II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Baby Food Safety Act 

5 of 2024’’. 


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1 SEC. 2. DEFINITION OF INFANT AND TODDLER FOOD. 

2 Section 201 of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 321) is amended by adding at the end the 

4 following: 

5 ‘‘(tt) The term ‘infant and toddler food’ means food 

6 that purports to be, or is represented as being, specifically 

7 for infants or children up to the age of 24 months.’’. 

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

9 TODDLER FOOD. 

10 (a) IN GENERAL.—Chapter IV of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amend12 ed by adding at the end the following: 

13 ‘‘SEC. 425. CONTAMINANTS IN FOOD, INCLUDING INFANT 

14 AND TODDLER FOOD. 

15 ‘‘(a) ADMINISTRATIVE ORDERS FOR CONTAMINANTS

16 IN FOOD.— 

17 ‘‘(1) IN GENERAL.—Within the applicable time18 frame specified in paragraph (4), the Secretary, by 

19 administrative order— 

20 ‘‘(A) shall establish limits on— 

21 ‘‘(i) lead, cadmium, mercury, and 

22 total arsenic in infant and toddler food; 

23 ‘‘(ii) lead, cadmium, mercury, and 

24 total arsenic in food pouches made with 

25 fruit or vegetable puree or juice; and 

26 ‘‘(iii) lead and arsenic in juice; and 


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1 ‘‘(B) if the Secretary determines appro2 priate upon review of relevant health data and 

3 other relevant available information, may— 

4 ‘‘(i) establish limits for additional con5 taminants in infant and toddler food; 

6 ‘‘(ii) establish limits for additional 

7 contaminants in juice; 

8 ‘‘(iii) establish limits for additional 

9 contaminants in food pouches made with 

10 fruit or vegetable puree or juice; and 

11 ‘‘(iv) revise limits established pursu12 ant to subparagraph (A). 

13 ‘‘(2) PROCEDURE.—In establishing or revising 

14 any limit under paragraph (1), the Secretary shall— 

15 ‘‘(A) evaluate relevant health data and 

16 other information the Secretary considers rel17 evant; 

18 ‘‘(B) take into account relevant differences 

19 among food types, groups, and categories, as 

20 appropriate, including the extent to which the 

21 presence of a contaminant cannot be avoided; 

22 and 

23 ‘‘(C) notwithstanding the requirements of 

24 subchapter II of chapter 5 of title 5, United 


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1 States Code, and chapter 6 of title 5, United 

2 States Code— 

3 ‘‘(i) publish any administrative order 

4 under paragraph (1) in the Federal Reg5 ister following— 

6 ‘‘(I) publication of a proposed 

7 order in the Federal Register; and 

8 ‘‘(II) consideration of comments 

9 to a public docket open for not fewer 

10 than 45 calendar days; and 

11 ‘‘(ii) set forth in any proposed or final 

12 administrative order under paragraph (1) 

13 a substantive summary of the valid sci14 entific evidence concerning the proposed or 

15 final limit. 

16 ‘‘(3) ADDITIONAL CONTAMINANTS; CHANGES TO

17 LIMITS.—If the Secretary determines appropriate 

18 after review of relevant data and available health in19 formation, the Secretary may revise any limit estab20 lished under this subsection by administrative order 

21 published in the Federal Register in accordance with 

22 paragraph (2)(C). 

23 ‘‘(4) TIMEFRAME FOR INITIAL LIMITS.— 

24 ‘‘(A) PROPOSED ORDERS.—Subject to the 

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1 retary shall issue proposed orders for limits 

2 under paragraph (1)(A) as follows: 

3 ‘‘(i) For lead, not later than Decem4 ber 31, 2025. 

