Baby Food Safety Act of 2021

II 117TH CONGRESS 1ST SESSION S. 1019 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 SENATE OF THE UNITED STATES MARCH 25, 2021 Ms. KLOBUCHAR (for herself and Ms. DUCKWORTH) introduced the following bill; which was read twice and referred to the Committee on Health, Edu- cation, Labor, and Pensions 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Baby Food Safety Act 4 of 2021’’. 5 SEC. 2. DEFINITION OF INFANT AND TODDLER FOOD. 6 Section 201 of the Federal Food, Drug, and Cosmetic 7 Act (21 U.S.C. 321) is amended by adding at the end the 8 following: 9 VerDate Sep 11 2014 18:18 Apr 20, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1019.IS S1019 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 1019 IS ‘‘(ss) The term ‘infant and toddler food’ means food 1 intended for sale to children up to 36 months of age, in- 2 cluding infant formula.’’. 3 SEC. 3. INFANT AND TODDLER FOOD HAZARD ANALYSIS 4 AND RISK-BASED PREVENTIVE CONTROLS. 5 (a) PREVENTIVE CONTROLS.—Section 418(c) of the 6 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 7 350g(c)) is amended— 8 (1) in paragraph (2), by striking ‘‘and’’ at the 9 end; 10 (2) in paragraph (3), by striking the period at 11 the end and inserting ‘‘; and’’; and 12 (3) by adding at the end the following: 13 ‘‘(4) the infant and toddler foods manufactured, 14 processed, packed, or held by such facility will com- 15 ply with the performance standards and action levels 16 for toxic elements in infant and toddler foods re- 17 quired under section 104 of the FDA Food Safety 18 Modernization Act.’’. 19 (b) VERIFICATION.—Paragraph (4) of section 418(f) 20 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 21 350g(f)) is amended to read as follows: 22 ‘‘(4) the preventive controls implemented under 23 subsection (c) are effectively and significantly mini- 24 mizing or preventing the occurrence of identified 25 VerDate Sep 11 2014 18:18 Apr 20, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1019.IS S1019 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 1019 IS hazards, including through the use of environmental 1 and product testing programs and other appropriate 2 means, including representative testing by manufac- 3 turers of infant and toddler foods that are finished 4 products; and’’. 5 (c) BIANNUAL REPORTING.—Section 418(h) of the 6 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 7 350g(h)) is amended by adding at the end the following: 8 ‘‘The owner, operator, or agent in charge of a facility that 9 manufactures infant and toddler foods shall make publicly 10 available on a web page a biannual report summarizing 11 the results of monitoring under subsection (d), and 12 verification results under subsection (f), with respect to 13 such facility and infant and toddler foods.’’. 14 SEC. 4. INFANT AND TODDLER FOOD ACTION LEVELS. 15 (a) PERFORMANCE STANDARD GUIDANCE DOCU- 16 MENTS AND REGULATIONS.—Section 104(b) of the FDA 17 Food Safety Modernization Act (21 U.S.C. 2201(b)) is 18 amended— 19 (1) in the matter preceding paragraph (1), by 20 striking ‘‘reduce the risk of serious illness or death’’ 21 and inserting ‘‘reduce the risk of serious illness, in- 22 cluding neurological impairment, or death’’; and 23 VerDate Sep 11 2014 18:18 Apr 20, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1019.IS S1019 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 1019 IS (2) in paragraph (1), by inserting ‘‘and toxic 1 elements in infant and toddler foods’’ before the 2 semicolon. 3 (b) ACTION LEVELS.—Section 104 of the FDA Food 4 Safety Modernization Act (21 U.S.C. 2201) is amended 5 by adding at the end the following: 6 ‘‘(e) ACTION LEVELS.— 7 ‘‘(1) IN GENERAL.—Beginning not later than 1 8 year after the date of enactment of the Baby Food 9 Safety Act of 2021, infant and toddler food is 10 deemed to be adulterated if it meets or exceeds the 11 action level or regulatory limit that is applicable with 12 respect to such food under this subsection. 13 ‘‘(2) INITIAL LEVELS.—The initial action levels 14 under this subsection are the following: 15 ‘‘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 VerDate Sep 11 2014 18:18 Apr 20, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1019.IS S1019 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 1019 IS ‘‘(3) INTERIM ACTION LEVELS.—Not later than 1 2 years after the date of enactment of the Baby 2 Food Safety Act of 2021, the Secretary shall— 3 ‘‘(A) review relevant health and dietary 4 data; and 5 ‘‘(B) by guidance, lower the initial action 6 levels established by paragraph (2) to further 7 minimize exposure to toxic elements in infant 8 and toddler food to further reduce potential 9 clinical or population-level health effects as indi- 10 cated by the Secretary’s review of relevant 11 health and dietary data. 12 ‘‘(4) FINAL REGULATORY LIMITS; PERIODIC RE- 13 VIEW.