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From: Food Quality & Safety magazine, October/November 2009

The Food Safety Countdown

Industry awaits new safety legislation, but change may not come until 2010

by Ted Agres

Long-awaited legislation to reform and modernize the nation’s food safety system will likely be put off until next year while the Senate continues to grapple with healthcare reform and other contentious issues.

Supporters had hoped Congress would pass legislation this year to overhaul the nation’s food safety laws for the first time in seven decades by requiring companies to implement safety plans and giving the U.S. Food and Drug Administration (FDA) authority to seize unsafe food shipments, order recalls, and fine violators. While the House passed its version of the legislation (HR 2749) with wide bipartisan support on July 30, the Senate has held only one committee hearing, on a different version of the bill (S 510), in late October. As of press time, the Senate was not expected to do much more until after the winter recess.

“My understanding is that the Senate will not take up food safety until next year,” said Rep. Rosa DeLauro (D-Conn.), a leading reform advocate and sponsor of a separate bill that would remove food oversight from the FDA and give it to a new agency called the Food Safety Administration. “This is about food safety science and where we want to go,” she told a global food safety policy forum convened by the Waters Corporation and the Center for Science in the Public Interest on October 14 in Washington.

But Sen. Tom Harkin (D-Iowa), chairman of the Senate Committee on Health, Education, Labor and Pensions (HELP), is pushing to make progress more quickly. “Hopefully, we can get this bill passed and to the White House before year’s end,” he said at a HELP Committee hearing on the food safety legislation in October. That timetable would be challenging, at best, since the committee as well as the full Senate first need to vote on the bill and then iron out any differences with the House version, all in the midst of other pressing issues.

Apart from the legislative process, the FDA and other agencies have been particularly active this year, rolling out several initiatives. These include:

  • launching an online Reportable Food Registry (RFR) to which manufacturers and processors must report potential contamination within 24 hours;
  • issuing commodity-specific guidances for growers and pro-cessors of leafy greens, tomatoes, and melons to help prevent contamination and foodborne illnesses; and
  • awarding $17.5 million in grants to support food and feed safety initiatives at the federal, state, and local levels.

“We can’t sit back and wait for a dangerous outbreak or epidemic and then do something,” Health and Human Services Secretary Kathleen Sebelius told the National Food Policy Conference, sponsored by the Consumer Federation of America and the Grocery Manufacturers Association (GMA), in September. “We need to be proactive and prevent these crises from happening in the first place.”

Bills on the Hill

In late July, the House passed the Food Safety Enhancement Act of 2009 (HR 2749), spearheaded by Rep. John D. Dingell (D-Mich.). The measure passed only after exempting producers of poultry, livestock, and feed grain from most of the requirements. The bill freed most farms from registration fees, record keeping, and traceability requirements and limited the scope of records required of grain handlers, restaurants, and grocery stores. These exemptions were inserted at the last minute after members of the House Agriculture Committee and many Republicans expressed concern that the bill would give the FDA too much authority over farms and food facilities already regulated by the U.S. Department of Agriculture (USDA).

As passed, HR 2749 requires most U.S. food manufacturing companies to register with the FDA and pay a $500 annual fee per facility (capped at $175,000 per company per year). The bill also requires FDA inspection of high-risk facilities at least every six to 12 months, low-risk facilities at least every 18 to 36 months, and warehouses and food storage facilities at least once every five years.

While some parts of Rep. DeLauro’s bill (HR 875) were incorporated into HR 2749, her most controversial element—stripping food oversight from the FDA and placing it in the hands of a new Food Safety Administration—was not (see “Food Fight,” June/July 2009, pp. 16-23). DeLauro’s bill had also gained notoriety because detractors warned it would outlaw organic farming, impose controls on back yard gardening, and stamp out local farmers markets throughout the country, although Rep. DeLauro insists none of these things would actually happen. While largely abated, many of these fears continue to swirl around HR 2749 on the Internet.

The Senate bill (S 510), drafted by Senate Majority Whip Richard J. Durbin (D-Ill.), is similar to, but distinct from, HR 2749. The House version, for example, requires annual registration fees from domestic and foreign food producers and imposes new civil and criminal penalties for violators. The Senate bill does neither. Certain actions that are “required” of the FDA in the House version are merely “authorized” in the other, and vice versa.

“S 510 is not a companion bill to HR 2749,” Durbin spokesman Max Gleischman told Food Quality. “S 510 will be the basis for whatever bill will be considered in the Senate.” The HELP Committee held a hearing on S 510 on October 22. Any difference between the Senate bill and the House version must be reconciled before the bill can be signed into law.

