GAO report faults FDA oversight of fresh produce
GAO report faults FDA oversight of fresh produce
WASHINGTON -- The Food & Drug Administration has no formal fresh produce program, spends very little money on fresh produce issues and conducts few inspections, according to a new report by the General Accountability Office.
"This report paints a frightening picture of the FDA's fresh produce safety efforts: insufficient resources and staff, infrequent inspections and a failure to punish known violators," Sen. Barbara Boxer (D-CA), who requested the audit of the FDA's program in 2006 after the spinach contamination outbreak, said in a Sept. 25 press statement. "This report should serve as a wake-up call to do more to protect the nation's food supply."
Despite naming fresh produce safety as one of its top priorities at the FDA, the new report found that the FDA spent about 3 percent of its total annual food-safety budget on fresh produce safety in fiscal years 2006 and 2007.
Within FDA's Center for Food Safety & Applied Nutrition, two staff members worked exclusively on produce safety issues during those fiscal years, with another 25 -- mostly researchers -- working on these issues. The FDA told GAO auditors that it needs at least five full-time people on produce safety and has received extra funds to hire four more people but has yet to fill the positions due to salary limitations, said the GAO's report, Food Safety: Improvements Needed in FDA Oversight of Fresh Produce.
"FDA officials also acknowledged that they have delayed work on fresh produce safety efforts because of other work, including counterterrorism efforts in response to the Bioterrorism Act and unplanned events such as outbreaks of foodborne illness and recalls of contaminated foods," said the report.
The February 2008 final guidance for fresh-cut operations was delayed at least six years because of competing priorities. Tight money has delayed two key produce safety initiatives: modernizing its good manufacturing practices regulations and updating its good agricultural practices guidance.
The report also took a look at the FDA's record in conducting U.S. produce inspections.
"Our analysis of FDA data showed that the number of domestic fresh produce inspections rose from 327 in fiscal year 2000 to a peak of 699 in fiscal year 2005, and then declined to 478 inspections in fiscal year 2007," said the report.
The GAO, the accounting arm of Congress, found that the FDA took little enforcement action against produce companies as a result of inspections. "Specifically, we identified 96 warning letters related to fresh produce, but their use declined substantially, with 66 issued in fiscal year 2000 and none issued in fiscal years 2005 through 2007," the report said.
During the same period, according to the FDA, the agency seized no fresh produce, sought no injunctions, and prosecuted no firms for fresh produce- related violations.
But this comes as fresh produce imports increased about 60 percent between 2002 and 2007.
The report recommends that the FDA update its good agricultural practices guidelines and its regulations on food manufacturing practices; seek explicit authority from Congress to adopt preventive controls for high-risk foods; and gain authority for enhanced access to records.
"I strongly urge the next president to make the necessary administrative changes recommended in this report, and I am committed to working with my colleagues to make sure that Congress passes common-sense legislation to help the FDA achieve its mission of keeping our food safe and healthy to eat," Sen. Boxer said in the statement.
FDA reform is expected to be one of the top priorities for Congress when it returns next year.
"This report paints a frightening picture of the FDA's fresh produce safety efforts: insufficient resources and staff, infrequent inspections and a failure to punish known violators," Sen. Barbara Boxer (D-CA), who requested the audit of the FDA's program in 2006 after the spinach contamination outbreak, said in a Sept. 25 press statement. "This report should serve as a wake-up call to do more to protect the nation's food supply."
Despite naming fresh produce safety as one of its top priorities at the FDA, the new report found that the FDA spent about 3 percent of its total annual food-safety budget on fresh produce safety in fiscal years 2006 and 2007.
Within FDA's Center for Food Safety & Applied Nutrition, two staff members worked exclusively on produce safety issues during those fiscal years, with another 25 -- mostly researchers -- working on these issues. The FDA told GAO auditors that it needs at least five full-time people on produce safety and has received extra funds to hire four more people but has yet to fill the positions due to salary limitations, said the GAO's report, Food Safety: Improvements Needed in FDA Oversight of Fresh Produce.
"FDA officials also acknowledged that they have delayed work on fresh produce safety efforts because of other work, including counterterrorism efforts in response to the Bioterrorism Act and unplanned events such as outbreaks of foodborne illness and recalls of contaminated foods," said the report.
The February 2008 final guidance for fresh-cut operations was delayed at least six years because of competing priorities. Tight money has delayed two key produce safety initiatives: modernizing its good manufacturing practices regulations and updating its good agricultural practices guidance.
The report also took a look at the FDA's record in conducting U.S. produce inspections.
"Our analysis of FDA data showed that the number of domestic fresh produce inspections rose from 327 in fiscal year 2000 to a peak of 699 in fiscal year 2005, and then declined to 478 inspections in fiscal year 2007," said the report.
The GAO, the accounting arm of Congress, found that the FDA took little enforcement action against produce companies as a result of inspections. "Specifically, we identified 96 warning letters related to fresh produce, but their use declined substantially, with 66 issued in fiscal year 2000 and none issued in fiscal years 2005 through 2007," the report said.
During the same period, according to the FDA, the agency seized no fresh produce, sought no injunctions, and prosecuted no firms for fresh produce- related violations.
But this comes as fresh produce imports increased about 60 percent between 2002 and 2007.
The report recommends that the FDA update its good agricultural practices guidelines and its regulations on food manufacturing practices; seek explicit authority from Congress to adopt preventive controls for high-risk foods; and gain authority for enhanced access to records.
"I strongly urge the next president to make the necessary administrative changes recommended in this report, and I am committed to working with my colleagues to make sure that Congress passes common-sense legislation to help the FDA achieve its mission of keeping our food safe and healthy to eat," Sen. Boxer said in the statement.
FDA reform is expected to be one of the top priorities for Congress when it returns next year.
