```

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 5103 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  2d Session
                                S. 5103

  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.

_______________________________________________________________________

                   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Food and Drug Administration Foods 
Accountability Act''.

SEC. 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.
                                 <all>
```