DATCP Docket No. 15-R-16 Final Rule Draft
Rules Clearinghouse No. 17-074 February 2, 2020
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 ch. ATCP 75 relating to retail food establishments, and to repeal and recreate ch. ATCP 75, Appendix, Wisconsin Food Code, also relating to retail food establishments and affecting small business. __________________________________________________________________________
Analysis Prepared by the Department of Agriculture, Trade and Consumer Protection
The Wisconsin Department of Agriculture, Trade and Consumer Protection (“Department” or “DATCP”) proposes to repeal and recreate Wis. Admin. Code ch. ATCP 75 (Retail Food Establishments) and Wis. Admin. Code ch. ATCP 75, Appendix (Wisconsin Food Code). This rule revision is necessary because the current rule reflects regulations derived from a federal Food and Drug Administration (FDA) model food code dating from 2009. This rule will bring Wisconsin regulatory requirements into substantial accord with the more recent 2013 Model Food Code issued by the FDA.
The Department typically updates the Wisconsin Food Code every four years without revising Wis. Admin. Code ch. ATCP 75, but with the present revision, the Department is also updating Wis. Admin. Code ch. ATCP 75 itself, due to the July 2016 merger of the Department’s Division of Food Safety with the Department of Health Service (DHS) Food Safety and Recreational Licensing Section (FSRLS) and the resulting creation of the Division of Food and Recreational Safety (DFRS) within DATCP. The merger of the two former entities necessitated a merger of the rules appertaining to FSRLS and DFS respectively, including the rules affecting retail food establishments (“RFEs.”) The present rule merges, clarifies, and updates the rules regulating all RFEs, both meal-serving establishments (restaurants) and non-meal serving enterprises. Statutes Interpreted
Wis. Stat. § 97.30, “Retail food establishments.”
Wis. Stat. § 97.29, “Food processing plants.”
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 Department has broad general authority, pursuant to Wis. Stat. § 93.07 (1), to adopt rules to implement programs under its jurisdiction. The Department also has general authority, pursuant to Wis. Stat. § 97.09 (4), to adopt rules specifying standards to protect the public from the sale of adulterated or misbranded foods. The Department has specific authority, pursuant to Wis. Stat. § 97.30 (5), to adopt rules for RFEs concerning fees; to set facility construction and maintenance standards; and to set rules for the design, installation, maintenance, and cleaning of equipment and utensils; personnel sanitation; food handling, display, and storage; and food sources and food labeling.
Related Statutes and Rules
Since the merger with DHS’s FSRLS in July of 2016, the Department has almost total regulatory responsibility for post-harvest food, pursuant to Wis. Stat. ch. 97 and inter-related administrative rules that strive for consistency with federal laws, regulations, and guidance. Relevant administrative rules cover retail food establishments (ATCP 75 and its Appendix), food processing plants (ATCP 70), dairy plants and farms (ATCP 65), and food warehouses (ATCP 71), as well as meat and poultry inspection and processing (ATCP 55). With the proposed rule revision, the Department rule will largely mirror the 2013 FDA Model Food Code, as well as FDA Model Food Code updates accepted by the FDA since 2013.
Plain Language Analysis
The rule updates Wis. Admin. Code ch. ATCP 75 by incorporating significant rule provisions in the now-repealed Wis. Admin. Code ch. DHS 196 (Restaurants) and by repealing requirements in Wis. Admin. Code ch. ATCP 75 concerning agent programs. Agent program rules are currently found in Wis. Admin. Code ch. ATCP 74 (Local Agents and Regulation), which also incorporates provisions from the repealed Wis. Admin. Code ch. DHS 192.
The transfer of DHS’ FSRLS to DATCP’s Division of Food Safety necessitated the merger of two food safety regulatory systems. One regulatory paradox was particularly in need of resolution: Restaurant operators could not wholesale food under the DHS rules, while RFE operators under DATCP’s authority could engage in a limited amount of wholesaling without holding a food processing plant license. By statute, the Department now licenses restaurants as RFEs, and therefore, restaurants enjoy the same limited ability to wholesale food. The Department undertook the present rule-making process and by January of 2018 had developed a draft rule that for the first time included definitions of “wholesale” and “retail”. The Department initially proposed to retain certain limitations and requirements derived from Wis. Admin. Code ch. ATCP 70 (Food Processing Plants) addressed to food processing activities for wholesale conducted by an RFE. The Department presented a final draft reflecting that framework to the Board of Agriculture, Trade and Consumer Protection (“Board”) in January 2018. Although the Board approved the draft, it became apparent in the aftermath of the Board meeting that industry participants felt that less restrictive limits and definitions would still adequately protect public health.
In light of this feedback, the Department opted to form a work group comprised of industry and local health department agent program representatives to further revise the rule. During deliberations, the work group determined that the safety of many food processing activities for wholesale, when done by RFEs, could be ensured by compliance with ATCP 75 and the ATCP 75 Appendix, and thus, no additional application of ATCP 70 requirements was necessary. The work group recognized that additional training would be necessary for local health department agent personnel, along with Department sanitarians, assigned to inspect RFEs performing these food processing activities for wholesale. The Department, as part of its ongoing work to train thoroughly food safety personnel at the state and local level, is committed to providing the necessary training.
