Wednesday 26 April 2017

Government Shutdwon FDA USDA

Impact of Government Shutdown on FDA and USDA

A government shutdown looks increasingly likely this week. The Office of Management and Budget (OMB) has asked agencies to begin making contingency plans. Their first stop will be their plans from 2011. The shutdown is expected to impact the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA).

FDA Shutdown

The Washington Post reports the FDA would continue “limited activities” at programs that are funded through industry user fees.  The Department of Health and Human Services, which oversees the FDA, said in a statement limited staff would be available to maintain critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues. Officials said the FDA would be unable to keep up the majority of its food safety, nutrition and cosmetics oversight. It’s unclear if other vital daily functions, like the FDA’s advisory committees, which are essential for the review of new molecular entities and high-risk medical devices, would remain scheduled. The agency would be forced to furlough 6,620 workers, or about 45 percent of its 14,779-person workforce. 

A federal response to food recalls and outbreaks would also likely be delayed because of staff furloughs at the U.S. Centers for Disease Control & Prevention (CDC), which works jointly with the FDA during an outbreak.

If there is a serious adverse event or basis to recall a product those activities must still be timely completed.

 

USDA Shutdown

In 2011 only special user fee programs remained staffed. The USDA released a contingency plan in 2011 listing the programs disrupted by a shutdown. For example, fresh and processed fruit and vegetable inspections under the Perishable Agricultural Commodities Act Program, which is supported by a special fee account, would continue during a possible shutdown, according to the 2011 plan. Programs without a special user fee that would be closed or under a skeleton crew include: marketing agreements and orders, the Microbiological Data Program,  the National Organic Standards Program, country-of-origin labeling, and the Pesticide Data Program. Limited seat, poultry and egg inspection services would continue. Inspections of fruits, vegetables and nursery products before they are shipped to the United States would not be disrupted, according to the plan for the Animal & Plant Health Inspection Service. Neither would agricultural inspections and quarantines that can be potentially damaging to U.S. crops.

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