Meeting the Requirements of FSMA in 2016

The produce safety rule impacts growers of fruit and vegetables intended for raw consumption. Here, growers will be required to adopt science-based microbial testing of and standards for water used for irrigation. The rule also elaborates on standards for manure application and for composting. (The preventive controls rule clarifies when a farm is covered by produce safety rule and when its activities may place it under preventive controls jurisdiction.)

FSMA grants FDA access to company records during routine inspections. Should problems arise, FDA will first seek voluntary corrections at the facility level. If that fails, the agency will use its enhanced administrative powers, such as detention and mandatory recalls, and only afterwards seek court-ordered injunctions, seizures, or criminal prosecutions. Overall, FDA hopes to encourage industry compliance through education and technical assistance by partnering with other federal, state, and local agencies.

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.

Budget Shortfall

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.

“If we receive [the requested] funding, we can move forward to implement this new, modern system in an effective and timely way,” said Taylor. “If we do not get the funding, we will lose momentum, and implementation will be badly disrupted.” The ongoing budget challenge is confronting not only FDA, but also USDA, CDC, and state and local agencies responsible for food inspections and public health surveillance. “If states are expected to implement the regulations and have their enforcement plans executed, they will have to be funded and everyone will have to be in lockstep with the training that is required for all inspectors,” Dr. Henry explains.

This funding shortfall may also slow FDA’s issuance of guidance documents, which industry relies on to adopt the new regulations. Agency officials expect to release guidance documents for the preventive control rules by the end of the first quarter of 2016, which would give large companies only nine months to prepare. But these may also be delayed by politics. “In my experience in Washington, once you hit May in an election year you start walking through quicksand and you grind to a halt by July and August,” says Dr. Acheson.