The work group extensively discussed whether an RFE conducting food processing activities for wholesale, yet exempt from having to hold a food processing plant license, should be required to develop a written recall plan (as required in ATCP 70). Dairy plants and food processing plants must develop a written recall plan, but the work group reached consensus that this requirement was poorly suited and likely ineffective for businesses predominantly engaged in retail activities. As a result, the revised rule states that RFEs are responsible for notifying their wholesale customers of any adulterated or misbranded products that the RFE may have sold to them, as deemed appropriate for the protection of public health. The RFE operator will choose the notification mechanism.
The work group’s efforts culminated in the newly revised final draft of ATCP 75, which does all of the following: a) re-defines “wholesale” and “retail”, b) clarifies the exemption for RFEs from the requirement to hold a food processing plant license when conducting limited (not more than 25% of gross annual food sales) food processing activities for wholesale, and c) re-draws boundaries on what types of food processing activities for wholesale are allowed. Perhaps the most important change in the wholesale and retail definitions is that the Department will no longer regard the transfer of food between two RFEs or food processing plants as wholesaling, so long as the same license holder operates the two businesses involved and the licensee transferring the food does not relinquish control of the food. This change reflects current guidance by the FDA and follows the United States Department of Agriculture (USDA) interpretations related to differentiating “retail” from “wholesale” transactions involving meat and poultry products.
The revised definitions for “wholesale” and “retail” reflect industry practice and the de facto usage of these terms in the marketplace, as well as the FDA’s interpretation and sanction of current industry practice. The new definitions also appear in the completed and published revision to Wis. Admin. Code ch. ATCP 70 (Food Processing Plants). The revised rule does continue to prohibit RFEs from processing canned low-acid or acidified foods for wholesale without holding a food processing plant license and complying with the requirements stated in Wis. Admin. Code ch. ATCP 70. The aim of the update definitions is to promote clarity and uniformity and ideally to facilitate enhanced business opportunities for industry participants.
RFEs operate under a wide range of business models, ranging from traditional restaurants, bakeries, and markets where all sales are made directly to consumers, on the one hand, to larger operations performing varying degrees of processing and wholesaling, on the other hand. The revisions to the rule take cognizance of a recently introduced business model in which a licensed RFE transports prepared food and conducts sales of individual meals directly to a workplace’s employees or guests of employees, for a limited number of days each week. Within boundaries delineated in the rule, an additional RFE license is not required for the workplace meal sales. The work group reviewed and approved this revision.
Some RFEs perform food processing for wholesale activities, which are regulated at the federal level by the FDA. This rule revision is calculated to ensure that these businesses do not fall outside the sweep of appropriate regulation. Wis. Admin. Code ch. ATCP 75 and its Appendix specifically govern retail sales and the internal transfer of food between businesses operated by the same license-holding entity. As revised, the rule, with the addition of federal requirements for juice and seafood processing, will apply to RFEs that conduct wholesaling only to a limited extent (< 25% of gross annual food sales). Businesses that predominantly wholesale the food they process must effectuate enhanced food safety systems, as required by provisions in Wis. Admin. Code ch. ATCP 70. With this rule revision, the Department has sought to eliminate duplication, clarify expectations, and, to the extent possible, avoid the need to procure multiple licenses for the same business. However, the Department justifiably weighed these objectives in the balance with safety concerns arising from gaps in regulation. Accordingly, this rule proposes that any business holding either a meat establishment license issued by the Department, or a grant of meat / poultry inspection from the federal government, must also obtain an RFE license if the business manufactures for retail sale any meat or poultry products that are never produced under meat inspection and never bear an inspection legend. Prior to this rule revision, meat establishments were allowed to retail up to 25% of total meat sales without holding an RFE license because of the frequent state or federal inspection of meat processing overall. However, it was adjudged during recent discussions that the available meat inspection resources are insufficient to adequately oversee meat and poultry products sold at retail without the state or federal mark of inspection and other safeguards attendant upon RFE status. Federal meat inspection staff are explicitly directed not to inspect retail meat and food operations. The rule revision eliminates the above-described exemption from the requirement to hold an RFE license. Expectations will thus be identical to those for businesses already licensed as RFEs to produce meat and poultry products only for retail sale.
The rule also defines and clarifies the rules for micro-markets, vending machines, and the vending machine commissaries defined in statute as serving both of those business types. The Department will license vending machine commissaries as food processing plants, which reflects the operations of these commissaries. In addition, the Department defines micro-markets so as to acknowledge that the latter typically operate without a human on the premises at all times to oversee operations, which is a requirement for other types of RFEs.
The revised Wis. Admin. Code ch. ATCP 75 Appendix, Wisconsin Food Code, provides greater clarification regarding variances and Hazard Analysis Critical Control Point (“HACCP”) plans, including the procedure for variance applications. New language also simplifies the protocols that establishments must follow when performing vacuum packing and sous-vide processing.
A significant change in the Wisconsin Food Code pertains to cheese curds. The Department based the revised language on a recent study of the likelihood of pathogenic bacterial growth on cheese curds. The study validates the current 24-hour-at-room-temperature limit for display of cheese curds processed under Cheddar cheese-making conditions. This scientific support of storage requirements for cheese curds allows the Department to meet Standard 1 of the FDA’s Voluntary National Retail Food Regulatory Standards Program by providing validation for any protocols that differ substantively from the FDA Model Food Code.
