03.18.20
Yesterday, the U.S. Food and Drug Administration (FDA) issued a statement communicating their intent to temporarily not enforce on-site audits and supplier verification under the Food Safety Modernization Act (FSMA). This comes in response to the travel restrictions and hazards associated with the COVID-19 pandemic. The agency intends to use other supplier verification methods instead.
Last month, FDA halted foreign inspections, and limited domestic travel to "mission critical" only through the month of April. However, within the past several days, the virus has spread across the globe and grown at an exponential rate in over 100 countries including the U.S.
In the meantime, the agency issued a series of guidance documents for the production of animal and human food, as well as additional information on COVID-19 aimed at stakeholders. These changes are intended to prevent severe disruptions in the food supply chain while the public health emergency remains ongoing.
“FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities,” the agency said. “Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word ‘should’ in FDA guidance means that something is suggested or recommended, but not required.”
The three food regulations in particular which FDA intends to stop enforcing temporarily are Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (part 117).
The U.S. government has issued a “Level 4-Do Not Travel” advisory for China, and, on March 11, the government issued a “Level 3- Reconsider Travel” advisory for global travel. Other countries across the globe have even placed restrictions on domestic travel. These restrictions will impact the ability of receiving facilities and importers operating under the Foreign Supplier Verification Programs (FSVP) rule to conduct or obtain onsite audits of their suppliers.
The guidance the agency released yesterday outlines the circumstances under which FDA does not intend to enforce the requirement to conduct or obtain an onsite audit of a food supplier when the food supplier is in a country or region covered by a travel restriction or advisory related to the pandemic.
Even if an FSVP importer, receiving facility, or supplier believes that an onsite audit is the appropriate verification activity, or is due for an audit in a region covered by a government travel restriction/advisory, FDA does not intend to enforce audit requirements. The same holds true for areas where audits are impossible to conduct or obtain.
Receiving facilities or FSVP importers are advised to select an alternative verification activity such as sampling and testing food, or reviewing relevant food safety records, and modify their food safety plan or FSVP for the temporary changes.
FDA anticipates that receiving facilities and FSVP importers will resume onsite audits within a resasonable period of time and update their food safety plans and FSVPs accordingly. FDA intends to provide timely notice before withdrawing the current policy.
Last month, FDA halted foreign inspections, and limited domestic travel to "mission critical" only through the month of April. However, within the past several days, the virus has spread across the globe and grown at an exponential rate in over 100 countries including the U.S.
In the meantime, the agency issued a series of guidance documents for the production of animal and human food, as well as additional information on COVID-19 aimed at stakeholders. These changes are intended to prevent severe disruptions in the food supply chain while the public health emergency remains ongoing.
“FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities,” the agency said. “Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word ‘should’ in FDA guidance means that something is suggested or recommended, but not required.”
The three food regulations in particular which FDA intends to stop enforcing temporarily are Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (part 117).
The U.S. government has issued a “Level 4-Do Not Travel” advisory for China, and, on March 11, the government issued a “Level 3- Reconsider Travel” advisory for global travel. Other countries across the globe have even placed restrictions on domestic travel. These restrictions will impact the ability of receiving facilities and importers operating under the Foreign Supplier Verification Programs (FSVP) rule to conduct or obtain onsite audits of their suppliers.
The guidance the agency released yesterday outlines the circumstances under which FDA does not intend to enforce the requirement to conduct or obtain an onsite audit of a food supplier when the food supplier is in a country or region covered by a travel restriction or advisory related to the pandemic.
Even if an FSVP importer, receiving facility, or supplier believes that an onsite audit is the appropriate verification activity, or is due for an audit in a region covered by a government travel restriction/advisory, FDA does not intend to enforce audit requirements. The same holds true for areas where audits are impossible to conduct or obtain.
Receiving facilities or FSVP importers are advised to select an alternative verification activity such as sampling and testing food, or reviewing relevant food safety records, and modify their food safety plan or FSVP for the temporary changes.
FDA anticipates that receiving facilities and FSVP importers will resume onsite audits within a resasonable period of time and update their food safety plans and FSVPs accordingly. FDA intends to provide timely notice before withdrawing the current policy.
