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Safety Zone By James Marsden
James Marsden is Kansas State University Regent’s Distinguished Prof. of Food Safety.

FDA’s proposed regulations on food safety

(The views and opinions expressed in this blog are strictly those of the author.)

Last week, the US Food and Drug Administration published two new food safety regulations as part of the implementation of the Food Safety Modernization Act of 2011.

The first proposed regulation would require food manufacturers to develop written food safety plans designed to prevent contamination of food products sold in the US. The rule would impact US food companies as well as companies in other countries that export foods to the United States. Food manufacturers would also be required to develop corrective action programs to deal with contamination when it does occur.

The second proposed regulation requires growers of fruits and vegetables to adopt science based methods for growing and harvesting that reduce the risk of contamination in these products. According to the proposal, large farms will have 26 months to comply after the rule becomes final.

The FDA will receive public comments on the proposal for the next 120 days and will then finalize the rules.

The proposed regulations represent a major change in approach for FDA. The emphasis is on prevention of foodborne hazards versus audits of food safety records and investigations of foodborne disease outbreaks. The written food plans will be subject to FDA review and will require all food manufacturers to address food safety hazards proactively.

In a press release announcing the proposed rules, Health and Human Services Secretary Kathleen Sebelius stated that "The FDA Food Safety Modernization Act is a common-sense law that shifts the food safety focus from reactive to preventive”.

The written food safety plans that will be required are largely based on the principles of HACCP. Most US food companies are already operating under HACCP systems and should readily comply with the new regulations when they go into effect. Small companies may require assistance in the development of written food safety plans that meet FDA requirements.  Small companies may also be impacted record keeping requirements that will likely increase and there may be a need for onsite food safety expertise.

 In my view, the biggest challenge for FDA will be the evaluation of plans developed by overseas food companies. The agency will also have to determine whether the plans actually reflect the company’s operations. The resources at FDA are already strained and the task of reviewing and approving written food safety plans from countries around the world may overwhelm those resources.  A third regulation will be published in the future to deal with the issue of verification for imported foods.

The issue of new revenue for FDA is still unresolved. Clearly, the Food Safety Modernization Act represents the biggest change in our nation’s food safety system since the passage of the Food, Drug and Cosmetic Act in 1938. FDA will need additional resources to properly implement and oversee the regulations associated with the Act. Food companies should expect to see registration fees and/or user fees at some point in the future. 

 

 

 

1/14/2013

 
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