US Food Safety Bill to Become Law

A new US food safety bill signed into law this month will increase FDA authority over the US food supply and increase the application of scientific standards to food safety. The Food Safety Modernization Act is the country’s first major food legislation since 1938. The Act is expected to be signed by President Obama early next year. The bill affects food retailers, producers and importers, as well as food-testing laboratories.

The legislation applies to the 80% of the US food supply that is inspected by the FDA, excluding meat and poultry, which are inspected by the Department of Agriculture. A major provision of the Act is the authority given to the FDA for the first time to issue mandatory food recalls if a voluntary recall is not forthcoming. The Act also addresses food imports. For example, it states that if US inspectors are prevented from inspection of a foreign food-processing facility, the imported product processed at that facility can be denied US entry.

Among the bill’s programs targeting laboratories that conduct food testing is one to support lab accreditation. The Secretary of Health and Human Services (HHS), who oversees the FDA, is required to establish a program for food testing by accredited labs within two years of the Act’s enactment, including the development of model standards. The program would work to improve the number of qualified labs and allows for the accreditation of foreign labs. Food testing under the program is required to begin 30 months after of the Act goes into effect. Under the program, laboratories’ results would be electronically delivered directly to the FDA.

The Act also provides for the greater integration of labs conducting food testing. In an effort led by the Department of Homeland Security, the HHS, the Department of Agriculture, the Department of Commerce and the EPA would maintain common methods among laboratories for reducing the time to detect and respond to a foodborne-illness outbreak. Following the HHS’s submission every two years of a report to Congress about programs for food safety and security, another report detailing the efforts is required. This report must address laboratory analysis capabilities, including the development of lab capacity and faster analytical techniques.

The legislation also includes new efforts for the prevention and containment of intentional food adulteration. It requires that within 18 months of the Act becoming law, regulations be developed to protect against intentional adulteration and that guidance documents be issued within a year of the Act’s enactment. In line with protection of the food supply, the Act also requires the development of a National Agriculture and Food Defense Strategy. The Strategy is to be issued one year after the bill becomes law.

To advance food science, within one year of enactment, the Act provides for the establishment of five Food Safety Integrated Centers of Excellence located at selected state health departments and each created in partnership with a university. The Centers will serve as a food safety resource and provide services such as epidemiological and environmental-monitoring training, analysis of responsiveness, and educational activities. Regional Centers may also be designated. The legislation also provides for grants for improved food safety training, outreach and technical assistance. Among the grants listed are those administered by the National Institute for Food and Agriculture for fiscal 2011–2015 for enhancing food safety, which includes building laboratory capacity.

The Act also addresses produce standards, requiring the development of science-based minimum standards for the production and harvesting of certain raw fruits and vegetables. One year after the Act becomes law, a notice of the proposed rulemaking must be published, including guidance covering the production and harvest of fresh produce. Other major provisions for food-processing facilities include the new record-keeping and documentation requirements for hazard analysis and risk-based preventive controls.

The new legislation also specifies how often the FDA must inspect food-processing facilities. High-risk facilities must be inspected once in the first five years after the law’s enactment and every three years thereafter. Other facilities must be inspected within seven years of enactment and every five years thereafter. New requirements also apply to foreign food-processing facilities, 600 of which must be inspected one year after enactment. In each successive five-year period, the FDA must double the number of foreign facilities inspected.

Food imports account for 15% of the US food supply. Sixty percent of fresh fruits and vegetables are imported as well as 80% of seafood. Among the new requirements for food imports are risk-based verifications of foreign suppliers and import certifications. The HHS is also required within two years of enactment to develop a plan for foreign governments’ “technical, scientific and regulatory food safety capacity.”

The Act also gradually increases staffing for the FDA’s Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and the Office of Regulatory Affairs’ related field activities from at least 4,000 in fiscal 2011 to at least 5,000 by fiscal 2014. For food defense, an increase in field staff of 150 is required by fiscal 2011.

Funding for the Act has not yet been allocated and is far from guaranteed as a new Congress will be in place. The Congressional Budget Office estimated that the Act will cost $1.39 billion over five years.

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