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Food safety reform bill HR 875 generates controversy
by Ted Agres
Among the myriad of issues being considered in Congress, few touch the lives of Americans as directly as food quality. So it should come as no surprise that impassioned debate surrounds some of the more than a dozen bills under consideration in the House and Senate to reform and modernize the nation’s food safety system. While everyone agrees that safer food is a laudable goal, there is far less consensus as to how, or even whether, it can be achieved.
Restructuring the nation’s food safety oversight system is a “tremendous undertaking,” said Eileen Harley Jarvis, federal affairs director of the Grocery Manufacturers Association. “We’re not opposed to the concept, but it would take a lot of time and effort to figure out the details,” she told Food Quality. One bill in the mix has generated more than its share of controversy. Introduced in February by Rep. Rosa DeLauro (D-Conn.), the Food Safety Modernization Act of 2009 (HR 875) seeks to better regulate food production and distribution by stripping food oversight from the Food and Drug Administration (FDA) and giving it to a new agency, the Food Safety Administration (FSA), which would have beefed-up enforcement powers, including authority to order recalls, seize unsafe food shipments, and fine violators. Company officials found liable for foodborne illnesses could be sentenced to up to 10 years in prison.
Sen. Richard Durbin (D-Ill.) introduced the Senate’s companion bill to HR 875, the FDA Food Safety Modernization Act (S 510), in March. Neither bill has emerged from its respective subcommittee.
Internet and Blogosphere Frenzy
Rep. DeLauro, who chairs the House Appropriations subcommittee that oversees FDA spending, had introduced similar legislation last September, but the bill was one of hundreds not acted on during that session. This year, the reintroduced bill sparked an Internet and blogosphere frenzy bordering on hysteria. Critics claimed large agribusiness and herbicide companies, in cahoots with federal regulators, secretly crafted the bill.
Among other things, detractors claimed HR 875 would outlaw organic farming, impose controls on backyard gardening, and stamp out local farmers markets throughout the country. Government inspectors, they warned, would soon be scrutinizing your backyard radishes and tomatoes.
Rep. DeLauro’s office was inundated with complaints from constituents and even fellow lawmakers asking what she had against backyard gardening. “All of my colleagues, I have colleagues who come up to me on both sides of the aisle and they say to me, ‘Rosa, what’s this about 875?’” she told the The Huffington Post in April.
At first, Rep. DeLauro tried to ignore the controversy, but the online allegations increased. According to rumors, Rep. DeLauro’s husband was a consultant for Monsanto, which pushed the legislation in order to outlaw organic farming and mandate use of chemical herbicides, fertilizers, and pesticides. The bill would create federal food police that could fine and imprison backyard gardeners. “Didn’t Stalin nationalize farming methods that enabled his administration to gain control over the food supply?” one blogger posted. “Didn’t Stalin use the food to control the people?”
In an attempt to defuse what had become a full-fledged urban legend, Rep. DeLauro posted “Myths and Facts,” a document about HR 875, on her congressional Web site. No, she said, the bill would not make organic and backyard farming illegal. No, it would not curtail farmers markets. No, her husband was neither consulting for Monsanto nor involved in drafting the legislation.
“The focus is on large producers, where the problem is centered, not small farmers or organic farmers,” Rep. DeLauro told Food Quality. Stripping food safety responsibilities from the FDA and placing them in the hands of a single agency would improve enforcement. “By ending the link between food safety and drug and device safety, there would be more focus on protecting the public from unsafe foods,” she said.
Laudable intentions, to be sure. But the path to making it happen continues to be bumpy.
A Patchwork Quilt
The nation’s food safety system is overseen by a patchwork of more than a dozen federal agencies, led by the FDA and the U.S. Department of Agriculture (USDA). Other responsible agencies include the Environmental Protection Agency—for pesticide and water quality standards—and the Centers for Disease Control and Prevention (CDC) for disease surveillance and outbreak response. Hundreds of state and local agencies are also involved.
