Recent Developments Show Renewed Interest in the Organizational Structure of FDA Food Programs | Hogan Lovells
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 (Law) (S.4520, HR 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 law’s co-sponsors believe that more funding, experience and transparency would help achieve these goals.4 In particular, the Act would create organizational changes and elevate certain food safety priority issues.
Title I provides for the “establishment of the administration of food security”, which includes:
- Creation of a food safety administration – The law would move some of the FDA’s food safety work from the FDA to the new HHS agency, including the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, the Office of Food Policy and Response, and the Food Regulatory Affairs components of the Office. These departments oversee 80% of the US food supply. USDA programs would not be transferred to the new administration.
- Consolidate leadership – The law would provide for an administrator who must have expertise in food safety and would report directly to the Secretary of HHS. The administrator would serve as the chief officer, appointed by the president by and with the advice and consent of the Senate.
Title II provides for the “Food Safety Administration Program”, which includes:
- Increased inspection frequency: The administrator would publish criteria for classifying food establishments into risk categories within six months. “High risk” facilities would be inspected at least once a year, “medium risk” at least every two years and “low risk” (including warehouses) at least every three years. All infant formula preparation facilities would be inspected at least every six months. In addition, whenever the Agency identifies a problem during an inspection (i.e. an observation on a Form 483 or its equivalent), the Agency must perform a follow-up compliance check within 30 days.5 Half of all inspections should be conducted by states.
- Promulgation of the traceability rule: The law requires the administrator to finalize the proposed rule, “Requirements for Additional Traceability Records for Certain Foods” (85 Fed. Reg. 59984 (September 23, 2021)), by November 7, 2022, which is the current deadline under a consent decree.
- Mandating transparency of shortages: If manufacturers of infant formula or essential medical foods become aware of circumstances that may lead to a shortage, they must notify the Administrator within five days.6 In addition, the new agency could impose criminal fines for failing to report a shortage.
FDA Review of Food Safety Programs
On July 19, 2022, Commissioner Califf announced that the FDA had initiated a comprehensive review of the food program, including its structure, function, direction, authorities, and funding.seven The commissioner said: “While the US food supply is safe and our Foods program experts have contributed significantly to making more nutritious food options available to consumers, the program has been challenged by the increasing diversity and complexity of the country’s food and supply chain systems. . Fundamental questions about structure, function, funding and leadership need to be addressed. Agency inspection activities related to the program should also be assessed, particularly in light of the constraints related to the COVID-19 pandemic.
The Reagan-Udall Foundation, an independent partner organization of the agency, will work with an external group of experts on the evaluation. During a Senate Appropriations subcommittee hearing on July 20e, Commissioner Califf clarified that the review will begin as soon as contracts are signed with those carrying out the work and a report will be issued within 60 working days of the start of the review. Additional details are expected to come from the FDA on the composition of the expert panel and the approach of those conducting the review.
We will continue to monitor the progress of the proposed project Food Safety Administration Act of 2022the FDA’s proposed review of its own food safety programs and other developments in this area.
1 Durbin, Blumenthal and DeLauro Introduce Food Safety Administration Act (July 13, 2022), For the text of the bill, see S.4520: Food Safety Administration Act of 2022, 117th Cong. (2022), HR8358: Food Safety Administration Act of 2022, 117th Cong. (2022).
2 Press Release: Bipartisan E&C Leaders Seek Update from FDA Commissioner on Agency’s Food Safety Reform Efforts, House Committee on Energy and Commerce (July 12, 2022).
3 See, for examplecoral beach, Public Action Groups Call for Separate FDA Food Branch to Streamline Food SafetyFood Security News (July 14, 2022).
4 Sen. Durbin (D-IL) and Congresswoman DeLauro (D-CT), Food Safety Administration Act of 2022
5 Currently, under the Food Safety Modernization Act, high-risk facilities must be inspected every three years.
6 The FDA’s FY2023 budget proposal included a legislative proposal regarding reporting of supply chain shortages for infant formula and medical foods.
7 Commissioner Califf, FDA conducts assessment of key agency activities to strengthen operationsFDA (July 19, 2022).