Senate passes food safety overhaul by wide margin

Robert Roos

Nov 30, 2010 (CIDRAP News) Ending months of delay, a large bipartisan majority in the US Senate today passed a bill that aims to make the nation's food supply safer by giving the Food and Drug Administration (FDA) more authority over food producers and requiring large producers and processors to develop detailed food safety plans.

To become law, the bill now must be reconciled with a more stringent House bill before this session of Congress ends in December. Sen. Tom Harkin, D-Iowa, who helped shepherd the bill through the Senate, said recently that House leaders told him they would accept the Senate version if it gained bipartisan support.

The bill clearly did that, passing this morning on a 73-25 vote, after the chamber brushed off a series of amendments. One of them would have replaced the entire bill with a much more modest measure authored by Sen. Tom Coburn, R-Okla.; that measure failed on a 36-62 vote.

After the Senate approved the bill, called the FDA Food Safety Modernization Act, Harkin said in a floor speech, "Today we've taken momentous steps to modernize food safety in America. This bill gives the FDA the authority the agency needs to protect Americans from foodborne illnesses. We have to now ensure that FDA has adequate resources to fulfill their profound responsibilities."

The movement to strengthen the FDA's food safety powers grew through a string of foodborne illness outbreaks in recent years, tied to products such as spinach, green onions, peanut butter, peppers, tomatoes, and eggs. The Senate bill had broad support from both consumer and public health groups and food industry groups, many of which praised the vote today.

"The biggest point with the whole bill is that it really changes how the FDA addresses food safety because it allows them to be a preventive agency rather than a reactive one," Chris Waldrop, director of the Consumer Federation of America's Food Policy Institute, told CIDRAP News.

The bill requires the FDA to inspect food facilities more often, empowers the agency to require food recalls instead of requesting them, expands its access to food facility records, and requires food producers and processors to identify possible hazards and develop prevention plans. The legislation also aims to make imported food safer by calling for more inspections of foreign food production facilities and requiring importers to verify the safety of foreign suppliers and imported food.

Some other elements of the bill, as summarized in a statement from Sen. Dick Durbin, D-Ill., one of its leading sponsors, are as follows:

It provides for laboratory accreditation bodies to ensure that US food-testing labs meet high standards and, in some circumstances, requires test results from those labs to be reported to the FDA.
It allows the FDA to permit "qualified third parties" to ensure that foreign food facilities meet US food safety standards.
It allows the FDA to suspend a food facility's registration if its products are deemed likely to be harmful.

Senate-House differences
The Senate legislation differs from the House version in certain important aspects, including fees the FDA can charge, regulation of small businesses and farms, and frequency of inspections. The House bill is more stringent on those points.

The Senate bill authorizes the FDA to charge fees to cover its costs for things like food recalls and re-inspections and to charge food importers a registration fee. But whereas the House bill calls for a $500 annual registration fee for domestic food facilities, the Senate bill does not.

Earlier this month, the Senate measure was amended to lighten its impact on small farmers and food businesses, generally those with less than $500,000 a year in sales. The amendment, authored by Sen. Jon Tester, D-Mont., drew opposition from some major industry groups, such as the United Fresh Produce Association.

Waldrop said the amendment excuses small food processors from the requirement to conduct a full hazard analysis and develop a detailed prevention plan. Instead, they would have to show either that they've prepared a more modest hazard analysis and safety plan or that they are complying with state and local requirements, as demonstrated by a license or permit, he explained.

Also under the Tester amendment, the Senate bill exempts small farms from produce standards that apply to larger operations, according to Waldrop. But the small farms' packaged products have to include a label with the name and address of the farm, and a sign with the same information would have to accompany unpackaged products, he said.

Under current law, many food processing facilities and produce farms can go for 5 to 10 years without an FDA inspection, according to the Center for Science in the Public Interest (CSPI), a nonprofit health advocacy group that praised the Senate bill today. Both the Senate and House bills would increase inspections, but to different degrees.

According to Waldrop, the Senate measure says that after the first year, high-risk facilities are to be inspected at least every 3 years, while low-risk facilities would get inspections every 5 years. Under the House version, high-risk facilities would be inspected every 6 to 12 months and low-risk facilities every 18 months to 3 years. The House also calls for inspections of food warehouses every 5 years, he said.

