DATCP Docket No. 14-R-11
Rules Clearinghouse No. 15-093
ORDER
OF THE WISCONSIN DEPARTMENT OF AGRICULTURE,
TRADE AND CONSUMER PROTECTION
ADOPTING RULES
The Wisconsin department of agriculture, trade and consumer protection hereby adopts the following rule to renumber ATCP 71.01 (6m), to amend ATCP 71.05 (7) (a), 70.18 (2) and 70.19 (1) (d); and to create ATCP 70.03 (7) (f), 71.01 (2m), 71.01 (6c), (6d), (6p), and (6t), 71.025, 71.02 (11), and 71.05 (8); relating to food warehouse and food processing plant licensing and operation, and affecting small business.
Analysis Prepared by the Department
of Agriculture, Trade and Consumer Protection
This proposed rule modifies current food warehouse rules to clarify which types of food processing activities in a food warehouse do not obligate a licensed food warehouse operator to obtain a separate food processing plant license. The proposed rule harmonizes the food warehouse refrigeration temperature requirements for eggs, dairy products, fish, and fishery products in reduced-oxygen packaging, and molluscan shellfish with the requirements found in other rules. To reduce confusion about which federal food safety regulations must be followed by food warehouse operators, the proposed rule adopts federal regulations by reference for certain types of food warehouses, and indicates that other food warehouses can qualify for an exemption from most requirements of the new Federal Preventive Controls−Human Food rule.
Statutes Interpreted
Statutes Interpreted: ss. 97.27, Stats. (Food warehouses), and 97.29, Stats. (Food processing plants).
Statutory Authority
Statutory Authority:   ss. 93.07 (1), 97.09 (4), 97.27 (5), and 97.29 (5), Stats.
Explanation of Statutory Authority
The Department of Agriculture, Trade and Consumer Protection (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 to promulgate rules related to food warehouses under s. 97.27 (5), Stats., which allows the Department to establish rules related to licensing fees and sanitary operation of food warehouses, such as standards for construction and maintenance of food storage facilities, record-keeping requirements, and temperature requirements. The Department also has specific authority to promulgate rules related to the sanitary operation of food processing plants under s. 97.29 (5), Stats.
Related Statutes and Rules
Wisconsin’s food warehouses and food processing plants are governed by ch. 97, Stats. (Food Regulation). Food warehouses are governed by s. 97.27, Stats., and food processing plants are governed by s. 97.29, Stats. Chapter ATCP 70, Wis. Adm. Code, interprets ch. 97, Stats., as it relates to food processing plants and Ch. ATCP 71, Wis. Adm. Code, interprets state statutes relating to food warehouses.
Plain Language Analysis
This proposed rule does all of the following:
Adds definitions for “licensee dealer,” a term applicable to the regulation of molluscan shellfish, and defined already in s. ATCP 70.21 (s); “Hazard Analysis Critical Control Point (HAACP) system” and “package” to s. ATCP 71.01.
Modifies s. ATCP 70.03 to specify molluscan shellfish-handling activities that may be done in a food warehouse, under a no-fee licensee dealer certification issued under s. ATCP 70.21 (2), and for which a separate food processing plant license is not required.
Creates new exemptions allowing a licensed food warehouse to do the following without a food processing plant license: 1) re-pack foods that are already packaged and labeled for retail sale into containers for further distribution, 2) combine two or more individually packaged and labeled food items into a combination package for retail sale, and 3) manufacture ice that is used for temperature control of food during shipment or storage.
Requires the operator of a licensed food warehouse that stores fish, fishery products, or molluscan shellfish to operate under a HACCP system.
Harmonizes the food warehouse refrigeration temperature requirements for eggs, dairy products, fish, and fishery products stored in reduced-oxygen packaging, and molluscan shellfish with the requirements found in ch. ATCP 88 (Eggs), ch. ATCP 65 (Milk and Milk Products), and ch. ATCP 70 (Food Processing Plants). This harmonization will reduce confusion for some food warehouse operators who store only the afore-mentioned products.
Modifies ss. ATCP 70.18 (2) and ATCP 70.19 (1) (d) to reflect current science on safe refrigeration temperatures for raw and processed fish and hot-smoked fish, in reduced-oxygen packaging.
Clarifies which portions of federal regulations implementing the Federal Food Safety Modernization Act (FSMA) must be followed by Wisconsin-licensed food warehouse operators.
Summary of, and Comparison with Existing or Proposed Federal Statutes and Regulations
This proposed rule revision will ensure Wisconsin’s requirements are consistent with U.S. Food and Drug Administration (FDA) regulations and expectations for minimizing food safety hazards, while reducing the state regulatory burden on some food warehouse operations.
Fish and fishery products regulations enforced by FDA require processors of these foods to conduct a hazard analysis and, if indicated, develop and follow a HACCP plan, i.e., implement a HACCP system. In developing a seafood HACCP plan, a processor identifies key food processing steps essential for ensuring safety and spells out how to monitor and document that each of these key steps is functioning properly and minimizing food safety risks. As part of their hazard analysis, processors are required by 21 CFR 123.6 (c) (1) to identify preventive measures for food safety hazards that could arise from contamination with microbiological, chemical, or physical hazards. Contamination of stored product may occur in a food warehouse if appropriate sanitary controls are not maintained, so a food warehouse holding fish and fishery products generally must operate in accordance with a HACCP plan.
The FDA recently published a final rule revising the agency’s definitions of current good manufacturing practice and requiring “food facilities” to implement Hazard Analysis and Risk-Based Preventive Controls. This rule, known as the Preventive ControlsHuman Foods rule, implements provisions of the FSMA. Food warehouses generally are food facilities as defined under FSMA and the Preventive ControlsHuman Foods rule. However, several exemptions and modified requirements may apply. A food warehouse that meets the FDA definition of a “qualified facility,” generally one that sells a small volume of food predominantly to consumers or retail food establishments, must only submit an attestation of its status to FDA and then comply with state regulations. A food warehouse that is subject to the FDA seafood HACCP regulations need not meet requirements to implement a food safety plan and supply chain management practices. A warehouse that is not subject to the FDA seafood HACCP regulations, and sells only unexposed packaged foods, also does not have to implement a food safety plan and supply chain management practices. However, if a food warehouse in this category is storing packaged foods for which time and temperature control are required to ensure product safety and wholesomeness, the food warehouse operator must develop and implement a temperature control and documentation system as defined in the rules. A food warehouse storing exposed food is required to implement a food safety plan and supply chain management practices. The proposed rule cites the pertinent sections of the FSMA rule so that Wisconsin-licensed food warehouse operators know what federal requirements they must meet.
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Links to Admin. Code and Statutes in this Register are to current versions, which may not be the version that was referred to in the original published document.