Food Safety Legislation Progresses Slowly

The first steps on real food safety reforms were the subject of a House hearing June 3 in the Energy and Commerce Committee's Subcommittee on Health. The subcommittee unveiled the Food Safety Enhancement Act of 2009, a synthesis of several different bills that had been introduced earlier this session.

In 2007, the Government Accountability Office (GAO) designated protection of the nation's food supply as a high-risk area requiring immediate attention. The high-risk designation is saved for those policy areas that require transformational change. In testimony [1] before the Energy and Commerce Committee in April 2007, GAO's Lisa Shames, Acting Director of Natural Resources and Environment, told Congress that "limitations in the federal government’s food recalls heighten the risk that unsafe food will remain in the food supply and ultimately be consumed. Food recalls are largely voluntary, and federal agencies responsible for food safety have no authority to compel companies to carry out recalls in these cases." There are 15 agencies that have responsibility for food safety under approximately 30 different laws, according to her testimony.

Since GAO designated food safety as a high-risk area, Congress has held 24 hearings on the issue, according to testimony [2] at the June 3 hearing by Caroline Smith DeWaal of the Center for Science in the Public Interest, who was testifying on behalf of members of the Safe Food Coalition. The Food Safety Enhancement Act Discussion Draft [3] unveiled May 26 was a combination of many of the more narrowly focused bills that have been introduced in Congress in recent years. It was aimed at the Food and Drug Administration (FDA), which oversees roughly 80 percent of the U.S. food supply. The bill contains provisions that:

• Focus on prevention of, not reaction to, foodborne illness outbreaks;
• Shift responsibility for the safety of products to manufacturers;
• Require both domestic and foreign food suppliers to register with FDA annually and implement safety plans that identify and protect food from hazards;
• Give FDA the power to set minimum safety plan specifications and the power to audit the plans;
• Require registered facilities to pay a $1,000 registration fee, as well as pay for re-inspections, recalls, and, possibly, export certificates;
• Set minimum inspection frequencies based on the level of risk of the facilities, with the goal of inspecting high-risk facilities at least once in every six to 18 months;
• Enhance FDA's ability to trace the origin of tainted foods by requiring industry to develop an interoperable record to ensure an effective and timely traceback of the distribution chain; and
• Provide FDA with enhanced authority to mandate recalls and detain unsafe foods

Dr. Margaret Hamburg, the newly-confirmed FDA commissioner, testified at the hearing [4], calling the legislation "a major step in the right direction." From FDA's perspective, an effective food safety system needs to focus on prevention, give FDA the legal enforcement tools to match its responsibilities, and provide the agency with sufficient resources to match the responsibilities. According to Hamburg, the bill accomplishes most of these goals. FDA has suffered budget cuts, lost staff, and been heavily criticized for its failure to adequately protect the public during a host of food safety incidents leading up to and following GAO's designation of food safety as a high-risk topic.

Surprisingly, as a result of many of the operational problems FDA has, Hamburg testified that the inspection frequencies outlined in the bill would "far exceed" the resources available to the agency. "It would be difficult, if not impossible, for FDA to hire and train thousands of additional staff so quickly – even while relying on inspections by state, local, and other federal and foreign government officials. As a result, FDA would support modification of these provisions to take into account the operational challenges involved, such as by changing these inspection frequencies," Hamburg said.

Food industry witnesses largely supported the bill but took issue with details of provisions addressing traceability, country-of-origin labeling, the size of the registration fees, and some of FDA's expanded powers, especially the extent of mandatory recall powers the agency would be given. They were largely supportive of more resources for FDA to meet its responsibilities. In complaints about the size of the fees on registered facilities, Pamela Bailey, President and CEO of the Grocery Manufacturers Association, presented [5] a somewhat contradictory argument, noting, "Our industry is ultimately responsible for the safety of its products, but securing the safety of the food supply is a government function which should be largely financed with government resources."

Several Republicans on the committee focused on the size of the registration fees and targeted those as a potential stumbling block for bipartisan support. They voiced objections to expanding FDA's powers to force recalls and use subpoenas, two powers that FDA does not have under current law.

Food safety advocates generally supported the bill. DeWaal, for example, called it "a strong bill" that addresses critical components in building a new framework for a modern food safety system. The preventive approach, coupled with inspections, traceability of foods, enhanced research and surveillance, more resources, and better enforcement tools, can lead to major improvements, she argued. She also claimed that better oversight by FDA helps the food industry by protecting it from damage suffered by recalls and outbreaks of pathogens. The $1,000 registration fee pales in comparison to the millions of dollars industry spends on advertising and the economic impacts of outbreaks.

Rep. John Dingell (D-MI) formally introduced the bill [6] June 8. The subcommittee completed a markup June 11 and subsequently referred the bill without amendments to the full committee.

Several bills addressing food safety improvements were introduced in the Senate early in the 111th Congress but have languished in the Agriculture, Nutrition, and Forestry Committee and the Health, Education, Labor, and Pensions Committee.