Removing ‘Food’ From FDA

Of the agency’s $109.5 million requested increase for food safety, $32 million would go to build a national integrated food safety system. This includes grants and cooperative agreements for additional facility inspection training for about 1,000 state and local inspectors, especially to implement the new preventive controls rules in late 2016. An additional $25 million would go to train a cadre of more than 2,000 existing FDA inspectors, compliance officers, and other food safety staff. Yet another $25.5 million would be used to implement the Foreign Supplier Verification Program, including training of more than 400 current investigative and compliance personnel and the hiring of more staff.

“Why do we need this money? Because a lot of work must be done right now to ensure that the FSMA rules are implemented smoothly and effectively in late 2016 and 2017,” said Michael R. Taylor, JD, FDA deputy commissioner for foods and veterinary medicine. “The bottom line is that without investment now, and sustained funding afterwards, there is the risk that the implementation of FSMA will be uneven or even delayed. This would be bad for everyone, including those who must meet the new standards and those who must enforce them,” Taylor said in an online posting.

A significant portion of FDA’s new funding would come from food industry user fees (increasing from $14.4 million to $206.2 million). These include a food facility registration and inspection fee to fund agency activities related to FSMA, and a food import fee. While drug and medical device manufacturers pay FDA user fees, they receive expedited product reviews in exchange. The food industry generally opposes user fees and Congress has consistently refused to appropriate them. A group of about 60 food industry associations signed a letter in February to leaders of the House and Senate appropriations committees urging lawmakers to appropriate all of FDA’s funding and not saddle industry with additional burdens.

Agres is a freelance writer based in Laurel, Md. Reach him at [email protected].