USFDA-Food Safety Modernization Act

The FDA Food Safety Modernization Act represents the most significant expansion of food safety requirements and FDA food safety authorities since the original enactment of the FD&C Act in 1938. It grants FDA a number of new powers, including mandatory recall authority, which the agency has sought for many years. The FSMA requires FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks. Therefore, implementation of the legislation is likely to take several years. An attachment to this memorandum identifies which provisions of the law are self-implementing and which provisions will require FDA regulations to implement.

The FSMA is divided into four titles: prevention of food safety hazards, detection of and response to food safety problems, improving the safety of imported foods, and miscellaneous provisions.

The following are key provisions of the new law:

  • New regulatory requirements
  • Food facilities are required to register with FDA biennially. Food from an unregistered facility may not be imported into the United States or introduced into interstate or intrastate commerce.
  •  Registered food facilities are required to conduct hazard analyses and to develop and implement written preventive controls plans.
  •  Registered food facilities must maintain additional records, including copies of their hazard analyses and preventive controls plans, related records, and additional records to assist FDA in tracking and tracing high-risk foods.
  •  Food importers are required to implement foreign supplier verification programs and to take steps to verify that the food they import is safe.
  •  Food facilities and food importers are subject to new fees, including a fee to be paid by each domestic food facility or importer that undergoes a re-inspection because of a material non-compliance identified during an initial inspection.
  •  Laboratory tests to be used for regulatory purposes must be performed by either a Federal laboratory or an accredited non-Federal laboratory, and lab test results must be sent directly to FDA.
  •  Food facilities will be inspected with greater frequency and not less often than once every 5 years.

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