The U.S. Food and Drug Administration (FDA) has begun to roll out new proposed rules pursuant to the Food Safety Modernization Act (FSMA) governing the importation of foreign foods. Specifically, the FDA has proposed rules creating a Foreign Supplier Verification Program (FSVP) and regulating the accreditation of third-party auditors. Taken together, these two proposed rules form a regulatory framework intended to bring internationally sourced food products destined for the United States in line with existing requirements for domestically sourced food. Per FDA, these rules are vital because the United States imports about 15 percent of its food supply (including 50 percent of fruit and 20 percent of vegetables) from about 150 different countries. The goal is for U.S. food importers to “achieve the same level of food safety as domestic growers and processors.”
The proposed rules are subject to a 120-day public comment period, ending Nov. 26, 2013, during which the agency will accept stakeholder input. The rules, outlined below, may be be accessed at www.fda.gov/fsma.
Foreign Supplier Verification Program
Pursuant to Section 301 of the FSMA, the FDA-proposed regulations require food importers to provide the FDA with adequate assurances that their foreign food suppliers provide the same level of food safety as that required of domestic food suppliers. Section 301 requires, for the first time, that food importers participate in a FSVP to verify that foreign food suppliers are using appropriate preventative controls. As the FDA explains, the FSVP requirement is consistent with the FSMA’s focus on “preventing food safety problems, rather than relying primarily on responding to problems after the fact.” Failure to comply with a FSVP could result in refusal of admission of the food into the U.S.
Who is affected?
For purposes of the FSVP, an importer is defined as the U.S. owner or consignee of the food at the time of entry, or, if there is no U.S. owner or consignee, the U.S. agent or representative of the foreign owner. The FDA appears to have been sensitive to the concerns of mere “importers of record,” some of whom may not be well positioned to take on the role of auditing their suppliers. In an introduction to the proposed rule, the FDA illustrates:
We agree with the majority of comments we received on how to define “importer,” which stated that the person who caused a food to be imported is the person who should be responsible for verifying that the food was produced in accordance with applicable U.S. safety requirements. This person has a direct financial interest in the food and is most likely to have knowledge and control over the product’s supply chain. This person is more likely to be the food’s U.S. owner (or consignee) than the importer of record for the food, which might be an express consignment operator with little to no knowledge of the safety regulations applicable to the products for which they obtain clearance from U.S. Customs and Border Protection (CBP).
What is required in a FSVP?
- Compliance Status Review: Importers, before importing a food, must review and document the status of the food and the supplier to determine whether the food would be appropriate to import. This documented status review would include a review of any FDA warning letters, import alerts and requirements for certification.
- Hazard Analysis: Importers must conduct and document a hazard analysis of the food to be imported. The importer must identify the hazards that are reasonably likely to occur with the food and determine the severity of potential illness associated with the hazard.
- Verification Procedures: Importers must maintain a written list of suppliers. If any hazards were identified in the hazard analysis, the importer is also required to establish written verification procedures. For hazards that are in the control of the importer or its customer, the importer must document, at least annually, the procedures taken to control the hazard. As for hazards not controlled by the importer or its customer, the FDA has proposed two alternative options. Under the first option, on-site auditing would be required for certain high-risk hazards whereas less serious hazards could be verified by various other activities, such as periodic sampling or review of the supplier’s safety records. Alternatively, under the second proposed option, an importer would be permitted to choose from among several verification activities and determine for itself how frequently such activities should be conducted, using its own risk-based analysis of the food product and supplier. Under both options, raw agricultural commodities that are fruits and vegetables would be subject to more specifically tailored audit activities for microbiological hazards.
- Review and Correct. Importers must review complaints, investigate adulteration or misbranding and take corrective actions.
- Reassess. Importers must reassess the effectiveness of its FSVP when the importer becomes aware of new information about hazards, or otherwise, every 3 years.
- Identification: An importer must ensure that its name and Dun and Bradstreet Data Universal Numbering System (DUNS) number is identified on each line entry of food product.
- Recordkeeping: Importers must maintain signed and dated records of all FSVP activities.
Exceptions and Alternatives
The FDA exempts certain food products and provides alternative procedures to avoid duplication of efforts where safety regulations are already in place or for administrative expediency when the safety risk is reduced. For example, imports of juice, fish and fish products (which are already regulated under the FDA’s Hazard Analysis and Critical Control Points procedures); food for personal consumption; alcoholic beverages; food that is not transshipped; food for re-export; and food for research or evaluation are exempt from the rule. Dietary supplements, low-acid canned food and small food importers would also be governed by modified procedures. And as an alternative to an on-site audit under the importer’s verification procedures, an importer may rely on results of an inspection of a foreign supplier conducted by the FDA or an officially recognized food safety authority.
Accreditation of Third-Party Auditors
The new proposed rules also allow the FDA to establish a third-party audit and certification program. Under the certification program, the FDA recognizes accreditation bodies that accredit third-party auditors and certification bodies that audit foreign food facilities and issue food and facility certifications. The audits are used for two primary purposes, both of which are further described under other sections of FSMA: (1) for participation in the FDA’s Voluntary Qualified Importer Program (VQIP), under which an importer may receive expedited review and entry of food into the U.S. if it imports food from facilities that have been certified by accredited third-party auditors; and (2) for mandatory certification of certain foods that the FDA has determined pose a food safety risk.
Under the proposed rule, facility audits by third-party auditors must be unannounced and include a records review, an on-site assessment and, where appropriate, an environmental or product sampling and analysis. If the auditor discovers a condition that could pose a serious risk to the public health, the auditor must notify the FDA immediately. If the auditor determines that the facility is in compliance with the applicable requirements, it may electronically issue to the FDA a certification for the facility, which may be valid for a maximum of 12 months.
The proposed rule also establishes eligibility requirements for accreditation bodies, certification bodies and third-party auditors and mandates various other accreditation and certification procedures, including procedures for the application, renewal and revocation of recognition and certification. The rule requires accreditation and certification parties to perform assessments of their respective accredited parties and certified facilities, as needed, as well as routine self-assessments. The rule also establishes and mandates recordkeeping and procedures to avoid conflicts of interest.
In a recent news release, the Grocery Manufacturers Association, a trade group representing food, beverage and consumer product companies, said the proposed rules “will place new and enhanced requirements on foreign suppliers and the accreditation of third party auditors that will help further protect the safety of food imported into the US.” However, some have raised questions as to what entities or individuals will be considered “importers” for purposes of the rule, because the importer will bear the burden of producing documentation and taking other actions to satisfy the new requirements being proposed. In addition, FDA Commissioner Margaret Hamburg and others have raised concerns regarding how the cost of the proposed rules should be borne. Lastly, some consumer advocates have criticized the extent to which the proposed regulatory structure relies on the ability of importers to self-regulate. Undoubtedly, these and other issues will be hotly debated during the rulemaking process.