Filling Science and Technology Gaps
To successfully implement FSMA, FDA needs to fill “critical knowledge gaps” to support its regulatory decision-making. According to a strategic plan for 2015-2018 prepared by the agency’s Center for Food Safety and Applied Nutrition (CFSAN), which is tasked with implementing FSMA, the knowledge gaps span several areas, including intervention and preventive control strategies for microbial and chemical hazards; development of improved field laboratory screening methods for contaminant detection; and advancing bioinformatics. CFSAN “is focused on setting science-based preventive control standards for the way industry produces, distributes, and markets food in order to strengthen the nation’s food safety system,” the CFSAN report states.
For several years FDA, CDC, and other agencies have been successfully utilizing full-genome sequencing and other genomic tools to identify pathogens implicated in foodborne outbreaks, including the recent Blue Bell Listeria situation. “We will see more of this in 2016,” Dr. Acheson predicts, as FDA inspectors collect environmental swabs during routine inspections and the genomic sequences are stored in online databases. “It’s almost like a criminal DNA database for later cross-referencing,” Dr. Acheson says. “And should inspectors find a positive sample, there may be short-term consequences for the plant including the issuance of a Form 483 for objectionable conditions,” he says.
A major ongoing problem is the lack of funds to implement FSMA rules. “FDA funding is the leading challenge in 2016,” notes Craig W. Henry, PhD, vice president for global business development, Americas, Decernis LLC. “Funding is well below what was projected and required to move forward with FSMA regulations.” FDA has requested $109.5 million in additional FSMA funding from Congress for fiscal 2016, which began Oct. 1, 2015. But the House allocated only $41.5 million and the Senate granted $45 million. And for the fourth consecutive year, both chambers rejected the agency’s requests for industry user fees, this year totaling $191.8 million in food facility registration and inspection fees. FDA’s proposed fiscal 2017 budget request will be presented to Congress in February 2016.