Rules Clearinghouse No. 17-073 December 11, 2019
PROPOSED ORDER
OF THE WISCONSIN DEPARTMENT OF AGRICULTURE,
TRADE AND CONSUMER PROTECTION
ADOPTING RULES
The Wisconsin department of agriculture, trade and consumer protection hereby proposes the following rule to repeal and recreate ATCP 70 relating to food processing plants, and affecting small business.
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Analysis Prepared by the Department of Agriculture, Trade and Consumer Protection
This rule repeals and recreates Wis. Admin Code ch. ATCP 70 (Food Processing Plants.) The rule is necessary to update and clarify Wisconsin’s food processing plant standards, and to incorporate new federal requirements designed to improve the nation’s food safety system.
Statutes Interpreted
Statutes Interpreted:
- Wis. Stat. § 97.29, “Food processing plants.” - Wis. Stat. § 97.30, “Retail food establishments.” - Wis. Stat. § 97.34, “Bottled drinking water and soda water beverage; standards; sampling and analysis.” - Wis. Stat. § 97.42, “Compulsory inspection of livestock or poultry, and meat or poultry products.” - Wis. Stat. § 97.605, “Lodging and vending licenses.” - Wis. Stat. § 97.61, “Vending machine commissary outside the state.” Statutory Authority
Explanation of Statutory Authority
The Wisconsin Department of Agriculture, Trade and Consumer Protection (“DATCP”) has broad general authority, under Wis. Stat. § 93.07 (1), to adopt rules to implement programs under its jurisdiction. DATCP also has general authority under Wis. Stat. § 97.09 (4) to adopt rules specifying standards to protect the public from the sale of adulterated or misbranded foods. DATCP has specific authority, under Wis. Stat. § 97.29 (5), to adopt rules establishing fees; setting facility construction and maintenance standards; and setting rules for the design, installation, maintenance, and cleaning of equipment and utensils; personnel sanitation; food handling and storage; sanitary production and food processing; and food sources and food labeling.
Related Statutes and Rules
21 CFR 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk based Preventive Controls for Human Food, is a critical foundation for the current rule. Related Wisconsin administrative rules include those pertaining to retail food establishments (Wis. Admin. Code ch. ATCP 75 and the Appendix to that rule); dairy plants (Wis. Admin. Code ch. ATCP 65), food warehouses (Wis. Admin. Code ch. ATCP 71), and meat and poultry establishments (Wis. Admin. Code ch. ATCP 55).
Plain Language Analysis
The proposed rule updates Wis. Admin. Code ch. ATCP 70 by adopting certain federal regulations that implement the requirements of the federal Food Safety Modernization Act (“FSMA”) for facilities subject to the new requirements. Specifically, the revised rule incorporates multiple subparts of 21 CFR 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk based Preventive Controls for Human Food, which has superseded 21 CFR 110, Current Good Manufacturing Practice in Manufacturing, Packaging, or Holding Human Food. The subparts of 21 CFR 117 pertain to preventive food safety systems, and have already been referenced in Wis. Admin. Code chs. ATCP 65 (Milk and Milk Products) and ATCP 71 (Food Warehouses and Milk Distributors). Since the majority of Wisconsin federally-registered food facilities subject to 21 CFR 117 are licensed as food processing plants, this rule features similar referencing to inform affected businesses. This revision also ensures that the requirements for Wisconsin-licensed food processing plants that are not subject to the federal rule, are clearly articulated.
The transfer of the Department of Health Services’ (DHS) Food Safety and Recreational Licensing program to DATCP’s Division of Food Safety necessitated the merger of two food safety regulatory systems. One regulatory issue was particularly in need of resolution: Restaurant operators were not allowed to wholesale food under the DHS regulation, while retail food establishment operators under DATCP’s authority could engage in a limited amount of wholesaling without holding a food processing plant license. By statute, restaurants are now licensed as retail food establishments and therefore also enjoy the same limited ability to wholesale food. In the current rule-making process, DATCP initially proposed to retain certain existing limits and requirements from its prior rule concerning food processing activities for wholesale conducted by a retail food establishment. The Board of Agriculture, Trade and Consumer Protection (“Board”) approved a draft rule reflecting this approach at its January 2018 meeting. This final draft also for the first time included definitions of “wholesale” and “retail”. However, after the Board meeting, it became apparent that industry participants felt that less restrictive limits and definitions would still adequately protect public health.
As a result of this feedback, DATCP formed a work group comprised of industry personnel and local health department agent program representatives. The group was tasked with further revision of the rule. During deliberations, the work group concluded that the safety of many wholesale food processing activities, when performed by retail food establishments, could be ensured by compliance with Wis. Admin. Code ch. ATCP 75 and the appendix thereto, Wisconsin Food Code. Thus, compliance with the additional requirements in Wis. Admin. Code ch. ATCP 70 was unnecessary. The work group recognized that additional training would be needed for local health department agent personnel, as well as DATCP sanitarians, who were assigned to retail food establishments performing these wholesale food processing activities. DATCP, as part of its ongoing mission to thoroughly train food safety personnel at the state and local level, is committed to providing both the necessary initial training and ongoing technical support.
The work group’s efforts culminated in a newly revised final draft of Wis. Admin. Code ch. ATCP 70 that redefined “wholesale” and “retail”, clarified the exemption for retail food establishments from the requirement to hold a food processing plant license when conducting limited (not more than 25% of gross annual food sales) wholesale food processing activities, and redrew the boundaries for permitted types of wholesale food processing activities. Perhaps the most salient change was that a transfer of food between two food processing plants or retail food establishments is not regarded as wholesaling, as long the two businesses involved are operated by the same licensed entity, and the firm transferring the food does not relinquish control of the food. This change reflects current guidance from the United States Food and Drug Administration (“FDA”) and the United States Department of Agriculture, Food Safety and Inspection Service.
