The department proposes a comprehensive review and revision of ch.
ATCP 80, relating to the food safety oversight of dairy plants in Wisconsin. The objective of this proposed rule is to modernize current dairy plant inspection rules in order to ensure compliance with federal Food and Drug Administration's (FDA) Pasteurized Milk Ordinance (PMO), accommodate advances in manufacturing dairy products, and continue ensuring the safety and quality of Wisconsin dairy products. The department will also determine whether and the extent to which revisions are needed to harmonize Wisconsin regulations with federal risk-based preventive controls regulations implemented under the Food Safety Modernization Act.
2. Description of Existing Policies Relevant to the Rule and of New Policies Proposed to be Included in the Rule and an Analysis of Policy Alternatives; the History, Background, and Justification for the Proposed Rule
Wisconsin has more than 400 licensed dairy plants. Grade A dairy plants produce pasteurized fluid milk and milk products such as cottage cheese, cream, and yogurt made using Grade A milk from Grade A dairy farms. Grade A milk and milk products must be processed in accordance with standards in the FDA's PMO and are thereby eligible for interstate commerce. The PMO is a guidance document and ch.
ATCP 80 is in substantial compliance with it. Ninety-eight percent of the milk produced in Wisconsin is Grade A. Chapter
ATCP 80 (Dairy Plants) is a comprehensive rule designed to address the specific challenges of manufacturing milk and dairy products and ensuring that these products are high-quality and safe to consume. Chapter
ATCP 80 establishes milk bacteriological and compositional quality standards, sets pasteurization requirements, requires milk testing to measure whether these standards are met, and establishes procedures for testing milk and recording results. Chapter
ATCP 80 also requires dairy plants to keep records of information needed to monitor the safety of their products, and ensure proper financial reporting. The rule also establishes inspection and enforcement requirements, including a requirement that Grade A plants be periodically audited against federal sanitation compliance standards. Finally, ch.
ATCP 80 includes labeling requirements for dairy products not sold for human food or animal feed.
Grade B dairy plants make products not covered under the PMO such as butter, ice cream, and cheese. Grade B products may be made from either Grade A or Grade B milk. Grade B milk comes from farms that have less stringent bacteriological requirements and are inspected less frequently.
FDA revises the PMO every two years. The current ch.
ATCP 80 rules, although largely in compliance with the PMO, must be revised periodically to maintain the needed consistency with the latest version of the PMO and to adapt to new innovations in the dairy industry. For example, the most recently adopted PMO contains new requirements related to aseptic processing and packaging of dairy products which have not been incorporated in ch.
ATCP 80.
The department will consider a variety of potential rule changes which mainly, but not exclusively, involve maintaining consistency with the PMO, and relate to topics such as: the statutory definition of a dairy product; delineation of financial responsibilities for milk contractors and dairy plant operators; equipment and facility standards; evaluation of a plant's water supply; microbiological standards for different products; limits for operating a pasteurizer after a seal has been broken; and variance procedures.
As part of its overall review of ch.
ATCP 80, the department will explore provisions consistent with impending federal regulations (implemented under the Food Safety Modernization Act) that require food processing plants to conduct a hazard analysis and develop a risk-based system of preventive controls. The department may propose rule changes addressing this topic, as needed.
Policy alternatives
FDA revises the PMO every two years and the department must periodically revise ch.
ATCP 80 to ensure substantial compliance with the PMO. If the department does not alter the current rule, the rule may not remain consistent with the PMO which could eventually lead to problems when the FDA audits the Wisconsin dairy inspection program for compliance. A failing regulatory audit score could jeopardize the ability of Wisconsin dairy producers and plants to participate in the Grade “A" program and to maintain Wisconsin's reputation as the Dairy State. Current regulations may not be adequate for addressing emerging food safety issues related to dairy processing.
3. Statutory Authority for the Rule (Including the Statutory Citation and Language)
93.07 Department duties. It shall be the duty of the department:
(1) Regulations. To make and enforce such regulations, not inconsistent with law, as it may deem necessary for the exercise and discharge of all the powers and duties of the department, and to adopt such measures and make such regulations as are necessary and proper for the enforcement by the state of chs.
93 to
100, which regulations shall have the force of law.
