November 2020 Regulatory Update | 2 of 2

These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from November 16 – November 30, 2020. Please contact Paul BensonTaylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business.

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FOOD SAFETY

  • FDA, USDA-FSIS, and CDC Announce New Outbreak Investigation Updates MUST READ

  • FDA Releases Final Guidance on Publicizing Retailers that Received Recalled Foods MUST READ

  • FDA Partners with CA Department of Food and Agriculture on Multi-Year Food Safety Study

  • FDA Files Two Food Additive Petitions for Consideration

USDA UPDATES

  • USDA-FSIS Announces New Flexibilities for Poultry Slaughter Establishments MUST READ

  • USDA Launches AskUSDA Contact Center Program

OTHER DEVELOPMENTS

  • President-Elect Biden’s Choice for Agriculture Secretary Could Have Big Implications for Hunger Policy

UPCOMING MEETINGS & CONFERENCES

  • December 10 (2:00 – 3:00 PM EST): Webinar on “4 Essentials for Effective Food Safety Management,” hosted by Plex. Register here.

  • December 14 (8:00 AM – 1:00 PM CT): Virtual open house tour of USDA-FSIS’s Midwestern Laboratory in St. Louis, MO. Register here.

  • February 18 – 19, 2021: Virtual Agricultural Outlook Forum (AOF), USDA’s largest annual meeting, on “Building on Innovation: A Pathway to Resilience.” Program to be announced in early December 2020. Register here.

  • View slide decks from past USDA-FSIS meetings and presentations here.

FOOD SAFETY 

FDA, USDA-FSIS, and CDC Announce New Outbreak Investigation Updates
November 18: FDA, USDA-FSIS, and CDC began publishing information on all active foodborne illness investigations “in an effort to improve outbreak investigations communications and transparency with the public,” according to USDA-FSIS’s Constituent Update.

As part of this initiative, FDA launched its Coordinated Outbreak Response and Evaluation (CORE) Investigation Table, which the agency’s Coordinated Outbreak Response and Evaluation Network (CORE) will update weekly with information about active outbreak investigations. The CORE Investigation Table is being rolled out as a 6-month pilot, “during which the Agency is interested in receiving feedback and after which FDA may adjust the table, if needed,” according to FDA’s Constituent Update. FDA described the table as a “stepping stone to help the public move from having little knowledge of an outbreak, through each stage of the investigation, and in the best-case scenarios, investigating agencies can provide detailed, actionable advice.”

Meanwhile, USDA-FSIS committed to updating an outbreak investigation table weekly and CDC committed to providing “information on the number of illness clusters they are investigating each week.”

Read FDA’s Constituent Update here and Press Announcement here. Access its CORE Investigation Table here. Read USDA-FSIS’s Constituent Update here and access CDC’s outbreak investigation table here.

 

FDA Releases Final Guidance on Publicizing Retailers that Received Recalled Foods
November 23:FDA released final guidance on publicizing lists of retailers that received recalled foods (“Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls; Guidance for Industry and FDA staff”).  According to the agency’s Federal Register Notice, releasing these retail consignee lists will help consumers “identify recalled food and…determine whether that food is in their possession as effectively and quickly as possible.” Prior to the release of this guidance, FDA policy prohibited the publication of such retailer lists in order to protect confidential business connections. Meanwhile, USDA-FSIS has released such lists routinely since 2007.  

Under the final guidance, FDA will focus on publicizing lists of retail consignees that have received foods classified as Class I recalls, “where there is a reasonable probability that the use of, or exposure to, the food will cause serious adverse health consequences or death to humans or animals.” That said, the agency also may release lists for some Class II food recalls – “particularly where a public warning has been issued or where there is an association with an outbreak of a foodborne illness,” according to the final guidance. Regardless of the food recall classification, FDA intends to publicize retailer lists only when both of the following recall conditions apply: (1) “the food is not easily identified as being subject to a recall from its retail packaging (or lack thereof)” and (2) “the food is likely to be available for consumption (i.e., given its shelf-life or perishability, it may still be in a consumer’s possession).”

