Senate Advances Food Safety Reform Bill
The Senate Health, Education, Labor and Pensions Committee unanimously approved by voice vote Nov. 18 legislation that would overhaul efforts to ensure the safety of imported and domestic food. The bill now moves to the full Senate, though it is unclear whether it will come up for a vote before the end of the year. The House passed its food safety legislation earlier this year.
As passed by the HELP committee, the FDA Food Safety Modernization Act (S. 510) includes the following provisions.
- requires importers to verify the safety of foreign suppliers and imported food and prohibits imports of food by importers who do not have such a program in place
- increases FDA inspections at all food facilities, including annual inspections of high-risk facilities and inspections of other facilities at least once every four years, and allows FDA to enter into agreements and arrangements with foreign governments to facilitate the inspection of foreign facilities
- expands current registration requirements by requiring all food facilities to register and renew that registration biennially and empowers the FDA to suspend a food facility's registration if there is a reasonable probability that food from that facility will cause serious adverse health consequences or death
- allows FDA to require certification or other assurance of safety for high-risk food imports and to deny entry to foods that lack certification or that are from a foreign facility or country that has refused U.S. inspectors
- allows FDA to administratively detain any food that is misbranded or adulterated under the Federal Food, Drug and Cosmetic Act
- requires prior notice for an imported food to include the name of any country that refused entry to the food
- gives FDA the authority to order a mandatory recall of a food product when a company fails to voluntarily recall the product on its own when a food is adulterated or contains undeclared allergens and will cause serious adverse health consequences or death to humans or animals
- creates a Voluntary Qualified Importer Program in which importers with a certification of safety for their foreign supplier can pay a user fee for expedited entry into the U.S.
- directs FDA to recognize accreditation bodies to accredit third parties to certify that foreign food facilities are in compliance with U.S. food safety standards and allows third-party certification to be used to participate in the Voluntary Qualified Importer Program or to fulfill import certification requirements established by FDA
- allows FDA to assess fees for compliance failures (recalls and re-inspections)
- requires all laboratory testing done for FDA regulatory purposes to be conducted by either an FDA lab or a lab accredited by an FDA-recognized accreditation body
- gives FDA expanded access to food facility records if it has a reasonable belief that a related article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals
- requires FDA to establish pilot projects to test and evaluate new methods for rapidly and effectively tracking and tracing fruits and vegetables and processed foods
- gives FDA the authority to set commodity-specific standards for the safety of fresh produce
- directs FDA to establish offices in at least five foreign nations
- increases funding for FDA food safety activities and directs FDA to incrementally increase field staff by 2014
Press sources report that committee members approved a handful of amendments to the bill before passing it but that none of these made substantive changes to the above provisions.