FDA Faces Lawsuit Over Food Safety Delays

The Federal Drug Administration (FDA), www.fda.gov, continues to face scrutiny from several government agencies as well as Congress for failure to enact required regulations.

A federal lawsuit has been filed regarding regulations passed by Congress in the Food Safety Modernization Act of 2011 in which it established three critical food safety programs to be implemented by the FDA. However, even though the FDA submitted its proposed regulations, the programs have been tied up at the White House Office of Information and Regulatory Affairs (OIRA) for a year.

Earlier this year, the Center for Food Safety and the Center for Environmental Health filed lawsuits against the FDA through the U.S. District Court for the Northern District of California. It was trying to force the agency to implement the programs as soon as possible.

FDA lawsuit

The FDA countered with a motion to dismiss the suit stating that the delays are not unreasonable given the complexity and large-scale scope of the tasks. It states that it has provided “enormous effort and resources to developing the novel and complex regulations” and is moving toward having the programs implemented.

Critics place the blame solely on the OIRA review process and attempts by the White House to avoid Republican political fallout during a presidential election year. Calls have been made for the FDA, the agency charged with implementation, to forgo the OIRA approval process and publish its proposed regulations immediately.

The three critical programs in question cover several aspects of the food safety chain including food growers, food importers, food processors and manufacturers. Under the new programs, growers will have to comply with “science-based” minimum sanitation standards. Importers will be required to provide documentation that their products were grown according to FDA food safety requirements. Processors and manufacturers will be required to have hazard analysis and critical control point (HACCP) programs in place.

FDA Under Scrutiny For Tainted Food Issues

In addition, the FDA faces other troubles. An increase in foodborne illness outbreaks and tainted food products has increased government awareness about protecting the safety of the United States food supply. The General Accounting Office (GAO) released a report earlier this year questioning the FDA food recall procedures. At that time, the GAO recommended that the agency develop “a comprehensive food recall communication policy and related implementation plans” to protect and notify the public safety better.

The FDA has put in place several initiatives to address the concerns raised by the report but is still under scrutiny from several government agencies and citizen watchdog groups to make sure changes are imminent.

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