FDA Releases Strategy for Tackling New Food Safety Regulations

In an effort to meet the needs of the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration released a strategy document detailing the guiding rules for implementing the act.

The FDA strategy document was issued May 2, outlining the agency’s plans for internal procedures, new ways of implementing regulations at food and feed facilities, changes concerning produce safety and a new import system.

The document also addressed preventive control rules and the FSMA import tool kit, after the remaining FSMA rules are issued in 2015 and 2016.

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The FDA also outlined how the agency will approach inspection, as well as collaboration with other local, national and international agencies. The approach places an emphasis on voluntary compliance and other measures.

A recent post on the agency’s “FDA Voice” blog called the approach a “springboard for discussion.”

“The strategy that will make FSMA a success requires significant change in how we at FDA do our work and how we work with our partners,” wrote FDA officials Michael R. Taylor and Howard Sklamberg.

The changes also include internal governance revisions, establishing a new FVM Governance Board; a reorganized version of the Foods Program Executive Committee.

The board is organized to help facilitate collaboration between the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary medicine (CVM), and the Office of Regulatory Affairs (ORA) for decisions regarding FSMA implementation.

The internal governance changes at the FDA were implemented to ensure all field and headquarter operations are “working seamlessly and efficiently to achieve public health goals” officials say.

The strategy document also contains plans for implementing the produce safety and preventive controls rules and the new import safety system. It focuses on implementing and facilitating voluntary compliance methods and strategies that focus on public health outcomes.

Plans Aim To Meet Major Food Safety Goals

The changes are a part of the overall plans for the FSMA rollout. FSMA was signed into law in December 2010. It is considered the biggest change in food safety oversight in 70 years and offered the FDA sweeping powers act on food poisoning outbreaks.

It grants the FDA the authority to force recalls and the ability to perform inspections on both foreign and domestic manufacturing facilities. To that end, the FDA plans to inspect 50,000 foreign and domestic food production facilities by 2015.

It was prompted by significant foodborne illnesses which caused public confidence in the United States food supply to diminish greatly. Approximately 76 million foodborne illnesses occur each year in the U.S.

Outbreaks of foodborne illness are also a threat to economic well being of the food system.

As such, FSMA was introduced with a plan to increase the scope and reach of the agency over several years. It was estimated the bill will cost nearly $1.4 billion by the time all aspects are implemented.


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