Agribusiness Alert: FDA Proposes Significant Regulatory Rules under FSMA related to Imported Foods, the Accreditation and Auditing of Foreign Facilities, and the Verification of Importers


The Food and Drug Administration (FDA) released for public comment two significant regulations promulgated under the 2011 Federal Food Safety Modernization Act (FSMA). The new regulations relate to food produced and processed in foreign facilities and imported into the United States. Specifically, the regulations address the accreditation of third party auditors that will be required to certify the foreign facilities and the verification requirements of importers. The two regulations are discussed in more detail below:

  • Accreditation of Third-Party Audits/Certification to Conduct Audits. The proposed regulations provide for accreditation of third-party auditors to conduct food safety audits on foreign facilities and certify that the foreign facilities are in compliance with the FSMA (the “Accreditation Rule”). The third-party auditors can be accredited directly by the FDA or through their respective foreign governments if the foreign government regulatory agency satisfies the FDA requirements. The Accreditation Rule can be summarized as:
    • Accredited Foreign Regulatory Agencies/Accredited Third-Party Auditors.  The foreign regulatory agency and third party auditors must meet certain eligibility requirements to be accredited under the program.         
    • Monitoring Requirements and Oversight. The foreign regulatory agency and third party auditors must also monitor and provide oversight of the foreign facilities and the rule provides for the removal of the certificate if the agency and/or auditor fail to comply.
    • Notice Requirements. The agency and/or auditor is required to notify FDA if/when conditions in the foreign facilities may cause or contribute a serious risk to public health.
    • Volunteer Qualified Importer Program. The Accreditation Rule also promulgates regulations for a foreign regulatory agency or third party auditor to expedite the review and certification of a foreign facility. 
  • Foreign Supplier Verification Program. The Foreign Supplier Verification Program (the “Verification Rule”) attempts to regulate importers of food produced and processed in foreign facilities and imported into the Unites States. The Verification Rule can be summarized as:
    • Compliance Review. The importer will be required to review whether the foreign facility is in compliance with the FSMA.
    • Hazard Analysis. The importer will be required to analyze the potential hazards with the respective imported food and the severity if a hazard would occur. The importer would then be required to monitor the activities of the foreign facility to adequately assure that the identified hazards are controlled.   
    • Verification. Each importer will be required to obtain an identifier for their company and must ensure that each food product imported into the United States is registered under their identification number.
    • Recordkeeping. The importer will be required to maintain records of compliance, hazard analyses, foreign supplier verification activities, investigations and corrective actions.

The regulations remain subject to public comment. Comments are due by November 26, 2013. Final regulations are expected in 2014. 

Earlier this year the FDA promulgated regulations establishing science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms. The FDA also proposed rules establishing preventive controls for human food that focuses on preventing problems that can cause foodborne illness. A general discussion of the regulations can be found at: The public comment period remains open for certain portions of the proposed regulations.

A general discussion of the Federal Food Safety Modernization Act can be found at

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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