97.09 Rules.
(4) The department may, by rule, establish and enforce standards governing the production, processing, packaging, labeling, transportation, storage, handling, display, sale, including retail sale, and distribution of foods that are needed to protect the public from the sale of adulterated or misbranded foods.
97.20 Dairy plants.
(4) Rule making. The department may promulgate rules to establish the fees required under sub. (2) (c) to (2) (w) or to govern the operation of dairy plants. The rules may include standards for the safety, wholesomeness and quality of dairy products; the construction, maintenance and sanitary operation of dairy plants; the design, installation, cleaning and maintenance of equipment and utensils; personnel sanitation; storage and handling of milk and fluid milk products; pasteurization and processing procedures; sampling and testing; and reports and record keeping. The rules may also set forth duties of dairy plants to inspect dairy farms, collect and test producer milk samples and make reports to the department.
4. Estimate of the Amount of Time that State Employees Will Spend to Develop the Rule and of Other Resources Necessary to Develop the Rule
DATCP estimates that it will use approximately 0.20 FTE staff to develop this rule. That includes time required for investigation and analysis, rule drafting, preparing related documents, holding public hearings, and communicating with affected stakeholders. DATCP will use existing staff to develop this rule.
5. Description of all Entities that may be Impacted by the Rule
Dairy plant operators will benefit from increased consistency of Wisconsin regulations with the PMO.
6. Summary and Preliminary Comparison of any Existing or Proposed Federal Regulation that is Intended to Address the Activities to be Regulated by the Rule
The proposed rule makes ch.
ATCP 80 more consistent with the PMO. Although compliance with the PMO is technically a voluntary effort by state regulatory agencies, Wisconsin is periodically evaluated by the FDA for compliance with the PMO. Failure to pass the FDA audit would jeopardize the state's interstate and international dairy industry.
7. Anticipated Economic Impact
This rule change is anticipated to have no negative impact, but a positive economic impact for Wisconsin's dairy industry. In many respects, it will make Wisconsin's regulations consistent with practices in other states, including those elsewhere in the Upper Midwest which adopt the latest version of the PMO by reference. The rule will not modify fees or have an economic impact on local governmental units or public utility taxpayers.
8. Contact Person
Steve Ingham, Division of Food Safety Administrator, DATCP
Phone: (608) 224-4701
Agriculture, Trade and Consumer Protection
This statement of scope was approved by the Governor on October 15, 2013.
Rule No.
Chapter
ATCP 60, Wis. Adm. Code (Existing).
Relating to
Dairy farms, and affecting small business.
Rule Type
Permanent.
1. Description of the Objective of the Rule
The department proposes a comprehensive review and revision of ch.
ATCP 60, relating to the inspection of dairy farms in Wisconsin. The objective of this proposed rule is to modernize current dairy farm inspection rules in order to ensure compliance with the most recent version of the Federal Food and Drug Administration's (“FDA's") Pasteurized Milk Ordinance (PMO), accommodate advances in dairying, and continue ensuring the safety and quality of Wisconsin milk. The department will also determine whether, and the extent to which, revisions are needed to improve the efficiency of Grade “A" dairy farm inspections and certain compliance procedures.
2. Description of Existing Policies Relevant to the Rule and of New Policies Proposed to be Included in the Rule and an Analysis of Policy Alternatives; the History, Background, and Justification for the Proposed Rule
Wisconsin ranks second nationally in milk production and operates the nation's largest state dairy inspection program. Wisconsin has by far the largest number of dairy farms operated by licensed dairy producers; the milk from each of these farms is shipped to one of the more than 400 licensed dairy plants in the state, or to a licensed dairy plant in another state. Chapter. ATCP 60 (Dairy Farms) lists dairy producer license and Grade “A" permit requirements, dairy farm standards, milk quality standards, procedures for examination of milk from dairy farms, and inspection and enforcement practices.
The department proposes working with industry to modernize language, definitions, and requirements for consistency with the PMO. The vast majority of dairy producers in Wisconsin have Grade “A" permits, which means that their milk, or pasteurized milk and certain other dairy products made from it, can be shipped across state and international boundaries. Milk moving in this manner, referred to as Grade “A" milk, must be produced, transported, and processed in accordance with the PMO. State regulations governing Grade “A" milk must be at least as stringent, and consistent with, the PMO. FDA revises the PMO every two years. The current ch.
