Don’t expect comment period extensions for the reproposed rules regarding the Food Safety Modernization Act (FSMA). That’s what Michael Taylor, the Food and Drug Administration’s deputy commissioner for foods and veterinary medicine, told attendees Wednesday at the United Fresh Produce Association Washington Conference. He said he had hoped to be discussing details of the reissued produce safety, Foreign Supplier Verification Program (FSVP) and preventive controls rules during the meeting, but all four rules are still under review at the Office of Management and Budget.

FDA’s Michael Taylor addressing the United Fresh Washington Conference on Wednesday.
The new proposals are expected to be released soon, but Taylor was unable to give an exact date for when. All he would say was, “We are very close.” The timeline for FSMA implementation is ever important, given that the first rules on preventive controls — both for human food and animal food — must be finalized by Aug. 30, 2015. FDA’s other court-mandated deadlines are Oct. 31, 2015, for produce safety, FSVP and third-party accreditation; March 31, 2016, for sanitary transport, and May 31, 2016, for intentional adulteration. “The court deadlines are really driving all of the timelines and planning that we’re doing, necessarily,” Taylor said. “My boss is potentially held in contempt if we don’t get the rules out.” He added that there will still be “a reasonable comment period” on the re-proposals “given that these are not new issues,” but that extended periods are not very feasible when sticking to the final deadlines. Taylor also provided attendees with an overview of the changes coming from FSMA regarding produce companies. At the end of his remarks, Taylor again emphasized the need for adequate resources for implementing FSMA. As budget presentations have stated, FDA needs the funding to develop guidance and provide technical assistance for industry, provide technical support for FDA inspectors, retrain the federal and state inspection force, and build the import oversight system mandated by FSMA. “I’m a broken record on this, but I’m duty-bound and it’s deadly serious stuff,” Taylor said. “There is a lot ahead of us … but it’s clearly worth it.” Speaking with reporters afterward, Taylor said that FDA “got the message on fees” and that, although the 2015 budget is still pending, “2016 really becomes the crucial year for getting the budget that we need to successfully implement.”