This advisory is published by Alston & Bird LLP to provide a summary of significant developments to our clients and friends. It is intended to be informational and does not constitute legal advice regarding any specific situation. This material may also be considered attorney advertising under court rules of certain jurisdictions. This week, the U.S. Food and Drug Administration (FDA) published two more proposed rules as part of the ongoing implementation of the FDA Food Safety Modernization Act (FSMA). Specifically, FDA published its proposed rules on (1) Foreign Supplier Verification Programs (FSVP) and (2) Accreditation of Third-Party Auditors. These rules are the third and fourth proposed rules that are cornerstones of the preventive food safety approach established under FSMA’s authorities. These rules also align with key components of the first two proposed rules on preventive controls and produce standards that FDA released back in January, both of which also focus on food safety risk reduction.
Oversight of Foreign Suppliers
The proposed FSVP rule would require all importers of food, unless exempt, to perform certain risk-based hazard analysis and verification activities to ensure effective control of safety risks associated with imported foods. Whereas FDA has historically focused on identifying food safety issues on entry, the purpose of these new import authorities is to make importers accountable for providing ongoing oversight and management of the safety risks they identify in their foreign supply chains.
Under the FSVP requirements, an importer must develop, maintain and follow an FSVP for each individual food it imports and periodically reassess and update its FSVPs every three years or as it becomes aware of new potential hazards associated with its imported foods. Each FSVP must include (1) a compliance status review of the food and potential foreign suppliers (including a review of warning letters and import alerts); (2) a hazard analysis to determine hazards reasonably likely to occur with each food (including injuries and illnesses possible); (3) verification activities demonstrating adequate control of the hazards identified (including onsite auditing of foreign facilities and periodic review of foreign supplier food safety records and testing of foods, dictated by the level of hazard identified according to two proposed verification schemes on which FDA is seeking comment); and (4) corrective actions for any complaints received. Moreover, importers would be required to provide a Dun & Bradstreet Data Universal Numbering System (DUNS) number to file its electronic entries with Customs and Border Protection and maintain records of having performed all of the above FSVP activities.
Although the FSVP requirements would apply to most imported foods under FDA’s regulatory jurisdiction, the proposed rules provide for both exemptions and modified requirements in certain limited circumstances. Importers of juice, fish or fishery products subject to hazard analysis and critical control points (HACCP) regulations, food for personal consumption, alcoholic beverages, food that is transshipped or imported for re-export, and food imported for research or evaluation are exempt from FSVP requirements. Under the proposed rule, modified requirements (though not the same in each instance) would also apply in the following circumstances:
- importation of dietary supplements or components (where the importer is subject to and in compliance with current good manufacturing practices for establishing and verifying specifications);
- importation of food by a very small importer or importation of food from a very small foreign supplier (less than $500,000 in annual food sales); and
- importation of food from a foreign manufacturer in good compliance standing with a food safety system that FDA has officially recognized.
Accreditation of Third-Party Auditors/Certification Bodies
The proposed rule on Accreditation of Third-Party Auditors/Certification Bodies establishes an additional mechanism to prevent harmful food from abroad from reaching domestic consumers. Ultimately, this accreditation program is designed to deputize third-party auditors to conduct food safety audits and issue certifications for foreign food facilities and the foods they produce. FDA expects this certification program to strengthen the safety assurances surrounding the global movement of food into the United States and enable more informed admissibility determinations.
Unlike the FSVP program, this proposed rule would not apply to importers, but instead establishes requirements for accreditation bodies and third-party auditors to ensure their competence and impartiality, free from financial interests or inducements. Although food importers will generally not be required to obtain certifications, importers may utilize these third-party audits to support their FSVP activities and FDA may later rely on these certifications to aid admissibility decisions under its still-in-development Voluntary Qualified Importer Program (VQIP). The proposed rule does not contain the accreditation standards themselves; rather, FDA will separately issue those in draft form and provide stakeholders with an opportunity to comment on its proposed accreditation standards. What this proposed rule does establish are the general eligibility requirements for recognition as either an accreditation body or thirdparty auditor. Accreditation bodies, which can be either a foreign government or a private third-party, would be charged with assessing third-party auditors for accreditation purposes. The proposed eligibility criteria would require, among other things, that both accreditation bodies and third-party auditors be accountable to FDA by submitting reports and notifications, such as the discovery of conditions posing serious health risks.
Under the current system, FDA does not review third-party food safety audits of foreign facilities, and there is no requirement for the submission of audit reports by third-parties to FDA. Under the proposed rule, however, accreditation bodies and auditors would be subject to extensive FDA monitoring and oversight, as well as revocation of accreditation for good cause.
Stakeholders have through November 26, 2013 to submit comments on these proposed rules. Although the FSVP proposed rule states that the regulations would become effective 60 days after the final rule is published in the Federal Register, FDA has proposed additional time—up to 18 months—for importers to come into compliance. Since the FSVP proposed rule is closely tied to the proposed rules on preventive controls and produce safety, compliance dates will hinge heavily on the implementation dates for final rules on preventive controls and produce safety. However, note that FDA plans to implement the Third-Party Accreditation rule as soon as possible after publication of the final rule and will separately publish final Model Accreditation Standards following the comments it receives on its draft standards, once issued.
Before November 26, when the comment period closes, companies relying on foreign suppliers or operating foreign food facilities should carefully review these proposed rules to raise any compliance challenges foreseeable with FDA. For example, companies should consider:
- whether Option 1 (requiring onsite auditing by an accredited auditor, FDA or a local authority having standards similar to FDA’s for microbiological hazards in raw agricultural fruits or vegetables and for hazards having a “reasonable probability” to result in serious adverse health consequences or death) or Option 2 (permitting importers to select the appropriate verification activity regardless of hazard level) is more feasible to adopt for FSVP verification activities;
- whether other types of foods should be exempt from or subject to modified FSVP requirements;
- whether the limited conflict of interest prohibitions on certain financial interests and inducements in the accreditation proposal are sufficient to ensure the independence of accreditation bodies and third-party auditors (as some financial interests are still permissible under the proposed rules); and
- whether the regulatory audit content requirements in the accreditation proposal are sufficiently descriptive to ensure uniformly prepared and meaningful reports to FDA to demonstrate whether or not a foreign entity complies with FDA’s food authorities.
While FDA has clearly put a great deal of work into drafting these proposed rules, stakeholders have an opportunity through their comments to shape the final rules in both of these areas.