Read FDA’s Federal Register Notice here and access the final guidance here.

 

FDA Partners with CA Department of Food and Agriculture on Multi-Year Food Safety Study
November 19:Following a series of E. coli O157:H7 outbreaks linked to California’s lettuce production regions, FDA has partnered with the California Department of Food and Agriculture (CDFA), the University of California, Davis, Western Center for Food Safety (WCFS), and Californian agricultural stakeholders to launch a multi-year study on improving food safety. This longitudinal study, which is included in the agency’s March 2020 Leafy Green STEC Action Plan, “will examine how pathogens survive and move through the environment and possibly contaminate produce through work with water quality, food safety, and agricultural experts,” according to FDA’s Constituent Update.

The agency hopes that findings from the study will “contribute new knowledge on how various environmental factors may influence bacterial persistence and distribution” in the California Central Coast region, which grows “a significant portion of the nation’s leafy greens.”

Read FDA’s Constituent Update here. Read about the Leafy Green STEC Action Plan in our March 2020 Regulatory Update here.

 

FDA Files Two Food Additive Petitions for Consideration
FDA recently announced the filing of two petitions regarding food additives in October.   

November 20: On October 15, FDA filed a petition, submitted by Colorcon, Inc., which proposed amending color additive regulations – specifically 21 CFR 73.70, “Calcium carbonate” – “to expand the safe use of calcium carbonate to include use in dietary supplement tablets and capsules…including coatings and printing inks” according to the agency’s Federal Register Notice.

The petitioner claimed that calcium carbonate is categorically excluded under 21 CFR 25.32(k) of “Foods, food additives, and color additives” because it “is intended to remain in food through ingestion by consumers and is not intended to replace macronutrients in food.” If FDA determines that the categorical exclusion does indeed apply to calcium carbonate after consideration of the petition, it will require the petitioner to conduct neither an environmental assessment nor an environmental impact statement. If it does not determine that the categorical exclusion applies, it will request that an environmental assessment be made available for public inspection.

November 27:On October 5, FDA filed a petition submitted by Ag Chem Resources, LLC, which proposed amending food additive regulations – specifically Title 21 of the Code of Federal Regulations (CFR) in part 573, “Food Additives Permitted in Feed and Drinking Water of Animals” – “to provide for the safe use of tannic acid as a flavoring agent in animal feed,” according to the agency’s Federal Register Notice.

The petitioner claimed that tannic acid should be categorically excluded under 21 CFR 25.32(r) of “Foods, food additives, and color additives” because it does not have a significant effect on the human environment individually or cumulatively. If FDA determines that the categorical exclusion does indeed apply to tannic acid after consideration of the petition, it will require the petitioner to conduct neither an environmental assessment nor an environmental impact statement. If it does not determine that the categorical exclusion applies, it will request that an environmental assessment be made available for public inspection.


USDA UPDATES

USDA-FSIS Announces New Flexibilities for Poultry Slaughter Establishments
November 20: USDA-FSIS announced new flexibilities for poultry slaughter establishments working with new antimicrobial “interventions” (procedures for preventing the contamination of poultry carcasses and parts by enteric pathogens, especially Salmonella, and fecal contamination). The agency will announce and seek comments on the new flexibilities in an upcoming Federal Register Notice.

Per 2016 poultry performance standard regulations, USDA-FSIS “performs routine verification sampling of raw poultry products in order to assess process control in all establishments,” according to the agency’s Constituent Update. The agency’s new flexibilities will allow an establishment to request that its products not be subject to testing under these Salmonella  performance standards “while the establishment begins using, for the first time, an intervention that has already been approved in FSIS Directive 7120.1: Safe and Suitable Ingredients used in the Production of Meat, Poultry, and Egg Products.” If the establishment’s intervention follows specific guidelines and meets specific criteria and if USDA-FSIS approves its request, the agency “will temporarily stop Salmonella testing related to the standards for a limited period of time (i.e., maximum of 4 weeks) in applicable product(s) subject to new interventions. FSIS will allow no more than one trial period every 52 weeks.”

