The enactment in December of the Consolidated Appropriations Act of 2020, including approval of the US Food and Drug Administration budget for fiscal year 2021, should ensure continuity in the nation’s food safety programs and initiatives as the Biden administration takes the nation’s helm.
The overall fiscal 2021 FDA budget, which includes the agency’s activities in the spheres of drugs and medical devices as well as food safety, provided for $3.21 billion in discretionary funding in fiscal year 2021. Including user fees, the FDA budget totaled $5.88 billion.
The budget as enacted by Congress fell short of the $6.2 billion in total funding for the FDA sought by the Trump administration in its proposed budget for fiscal year 2021 that was unveiled in February last year.
Congress approved a $45.25 million increase in program funding for the FDA over the fiscal year 2020 enacted level (comprising a net increase of $42.25 million in appropriations supplemented by savings of $3 million from the one-time, fiscal year 2020 appropriation for a machine learning program).
The increase in program funding from fiscal year 2020 included an additional $22 million for the agency’s medical products programs, $15.25 million for its food safety programs and $8 million for cross-cutting initiatives (including $7 million for artificial intelligence programs).
The approved budget authority for the FDA food safety program in fiscal year 2021 was $1,099,160,000 compared with an enacted $1,088,881,000 in fiscal year 2020. Of the 2021 total, $343.789 million will be directed to the Center for Food Safety and Applied Nutrition (CFSAN) and $753.751 million to FDA field activities.
Of the additional $15.25 million in funding appropriated for the FDA’s food safety programs, $1 million was allocated to enhance the CFSAN’s ability to ensure contaminated food is detected and removed from the marketplace as quickly as possible. The FDA had requested a $1.2 million increase for that purpose in its budget proposal.
In its budget request, the FDA noted, “The increased number of detected outbreaks and subsequent investigations resulting from the success of Whole Genome Sequencing (WGS) has greatly increased FDA’s workload to identify and mitigate potential food safety concerns.”
Congress, as requested by the FDA, provided $5 million in funding for assignment across several offices to enable the agency to continue regulating the use of cannabis-derived substances, such as cannabidiol (CBD), in FDA-regulated products such as dietary supplements and when used as unapproved food and feed additives.
Of the $5 million in funding for cannabis regulation, $2 million will be directed to the Office of Regulatory Affairs, the lead agency for FDA’s field activities including inspection of regulated products, $2 million to CFSAN, $500,000 to FDA headquarters and $500,000 to the Center for Veterinary Medicine.
The Acheson Group, in its initial analysis of the fiscal 2021 budget, said, “Although cannabis legalization is continuing to make strides both federally and statewide, FDA has continued to hold a tight rein on food/food additive and dietary supplement approvals. Whether the $5 million granted for this regulation will increase the agency’s stringency or enable it to begin to allow for edible uses on the federal level is yet to be seen.”
Congress also appropriated $6 million for a Shrimp Import Inspection Pilot Program, $1.25 million for allergen labeling, $1 million for cosmetics, and $1 million for the National Antimicrobial Resistance Monitoring System.
Congress in approving the funding for allergen labeling voiced concern that the recent FDA Draft Guidance for Industry on Voluntary Disclosure of Sesame was insufficient to protect Americans with a sesame allergy and directed the FDA to consider further action to require sesame to be labeled the same as other major allergens.
Congress also provided $8 million for “cross-cutting measures” for both food safety and medical products, including $7 million for the employment of artificial intelligence and other emerging technologies.
With regard to these measures, the Acheson Group said, “With another key component of the New Era blueprint that of ‘leveraging technology and other tools to create a safer and more digital, traceable food system,’ and the pilot program the agency began in 2020 leveraging artificial intelligence and machine learning for the review of imported foods at ports of entry, it should come as no surprise that FDA requested $10.2 million (in its proposed fiscal 2021 budget issued last February) for technology. Even if nearly half the funding goes toward public health initiatives (as requested), the technological applications and lessons learned can likely be transferred as well toward food.”