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

This Regulatory Update includes information from May 1 through May 15, 2020. Please contact Leah Ziemba, Paul Benson, or Taylor Fritsch for additional information on regulatory issues that may impact your business.

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COVID-19 DEVELOPMENTS

  • MUST READ  Nearly Half of U.S. COVID-19 Hotspots Linked to Meat Processing Plants
  • MUST READ  Secretary of Agriculture Perdue Issues Letters Following Executive Order for Meatpacking Industry
  • MUST READ  WI Secretary of Agriculture Seeks Temporary USDA Exception Allowing State-Inspected Meat to Cross State Lines
  • USDA Applauds Missouri Court Ruling on OSHA’s Primary Jurisdiction Over Meatpacking Employee Safety

COVID-19 INDUSTRY GUIDANCE

  • MUST READ  FDA Issues Re-Opening Best Practices Checklist and Infographic for Retail Food Establishments
  • FDA Offers Tips on Food Shopping During COVID-19
  • FDA Releases Guidance Document on Returning Refrigerated Vehicles and Storage Units Used During COVID-19 to Food Uses

OTHER DEVELOPMENTS OF INTEREST

  • MUST READ  USDA Announces Final Rule on Plant Biotechnology Regulations
  • GAO Releases Report on Regulating Cell-Cultured Meat for FDA and USDA
  • Botanical Safety Consortium to Hold First Annual Meeting

COVID-19 DEVELOPMENTS

Nearly Half of U.S. COVID-19 Hotspots Linked to Meat Processing Plants
May 15:An analysis by The Guardian found that at least 12 of America’s 25 COVID-19 hotspots (counties with the highest infection rates per capita) are linked to meat processing plants, where close quarters and cramped conditions make social distancing difficult.

According to the Midwest Center for Investigative Reporting, there were at least 51 COVID-19-related deaths and at least 12,500 COVID-19 cases in the meatpacking industry across the U.S. as of May 10. As of May 11, 4,585 Tyson workers in 15 states had been diagnosed with COVID-19 and 18 had died of it, yet the major meat processing company continued to face criticism for not offering full paid sick leave.  Meanwhile, close to 300 FSIS food safety inspectors were off sick or under self-quarantine due to COVID-19, and a fourth FSIS inspector died of COVID-19 complications on May 13.

Between March and May, at least 30 meat processing plants suspended operations, but many are beginning to reopen after President Trump’s Executive Order 13917, which directed meat and poultry processing facilities to remain open during the COVID-19 public health emergency. Secretary of Agriculture Sonny Perdue “applauded the safe reopening of [14] critical infrastructure meatpacking facilities across the United States” in a May 8 USDA press release. Despite USDA’s cautious optimism, Andre Nogueira, the CEO of JBS USA Holdings Inc. (the largest beef producer in the U.S.), said in a May 15 interview that COVID-19 countermeasures in meat processing plants likely will slow down meat production for months.

Read USDA’s May 8 press release here.

 

Secretary of Agriculture Perdue Issues Letters Following Executive Order for Meatpacking Industry
May 6: Secretary of Agriculture Sonny Perdue sent letters to meat processing company leadership and Governors nationwide establishing USDA’s expectations for the implementation of President Trump’s Executive Order 13917.

In the letters, Secretary Perdue directed meat and poultry processors to use guidance from the Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA) for the meat and poultry processing industry, issued April 26, 2020, “to implement practices and protocols for staying operational or resuming operations while safeguarding the health of the workers and the community,” as stated in his letter to the Governors. In his letter to meat processing company leadership, he urged plants to resume operations “as soon as they are able after implementing the CDC/OSHA guidance for the protection of workers.”

Read USDA’s press release here, Secretary Perdue’s letter to the Governors here (PDF) and letter to meat processing company leadership here (PDF), our report on the Executive Order here, and our report on CDC and OSHA’s guidance here

 

WI Secretary of Agriculture Seeks Temporary USDA Exception Allowing State-Inspected Meat to Cross State Lines
May 6:Randy Romanski, the interim secretary of Wisconsin’s Department of Agriculture, Trade and Consumer Protection (DATCP), requested a temporary exception allowing the sale and donation of state-inspected meat across state lines.