The FDA oversees about 80% of the U.S. food supply, including $417 billion in domestic food and $49 billion in imported food annually. The agency is responsible for ensuring the safety of almost all food products sold in the U.S., except for meat, poultry, and some egg products, all of which are regulated by USDA.
The task is daunting: There are 44,000 food manufacturers and processors, 114,000 food retailers, and 935,000 restaurants in the U.S. According to the CDC, 76 million Americans get sick annually from unsafe food products; 325,000 of them are hospitalized, and 5,000 die from foodborne hazards. Salmonella alone infects an estimated 1.4 million Americans each year, killing more than 400 of them.
“Just in the past two years, American consumers have been confronted with melamine in milk, tainted peppers, Salmonella in peanut products, and E. coli in spinach,” said Rep. John Dingell (D-Mich.), chairman emeritus and cosponsor of food safety legislation being drafted by the House Energy and Commerce Subcommittee on Health, in comments prepared for a hearing in June.
The measure, called the Food Safety Enhancement Act of 2009 (HR 2749), has emerged as the main food safety bill in the House. It combines elements from other bills, mainly the following:
- HR 759, the Food and Drug Administration Globalization Act, also sponsored by Rep. Dingell;
- HR 1332, the Safe Food Enforcement, Assessment, Standards, and Targeting Act (FEAST), sponsored by Reps. Jim Costa (D-Calif.) and Adam Putnam (R-Fla.); and
- Rep. DeRosa’s HR 875.
Republicans are willing to work with the Democrat majority to craft a bipartisan food safety overhaul bill, said Rep. Joe Barton (R-Texas), the committee’s ranking member and a cosponsor of the Costa-Putnam bill.
The Food Safety Enhancement Act, which was approved by the House Energy and Commerce Committee in June and which may be voted on in the full House before the August summer recess, would require that:
- the FDA create an electronic, interoperable record-keeping system that manufacturers would be required to use so the agency could quickly trace the source of any outbreak to its origin;
- the FDA set standards for food safety and give the agency stronger enforcement authorities, including civil and criminal penalties, access to records, and the power to order recalls;
- the FDA inspect food facilities at established minimum intervals; and
- companies conduct hazard and risk analyses of their products and implement and document preventive controls.
The FDA generally relies on state and local authorities to oversee food grown on farms. The draft bill would require the agency to develop “national science-based safety standards” to reduce on-farm food contamination. “I am confident that farmers have nothing to fear from this bill,” said committee chairman Rep. Henry Waxman (D-Calif.), in an attempt at reassurance, in comments prepared for a June hearing. Because FDA regulations are created with input from the public, “stakeholders will be able to work with FDA to ensure that the best possible standards and practices are adopted,” Rep. Waxman said.
The measure would also require every U.S. food manufacturing company to register with the FDA and pay a $500 annual fee per facility and capped at $175,000 per company annually. The bill would require FDA inspections every six to 18 months for high-risk facilities, every 18 to 36 months for low-risk facilities, and every three to four years for warehouses.
In addition to this, the Obama Administration has requested $260 million for FDA food safety activities in fiscal year 2010, which begins Oct. 1, 2009. This amount includes $94.4 million in new user fees to register food facilities and increase food inspections, issue food and fee export certifications, and reinspect food facilities that fail to meet safety standards.
Combined with the $500 per facility annual fee, industry user fees would total $375 million annually, an amount that would “sadly not be adequate to implement the portfolio of activities laid out in the [draft] legislation,” FDA Commissioner Margaret Hamburg told the House subcommittee in June.
The food industry and some Republicans are not convinced of the need for additional fees. “We are not opposed to all fees,” said Pamela Bailey, chief executive of the Grocery Manufacturers Association, in prepared congressional testimony in June. “We are concerned about the size and purpose of the significant new fees proposed in the discussion draft. … We are concerned that a broadly applied fee to finance basic FDA functions, including inspections and enforcement, creates an inherent conflict of interest that will erode, rather than improve, consumer confidence.”
