This week, the Food & Drug Administration (FDA) made a series of announcements in connection with its efforts to address the outbreak of COVID-19. The Agency sought to reassure the American public that the U.S. food supply remains safe and that there is no evidence of food or food packaging being associated with the transmission of COVID-19. The Agency also announced plans to scale back domestic and foreign food facility inspections and temporarily halt enforcement of supplier verification onsite requirements for receiving facilities and importers under the Food Safety Modernization Act (FSMA).
We’ll continue to monitor for updates and post them here. More details follow on these and other FDA COVID-19 related developments.
- Food safety, shortages, and COVID-19 transmission. In a press conference on Wednesday, the Agency reiterated that the food supply is safe and robust, and that industry has reassured the Agency that current shortages in stores are indicative of heavy consumer demand and not an overall issue with food supply. Also in a release and in FAQs from the Centers for Disease Control and Prevention (CDC) published on FDA’s website, the Agency noted that while “possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes,” this is not thought to be the primary way the virus is transmitted and “there is no evidence to support transmission of COVID-19 associated with food.” As a result, FDA indicated that food does not need to be recalled or otherwise removed from commerce if a food industry employee tests positive for COVID-19.
- Domestic food facility inspections. Also on Wednesday, FDA announced that it would temporarily postpone all domestic routine surveillance facility inspections. Some for-cause inspection assignments may proceed if determined to be “mission-critical,” and if there is a “way to get there to accomplish them in a way that does not put anyone at risk,” according to Michael Rogers, the assistant commissioner for human and animal food operations in the Office of Regulatory Affairs (ORA). In a departure from current practice of conducting unannounced inspections, Mr. Rogers indicated that the majority of domestic inspections would be announced for the foreseeable future.
- Supplier verification requirements. On Tuesday, the Agency issued guidance announcing its intention to exercise enforcement discretion in connection with supplier verification onsite audit requirements for receiving facilities and importers. These requirements derive from three separate rules promulgated to implement FSMA, the Preventive Controls for Human Food (PC Human Food) rule, Preventive Controls for Animal Food (PC Animal Food) rule, and Foreign Supplier Verification Programs (FSVP) rule– and require receiving facilities and importers to conduct supplier verification activities based on the hazard analysis conducted as part of their written Food Safety Plan or FSVP. The Guidance explained that FDA does not intend to enforce these requirements, provided the following criteria are met:
- A receiving facility or FSVP importer has determined that an onsite audit is the appropriate verification activity for an approved supplier, as reflected by its written food safety plan or FSVP;
- The supplier that is due for an onsite audit is in a region or country covered by a government travel restriction or travel advisory related to COVID-19;
- Because of the travel restriction or travel advisory, it is temporarily impracticable for the receiving facility or FSVP importer to conduct or obtain the onsite audit of the supplier; and
- The receiving facility or FSVP importer temporarily selects an alternative verification activity or activities, such as sampling and testing food or reviewing relevant food safety records, and modifies its food safety plan or FSVP to incorporate the alternative activity or activities. The alternative verification activity or activities are designed to provide temporary assurance that the hazard requiring a supply-chain-applied control (or, for FSVP, the hazard that is being controlled by the foreign supplier) has been significantly minimized or prevented during the period of onsite audit delay.
- Foreign food facility inspections. Earlier this month, FDA announced that it planned to postpone most foreign facility inspections through April. The Agency plans to conduct “mission-critical” inspections on a case-by-case basis and work with the U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products.
The Agency has also emphasized that it has a strong partnership across public and private sectors and is coordinating daily with industry and other agencies. FDA also noted that the food and agriculture sectors are classified as critical infrastructure for purposes of federal and state directives and thus employees should be able to continue to go to and from work in communities with curfews and shelter-in-place directives. FDA urged food companies that experience any supply-chain problems to contact FEMA’s National Business Emergency Operations Center at NBEOC@fema.dhs.gov.
More resources on the FDA’s response to COVID-19 are available on its website here.