I 

117TH CONGRESS 

1ST SESSION H. R. 2229 

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

of toxic elements in, and otherwise regulate, infant and toddler food, 

and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 26, 2021 

Mr. KRISHNAMOORTHI (for himself and Mr. CA ́RDENAS) 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 

limit the presence of toxic elements in, and otherwise 

regulate, 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 2021’’. 

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

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

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

9 following: 


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1 ‘‘(ss) The term ‘infant and toddler food’ means food 

2 intended for sale to children up to 36 months of age, in3 cluding infant formula.’’. 

4 SEC. 3. INFANT AND TODDLER FOOD HAZARD ANALYSIS 

5 AND RISK-BASED PREVENTIVE CONTROLS. 

6 (a) PREVENTIVE CONTROLS.—Section 418(c) of the 

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

8 350g(c)) is amended— 

9 (1) in paragraph (2), by striking ‘‘and’’ at the 

10 end; 

11 (2) in paragraph (3), by striking the period at 

12 the end and inserting ‘‘; and’’; and 

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

14 ‘‘(4) the infant and toddler foods manufactured, 

15 processed, packed, or held by such facility will com16 ply with the performance standards and action levels 

17 for toxic elements in infant and toddler foods re18 quired under section 104 of the FDA Food Safety 

19 Modernization Act.’’. 

20 (b) VERIFICATION.—Paragraph (4) of section 418(f) 

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

22 350g(f)) is amended to read as follows: 

23 ‘‘(4) the preventive controls implemented under 

24 subsection (c) are effectively and significantly mini25 mizing or preventing the occurrence of identified 


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1 hazards, including through the use of environmental 

2 and product testing programs and other appropriate 

3 means, including representative testing by manufac4 turers of infant and toddler foods that are finished 

5 products; and’’. 

6 (c) BIANNUAL REPORTING.—Section 418(h) of the 

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

8 350g(h)) is amended by adding at the end the following: 

9 ‘‘The owner, operator, or agent in charge of a facility that 

10 manufactures infant and toddler foods shall make publicly 

11 available on a webpage a biannual report summarizing the 

12 results of monitoring under subsection (d), and 

13 verification results under subsection (f), with respect to 

14 such facility and infant and toddler foods.’’. 

15 SEC. 4. INFANT AND TODDLER FOOD ACTION LEVELS. 

16 (a) PERFORMANCE STANDARD GUIDANCE DOCU17 MENTS AND REGULATIONS.—Section 104(b) of the FDA 

18 Food Safety Modernization Act (21 U.S.C. 2201(b)) is 

19 amended— 

20 (1) in the matter preceding paragraph (1), by 

21 striking ‘‘reduce the risk of serious illness or death’’ 

22 and inserting ‘‘reduce the risk of serious illness, in23 cluding neurological impairment, or death’’; and 


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1 (2) in paragraph (1), by inserting ‘‘and toxic 

2 elements in infant and toddler foods’’ before the 

3 semicolon. 

4 (b) ACTION LEVELS.—Section 104 of the FDA Food 

5 Safety Modernization Act (21 U.S.C. 2201) is amended 

6 by adding at the end the following: 

7 ‘‘(e) ACTION LEVELS.— 

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

9 year after the date of enactment of the Baby Food 

10 Safety Act of 2021, infant and toddler food is 

11 deemed to be adulterated if it meets or exceeds the 

12 action level or regulatory limit that is applicable with 

13 respect to such food under this subsection. 

14 ‘‘(2) INITIAL LEVELS.—The initial action levels 

15 under this subsection are the following: 

‘‘Toxic Element Action Level 

Inorganic arsenic ............ 10 ppb for infant and toddler food (except cereal) 

and 15 ppb for infant and toddler food that is 

cereal 

Cadmium ........................ 5 ppb for infant and toddler food (except cereal) 

and 10 ppb for infant and toddler food that is 

cereal 

Lead ............................... 5 ppb for infant and toddler food (except cereal) 

and 10 ppb for infant and toddler food that is 

cereal 

Mercury .......................... 2 ppb 


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1 ‘‘(3) INTERIM ACTION LEVELS.—Not later than 

2 2 years after the date of enactment of the Baby 

3 Food Safety Act of 2021, the Secretary shall— 

4 ‘‘(A) review relevant health and dietary 

5 data; and 

6 ‘‘(B) by guidance, lower the initial action 

7 levels established by paragraph (2) to further 

8 minimize exposure to toxic elements in infant 

9 and toddler food to further reduce potential 

10 clinical or population-level health effects as indi11 cated by the Secretary’s review of relevant 

12 health and dietary data. 

