In FDA’s 2016 Foods Program Budget, a Heavy Dose of Fees for Food Safety (Again)

By Ricardo Carvajal –

Given the effort that FDA has put into FSMA implementation thus far, it comes as no surprise that the agency’s budget for 2016 places a heavy emphasis on the resources that the agency believes are needed to finish the job.  The focus on FSMA and food safety is established up front in the Commissioner’s cover letter, which gives primacy to FSMA implementation in the agency’s justification for a budget authority increase.  The remainder of the document doesn’t let up, with some 115 references to FSMA.

The budget acknowledges what was already evident to many observers – FSMA implementation has drawn resources away from other food-related priorities (“FDA has proactively reprioritized current resources, including the FY 2016 increase, to ensure they are directed to the highest priorities for food and feed safety modernization.”)  However, FDA makes clear that reprioritization won’t yield sufficient funds going forward:

Without the requested budget authority, FDA will be unable to:

• implement fundamental FSMA requirements for domestic food and feed safety on a timely basis
• acquire the technical staffing needed to support FSMA implementation
• train FDA and state inspectors in the new FSMA prevention paradigm and preventive controls system, as needed to ensure effective and consistent inspections 
• provide the necessary guidance and technical assistance to industry, particularly small producers and businesses, on how to meet the new requirements resulting from the shift toward preventing food and feed contamination
• adequately support the FSMA goal of strengthening state roles in a national integrated food safety system
• adequately assure the safety of imported food by building and implementing the import safety system mandated by FSMA.

The budget goes on to explain in detail the activities that would be supported by an increase in the agency’s budget authority (@ $84M), but that increase pales in comparison to the @ $169M increase that would be supported by proposed user fees.  In what is becoming an annual ritual, FDA is asking for a variety of user fees – for imports, food facility registration and inspection, cosmetics registration, and food contact substance notification.  In sum, if all of the proposed user fees were to be authorized and implemented, then user fees would go from accounting for less than 2% of the foods program budget in FY 2015 to accounting for almost 20% of that budget in FY 2016.

The budget acknowledges that the proposed user fees would be “contingent upon the enactment of authorizing legislation.”  Previous efforts to secure such legislation have foundered, and it’s not clear why the result this year would be any different.  That could put the agency in an interesting position as it seeks to comply with a court-supervised deadline for issuing the final rules to implement FSMA (see our previous post here).