On July 29, 2013, the US Food and Drug Administration published two additional proposed rules to implement fundamental provisions of the FDA Food Safety Modernization Act of 2011 (FSMA or the Act). These two proposals are intended to implement provisions of the Title III of the FSMA, which includes measures to improve the safety of imported food.
Specifically, the first proposed rule would implement Section 301 of the Act, which requires importers to have in place programs to ensure that imported food (for both humans and animals) meets the safety standards of the Federal Food, Drug, and Cosmetic Act (FFDCA). Under the proposed rule, each importer must establish, maintain, and follow a Foreign Supplier Verification Program (FSVP) for each food that it imports, unless otherwise exempted.
The second proposed rRule would implement Section 307 of the Act, which established a procedure for the accreditation of third-party auditors to certify that foreign entities in the import supply chain are in compliance with the FFDCA. Section 307 also requires FDA to develop a system for recognizing individual accreditation bodies, as well as model accreditation standards.
Foreign Supplier Verification Programs
For purposes of the FSVP proposal, an “importer” is defined as the US owner or consignee of the article of food when it enters the United States or, if there is no owner or consignee at the time of entry, the US agent of representative of the foreign owner or consignee. Accordingly, under the proposed definition, the importer of an article of food could be the importer of record as well.
Generally, an importer’s FSVP would be required to include the components outlined below:
- Perform Food and Supplier Compliance Status Review
Each importer would be required to review the compliance status of the food and the potential foreign supplier before importing the food, and periodically thereafter. Such a review would need to include determining whether either the food or the supplier has been the subject of any FDA Warning Letters, import alerts, or requirements for certification related to the safety of the food (which would be issued by FDA under FFDCA Section 801(q), as added by Section 303 of the Act). Other information relevant to the compliance status of a food or foreign supplier would include Establishment Inspection Reports, FDA Form 483s (inspectional reports), recall notices, and documents related to injunctions or seizures.
“Foreign supplier” would be defined as a facility that manufactures/processes the food, raises the animal, or harvests the food that is exported to the United States without further manufacturing/processing by another establishment that is not of a de minimis nature (e.g., adding labeling).
- Conduct Hazard Analysis
Each importer would be required either to analyze the hazards associated with each food that they import or to review and evaluate the hazard analysis conducted by the food’s foreign supplier. The hazard analysis must identify the hazards that are reasonably likely to occur with the food being imported and evaluate the severity of the illness or injury if such a hazard were to occur.
- Maintain a Written List of Foreign Suppliers
All importers would be required to maintain a written list of foreign suppliers from whom food is received and to establish and follow adequate written procedures for conducting the verification activities developed under the individual importer’s FSVP.
- Develop and Implement Appropriate Verification Activities for Hazards That Are Reasonably Likely to Occur
Each importer would be required to verify that the hazards identified in the hazard analysis as reasonably likely to occur are adequately controlled. If the importer’s hazard analysis concludes that there are no hazards that are reasonably likely to occur, then verification activities are not required to be implemented as part of the importer’s FSVP (although the FSVP would still need to be reassessed every three years, as noted below).
If the importer is going to control a hazard (instead of the foreign supplier or its own supplier controlling the hazard), the importer would be required to document at least annually that it has established and is following procedures that adequately control the hazard. If the importer’s customer is going to control a hazard, the importer would need to obtain written assurance at least annually that the customer has established and is following procedures that adequately control the hazard. The customer’s written assurance also would need to describe briefly how the customer is controlling the identified hazard.
For hazards that are not going to be controlled by the importer or its customer (that is, hazards that will be controlled by the foreign supplier), the FDA is proposing two options, and the Agency is seeking comment on the two proposed alternative options for supplier verification. The first option proposes different approaches for high-risk and other hazards, while the second option proposes giving complete discretion to the importer when determining the appropriate type(s) of verification activities for each identified hazard.
