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

This Regulatory Update includes information from April 13 through April 30, 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

  • President Trump Signs Executive Order to Keep Meat and Poultry Processing Plants Open  MUST READ
  • USDA Announces Coronavirus Food Assistance Program  MUST READ
  • Director of Center for Food Safety and Applied Nutrition Summarizes FDA’s Flexible COVID-19 Policies
  • FDA and USDA Update COVID-19 Webpages

COVID-19 INDUSTRY GUIDANCE

  • MUST READ: FDA Releases Guidance Document on Maintaining Essential Operations During COVID-19  MUST READ
  • CDC and OSHA Release Interim Guidance for Meat and Poultry Industry  MUST READ
  • FDA Releases Fact Sheet on Use of PPE in Food and Agriculture Sector
  • FDA Releases Guidance on FSMA Accredited Third-Party Certification Program
  • National Restaurant Association Releases Guidance on Reopening Restaurants During COVID-19
  • CDC Releases Guidance for Grocery and Food Retail Workers During COVID-19

FOOD SAFETY, LABELING, CLAIMS & MARKETING

  • FDA to Discontinue Strict Enforcement of Skim Milk Labeling Rule
  • Researchers Find Link Between Unpasteurized Milk and Infections

COVID-19 DEVELOPMENTS

President Trump Signs Executive Order to Keep Meat and Poultry Processing Plants Open

April 28:In order to “to ensure a continued supply of protein for Americans” during the COVID-19 pandemic, President Trump signed Executive Order 13917 under the Defense Production Act, declaring meat and poultry processing facilities part of the U.S.’s critical infrastructure and compelling them to remain open during the public health emergency (“Delegating Authority Under the Defense Production Act With Respect to Food Supply Chain Resources During the National Emergency Caused by the Outbreak of COVID-19”).

The Executive Order states that “the Secretary of Agriculture shall take all appropriate action…to ensure that meat and poultry processors continue operations” consistent with CDC and OSHA’s interim guidance for meat and poultry processing plants, released a day before President Trump signed the Executive Order (see below). According to USDA’s press release, the agency “will work with meat processing to affirm they will operate in accordance with the CDC and OSHA guidance, and then work with state and local officials to ensure that these plants are allowed to operate to produce the meat protein that Americans need. USDA will continue to work with the CDC, OSHA, FDA, and state and local officials to ensure that facilities implementing this guidance to keep employees safe can continue operating.”

Read the Executive Order here and USDA’s press release here.

 

USDA Announces Coronavirus Food Assistance Program
April 17:USDA launched its Coronavirus Food Assistance Program (CFAP), a $19 billion immediate relief program to “provide critical support to our farmers and ranchers, maintain the integrity of our food supply chain, and ensure every American continues to receive and have access to the food they need,” according to USDA’s press release.

USDA will draw on the Coronavirus Aid, Relief, and Economic Security Act (CARES) and the Families First Coronavirus Response Act (FFCRA), among other existing authorities, to fund the two main elements of CFAP. First, CFAP will provide farmers and ranchers $16 billion in direct support “based on actual losses…where prices and market supply chains have been impacted” and “additional adjustment and marketing costs resulting from lost demand and short-term oversupply for the 2020 marketing year caused by COVID-19.” Second, USDA will “purchase $3 billion in fresh produce, dairy, and meat” through CFAP, beginning the procurement with an estimated $100 million in fresh fruits and vegetables monthly, $100 million in dairy products monthly, and $100 million in meat products monthly. “The distributors and wholesalers will then provide a pre-approved box of fresh produce, dairy, and meat products to food banks, community and faith based organizations, and other non-profits serving Americans in need.”

In addition to CFAP, USDA  may draw upon an additional $873.3 million in Section 32 funding “to purchase a variety of agricultural products for distribution to food banks,” and the CARES Act and FFCRA have provided at least $850 million “for food bank administrative costs and USDA food purchases, of which a minimum of $600 million will be designated for food purchases.”

Read USDA’s press release here.

 

Director of Center for Food Safety and Applied Nutrition Summarizes FDA’s Flexible COVID-19 Policies
April 21:In an FDA Voices article, Dr. Susan Mayne, Director of the Center for Food Safety and Applied Nutrition, described FDA’s release of temporary guidance “that provides flexibility to various segments of the food industry—restaurants, food manufacturers, producers and retail establishments—to help support the food supply chain and meet consumer demand in this time of crisis.”

For details on the temporary policies on nutrition labeling, menu labeling, and shell eggs that Dr. Mayne summarizes, please see our March 2020 and April 2020 (Part 1) Regulatory Updates.

Read the FDA Voices article here, our March 2020 Regulatory Update on the temporary nutrition labeling policy here, and our April 2020 (Part 1) Regulatory Update on the temporary menu labeling and shell egg policies (forthcoming).

 

FDA and USDA Update COVID-19 Webpages
FDA and USDA continue to update their COVID-19 webpages. On April 20, FDA updated its food safety page by addressing the question, “Where should the food industry go for guidance about business operations?” with a recommendation that food facilities “follow protocols set by local and state health departments” and coordinate with local health officials using the National Association of County and City Health Officials (NACCHO) Directory of Local Health Departments.

Visit FDA’s main COVID-19 webpage here, FAQ page here, and food safety page here. Visit USDA’s COVID-19 FAQ page here. Access the NACCHO Directory of Local Health Departments here.


COVID-19 INDUSTRY GUIDANCE

FDA Releases Guidance Document on Maintaining Essential Operations During COVID-19 
April 24:FDA released a guidance document outlining “key steps that employers and workers can take to help stay open, prevent and slow the spread of COVID-19, and support continuity of essential operations if workers are diagnosed with or exposed to COVID-19, or show symptoms associated with COVID-19.” The document compiles CDC recommendations on precautions to reduce COVID-19 transmission and on continuing essential operations when employees are exposed to, show symptoms of, or test positive for COVID-19. 
 
