Explore this issueOctober/November 2013
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Major U.S. food industry associations and consumer groups are guardedly optimistic that the FDA’s recently proposed regulations on import safety and third-party auditors will improve the safety of food products obtained from foreign countries. But experts also warn that the additional costs of complying with the new rules including obtaining audits and certifications, recordkeeping, and reporting will be passed onto consumers through higher prices.
The draft regulations, published in the Federal Register on July 29, 2013 to implement portions of the Food Safety and Modernization Act (FSMA), are intended to hold imported food to the same safety standards as domestically produced products. But there are also concerns that foreign companies will be held to more stringent requirements, such as undergoing audits by independent third parties. This, some experts say, might spark complaints from major trading partners because U.S. companies are not subject to the same requirements.
“If the U.S. is to stay commensurate with the World Trade Organization, whatever the U.S. government will require of foreign facilities also needs to be required of domestic companies,” says Craig Henry, a director at Deloitte & Touche LLP. “However, the third-party accreditation rule focuses only on foreign facilities. Therefore, it may be possible for U.S. trading partners to raise concerns unless U.S. exporters are held to the same standards,” Henry tells Food Quality & Safety magazine.
David Acheson, MD, director of the food and import safety practice at Leavitt Partners and a former FDA associate commissioner of foods, agrees. “We may see some pushback on trade issues. The biggest red flag is that we’re going to require importers to do different things and, on the face of it, it isn’t equal,” Acheson tells Food Quality & Safety. “We will see more noise and traction around that than anything else.”
Under the new proposed rules, U.S. importers, for the first time, must verify that their suppliers are meeting U.S. food safety requirements no matter where food is produced. In general, importers would be required to have a plan in place for each imported food, including identification of likely hazards associated with each food, and conduct activities to reasonably assure that those hazards are adequately controlled. “These proposed rules, as envisioned by the statute, rely on strong partnerships with industry and foreign governments to ensure the safety of their food products,” says Michael R. Taylor, deputy FDA commissioner for foods and veterinary medicine.
The need for such controls is growing. About 15 percent of all U.S. food is imported, including 80 percent of seafood, about 50 percent of fresh fruits, and 20 percent of fresh vegetables. Despite this volume, FDA physically inspects less than 2 percent of all food imports. The two new rules “will help prevent food safety problems before foods arrive in the U.S. instead of relying primarily on catching problems at the port,” Taylor tells Food Quality & Safety. “They are central to the FDA’s vision of a system that provides significantly elevated assurances about the safety of food consumed in the United States moving in international trade and creates a level playing field for producers and processers in the United States and abroad.”
This might spark complaints from major trading partners because U.S. companies are not subject to the same requirements.
FSMA requires FDA to create the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP) and Accreditation of Third-Party Auditors. The FSVP defines U.S. importers as either the U.S. owner or consignee at the time of entry, the U.S. agent, or the U.S. representative of the foreign owner or consignee. The importer is required to develop, maintain, and follow a verification program for each food it imports (unless the food is exempted). Some of the required activities include the following.