With DATCP’s Division of Food Safety merger with the Department of Health Services’ (DHS’) Food Safety and Recreational Licensing (“FSRL”) Section to form the new Division of Food and Recreational Safety (“DFRS”), DATCP’s authority, pursuant to ch. 97, Stats., currently includes responsibilities for the related administrative rules covering all retail food establishments, including restaurants, dairy plants, warehouses, and meat and poultry processing.
Plain Language Analysis
DATCP has updated ATCP 70 with the incorporation by reference of provisions of Federal regulations that implement the requirements of the federal Food Safety Modernization Act (FSMA). This involves multiple subparts of the recently created 21 CFR 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk based Preventive Controls for Human Food, formerly 21 CFR 110, Current Good Manufacturing Practice in Manufacturing, Packaging, or Holding , Human Food, pertaining to preventive food safety systems that have already been referenced in chs. ATCP 65 (Milk and Milk Products) and ATCP 71 (Food Warehouses and Milk Distributors). Since the majority of Wisconsin food facilities, already subject to this federal rule, are licensed as food processing plants, this proposed rule includes similar referencing for the sake of consistency. This revision also ensures that the requirements for Wisconsin-licensed food processing plants, not subject to the federal rule, are clearly articulated. With DATCP’s Division of Food Safety merger with DHS’ FSRL to form the new Division of Food and Recreational Safety (“DFRS”), a merger of the two food safety regulatory systems became necessary. A major change involving food processing plants is the fact that restaurant operators were not allowed to wholesale food under DHS regulation, while retail food establishment operators, under DATCP’s authority, could engage in a limited amount of wholesaling. At present, restaurant operators are now licensed as retail food establishments and therefore now enjoyed a limited ability to wholesale food. The new ATCP 70 clarifies both the exemption from the requirement to hold a food processing plant license as well as the requirements for food processing and subsequent wholesaling now allowed in licensed retail food establishments. The new ATCP 70 also incorporates, for the first time, specific definitions for wholesaling and retailing concomitantly being incorporated into ATCP 75 (Retail Food Establishments) and ATCP 55 (Meat and Meat Food Products). DATCP expects these updates to promote clarity, uniformity, and improved guidance to food businesses in Wisconsin.
In addition, the new ATCP 70 contains language designed to specifically clarify the responsibilities for operators of retail food establishments. Besides the afore-mentioned exemption from the requirement of holding a food processing plant license, operators will better understand their duty to follow the safety, processing, and labeling requirements in ATCP 70 for the production of food for wholesaling. These provisions not only level the playing field for industry, but, more importantly, also ensure that certain ATCP 70 requirements are in place to ensure food safety. Examples of such requirements include provisions for a written recall plan and a written food safety plan for facilities subject to FSMA rules.
In revising this rule, DATCP sought to eliminate duplication, improve regulatory transparency, and, to the extent possible, ensure that food businesses are not required to hold multiple licenses, except when completely necessary. In doing so, DATCP never relinquishes its public health mission or compromises its directive to ensure that food is produced safely and pursuant to some responsible form of inspection. In some cases, such as meat establishments that produce some products under a state license or a federal grant of inspection and other products separate from that inspection, businesses will be allowed to obtain a retail food establishment license from the state or local agency with jurisdiction in that area, in addition to the state meat establishment license or federal grant of meat inspection. This ensures that those businesses will be allowed to sell product at retail that was not produced under either the federal or state meat inspection programs because those programs are not allowed to inspect and regulate retail operations.
Another substantive change is to end the licensing of food processing plants that are located in homes after the date this rule becomes effective. It should be noted that food processing plants currently located in residences will not be able to expand their facilities after the effective date of this rule. This rule also requires that food processing plants that are currently located in residential or commercial buildings must have a door that opens to the outside or into a community space.
Further, the rule adopts the Model Ordinance for Molluscan Shellfish, now Marine Shellfish, which replaces all of s. ATCP 70.21, except the section on illnesses and outbreaks associated with shellfish. This modification will keep the state’s regulations current with the national rules on shellfish processing and marketing. Other clarifications, changes, and additions are as follow:
• This rule addresses requirements for vending machines, micro-markets, and the commissaries for both of these entities, as well as in the new ch. ATCP 75, and the Appendix to ATCP 75, The Wisconsin Food Code, to ensure consistency and clarity in requirements for both the food processing part of the operation and the retail food business. • This rule clarifies extended runs and waivers allowing those runs, while clarifying and expanding the list of food processing activities during which daily cleaning and sanitizing are not required.
• This rule clarifies that filing and obtaining process-authority approval for processes used in the making of acidified or low acid canned foods is mandatory.
• This rule expands the ability of food processing plants to obtain waivers or variances from DATCP for non-standardized and innovative processing and procedural activities. Prior to this revision, these waivers and variances could only be obtained by food processing plants for structural and equipment issues.
• This rule updates and clarifies the language dealing with the standards and testing of operations water and ingredient water used in the various bottling and processing operations in Wisconsin, and finished product sampling and analysis for bottling establishments.
• This new rule also expands the scope of the bottling rules to cover more than just bottled water and soda to match the expansion of this rapidly changing and innovative segment of the bottling industry.