Both bills expand the FDA's access to food safety records, but they differ some on the details, according to Waldrop. The Senate version increases the FDA's authority to access all the records for a given processing facility, rather than for just one production line at a time, while the House version limits access to records on farms, he said.

Applause from consumer groups
The Senate's action drew applause from a variety of consumer and public health groups today, though some noted that the House measure is stronger.

"Everyone who eats will benefit from this historic legislation," said Michael F. Jacobson, CSPI executive director, in a statement. "FDA will have new tools to help ensure that America's food supply is safer, causing fewer illnesses and deaths."

The CSPI statement noted that the bill was stalled in the Senate for more than a year, and its passage came only after Senate leaders "agreed to several weakening compromises, including exemptions for many smaller facilities and reductions in the frequency of inspections. CSPI hopes that all those shortcomings will be corrected in future years."

The National Association of County and City Health Officials (NACCHO) said the Senate bill would strengthen the food safety efforts of local health agencies as well as the FDA.

"Once this bill is signed into law, it will support and improve coordination between local health departments and their state and federal partners, which will ultimately result in better strategies to prevent and control food borne illness," NACCHO Executive Director Robert M. Pestronk said in a statement. "This is a necessarybut not sufficientstep toward addressing the impacts of budget cuts and job losses on core local health department services, including those that help keep food and the public safe."

The American Public Health Association (APHA) also praised the legislation. "We are pleased by this renewed effort to improve the capacity and coordination of federal, state and local government agencies, which are at the front lines of preventing, detecting, and responding to outbreaks," said APHA President Georges Benjamin, MD.

A New York Times report today noted that many food safety advocates and industry groups preferred the House legislation because it includes more funding for the FDA and fewer exemptions from the new regulations, but they said it was "far better than nothing."

One food safety and infectious disease expert, Michael T. Osterholm, PhD, MPH, said the Senate bill will be helpful if enacted, but he was very disappointed by some gaps in it. Osterholm is director of the University of Minnesota Center for Infectious Disease Research and Policy, publisher of CIDRAP News.

"I think the new authorities for inspections are a step forward, but there's no funding for it," he said. "How can we require the FDA to provide for a comprehensive food safety regulatory system when in fact they dont have the resources to do it? To me that is a major shortcoming."

Osterholm criticized the regulatory exemptions for small food processors and farms, saying that only 5% of foodborne Salmonella isolates have come from food from the largest companies. "We believe that many of these are from smaller regional operations that are now being exempted from this bill," he said.

In addition, he said that while mandatory recall authority for the FDA is long overdue, it is unlikely to make a big difference for public health, since food companies have usually been quick to voluntarily recall foods when necessary. "There will be rare instances when having recall authority will be helpful, but it won't be the centerpiece of any food safety program."

Osterholm's bottom-line view is that the Senate bill marks an improvement, but not a huge one. "We've been so used to not having a modernized food safety system at the FDA that, in fact, incremental changes appear to be monumental," he said.

Another foodborne disease expert, Craig Hedberg, PhD, associate professor of occupational and environmental health at the University of Minnesota, offered a somewhat brighter view of the Senate legislation. He said the bill isn't perfect, and concerns about how it will be funded are valid, but it has important provisions.

"It establishes a foundation of hazard analysis and preventive controls as the framework for food safety, and requires all food producers to adopt the framework," Hedberg commented by e-mail. "Even though the Tester amendment exempted small producers from some of the provisions of the bill, it requires them to identify hazards and use preventive controls. This primary focus on prevention is the most important aspect of the bill. The bill also makes several provisions for improving foodborne disease surveillance and traceability.

"With a more robust focus on prevention, and improved surveillance, the food system should be better prepared to rapidly respond to foodborne outbreaks that occur. Whether this leads to use of the mandatory recall authority, or more rapid voluntary responses by industry, it should help reduce the impact of the outbreaks that are inevitable, due to the complexity of our food systems, and the emergence of new foodborne disease hazards."

Hedberg added that it will take considerable time to see the effectiveness of the legislation, assuming it is enacted. "I think it is a good step forward, but we all have a long way to go to realize its potential," he said.