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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4728 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  2d Session
                                S. 4728

To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety 
 of food and limit the presence of contaminants in infant and toddler 
                     food, and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                July 11 (legislative day, July 10), 2024

Ms. Klobuchar (for herself and Ms. Duckworth) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety 
 of food and limit the presence of contaminants in infant and toddler 
                     food, 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 ``Baby Food Safety Act of 2024''.

SEC. 2. DEFINITION OF INFANT OR TODDLER FOOD.

    Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321) is amended by adding at the end the following:
    ``(tt) The term `infant or toddler food' means food that purports 
to be, or is represented as being, for infants or children up to the 
age of 24 months. Such term does not include infant formula.''.

SEC. 3. CONTAMINANTS IN FOOD, INCLUDING INFANT OR TODDLER FOOD.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended by adding at the end the 
following:

``SEC. 425. CONTAMINANTS IN FOOD, INCLUDING INFANT OR TODDLER FOOD.

    ``(a) Administrative Orders for Contaminants, Including Toxic 
Elements, in Food.--
            ``(1) In general.--
                    ``(A) Required limits.--The Secretary, by 
                administrative order, shall establish limits on the 
                toxic elements of lead, cadmium, mercury, and arsenic 
                (or a species of any such toxic element) in--
                            ``(i) any infant or toddler food; and
                            ``(ii) food predominantly composed of a 
                        fruit or vegetable puree or juice;
                    ``(B) Additional limits.--If the Secretary 
                determines appropriate upon review of relevant health 
                data and other relevant available information, the 
                Secretary, by administrative order, may--
                            ``(i) establish limits for contaminants, 
                        including toxic elements, in infant or toddler 
                        food, in addition to the limits for toxic 
                        elements described in subparagraph (A); and
                            ``(ii) establish limits for contaminants, 
                        including toxic elements, in food predominantly 
                        composed of a fruit or vegetable puree or 
                        juice, in addition to the limits for toxic 
                        elements described in subparagraph (A); and
            ``(2) Procedure.--In establishing or revising any limit 
        under paragraph (1), the Secretary shall--
                    ``(A) evaluate relevant health data and 
                assessments, data from State and local health 
                departments, and other information the Secretary 
                considers relevant;
                    ``(B) take into account relevant differences among 
                food types, groups, and categories, as appropriate, 
                including the extent to which the use of such 
                substances cannot be avoided in the production of the 
                applicable food and its ingredients, based on an 
                evaluation of alternative ingredients, use of best 
                manufacturing and agricultural practices, and full 
                compliance with section 418; and
                    ``(C) notwithstanding the requirements of 
                subchapter II of chapter 5 of title 5, United States 
                Code, and chapter 6 of title 5, United States Code--
                            ``(i) publish any administrative order 
                        under paragraph (1) in the Federal Register 
                        following--
                                    ``(I) publication of a proposed 
                                order in the Federal Register; and
                                    ``(II) consideration of comments to 
                                a public docket open for not fewer than 
                                45 calendar days; and
                            ``(ii) set forth in any proposed or final 
                        administrative order under paragraph (1) a 
                        substantive summary of the valid scientific 
                        evidence concerning the proposed or final 
                        limit.
            ``(3) Changes to limits.--If the Secretary determines 
        appropriate after review of relevant data and assessments and 
        other available and relevant health information, the Secretary 
        may revise any limit established under this subsection by 
        administrative order published in the Federal Register in 
        accordance with paragraph (2).
            ``(4) Timeframe for initial limits.--
                    ``(A) Proposed orders.--Subject to the requirements 
                of paragraph (2), the Secretary shall issue proposed 
                orders for limits under paragraph (1)(A) as follows:
                            ``(i) For lead, not later than December 31, 
                        2025.
                            ``(ii) For arsenic, not later than December 
                        31, 2025.
                            ``(iii) For cadmium, not later than April 
                        30, 2026.
                            ``(iv) For mercury, not later than April 
                        30, 2028.
                    ``(B) Final orders.--The Secretary shall issue each 
                final administrative order for a limit established 
                pursuant to subparagraph (A) or (B) of paragraph (1) 
                not later than 18 months after issuance of the 
                respective proposed order.
            ``(5) Criteria.--The limits established under this section 
        shall represent the level at which the contaminant may render 
