FDA Food Safety Modernization Act:
Impact on processors and manufacturers

"We will of course continue to act to remove contaminated food from commerce, but the ultimate goal of our inspection and enforcement program must be to achieve high rates of compliance with prevention-oriented standards of the kind envisioned by [the new legislation], and to do this, we envision our investigators conducting a wider array of inspection activities than is common today and targeting those activities in ways that get the maximum compliance and public health bang for the buck."
-- Congressional Testimony , of Michael R. Taylor, Deputy Commissioner for Foods, Food and Drug Administration (FDA), May 6, 2010

As Michael Taylor's testimony given earlier this year indicates, the FDA, driven by sweeping new legislation, "plans to shift the focus of inspections from collecting evidence of food safety problems after they have occurred to ensuring that food companies are doing what is necessary to prevent problems in the first place." Additionally, if a company manufactures or processes food for consumption in the U.S., it will likely face significant new safety and recordkeeping requirements with a heavy focus on prevention. Some of these requirements are discussed below:


Registration or re-registration with the FDA on a biennial, for domestic or foreign firms.

Food safety plan

Development of a food safety plan at registered facilities that includes an analysis of hazards and a plan for implementing and monitoring preventative controls to mitigate risk. This may require the development of greater capacity to track and trace food and ingredients with faster response times. FDA will have access to a registered company's food safety plan. FDA will have access to additional records if there is a responsible believe the food may be contaminated and lead to serious adverse health effects or death.

Food defense plan

Create a food defense plan for vulnerable food that protects food from deliberate contamination through the establishment of robust controls.

Import scrutiny

Greater regulatory scrutiny of imported food including new certification requirements for certain high-risk foods. Companies will need to provide assurance that the food they import complies with the Food, Drug and Cosmetic Act, which will mean increased due diligence of foreign suppliers.

The FDA will be given increased authority and resources to enforce these new requirements. Inspection frequency will increase, as will the civil penalties for failure to comply.