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:
(d) If hot-smoked fish contained in the package reduced-oxygen packaging as defined in sub. ATCP70.02 (22n) are sold or distributed in an unfrozen state, the words “PERISHABLE – KEEP REFRIGERATED AT OR BELOW 38° F.” in conspicuous letters at least the size of those used in the food name.
Section 4. ATCP 71.01 (2m) is created to read:
Section 5. ATCP 71.01 (6c), (6d), (6p) and (6t) are created to read:
(6c) “HACCP system” means the process of analyzing food manufacturing or storage for food safety hazards, and developing and implementing a written hazard analysis and critical control points plan in accordance with 21 CFR, part 123.6 – 123.9. (6d) “Licensee dealer” means the operator of a food processing plant or food warehouse licensed in Wisconsin for the activities of shellstock shipper, shucker-packer, repacker, or reshipper.
(6p) “Package” has the meaning given in ATCP 90.01(16).
ATCP 71.01 (6t) “Qualified facility” has the meaning given in 21 CFR 117.3. Section 6. ATCP 71.01 (6m) is renumbered as ATCP 71.01(6h).
Section 7. ATCP 71.025 is created to read:
71.025 Shellfish licensee dealer certification. No person may operate as a shellfish licensee dealer without a valid annual certificate issued by the department under ATCP 70.21. A certificate is issued annually by the department under ATCP 70.21 (3).
Section 8. ATCP 71.02 (11) is created to read:
(11) Federal requirements. (a) A food warehouse which is also a qualified facility shall comply with the requirements of this chapter and 21 CFR 117.5(a). (b) A food warehouse that is a facility, but is not a qualified facility, and only stores unexposed packaged potentially hazardous food shall comply with the requirements of this chapter, and 21 CFR 117.7 and 117.206. (c) A food warehouse that is a facility, but is not a qualified facility, and stores exposed food shall comply with the requirements of this chapter and 21 CFR 117, Subparts C and G. Section 9. ATCP 71.05 (7) (a) is amended to read:
(a) Potentially hazardous refrigerated food stored at a food warehouse shall at all times be kept refrigerated at a temperature of 40°F. (4°C.) or below, except:
1.
Eggs shall be kept refrigerated at an ambient temperature of 45°F. (7°C.) or below.2.
Dairy products as defined in s. 97.20 (1) (b) 1. through 5., Stats., shall be kept at 45 ° F. (7° C.) or below.3.
Fish and fishery products in reduced-oxygen packaging as defined in sub. ATCP 70.02 (22n) shall be kept at or below 38° F (3° C.), in accordance with s. ATCP 70.18 and s. 70.19. 4.
Molluscan shellfish shall be iced or refrigerated to the extent necessary to maintain internal shellstock temperature as required in s. ATCP 70.21, and5.
Potentially hazardous frozen food shall at all times be kept frozen at a temperature of 5°F. (-15°C.) or below.Section 10. ATCP 71.05 (8) is created to read:
(8) Fish or fishery products haccp system required. A licensed food warehouse that engages in the storage of fish as defined in 21 CFR 123 (d), fishery products as defined in 21 CFR 123.3 (e), or molluscan shellfish as defined in 21 CFR 123.3 (h) shall operate under a seafood HACCP system in accordance with the applicable requirements in Subch. IV, ATCP 70.
Section 11. Effective date and initial applicability. This rule takes effect on the first day of the month following publication in the Wisconsin administrative register, as provided under s. 227.22(2)(intro.).