ATCP 60 rules, although largely in compliance with the PMO, must be revised periodically to maintain the needed consistency with the latest version of the PMO and adapt to new innovations in the dairy industry. For example, the PMO now specifically addresses automated milking installations (“robotic" milking), while ch.
ATCP 60 does not.
The department will consider a variety of potential rule changes which relate to topics such as dairy farm water supply and well testing, reporting by dairy plants of milk quality test results, procedures and ramifications of Grade A permit suspension, variance procedures, robotic milking, and review of plumbing projects and dairy farm equipment installations. The department will also work with industry to determine whether changes in the Somatic Cell Count (SCC) standard in ch.
ATCP 60 are needed for Wisconsin to maintain a competitive position in national and international dairy markets.
As part of its overall review of ch.
ATCP 60, the department will explore alternatives, consistent with the PMO, for conducting Grade A farm inspections more efficiently. The department will also re-evaluate rules that require progressive corrective actions to be taken by dairy producers. For example, the department will assess the adequacy of the current rule specifying a corrective action to be taken after the first milk sample yielding a positive drug residue result. The department may also evaluate whether ch.
ATCP 60 provides adequate milk safety regulatory oversight when cattle sold for slaughter by a dairy producer are found to contain drug residues. The department may propose rule changes addressing these topics, as needed.
Policy alternatives
FDA revises the PMO every two years and the department must periodically revise ch.
ATCP 60 to incorporate changes to ensure compliance with the PMO. If the department does not alter the current rule, the rule may not remain consistent with the PMO, which could eventually lead to problems when the FDA audits the Wisconsin dairy inspection program for compliance. A failing regulatory audit score could jeopardize the ability of Wisconsin dairy producers and plants to participate in the Grade “A" program and to maintain Wisconsin's reputation as the Dairy State. Current regulations may not be adequate for addressing emerging economic and food safety issues related to dairy farming. For example, maintaining the current SCC standard may result in many of the state's Grade “A" dairy producers trying to meet different SCC standards if they export Grade “A" dairy products to countries with a more stringent SCC standard than the one currently in place in ch.
ATCP 60. Without a rule revision, the department would continue trying to enforce rules that were designed for more traditional milking operations without consideration of innovative dairying practices such as robotic milking. Finally, if the current rules are not revised, the department may miss opportunities to improve the cost-effectiveness of on-site dairy farm inspections.
3. Statutory Authority for the Rule (Including the Statutory Citation and Language)
93.07 Department duties. It shall be the duty of the department:
(1) Regulations. To make and enforce such regulations, not inconsistent with law, as it may deem necessary for the exercise and discharge of all the powers and duties of the department, and to adopt such measures and make such regulations as are necessary and proper for the enforcement by the state of chs.
93 to
100, which regulations shall have the force of law.
97.09 Rules.
(4) The department may, by rule, establish and enforce standards governing the production, processing, packaging, labeling, transportation, storage, handling, display, sale, including retail sale, and distribution of foods that are needed to protect the public from the sale of adulterated or misbranded foods.
97.22 Milk producers.
(8) Rule making. The department may promulgate rules to establish the fees required under sub. (2) (b) or (4) (a) or to govern the operation of dairy farms by milk producers. The rules may include standards for any of the following:
(a) The safety, wholesomeness and quality of milk.
(b) The sanitary construction and maintenance of dairy farm facilities used in milk production.
(c) The availability of safe and adequate water supplies for milk production.
(d) The sanitary construction, maintenance and cleaning of equipment and utensils used in milk production.
(e) Personnel sanitation related to milk production.
(f) Sanitary procedures for the production of milk, including but not limited to the handling, transfer, and storage of milk on a dairy farm.
4. Estimate of the Amount of Time that State Employees Will Spend to Develop the Rule and of Other Resources Necessary to Develop the Rule
DATCP estimates that it will use approximately 0.20 FTE staff to develop this rule. That includes time required for investigation and analysis, rule drafting, preparing related documents, holding public hearings, and communicating with affected stakeholders. DATCP will use existing staff to develop this rule.
5. Description of all Entities that may be Impacted by the Rule
Dairy producers and dairy plant operators will benefit from increased consistency of Wisconsin regulations with the PMO. Consumers and the department will benefit from greater cost-effectiveness in conducting on-site dairy farm inspections.
