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

This Regulatory Update includes information from April 1 through April 17, 2020. Please contact Leah Ziemba, Paul Benson, or Taylor Fritsch for additional information on regulatory issues that may impact your business.

For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, to help navigate this challenging time, please follow these hyperlinks to Michael Best’s COVID-19 Resource Center and CARES Act Relief Resource Center. 

 

COVID-19 DEVELOPMENTS

  • FDA to Temporarily Conduct FSVP Importer Inspections Remotely  MUST READ
  • FDA Releases Guidance on Temporary Egg Packaging and Labeling Policy  MUST READ
  • FDA Releases Guidance on Temporary Egg Safety Rule Policy  MUST READ
  • USDA Announces Temporary Labeling Flexibilities for COOL Requirements  MUST READ
  • FDA Issues Best Practices on Safe Food Handling and Employee Health in Retail Food Settings During COVID-19 Public Health Emergency
  • FDA Releases Guidance on Temporary Restaurant Menu Labeling Requirements
  • FDA Releases Fact Sheet on Diverting Human Food for Animal Food Use
  • FDA and USDA Update COVID-19 Webpages

FOOD LABELING, CLAIMS & MARKETING

  • FDA Reopens Comment Period on Ultrafiltered Milk in Cheeses
  • FDA Extends Reopened Comment Period on Food Standards of Identity Modernization

FOOD SAFETY

  • FDA Commissioner Addresses Food Safety During and After COVID-19

OTHER DEVELOPMENTS OF INTEREST

  • Consumer Brands Association Calls for Creation of Office of Supply Chain and Criticizes Conflicting Guidance on PPE Use
  • Meat Processing Plant Closures Threaten Retail Supply Chain
  • USDA Invites Public Input on Its Agriculture Innovation Agenda

COVID-19 DEVELOPMENTS

FDA to Temporarily Conduct FSVP Importer Inspections Remotely
April 3: FDA announced that it would begin requesting importers required to send records under the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP) rule to send them electronically during the COVID-19 public health emergency. 

According to FDA’s Constituent Update, “Because of the travel restrictions, social distancing, and other advisories associated with the COVID-19 outbreak … most routine onsite inspections are temporarily impractical to conduct at this time. Therefore, the Agency will shift to temporarily conducting FSVP inspections remotely as practical until further notice.” FDA will conduct previously assigned routine and follow-up inspections remotely, and it will prioritize inspections of “FSVP importers of food from foreign suppliers whose onsite food facility or farm inspections have been postponed due to COVID-19.”

Read FDA’s Constituent Update here and the FSVP final rule here. Learn more about the final rule here.

 

FDA Releases Guidance on Temporary Egg Packaging and Labeling Policy
April 3:FDA announced the availability of a final guidance on its “Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency.” Due to the increased demand for shell eggs and the limited availability of appropriately labeled retail packaging during the COVID-19 pandemic, FDA will temporarily exercise flexibility in its enforcement of specific packaging and labeling requirements.

For the duration of the COVID-19 public health emergency, FDA does not intend to object to retail food establishments’ sale of shell eggs in cartons or flats without labels, given the following conditions: (1) The establishment clearly displays the statement of identity; the name and place of the manufacturer, packer, or distributor; and safe handling instructions for shell eggs not processed to destroy all Salmonella at the point of purchase, (2) The establishment sells the shell eggs by the complete carton or flat, (3) The establishment does not provide any nutrition claims at the point of purchase for the shell eggs, and (4) If the establishment sells shell eggs from multiple suppliers at the same time and location, it makes it clear which point of sale labeling applies to which shell eggs.

Read FDA’s Constituent Update here and access the final guidance here.

 

FDA Releases Guidance on Temporary Egg Safety Rule Policy
April 6: FDA announced the availability of a final guidance on its “Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency.” FDA will provide shell egg producers greater flexibility to sell their eggs for distribution to retail establishments for the duration of the COVID-19 public health emergency.

The “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation,” better known as the Egg Safety Rule, requires shell egg producers that sell directly to consumers in retail locations to take certain measures to prevent Salmonella Enteritidis contamination, to maintain records of their compliance with the rule, and to register with the FDA. Under its temporary policy, FDA “does not intend to object if shell eggs from a poultry house consisting solely of laying hens up to 45 weeks of age are sold to the table egg market” under a variety of conditions listed in its Constituent Update.

Read FDA’s Constituent Update here and the Egg Safety Rule here (PDF). Access the final guidance here.

 

USDA Announces Temporary Labeling Flexibilities for COOL Requirements
April 13: In response to the challenges of the COVID-19 public health emergency, USDA announced that it temporarily will “allow the re-distribution of food products intended for foodservice to be sold in retail establishments” and will provide labeling flexibilities for its Country of Origin Labeling (COOL) requirements, according to its news release. This temporary labeling flexibility will facilitate the diversion of food from restaurants to retail as food establishments struggle to meet growing demand during the pandemic.