Read FDA’s guidance document here (web format) and here (PDF format). 

 
CDC and OSHA Release Interim Guidance for Meat and Poultry Industry 
April 27: CDC and the Occupational Safety and Health Administration (OSHA) of the Department of Labor released guidance that is “specific to the meat and poultry processing industry in order to facilitate ongoing operations and support the food supply, while also mitigating the risk of spreading COVID-19,” according to USDA’s press release. 
 
The guidance addresses the exposure risk for meat and poultry processing employees, how to create a COVID-19 assessment and control plan, the use of cloth face covering in meat and poultry processing facilities and PPE, return-to-work policies, and workers’ rights, among other topics.
 
Read USDA’s press release here and the interim guidance here.
 
FDA Releases Fact Sheet on Use of PPE in Food and Agriculture Sector
April 24:FDA released a fact sheet distinguishing between each design, purpose, and wear and care of respirators, disposable facemasks, and cloth face coverings. The fact sheet emphasizes CDC’s recommended “use of simple cloth face coverings to slow the spread of the virus and to help people who are unaware they have the virus from spreading it to others.”
 
Read FDA’s fact sheet here (web format) and here (PDF format).   
 
FDA Releases Guidance on FSMA Accredited Third-Party Certification Program
April 22: FDA issued a final guidance on its “Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency.” The guidance explains FDA’s temporary flexibility towards conducting onsite monitoring activities during the COVID-19 public health emergency “so that recognized accreditation bodies (ABs) can maintain the accreditations of certification bodies (CBs), and so that already-issued certifications need not lapse, where certain safeguards are in place,” according to FDA’s Constituent Update.
 
FDA expressed its intent not to enforce certain onsite monitoring requirements, given the temporary impracticality of conducting onsite monitoring activities. Furthermore, it “does not intend to enforce the requirement that the accredited CBs issue [import] certificates for a term only up to 12 months, in certain circumstances.”
 
Read FDA’s Constituent Update here and access the final guidance here.  


 
National Restaurant Association Releases Guidance on Reopening Restaurants During COVID-19 
April 28: The National Restaurant Association’s ServSafe team partnered with FDA, academia, industry representatives, the Conference for Food Protection, and Ecolab Inc. to release its restaurant reopening guidance. According to the National Restaurant Association’s article in Restaurant Business, “[t]he guidance offers instruction on how to begin serving customers in partial- and full-service capacities. The National Restaurant Association encourages combining the guidelines with existing corporate policies, the FDA Food Code, ServSafe training and recommendations from local health officials.”
 
Read the National Restaurant Association article here and access the guidance here.

 
 
CDC Releases Guidance for Grocery and Food Retail Workers During COVID-19 
April 13: CDC released guidance for grocery and food retail workers on protecting themselves against COVID-19 and limiting its spread. The guidance also offers recommendations for their employers to maintain healthy work environments and reduce transmission amongst employees.
Read CDC’s guidance here.

 

FOOD SAFETY, LABELING, CLAIMS & MARKETING

FDA to Discontinue Strict Enforcement of Skim Milk Labeling Rule
April 22: In a striking letter to a Maryland dairy farm, FDA indicated its intent not to enforce the skim milk labeling requirements that the farm had deemed “misleading” in a 2018 lawsuit.

As we explained in our March 2020 Regulatory Update, FDA regulations require skim milk producers that do not add back the vitamins A and D lost in the cream skimming process to label their skim milk as “imitation.”  In 2018, South Mountain Creamery (“SMC”) owner Randy Sowers sued FDA for this requirement, raising First Amendment speech claims. On February 26, 2020, the U.S. District Court for the Middle District of Pennsylvania dismissed the suit without prejudice. The court found that SMC could not state a justiciable claim because the labeling rules did not pose a real threat to the company and because FDA’s July 10, 2018 letter to the farm had stated that it would not enforce the labeling requirement if the farm’s skim milk label noted that the milk did not contain the added vitamins.

In an April 2020 follow-up letter to SMC, FDA reiterated its intent not to enforce the skim milk labeling requirement: “[Y]ou asked whether FDA expects State authorities to enforce federal labeling regulations regarding SMC’s distribution of non-fat non-fortified milk that is neither labeled as ‘imitation’ (based on the absence of vitamins A and D) nor fortified with vitamins A and D. We do not.” FDA also confirmed that, if the agency decided to change its enforcement policy in the future, it would not retroactively punish dairy farms that had not labeled their additive-free skim milk as “imitation.”

Read FDA’s April 2020 letter to South Mountain Creamery here (PDF) and read about the South Mountain Creamery case in our March 2020 Regulatory Update here.

 

Researchers Find Link Between Unpasteurized Milk and Infections
April 17:CDC’s weekly Morbidity and Mortality Weekly Report published information about research that found a connection between the consumption of raw milk and brucellosis, “a serious zoonotic infection” that “can become chronic and potentially life-threatening” without proper treatment (“Notes from the Field: Brucella abortus RB51 Infections Associated with Consumption of Raw Milk from Pennsylvania — 2017 and 2018”).

The research team, which included scientists from various state departments of health, CDC, and other federal agencies, investigated a 19-state outbreak of brucellosis illnesses, which has been connected to unpasteurized milk from Miller’s Biodiversity Farm in Pennsylvania.

The researchers recommended that “all milk should be pasteurized…[t]o eliminate infection risk from milkborne pathogens” and found that “[r]aw milk consumption is also associated with serious illnesses caused by other pathogens, including Campylobacter spp., Shiga toxin–producing Escherichia coli, and Salmonella spp.”

Read the report here.

 

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