In a letter to Joseph Priore, the Acting Regional Director of FSIS, Romanski advocated for the unique exception in order to “move additional livestock through slaughter facilities, decrease the number of animals euthanized, and increase the amount of meat available to consumers.” Romanski noted that Wisconsin’s meat and poultry inspection program is considered “at least equal” to federal requirements and that its Cooperative Interstate Shipment (CIS) program is considered to be the “same as” the federal program. “During this COVID-19 public health emergency,” he wrote, “I believe we need to work together to identify challenges and new opportunities to overcome those challenges.”

Read Interim Secretary Romanski’s letter to USDA here.

 

USDA Applauds Missouri Court Ruling on OSHA’s Primary Jurisdiction Over Meatpacking Employee Safety
May 6: Secretary of Agriculture Sonny Perdue applauded a Missouri federal court for ruling that the Occupational Safety and Health Administration (OSHA) “has the primary jurisdiction over worker’s safety in meat processing plants across the country during the COVID-19 national emergency,” according to USDA’s press release.

Secretary Perdue said in his statement, “Since President Trump issued his Executive Order last week to keep these critical facilities operating, USDA has been working hand in hand with OSHA and the CDC to ensure meat processing facilities are abiding by Federal guidelines. This ruling is directly in line with what the Federal government has been calling for companies and communities to do in light of the President’s Executive Order.”

Read USDA’s press release here.


COVID-19 INDUSTRY GUIDANCE

FSIS Extends Temporary Labeling Allowances to Facilitate Continued Redirection of Meat and Poultry to Retail Sales
May 1:USDA-FSIS announced an extension of temporary labeling allowances to facilitate the redirection of meat and poultry products for retail sale for an additional 60 days, or until June 26, 2020.

On March 27, 2020, FSIS announced that it would exercise enforcement discretion to permit certain labeling changes temporarily to assist in keeping retail meat cases well-stocked in light of the current public health crisis. Specifically:

  • Federal establishments producing product intended for distribution to hotels, restaurants, or similar institutions will have modified labels applied by the federal establishment to allow the products to be sold at retail. Labels are required to bear all required elements, but FSIS will not object to labels without nutrition labeling, even if the product would not ordinarily be exempt from nutrition labeling under 9 CFR Sections 317.400 and 381.500.
  • Bulk products labeled for hotels, restaurants, or similar institutions may be distributed to retail if the retailer will repackage the product into smaller consumer size packages and apply a label. The label applied to repackaged product must bear all required elements except for the USDA mark of inspection. Products bearing statements of limited use on outer product packaging (e.g., “for school foodservice use only”) may be distributed to a retail outlet for repackaging and labeling.
  • Fully labeled containers of meat or poultry products in unlabeled protective coverings may be distributed to a retailer for labeling, even if the product bears a statement of limited use that would normally indicate that the product is for hotels, restaurants, and similar institutions.  During the temporary allowance, FSIS will not object to the container being distributed to retail and the retailer applying a label to the protective covering so that the product may be sold at retail on a temporary basis (see date below).

Read USDA’s Constituent Update here.

 

FDA Issues Re-Opening Best Practices Checklist and Infographic For Retail Food Establishments
May 8:FDA released a checklist and an infographic to assist retail food establishments that were closed or partially closed during the COVID-19 pandemic as they reopen for business. According to its Constituent Update, the documents will “help businesses that prepare food to serve or sell to the public directly, such as restaurants, bakeries, bars and carry-outs, protect employee and public health as they reopen for business.”

The checklist includes information on food and non-food contact services, food temperature control, and employee screening, as well as additional resources from the Centers for Disease Control and Prevention (CDC) and the Environmental Protection Agency (EPA). The infographic, which was “designed to enhance communication and understanding among a diverse workforce,” reiterates “critically important practices for employee and public health” that businesses must maintain as they reopen.

