Even with the White House Office of Management and Budget now sitting on several Food Safety Modernization Act rules for more than a year, the Food and Drug Administration wants the U.S. District Courts to provide the administration with more time.
In a late November motion to dismiss a lawsuit filed against the FDA and the Office of Management and Budget by the Center for Food Safety and the Center for Environmental Health seeking prompt FDA implementation of food safety rules, the FDA asked the U.S. District Court in Northern California to give it more time to implement complex and wide-ranging food safety regulations.
“FDA’s decisions regarding enforcement actions are not subject to judicial review, and the defendants have not, as a matter of law, unreasonably delayed the adoption of regulations implementing FSMA,” government lawyers argued in the motion.
The rules that the Office of Management and Budget has been reviewing for more than a year include Hazard Analysis and Risk Based Preventive Controls (under review at OMB since Nov. 22, 2011), the Foreign Supplier Verification Program (under review since Nov. 28 of 2011), the Current Good Manufacturing Practice and Hazard Analysis and Risk-Benefit Preventive Controls for Food for Animals (under review at OMB since Dec. 5, 2011) and the Produce Safety Regulation (under review since Dec. 9, 2011).
Industry leaders have also been impatient with lack of movement by OMB on the food safety regulations.
Some have speculated the proposed rules were slowed by election-year politics. That reason no longer applies after the November election, but the rules continue to languish at OMB.
Now, Tom O’Brien, Washington, D.C.-based representative for the Newark, Del.-based Produce Marketing Association, said the Office of Management and Budget website http://1.usa.gov/Wo6cma shows the FDA in late November submitted the proposed regulation on accreditation of third parties to conduct food safety audits and for other purposes to the Office of Management and Budget.
“I don’t know if that review (by OMB) will take place in time for it to come out with the other (food safety regulations), but we don’t know when the others are coming out and it may be possible,” he said.
David Gombas, senior vice president of food safety and technology for Washington, D.C.-based United Fresh Produce Association, said Dec. 18 that the delay has become the number one question n the industry.
“A year is way too long to wait to see what these rules say,” Gombas said. “They are just proposed rules, so let’s get them out there and take a look at them already.”
Even knowing the reason for the long delay would be helpful, Gombas said.
In their lawsuit against the FDA and OMB, the Center for Food Safety and the Center for Environmental Health said the delay in the regulations is “unlawful” and they’re seeking a a court order that would require FDA to enact FSMA regulations by a court-imposed deadline and would prevent the OMB from delaying FDA’s compliance with that deadline.