Read USDA-FSIS’s Constituent Update here.

 

USDA Launches AskUSDA Contact Center Program
November 18: USDA launched the AskUSDA Contact Center program, which will serve as the agency’s “‘one front door’ for phone, chat, and web inquires” to “transform…how the public interacts with USDA,” according to the agency’s Press Release.

AskUSDA is a “centralized contact center” that provides customer service assistance and public information about USDA’s programs and resources via phone, e-mail, and web chat with trained AskUSDA representatives. AskUSDA also hosts over five thousand articles answering commonly asked questions about USDA’s 29 agencies and offices.

“The public can contact AskUSDA by phone at (833) ONE-USDA with representatives available 9:00am-5:30pm EST weekdays. The website…is available 24/7 and includes live chat agents available 10:00am-6:00pm EST on weekdays. Inquiries can also be sent via email at any time to [email protected].”

Read USDA’s Press Release here and visit the AskUSDA website here.


OTHER DEVELOPMENTS

President-Elect Biden’s Choice for Agriculture Secretary Could Have Big Implications for Hunger Policy 
Whomever President-Elect Biden chooses for Secretary of Agriculture will have the opportunity to shape the administration’s policy priorities. With the stakes so high, the debate over this choice has become intense, “pitt[ing] Democrats eager to emphasize issues like hunger and nutrition against more traditional members of the party who believe the department should represent rural America,” as The New York Times expressed on November 26.

Rep. Marcia L. Fudge (D-OH), who chairs the House Agriculture Committee’s Subcommittee on Nutrition, Oversight and Department Operations, is expected to focus on anti-hunger policies should she be chosen as USDA Secretary. Rep. Fudge has the support of various high-profile progressive Democrats and African American legislators, including Senator Sherrod Brown (D-OH), Rep. Filemon Vela (D-TX), Rep. Bennie Thompson (D-MS), and Rep. James E. Clyburn (D-SC), whom the Times described as “the highest-ranking Black member of Congress and perhaps Mr. Biden’s most important supporter in the Democratic primary.” Rep. Clyburn is advocating strongly for Rep. Fudge, telling the Times that “It’s time for Democrats to treat the Department of Agriculture as the kind of department it purports to be…[USDA’s budget] deals with consumer issues and nutrition and things that affect people’s day-to-day lives.” Rep. Fudge earned support from labor unions, meat-packing workers, and anti-hunger groups for her hunger advocacy, criticism of current USDA Secretary Sonny Perdue’s proposed rules to tighten Supplemental Nutrition Assistance Program (SNAP) eligibility, and opposition to USDA-FSIS waivers allowing meat and poultry plants to accelerate carcass inspection line speed. If chosen, Rep. Fudge would become the first African American woman to serve as Secretary of Agriculture.

On the other hand, Heidi Heitkamp, a former North Dakota senator, and Tom Vilsack, the former Iowa governor and USDA Secretary under President Obama, are expected to focus on rural America should either be picked for the role. Centrist Democrat Heitkamp campaigned for Biden on behalf of his “great rural plan” and told the Times that she predicted Biden would “pick the person who can implement that rural plan.” She faces backlash from progressives, who view her as “too friendly with big agribusinesses and fossil fuel interests,” according to Politico. Rep. Clyburn expressed concern that choosing Vilsack, meanwhile, would help turn Biden’s term into President Obama’s third term and stated that “There’s a strong feeling that Black farmers didn’t get a fair shake” under Vilsack when he was USDA Secretary.

Given this ongoing debate, Biden may be unable to satisfy both moderate and progressive Democrats with his USDA Secretary pick. 

 

 

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