I 

118TH CONGRESS 

1ST SESSION H. R. 6770 

To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety 

of infant and toddler food, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 13, 2023 

Mrs. SYKES (for herself, Mr. PALLONE, Mr. CA ́RDENAS, and Mr. 

KRISHNAMOORTHI) introduced the following bill; which was referred to 

the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

ensure the safety of 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 ‘‘Improving Newborns’ 

5 Food and Nutrition Testing Safety Act of 2023’’ or the 

6 ‘‘INFANTS Act of 2023’’. 

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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 which purports to be or is represented as food for children 

7 up to 24 months of age, including infant formula.’’. 

8 SEC. 3. CONTAMINANTS IN FOOD. 

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

10 Act (21 U.S.C. 341 et seq.) is amended by adding at the 

11 end the following: 

12 ‘‘SEC. 425. SAMPLING AND TESTING FOR CONTAMINANTS IN 

13 FOOD. 

14 ‘‘(a) SAMPLING AND TESTING.— 

15 ‘‘(1) IN GENERAL.—The owner, operator, or 

16 agent in charge of a food facility that manufactures 

17 or processes food, including infant and toddler food, 

18 in final product form intended for sale to consumers 

19 shall— 

20 ‘‘(A) collect representative samples of each 

21 such food; and 

22 ‘‘(B) conduct testing of the samples for 

23 contaminants, including toxic elements. 

24 ‘‘(2) REQUIREMENT FOR SAMPLING PLAN.— 

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

2 or agent in charge of a facility described in 

3 paragraph (1) shall— 

4 ‘‘(i) prepare a written sampling plan 

5 for all sampling and testing required under 

6 this section; and 

7 ‘‘(ii) ensure that all sampling and 

8 testing conducted under this section is con9 ducted in accordance with the sampling 

10 plan. 

11 ‘‘(B) REQUIREMENTS.—A sampling plan 

12 under subparagraph (A) shall identify— 

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

14 sample unit size based upon appropriate 

15 criteria for identifying, in a representative 

16 fashion, the levels of contaminants in each 

17 food; and 

18 ‘‘(ii) one or more appropriate test 

19 methods and procedures to be used to ana20 lyze the samples. 

21 ‘‘(C) GUIDANCE.—Not later than 18 

22 months after the date of enactment of this sec23 tion, the Secretary shall issue guidance to assist 

24 food facilities in developing sampling plans. 

25 Such guidance may, as determined appropriate 

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1 by the Secretary, address when samples should 

2 be tested for specific species of contaminants. 

3 ‘‘(3) CONTAMINANTS TO BE TESTED.—Each 

4 sample taken pursuant to a sampling plan under 

5 this section shall be tested for levels of lead, cad6 mium, mercury, arsenic, and any other contaminant, 

7 including other toxic elements, that the Secretary 

8 may specify by regulation. 

9 ‘‘(4) FREQUENCY OF TESTING.—The sampling 

10 and testing conducted under this section shall be 

11 conducted at least once per quarter of each calendar 

12 year. 

13 ‘‘(5) FOODS TO BE TESTED.—The sampling 

14 and testing conducted under this section shall be 

15 conducted for— 

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

17 package form; and 

18 ‘‘(B) such other foods as the Secretary 

19 may specify, by regulation, as appropriate to 

20 protect public health. 

21 ‘‘(b) RECORDKEEPING.— 

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

23 agent in charge of a facility described in subsection 

24 (a)(1) shall maintain, for not less than 2 years or 

25 the shelf-life of each infant and toddler food manuVerDate Sep 11 2014 04:48 Dec 30, 2023 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H6770.IH H6770
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1 factured or processed at the facility, whichever is 

2 longer, records documenting the sampling and test3 ing conducted under this section with respect to the 

4 food. 

5 ‘‘(2) REQUIREMENTS.—Records required by 

6 paragraph (1) to be maintained shall include a de7 tailed description of the foods sampled and tested, 

8 the number of samples and tests performed, the size 

9 and number of items in each sample unit, a copy of 

10 the facility’s sampling plan, identification of the en11 tity conducting the sampling, identification of the 

12 entity conducting the testing, and the analytical 

13 methods used to perform the sampling and testing. 

14 ‘‘(3) APPLICABILITY.—This subsection applies 

15 to all records of sampling and testing conducted 

16 under this section, regardless of the findings. 

17 ‘‘(c) LABORATORY ACCREDITATION.—The owner, op18 erator, or agent in charge of a food facility described in 

19 subsection (a)(1) shall ensure that testing conducted pur20 suant to this section is performed in accordance with 

21 international standards by a laboratory that is accredited 

22 by an accreditation body that conforms to international 

23 accreditation standards. Testing conducted under this sec24 tion is not subject to the requirements regarding labora25 tory accreditation described in section 422. 