5 ‘‘(ii) For total arsenic, not later than 

6 December 31, 2025. 

7 ‘‘(iii) For cadmium, not later than 

8 April 30, 2026. 

9 ‘‘(iv) For mercury, not later than 

10 April 30, 2028. 

11 ‘‘(B) FINAL ORDERS.—The Secretary shall 

12 issue each final administrative order for a limit 

13 established pursuant to paragraph (1)(A) not 

14 later than the earlier of— 

15 ‘‘(i) the applicable deadline for a final 

16 order specified in paragraph (1); or 

17 ‘‘(ii) 18 months after issuance of the 

18 respective proposed order. 

19 ‘‘(5) CRITERIA.—The limits established under 

20 this section shall represent the level at which the 

21 Secretary finds necessary for the protection of public 

22 health. In determining such limits the Secretary 

23 shall take into account the extent to which the use 

24 of such substance is required or cannot be avoided 

25 in the production of each such article, and the other 


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1 ways in which a consumer may be affected by the 

2 same or other contaminants, taking into consider3 ation relevant information and data that has been 

4 made available. 

5 ‘‘(6) ADULTERATED FOOD.—A food may be de6 termined adulterated, at the final product stage, 

7 under section 402(j), if such food bears or contains 

8 any contaminant in excess of a limit established 

9 under this subsection when considering variability of 

10 the validated method of analysis. 

11 ‘‘(7) PERIODIC REVIEW.—The Secretary shall 

12 periodically review the limits established under this 

13 subsection, taking into consideration relevant infor14 mation and available data to consider whether such 

15 limits should be revised, following the procedure de16 scribed in paragraph (2), in accordance with the cri17 teria specified in paragraph (5). 

18 ‘‘(b) SAMPLING AND TESTING FOR CONTAMINANTS

19 IN FOOD, INCLUDING INFANT AND TODDLER FOOD.— 

20 ‘‘(1) IN GENERAL.—Beginning not later than 

21 180 days after the date of enactment of the Baby 

22 Food Safety Act of 2024, the owner, operator, or 

23 agent in charge of a facility engaged in manufac24 turing or processing infant and toddler food, food 

25 pouches made with fruit or vegetable puree or juice, 


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1 or juice for consumption in the United States 

2 shall— 

3 ‘‘(A) have a control program pursuant to 

4 section 418 in place for contaminants subject to 

5 ordered limits under subsection (a), or be in 

6 compliance with the Juice Hazard Analysis 

7 Critical Control Points Program of the Food 

8 and Drug Administration, as applicable; 

9 ‘‘(B) be in compliance with regulations 

10 promulgated under section 420(b); 

11 ‘‘(C) collect representative samples of each 

12 such food in final product form in accordance 

13 with a sampling plan described in paragraph 

14 (2); and 

15 ‘‘(D) conduct testing of the samples col16 lected from the final food product for contami17 nants, in accordance with such sampling plan. 

18 ‘‘(2) REQUIREMENTS FOR SAMPLING PLAN.— 

19 ‘‘(A) IN GENERAL.—The owner, operator, 

20 or agent in charge of a facility described in 

21 paragraph (1) shall— 

22 ‘‘(i) prepare a written sampling plan 

23 for all sampling and testing required under 

24 this subsection; and 


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1 ‘‘(ii) ensure that all sampling and 

2 testing conducted under this subsection is 

3 conducted in accordance with the sampling 

4 plan. 

5 ‘‘(B) SAMPLING PLAN.—A sampling plan 

6 required by subparagraph (A) shall identify— 

7 ‘‘(i) the number of sampling units and 

8 sample unit size based upon appropriate 

9 criteria for identifying, in a representative 

10 fashion, the levels of contaminants in each 

11 food; and 

12 ‘‘(ii) one or more appropriate test 

13 methods and procedures to be used to ana14 lyze the samples. 

15 ‘‘(C) GUIDANCE.—Not later than 18 

16 months after the date of enactment of the Baby 

17 Food Safety Act of 2024, the Secretary shall 

18 issue guidance to assist facilities described 

19 under paragraph (1) with developing sampling 

20 plans. Such guidance may, as the Secretary de21 termines appropriate, address when samples 

22 should be tested for specific species of contami23 nants. 

