“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.
The bottom line is that “industry has to be ready in 2016,” Dr. Henry tells Food Quality & Safety. “Things will become clearer once we see how the agency undertakes inspections after Sept. 30, 2016.”