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FOOD SAFETY

To Our Health!

Public Health Reform Can Ensure a Safer Food Supply

Mark Roh, U.S. Food and Drug Administration's acting regional director holds a bag of tomatoes being tested for salmonella bacteria at FDA's southwest regional research lab, in Irvine, Calif., Monday June 9, 2008, where microbiologists are working to trace the source of the outbreak SOURCE: AP/Kevork Djansezian Mark Roh, U.S. Food and Drug Administration's acting regional director holds a bag of tomatoes being tested for salmonella bacteria at FDA's southwest regional research lab, in Irvine, California, Monday June 9, 2008, where microbiologists were working to trace the source of the outbreak.

Mere weeks after securing health insurance reform, Congress and the Obama Administration are close to enacting legislation of nearly comparable importance to America’s public health—in the form of comprehensive food safety legislation. The longer they wait, the more Americans will get sick. Just this week, a food distributor initiated a 23-state recall of romaine lettuce infected with E. coli bacteria that has already sickened 19 people in Michigan, Ohio, and New York.

Deficiencies in the regulation of the American food supply constitute the most serious and persistent gap in American consumer protection.

For years, public and food industry officials have maintained that the American food supply is one of the safest in the world. Yet in 1999, the Centers for Disease Control and Prevention  estimated that food borne pathogens caused 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths annually in the United States. Now, more than ten years later, American families still face the same meaningful risks of illness or death from their food. While incidents involving some foodborne microbes have declined significantly, others have not abated in years. While incidents involving some foodborne microbes have declined significantly, according to the CDC, others have not abated in years.

These everyday dangers are evident from periodic, dramatic nationwide outbreaks of foodborne illness. These range from the infamous 1993 Jack-in-the-Box hamburger E. coli outbreak that struck hundreds, including many children, to the recent 2008 salmonella outbreak—the largest ever—that federal officials mistakenly attributed to tomatoes, before belatedly identifying the Mexican jalapeno peppers that sickened over 1,200 Americans.

Federal food safety officials openly acknowledge the persistence of this public health threat. Last October, Commissioner of Food and Drugs Peggy Hamburg echoed the CDC’s 1999 statistics in Senate testimony, acknowledging that every year “millions of people in the United States suffer from food borne illness, hundreds of thousands are hospitalized, and thousands die.” This staggering toll in health is matched by a tremendous economic impact. Last month, the Pew Charitable Trusts and Georgetown University concluded that the American economy incurs annual economic losses of $152 billion from medical costs, disability, and losses to quality of life attributable to food borne illnesses.

Deficiencies in the regulation of the American food supply constitute the most serious and persistent gap in American consumer protection. But solving the problem requires a combination of legislation to strengthen oversight authority, resources necessary to implement reforms, and an administration with the courage to take on difficult political choices. Thus far, that elixir has proven as elusive as health insurance reform. Sporadic congressional interest, historic infighting between the two principal agencies responsible for food safety, the Food and Drug Administration and the U.S. Department of Agriculture, and effective opposition from food producers and agricultural interests, have all but assured for many years that meaningful food safety reforms did not occur. But the chances of real reform are looking healthy.

This year, the possibility of action is significant. In the House of Representatives, Congressman John Dingell’s (D-MI) H.R. 2749, the Food Safety Enhancement Act of 2009, moved quickly last summer through committee markup and passed the House by a commanding 280-150 vote. The legislation would provide FDA with stronger authority to conduct inspections, mandate performance standards and preventive controls, and review records in order to trace outbreaks and unsafe food imports. The FDA would also strengthen nationwide laboratory capacity to test food samples and gain clear authority to mandate recalls of contaminated food. While the agency can mandate recalls for medical devices, it currently lacks the authority to do the same for contaminated food products. According to a 2010 Government Accountability Office report, “Limitations in FDA’s food recall authorities heighten the risk that unsafe food will remain in the food supply.” Under the proposed legislation, the agency would even have the power to quarantine regions where it suspects outbreaks originate. An effective combination of regulatory reforms and legislative compromises, the bill has broad bipartisan support, as well as the support, or absence of opposition, from regulated food industries and agricultural interests.

As Republican Congressman Shimkus (R-IL), a leading member of the House Energy and Commerce Committee, said, “We just couldn’t sit on the sidelines anymore as we saw case after case of food-borne illnesses. We had to come together in a way to address this.”

In the Senate, Richard Durbin’s (D-IL) S. 519, the FDA Food Safety Modernization Act, moved swiftly by voice vote through committee and is expected to reach the floor this month. The legislation has been amended to reflect reasonable compromises that have the bipartisan support of key senators, including Senate Health, Education, Labor, and Pensions Committee Chairman Tom Harkin (D-IA), fellow Democratic Senator Chris Dodd (CT), and Republican Senators Mike Enzi (WY) and Judd Gregg (NH). Like H.R. 2749, the Senate legislation strengthens FDA authority to regulate food, increase inspections, establish science-based standards, and better cope with the ever-expanding volume of imported foods.

Just as important, the Obama administration has heightened enforcement of consumer protections, selecting new, like-minded leadership at FDA and USDA committed to better coordinating their work and improving federal oversight of food safety. Commissioner Hamburg is a physician and public health leader who considers food safety “a core public health issue.” Deputy Commissioner for Foods Mike Taylor is a widely respected leader in food safety, having served as USDA undersecretary for food safety, as well as an FDA deputy commissioner under former commissioner David Kessler. At USDA, deputy undersecretary for food safety Jerry Mande worked with Taylor at FDA and Dr. Elisabeth Hagen, the department’s chief medical officer, has been nominated as the new undersecretary for food safety. Finally, the administration has matched its rhetoric and appointments with funding: the FDA’s Fiscal Year 2011 budget calls for a $326 million increase to “transform” food safety through $88 million in appropriations and $239 million in industry-funded user fees.

If the Senate successfully completes ongoing negotiations on a managers’ amendment and can bring S. 519 to a floor vote, the remaining steps to enacting comprehensive food safety reforms will be few. With few major substantive differences between the House and Senate bills, a bipartisan Congress would have to stumble badly to fail to deliver a law to President Obama for his signature before it adjourns this year. Provided enactment of these new authorities can be matched with equal commitments in funding, the federal government will have secured and begun implementing landmark reforms that will improve the safety of the food supply and better protect the health of all Americans.

Paul Kim is a partner at Foley Hoag LLP, and former deputy staff director for health under Senator Edward M. Kennedy and counsel to Congressman Henry Waxman.

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