A Question of Turf
Granting the FDA sweeping new inspection and enforcement authority could raise jurisdictional questions as long as food safety oversight is shared with other agencies. This is where Rep. DeLauro’s bill might help.
The new FSA, which would be part of the Department of Health and Human Services, would assume authority and responsibility for managing the food safety programs, budget, and personnel formerly attached to the FDA, as well as the surveillance and investigation of foodborne illnesses currently conducted by the CDC. (The bill does not address transferring the USDA’s meat and poultry responsibilities.) The FDA would be renamed the Federal Drug Administration and would be responsible for regulating drugs, medical devices, and cosmetics.
Many consumer groups, major food-related trade associations, and large food producers support HR 875’s goals. “Ensuring food safety is the highest priority of our industry,” said Kirstie Foster, corporate public relations manager at General Mills. “We expect reform will encompass both greater authority and greater capacity to strengthen our overall ability to prevent and respond to food safety issues nationally,” she told Food Quality in an e-mail response to questions about HR 875.
Kraft Foods “supports the requirement for comprehensive food safety plans so that every manufacturer will take a preventive approach to identifying and evaluating potential hazards,” said spokesperson Susan Davison. But breaking apart FDA to create two separate agencies “would require a significant up-front investment and an ongoing increase in operating funds,” she told Food Quality. “Whether the money would be better spent for activities that directly affect food safety is an important consideration. We support constructive debate on this subject,” she added.
Like the Food Safety Enhancement Act emerging in the House, Rep. DeLauro’s bill would make food producers responsible for health hazards in their operations, would meet federal standards for preventing or removing contaminants and pathogens from food, and would be subject to regular inspections by federal officials based on the risk profiles of their products. Should prevention fail, the FSA could order recalls, seize unsafe food before it enters the market, and impose fines of up to $1 million per offense per day. According to the bill, “the person” who commits a violation “with respect to adulterated or misbranded foods” shall be imprisoned for up to five years in case of “serious illness” and up to 10 years in case of death.
“The intent of this legislation is to make sure that large industrial food processors, such as the peanut processing plant in Georgia that was responsible for the Salmonella outbreak that killed nine people, do not produce unsafe foods,” Rep. DeLauro said.
Controversy Abated But Not Gone
Controversy over the DeLauro bill has abated but not disappeared, with organic farming and natural foods proponents acknowledging that earlier allegations were false. The Cornucopia Institute, which advocates for organic farming, and the Farm-to-Consumer Legal Defense Fund (FTCLDF), which supports raw milk production and distribution, both criticize HR 875 and other congressional reform bills for their “one-size-fits-all” approach. Provisions aimed at large-scale industrial farms and processors “would likely put smaller and organic producers at an economic and competitive disadvantage,” the Cornucopia Institute said on its Web site.
Those engaged in raw milk production and distribution, the FTCLDF said, can expect increased attention from the FSA if its inspectors are given authority to inspect those farms as often as weekly. “Many foods that would not be considered adulterated under current standards would be found to be adulterated under the definition contained in HR 875,” the institute says, noting that the FDA considers pasteurization the only safe means for milk handling.
Lending credence to the concerns of small and local food producers, Section 406 of HR 875 instructs the government to “presume” that interstate commerce exists in any food safety enforcement action. Does this mean that backyard gardens and local farmers markets could, in fact, come under the scrutiny of federal inspectors even though Rep. DeLauro insists that is not her intention?
Rep. DeLauro maintains that the U.S. Constitution’s commerce clause prevents the government from regulating commerce that doesn’t cross state lines. But a 1942 Supreme Court ruling (Wickard v. Filburn) affirmed that even home gardens (in that case, a farmer growing wheat for his own use) are subject to federal laws regulating interstate commerce. Rep. DeLauro has since said that she is open to making technical changes and clarifications to the bill if these are needed to reassure small and local growers.
Agres is a freelance writer based in Laurel, Md. Reach him at email@example.com.