FDA says it won't meet latest food registry deadline

Source of Article:  http://www.nextgov.com/nextgov/ng_20090402_4511.php



Despite a massive and deadly salmonella outbreak in peanuts and now recalls of pistachios for the same foodborne pathogen, FDA is again delaying a registry meant to be up and running last summer that would track contaminated foods and serve as an early warning system.

FDA Acting Assistant Commissioner for Legislation Stephen Mason wrote Senate Health, Education, Labor and Pensions ranking member Michael Enzi Tuesday informing the senator the agency would miss the new spring deadline it hoped to meet.

"However, barring unforeseen events, system development for the registry should be completed within 2009," Mason wrote. FDA and NIH will then conduct another month of testing once the registry is complete before putting it up live.

Enzi wrote FDA last month, asking the agency to explain its progress on the registry.

"American families have suffered the terrible health consequences of foodborne illness while FDA drags its feet on enforcing existing food safety laws," Enzi wrote. "Had the registry and reporting requirements been in effect, these recalls could have proceeded more rapidly and fewer Americans would have become sick from contaminated food."

FDA just warned consumers about the salmonella outbreak in pistachios this week. The recent outbreak in peanuts led to nine deaths and nearly 700 illnesses.

Enzi asked for the update given that FDA has since asked for new food safety powers since Congress signed the registry into law.

House Energy and Commerce Democratic Reps. John Dingell and Bart Stupak, both of Michigan, and Frank Pallone of New Jersey, have sought to give FDA additional resources and authority to police regulated products. Policy experts expect the food safety provisions to be broken off and passed on their own before lawmakers consider the drug, medical device and cosmetic provisions.

Congress required the food registry and outlined reporting requirements in a 2007 law that set user fee levels for drugs and medical devices and revamped FDA's drug safety efforts, and, to a lesser extent, the agency's food safety activities.

Tony Corbo, a lobbyist for the group Food & Water Watch, said he is concerned FDA is stretched too thin to focus on creating the registry.

"I have a feeling, the fact they've had all these recalls and people are running all over the place, they've diverted their attention from it," Corbo said.

Without the electronic registry, food companies and federal, state and local health officials report incidents to a fragmented system operated through district FDA offices.

FDA says the move to the electronic registry required by law is postponed because integrating the requirements with an electronic reporting system for reporting adverse medical events already under development in collaboration with the National Institutes of Health has taken longer the expected. Much like food, reporting on adverse reactions to pharmaceuticals and medical devices is spread across several different databases, some electronic, some paper-based.

FDA and NIH are working to integrate all the databases into one dubbed MedWatch Plus, where it would house the food registry as well. Mason wrote that combining adverse events on all FDA-regulated products into a single database would prove more cost-effective and user friendly.


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