6. Summary and Preliminary Comparison of any Existing or Proposed Federal Regulation that is Intended to Address the Activities to be Regulated by the Rule
The proposed rule makes ch.
ATCP 60 more consistent with the PMO. Although compliance with the PMO is technically a voluntary effort by state regulatory agencies, Wisconsin is periodically evaluated by the FDA for compliance with the PMO. Failure to pass the FDA audit would jeopardize the state's interstate and international dairy industry.
7. Anticipated Economic Impact
This rule change is anticipated to have no negative impact, but a positive economic impact for Wisconsin's dairy industry. In many respects, it will make Wisconsin's regulations consistent with practices in other states, including those elsewhere in the Upper Midwest which have adopted the latest version of the PMO by reference. The rule will not modify fees or have an economic impact on local governmental units or public utility taxpayers.
8. Contact Person
Steve Ingham, Division of Food Safety Administrator, DATCP
Phone: (608) 224-4701
Agriculture, Trade and Consumer Protection
This statement of scope was approved by the Governor on October 15, 2013.
Rule No.
Chapters ATCP 93 (existing as ch. SPS 310 — to be renumbered by LRB) and 94 (existing as ch. SPS 348 — to be renumbered by LRB); sections SPS 305.02, 305.06, 305.68, and 305.82 to 305.89, Wis. Adm. Code.
Relating to
Flammable, Combustible and Hazardous Liquids; and Petroleum and Other Liquid Fuel Products.
Rule Type
Permanent.
1. Description of the Objective of the Rule
1.1 Incorporating programs transferred from DSPS
With the enactment of
2013 Wisconsin Act 20 (the biannual budget bill), the state of Wisconsin transferred the
Flammable, Combustible and Hazardous Liquids program (“tanks inspection program") and
Petroleum and Other Liquid Fuel Products program (“petroleum inspection program") from the Department of Safety and Professional Services (“DSPS") to the Department of Agriculture, Trade and Consumer Protection (“DATCP"). Act 20 authorizes the transfer of existing administrative rules relating to these programs from DSPS to DATCP (with the approval of the Secretary of the Department of Administration). [See Section 9138, (2) (fm) and (4) (f).] The Legislative Reference Bureau will use its authority to renumber the affected rules from Chapters
SPS 310 and
348 to Chapters
ATCP 93 and
94.
Other aspects of the transfer must be addressed through administrative rulemaking. DATCP intends to initiate rule revisions to make technical and organizational changes to the portions of chs.
SPS 302 and
305 that relate specifically to the tanks and petroleum inspection programs. Chapters
SPS 302 and
305 also contain general administrative provisions (licensing, enforcement, etc.) that relate to a wide variety of DSPS regulatory programs. DATCP will consider incorporating similar provisions directly into Chs.
SPS 310 and
SPS 348 as necessary to administer the tanks and petroleum inspection programs. These changes will integrate the tanks and petroleum inspection programs into DATCP's other regulatory programs and will provide clarity to regulated industries.
1.2 Updating existing rule relating to tanks
Before these programs were transferred to DATCP (effective July 1, 2013), tanks inspection program staff and DSPS legal staff had been actively working on rule changes to SPS 310. The scope statement for this rulemaking was published in January, 2011. A working draft of a proposed rulemaking order has been transferred to DATCP. DATCP intends to evaluate and further develop this draft and incorporate many of the proposed changes into this rulemaking project. The proposed revisions would make numerous minor technical changes to the rule to make it more readable and practical. The proposed revisions would also bring the rule into alignment with current EPA standards and current generally accepted industry practices.
DATCP will also consider updating the fee structure for underground storage tank permits to conform to other DATCP licensing and permit programs. Currently, there is no financial penalty for tank operators who fail to file permit renewals by the annual expiration date. Many similar DATCP programs incorporate a late surcharge or other penalty.
1.3 Updating existing rule relating to petroleum and other liquid fuel products.
Chapter
SPS 348 incorporates by reference ASTM standards for fuel specifications and testing procedures. Many of the standards referenced in the current version of SPS 348 are from 2007 or 2008. DATCP will consider updating these references to more recent versions of the ASTM standards. The more recent standards for gasoline require gasoline to meet specifications after ethanol is mixed into the gasoline.
