FDA missed deadlines may continue

05/04/2012 12:55:00 PM
Tom Karst

DALLAS — The Food and Drug Administration badly missed statutory deadlines in January for issuing food safety regulations this year, and significant hurdles remain before any produce safety rule will take effect.

The mammoth undertaking of overhauling U.S. food safety laws is no easy task, said David Durkin, principal with Olsson Frank Weeda Terman Matz PC. Durkin said some believe that if the produce safety rule is not issued by the end of May, it will not be issued until after the election this November.

Durkin and David Arvelo, small business representative for the Food and Drug Administration Southwest Regional Office, spoke at a May 1 workshop at the United Fresh Produce exposition. Arvelo did not speak about when the produce safety rule will be published.

While the FDA submitted the produce rule to the Office of Management and Budget in December, Durkin said it was not enough time for the OMB to feel comfortable with the rule before the January statutory deadline set by Congress.

An economic impact analysis of any federal regulation with more than a $100 million effect is required, and Durkin said that analysis is important because it could be used by opponents to challenge the rule. Separately, the FDA also must prepare a regulatory flexibility analysis to certify to the Small Business Administration about the impact of the rule on the economy.

When the proposed food safety rules are published, Durkin said the agency will provide a minimum of 120 days for comment. After comments are received and responded to, the FDA will again submit the proposed rules to the Office of Management, which Durkin could mean another significant delay in the process.

Agencies, including the Office of the Trade Representative will also weigh in with their opinions about the proposed regulation, Durkin said.

Given the delays, Durkin said the industry will have plenty of time to make their voices heard about the effects of these proposed rules once they are published.



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Brunhilde Merker, CEO    
USA, FL  |  May, 07, 2012 at 04:49 PM

When I read this story it sounds like all the world has to wait for something surprising in food safety that has never been used before. The new food safety regulations are only some new updates to the old GAP’s and the FDA Bio-Terrorism law. Nothing is really new about how to produce safe food or feed. As everybody can read at the FDA website http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm261672.htm as the final rules are out since July 3, 2011. From this day on, FDA (FSMA) is able to detain food the agency believes has been produced under unsanitary or unsafe conditions. This sentence means that FDA expects from the industry to produce safe food/feed under sanitary conditions. To suggest a false believe that there is all the time in the world to wait for something out of the ordinary is not a help for the industry members as we can see on daily FDA inspections and warning letters plus recalls. Just who has a interest in misleading members in the produce industry? Here is what Dr. David Acheson says: Zero tolerance for unsafe food ... http://webcache.googleusercontent.com/search?q=cache:omdQi5h7W34J:www.astaspice.org/files/public/AchesonApril23,2012ASTA.pdf+dr.+david+acheson+unsafe+food&cd=5&hl=en&ct=clnk&gl=us

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