24 ‘‘(3) CONTAMINANTS TO BE TESTED.—In car25 rying out the sampling and testing under this subVerDate Sep 11 2014 19:14 Jun 11, 2024 Jkt 049200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4303.IS S4303

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1 section, the owner, operator, or agent in charge of 

2 a facility described in paragraph (1) shall ensure 

3 that each sample is tested for levels of— 

4 ‘‘(A) lead, cadmium, mercury, and total ar5 senic; 

6 ‘‘(B) any other contaminant that the Sec7 retary may specify by regulation, and in accord8 ance with the sampling plan under paragraph 

9 (2). 

10 ‘‘(4) FOODS TO BE TESTED.—The sampling 

11 and testing conducted under this subsection shall be 

12 conducted for— 

13 ‘‘(A) infant and toddler foods, in final 

14 product form; 

15 ‘‘(B) pouches made with fruit and vege16 table puree or juice; 

17 ‘‘(C) juice; and 

18 ‘‘(D) such other foods in final product 

19 form as the Secretary may specify, by regula20 tion, as appropriate to protect the public health. 

21 ‘‘(5) RECORDKEEPING.— 

22 ‘‘(A) IN GENERAL.—The owner, operator, 

23 or agent in charge of a facility described in 

24 paragraph (1) shall maintain, for not less than 

25 2 years or the shelf-life of each food product 


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1 manufactured or processed by the facility, 

2 whichever is longer, records documenting the 

3 sampling plan and results of testing conducted 

4 under this subsection with respect to the food. 

5 The owner, operator, or agent in charge of such 

6 a facility shall make such records available for 

7 inspection by the Secretary upon request by the 

8 Secretary. 

9 ‘‘(B) REQUIREMENTS.—The records main10 tained as required under subparagraph (A) 

11 shall include— 

12 ‘‘(i) a detailed description of the foods 

13 sampled and tested; 

14 ‘‘(ii) the number of samples and tests 

15 performed; 

16 ‘‘(iii) the size and number of items in 

17 each sample unit; 

18 ‘‘(iv) a copy of the sampling plan re19 quired under paragraph (2); 

20 ‘‘(v) identification of the entity con21 ducting the sampling; 

22 ‘‘(vi) identification of the entity con23 ducting the testing; and 


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1 ‘‘(vii) identification of the analytical 

2 methods used to perform the sampling and 

3 testing. 

4 ‘‘(C) APPLICABILITY.—The requirements 

5 of this paragraph shall apply to all records of 

6 sampling and testing conducted pursuant to 

7 this subsection, regardless of the findings. 

8 ‘‘(6) LABORATORY ACCREDITATION.—The 

9 owner, operator, or agent in charge of a facility de10 scribed in paragraph (1) shall ensure that testing re11 quired pursuant to this subsection is performed in 

12 accordance with international standards by a labora13 tory that is accredited by an accreditation body that 

14 conforms to international accreditation standards. 

15 Testing conducted under this subsection is not sub16 ject to the requirements regarding laboratory accred17 itation described in section 422. 

18 ‘‘(7) SAMPLING AND TESTING PROGRAM.—The 

19 Secretary shall develop and implement a sampling 

20 and testing program for infant and toddler food for 

21 sale to consumers that is sufficient to— 

22 ‘‘(A) support the periodic review under 

23 subsection (a)(7) of limits on lead, cadmium, 

24 mercury, and arsenic in infant and toddler food; 

25 and 


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1 ‘‘(B) independently verify the effectiveness 

2 of the sampling and testing conducted pursuant 

3 to this subsection by the owner, operator, or 

4 agent in charge of a food facility. 

5 ‘‘(8) GUIDANCE.—The Secretary shall issue 

6 guidance to assist food facilities in complying with 

7 this subsection. 

