S.510 - FDA Food Safety Modernization Act111th Congress (2009-2010)
Summary: S.510 — 111th Congress (2009-2010)
Passed Senate amended (11/30/2010)
(This summary will be expanded.)
FDA Food Safety Modernization Act - Title I: Improving Capacity to Prevent Food Safety Problems - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the food safety activities of the Secretary of Health and Human Services (HHS), including to authorize the Secretary to inspect records related to food.
Exempts certain establishments that sell food directly to consumers, such as roadside stands, farmers markets or participants in a community supported agriculture program, from specified requirements of this Act.
Requires each owner, operator, or agent in charge of a food facility to identify and implement preventive controls to significantly minimize or prevent hazards that could affect food manufactured, processed, packed, or held by such facility. Sets forth provisions governing exemptions from such requirements for certain facilities.
Requires the Secretary to: (1) issue guidance documents to reduce the risk from the most significant foodborne contaminants; and (2) establish minimum standards for the safe production and harvesting of fruits and vegetables based on known safety risks. Authorizes the Secretary to issue exemptions and variances from such standards.
Directs the Secretary to assess and collect fees related to: (1) food facility reinspection; (2) food recalls; (3) the voluntary qualified importer program; and (4) importer reinspection.
Directs the Secretary to develop voluntary food allergy and anaphylaxis management guidelines for schools and early childhood education programs.
Title II: Improving Capacity to Detect and Respond to Food Safety Problems - Requires the Secretary to: (1) allocate resources to inspect facilities and imported food according to the known safety risks of the facilities or food; and (2) establish a product tracing system to track and trace food that is in the United States or offered for import into the United States.
Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to enhance foodborne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on foodborne illnesses.
Gives the Secretary the authority to order a recall of an article of food.
Title III: Improving the Safety of Imported Food - Requires U.S. importers to perform risk-based foreign supplier verification activities to verify that imported food is produced in compliance with applicable requirements related to hazard analysis and standards for produce safety and is not adulterated or misbranded.
Requires the Secretary to establish a program to expedite review and importation of food offered for importation by U.S. importers who have voluntarily agreed to participate in such program.
Authorizes the Secretary to: (1) require a certification that an article of food imported or offered for import complies with applicable requirements of this Act; and (2) enter into arrangements and agreements with foreign governments to facilitate the inspection of registered foreign facilities. Requires food to be refused admission into the United States if permission to inspect the food facility is denied by the facility owner, operator, or agent or the foreign country.
Sets forth provisions governing the establishment of a system to recognize bodies that accredit third-party auditors and audit agents to certify that foreign entities meet applicable FFDCA requirements for importation of food into the United States.
Title IV: Miscellaneous Provisions - Authorizes appropriations for FY2011-FY2015 for the activities of the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and related field activities in the Office of Regulatory Affairs of the Food and Drug Administration (FDA). Directs the Secretary to increase the field staff of such Centers and Office.
Establishes whistleblower's protections for employees of entities involved in the manufacturing, processing, packing, transporting, distribution, reception, holding, or importation of food who provide information relating to any FFDCA violation.