II 118th CONGRESS 2d Session S. 5103 IN THE SENATE OF THE UNITED STATES September 19, 2024 Mr. Budd (for himself and Mr. Markey ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To require the Secretary of Health and Human Services to develop a strategic plan for the Human Foods Program of the Food and Drug Administration and the food functions of the Office of Inspections and Investigations, and for other purposes.

1. Short title This Act may be cited as the Food and Drug Administration Foods Accountability Act . 2. Food and Drug Administration Foods Accountability Act (a) FDA Human Foods Program strategic plan (1) In general Not later than September 30, 2025, and at least every 4 years thereafter, the Secretary of Health and Human Services (referred to in this section as the Secretary ) shall develop and submit to the appropriate committees of Congress and post on the website of the Food and Drug Administration a strategic plan for the Human Foods Program of the Food and Drug Administration and the food functions of the Office of Inspections and Investigations (or any successor programs of the Food and Drug Administration responsible for the regulation of human foods). (2) Content of strategic plan The strategic plan under paragraph (1) shall include— (A) strategic goals and priorities related to— (i) food safety, including implementation of the FDA Food Safety Modernization Act ( Public Law 111–353 ) and coordination and engagement across the Food and Drug Administration with Federal, State, local, and Tribal entities and private sector entities, to improve food safety oversight; (ii) food safety inspections, including coordination and engagement across the Food and Drug Administration to meet inspection goals and coordination with Federal agencies, including the Centers for Disease Control and Prevention and the Department of Agriculture, and State, local, and Tribal entities to oversee food safety and conduct related inspections; (iii) administration of the Office of Critical Foods and related activities of the food functions of the Office of Inspections and Investigations and other offices or divisions of the Food and Drug Administration, including identification of any potential interruption in the supply of critical foods and what steps such Office would take in response, incorporating lessons from previous similar scenarios; (iv) initiatives to support nutritional health, including initiatives and activities of the Center for Excellence in Nutrition designated by the Secretary under the Human Foods Program, evidence-based initiatives to address chronic diet-related diseases, and administration of food labeling requirements, engagement with the Dietary Guidelines Advisory Committee in years when the Committee is reviewing updates to the Dietary Guidelines, and any other programs related to nutrition; (v) activities and programs to support recruiting, hiring, training, developing, and retaining a qualified workforce within the Human Foods Program and the food functions of the Office of Inspections and Investigations, including any cooperative programs with other entities to support recruitment and training of food safety inspectors, and reviewers to support review of regulatory submissions for food products; (vi) in the first such plan, specific metrics and other information identifying improvements made as a result of the reorganization of the Center for Food Safety and Applied Nutrition and establishment of the Human Foods Program and the food functions of the Office of Inspections and Investigations, including how any full-time equivalent positions within the Food and Drug Administration have been reallocated under the reorganization, and benchmarks against which to assess the performance of the Human Foods Program and the food functions of the Office of Inspections and Investigations; and (vii) other priorities identified by the Secretary; (B) specific activities and strategies for achieving the goals and priorities identified under subparagraph (A), and progress towards achieving such goals and priorities; (C) specific activities and strategies for improving and streamlining internal coordination and communication within the Food and Drug Administration, including for activities and communications related to signals of potential public health concerns, as well as other agencies and offices of the Department of Health and Human Services and other Federal departments and agencies, as appropriate; (D) specific activities and strategies for improving and streamlining coordination and communication with non-Federal stakeholders, including steps to improve outreach regarding rulemaking activities; and (E) challenges and risks the Human Foods Program is expected to face in meeting its strategic goals and priorities, and the activities the Human Foods Program will undertake to overcome those challenges and mitigate those risks. (3) Evaluation of progress Not later than September 30, 2027, and every 2 years thereafter, the Secretary shall submit to the appropriate committees of Congress and post on the website of the Food and Drug Administration a progress report that includes— (A) a description of the progress the Secretary has made toward the goals and priorities identified under paragraph (2)(A) in the most recent strategic report submitted under paragraph (1); and (B) whether actions taken in response to the most recently submitted strategic plan improved the capacity of the Food and Drug Administration to achieve the strategic goals and priorities set forth in previous strategic plans. (4) Updates The Secretary shall, as appropriate, update the strategic plan to account for significant changes in the production and regulation of foods or the scientific evidence related to nutrition and food production, or other significant changes, as the Secretary determines appropriate. (b) GAO report (1) In general Not later than September 30, 2028, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report assessing the initial strategic plan submitted under subsection (a). (2) Contents of report The report required under paragraph (1) shall include an assessment of— (A) the development and implementation of the strategic plan, including the sufficiency of the plan, progress of the Human Foods Program in meeting the results-oriented goals and priorities identified in such plan, and any gaps in such implementation; (B) how the Human Foods Program applies hiring authorities under section 714A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379d–3a ); and (C) recommendations for the Human Foods Program to address the identified challenges, improve its implementation of the Human Foods Program strategic plan, and to otherwise improve the public health mandate of the Food and Drug Administration.