OMB Makes Cuts to FSMA Regulatory Package

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.