DATCP Docket No. 17 – R - 05 Proposed Hearing Draft
Rules Clearinghouse No. ___ September 21, 2017
OF THE WISCONSIN DEPARTMENT OF AGRICULTURE,
TRADE AND CONSUMER PROTECTION
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.
Analysis Prepared by the Department
of Agriculture, Trade and Consumer Protection
This rule repeals and recreates ATCP 70, “Food Processing Plants.” This rule is necessary to update Wisconsin’s food processing standards and incorporate new federal requirements designed to improve the nation’s food safety system, to update and coordinate references to food processing in retail food establishments (as well as deal with products not currently being inspected in state and federal meat establishments), to address vending machine and micro-market commissaries, and to modernize and clarify Wisconsin’s standards for food processing.
Statutes Interpreted: ss. 97.20, Stats., “Dairy Plants:” 97.29, Stats., “Food processing plants;” 97.30, Stats., “Retail food establishments;” 97.34, Stats., “Bottled drinking water and soda water beverage; standards; sampling and analysis;” 97.42, Stats., “Compulsory Inspection of livestock or poultry, and meat or poultry products;” 97.605, “Lodging and vending licenses,” and 97.61, Stats, “Vending machine commissary outside the state.”
Explanation of Statutory Authority
The Wisconsin Department of Agriculture, Trade and Consumer Protection (“DATCP”) has broad general authority, under s. 93.07 (1), Stats., to adopt rules to implement programs under its jurisdiction. DATCP 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. DATCP has specific authority, under s. 97.29 (5) to adopt rules establishing fees, setting facility construction and maintenance standards, setting standards for the design, installation, maintenance, and cleaning of equipment and utensils, personnel sanitation, food handling and storage, sanitary production and processing of food, food sources, and labels.
Related Statutes and Rules
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