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1 ‘‘(d) RECORDS AVAILABILITY.— 

2 ‘‘(1) IN GENERAL.—The owner, operator, or 

3 agent in charge of a food facility described in sub4 section (a)(1) shall make all records required under 

5 this section available promptly to the Secretary, 

6 upon request, for inspection and copying. Upon re7 quest of the Secretary, such an owner, operator, or 

8 agent in charge shall provide within a reasonable 

9 time an English translation of records maintained in 

10 a language other than English. 

11 ‘‘(2) RECORDS AVAILABILITY IN LIEU OF AN IN12 SPECTION.—Any records that the Secretary may in13 spect under this section shall, upon the request of 

14 the Secretary, be provided to the Secretary by the 

15 owner, operator, or agent in charge of a food facility 

16 described in subsection (a)(1), in advance of or in 

17 lieu of an inspection, within a reasonable timeframe, 

18 within reasonable limits, and in a reasonable man19 ner, and in either electronic or physical form, at the 

20 expense of such owner, operator, or agent. The Sec21 retary’s request shall include a sufficient description 

22 of the records requested. 

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

24 requested under paragraph (2), the Secretary shall 

25 provide to the person confirmation of receipt. 

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1 ‘‘(4) AUTHORITY OF THE SECRETARY.—Noth2 ing in this subsection supplants the authority of the 

3 Secretary to conduct inspections otherwise permitted 

4 under this Act in order to ensure compliance with 

5 this Act. 

6 ‘‘(e) DELAYED APPLICABILITY.—The requirements 

7 for sampling and testing under this section apply begin8 ning on the date that is 180 days after the date on which 

9 the Secretary publishes the guidance required by sub10 section (a)(2)(C).’’. 

11 SEC. 4. ADULTERATION. 

12 Section 402 of the Federal Food, Drug, and Cosmetic 

13 Act (21 U.S.C. 342) is amended by adding at the end the 

14 following: 

15 ‘‘(j) If it is an article of food and the owner, operator, 

16 or agent in charge of a food facility that manufactures 

17 or processes such food— 

18 ‘‘(1) is subject to the requirements of section 

19 425; and 

20 ‘‘(2) fails to comply with the requirements of 

21 such section with regard to that article.’’. 

22 SEC. 5. RECORDS FOR OR IN LIEU OF CERTAIN INSPEC23 TIONS. 

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

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

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1 (1) by redesignating subparagraphs (B), (C), 

2 and (D) as subparagraphs (C), (D), and (E), respec3 tively; 

4 (2) by inserting after subparagraph (A) the fol5 lowing: 

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

7 Secretary may inspect under authority of this Act from 

8 a person that owns or operates an establishment that is 

9 engaged in any of the activities described in clause (ii) 

10 shall, upon the request of the Secretary, be provided to 

11 the Secretary by such person, in advance of or in lieu of 

12 an inspection, within a reasonable timeframe, within rea13 sonable limits, and in a reasonable manner, and in either 

14 electronic or physical form, at the expense of such person. 

15 The Secretary’s request shall include a sufficient descrip16 tion of the records requested. 

17 ‘‘(ii) The activities described in this clause are the 

18 following: 

19 ‘‘(I) The manufacturing, processing, packing, 

20 transporting, distributing, receiving, holding, or im21 porting of an article of food. 

22 ‘‘(II) The distribution or use of animal feed 

23 bearing or containing a veterinary feed directive 

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

25 and 

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

2 ‘‘(F) Section 703 does not apply to requests for 

3 records or other information when those requests are 

4 made under this section.’’. 

5 SEC. 6. MANDATORY RECALL AUTHORITY. 

6 Section 423(a) of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 350l(a)) is amended by inserting ‘‘or 

8 if the Secretary determines through any means that an 

9 article of infant and toddler food (other than infant for10 mula) bears or contains a contaminant that renders the 

11 product adulterated under section 402(a)(1),’’ after ‘‘ani12 mals,’’. 

13 SEC. 7. REPORT FINAL PRODUCT POSITIVE TEST RESULTS 

14 FOR RELEVANT PATHOGENS IN INFANT FOR15 MULA. 

16 Section 412 of the Federal Food, Drug, and Cosmetic 

17 Act (21 U.S.C. 350a) is amended— 

18 (1) in subsection (e)— 

19 (A) in paragraph (1)— 

20 (i) in the first sentence, by striking 

21 ‘‘promptly’’ and inserting ‘‘, within 24 

22 hours of acquiring such knowledge,’’; and 

23 (ii) in the second sentence, by striking 

24 ‘‘the infant formula’’ and inserting ‘‘an in25 fant formula’’; 

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1 (B) by redesignating paragraph (2) as 

2 paragraph (4); 

3 (C) in paragraph (4), as so redesignated, 

4 by striking ‘‘paragraph (1)’’ and inserting 

5 ‘‘paragraphs (1) and (2)’’; and 

6 (D) by inserting after paragraph (1) the 

7 following: 