        the infant or toddler food injurious to health. In determining 
        such limits the Secretary shall take into account the extent to 
        which the use of such substance cannot be avoided in the 
        production of each such food and its ingredients, based on an 
        evaluation of alternative ingredients, use of best 
        manufacturing and agricultural practices, and compliance with 
        section 418.
            ``(6) Adulterated food.--A food may be determined 
        adulterated, at the final product form, under section 402(j), 
        if such food bears or contains any contaminant (including any 
        toxic element) in excess of a limit established under this 
        subsection.
            ``(7) Periodic review.--The Secretary shall review, not 
        less frequently than every 4 years, the limits established 
        under this subsection, taking into consideration relevant 
        information and available data to consider whether such limits 
        should be revised, following the procedure described in 
        paragraph (2), in accordance with the criteria specified in 
        paragraph (5).
    ``(b) Sampling and Testing for Toxic Elements and Contaminants in 
Food, Including Infant and Toddler Food.--
            ``(1) In general.--Beginning not later than 180 days after 
        the date of enactment of the Baby Food Safety Act of 2024, the 
        owner, operator, or agent in charge of a facility engaged in 
        manufacturing or processing infant or toddler food; food 
        predominantly composed of a fruit or vegetable puree or juice; 
        or such other food as the Secretary may specify by regulation, 
        for consumption in the United States, shall--
                    ``(A) have a control program in place for toxic 
                elements and contaminants subject to limits under 
                subsection (a)(1);
                    ``(B) collect representative samples of each such 
                food in final product form in accordance with a 
                sampling plan described in paragraph (2); and
                    ``(C) conduct testing of the samples collected from 
                the final food product for toxic elements and 
                contaminants, in accordance with a sampling plan 
                described in paragraph (2).
            ``(2) Requirements for sampling and testing plan.--
                    ``(A) In general.--The owner, operator, or agent in 
                charge of a facility described in paragraph (1) shall--
                            ``(i) prepare a written plan for all 
                        sampling and testing required under this 
                        subsection; and
                            ``(ii) ensure that all sampling and testing 
                        conducted under this subsection is conducted in 
                        accordance with the plan described in clause 
                        (i).
                    ``(B) Sampling plan.--A sampling and testing plan 
                required by subparagraph (A) shall identify--
                            ``(i) the number of sampling units and 
                        sample unit size based upon appropriate 
                        criteria for identifying, in a representative 
                        fashion, the levels of toxic elements and 
                        contaminants in each food;
                            ``(ii) one or more appropriate test methods 
                        and procedures to be used to analyze the 
                        samples; and
                            ``(iii) appropriate testing frequencies not 
                        less frequently than every quarter and whenever 
                        a significant change in the product or process 
                        necessitates such testing.
                    ``(C) Guidance.--Not later than 18 months after the 
                date of enactment of the Baby Food Safety Act of 2024, 
                the Secretary shall issue guidance to assist facilities 
                described under paragraph (1) with developing sampling 
                and testing plans. Such guidance shall address the 
                standards for adequate and appropriate sampling and 
                testing of each toxic element and contaminant as 
                required by the Secretary, the minimum frequency at 
                which samples should be tested for toxic elements and 
                contaminants or specific species of toxic elements or 
                contaminants, and standards for compliance.
            ``(3) Contaminants to be tested.--In carrying out the 
        sampling and testing under this subsection, the owner, 
        operator, or agent in charge of a facility described in 
        paragraph (1) shall ensure that each sample is tested for 
        levels of--
                    ``(A) lead, cadmium, mercury, and arsenic; and
                    ``(B) any other contaminant that the Secretary may 
                specify, in accordance with the sampling plan under 
                paragraph (2).
            ``(4) Foods to be tested.--The sampling and testing 
        conducted under this subsection shall be conducted for--
                    ``(A) infant and toddler foods, in final product 
                form;
                    ``(B) foods predominantly composed of a fruit or 
                vegetable puree or juice; and
                    ``(C) such other foods in final product form as the 
                Secretary has specified, as appropriate for the 
                protection of public health.
            ``(5) Recordkeeping.--
                    ``(A) In general.--The owner, operator, or agent in 
                charge of a facility described in paragraph (1) shall 
                maintain, for not less than 2 years or the shelf life 
                of each food product manufactured or processed by the 
                facility, whichever is longer, records documenting the 
                sampling plan and results of testing conducted under 
                this subsection with respect to the food. The owner, 
