DATCP Docket: 19-R-09
Clearinghouse Rule: 23-003
Final Rule
April 21, 2023
THE DEPARTMENT OF AGRICULTURE, TRADE AND CONSUMER PROTECTION’S PROPOSED ORDER TO ADOPT PERMANENT RULES
PROPOSED ORDER
The Wisconsin Department of Agriculture, Trade and Consumer Protection proposes an order to repeal ss. ATCP 57.10 (9), 57.12 (8) (f), (10), 57.14 (7) (f), 57.16 (5) (f); amend ss. ATCP 57.10 (2) (j) (note), (7), (11), 57.12 (1) (b) (note), 57.12 (2) (j) (note), (7) (a), 57.14 (2) (g) (note), (7) (a), 57.16 (2) (i) (note), (5) (a), 57.20 (2) (c) (note), (4), 57.26 (3) (a); repeal and recreate ss. ATCP 57.01, 57.18; and create ss. ATCP 57.10 (1m), 57.12 (1m), 57.14 (1m), (2) (h), 57.20 (3) (c), 57.22 (3) (gg) and (r); relating to Inedible Animal By-Products.
Analysis Prepared by the Department of Agriculture, Trade and Consumer Protection
Statutes Interpreted: s. 95.72, Stats. Explanation of Agency Authority
Subsection 95.72 (2), Stats., provides statutory authority for the licensing of businesses that collect or process dead animals as a renderer, animal food processor, grease processor, or collector. Subsection 95.72 (5), Stats., gives the department specific rulemaking authority for the “collection, transportation, processing, rendering and disposal of dead animals, entrails and paunch materials, the slaughtering of animals for animal food processing or rendering, the location, construction and maintenance of all buildings, facilities and equipment used in collecting, slaughtering and processing operations, the sale or use of dead animal products as food for animals, the issuance of licenses or permits and other rules for the conduct of operations subject to a license under this section.”
Related Statutes and Rules
Plain Language Analysis
A revision of ch. ATCP 57 is necessary, due to changes in business practices, and updates to the Code of Federal Regulations (CFR) which include the implementation of definitions from the United States Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), related to the production of animal feed. 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.
