The proposed rule harmonizes definitions with relevant federal regulations. Establishments in Wisconsin are governed by the state for their business activities, but also have oversight by the United States Department of Agriculture (USDA) and the FDA, who oversee interstate and international distribution. The updated definitions create a smooth integration with relevant federal regulations.
The proposed rule addresses current and emerging business models. Truck transfer stations, which are used by animal food processors and renderers to be more efficient and cost effective, have been added to align with s. 95.72 (8), Stats. Building requirements have been clarified to match statute. This allows registration and reciprocity by agreement with contiguous states which allows more efficient and effective business planning. The exemption for an operator of a grease processing plant that is solely engaged in the production of bio-diesel or other biofuels has been removed.
Carcass dealer registration has been removed from the rule. There have not been any registrations of carcass dealers for over thirty years, and it is not a current business practice.
Marking of vehicles has been clarified and requires the vehicle to be identified as “Inedible – Not Intended for Human Food.” This is to clearly separate and differentiate between inedible meat products and those intended as food for human consumption. The vehicles have a single use purpose limited to inedible products only.
Significant input from industry suggested that a variety of waterproof tarpaulin or other cleanable coverings could meet sanitary transport requirements for truck boxes or trailers that are leak proof, even if not fully enclosed. The rule has been modified to address the need to prevent leakage, but to allow industry to innovate to meet requirements without being overly prescriptive.
The proposed rule addresses two additional denaturants that industry has requested due to evolving technology and application of denaturants. They are liquid charcoal and a black dye; both will impart the color needed to assure the product cannot be diverted into the human food chain.
Summary of, and Comparison with, Existing or Proposed
Federal Statutes and Regulations
Title 9 of the CFR is enforced by the USDA Food Safety and Inspection Service. 9 CFR Part 325 addresses transportation and other transactions concerning dead, dying, disabled or diseased livestock, and parts of carcasses of livestock that have died other than by slaughter. Importantly, these regulations apply to livestock that are legally “in commerce” as defined by USDA. As such they may not be applicable to all Wisconsin businesses handling carcasses and carcass materials. In addition, these federal regulations do not overlap requirements of ch. ATCP 57. Title 21 of the CFR contains applicable FDA regulations, namely Subchapter E. Animal Drugs, Feeds, and Related Products. Of particular relevance, 21 CFR Part 589 address substances prohibited from use in animal food or feed. The combination of USDA and FDA regulations (9 CFR Part 325 and 21 CFR Part 589, respectively) is intended to prevent the spread of Transmissible Spongiform Encephalopathies (TSE’s; caused by prions) via animal food or feed. There is little overlap of these regulatory requirements and those of ch. ATCP 57. Regulations implementing FSMA address a broader range of hazards besides TSE-causing prions, and require animal food facilities to have a food safety plan in place that includes a hazard analysis, and the implementation of risk-based preventive controls to minimize or prevent those hazards identified as known or reasonably foreseeable. FSMA definitions found in 21 CFR Part 507 have been incorporated in this rule. Summary of Comments Received during Preliminary Comment Period
and at Public Hearing on Statement of Scope
The department held a preliminary public hearing on the Statement of Scope (SS 783A2) on March 15, 2021 and accepted public comments until March 29, 2021. The department received no oral comments during the preliminary hearings and one written comment. The department considered the comment which included the consideration of adding, expanding, clarifying or eliminating definitions. They also wanted to share that they are a global company regulated by other state and federal programs and would prefer less prescriptive rule revisions to allow industry to develop policies, practices, and safeguards that best fit the facilities and business culture. The commenter also expressed a desire to participate in the process as an industry expert.
Comparison with Rules in Adjacent States
Illinois
Illinois regulates inedible animal by-products through the Illinois Compiled Statutes, Animal Mortality Act (225 ILCS 610) and Meat and Poultry Inspection Act (225 ILCS 650). Regulations include licensing and fees, processing and handling regulations, facility standards, sanitation and labeling regulations, and enforcement provisions.
Illinois has several classifications of license depending on what materials are collected. Vehicle permits are required and the classification with specific naming conventions are required on the vehicle as well as address and business name.
Iowa
Iowa regulates inedible animal by-products through Iowa’s Code section 167 and 189a, and by Administrative Codes, Chapters 61 “Dead Animal Disposal,” and 76 “Meat and Poultry Inspection.” Regulations include licensing and fees, processing and handling regulations, facility standards, sanitation and labeling regulations, and enforcement provisions. Iowa also requires inedible carcasses, carcass materials, and products to be identified and labeled similar to the requirements in Wisconsin. Iowa has incorporated federal regulations into their program. Vehicle permits are required for vehicles used to transport carcass and carcass materials. Vehicles also are required to identify the license holder and the address.
Michigan
Michigan regulates inedible animal by-products through Act 239 of 1982 BODIES OF DEAD ANIMALS. The act includes licensing and fees, processing and handling regulations, facility standards, sanitation and labeling requirements, and enforcement provisions.
Michigan also requires vehicles used to transport carcass and carcass materials to be registered, and identification on the vehicle that the material is not intended for human consumption. Vehicles also are required to identify the license holder and the address.
Minnesota
Minnesota regulates inedible animal by-products through Minnesota Statutes section 31A “Meat and Poultry Inspection” and 35 “Animal Health,” and Minnesota Administrative rules Chapter 1540 “Meat Inspection.” Regulations include licensing and fees, processing and handling regulations, facility standards, sanitation and labeling regulations, and enforcement provisions. Minnesota addresses reciprocity in their statute with adjacent states.
Minnesota also requires inedible carcasses, carcass materials, and products to be identified and labeled similar to the requirements in Wisconsin. Minnesota incorporated 31A.21 “Cooperation with Federal Government” into their program. Vehicle permits are required for vehicles used to transport carcass and carcass materials.
Summary of Factual Data and Analytical Methodologies
Feedback on ch. ATCP 57 was solicited through an advisory committee during both the scope statement and rule development. There were approximately five meetings throughout fiscal year 2021 and 2022. We took all the information from a series of virtual public meetings into consideration during the modification of the rule. The department continually sought feedback on ch. ATCP 57 from industry stakeholders and notified license or registration holders in advance of public meetings. Analysis and Supporting Documents used to Determine Effect on Small Business or in Preparation of an Economic Impact Analysis
The department does not anticipate a significant fiscal impact from the proposed rule revisions. There may be some cost for licensing for certain, previously unlicensed, dead animal collection businesses that move into the rendering and animal food processing realms. Pursuant to current requirements for licensing in s. 95.72 (2) (c), Stats., the cost would be $100 per business per year. However, there would likely be only a small number of persons requiring such a license. Fiscal Estimate and Economic Impact Analysis
The Fiscal Estimate and Economic Impact Analysis is attached.
Effect on Small Business
The Department’s Regulatory Review Coordinator may be contacted by:
Telephone at (608) 224-5024
The Regulatory Flexibility Analysis is attached.
Department Contact Person
Paul Pierce
Division of Food and Recreational Safety
Department of Agriculture, Trade and Consumer Protection
P.O. Box 8911
Madison, WI 53708-8911
(608) 224-4731
Place Where Comments are to Be Submitted and Deadline for Submission:
Comments must be received on or before March 31, 2023 to be included in the record of rule-making proceedings. Submit comments:
By mail to:
Paul Pierce
Division of Food and Recreational Safety
Department of Agriculture, Trade and Consumer Protection
P.O. Box 8911
Madison, WI 53708-8911
(608) 224-4731