While generally supportive of S 510, FDA Commissioner Margaret A. Hamburg, MD, told the Senate panel that the bill needed to be strengthened by providing funding through registration fees and by giving the agency “explicit authority” to obtain food records during routine facility inspections, as opposed to access only in case of emergencies, as is now the case. “This authority is essential to enable FDA to identify problems and require corrections before people become ill,” she told the Senate committee.

Most consumer groups and food industry organizations like the direction Congress is moving in. The GMA supports many of the provisions of S 510, said its communications director, Scott W. Openshaw. “Following the House’s recent passage of food safety reform legislation, we strongly urge the Senate to swiftly follow suit and pass its own food safety bill as quickly as possible,” he told Food Quality.

Reportable Food Registry

In September, the FDA unveiled its electronic food registry. Food facilities that manufacture, process, or hold food for consumption in the U.S. must report, within 24 hours, any “reasonable probability” of severe health problems to a person or an animal.

Mandated by the Food and Drug Administration Amendments Act of 2007 (PL 110-85), the reporting rule applies to all food and animal feed regulated by the FDA, except infant formula and dietary supplements, which have separate requirements. Examples of reportable causes include bacterial contamination, allergen mislabeling, or elevated levels of chemical components. Companies that either destroy the food or find and correct the problem before shipping it are not obligated to report.

“There’s been a lag time; we learn about problems after people get sick,” said Michael R. Taylor, a George Washington University food safety expert and senior advisor to the FDA commissioner. “Working with the food industry, we can swiftly remove contaminated products from commerce and keep them out of consumers’ hands,” Taylor told reporters in September. While many companies already voluntarily submit reports about possible contamination, the law “makes this a duty that all food facilities have,” he said.

Industry reaction to the new database has been generally favorable. “At Kraft Foods, we fully support efforts that will strengthen America’s food safety systems,” said spokesperson Susan Davison. “We believe that the launch of the food registry will help do that,” she told Food Quality.

In September, the Food Marketing Institute and GS1 US, the electronic data-exchange and standards-setting organization, announced the Rapid Recall Exchange, a non-governmental online service through which manufacturers, wholesalers, and retailers can communicate about food and product recalls. The Exchange replaces and improves upon the Product Recall Portal, company officials said. “The food industry is ultimately responsible for the safety of its products,” noted Pamela G. Bailey, president and chief executive of the GMA, which, along with the National Grocers Association, supports the new system.

Commodity Guidances

In late July, the FDA announced three new draft safety guidelines for growers of “priority commodities,” including melons, lettuce and leafy greens, and tomatoes, produce at high risk for contamination by Salmonella, Escherichia coli O157:H7, norovirus, and other pathogens. The guidances cover supply chain activities like field selection, planting, growing, harvesting, packing, storage, distribution, preparation, and food handling. “These new food safety guidelines will facilitate the development of enforceable food safety standards,” Dr. Hamburg said.

The guidances are based on best practices developed by the produce industry with the assistance of the FDA and are voluntary, at least until food safety legislation is passed into law, points of contention for consumer groups. “Consumers Union [CU] believes that a far better solution is to pass Food and Drug Administration food safety reform as soon as possible,” said Elisa Odabashian, director of CU’s West Coast office. “The FDA’s weakness, in terms of lack of authority and resources, has created a vacuum that has allowed these problems to develop and must be remedied” with legislation, Odabashian said in testimony before the USDA in September.

“The increased demand for fresh produce presents restaurant operators with a great opportunity and responsibility,” said Beth Johnson, National Restaurant Association executive vice president of public affairs. “We are pleased with the increased attention to food safety by the Congress, the administration, and the industry and support the development of science-based national standards for fresh fruits and vegetables,” she told Food Quality.

The FDA in October announced it had awarded 83 grants—totaling $17.5 million—to fund cooperative agreements among Federal, state, and local agencies to improve food and safety initiatives. The states of Virginia, Texas, and Washington received $1.5 million to create and outfit rapid response teams to work with federal authorities in case of any food-related threat or emergency.

“The grants are another step in the FDA’s continuing efforts to build an integrated food safety system between Federal, state, and local partners,” Michael Chappell, the agency’s acting associate commissioner for regulatory affairs, said in a statement.

Agres is a freelance writer based in Laurel, Md. Reach him at



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