FDA has published two proposed rules to implement to provisions of the Food Safety Modernization Act (FSMA) related to the safety of imported foods.
See our memoranda on these two new proposed rules here and here.
One of the most important aspects of FSMA is the new approach it takes to ensuring the safety of imported foods. FDA officials have accurately described the change in how FDA regulates imported foods as a paradigm shift. Instead of relying primarily on inspection of imported foods at the port of entry, FDA will try to ensure the safety of imported foods before they reach U.S. shores. FSMA does this by requiring foreign producers to implement food safety plans (and requiring foreign farms to meet safety standards for fresh produce).
But, who will verify compliance by foreign manufacturers and food farms that export to the U.S.? FSMA requires FDA to increase the number of foreign inspections it performs, but FDA inspections will never reach most exporting facilities. The two proposed rules published this week explain how FDA will ensure compliance by “foreign suppliers”:
- The FSVP rule will require U.S. importers to verify their foreign suppliers; and
- The Third-Party Auditor/Certification Body rule will create a system for audits of foreign facilities by private auditors/certification bodies and accreditation of those auditors by FDA-recognized accreditation bodies. Actual audit standards await the development of FDA guidance documents. Certification of foreign suppliers by an accredited auditor/certification body may then be used by importers as a verification tool under the FSVP rule.
Below are some noteworthy features of the two proposed rules:
- The “importer” would be defined as the U.S. owner or consignee of the imported food at time of entry. If there is no U.S. owner or consignee, the importer would be the designated U.S. agent or representative of the foreign owner or consignee. Earlier reports that FDA would hold the importer of record responsible for foreign supplier verification turned out to be incorrect.
- How will FDA know who is the “importer” for each article of imported food? For each line entry of food, the importer would be required to ensure that its name and DUNS (Dun & Bradstreet Data Universal Numbering System®) number are provided electronically when filing entry with Customs.
- For most imported foods, the importer would be subject to a host of new requirements, including requirements to:
- Develop an FSVP;
- Maintain a written list of all its foreign suppliers;
- Review the compliance status of each imported food and foreign supplier (e.g., by reviewing FDA Warning Letters and Import Alerts);
- Conduct a hazard analysis for each imported food to identify hazards reasonably likely to occur in that food;
- Establish and follow written procedures for conducting foreign supplier verification activities;
- Review all complaints, investigate instances of adulteration and misbranding, and take corrective actions;
- Conduct a reassessment of the FSVP every 3 years; and
- Maintain a long list of required FSVP documents, make them available to FDA upon request, and send them to FDA electronically upon written request.
- FDA appears to believe that onsite audits are the “gold standard” for supplier verification. In the FSVP proposed rule, FDA is considering requiring annual onsite audits of foreign suppliers if the food being imported is one involving a hazard that poses a risk of serious adverse health consequences. In the preamble, FDA even hints that it might revisit the requirements for importers of seafood and juice products in its HACCP regulations and require annual onsite audits of foreign suppliers of those products.
- In the preamble to the FSVP proposed rule, FDA states that it “intends to align regulations implementing supplier verification under section 419 [preventive controls] and regulations implementing FSVP under section 805 to the fullest extent.” This suggests that some supplier verification requirements are likely to be included in the final rule on preventive controls for human food, even though they were not in the proposed rule.
- How will FDA use certifications issued by accredited third-party auditors/certification bodies? FDA will use them to: (1) establish a foreign facility’s eligibility to participate in the Voluntary Qualified Importer Program (VQIP), participants in which will benefit from expedited import processing; and (2) admit imported foods that require certification as a condition of admission. In addition, FDA proposes to allow importers to use regulatory audits of foreign suppliers by an accredited auditor/certification body to meet their FSVP requirements.
- Given these limited uses, foreign companies should not assume they will need to be audited and certified by an accredited auditor/certification body. In fact, the Third-Party Auditor/Certification Body proposed rule carries no effective date. It seems the system it creates would only have to come into play if FDA makes a determination that specific food imports require certification by an accredited auditor/certification body as a condition of admission under Federal Food, Drug, and Cosmetic Act (FD&C Act) § 801(q).
When a foreign facility is audited by an accredited auditor/certification body, FDA will receive copies of the audit report (for regulatory audits only) and lab test results, as well as notice of any serious food safety issues. Under the Third-Party Auditor/Certification Body proposed rule, accredited auditors/certification bodies would be required to report to FDA any conditions presenting a serious risk to public health identified during a food safety audit of a foreign entity. Auditors/certification bodies would also be required to send copies of their regulatory audit reports to FDA within 45 days of completing an audit. FDA says it will “use information from such audits for other related purposes in enforcing the FD&C Act.” Finally, auditors/certification bodies would be required to use accredited laboratories, and FSMA requires accredited labs to report test results directly to FDA.