The revised definitions of “wholesale” and “retail” reflect industry practice and the current interpretation of these terms in the marketplace, as well as FDA’s recent guidance and its sanction of industry practice. The revised definitions also appear in the pending revision to Wis. Admin. Code ch. ATCP 75 (Retail Food Establishments). While the revised rule continues to prohibit retail food establishments from processing canned low-acid or acidified foods for wholesale without holding a food processing plant license and complying with Wis. Admin. Code ch. ATCP 70 requirements, DATCP expects the other updates to clarify and facilitate enhanced business opportunities for retail food establishments in Wisconsin.
Another theme of early discussions of the proposed rule revision was the question of whether additional regulations were necessary to ensure sanitary conditions in food processing plants sharing a building with a residence. The initial draft of the revised rule forbade the licensing of any new or remodeled food processing plant in this situation. However, the working group agreed there was no need for an outright ban or other additional regulation to ensure adequate separation between residential and processing activities or access for DATCP inspections. Accordingly, the proposed revision was deleted.
In addition to resolving these complex issues, the revised rule makes several other changes. The rule adopts the Model Ordinance for molluscan shellfish, now marine shellfish, with the Ordinance replacing all of Wis. Admin. Code s. ATCP 70.21 except for the existing subsection addressing illnesses and outbreaks associated with shellfish. This modification will keep Wisconsin’s regulations current with national standards for shellfish processing and marketing.
This revised rule also:
- Updates the definition of “food processing” to include the activities of a vending machine commissary.
- Updates the definition of “food processing plant” to conform to the statutory definition.
- Clarifies the definition of extended runs, i.e., continuous processing not interrupted by daily cleaning and sanitizing, and the scope of waivers allowing those runs, while clarifying and expanding the list of food processing activities during which daily cleaning and sanitizing are not required. The duration and review of such waivers are also defined.
- Updates certain outdated restrictions on hot-smoked, vacuum-packed fish. Previous requirements were unique to Wisconsin whereas the updates mirror requirements in other states and are based on current FDA guidance.
- Mandates filing and obtaining process-authority approval for processes used in the preparation of canned acidified or low acid foods.
- Enables food processing plants to obtain waivers from DATCP for variances to allow non-standardized and innovative equipment, utensil, processes and procedures. Prior to this revision, waivers and variances could only be obtained by food processing plants for structural and equipment issues. Waivers related to facility construction do not have an expiration date while waivers related to equipment, utensils, processes, procedures, and alternative cleaning and sanitizing frequencies are for a period of five years, but do not expire until the department takes action on a request for reissuance as long as the license holder makes a timely application for reissuance.
- Updates and clarifies language pertaining to the standards for, and testing of, operations water and ingredient water used in the various bottling and processing operations in Wisconsin, as well as finished product sampling and analysis for bottling establishments.
- Expands the scope of bottling rules to encompass more than bottled water and soda, thereby keeping pace with this rapidly changing and innovative segment of the bottling industry.
- Maintains the regulatory floor of $25,000 in sales for food processing plants that are required to pay the canning license fee surcharge.
- Clearly specifies requirements exempted by so-called “grandfather clauses,” that apply to a continuing license-holder who does not increase processing area dimensions (floor-wall junctions, floor drainage, and service sink or curbed drain); install, substantially reconstruct, or extensively alter toilet facilities (separately vented to the outside, equipped with an exhaust fan capable of creating a negative pressure, and do not open directly into a food processing area); install, substantially reconstruct, or extensively alter hand-washing facilities for toilet rooms (tempered or hot-cold mixed water, non-hand operated faucets) or for food processing areas (not located in the food processing area, tempered or hot-cold mixed water, non-hand operated faucets); or install a warewashing sink (3 compartments).
- Requires license holders that install toilet rooms after the effective date of the rule and food processing plants that are initially licensed or licensed to a new operator after the effective date of the rule to have toilet rooms contiguous with the food processing plant.
Federal and Surrounding State Programs
Federal Programs
The major federal regulations implementing FSMA and applicable to food processing plants are found in 21 CFR 117. Other federal regulations apply to canned low acid (21 CFR 113) and acidified (21 CFR 114) foods, seafood processing (21 CFR 123) and juice processing (21 CFR 120). Current language on the molluscan shellfish program was deleted in order to adopt the Federal Model Ordinance, applicable to marine shellfish shipped for wholesale, in order to provide that segment of the Wisconsin food industry with regulatory consistency within interstate commerce.
Surrounding State Programs
Michigan, Iowa, and Minnesota license and regulate food processing facilities within their borders as Wisconsin does. Illinois food processors are regulated only by the FDA. Wisconsin, Illinois, and Michigan also have state programs for the National Shellfish Sanitation Program which allows them to receive, process, and ship shellfish interstate.
Data and Analytical Methodologies
In order to identify potential changes to the rule, DATCP reviewed recent changes in FDA regulations such as those implementing FSMA, FDA guidance on the applicability of Hazard Analysis and Critical Control Point (“HACCP”) requirements for juice and seafood processors; Wisconsin statutes and rules for food processing plants, retail food establishments, meat establishments, and dairy plants; and current industrial practices. Upon learning of industry concerns about proposed licensing and regulatory requirements for retail food establishments conducting food processing for wholesale activities, DATCP delayed further consideration of the rule and convened a collaborative work group comprised of industry and local health department agent personnel to review and revise the requirements. The work group’s conclusions are reflected in the present revised rule.