                operator, or agent in charge of such a facility shall 
                make such records available for inspection and copying 
                by the Secretary upon request by the Secretary.
                    ``(B) Requirements.--The records maintained as 
                required under subparagraph (A) shall include--
                            ``(i) a detailed description of the foods 
                        sampled and tested;
                            ``(ii) the number of samples and tests 
                        performed;
                            ``(iii) the size and number of items in 
                        each sample unit;
                            ``(iv) a copy of the sampling plan required 
                        under paragraph (2);
                            ``(v) identification of the entity 
                        conducting the sampling;
                            ``(vi) identification of the entity 
                        conducting the testing;
                            ``(vii) identification of the analytical 
                        methods used to perform the sampling and 
                        testing;
                            ``(viii) analytical findings of the 
                        sampling and testing; and
                            ``(ix) such other data and information as 
                        the Secretary may require.
                    ``(C) Applicability.--The requirements of this 
                paragraph shall apply to all records of sampling and 
                testing conducted pursuant to this subsection, 
                regardless of the findings.
            ``(6) Laboratory accreditation.--The owner, operator, or 
        agent in charge of a facility described in paragraph (1) shall 
        ensure that testing required pursuant to this subsection is 
        performed in accordance with international standards by a 
        laboratory that--
                    ``(A) is in compliance with the requirements 
                regarding laboratory accreditation described in section 
                422; or
                    ``(B) if the requirements described in subparagraph 
                (A) do not apply to the laboratory, is accredited by an 
                accreditation body that conforms to international 
                accreditation standards.
            ``(7) Sampling and testing program.--The Secretary shall 
        develop and implement a sampling and testing program for infant 
        and toddler food that is sufficient to--
                    ``(A) support the periodic review under subsection 
                (a)(7) of limits on toxic elements in infant and 
                toddler food; and
                    ``(B) independently verify that products are 
                compliant with the limits proscribed pursuant to this 
                subsection.
    ``(c) Record Availability.--
            ``(1) In general.--Upon request by the Secretary, the 
        owner, operator, or agent in charge of a facility described in 
        subsection (b)(1) shall--
                    ``(A) make all records required under this section 
                available promptly to the Secretary for inspection and 
                copying; and
                    ``(B) provide within a reasonable time an English 
                translation of such records maintained in a language 
                other than English.
            ``(2) Record availability.--Any records that the Secretary 
        may inspect under this section shall, upon the request of the 
        Secretary, be provided to the Secretary by the owner, operator, 
        or agent in charge of a facility described in subsection 
        (b)(1), in advance of or in lieu of an inspection, within a 
        reasonable timeframe, within reasonable limits, and in a 
        reasonable manner, and in either electronic or physical form, 
        at the expense of such owner, operator, or agent. The 
        Secretary's request shall include a sufficient description of 
        the records requested.
            ``(3) Confirmation.--Upon receipt of records requested 
        under paragraph (1) or (2), the Secretary shall provide to the 
        owner, operator, or agent described in paragraph (2) 
        confirmation of the receipt.
            ``(4) Authority of the secretary.--Nothing in this 
        subsection supplants the authority of the Secretary to conduct 
        sampling, testing, or inspections otherwise permitted under 
        this Act in order to ensure compliance with this Act.
    ``(d) Delayed Applicability.--The requirements for sampling and 
testing under this section shall apply beginning on the date that is 2 
years after the date of enactment of this subsection.''.
    (b) Importer Requirements.--Section 805(c)(4) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 384a(c)(4)) is amended, by inserting 
``monitoring and verifying the accuracy of records described in section 
425(b)'' after ``for shipments,''.
    (c) Enforcement.--
            (1) Adulteration.--Section 402 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 342) is amended by adding at the 
        end the following:
    ``(j) If it is an article of food in final product form that is an 
infant and toddler food, a food predominantly composed of a fruit or 
vegetable puree or juice, or such other food as the Secretary may 
specify and--
            ``(1) such food bears or contains any toxic element or 
        contaminant in excess of a limit established under section 
        425(a); or
            ``(2) the owner, operator, or agent in charge of a facility 
        that manufactures or processes the food is not in compliance 
        with subsection (b) or (c) of section 425.''.
            (2) Prohibited act.--Section 301 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 331) is amended by adding at the 
        end the following:
    ``(jjj) The failure of an owner, operator, or agent in charge of a 
facility that manufactures or processes food to comply with applicable 
requirements under subsection (b) or (c) of section 425.''.