Under the COOL labeling law, retailers selling covered commodities at retail establishments (including “muscle cut and ground meats … wild and farm-raised fish and shellfish; fresh and frozen fruits and vegetables; peanuts, pecans, and macadamia nuts; and ginseng”) must include labels with information about the commodities’ origins. Under USDA’s temporary period of labeling flexibilities, however, USDA “will not take enforcement action against the retail sale of commodities that lack an appropriate country of origin or method of production label, provided that the food does not make any country of origin or method of production claims,” effective April 20, 2020 and for a period of 60 days.

Read USDA’s News Release here and learn more about the COOL labeling law here.

 

FDA Issues Best Practices on Safe Food Handling and Employee Health in Retail Food Settings During COVID-19 Public Health Emergency
April 9: FDA released a factsheet and companion infographic to inform retail food stores, restaurants, and pick-up and delivery services about best practices for the safe preparation and delivery of food to the public, in addition to best practices for “employee health and personal hygiene, cleaning and sanitizing,” according to its Constituent Update.

Read FDA’s Constituent Update and access its attachments here.

 

FDA Releases Guidance on Temporary Restaurant Menu Labeling Requirements
April 1: FDA announced the availability of a final guidance on its “Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency.” For the duration of the public health emergency, FDA will be more flexible in enforcing menu nutrition labeling requirements in chain restaurants and similar retail food establishments.

According to FDA’s Constituent Update, “restaurants and similar retail food establishments that are part of a chain with 20 or more locations, doing business under the same name, and offering for sale substantially the same menu items” must provide nutrition information and calorie counts on menus and menu boards under FDA regulations. Due to the destabilizing effects of the COVID-19 crisis on these covered establishments; however, FDA will not object to a failure to meet the menu labeling requirements during this public health emergency.

Read FDA’s Constituent Update here. Access the final guidance here and learn more about FDA’s menu labeling requirements here.

 

FDA Releases Fact Sheet on Diverting Human Food for Animal Food Use
FDA’s Center for Veterinary Medicine (CVM) released a fact sheet on “Safely distributing unused human food for animal food use” to guide restaurants and other food suppliers looking to repurpose unused food inventories during the COVID-19 public health emergency. 

The fact sheet includes various “Do’s” and “Don’ts” of the process. For example, food suppliers may distribute human food that is safe for human consumption but that has supply-chain or food quality issues (e.g. stale food) for animal food use. They should not, however, distribute foods with ingredients that are unsafe for the target animal. The fact sheet also describes FDA’s policies on diverting human foods containing meat for animal food use, distributing packaged foods, labeling requirements, and holding requirements.

Read FDA’s fact sheet here (PDF) and learn more about the CVM here.

 

FDA and USDA Update COVID-19 Webpages
Since March 30, FDA has updated its COVID-19 food safety webpage with advice for companies whose employees test positive for COVID-19, as well as information about social distancing, disinfecting, and other precautions for businesses. USDA also continues to update its COVID-19 FAQ page.

Visit FDA’s main COVID-19 webpage here, FAQ page here, and food safety page here. Visit USDA’s COVID-19 FAQ page here.


FOOD LABELING, CLAIMS & MARKETING

FDA Reopens Comment Period on Ultrafiltered Milk in Cheeses
April 15: FDA is seeking additional public comment on a proposed rule amending the definitions of “milk” and “nonfat milk” in cheeses and cheese products to better align with international food standards of identity. 

Originally published in October 2005, the proposed rule (“Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk,” 70 Fed. Reg. 60,751) would alter FDA’s definitions of “milk” and “nonfat milk” to permit the use of fluid ultrafiltered milk (UF) – mechanically filtered raw or pasteurized milk – in cheese production. FDA’s current food standards of identity for cheeses do not conform with the international Codex standards, since its current definitions of “milk” and “nonfat milk” “do not provide for the use of fluid or dried filtered milk or … nonfat milk as basic dairy ingredients in standardized cheeses and related cheese products,” according to the rulemaking.

FDA has reopened the comment period to gather additional stakeholder comments. To ensure consideration by the agency, comments on the proposed rule must be submitted by August 13, 2020. Read FDA’s Constituent Update here and the proposed rule here.

 

FDA Extends Reopened Comment Period on Food Standards of Identity Modernization
April 17: FDA is seeking additional public comment on a proposed rule establishing general principles to consider when modernizing food standards of identity (“Food Standards; General Principles and Food Standards Modernization,” 70 Fed. Reg. 29,214). The agency extended its comment period, initially reopened in February 2020, to gather new information on FDA-specific aspects of the 2005 proposed rule.

To ensure consideration by the agency, comments on the proposed rule now must be submitted by July 20, 2020. Read FDA’s Constituent Update here and the proposed rule here.