• This rule generally updates and clarifies definitions, licensing requirements and exemptions, as well as exempt wholesaling requirements and limitations, to keep pace with industry and regulatory needs.
• This rule removes the lower sales limit of $25,000 on persons who must pay the canning surcharge to reflect the very real need for DATCP’s staff to provide extensive information, consultation, and service to persons manufacturing canned foods.
• This rule will be consistent with the Retail Food Establishment and Meat and Meat Food Products rules to ensure consistency throughout food processing businesses of all types and a regulatory presence for all foods, regardless of where they are produced. This is in keeping with the scope of ch. 97, Stats., requiring the Department to regulate food safety wherever that food is produced, stored, or offered for sale. • The proposed rule protects the consistent quality of the Wisconsin “brand” by removing many of the long-expired ”Grandfather Clause” dates in the existing rule and replacing them with language about gaining compliance for structural standards in existing buildings and updating the expectations for structural standards in new plants. Most significantly, the proposed rule promotes consistent food safety by not allowing a food processing plant in a residence to be licensed after the effective date of this rule.
Federal and Surrounding State Programs
Federal Programs
A major objective was to include the updated language in 21 CFR 117 which replaced 21 CFR 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding for Human Food, and is the cornerstone of the regulations implementing FSMA. ATCP 70.04 was specifically inserted to address this issue, and definitions for “facility” and “qualified facility” were also inserted to facilitate the department’s implementation of those federal requirements. Current language on the molluscan shellfish program was deleted in order to adopt the Federal Model Ordinance, in order to provide that segment of the Wisconsin food industry regulatory consistency within interstate commerce.
Surrounding State Programs
Michigan, Iowa, Minnesota license and regulate food processing facilities within their borders as does Wisconsin. 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 and guidelines such as the rules implementing FSMA; Wisconsin statutes and rules for food processing plants, retail food establishments, meat establishments, and dairy plants; and current industrial practices.
Material Incorporated by Reference
21 CFR 117, Current Good Manufacturing Practice, Hazard Analysis and Risk based Preventive Controls for Human Food.
21 CFR 108, Emergency Permit Control (Canning Process Filing Requirements). 21 CFR 113, Thermally Processed Low-acid foods packaged in hermetically sealed containers (Canning). 21 CFR 120, Hazard Analysis and Critical Control Point (HACCP) Systems (Juice HACCP). 21 CFR 123, Fish and Fishery Products (Seafood HACCP). National Shellfish Sanitation Program – Guide for the Control of Molluscan Shellfish, Model Ordinance.
Effect on Small Business
The businesses affected by this rule run the gamut from very small to very large operations. The businesses range from one- and two-person popcorn wholesalers to multi-national corporations that are on the cutting edge of food science. The Department’s challenge is to write and then enforce applicable and consistent requirements that do not penalize either end of this range of business types.
If the proposed rule is adopted, some small food processing plants may incur immediate costs to meet the requirement to have a door that opens to the outside rather than to a residential vestibule. There is also a potential cost for a small number of businesses that have not upgraded their facilities since the “grandfather clauses” were put in place over thirty years ago. They will now need to upgrade warewashing and handwashing sinks or provide a non-residential restroom for the facility. Another cost that may be incurred by a few very small businesses is the $320 canning surcharge, which currently is not assessed for food processing plants manufacturing and selling less than $25,000 of food per year. The Department’s Manufactured Food Specialists spend a disproportionate amount of time working with very small canning businesses, and this surcharge recoups these costs. The service provided by the Department is comparable to that of consultants who are not economically available to operations in the <$25,000/year category.
Much of the focus of the proposed rule revision is on clarification and the updating of existing regulations such as the various exemptions from a food processing plant license, and the clarification of the various record-keeping requirements.
A positive impact of this rule revision on all classes of business is the expanded ability of food processing plants to apply for processing or procedural waivers. This will potentially allow the use of new and innovative techniques and processes so long as the processor can demonstrate that food safety is not compromised.
No economic impact comments were received during the August 8 – September 7, 2017 comment period. However, meat establishments that produce some products under a state license or a federal grant of inspection, as well as other products separate from that inspection, may be required to hold a retail food establishment license from the state or local agency with jurisdiction in that area in addition to holding the state meat establishment license or federal grant of meat inspection. Allowing these meat establishments to also hold a retail food establishment license will make it possible for them to retail the unique meat and poultry products that the state is known for since those products will now be produced under inspection. This additional oversight more closely meets consumer expectations and provides a level playing field between these establishments and other, non-meat inspection establishments that produce the same types of meat and poultry products for sale at retail. These other non-meat inspection establishments have always been subject to licensing and regulation by the state or local food inspection system.
DATCP Contact
Questions and comments (including hearing comments) related to this rule may be directed to:
Peter Haase, Director
Bureau of Food and Recreational Businesses
Department of Agriculture, Trade and Consumer Protection
P.O. Box 8911
Madison, WI 53708-8911
Telephone: (608) 224-4711
Rule comments will be accepted up to two weeks after the last public hearing is held on this rule. Hearing dates will be scheduled after this rule is approved by the Board of Agriculture, Trade and Consumer Protection.
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Section 1. ATCP 74 is repealed and recreated to read:
