Recent developments point to renewed interest in the organizational structure of Foods Programs at FDA

Food Safety Administration Act of 2022

On July 13, 2022, Senator Dick Durbin (D-IL), Senator Richard Blumenthal (C-CT), and Representative Rosa DeLauro (D-CT-03) introduced the bicameral Food Safety Administration Act of 2022 (Act) (S.4520, H.R. 8358).¹ This effort builds on the recent push by lawmakers² and consumer groups³ who believe the Food and Drug Administration (FDA) should respond more quickly and effectively to food safety issues. The Act’s co-sponsors believe that more funding, experience, and transparency would enable these goals.⁴ In particular, the Act would create organizational changes and elevate certain priority issues with respect to food safety.

Title I provides for the “Establishment of Food Safety Administration,” which includes:

• Creating a Food Safety Administration – The Act would move part of the FDA’s food safety work out from under the FDA and into the new agency in HHS, including the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, the Office of Food Policy and Response, and those components of the Office of Regulatory Affairs affecting food. These departments oversee 80% of the U.S. food supply. USDA programs would not be shifted to the new Administration.

• Consolidating Leadership – The Act would provide for an Administrator who must have food safety expertise and would report directly to the HHS Secretary. The Administrator would serve as a principal officer, appointed by the President by and with the advice and consent of the Senate.

Title II provides for the “Administration of Food Safety Program,” which includes:

• Increasing Inspection Frequency: The Administrator would issue criteria to classify food facilities into risk categories within six months. “High-risk” facilities would be inspected at least once per year, “intermediate-risk” at least every two years, and “low-risk” (including warehouses) at least every three years. All infant formula facilities would be inspected at least every six months. Additionally, whenever the Agency identifies an issue during an inspection (i.e., an observation on a Form 483 or its equivalent), the Agency must conduct a follow-up compliance check within 30 days.⁵ Half of all inspections would be required to be conducted by the states.

• Promulgating the Traceability Rule: The Act requires that the Administrator finalize the proposed rule, “Requirements for Additional Traceability Records for Certain Foods” (85 Fed. Reg. 59984 (Sep. 23, 2021)), by November 7, 2022, which is the current deadline pursuant to a consent decree.

• Mandating Shortage Transparency: If manufacturers of infant formula or essential medical foods become aware of circumstances that could lead to a shortage, they must notify the Administrator within five days.⁶ In addition, the new agency could impose criminal fines for failure to report a shortage.

FDA Review of Food Safety Programs

On July 19, 2022, Commissioner Califf announced that FDA has initiated a full review of the Foods Program, including its structure, function, leadership, authorities and funding.⁷ The Commissioner stated: “While America’s food supply is safe, and our Foods program experts have significantly contributed to the availability of more nutritious food options for consumers, the program has been stressed by the increasing diversity and complexity of the nation’s food systems and supply chain. Fundamental questions about the structure, function, funding and leadership need to be addressed. The agency’s inspectional activities related to the program also need to be evaluated, particularly in light of stresses related to the COVID-19 pandemic.”

The Reagan-Udall Foundation, an independent partner organization for the agency, will be working with an external group of experts on the evaluation. At a Senate Appropriations Subcommittee Hearing on July 20^th, Commissioner Califf specified that the review will begin as soon as contracts are signed with those conducting the work and that a report will be issued within 60 business days of when the review begins. Additional details are expected to come from FDA on the composition of the expert panel and the approach of those conducting the review.

Next steps

We will continue to monitor the progress of the proposed Food Safety Administration Act of 2022, FDA’s proposed review of its own food safety programs, and other developments in this space. Please reach out if you have questions on this or any other matter.

Authored by Elizabeth Fawell.

References

1 Durbin, Blumenthal, DeLauro Introduce Food Safety Administration Act (July 13, 2022), For text of bill, see S.4520: Food Safety Administration Act of 2022, 117th Cong. (2022), H.R.8358: Food Safety Administration Act of 2022, 117th Cong. (2022).

2 Press Release: Bipartisan E&C Leaders Request Update From FDA Commissioner on Agency’s Food Safety Reform Efforts, House Committee on Energy & Commerce (July 12, 2022).

3 See, e.g., Coral Beach, Public action groups call for separate food arm at FDA to streamline food safety, Food Safety News (July 14, 2022).

4 Senator Durbin (D-IL) and Congresswoman DeLauro (D-CT), Food Safety Administration Act of 2022 One-Pager

5 Currently, under the Food Safety Modernization Act, high-risk facilities must be inspected every three years.

6 FDA’s FY 2023 budget proposal included a legislative proposal regarding supply chain shortage reporting for infant formulas and medical foods.

7 Commissioner Califf, FDA Conducting Evaluation of Key Agency Activities to Strengthen Operations, FDA (July 19, 2022).