President Barack Obama and Congress recently began efforts aimed at shoring up the Food and Drug Administration (FDA), an agency battered by recent consumer safety problems and declining resources. In a March 14 address, Obama named two officials he wants to lead the agency and announced the creation of a working group to propose food safety reforms. Congress is once again trying to craft legislation aimed at providing greater consumer protections and restoring resources to the agency.

Obama named Dr. Margaret Hamburg as his choice to lead FDA and Baltimore Health Commissioner Dr. Joshua Sharfstein as Hamburg's deputy. Hamburg is a former New York City health commissioner and served in President Clinton's Department of Health and Human Services. Industry, public interest groups, and congressional representatives praised Hamburg both for her qualifications and for her status as an outsider, according to a March 15 Washington Post article.

A March 14 White House press release states that the Food Safety Working Group "will be chaired by the Secretaries of Health and Human Services and the Department of Agriculture and it will coordinate with other agencies and senior officials to advise the President on improving coordination throughout the government, examining and upgrading food safety laws, and enforcing laws that will keep the American people safe." The need for the group stems from the increased incidents of illness from contaminated food and FDA's inability to inspect the 150,000 food plants and warehouses under its purview. Agriculture Secretary Tom Vilsack has been confirmed and is in place. Obama nominated Kansas Governor Kathleen Sibelius to head Health and Human Services (HHS), the department that houses FDA.

In his address, Obama indicated the agency has been underfunded and understaffed, which hinders FDA's food inspection capabilities. He pledged to "significantly increas[e] the number of food inspectors" at FDA.

FDA has faced the wrath of Congress and the public over problems with food and drug safety. Currently, the agency faces the salmonella contamination of peanut products made by the Peanut Corporation of America (PCA), which has left nine people dead and nearly 700 sickened since September 2008. The peanut product incident follows the salmonella contamination of peppers from Mexico in 2008.

The House Energy and Commerce Committee's Subcommittee on Oversight and Investigations conducted two hearings on the salmonella contamination incident. The first hearing was Feb. 11 and focused on the broad failures by government and private-sector inspectors, individual companies purchasing products from PCA failing to take active measures to ensure the safety of their suppliers, and PCA's failure to report contamination and stop selling its products after learning of the contamination.

The subcommittee held its second hearing March 19 on the role industry plays in regulating food safety in the context of the peanut products contamination. The three witnesses at the hearing represented companies using PCA's products, and all had assurances from PCA that its manufacturing plants passed safety inspections. PCA received superior ratings from the firm it hired to inspect its facilities at announced inspection times and passed the results of the inspections to its customers. All the companies had in place their own safety and quality assurance procedures that met or exceeded industry practices.

However, this system of inspections and quality control programs did not prevent the companies from withdrawing their products from circulation once they learned from government safety inspectors that their products were targets of investigations in the salmonella outbreak. PCA is now under investigation for "knowingly selling" contaminated peanut products, which has resulted in the largest food recall in U.S. history, according to a March 20 Washington Post article on the hearing. (A list of the recalled products is available on FDA's website at http://www.fda.gov/oc/opacom/hottopics/salmonellatyph.html.)

One of the witnesses, David Mackay, president and chief operating officer of Kellogg Company, proposed the most far-reaching recommendations during the hearing. The recall of Kellogg's products cost the company between $65 and $70 million, and Mackay argued that cost is a direct result of not being able to manage for the presence of unscrupulous companies that can circumvent quality assurance mechanisms and government oversight. His testimony called for a single food safety agency with broad research and oversight responsibilities complimented by a permanent advisory council of government and industry experts to enhance "science-based food safety policies and standards." He argued that all food manufacturers, in an effort to prevent outbreaks, should be required to conduct risk analyses and develop food safety plans that FDA would review. Also, Mackay said FDA should inspect annually all high-risk food manufacturers and should be given mandatory recall authority so that delays in getting contaminated products off store shelves can be minimized.

Although the other witnesses did not provide specific lists of recommendations, under questioning from subcommittee members, they supported more rigorous regulatory approaches than currently exist. For example, all of the witnesses supported having unannounced inspections and requirements to supply the results of those inspections to FDA. They also supported accreditation of third-party testing companies and mandatory testing of high-risk products and reporting of negative test results. One witness thought FDA had sufficient resources to carry out its responsibilities, but the other two witnesses did not think the agency had the necessary resources to provide adequate safety.

Many of these recommendations, and many others, are contained in numerous food safety bills that have been introduced in Congress this session. The bills address such issues as creating a single food safety agency, a food tracking system to trace the origins of products, enhanced risk-based inspection systems with mandatory testing and reporting, and enhanced authority and enforcement powers for federal agencies with food safety responsibilities. Congress, the administration, many businesses, and the public are aligned in favor of an enhanced regulatory system to help ensure the safety of the food supply. The costs of inaction are great to both business and the public. It remains to be seen if a set of meaningful reforms will follow from the broad support that currently exists.