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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