FDA Ready to Finish FSMA Rules

SAN DIEGO — The Food and Drug Administration is set to finish the rules for the Food Safety Modernization Act under a court-ordered schedule, Mike Taylor, the FDA deputy commissioner for food, said here Sunday at the American Farm Bureau Federation convention.

Federal courts have ordered the FDA to publish the final rule for feed manufacturing and preventive controls by August, for foreign suppliers and produce by October and for intentional adulteration and food transportation in 2016.

Usually, Taylor noted, he cannot predict when a rule will be finalized but these are court-ordered deadlines.

The staff is now “fully taking advantage” of the comments submitted by a wide range of groups before the comment period ended on December 15, Taylor told The Hagstrom Report after his presentation. Those groups, ranging from the National Grain and Feed Association to the American Feed Trade Association and the National Sustainable Agriculture Coalition, all expressed concerns with the rules as written.

FDA is “not soliciting more comments,” Taylor said, but he noted that he has traveled to 20 states and he and FDA staff have visited many farms during the development of the rule.

FSMA, which passed Congress after a series of foodborne-illness outbreaks involving produce, will bring “profound changes” to FDA because it is moving from “relying on enforcement to a model that says let’s work to facilitate compliance.”

The exemption for farms with less than $500,000 in sales with half of that production sold directly to consumers within 225 miles of the farm was “part of the politics that got FSMA enacted,” Taylor said.

He noted that those small farms are still subject to adulteration provisions and are subject to inspections and to market pressures.

Taylor noted that, despite the exemption, many small producers “don’t feel at all exempt” because they believe that the marketplace will force them to follow the same rules.