Under Option 1, if the foreign supplier is going to control the hazard at its establishment and there is a reasonable probability that exposure to the hazard would cause serious adverse health consequences or death to humans or animals (SAHCODHA), the importer would be required to conduct periodic onsite auditing of the foreign supplier (or obtain documentation of onsite auditing, using an accredited third-party auditor or other auditor).1 Further, for SAHCODHA hazards, onsite audits alone may not be sufficient to ensure that the hazard is adequately controlled, making it necessary for the importer to conduct one or more additional verification activities (as appropriate).
For non-SAHCODHA hazards that the foreign supplier controls (i.e., less serious hazards and hazards that the foreign supplier verifies have been controlled by its own supplier), under Option 1, the importer would have the flexibility to determine what verification activities are appropriate for the food product and its identified hazards, taking into consideration the risk presented by the hazard and the food’s and the foreign supplier’s compliance status. Verification activities could include onsite auditing of foreign suppliers, periodic or lot-by-lot sampling and testing of food, periodic review of foreign supplier food safety records, and/or other appropriate risk-based activities that the importer has identified as suitable to verify adequate control of the hazard.
Under Option 2, for all hazards that the foreign supplier is going to control (or verify that its own supplier is controlling), the importer would be permitted to select one or more verification procedures from those listed in the proposal. The importer also would be responsible for selecting how often to conduct those verification activities. The importer would need to make those verification decisions after considering the risk presented by the hazard, the probability that exposure to the hazard will result in serious harm, and the food’s and the foreign supplier’s compliance status.
- Conduct Investigative and Corrective Actions (as Needed)
Each importer would be required to review any complaints concerning the foods that it imported, investigate the cause(s) of the food’s adulteration or misbranding (with respect to allergen labeling), and take necessary corrective actions in the case of supplier non-compliance.
- Periodically Reassess the FSVP
Each importer would be required to reassess each FSVP every three years. However, if the importer becomes aware of new information about potential hazards associated with the food (for example, a change in the source of raw materials or product formulation), the FSVP would need to be reassessed at that time.
- Ensure Importer Identification at Entry
Each importer would be required to obtain a unique DUNS number from Dun and Bradstreet to ensure that its name and DUNS number are provided to US Customs and Border Protection (electronically) with each line entry of food that is offered for importation into the US.
- Maintain Records
Each importer would be required to keep certain records related to its FSVP for specified periods of time, and those records must be maintained in English.
Finally, FDA proposes the compliance date to be 18 months after the publication date of the Final Rule. In many cases, however, the importer would not be required to comply with FSVP requirements until six months after the foreign supplier of the food is required to comply with applicable final rules on the Preventive Controls for Human/Animal Food (while the Human Preventive Controls proposal was released in January 2013, but the parallel proposal for Animal Food has not yet been published).
Accreditation of Third-Party Auditors
Under the Proposed Rule on the Accreditation of Third-Party Auditors, FDA would recognize accreditation bodies, which would then accredit third-party auditors to conduct food safety audits and issue certifications for foreign facilities and food under two other import-safety provisions enacted by the FSMA. These certifications consist of (1) a certification required as a condition for importing foods previously determined by FDA to pose a safety risk under FSMA Section 303, and (2) a food facility certification that is necessary in order for an importer of a facility’s products to participate in the Voluntary Qualified Importer Program established under FSMA Section 302. The certification programs are intended to assist the Agency in making admissibility decisions for imported food products, and, in the case of facility certifications, to reduce the number of redundant food safety audits.
The Proposed Rule sets forth basic eligibility requirements for an entity to become an FDA-recognized accreditation body or an accredited third-party auditor (either of which can be foreign government agencies or private third parties). It also lays out the requirements that accreditors and auditors must meet when accrediting third parties and conducting audits of foreign food facilities and foods under the program, respectively.
FDA states that it will implement the accreditation program as soon as possible after publishing the Final Rule, as well as Model Accreditation Standards (which will be released separately and have not yet been issued in draft form). Once the program goes into effect, accreditation bodies would be able to apply for FDA recognition, and once FDA-recognized accreditation bodies begin accepting applications, third-party auditors could begin seeking the necessary accreditation to conduct regulatory audits for the issuance of certifications under the FSMA.