Food Safety Modernization Act broadens FDA oversight and enforcement authority
Last May, a Government Accountability Office (GAO) report found room for improvement in the way the Food and Drug Administration (FDA) oversees the safety of U.S. food imports. Imports from more than 150 countries and territories constitutes 15% of the U.S. food supply – including 60% of fresh fruits and vegetables and 80% of seafood. The FDA physically examines about 1% of imported food.
Now the FDA Food Safety Modernization Act of 2010 (full text here), signed into law by President Obama January 4, expands FDA oversight and beefs up its enforcement authority over the food supply in general, and imports in particular.
Under the law’s Title I provisions, the FDA is empowered to collect fees for participation in a “qualified importer program.” An interim rule will direct the FDA to alert Customs and Border Protection (CBP) when food is refused admittance at one port to prevent its admittance at any port (“port shopping”).
Under Title II provisions aimed at building capacity to prevent food safety problems, the law mandates that the FDA inspect not fewer than 600 foreign food facilities in the first year of enactment. The number of inspected facilities is to double each year thereafter for the next five years. (In 2008 the FDA inspected 153 foreign food facilities out of an estimated 189,000.) The FDA has a year to study the feasibility of developing a unique identification number for each registered food facility and each broker that imports food. International systems for tracing food products will also be evaluated.
The law’s Title III provisions are focused on improving the safety of imported food and include:
- Requiring importers to perform food safety “supplier verification.” Importers of seafood, juice and low-acid canned food that comply with existing regulations are in compliance with the new requirement. (Section 301)
- Offering expedited review and importation of food for importers that meet standards for a voluntary “qualified importer program.” (Section 302)
- Authorizing the FDA to require certification of safety for high-risk food imports, and to refuse admission to imports lacking certification. (Section 303)
- Requiring that prior notice for an imported food include the name of any country that has refused entry to the food. (Section 304)
- Permitting the FDA to enter agreements with foreign governments to facilitate inspections of foreign facilities, and to refuse entry to food from facilities where inspection has not been permitted. (Section 306)
- Directing the FDA to recognize accredited third-party auditors to certify foreign food facilities are in compliance with U.S. food safety standards. (Section 307)
- Directing the FDA to establish offices in at least five foreign nations. (Section 308)