Food and agribusiness survey

The US Food and Drug Administration and FSMA

The FSMA/protecting food safety

The Food Safety Modernization Act (FSMA), enacted on January 4, 2011, is the US Food and Drug Administration's most sweeping reform in over 70 years. FSMA gives the FDA a new public health mandate in response to the changes that have occurred in the global food system over the last 25 years. It incorporates a greater scientific understanding of foodborne illness and its consequences, recognizing preventable foodborne illness as a significant public health problem and a threat to the economic health of the food system.

FSMA is based on the need to protect food safety in the global food system.

It requires the FDA to implement new rules and mandates in the following areas:

  • prevention
  • inspection and compliance
  • agency response
  • importation

The FDA/ drafting new rules

The FDA is in the process of drafting appropriate rules and guidance, which will underpin the standards required by FSMA. The industry will need to put systems in place to comply with these rules.

The FDA/inspection mandate

FSMA provides the FDA with a fresh mandate covering the frequency with which food and feed facilities are inspected and its public health prevention framework calls for a complete change in the FDA's use of its inspection authority. As a result, the FDA is set to adopt a wider range of inspection, sampling, testing, and other data collection mechanisms.

The FDA/enforcement tools

New enforcement tools are now available under FSMA – including mechanisms for administrative compliance and judicial enforcement – and the FDA will make use of these tools.

FSMA gives the FDA the authority to suspend food facility registrations. It exercised this power for the first time in 2012 with the suspension of Sunland Inc (a New Mexico producer of nuts and nut-and-seed spreads whose plant was connected to a salmonella outbreak that affected some 35 people across 19 states) and is expected to enforce compliance still more often in the future.

The FDA has not yet taken a great deal of action under FSMA, but that could all change soon.

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