8 ‘‘(c) RECORD AVAILABILITY.— 

9 ‘‘(1) IN GENERAL.—Upon request by the Sec10 retary, the owner, operator, or agent in charge of a 

11 facility described in subsection (b)(1) shall— 

12 ‘‘(A) make all records required under this 

13 section available promptly to the Secretary for 

14 inspection and copying; and 

15 ‘‘(B) provide within a reasonable time an 

16 English translation of such records maintained 

17 in a language other than English. 

18 ‘‘(2) RECORD AVAILABILITY IN LIEU OF AN IN19 SPECTION.—Any records that the Secretary may in20 spect under this section shall, upon the request of 

21 the Secretary, be provided to the Secretary by the 

22 owner, operator, or agent in charge of a facility de23 scribed in subsection (b)(1), in advance of or in lieu 

24 of an inspection, within a reasonable timeframe, 

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1 ner, and in either electronic or physical form, at the 

2 expense of such owner, operator, or agent. The Sec3 retary’s request shall include a sufficient description 

4 of the records requested. 

5 ‘‘(3) CONFIRMATION.—Upon receipt of records 

6 requested under paragraph (1) or (2), the Secretary 

7 shall provide to the owner, operator, or agent de8 scribed in paragraph (2) confirmation of the receipt. 

9 ‘‘(4) AUTHORITY OF THE SECRETARY.—Noth10 ing in this subsection supplants the authority of the 

11 Secretary to conduct sampling, testing, or inspec12 tions otherwise permitted under this Act in order to 

13 ensure compliance with this Act. 

14 ‘‘(d) DELAYED APPLICABILITY.—The requirements 

15 for sampling and testing under this section shall apply be16 ginning on the date that is 2 years after the date of enact17 ment of this subsection. 

18 ‘‘(e) PREEMPTION OF STATE AND LOCAL REQUIRE19 MENTS REGARDING FOOD INGREDIENTS AND CONTAMI20 NANTS IN FOOD, INCLUDING INFANT AND TODDLER

21 FOOD.—No State or political subdivision of a State may 

22 establish or continue in effect with respect to contami23 nants in food, including infant and toddler food, food 

24 pouches made with fruit or vegetable puree or juice, and 

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1 tion to, or not identical with any requirement under this 

2 section, and relates to contaminant sampling and testing, 

3 contaminant limits, disclosure of contaminant test results, 

4 contaminant labeling, contaminant warnings, or any other 

5 matter related to contaminants in food.’’. 

6 (b) IMPORTER REQUIREMENTS.—Section 805(c)(4) 

7 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

8 384a(c)(4)) is amended, by inserting ‘‘, including as de9 scribed in section 425(b)’’ before the period at the end. 

10 (c) ENFORCEMENT.— 

11 (1) ADULTERATION.—Section 402 of the Fed12 eral Food, Drug, and Cosmetic Act (21 U.S.C. 342) 

13 is amended by adding at the end the following: 

14 ‘‘(j) If it is an article of food in final product form 

15 that is an infant and toddler food, a food pouch made with 

16 fruit or vegetable puree or juice, or juice and— 

17 ‘‘(1) such food bears or contains any contami18 nant in excess of limits established under section 

19 425(a); or 

20 ‘‘(2) the owner, operator, or agent in charge of 

21 a facility that manufactures or processes the food is 

22 not in compliance with subsection (b) or (c) of sec23 tion 425.’’. 


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1 (2) PROHIBITED ACT.—Section 301 of the Fed2 eral Food, Drug, and Cosmetic Act (21 U.S.C. 331) 

3 is amended by adding at the end the following: 

4 ‘‘(jjj) The failure of an owner, operator, or agent in 

5 charge of a facility that manufactures or processes food 

6 to comply with applicable requirements under subsection 

7 (b) or (c) of section 425.’’. 

