[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4303 Introduced in Senate (IS)]

<DOC>






118th CONGRESS
  2d Session
                                S. 4303

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

                              May 9, 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 AND 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 and toddler food' means food that purports 
to be, or is represented as being, specifically for infants or children 
up to the age of 24 months.''.

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

    ``(a) Administrative Orders for Contaminants in Food.--
            ``(1) In general.--Within the applicable timeframe 
        specified in paragraph (4), the Secretary, by administrative 
        order--
                    ``(A) shall establish limits on--
                            ``(i) lead, cadmium, mercury, and total 
                        arsenic in infant and toddler food;
                            ``(ii) lead, cadmium, mercury, and total 
                        arsenic in food pouches made with fruit or 
                        vegetable puree or juice; and
                            ``(iii) lead and arsenic in juice; and
                    ``(B) if the Secretary determines appropriate upon 
                review of relevant health data and other relevant 
                available information, may--
                            ``(i) establish limits for additional 
                        contaminants in infant and toddler food;
                            ``(ii) establish limits for additional 
                        contaminants in juice;
                            ``(iii) establish limits for additional 
                        contaminants in food pouches made with fruit or 
                        vegetable puree or juice; and
                            ``(iv) revise limits established pursuant 
                        to subparagraph (A).
            ``(2) Procedure.--In establishing or revising any limit 
        under paragraph (1), the Secretary shall--
                    ``(A) evaluate relevant health data 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 presence of a 
                contaminant cannot be avoided; 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) Additional contaminants; changes to limits.--If the 
        Secretary determines appropriate after review of relevant data 
        and available 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)(C).
            ``(4) Timeframe for initial limits.--
                    ``(A) Proposed orders.--Subject to the requirements 
                of paragraph (2)(C), 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 total 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 paragraph (1)(A) not later than the earlier 
                of--
                            ``(i) the applicable deadline for a final 
                        order specified in paragraph (1); or
                            ``(ii) 18 months after issuance of the 
                        respective proposed order.
            ``(5) Criteria.--The limits established under this section 
        shall represent the level at which the Secretary finds 
        necessary for the protection of public health. In determining 
        such limits the Secretary shall take into account the extent to 
        which the use of such substance is required or cannot be 
        avoided in the production of each such article, and the other 
        ways in which a consumer may be affected by the same or other 
        contaminants, taking into consideration relevant information 
        and data that has been made available.
            ``(6) Adulterated food.--A food may be determined 
        adulterated, at the final product stage, under section 402(j), 
        if such food bears or contains any contaminant in excess of a 
        limit established under this subsection when considering 
        variability of the validated method of analysis.
            ``(7) Periodic review.--The Secretary shall periodically 
        review 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 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 and toddler food, food 
        pouches made with fruit or vegetable puree or juice, or juice 
        for consumption in the United States shall--
                    ``(A) have a control program pursuant to section 
                418 in place for contaminants subject to ordered limits 
                under subsection (a), or be in compliance with the 
                Juice Hazard Analysis Critical Control Points Program 
                of the Food and Drug Administration, as applicable;
                    ``(B) be in compliance with regulations promulgated 
                under section 420(b);
                    ``(C) collect representative samples of each such 
                food in final product form in accordance with a 
                sampling plan described in paragraph (2); and
                    ``(D) conduct testing of the samples collected from 
                the final food product for contaminants, in accordance 
                with such sampling plan.
            ``(2) Requirements for sampling plan.--
                    ``(A) In general.--The owner, operator, or agent in 
                charge of a facility described in paragraph (1) shall--
                            ``(i) prepare a written sampling 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 sampling plan.
                    ``(B) Sampling plan.--A sampling 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 contaminants in each 
                        food; and
                            ``(ii) one or more appropriate test methods 
                        and procedures to be used to analyze the 
                        samples.
                    ``(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 
                plans. Such guidance may, as the Secretary determines 
                appropriate, address when samples should be tested for 
                specific species of contaminants.
            ``(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 total arsenic;
                    ``(B) any other contaminant that the Secretary may 
                specify by regulation, and 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) pouches made with fruit and vegetable puree 
                or juice;
                    ``(C) juice; and
                    ``(D) such other foods in final product form as the 
                Secretary may specify, by regulation, as appropriate to 
                protect the 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 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; and
                            ``(vii) identification of the analytical 
                        methods used to perform the sampling and 
                        testing.
                    ``(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 is accredited by an accreditation body that 
        conforms to international accreditation standards. Testing 
        conducted under this subsection is not subject to the 
        requirements regarding laboratory accreditation described in 
        section 422.
            ``(7) Sampling and testing program.--The Secretary shall 
        develop and implement a sampling and testing program for infant 
        and toddler food for sale to consumers that is sufficient to--
                    ``(A) support the periodic review under subsection 
                (a)(7) of limits on lead, cadmium, mercury, and arsenic 
                in infant and toddler food; and
                    ``(B) independently verify the effectiveness of the 
                sampling and testing conducted pursuant to this 
                subsection by the owner, operator, or agent in charge 
                of a food facility.
            ``(8) Guidance.--The Secretary shall issue guidance to 
        assist food facilities in complying with 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 in lieu of an inspection.--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.
    ``(e) Preemption of State and Local Requirements Regarding Food 
Ingredients and Contaminants in Food, Including Infant and Toddler 
Food.--No State or political subdivision of a State may establish or 
continue in effect with respect to contaminants in food, including 
infant and toddler food, food pouches made with fruit or vegetable 
puree or juice, and juice, any requirement that is different from, or 
in addition to, or not identical with any requirement under this 
section, and relates to contaminant sampling and testing, contaminant 
limits, disclosure of contaminant test results, contaminant labeling, 
contaminant warnings, or any other matter related to contaminants in 
food.''.
    (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 
``, including as described in section 425(b)'' before the period at the 
end.
    (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 pouch made with fruit or vegetable 
puree or juice, or juice and--
            ``(1) such food bears or contains any contaminant in excess 
        of limits 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)). 
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 
inspect 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 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 person. The 
Secretary's request shall include a sufficient description of the 
records requested.
    ``(ii) The activities described in this clause are records relating 
to--
            ``(I) the manufacturing, processing, 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 or other information 
obtained 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 if the Secretary determines through any means that an 
article of infant and toddler food (other than infant formula) bears or 
contains a contaminant that renders the product adulterated under 
section 402(a)(1),''.

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 shall 
establish and implement an environmental monitoring program to verify 
the effectiveness of sanitation and hygiene controls where the food has 
the potential to be exposed to environment pathogens during the 
manufacturing and packing process. 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, 
lead, arsenic, mercury, 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.
    ``(e) Records.--
            ``(1) Availability to the secretary.--A manufacturer shall 
        make all the records required under this section available 
        promptly to the Secretary, upon request, for inspection and 
        copying.
            ``(2) Maintenance.--Records of environmental 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 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 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 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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