The Food and Drug Administration has suspended enforcement of verifying Food Safety Modernization Act audit requirements for importers and food facilities because of the coronavirus COVID-19 spread.
Two FSMA regulations require facilities that receive imported produce and importers be audited, which includes onsite visits, sampling and testing and reviews of food safety records. Those regulations are the Preventive Controls for Human Food Rule; and Foreign Supplier Verification Programs (FSVP) Rule, according to an FDA notice on the enforcement suspension.
When the U.S. government-initiated travel bans in countries that export the U.S., including China, and other governments issued similar bans, including Italy, inspections stopped immediately. Other advisories have limited the ability for inspectors to be on site in exporting countries, according to the FDA notice.
The FDA has dropped onsite audit requirements if:
- A receiving facility or FSVP importer has determined that onsite audits are appropriate for suppliers, as indicated in food safety plans;
- Suppliers due for audits are in a region/country covered by travel restriction/advisory due to the virus;
- It is impractical for those audits because of those travel restrictions; or
- Importers and facilities choose alternative verifications such as sampling and testing, and reviewing of food safety records, and modifies the food safety plan accordingly.
The FDA plans to “provide timely notice before withdrawing this policy,” according to its notice.