8 SEC. 4. IMPLEMENTATION OF FOOD TRACEABILITY PLAN; 

9 STUDY ON INSPECTIONS; REPORTING ON IN10 SPECTIONS. 

11 (a) IMPLEMENTATION PLAN.—The Secretary of 

12 Health and Human Services (referred to in this section 

13 as the ‘‘Secretary’’), acting through the Commissioner of 

14 Food and Drugs, in coordination with the FDA Human 

15 Foods Program and the Center for Food Safety and Ap16 plied Nutrition, shall finalize an implementation plan for 

17 the Food and Drug Administration to achieve its goal of 

18 compliance, not later than January 20, 2026, with the rule 

19 issued by the Food and Drug Administration titled, ‘‘Re20 quirements for Additional Traceability Records for Cer21 tain Foods’’ (87 Fed. Reg. 70910 (November 21, 2022)). 

22 Such plan shall include a description of— 

23 (1) any resource needs of the Food and Drug 

24 Administration; 


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1 (2) strategies for facilitating compliance with 

2 the rule; and 

3 (3) detailed plans for communicating with and 

4 educating regulated entities, non-Federal regulatory 

5 partners, and regulatory staff of the Food and Drug 

6 Administration about the requirements under the 

7 rule. 

8 (b) STUDY ON INSPECTIONS.—The Secretary shall— 

9 (1) conduct a study to— 

10 (A) determine the annual number of facil11 ity inspections that is sufficient to determine 

12 that imported foods are held to the same safety 

13 standards as domestic food; and 

14 (B) identify whether such inspection tar15 gets are consistent with the targets in the most 

16 recent annual report regarding food conducted 

17 under section 1003(h) of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 393(h)); 

19 and 

20 (2) not later than 1 year after the date of en21 actment of this Act, submit a report to Congress on 

22 the findings of such study, and, if applicable, any 

23 factors preventing the Secretary from meeting its 

24 goal for the number of inspections and a plan to en25 sure that such goal is met in the next 2 years. 


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1 (c) ANNUAL REPORT REGARDING FOOD.—Section 

2 1003(h)(1) of the Federal Food, Drug, and Cosmetic Act 

3 (21 U.S.C. 393(h)(1)) is amended— 

4 (1) in subparagraph (E), by striking ‘‘and’’ at 

5 the end; 

6 (2) in subparagraph (F), by striking the period 

7 and inserting ‘‘; and’’; and 

8 (3) by adding at the end the following: 

9 ‘‘(G) the nature of domestic facility and 

10 foreign facility inspections described in subpara11 graph (C), the aggregate inspection findings of 

12 such inspections, and the compliance rate of 

13 foreign food importers with certification stand14 ards;’’. 

15 SEC. 5. RECORDS FOR OR IN LIEU OF CERTAIN INSPEC16 TIONS. 

17 Section 704(a)(4) of the Federal Food, Drug, and 

18 Cosmetic Act (21 U.S.C. 374(a)(4)) is amended— 

19 (1) by redesignating subparagraphs (B) 

20 through (D) as subparagraphs (C) through (E), re21 spectively; 

22 (2) by inserting after subparagraph (A) the fol23 lowing new subparagraph: 

24 ‘‘(B)(i) Any records or other information that the 

25 Secretary may inspect under authority of this Act from 


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1 a person that owns or operates, or is an agent in charge 

2 of, an establishment that is engaged in any of the activi3 ties described in clause (ii) shall, upon the request of the 

4 Secretary, be provided to the Secretary by such person, 

5 in advance of or in lieu of an inspection, within a reason6 able timeframe, within reasonable limits, and in a reason7 able manner, and in either electronic or physical form, at 

8 the expense of such person. The Secretary’s request shall 

9 include a sufficient description of the records requested. 

10 ‘‘(ii) The activities described in this clause are 

11 records relating to— 

12 ‘‘(I) the manufacturing, processing, packing, 

13 transporting, distributing, receiving, holding, or im14 porting of an article of food; or 

15 ‘‘(II) the distribution or use of animal feed 

16 bearing or containing a veterinary feed directive 

17 drug, or the issuance of a veterinary feed directive.’’; 

18 and 

19 (3) by adding at the end the following: 

20 ‘‘(F) Section 703 does not apply to records or other 

21 information obtained pursuant to a request made under 

22 this section.’’. 

