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 Controls−Human Foods rule, implements provisions of the FSMA. Food warehouses generally are food facilities as defined under FSMA and the Preventive Controls−Human 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.
Comparison with Rules in Adjacent States
Iowa and Minnesota
Iowa and Minnesota license and regulate food warehouses as food processing plants. Minnesota issues many food warehouse operators a Wholesale Food Handler License, while cold storage facilities must hold a Wholesale Food Processor or Manufacturer License (Chapter 28A, Minnesota Statues). Iowa licenses food warehouses as Food Processing Plants under Chapter 137F, Iowa Code. Dry food storage, refrigerated storage, frozen storage, and repackaging/relabeling are listed as facility subcategories for food warehouses on the Iowa Food Processing Plant License application form. Unlike in Wisconsin, a food warehouse operator who also conducts food processing in either Iowa or Minnesota would hold one license that would cover both warehouse and processing activities. The license fees in both states are determined based on the overall value of the food processed and stored. Both Iowa and Minnesota adopt 21 CFR 110 (Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food), and inspect warehouses for compliance with requirements therein related to basic sanitation, facility and equipment, and personnel. The Preventive Controls−Human Food rule implementing FSMA will replace 21 CFR 110 with Subpart B (Current Good Manufacturing Practice) of 21 CFR 117. Neither Iowa or Minnesota participate in the Interstate Shellfish Sanitation Conference (ISSC) and therefore businesses in these states cannot store, sort, shuck, repack, or otherwise process molluscan shellfish for interstate commerce. Wisconsin is a member of ISSC and has regulations for processing of shellfish for interstate commerce.
Illinois
Illinois does not currently require licensing of food warehouses or food processing plants. Illinois has specific statutory requirements for cold storage facilities, but other food storage facilities are treated as food processing plants. While the Illinois Department of Public Health oversees food processing plants, including most food warehouses, the Illinois Department of Agriculture is responsible for regulating refrigerated warehouses. Illinois’ food warehouse regulations are described in “Manufacturing, Processing, Packing or Holding of Food Code,” which is found in Part 730 of Title 77 (1) (m) of their administrative code.
Illinois is a participant in the ISSC and regulates the processing of molluscan shellfish for interstate commerce.
Michigan
Under the Michigan Food Law, Michigan defines a food warehouse as a food establishment that “stores or distributes prepackaged food, including a small or large food warehouse, distribution center, transfer station, public cold storage facility, or reclamation center.” Michigan requires food warehouse operators to hold a separate food warehouse license, and, like Iowa and Minnesota, regulates food warehouses under adopted federal regulations (21 CFR 110). Like Illinois, Michigan is an ISSC member and has promulgated regulations related to molluscan shellfish processing for interstate commerce.
Summary of Factual Data and Analytical Methodologies
Proposed rule changes were developed after consultation with industry, a review of federal requirements, and a review of practices in neighboring states.
Analysis and Supporting Documents used to Determine Effect on Small Business
We determined the effect on small business after contacting industry and reviewing licensing data within the Department’s records.
Effect on Small Business
This rule change is expected to have a small economic impact on warehouse operators storing fish, fishery products, or molluscan shellfish, as some will have to devote time and resources to obtain HACCP training, conduct a hazard analysis, and, if indicated, develop and follow a HACCP plan. Some warehouse operators will have to obtain no-fee licensee dealer certification if they engage in specified activities with molluscan shellfish destined for interstate commerce. The exemption from obtaining a separate food processing plant license, in addition to a food warehouse license, for repacking of already-packaged foods, may reduce the economic burden on small businesses.
DATCP Contact
Peter Haase, Director
Bureau of Food Safety and Inspection
Department of Agriculture, Trade and Consumer Protection
P.O. Box 8911
Madison, WI 53708-8911
Telephone: (608) 224-4711
_____________________________________________________________________________
Section 1. ATCP 70.03 (7) (f) is created to read:
(f) A licensed food warehouse under s. 97.27, Stats., at which one or more of the following activities are the only food processing activities performed: 1.
Repacking molluscan shellfish, provided that the licensed warehouse operator holds a licensee dealer certification as required under ATCP 70.21 (2), that annual inventory value of molluscan shellfish repacked at the licensed warehouse does not exceed 25% of the gross annual inventory value of the food warehouse, and the licensed food warehouse meets all of the applicable requirements of ATCP 70.21. 2.
Packing food items that are already packaged and labeled for retail sale into containers for further distribution. 3.
Combining two or more food items that are already individually packaged and labeled for retail sale into a combination package for retail sale, if the label on each individual item inside the combination package remains visible or if the package of combined items is labeled for retail sale. All packaging and labels shall comply with ATCP 70.10. 4.
Manufacturing ice for use in the shipment of foods, or to cool or keep foods cold while in transit or stored in the warehouse. Ice used for this purpose must meet the standards in ATCP 70.07 (8). Ice must be made on site in a commercial ice machine and may not be bagged, distributed or sold separately from food items that it is used to cool. Section 2. ATCP 70.18 (2) is amended to read:
(2) Raw or pProcessed fish that is packaged in reduced-oxygen packaging, as defined in sub. ATCP 70.02 (22n), shall immediately be refrigerated to a temperature of 38° F. (3° C.) or below, and shall be kept at or below that temperature until sold to consumers at retail, unless one of the following applies:
Section 3. ATCP 70.19 (1) (d) is amended to read:
