April 4, 2013

OMB makes cuts to FSMA regulatory package

From: Shook Hardy & Bacon LLP

Mark Anstoetter and Madeleine McDonough

According to news sources, the White House Office of Management and Budget (OMB) removed some provisions from the regulatory implementation package that the Food and Drug Administration (FDA) proposed under the Food Safety Modernization Act (FSMA). Analysis of documents submitted to the rulemaking docket apparently reveals that the following requirements were removed from the draft rules submitted for OMB review: (i) company programs to monitor the environment for pathogens, (ii) finished product testing for pathogens, (iii) the assumption that pathogens found on food contact materials are also in the food, (iv) a supplier approval and verification program, (v) company review of consumer safety complaints, and (vi) FDA authority to copy company records. See Food Politics and Law360, March 25, 2013.

Meanwhile, the Center for Food Safety has reportedly called on a federal court in California to impose deadlines on FDA to implement food safety regulations, arguing that the FSMA set certain rulemaking deadlines that have been missed. A U.S. Department of Justice attorney reportedly responded by noting, “Congress set tremendous tasks for the agency, and in no detail. We didn’t get any new staff, or a new center, as we did with tobacco regulation. We got, ‘You’re the experts; you know how to deal with food safety; we want you to tighten the system.’” The court apparently questioned whether it had the authority to impose or enforce deadlines on the agency. See Law360, March 27, 2013.

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