WASHINGTON – Dr. Margaret Hamburg, commissioner of the Food and Drug Administration, appeared before the Senate’s committee on health, education, labor and pensions on Oct. 22 to discuss reforming the food safety system. Her appearance came with the House of Representative’s "Food Safety Enhancement Act of 2009" and the U.S. Senate’s "F.D.A. Food Safety Modernization Act" heading to conference. While noting the bills show there is "broad agreement on the general direction of food safety reform," Ms. Hamburg added areas of the bills need improvement.

Focusing her comments specifically on the Senate bill, S. 510, Ms. Hamburg said it represents a comprehensive and significant modernization of the food safety system and provides the F.D.A. with some essential legal tools. She still noted room for improvement.

"For example, S. 510 does not provide F.D.A. with explicit authority to access food records during routine inspections, one of the key authorities identified by the (President’s Food Safety) Working Group," she said. "Routine records access is a critical component of a food safety regulatory framework and is one of the most significant gaps in F.D.A.’s existing authority. Although F.D.A. has routine records access for certain other F.D.A.-regulated products, and U.S.D.A. has routine records access for U.S.D.A.-regulated products, F.D.A. does not have explicit authority for routine access to records for the vast majority of foods under its jurisdiction. This authority is essential to enable F.D.A. to identify problems and require corrections before people become ill."

Another "key legal tool" she said is not included in S. 510 involves information sharing.

"Enhancing F.D.A.’s information sharing authority is a critical element of an integrated federal/state system and is also essential for effective public health communications with F.D.A.’s international regulatory partners," she said. "The Working Group highlighted the need to improve information sharing during a foodborne illness outbreak to speed the epidemiological investigation and traceback of the source of the illnesses to protect consumers and help industry recover faster.

"F.D.A. recommends that language be included similar to that in section 112(b) of H.R. 2749. Under that provision, F.D.A. may provide federal agencies, state and local government agencies, foreign government agencies, and certain international organizations both confidential commercial and trade secret information relating to food with provisions to ensure its confidentiality, consistent with international obligations."

Other aspects of the Senate bill Ms. Hamburg would like to see enhanced include improved regulatory enforcement mechanisms, consistent funding for the agency’s potential new responsibilities, and more flexibility in how the agency inspects foreign food facilities.

"This is a historic moment for food safety in the United States – a moment for F.D.A. and its sister agencies in the federal government to rise to the challenges of the 21st century," said Ms. Hamburg. "Success means fewer hospitalizations and deaths, fewer economically devastating recalls, and greater health for the American people."