The long-delayed food safety legislation introduced in the last Congress was signed into law by President Obama on January 4, 2011. The sweeping Food Safety Modernization Act gives the Food and Drug Administration (FDA) the right to require recalls of unsafe food products and provides greater federal oversight of food production; authorizes mandatory food recalls in cases of food-borne illnesses; and requires FDA to conduct inspections of food manufacturers on a more frequent basis and to require that food processors have food-safety plans.

While much of the focus has been on how the law will affect domestic producers, foreign producers can expect significant new requirements if they plan to export food to the United States. Some of the most significant provisions of the new law for foreign producers and US importers are:

• Food importers must have a program in place to verify that imported food is produced in accordance with US requirements, is not adulterated, and does not contain undeclared allergens. FDA is required to issue guidance on the development of foreign supplier verification programs and to promulgate regulations in this area. FDA would be required to publish a list of importers participating in the program. Importers of foods governed by the Hazard Analysis and Control Point System (HACCP) (such as seafood, juice, and low-acid canned foods) would not be subject to this requirement.
• FDA is authorized to establish, in consultation with Customs and Border Protection (CBP), a program for expedited review and importation of products from importers voluntarily participating in a qualified importer program. Participation in the program would require third-party certification, a consideration of the compliance history of the foreign supplier, and other factors.
• Third-party certification may be required for imports, based on risks associated with the type of food, or a finding by FDA that a given country’s food safety system is inadequate. If FDA determines third-party certification is necessary, FDA must identify the inadequacies and establish a process for the foreign government to inform the agency of improvements to its program.
  
  Third-party certification would include FDA-approved accreditation bodies to evaluate and accredit third-party auditors. The third-party auditors would certify foreign facilities meet US food safety requirements. FDA would be authorized to monitor auditors, conduct its own inspections, and review inspection reports generated by third-party auditors.
• FDA is authorized to enter into agreements with foreign countries to facilitate the inspection of registered foreign facilities and require that inspection resources be directed to those facilities that present the highest risk.
• FDA is required to coordinate with CBP on any food refused admission into the United States to prevent port shopping.

Imported food accounts for roughly 15 percent of the US food supply according to the US Department of Agriculture. Certain food sectors account for even more. For example, about 80 percent of the nation’s seafood and one-third of the fruit and nuts are imported. In addition, foreign ingredients are included in many foods that are produced in the United States, such as cereals.

There is still a question regarding how the FDA will enforce the new law. New regulations need to be promulgated to implement the law. Also, as of yet, no funds have been appropriated to the FDA to allow it to exercise its new authorities. FDA currently has only enough inspectors to inspect about one percent of the food imported into the United States, and will need to hire more inspectors to carry out the new law’s import inspection requirements. Given that the new Republican-led House of Representatives has expressed misgivings about the bill, it is possible that the FDA will not receive the funds to hire new inspectors or to perform its other new obligations under the Food Safety Modernization Act.

Arent Fox will monitor implementation of the new food safety laws and will provide updates of the most important points for food producers and importers. If you have questions about the new food safety legislation, please contact the Arent Fox attorney with whom you work or a member of Arent Fox’s International Trade Practice Group.