23 SEC. 6. MANDATORY RECALL AUTHORITY. 

24 Section 423(a) of the Federal Food, Drug, and Cos25 metic Act (21 U.S.C. 350l(a)) is amended by inserting 


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1 after ‘‘animals,’’ the following: ‘‘or if the Secretary deter2 mines through any means that an article of infant and 

3 toddler food (other than infant formula) bears or contains 

4 a contaminant that renders the product adulterated under 

5 section 402(a)(1),’’. 

6 SEC. 7. ENVIRONMENTAL MONITORING. 

7 Chapter IV of the Federal Food, Drug, and Cosmetic 

8 Act (21 U.S.C. 341 et seq.), as amended by section 3, 

9 is further amended by adding the following: 

10 ‘‘SEC. 426. ENVIRONMENTAL MONITORING OF INFANT AND 

11 TODDLER FOOD. 

12 ‘‘(a) IN GENERAL.—A manufacturer of infant and 

13 toddler food shall establish and implement an environ14 mental monitoring program to verify the effectiveness of 

15 sanitation and hygiene controls where the food has the po16 tential to be exposed to environment pathogens during the 

17 manufacturing and packing process. The environmental 

18 monitoring program shall be written and include proce19 dures for determining sample location, number of samples 

20 to be taken, and timing and frequency of sample collection 

21 and testing. 

22 ‘‘(b) ORGANISMS SAMPLED.—The environmental 

23 monitoring program under subsection (a) shall include 

24 testing for environmental pathogens, lead, arsenic, mer25 cury, or a reliable indicator organism. 


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1 ‘‘(c) SAMPLING LOCATION AND NUMBER OF SAM2 PLES.—A manufacturer of infant and toddler food shall 

3 ensure that the sampling locations from which samples 

4 will be taken, and the number of sites to be tested during 

5 routine environmental monitoring are adequate to deter6 mine whether sanitation and hygiene controls are effective. 

7 ‘‘(d) TIMING AND FREQUENCY.—The timing and fre8 quency for collecting and testing samples shall be ade9 quate to determine whether sanitation and hygiene con10 trols are effective. 

11 ‘‘(e) RECORDS.— 

12 ‘‘(1) AVAILABILITY TO THE SECRETARY.—A 

13 manufacturer shall make all the records required 

14 under this section available promptly to the Sec15 retary, upon request, for inspection and copying. 

16 ‘‘(2) MAINTENANCE.—Records of environmental 

17 monitoring conducted pursuant to this section shall 

18 be established and maintained by the manufacturer 

19 for not less than 2 years or the shelf-life of the food, 

20 whichever is longer. 

21 ‘‘(3) CONDITIONS OF INSPECTION.—Any 

22 records that the Secretary may inspect under this 

23 section shall, upon the request of the Secretary, be 

24 provided to the Secretary by the manufacturer, in 

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1 sonable timeframe, within reasonable limits, and in 

2 a reasonable manner, and in either electronic or 

3 physical form, at the expense of such manufacturer. 

4 The Secretary’s request shall include a sufficient de5 scription of the records requested. 

6 ‘‘(4) CONFIRMATION OF RECEIPT.—Upon re7 ceipt of the records requested under paragraph (3), 

8 the Secretary shall provide to the manufacturer con9 firmation of receipt. 

10 ‘‘(f) AUTHORITY OF THE SECRETARY.—Nothing in 

11 this section supplants the authority of the Secretary to 

12 conduct inspections otherwise permitted under this Act in 

13 order to ensure compliance with this Act. 

14 ‘‘(g) EFFECTIVE DATE.—The requirements of this 

15 section shall apply beginning on the date that is 2 years 

16 after the date of enactment of the Baby Food Safety Act 

17 of 2024. 

18 ‘‘(h) RULE OF CONSTRUCTION.—Nothing in this sec19 tion shall be construed to exempt any manufacturer from 

20 the requirements of this Act, including the requirements 

21 under section 418.’’. 

Æ 


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