On March 18, the U.S. Food and Drug Administration (FDA) hosted a call with Frank Yiannas, Deputy Commissioner, Office of Food Policy and Response, Michael Rogers, Assistant Commissioner for Human and Animal Food Operations, Office of Regulatory Affairs, and Dr. Susan Mayne, Director, Center for Food Safety and Applied Nutrition, to inform food industry stakeholders about the agency’s activities during the COVID-19 pandemic. While stressing that it is responding to COVID-19 concerns with maximum flexibility, FDA focused on three critical areas of concern: food safety, maintaining a stable food supply and food safety inspections.
FDA underscored that there is no evidence that COVID-19 can be transmitted to humans through food and food packaging. COVID-19 is a respiratory illness, not gastrointestinal. If a worker tests positive for COVID-19, a food producer should consult with the local health department, follow U.S. Centers for Disease Control and Prevention (CDC) guidelines, perform deep cleaning and sanitizing, and inform potentially impacted employees. Product recalls or withdrawals would not typically be necessary if a food facility employee is diagnosed with COVID-19. Instead, food facilities should focus on preventing employee-to-employee transmission within the facility by increasing sanitation efforts and educating employees on frequent handwashing and hygiene policies. Additional details can be found here.
Stable Food Supply
FDA emphasized that there are no food shortages within the U.S. food supply. Consumer demand, not supply shortage, may cause some foods to be temporarily low in stock at the retail level. FDA confirmed that the Department of Homeland Security (DHS) identifies food and agriculture as a “critical infrastructure sector.” As a result, executive orders mandating closure of non-essential businesses should not apply to food manufacturing facilities. This exemption should extend to manufacturers of animal feed and pet food, which are included in the definition of “food” under the Federal Food, Drug, and Cosmetic Act (FDCA). FDA advised that businesses facing potential closure by local governments or restrictions on activities that effectively limit supply chains (for instance, general transportation issues or those that would impede efforts to supply food to quarantined areas) should notify the Federal Emergency Management Agency National Business Emergency Operations Center (FEMA NBEOC).
FDA will temporarily limit domestic inspections to focus resources on mission-critical and for-cause inspections. Examples include inspections related to a foodborne illness outbreak or a Class I recall. For all for-cause inspections, FDA will consider public safety and protecting the health of FDA personnel and facility employees by reviewing company food safety documentation in lieu of a physical inspection of the facility when necessary.
FDA also provided the following specific guidance on other types of inspections:
- Domestic routine surveillance inspections have been postponed. Additional details can be found here.
- Foreign facility inspections have been postponed through April 2020, and any foreign facility inspections deemed mission-critical will be evaluated on a case-by-case basis.
- Onsite supplier audit requirements of food facilities will not be enforced. This includes onsite audit requirements for Supplier Verification and the Foreign Supplier Verification Program, as required by the Food Safety Modernization Act (FSMA). Additional details on the Temporary Guidance are found here.
FDA also temporarily changed its policy on announcing inspections. To the extent FDA performs a facility inspection, the agency will pre-announce the inspection. Additional details can be found here.
Summary: Extraordinary Measures
These are unprecedented times. FDA is taking extraordinary measures to meet its critical mission of protecting the public health by safeguarding the food supply and ensuring that the food supply chain will continue to operate efficiently and unhindered.
For additional information, please consult the following resources:
- Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections
- Food Safety and the Coronavirus Disease 2019 (COVID-19) Questions & Answers
- Guidance for Industry: Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency
- FDA’s Food and Cosmetics Information Center
As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.