Read FDA’s Constituent Update here and view both documents here.

 

FDA Offers Tips on Food Shopping During COVID-19
May 1:FDA released information and a corresponding video on safe shopping and safe food storage and preparation practices during the COVID-19 pandemic. The information sheet covers topics from wearing face coverings to wiping down shopping carts, and it notes that although “there is no evidence of food packaging being associated with the transmission of COVID-19…if you wish, you can wipe down product packaging and allow it to air dry, as an extra precaution.”

Read FDA’s information sheet here.

 

FDA Releases Guidance Document on Returning Refrigerated Vehicles and Storage Units Used During COVID-19 to Food Uses
May 12:FDA released a guidance document on “Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic.”

The final guidance addresses how to restore refrigerated food transport vehicles and refrigerated food storage units “used for the temporary preservation of human remains during the COVID-19 pandemic” for use in the transport and storage of human and animal food. It includes information on cleaning and disinfecting these vehicles and storage units, in addition to the conditions in which FDA recommends not returning them to their previous service.

Access the final guidance here.


OTHER DEVELOPMENTS OF INTEREST

USDA Announces Final Rule on Plant Biotechnology Regulations
May 14:USDA announced its finalization of the Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule, which will “facilitate the development and availability of [plant biotechnologies]…through a transparent, consistent, science-based, and risk-proportionate regulatory system,” according to its press release.

The SECURE rule is USDA’s first major update to its plant biotechnology regulations in over 30 years, and it reflects the Animal Plant Health Inspection Service’s (APHIS) years of experience with determining which genetically modified plants to regulate for plant pest risk. The final rule establishes a more efficient plant identification process that “focus[es] on the properties of the plant rather than on its method of production. APHIS will evaluate [genetically engineered] plants…for plant pest risk under a new process called a regulatory status review, regulating only those that plausibly pose an increased plant pest risk.”

Read USDA’s press release here and an unofficial version of the final rule (PDF) here.

 

GAO Releases Report on Regulating Cell-Cultured Meat for FDA and USDA
May 7:The U.S. Government Accountability Office (GAO) publicly released its April 2020 report containing recommendations for federal regulation of cell-cultured meat (“FDA and USDA Could Strengthen Existing Efforts to Prepare for Oversight of Cell-Cultured Meat”).

GAO reviewed FDA and USDA’s 2019 interagency agreement for oversight of cell-cultured meat and found that it “could more fully incorporate practices to enhance and sustain collaboration, such as defining outcomes.” GAO ultimately offered five recommendations, one of which was for the agencies to incorporate “leading practices for effective collaboration” into the agreement. “By fully incorporating leading practices into their efforts to collaborate,” the report highlights note, “the agencies could minimize potential overlap and fragmentation, use resources in a more efficient manner, and better ensure the public and other key stakeholders have clarity about the agencies’ oversight responsibilities.”

Visit GAO’s webpage on the report here. Read highlights of the report here (PDF) and the full report here (PDF).

 

Botanical Safety Consortium to Hold First Annual Meeting
May 4:FDA announced that the Botanical Safety Consortium (BSC), a forum created by FDA, the National Institute of Environmental Health Sciences (NIEHS), and the Health and Environmental Sciences Institute (HESI), will have its first annual meeting on May 29, 2020 from 9:00 AM–12:45 PM EDT via a webcast that will be recorded. “Objectives of the meeting,” according to FDA’s Constituent Update, “include recruiting new members and soliciting input into current scientific challenges and opportunities related to botanical ingredient safety.”

The BSC officially was convened in November 2019 through a memorandum of understanding between its founding agencies. Its mission is to provide a forum for “scientists from government, academia, consumer health groups, industry, and nonprofit organizations from around the world…to generate a sound scientific basis for integrating existing safety data and the latest toxicology tools to evaluate safety in botanical dietary supplements.”

Read FDA’s Constituent Update on the May 2020 BSC meeting here and its Constituent Update on the November 2019 convening of the BSC here. Visit the BSC website here.

 

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