The FDA has finally released two Food Safety Modernization Act (FSMA) rules designed to improve the safety of imported foods. The rules will require that anyone importing food into this country must verify that the supplier is using prevention-based food safety practices. They must also create a system for certifying third-party auditors.
These rules will hopefully prevent outbreaks such as the hepatitis A outbreak linked to imported pomegranate seeds that has sickened more than 150 people in this country. Eight of the 19 multi state foodborne illness outbreaks that have occurred since FSMA became law in January 2011 have been linked to imported foods. The rules have been stalled at the Office of Management and Budget for more than 1-1/2 years.
The proposed rule for foreign supplier verification requires that importers must review the compliance status of the food and the supplier. Each imported food must be analyzed for the hazards associated with it. Importers must either audit the suppliers, sample and test the food, or review their safety records. In addition, importers must review complaints received, investigate the cause, and take corrective action. And detailed records must be kept, including hazard analyzes, document compliance status reviews, and reassessments.
For the rule on accreditation of third-party auditors, first the accreditation bodies must be recognized. This body can be a foreign government, agency, or private third-party group. The bodies must monitor performance of the auditors, assess and correct problems in its own performance, protect against conflicts of interest, and maintain and provide FDA access to their records. The auditors must ensure that their audits are competent and objective, submit reports to the FDA, and notify the FDA upon finding any condition that poses a serious risk to the public health.
FDA Commissioner Dr. Margaret Hamburg said in a statement, “we must work toward global solutions to food safety so that whether you serve your family food grown locally or imported you can be confident that it is safe.” Michael R. Taylor, deputy commissioner for foods and veterinary medicine at the FDA said in a statement, “FSMA provides the FDA with a modern tool kit that shifts the paradigm for imports, as well as domestic foods, from a strategy of reaction to one of systematic prevention.”
Christopher Waldrop of the Consumer Federation of America released a statement about the rules. “Assuring the safety of imported food is essential to help prevent foodborne illness and protect consumers. We look forward to reviewing the proposals carefully and providing comments to the agency.”
