FDA Releases Proposed Rules on the Foreign Supplier Verification Program and the Accreditation of Third Party Auditors
The FDA published today, July 26, proposed regulations implementing the Foreign Supplier Verification Program (FSVP) and Third-party Auditor Accreditation under the Food Safety Modernization Act (FSMA). Under the proposed rules, the importer or its U.S. agent must provide assurances that imported food meets FSMA standards or face denial of entry and/or eligibility to participate in FDA’s voluntary qualified importer program (VQIP) for expedited review and entry of food, which is currently in development.
The FDA’s 175-page tome on the FSVP sets forth details of the importer’s obligations under the proposed rule, placing for the first time the responsibility for ensuring the safety of imported food squarely on the shoulders of the importer or, if foreign, the importer’s U.S. agent.
The FDA’s 217-page proposed rule on the Accreditation of Third-party Auditors further details the requirements and circumstances guiding FDA’s use of certifications from accredited auditors in determining whether to admit certain imported food into the United States. The rule contains requirements for accreditation bodies seeking FDA recognition as well as requirements for third-party auditors seeking accreditation.
Proposed Rule on FSVP
The proposed rule on the FSVP requires that U.S.-based importers or the U.S. agents of foreign importers:
- Investigate the compliance status of their suppliers, including determining whether the suppliers have received FDA warning letters and import alerts or are the subject of certification requirements under the Food, Drug and Cosmetic Act;
- Analyze the hazards associated with each food they import and evaluate the likely scope of illness or injury should a hazard occur;
- Engage in verification activities such as on-site auditing of foreign suppliers, lot sampling and testing of food, and supplier food safety records reviews;
- Maintain a list of foreign suppliers and create and follow written procedures for verification activities;
- Have a mechanism for reviewing and investigating complaints and take appropriate corrective actions;
- Review and revise their FSVP every three years or more often if problems arise;
- Obtain a DUNS number to be provided with entry filings; and
- Maintain records substantiating compliance with all FSVP required activities.
The proposed rules on the FSVP also set forth a risk-based approach to foreign supplier verification, based on who is to control hazards that are reasonably likely to occur.
Relieved from certain FSVP requirements are importers of dietary supplements, very small imports, and importations from food suppliers in good compliance standing that the FDA has officially recognized as comparable to counterparts in the United States.
The proposed rule would exempt from FSVP requirements certain juice and seafood from facilities in compliance with federal safety regulations, food imported for research, food imported for personal consumption, alcoholic beverages, and food that is imported for further processing or transshipped.
Proposed Rule on Accreditation of Third-Party Auditors
FDA anticipates using certifications issued by accredited third-party auditors to facilitate VQIP in order to provide for expedited review and entry of food into the U.S. To participate in VQIP, importers must import food from certified facilities. In addition, under FSMA, FDA has authority to require certification under the Food, Drug and Cosmetic Act as a condition of entry for certain foods that FDA has determined pose a food safety risk. Such certifications may be provided by an accredited third-party auditor.
The proposed rule on the Accreditation of Third-Party Auditors contains:
- Procedures for recognition and accreditation;
- Requirements relating to monitoring and oversight of participating accreditation bodies and auditors; and
- Requirements relating to auditing and certification of foreign food facilities and food under the program and for notifying the FDA of conditions in an audited facility that could cause or contribute to a serious risk to the public health.
Apart from the proposed rule, FDA will also issue draft model accreditation standards to specify what qualifications a certification body must have to receive accreditation. The FDA will look to the standards in place when FSMA was enacted for guidance, and will issue the Model Accreditation Standards in draft and open a docket to accept comments. Following review and consideration of comments received, FDA will finalize the standards.
Sandler, Travis & Rosenberg, PA has created a white paper setting forth additional details. Download copy below.