—The Secretary shall— 14 ‘‘(A) not later than 3 years after the date 15 of enactment of the Baby Food Safety Act of 16 2021, by regulation set regulatory limits lower 17 than the action levels established by paragraphs 18 (2) and (3) to levels protective of infant and 19 toddler neurological development, taking into 20 account the most sensitive testing available; and 21 ‘‘(B) every 5 years thereafter— 22 ‘‘(i) review the levels established 23 under this subsection to consider whether 24 such levels should be lowered further con- 25 VerDate Sep 11 2014 18:18 Apr 20, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1019.IS S1019 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 1019 IS sistent with the standard described in sub- 1 paragraph (A); and 2 ‘‘(ii) if so, by regulation so lower such 3 levels. 4 ‘‘(5) TOXIC ELEMENTS.—The Secretary may by 5 guidance or regulation, as applicable, establish in- 6 terim action levels and regulatory limits for toxic ele- 7 ments in infant and toddler food in addition to the 8 toxic elements specified in the table in paragraph (2) 9 if determined by the Secretary to be appropriate 10 upon review of relevant health and dietary data. 11 ‘‘(6) PROGRESS REPORTS.—Not later than 1 12 year, 2 years, and 3 years after the date of enact- 13 ment of the Baby Food Safety Act of 2021, the Sec- 14 retary shall submit a report to the Congress con- 15 taining— 16 ‘‘(A) a summary of progress towards es- 17 tablishing the required levels under this sub- 18 section; 19 ‘‘(B) an evaluation of the effectiveness of 20 preventive controls for infant and toddler food 21 based on monitoring results and verification re- 22 sults under section 418 of the Federal Food, 23 Drug, and Cosmetic Act (21 U.S.C. 350g) com- 24 pared to levels under this subsection; and 25 VerDate Sep 11 2014 18:18 Apr 20, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1019.IS S1019 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 1019 IS ‘‘(C) an estimate of progress in reducing 1 the cumulative exposure of children to toxic ele- 2 ments in infant and toddler food.’’. 3 (c) DEFINITION.—Section 104 of the FDA Food 4 Safety Modernization Act (21 U.S.C. 2201(b)), as amend- 5 ed by subsections (a) and (b), is further amended by add- 6 ing at the end the following: 7 ‘‘(f) INFANT AND TODDLER FOOD DEFINED.—In 8 this section, the term ‘infant and toddler food’ has the 9 meaning given to such term in section 201(ss) of the Fed- 10 eral Food, Drug, and Cosmetic Act.’’. 11 (d) MANDATORY RECALL AUTHORITY.—Section 12 423(a) of the Federal Food, Drug, and Cosmetic Act (21 13 U.S.C. 350l(a)) is amended— 14 (1) by striking ‘‘(other than infant formula)’’; 15 and 16 (2) by inserting after ‘‘animals,’’ the following: 17 ‘‘or the Secretary determines that an article of in- 18 fant and toddler food contains a toxic element that 19 meets or exceeds the action level applicable under 20 subsection (e) of section 104 of the FDA Food Safe- 21 ty Modernization Act,’’. 22 (e) PUBLIC AWARENESS CAMPAIGN.—Section 1009 23 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 24 399) is amended— 25 VerDate Sep 11 2014 18:18 Apr 20, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1019.IS S1019 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 1019 IS (1) by redesignating subsection (h) as sub- 1 section (i); and 2 (2) after executing the amendment made by 3 paragraph (1), by inserting after subsection (g) the 4 following: 5 ‘‘(h) BABY FOOD PUBLIC AWARENESS CAMPAIGN.— 6 The Secretary, acting through the Director of the Centers 7 for Disease Control, shall carry out a public awareness 8 campaign to highlight the risks posed by toxic elements 9 in infant and toddler food and make recommendations to 10 the public with respect to such toxic elements and food.’’. 11 (f) GRANTS FOR FARMING RESEARCH.—Section 401 12 of the FDA Food Safety Modernization Act (Public Law 13 111–353; 124 Stat. 3967) is amended by adding the end 14 the following: 15 ‘‘(c) GRANTS FOR FARMING RESEARCH.— 16 ‘‘(1) IN GENERAL.—The Commissioner of Food 17 and Drugs shall commission the National Academy 18 of Sciences (or, if the National Academy declines, 19 another appropriate entity) to conduct research on 20 agricultural methods of minimizing levels of toxic 21 heavy metals in crops. 22 VerDate Sep 11 2014 18:18 Apr 20, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1019.IS S1019 pamtmann on DSKBC07HB2PROD with BILLS 9 •S 1019 IS ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 1 To carry out this subsection, there is authorized to 2 be appropriated $50,000,000.’’. 3 Æ VerDate Sep 11 2014 18:18 Apr 20, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6301 E:\BILLS\S1019.IS S1019 pamtmann on DSKBC07HB2PROD with BILLS