Compliance status review. Before importing the food and periodically thereafter, importers must review the compliance status of the food and the supplier. This includes the existence of any FDA warning letters, import alerts, and certain certification requirements.
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Explore This IssueOctober/November 2013
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Hazard analysis. Importers must identify and analyze any hazards that are reasonably likely to occur in each food and evaluate the severity of illness or injury that might develop.
Verification activities. To provide assurances that risks are controlled, importers must conduct verification activities such as onsite auditing of foreign suppliers; periodic or lot-by-lot sampling and testing; periodic review of foreign supplier food safety records; or other “appropriate” risk-based procedures. Instead of performing an audit, an importer may use an FDA inspection or inspection by a recognized food safety authority in the foreign country if it has been conducted within the previous 12 months.
Corrective actions. Importers must review any complaints they receive, investigate the cause or causes of adulteration or misbranding, take corrective actions, and revise their FSVPs if deemed inadequate.
Periodic reassessments. Importers must reassess their FSVPs at least every three years or sooner if they become aware of new information about potential hazards, such as changes to the source of raw materials or product formulation.
Recordkeeping. Importers must keep records documenting all of the above.
The food safety law exempts from FSVP imported juice and seafood from facilities that comply with HACCP regulations because importers are already subject to supplier verification requirements. “Requiring supplier verification for these foods under the FSVP regulations would be duplicative,” Taylor explains. Modified FSVP requirements apply to imported dietary supplements and components; food imported by “very small” importers or from “very small” foreign suppliers (having no more than $500,000 in annual sales); or food from a foreign supplier in good standing in a country whose food safety system is recognized by FDA as equivalent to that of the U.S. (such as New Zealand).
FSMA also requires FDA to establish a program for the Accreditation of Third-Party Auditors for foreign food facilities. In this, FDA will recognize accreditation bodies which, in turn, will accredit third-party auditors to conduct food safety audits and issue certifications for foreign facilities and food. The FDA is also developing draft model standards by which organizations would qualify for accreditation, such as minimum education and experience levels for their auditors and audit agents. By law, FDA is to look to already existing standards, such as international voluntary consensus standards and current practices of accreditation bodies.
The third-party auditor could be a foreign government, a foreign cooperative, or other third party as long as it has legal standing and meets other standards, such as for competency. Third-party auditors are to conduct “vigorous audits,” submit reports of audits used for certification purposes to the FDA, and notify the agency if they find any serious public health risks. This program will become the basis for the upcoming Voluntary Qualified Importer Program, which will allow expedited review and entry into the U.S. of food produced by certified foreign facilities. While the FSVP does not require importers to use accredited third-party auditors, the FDA anticipates that importers may increasingly rely on them once the program is in place.
The FDA estimates compliance with the new rules will cost the U.S. food industry about $500 million annually.
Pros and Cons
Reaction to the two rules from industry and trade groups has been generally, if cautiously, favorable. David Gombas, senior vice president for food safety and technology at United Fresh Produce Association, says, “Initially we don’t see any surprises in FDA’s draft rules on imported foods and third-party auditor accreditation. However, it’s important that we thoughtfully review them in a line-by-line fashion, including analysis of their interaction with other FSMA draft rules, to ensure they advance food safety and are workable for the industry.”