By DOUG SCHMITZ
KNOXVILLE, Tenn. — A new U.S. Food and Drug Administration (FDA) rule will impose stricter health regulations for importers, holding them solely responsible and accountable for their products’ food safety.
“In fiscal year 2011, nearly 10.5 million product lines of food – representing unique food products – were imported into the United States,” wrote Daryll Ray and Harwood Schaffer of the Agricultural Policy Analysis Center at the University of Tennessee-Knoxville, of the new rule, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP).
“Human and animal food constitutes nearly 40 percent of all imported product lines regulated by the FDA. About 15 percent of all food consumed in the United States is imported, including approximately 50 percent of fresh fruit and 20 percent of fresh vegetables.”
According to Ray and Schaffer, FSVP is one of two new food safety rules published by the FDA in the Federal Register on July 29, complementing two proposed rules the agency issued in January. Under FSVP, importers will be required to certify to the FDA the human and animal food they import meets the same safety standards as food grown and processed in the United States. “All four of these proposed rules have been developed by the FDA in accordance with the Food Safety and Modernization Act (FSMA), with more to come,” they added.
With the other rule, Accreditation of Third-Party
Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications, third parties will be able to conduct “food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce.”
Ray and Schaffer said the FSVP regulations “would require importers to help ensure that food imported into the United States is produced in compliance with processes and procedures.”
The rule will include “reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under the hazard analysis and risk-based preventive controls and standards for produce safety sections of the Federal Food, Drug and Cosmetic Act (the FD&C Act), is not adulterated and is not misbranded with respect to food allergen labeling.
“Given the occasional foodborne illness outbreaks that have resulted from imported foods and the melamine contamination of pet food, it is clear that Congress is not likely to provide the FDA with sufficient funds to hire enough inspectors to examine all of the food arriving at U.S. ports of entry, nor does that make good sense,” the authors wrote. “What the FSVP proposed rule does is turn the food safety paradigm on its head.
“Instead of the cat-and-mouse game that expects port inspectors to find the unsafe food that is coming across the border, it makes sense to put that responsibility for the safety of imported food on the importers who have the necessary contacts with foreign producers and manufacturers,” Ray and Schaffer added.
In its brochure Strengthening Oversight of Food Imports, the FDA wrote: “Importers would have to establish that the foods being imported to the United States have been produced in a manner consistent with U.S. standards.”
It requires that importers:
•Identify hazards associated with each food
•Conduct or obtain documentation of verification activities that could include on-site auditing, sampling and testing, to provide adequate assurances the identified hazards are being controlled
•Take appropriate corrective action if hazards are not being adequately controlled
Ray and Schaffer wrote this shift in making the importers and their foreign food producers and processors responsible for meeting U.S. food safety standards also shifts costs that traditionally have been borne the public at large to those providing the food.
In addition, the whole focus of the FSMA shifts the costs of foodborne illnesses from treatment to prevention, potentially having a positive impact on health care costs in the United States.
To accommodate small-scale importers and small-scale foreign producers, the FDA has modified the requirements in such a way that these entities can participate in the market, while at the same time assuring the public the imported food they eat is safe.
“The understanding that the principal responsibility for food safety resides with industry forms the basis of our proposed regulations implementing not only the FSVP provisions but also the preventive controls and produce safety provisions of FSMA,” the FDA said in its proposed rule on FSVP.
The FDA would maintain control of this process by recognizing bodies that accredit third-party auditors who do the audits of foreign food facilities and issue the food and facility certifications. Many of the needed accreditation bodies have already been established in response to industry needs. This, the FDA wrote, “will help assure us of the validity and reliability of certifications and other information resulting from the food safety audits they conduct.”