8 ‘‘(2) If the result of any in-process or finished prod9 uct testing of an infant formula that has been processed 

10 by the manufacturer is confirmed as a positive analytical 

11 result for any environmental pathogen (as defined in sec12 tion 117.3 of title 21, Code of Federal Regulations (or 

13 any successor regulation)), the manufacturer shall— 

14 ‘‘(A) within 24 hours of acquiring such con15 firmation, notify the Secretary of such confirmation 

16 regardless of whether such infant formula has left 

17 an establishment subject to the control of the manu18 facturer; 

19 ‘‘(B) consult with the Secretary for proper dis20 posal and properly dispose of the affected product; 

21 and 

22 ‘‘(C) provide to the Secretary results and iso23 lates from a positive sample of such infant formula. 

24 ‘‘(3) Not later than 90 days after receipt of a notifi25 cation under paragraph (1) or (2), the Secretary shall conVerDate Sep 11 2014 04:48 Dec 30, 2023 Jkt 049200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H6770.IH H6770
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1 firm through the collection of documentation that the 

2 manufacturer submitting the notification performed, or is 

3 performing, appropriate corrective action. The manufac4 turer shall make such documentation available to the Sec5 retary during an inspection and, upon request of the Sec6 retary, electronically or by other means.’’. 

7 SEC. 8. ENVIRONMENTAL MONITORING. 

8 Section 412 of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 350a) is amended by adding at the end 

10 the following: 

11 ‘‘(n) REQUIREMENTS FOR ENVIRONMENTAL MONI12 TORING FOR CRONOBACTER SPP AND SALMONELLA.— 

13 ‘‘(1) IN GENERAL.—A manufacturer of pow14 dered infant formula shall establish and implement 

15 an environmental monitoring program to verify the 

16 effectiveness of sanitation and hygiene controls 

17 where the food has the potential to be exposed to 

18 Cronobacter spp. or Salmonella. The environmental 

19 monitoring program shall be written and include 

20 procedures for determining sampling location, num21 ber of samples to be taken, and timing and fre22 quency of sample collection and testing. 

23 ‘‘(2) SAMPLING LOCATION AND NUMBER OF

24 SAMPLES.—A manufacturer of powdered infant for25 mula shall ensure that the sampling locations from 

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1 which samples will be taken, and the number of sites 

2 to be tested during routine environmental moni3 toring pursuant to an environmental monitoring pro4 gram under paragraph (1), are adequate to deter5 mine whether sanitation and hygiene controls are ef6 fective. 

7 ‘‘(3) TIMING AND FREQUENCY.—A manufac8 turer of powdered infant formula shall ensure that 

9 the timing and frequency for collecting ant testing 

10 samples pursuant to an environmental monitoring 

11 program under paragraph (1) are adequate to deter12 mine whether sanitation and hygiene controls are ef13 fective. 

14 ‘‘(4) RECORDS.— 

15 ‘‘(A) AVAILABILITY TO THE SECRETARY.— 

16 A manufacturer of powdered infant formula 

17 shall make all records required under this sub18 section available promptly to the Secretary, 

19 upon request, for inspection and copying. 

20 ‘‘(B) MAINTENANCE.—Records of environ21 mental monitoring conducted pursuant to this 

22 subsection shall be maintained for not less than 

23 2 years or the shelf-life of the infant formula, 

24 whichever is longer. 

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1 ‘‘(C) CONDITIONS OF INSPECTION.—Any 

2 records that the Secretary may inspect under 

3 this subsection shall, upon the request of the 

4 Secretary, be provided to the Secretary by the 

5 manufacturer of powdered infant formula, in 

6 advance of or in lieu of an inspection, within a 

7 reasonable timeframe, within reasonable limits, 

8 and in a reasonable manner, and in either elec9 tronic or physical form, at the expense of such 

10 manufacturer. The Secretary’s request shall in11 clude a sufficient description of the records re12 quested. 

13 ‘‘(D) CONFIRMATION OF RECEIPT.—Upon 

14 receipt of records requested under subpara15 graph (C), the Secretary shall provide to the 

16 person confirmation of receipt. 

17 ‘‘(5) AUTHORITY OF THE SECRETARY.—Noth18 ing in this subsection supplants the authority of the 

19 Secretary to conduct inspections otherwise permitted 

20 under this Act in order to ensure compliance with 

21 this Act. 

22 ‘‘(6) DELAYED APPLICABILITY.—The require23 ments of this subsection apply beginning on the date 

24 that is 180 days after the date of enactment of this 

25 subsection. 

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1 ‘‘(7) RULE OF CONSTRUCTION.—Nothing in 

2 this subsection shall be construed to exempt an in3 fant formula manufacturer from the requirements of 

4 this Act, including the requirements of this section 

5 and section 418.’’. 

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