13 ‘‘(4) FINAL REGULATORY LIMITS; PERIODIC RE14 VIEW.—The Secretary shall— 

15 ‘‘(A) not later than 3 years after the date 

16 of enactment of the Baby Food Safety Act of 

17 2021, by regulation set regulatory limits lower 

18 than the action levels established by paragraphs 

19 (2) and (3) to levels protective of infant and 

20 toddler neurological development, taking into 

21 account the most sensitive testing available; and 

22 ‘‘(B) every 5 years thereafter— 

23 ‘‘(i) review the levels established 

24 under this subsection to consider whether 

25 such levels should be lowered further conVerDate Sep 11 2014 02:57 May 25, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2229.IH H2229

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1 sistent with the standard described in sub2 paragraph (A); and 

3 ‘‘(ii) if so, by regulation so lower such 

4 levels. 

5 ‘‘(5) TOXIC ELEMENTS.—The Secretary may by 

6 guidance or regulation, as applicable, establish in7 terim action levels and regulatory limits for toxic ele8 ments in infant and toddler food in addition to the 

9 toxic elements specified in the table in paragraph (2) 

10 if determined by the Secretary to be appropriate 

11 upon review of relevant health and dietary data. 

12 ‘‘(6) PROGRESS REPORTS.—Not later than 1 

13 year, 2 years, and 3 years after the date of enact14 ment of the Baby Food Safety Act of 2021, the Sec15 retary shall submit a report to the Congress con16 taining— 

17 ‘‘(A) a summary of progress towards es18 tablishing the required levels under this sub19 section; 

20 ‘‘(B) an evaluation of the effectiveness of 

21 preventive controls for infant and toddler food 

22 based on monitoring results and verification re23 sults under section 418 of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 350g) com25 pared to levels under this subsection; and 


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1 ‘‘(C) an estimate of progress in reducing 

2 the cumulative exposure of children to toxic ele3 ments in infant and toddler food.’’. 

4 (c) DEFINITION.—Section 104 of the FDA Food 

5 Safety Modernization Act (21 U.S.C. 2201(b)), as amend6 ed by subsections (a) and (b), is further amended by add7 ing at the end the following: 

8 ‘‘(f) INFANT AND TODDLER FOOD DEFINED.—In 

9 this section, the term ‘infant and toddler food’ has the 

10 meaning given to such term in section 201(ss) of the Fed11 eral Food, Drug, and Cosmetic Act.’’. 

12 (d) MANDATORY RECALL AUTHORITY.—Section 

13 423(a) of the Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 350l(a)) is amended— 

15 (1) by striking ‘‘(other than infant formula)’’; 

16 and 

17 (2) by inserting after ‘‘animals,’’ the following: 

18 ‘‘or the Secretary determines that an article of in19 fant and toddler food contains a toxic element that 

20 meets or exceeds the action level applicable under 

21 subsection (e) of section 104 of the FDA Food Safe22 ty Modernization Act,’’. 

23 (e) PUBLIC AWARENESS CAMPAIGN.—Section 1009 

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

25 399) is amended— 


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1 (1) by redesignating subsection (h) as sub2 section (i); and 

3 (2) after executing the amendment made by 

4 paragraph (1), by inserting after subsection (g) the 

5 following: 

6 ‘‘(h) BABY FOOD PUBLIC AWARENESS CAMPAIGN.— 

7 The Secretary, acting through the Director of the Centers 

8 for Disease Control, shall carry out a public awareness 

9 campaign to highlight the risks posed by toxic elements 

10 in infant and toddler food and make recommendations to 

11 the public with respect to such toxic elements and food.’’. 

12 (f) GRANTS FOR FARMING RESEARCH.—Section 401 

13 of the FDA Food Safety Modernization Act (Public Law 

14 111–353; 124 Stat. 3967) is amended by adding the end 

15 the following: 

16 ‘‘(c) GRANTS FOR FARMING RESEARCH.— 

17 ‘‘(1) IN GENERAL.—The Commissioner of Food 

18 and Drugs shall commission the National Academy 

19 of Sciences (or, if the National Academy declines, 

20 another appropriate entity) to conduct research on 

21 agricultural methods of minimizing levels of toxic 

22 heavy metals in crops. 


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1 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

2 To carry out this subsection, there is authorized to 

3 be appropriated $50,000,000.’’. 

Æ 


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