SEC. 4. IMPLEMENTATION OF FOOD TRACEABILITY PLAN; STUDY ON INSPECTIONS; 
              REPORTING ON INSPECTIONS.

    (a) Implementation Plan.--The Secretary of Health and Human 
Services (referred to in this section as the ``Secretary''), acting 
through the Commissioner of Food and Drugs, in coordination with the 
FDA Human Foods Program and the Center for Food Safety and Applied 
Nutrition, shall finalize an implementation plan for the Food and Drug 
Administration to achieve its goal of compliance, not later than 
January 20, 2026, with the rule issued by the Food and Drug 
Administration titled, ``Requirements for Additional Traceability 
Records for Certain Foods'' (87 Fed. Reg. 70910 (November 21, 2022)) 
(or any successor rule). Such plan shall include a description of--
            (1) any resource needs of the Food and Drug Administration;
            (2) strategies for facilitating compliance with the rule; 
        and
            (3) detailed plans for communicating with and educating 
        regulated entities, non-Federal regulatory partners, and 
        regulatory staff of the Food and Drug Administration about the 
        requirements under the rule.
    (b) Study on Inspections.--The Secretary shall--
            (1) conduct a study to--
                    (A) determine the annual number of facility 
                inspections that is sufficient to determine that 
                imported foods are held to the same safety standards as 
                domestic food; and
                    (B) identify whether such inspection targets are 
                consistent with the targets in the most recent annual 
                report regarding food conducted under section 1003(h) 
                of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                393(h)); and
            (2) not later than 1 year after the date of enactment of 
        this Act, submit a report to Congress on the findings of such 
        study, and, if applicable, any factors preventing the Secretary 
        from meeting its goal for the number of inspections and a plan 
        to ensure that such goal is met in the next 2 years.
    (c) Annual Report Regarding Food.--Section 1003(h)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(h)(1)) is amended--
            (1) in subparagraph (E), by striking ``and'' at the end;
            (2) in subparagraph (F), by striking the period and 
        inserting ``; and''; and
            (3) by adding at the end the following:
                    ``(G) the nature of domestic facility and foreign 
                facility inspections described in subparagraph (C), the 
                aggregate inspection findings of such inspections, and 
                the compliance rate of foreign food importers with 
                certification standards;''.

SEC. 5. RECORDS FOR OR IN LIEU OF CERTAIN INSPECTIONS.

    Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 374(a)(4)) is amended--
            (1) by redesignating subparagraphs (B) through (D) as 
        subparagraphs (C) through (E), respectively;
            (2) by inserting after subparagraph (A) the following new 
        subparagraph:
    ``(B)(i) Any records or other information that the Secretary may 
remotely inspect or copy under authority of this Act from a person that 
owns or operates, or is an agent in charge of, an establishment that is 
engaged in any of the activities described in clause (ii) shall, upon 
the request of the Secretary, be provided to the Secretary by such 
person, in advance of, at the time of, or in the case in which an in-
person inspection would be unsafe, in lieu of, an in-person, on-site 
inspection, within a reasonable timeframe, within reasonable limits, 
and in a reasonable manner, and in either electronic or physical form, 
at the expense of such person. The Secretary's request shall include a 
sufficient description of the records or other information requested.
    ``(ii) The activities described in this clause are records relating 
to--
            ``(I) the manufacturing, processing, sampling, testing, 
        packing, transporting, distributing, receiving, holding, or 
        importing of an article of food; or
            ``(II) the distribution or use of animal feed bearing or 
        containing a veterinary feed directive drug, or the issuance of 
        a veterinary feed directive.''; and
            (3) by adding at the end the following:
    ``(F) Section 703 does not apply to records obtained or copied, or 
other information obtained or copied pursuant to a request made under 
this section.''.

SEC. 6. MANDATORY RECALL AUTHORITY.

    Section 423(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 350l(a)) is amended by inserting after ``animals,'' the 
following: ``or that an article of food is adulterated under paragraph 
(a)(1) or (j) of section 402,''.

SEC. 7. ENVIRONMENTAL MONITORING.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341 et seq.), as amended by section 3, is further amended by adding the 
following:

``SEC. 426. ENVIRONMENTAL MONITORING OF INFANT AND TODDLER FOOD.

    ``(a) In General.--A manufacturer of infant and toddler food (other 
than infant formula) shall establish and implement an environmental 
monitoring program to verify the effectiveness of sanitation and 
hygiene controls during the manufacturing and packaging process where 
the food has the potential to be exposed to pathogens. The 
environmental monitoring program shall be written and include 
procedures for determining sample location, number of samples to be 
taken, and timing and frequency of sample collection and testing.
    ``(b) Organisms Sampled.--The environmental monitoring program 
under subsection (a) shall include testing for environmental pathogens 
or a reliable indicator organism.
    ``(c) Sampling Location and Number of Samples.--A manufacturer of 
infant and toddler food shall ensure that the sampling locations from 
which samples will be taken, and the number of sites to be tested 
during routine environmental monitoring are adequate to determine 
whether sanitation and hygiene controls are effective.
    ``(d) Timing and Frequency.--The timing and frequency for 
collecting and testing samples shall be adequate to determine whether 
sanitation and hygiene controls are effective, and shall occur not less 
frequently than every 3 years.
    ``(e) Records.--
            ``(1) Availability to the secretary.--A manufacturer of 
        infant and toddler food shall make all the records required 
        under this section available promptly to the Secretary, upon 
        request by the Secretary, for inspection and copying.
            ``(2) Maintenance of records pertaining to environmental 
        monitoring.--Records of environmental sampling, testing, and 
        monitoring conducted pursuant to this section shall be 
        established and maintained by the manufacturer for not less 
        than 2 years or the shelf life of the food, whichever is 
        longer.
            ``(3) Conditions of inspection.--Any records or other 
        information that the Secretary may inspect under this section 
        shall, upon the request of the Secretary, be provided to the 
        Secretary by the manufacturer, in advance of, at the time of, 
        or in the case in which an in-person inspection would be 
        unsafe, in lieu of, an in-person, on-site inspection, within a 
        reasonable timeframe, within reasonable limits, and in a 
        reasonable manner, and in either electronic or physical form, 
        at the expense of such manufacturer. The Secretary's request 
        shall include a sufficient description of the records 
        requested.
            ``(4) Confirmation of receipt.--Upon receipt of the records 
        requested under paragraph (3), the Secretary shall provide to 
        the manufacturer confirmation of receipt.
    ``(f) Authority of the Secretary.--Nothing in this section 
supplants the authority of the Secretary to conduct inspections 
otherwise permitted under this Act in order to ensure compliance with 
this Act.
    ``(g) Effective Date.--The requirements of this section shall apply 
beginning on the date that is 2 years after the date of enactment of 
the Baby Food Safety Act of 2024.
    ``(h) Rule of Construction.--Nothing in this section shall be 
construed to exempt any manufacturer from the requirements of this Act, 
including the requirements under section 418.''.
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