCP 65 (Milk and Milk Products.) Consolidation of these two rule chapters will eliminate numerous, and sometimes confusing, cross-references between the two chapters. In recent years, there has been increased interest in the operation of small dairy plants on the same site as the dairy farm supplying the milk. The operators of these “farmstead” or “artisanal” dairy plants can now find most of the rules affecting their business in one chapter, rather than two. The rule revises certain existing provisions and creates new provisions, as necessary, to ensure: 1) Wisconsin’s Grade “A” and Grade “B” dairy sectors comply with the applicable PMO, FSMA, and USDA requirements when they meet Wisconsin regulatory requirements, and 2) state regulations do not unnecessarily hinder technological advancement by Wisconsin’s internationally recognized dairy industry. Revisions to modernize dairy farm and dairy plant regulations.
The following describes specific revisions made in the proposed rule to modernize and consolidate Wisconsin’s dairy farm and dairy plant regulations:
Revisions in General Terminology
Wording was changed throughout to provide greater clarity and modernize terms. For example, references to “milk haulers” were changed to “bulk milk weigher and samplers” to reflect the actual name of the license held by people who collect, sample, and transport milk. References to “inspectors” were changed to “division representatives” to reflect the broader range of staff, e.g., sanitarians, food scientists, and regulatory specialists, who may conduct inspections or investigations. References to “division” or “department” staff were also changed throughout to more clearly align the rules with the roles and duties performed by each unit. For example, division representatives conduct inspections, while the department issues, suspends, and revokes licenses. Subchapter, section, and subsection chapter titles were also revised throughout to more clearly reflect the content of the rule.
ATCP 65.01, Definitions.
• ATCP 65.01, as renumbered, includes the following revisions:
• Adds definitions for “abnormal milk,” “aseptic processing and packaging system,” “bulk tank unit,” “facility,” “grade A producer permit,” and “qualified facility.”
• Repeals and replaces definitions for “C-I-P equipment,” “C-I-P milking equipment,” and “C-I-P milk pipelines” with a definition of “C-I-P” and numbered this definition as 65.01 (9).
• Updates the definition for “dairy product” to be consistent with current statute.
• Replaces the term “food safety division” with “division.”
• Expands the definition for “grade B milk” to clarify that grade B milk is not processed into fluid milk for consumption; it is only used in the production of non-grade “A” dairy products.
• Broadens the definition for “equipment” to cover equipment used on dairy farms and in dairy plants.
• Repeals the definition from ATCP 60.01 (6) for “dairy plant” and replaces it with a modification of the definition from ATCP 80.01 (5) for “dairy plant.”
• Revises the definition of “milk” to be consistent with the PMO definition by including the phrase “practically free of colostrum, obtained by the complete milking of one or more healthy milking animals.”
• Revises the definition of “milk contractor” to indicate that a milk contractor can, while not operating an actual dairy plant, submit a milk producer license application on behalf of one or more milk producers and thereby certify that each milk producer’s dairy farm and milking operations comply with applicable requirements under this chapter.
• Expands the definition “procure milk” to clarify that procured milk must be acquired directly from a licensed milk producer.
• Clarifies that “sanitizers” shall be in compliance with 21 CFR part 178.1010 or otherwise approved by the division. • Repeals the definitions for “single-service utensil” and “single-service package” and replaced them with a definition for “single-service articles.”
ATCP 65.02, Milk producer license and permits; and fees.
ATCP 65.02 is retitled from “Milk producer license; fees” to “Milk producer licenses and permits; fees.” This section is revised to consolidate all information about the milk producer license (required for Grade “A” and Grade “B” dairy farms), Grade “A” permits, and fees from ss. ATCP 60.02, 60.03, 60.04, and 60.05. ATCP 65.02 (1) clarifies that a license is required for each milk producer, species of milk animal milked by a single milk producer, and dairy farm operated by a milk producer at which milk is produced and offered for sale. Previously, not all of these parameters were specifically mentioned.
ATCP 65.02 (2) is revised to clarify that a representative of the dairy plant or milk contractor may submit an application on behalf of a milk producer and that the dairy plant or milk contractor representative shall certify that both the dairy farm and milking operations comply with applicable requirements in this chapter.
ATCP 65.02 (4) (b) adds the due date of April 30 for paying the annual license fee.
ATCP 65.02 (4) (b) 2. specifies that the milk producer license fee is non-refundable.
ATCP 65.02 (8), “Milk produced for custom processing,” is created by consolidating existing requirements for custom processing a producer’s milk. Requirements for custom processing were not otherwise changed.
ATCP 65.02 (12) “Grade A permits at a single dairy farm operated by multiple dairy producers,” is added to describe conditions under which more than one Grade “A” milk producer permit may be held on one dairy farm.
ATCP 65.04, Dairy plant licenses and permits; fees.
ATCP 65.04 consolidates all dairy plant licensing and Grade “A” permit requirements, and fee information found in ss. ATCP 80.02, 80.04, and 80.06. ATCP 65.04 (1) (b) 1. clarifies that no dairy plant license is required for a farm manufacturing dairy products solely for the owner/operator, members of the farm household, or nonpaying farm guests, or employees.
ATCP 65.04 (1) (b) 2. exempts appropriately licensed restaurants from a dairy plant license if they prepare or process dairy products made from commercially pasteurized dairy products. However, licensed restaurants are not allowed to package Grade “A” dairy products for retail sale without a dairy plant license.
ATCP 65.04 (1) (b) 3. exempts retail food establishments licensed under s. 97.30, Stats., from a dairy plant license if they process non-Grade “A” dairy products made from commercially pasteurized dairy products solely for retail sale at the establishment. ATCP 65.04 (8) specifies that dairy plant license fees are non-refundable.
ATCP 65.08, Milkhouse.
