House Appropriations Committee Chair Rosa L. DeLauro (D-CT) and House Appropriations Agriculture, Rural Development, Food, and Drug Administration, and Related Agencies Subcommittee Chair Sanford D. Bishop, Jr. (D-GA), have sent a letter to Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock, M.D., requesting transparency related to the budget for food safety programs at the FDA.
The White House installed Woodcock as acting FDA commissioner on Jan. 20. She joined FDA in 1986, rising to become one of its top officials. Prior to being named acting FDA commissioner, she was assigned to “Operation Warp Speed” to deliver COVID-19 vaccines to the market and was principal medical advisor to the commissioner.
Her involvement with food safety at the agency, however, has been limited. Woodcock recently responded to questions about whether food safety might be neglected with so many of its other priorities including bringing the COVID-19 pandemic to a close.
“My answer to you, and I tell you this very sincerely, is not on my watch, “ she said.
The letter from DeLauro and Bishop demands answers to some specific questions about the FDA’s Office of Regulatory Affairs (ORA).
The letter says ORA “receives approximately 70 percent of the funds Congress appropriates for the food program. We are concerned that ORA’s substantial overhead and lack of transparency and accountability in resource management present obstacles to the efficient and effective use of ORA’s appropriated resources and fulfillment of the prevention mandate of FDA’s food program.”
Considering the FDA’s recent proposal to reduce the inspection frequency requirements under the Food Safety Modernization Act (FSMA), DeLauro and Bishop are seeking information on staffing levels, positions, and functions in the Office of Regulatory Affairs related to the food program to determine whether additional budget transparency, accountability, and efficiencies are needed.
DeLauro and Bishop are also demanding answers from Woodcock that they say are necessary for House budget writers to have for developing the FDA budget for the Fiscal Year 2022, which begins on Oct. 1. These are the questions:
- What accounts for the significant declines from FY 2018 to FY 2019 in the number of domestic inspections, import exams, and import analyses performed by ORA?
- What accounts for the vacancies in ORA food inspection and compliance positions?
- What are the staffing levels and vacancy rates in all other ORA positions that play roles related to food?
- To the extent ORA was not able to staff its food positions at the FTE (full-time employee) level for which dollars were appropriated in FY 2019 and FY 2020, please provide details on how ORA allocated these funds.
- Why are ORA inspection and compliance staff assumed to devote only 950 hours per year to operational work? How is the remainder of the time allocated?
- For FY 2019 and FY 2020, please provide detailed, quantitative information on the ORA organizational units and functions, staff positions, and FTEs engaged in operational and non-operational work related to the food program.
- What is the decision making process within the FDA for how food resources are allocated between operational and non-operational functions? Also, what is the decision making process for how food resources are allocated among program areas, such as domestic and foreign inspections, import oversight, and laboratory analysis?
- How does ORA evaluate and report the extent to which it completes the tasks in the annual work plan? Please provide any such reports for FY 2015 – FY 2020.
- Please provide estimates of the average cost of ORA’s domestic and foreign inspections, the methodology for developing these estimates, and a comparison of ORA’s average inspection costs with the costs of state inspections.
Finally, DeLauro and Bishop say that FDA’s Center for Food Safety (CFSAN) is ultimately responsible for safeguarding the food supply especially as set forth in the Food Safety Modernization Act.
“However, CFSAN has no role in planning the use of ORA’s non-operational resources, which results in lack of transparency, even within FDA on how ORA uses its resources for the food program.”
Since taking office, Woodcock has been subject to both letters of support and opposition to a still uncertain White House about who should get the permanent appointment as FDA commissioner.