January 4, 2011
On January 4, 2011, President Obama signed the FDA Food Safety Modernization Act into law. This legislation is the first major overhaul of the Food and Drug Administration’s food safety responsibilities since 1938 and is a first step towards modernizing FDA’s food safety program. It will take several years to put the law into effect and Congress will have to appropriate an additional $1.4 billion over the next five years to give the FDA the resources it needs to implement and enforce the law.
The law only covers foods under the FDA’s jurisdiction (including produce and processed foods.) It does not cover meat, poultry, or certain egg products that are regulated by the USDA.
Two provisions of the new law take effect immediately:
- The law gives the FDA mandatory recall authority when a food manufacturer refuses to initiate a product recall voluntarily.
- The law gives FDA inspectors enhanced authority to review a company’s food safety records if they suspect that the firm is putting adulterated product into commerce. (This is still not as much authority as USDA inspectors, who can review a meat or poultry company’s records at any time.)
Other major provisions of the new law need to be implemented and funded before they go into effect. The FDA will develop many of these pieces through a rulemaking process that includes public comment, and Congress must give the FDA resources to develop these programs and enforce them.
More important points about the legislation:
- The law establishes a schedule for FDA inspection of food processing facilities – after several years, the agency will inspect once every three years for “high-risk” food facilities and once every five years for “low-risk” facilities. The FDA has to determine how the risk categories are defined. (For comparison, USDA-regulated meat and poultry facilities are inspected daily.)
- The law requires food processors to develop food safety plans that reduce the possibility of putting adulterated food into commerce.
- The law directs the FDA to develop produce safety standards. Several provisions of the law direct the agency to consider organic standards, wildlife protection and conservation measures as they develop these standards.
- The law creates a grant program for training small processors and farmers to assist them as they come into compliance with the produce safety or food safety plan requirements.
- The law directs the FDA to create pilot projects for creating traceability programs for food.
- The law requires that food importers certify that the safety of the food they are bringing into the country meets U.S. standards.
- The law directs the FDA to double its inspection of foreign food facilities that export products to the U.S. every year, for five years. The FDA is scheduled to visit 600 foreign facilities in fiscal year 2011. The schedule outlined in the law would bring the total of foreign inspections to over 19,000 in fiscal year 2016.
- The law sets a target of 5000 food safety employees at the FDA by fiscal year 2014. To meet this target, it will need to hire about 2000 more food safety employees than the agency currently has.
- The law establishes whistleblower protections for the FDA and company employees who report violations of the law or other food safety regulations.
Protecting Food Safety and Small Farmers
There was a lot of controversy and discussion about the impact this law will have on small farms and small food processors. Food & Water Watch and many other groups advocated for a provision in the bill that exempts certain small processors and farmers from the food safety plan and produce safety requirements. To be eligible for this exemption, farms or businesses must gross less than $500,000 per year and sell a majority of their food products directly to consumers, restaurants and grocery stores within a 275-mile radius from their place of business (or the same state.) They must demonstrate that they are in compliance with state and local food safety laws. The exemption is removed if their products are implicated in a foodborne illness outbreak.