 

FOOD SAFETY

FDA Once Again Extends Comment Period for Proposed Rule on Laboratory Accreditation
April 3: Responding to requests from several food industry associations focused on “critical infrastructure operations” during the COVID-19 pandemic, FDA extended the comment period on a November 2019 proposed rule, “Laboratory Accreditation for Analyses of Foods” (84 Fed. Reg. 59,452), for the second time since February 2020. The proposed rule aims to create a program for human and animal food testing by accredited laboratories in specific circumstances, as required by the Federal Food, Drug, and Cosmetic Act. 

To ensure consideration by the agency, comments on the proposed rule now must be submitted by July 6, 2020. Read FDA’s Constituent Update here and the proposed rule here.   

 

FDA Commissioner Addresses Food Safety During and After COVID-19
April 16: FDA Commissioner Frank Yiannas answered questions about the safety and availability of the U.S. food supply during and after the COVID-19 pandemic in a Question-and-Answer style interview. 

Yiannas addressed concerns about the ostensible food shortages in supermarkets, saying that “[t]he retail supply chain remains strong. For those products that have been out of stock, manufacturers and retailers of both human and animal foods are working around the clock to replenish shelves.” He reiterated that “[t]here is NO evidence of food or food packaging being associated with transmission of COVID-19” and detailed steps FDA has taken to divert excess food originally bound for restaurants to consumers. Finally, he detailed lessons learned during the pandemic: “This experience has…reinforced something I already knew – how important it is for government to work with the private sector…we can do so much more together. The truth of that statement has really been brought home because we cannot get through a crisis of this magnitude without effective public-private partnerships.”

Read “A Conversation with Frank Yiannas” here.


 

OTHER DEVELOPMENTS OF INTEREST

Consumer Brands Association Calls for Creation of Office of Supply Chain and Criticizes Conflicting Guidance on PPE Use
April 8: The Consumer Brands Association (CBA) (formerly the Grocery Manufacturers Association) encouraged the creation of a White House Office of Supply Chain in an April 8 letter to President Trump and called for “three important steps to protect American workers’ access to essential products” during the COVID-19 pandemic in its April 9 press release.

In its letter to President Trump, the CBA emphasized “the need for a more coordinated effort to deliver personal protective equipment (PPE) across the critical infrastructure supply chain” through the establishment of a White House Office of Supply Chain.

In its press release, the CBA noted conflicting information about the use of PPE by essential workers, pointing out the CDC and FEMA’s contradictory policies on PPE use, before advocating for three steps the federal government should take to protect  U.S. workers’ access to PPE: (1) Creating a White House Office of Supply Chain, (2) Establishing that all essential critical infrastructure employees should have access to PPE, and (3) Granting essential workers priority access to COVID-19 testing.

Read the CBA’s Press Release here and its letter to President Trump here (PDF).

 

Meat Processing Plant Closures Threaten Retail Supply Chain
As meat processing plants around the United States experience closures and high rates of employee illness and absenteeism during the COVID-19 public health emergency, local producers and national suppliers face the growing threat of falling prices, while consumers worry about potential shortages of beef, poultry, and pork in supermarkets.

On April 12, Smithfield Foods’s Sioux Falls pork processing plant, which accounts for approximately 5% of the nation’s pork supply, closed until further notice after 293 of its 3,700 employees tested positive for COVID-19. Meanwhile, the virus has infected hundreds of employees at large meat processing plants in Colorado, Pennsylvania, Iowa, and Mississippi and has caused an unknown number of employees nationwide to stay home for fear of infection.  Across the pork, beef, and chicken sectors, at least half a dozen processing plants have closed temporarily. Depending on the lengths of such closures, they could affect the supply chain from ranchers down to the supermarket consumer.

The diminished meat processing capacity already has started driving down prices and hurting farmers and ranchers. In response, producers have begun shifting meat originally bound for restaurants to grocery stores. Experts remain divided on whether these plant closures and the resulting diminished production will cause meat shortages or higher meat prices in supermarkets. Such a result, it seems, depends wholly on timing.

 

USDA Invites Public Input on Its Agriculture Innovation Agenda
April 1: In an effort to advance its Agriculture Innovation Agenda (AIA), USDA is calling for public and private sector input on “the most important innovation opportunities to be addressed in the near and long term” to inform its research and innovation goals, according to USDA’s press release.

Launched in February 2020, the AIA is a department-wide, multi-phase initiative to prepare the U.S. agricultural system for future global demand and to “achieve the goal of increasing production by 40 percent while cutting the environmental footprint of U.S. agriculture in half by 2050,” as stated in its AIA press release.

USDA’s Request for Information (RFI) asks respondents, especially members of the agricultural and scientific community, “to identify transformational innovation opportunities for the next era of agriculture productivity and environmental conservation and propose approaches to these opportunities with an eye to the public and private sector research needed to support them,” according to its RFI press release. USDA will draw on the requested stakeholder input to develop a U.S. agriculture innovation strategy for release by the end of 2020.

Read USDA’s RFI press release here, its RFI here (PDF), and its AIA press release here.

 

 

 

THANKS TO OUR PREMIUM MEMBERS