The U.S. Senate has passed new legislation that would give the FDA vastly increased powers to prevent food poisoning outbreaks.
In a 75-25 bipartisan vote, the Senate approved the Food Safety Modernization Act (S. 510), which would increase the number of foreign and domestic facilities that the FDA inspects annually and would allow the FDA to force recalls of contaminated food.
If the bill is to make it to President Barack Obama’s desk before the end of the current session, the House of Representatives now must decide whether to approve the Senate version of the bill without a conference.
The House passed an earlier version of the bill in 2009, but the Senate version has significant changes that include an exception for some food producers who have annual revenue of less than $500,000. Democrat Senate leaders say they have had assurances that the House will approve the Senate version.
President Obama is a supporter of the bill and has urged the House to act quickly.
Provisions in the bill include a schedule to inspect 50,000 foreign and domestic food production facilities by 2015 by either the FDA or state, federal or local agencies acting on the FDA’s behalf. In the first year alone, the FDA would inspect 600 foreign facilities, an area where the agency has performed poorly in the past. That number would double each year for five years.
Another major provision would give the FDA the power to order direct recalls of food suspected of being contaminated, greatly reducing the current bar federal regulators have to meet to require a recall. Currently, the FDA relies mostly on food manufacturers to voluntarily recall contaminated food from shelves.
The bill has received wide support from the food industry, although smaller producers have complained that the bill may put them at a disadvantage to larger companies. Although the bill has enjoyed bipartisan support, there are some Republicans who believe the bill will be too much of a burden on growers and food producers, and fear that the FDA will become “trigger happy” with its newfound recall power.
There are approximately 76 million foodborne illnesses each year in the United States, according to a report released in June, “Enhancing Food Safety: The Role of the Food and Drug Administration,” which was requested by Congress. Those illnesses cause more than 300,000 hospitalizations and 5,000 deaths annually.
For the FDA to properly regulate an estimated 80% of the nation’s food supply, the agency’s food safety departments need to be restructured to fit a risk-based approach that coordinates data and expertise to quickly find the weak links in the food production and distribution chains where contamination and other problems are most likely to occur, analysts said in the report. Then the agency would be able to quickly and efficiently target the problem areas with the necessary resources and increase its chances of catching dangerous, and sometimes deadly, food outbreaks before they occur.
The Congressional Budget Office (CBO) estimates that the new bill would cost $1.4 billion over five years. The U.S. Centers for Disease Control and Prevention estimates that foodborne illnesses cost the country $152 billion annually.
The bill was propelled to the forefront of the Senate’s agenda following a national egg recall that federal investigators estimate sickened about 1,500 people with salmonella. One of the egg farms implicated in the outbreak had a long history of FDA violations.