(g) Specifications and standards for location, construction, operation, facilities, equipment, and sanitation for any premises, establishment, or mobile facility where slaughter or processing is carried on, including custom slaughtering of livestock or poultry and custom or retail processing of meat or poultry products.
(h) Conditions of sanitation under which meat or poultry products shall be stored, transported, or otherwise handled by any person engaged in the business of buying, selling, freezing, storing, transporting, or processing meat or poultry products. 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:
The Department estimates that it will use approximately 0.20 FTE staff to develop this rule, including time required for investigation and analysis, rule drafting, preparing related documents, coordinating advisory committee meetings, holding public hearings, and communicating with affected persons and groups. The Department will use existing staff to develop this rule.
5. Description of all entities that may be impacted by the rule:
This rule will affect Wisconsin food processors who produce products other than meat, poultry, or dairy for wholesale. It will also affect persons who produce a limited amount of food products, other than meat, poultry, or dairy, at retail establishments for wholesale. The rule specifically applies to persons who do canning, both of low-acid and acidified foods, bottling of water, juice, tree products, and other beverages and food products, fish and molluscan shellfish processors, and persons performing these operations in establishments licensed under different administrative rules, yet are still bound by the requirements of ATCP 70. The rule could also help those producers market their product in interstate and international commerce and could help Wisconsin’s food processors develop and market new products.
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:
Food Safety Modernization Act -- FSMA (P.L. 111-353) was signed into law on January 4, 2011 as a comprehensive reform of the food safety system. According to FDA, FSMA addressed five major components of the food safety system, including requiring FDA to develop comprehensive, prevention-based controls across the food supply to prevent food safety problems and allowing FDA to apply inspection in a risk-based manner and adopt innovative inspection approaches. It provided new mechanisms for ensuring the safety of imported foods. FSMA also gave FDA mandatory recall authority and expanded FDA’s authority to detain food that is potentially in violation of the law and to suspend a food facility’s registration. Finally, it established tools for strengthening collaboration between federal, state and local governments by directing FDA to improve training of state and local officials. FDA has finalized several rules to implement FSMA. Most significantly for this proposed rule revision is Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR 117), which replaces Current Good Manufacturing, Packing, and or Holding Human Food (21 CFR 110). 21 CFR 117 requires certain food manufacturing facilities to develop a written food safety plan to implement a risk-based preventive control system, which includes a hazard analysis to identify potential food safety hazards and preventive control systems to minimize or eliminate hazards. This rule revision will examine 21 CFR 117 to determine the extent to which establishments covered by ch. ATCP 70 are required to comply with these federal regulations and to incorporate requirements into ch. ATCP 70 as appropriate. 21 CFR 117 also replaced certain requirements previously found in 21 CFR 110 not related to FSMA requirements. This rule revision will also evaluate ch. ATCP 70 to ensure it accurately reflects these updated guidance and requirements for Good Manufacturing Practices, Equipment and Utensil requirements, Structure and Grounds requirements, and Processing Controls as they are currently contained in 21 CFR 117. Inspection of Siluriformes Fish -- In December 2015, USDA issued new regulations for inspection of Siluriformes fish, including catfish. The 2008 Farm Bill amended the Federal Meat Inspection Act (FMIA) to include “catfish” as an amenable species under the FMIA, transferring responsibility for inspecting catfish from FDA to USDA. The 2014 Farm Bill further expanded the type of fish to be inspected by USDA to all fish of the order Siluriformes, which includes catfish among other types of fish.
Prior to the transfer, U.S. catfish processors, exporters, and importers had been subject to FDA’s seafood Hazard Analysis Critical Control Point (HACCP) regulations (21 CFR 123) and requirements under the Food, Drug, and Cosmetic (FD&C) Act (76 FR 10437). Wisconsin-licensed fish processors also must comply with FDA’s seafood HACCP regulations as cited in ATCP 70 and 71. FDA’s regulations on current good manufacturing practices (21 CFR 110) and on recordkeeping and registration requirements (21 CFR part 1, subparts H and J) also applied. Imported fish and fish products were required to come from a country with an active memorandum of understanding with FDA that ensured the product was in compliance with an equivalent foreign inspection system and that the importer had written verification that fish and fish products were processed in accordance with FDA regulations. The new USDA regulations, which went into effect March 1, 2016, adapted existing meat inspection regulations to the inspection of Siluriformes fish, with a few modifications to accommodate the difference between fish and meat. Although the new regulations transfer responsibility from FDA to USDA, the Department has been notified that inspection of Siluriformes fish will not become a component of the state’s meat inspection program, which is operated under a cooperative agreement with USDA. Nonetheless, Wisconsin plans to examine the new federal regulations to determine whether, and to what extent, Wisconsin’s food processing rules require modification to accommodate the new rules for inspection of fish of the order Siluriformes.
7. Anticipated economic impact
The Department expects the proposed rule to have only a minimal economic impact on Wisconsin’s food processing industry. Chapter ATCP 70 is an existing rule, and the focus of opening it is not to add to its scope, but to update it, reconcile it with existing rules, and clarify its provisions. Contact Person: Steve Ingham, Division of Food and Recreational Safety Administrator; Phone (608) 224-4701.
