Washington, D.C. – The Food and Drug Administration's proposed regulation of produce safety may be unveiled as early as mid-2011, but even then the real work will be just starting.

Produce safety regulation slowly taking shape, FDA officials report

Officials from the agency briefed the U.S. Department of Agriculture Fruit and Vegetable Industry Advisory Committee and attendees to the United Fresh Produce Association Washington Public Policy Conference about the status of the agency’s produce safety regulation in mid-September.

Leanne Skelton, senior policy analyst at the FDA Office of Food Safety, said the agency is developing an education and outreach component to the regulation. "We view this as crucial," she said.

Skelton and Jim Gorny, senior adviser on produce at the FDA Office of Food Safety, spoke to the advisory committee during the afternoon session on Sept. 13. On Sept. 15, Samir Assar, director of produce safety at the FDA's Office of Food Safety, spoke to WPPC attendees about the same topic.

Assar said the agency is working through more than 900 comments on the recently closed federal docket that asked for input on risk-based and scale-appropriate produce safety regulations at the farm and at the packinghouse.

"We are committed to developing a regulation that sets forth a standard for produce safety and ensures a high degree of compliance," Assar said.

Produce safety regulation slowly taking shape, FDA officials report

Tom Karst

Samair Assar, director of produce safety at the FDA's Office of Food Safety, briefs Washington Public Policy Conference attendees on the status of produce safety regulation.

He said agency officials have engaged all stakeholders in the process, visiting 13 states and many farms in the past several months.

Gorny said a mid-2011 introduction of a proposed produce safety regulation is possible, though uncertainties remain about yet-to-be passed congressional food safety legislation.

"We're moving forward on this, but keeping an eye on legislation," Gorny said.

Skelton said much remains to be done in the writing of the produce safety regulation, including publication of a proposed rule, a comment period and then FDA writing of a final rule taking account all the comments received.

The FDA must also look at the effect of the regulation relative to the paperwork reduction act, impact on small business, the potential ramifications for trade, environmental considerations and costs and benefits to producers.

Beside the USDA, other agencies that have been consulted in produce safety rulemaking include the Environmental Protection Agency, Occupational and Safety Health Administration, Customs and Border Protection and the Fish and Wildlife Service. In addition, state agencies also are being consulted.

“There is a general sense that food safety trumps everything it is just a matter of tying it all together," Skelton said.

Skelton also said the FDA is pondering the issues of compliance and enforcement of the regulation, and how those goals will be built and implemented.

“Who would play a role in FDA enforcement; that piece we are working on now," she said. However, enforcement will only happen when a final rule is in effective.

"That's when the enforcement action would happen and that's still a ways off," she said.