The majority of both total funding and total staffing, however, is with the Food Safety and Inspection Service (FSIS) at the U.S. Department of Agriculture (USDA), which regulates most meat and poultry, and the Food and Drug Administration (FDA) at the U.S. Department of Health and Human Services (HHS), which regulates virtually all other foods. It then provides a detailed overview of the major provisions in the newly enacted law—the FDA Food Safety Modernization Act (FSMA, P.L. In the 111 th Congress, major food safety legislation—the subject of this report—was passed, focusing on changes related to FDA, not USDA. §§ 301 et seq.). The 110 th Congress made several amendments to FDA's food safety authorities, and increased funding for the primary food safety agencies, but more comprehensive food safety legislation was not enacted. FSMA generally expands or modifies existing FDA authorities under the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. Among its many provisions, the new law increases frequency of inspections at food facilities, tightens record-keeping requirements, extends more oversight to certain farms, and mandates product recalls if a firm fails to institute them voluntarily. FSMA requires food processing, manufacturing, shipping, and other regulated facilities to conduct an analysis of the most likely food safety hazards and to design and implement risk-based controls to prevent them. The new law requires the establishment of science-based "performance standards" for the most significant food contaminants. The new law also requires that additional registration information be submitted. Imported Food Safety . FSMA increases scrutiny of food imports, which account for a growing share of U.S. consumption; food import shipments must be accompanied by documentation that they can meet safety standards that are at least equivalent to U.S. standards. Such certifications may be provided by foreign governments or other so-called third parties accredited in advance. FSMA also contains provisions for certifying or accrediting laboratories, including private laboratories, to conduct sampling and testing of food, among other provisions. The law provides for limited amounts of fees and other offsets; its implementation will depend largely on discretionary appropriations. Some have already questioned whether an expanded investment in this area is appropriate in the current budgetary climate. 111-353), with Previously Existing Law
The 111th Congress passed comprehensive food safety legislation in December 2010 (the FDA Food Safety Modernization Act, or FSMA, P.L. 111-353). Although numerous agencies share responsibility for regulating food safety, this newly enacted legislation focused on foods regulated by the Food and Drug Administration (FDA) and amended FDA's existing structure and authorities, in particular via the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. §§ 301 et seq.). The new law does not directly affect activities at the U.S. Department of Agriculture (USDA), which oversees the safety of most meat and poultry.
FSMA generally expands or modifies existing FDA authorities rather than creating a new food safety structure or authorities. Among its many provisions, the new law will increase frequency of inspections at food facilities, tighten record-keeping requirements, extend more oversight to certain farms, and mandate product recalls if a firm fails to institute them voluntarily. The new law will require food processing, manufacturing, shipping, and other regulated facilities to conduct an analysis of the most likely safety hazards and to design and implement risk-based controls to prevent them. FSMA also will facilitate the establishment of science-based "performance standards" for the most significant food contaminants. Other provisions in the new law are also intended to improve the nation's foodborne illness surveillance systems. FSMA also mandates increased scrutiny of food imports, which account for a growing share of U.S. consumption; food import shipments will have to be accompanied by documentation that they can meet safety standards that are at least equivalent to U.S. standards. Such certifications might be provided by foreign governments or other so-called third parties accredited in advance. FSMA also contains provisions for certifying or accrediting laboratories, including private laboratories, to conduct sampling and testing of food, among other provisions. This report provides a detailed overview of these and other major provisions in the newly enacted law.
The 112th Congress will likely provide oversight and scrutiny of how the law is implemented, including FDA's coordination with other federal agencies. Implementation of the law will depend largely on the availability of discretionary appropriations, and some have questioned whether funding should be provided in the current budgetary climate. In addition, the 112th Congress may consider changes to other food safety laws and policies that continue to be actively debated in Congress. Continued congressional interest in reforming the nation's food safety laws and in monitoring food safety issues is expected, given other perceived problems with the current food safety system.