[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 1019 Introduced in Senate (IS)]

<DOC>






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, 
                     Education, 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 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 2021''.

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:
    ``(ss) The term `infant and toddler food' means food intended for 
sale to children up to 36 months of age, including infant formula.''.

SEC. 3. INFANT AND TODDLER FOOD HAZARD ANALYSIS AND RISK-BASED 
              PREVENTIVE CONTROLS.

    (a) Preventive Controls.--Section 418(c) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 350g(c)) is amended--
            (1) in paragraph (2), by striking ``and'' at the end;
            (2) in paragraph (3), by striking the period at the end and 
        inserting ``; and''; and
            (3) by adding at the end the following:
            ``(4) the infant and toddler foods manufactured, processed, 
        packed, or held by such facility will comply with the 
        performance standards and action levels for toxic elements in 
        infant and toddler foods required under section 104 of the FDA 
        Food Safety Modernization Act.''.
    (b) Verification.--Paragraph (4) of section 418(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 350g(f)) is amended to read as 
follows:
            ``(4) the preventive controls implemented under subsection 
        (c) are effectively and significantly minimizing or preventing 
        the occurrence of identified hazards, including through the use 
        of environmental and product testing programs and other 
        appropriate means, including representative testing by 
        manufacturers of infant and toddler foods that are finished 
        products; and''.
    (c) Biannual Reporting.--Section 418(h) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 350g(h)) is amended by adding at the end 
the following: ``The owner, operator, or agent in charge of a facility 
that manufactures infant and toddler foods shall make publicly 
available on a web page a biannual report summarizing the results of 
monitoring under subsection (d), and verification results under 
subsection (f), with respect to such facility and infant and toddler 
foods.''.

SEC. 4. INFANT AND TODDLER FOOD ACTION LEVELS.

    (a) Performance Standard Guidance Documents and Regulations.--
Section 104(b) of the FDA Food Safety Modernization Act (21 U.S.C. 
2201(b)) is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``reduce the risk of serious illness or death'' and inserting 
        ``reduce the risk of serious illness, including neurological 
        impairment, or death''; and
            (2) in paragraph (1), by inserting ``and toxic elements in 
        infant and toddler foods'' before the semicolon.
    (b) Action Levels.--Section 104 of the FDA Food Safety 
Modernization Act (21 U.S.C. 2201) is amended by adding at the end the 
following:
    ``(e) Action Levels.--
            ``(1) In general.--Beginning not later than 1 year after 
        the date of enactment of the Baby Food Safety Act of 2021, 
        infant and toddler food is deemed to be adulterated if it meets 
        or exceeds the action level or regulatory limit that is 
        applicable with respect to such food under this subsection.
            ``(2) Initial levels.--The initial action levels 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
------------------------------------------------------------------------

            ``(3) Interim action levels.--Not later than 2 years after 
        the date of enactment of the Baby Food Safety Act of 2021, the 
        Secretary shall--
                    ``(A) review relevant health and dietary data; and
                    ``(B) by guidance, lower the initial action levels 
                established by paragraph (2) to further minimize 
                exposure to toxic elements in infant and toddler food 
                to further reduce potential clinical or population-
                level health effects as indicated by the Secretary's 
                review of relevant health and dietary data.
            ``(4) Final regulatory limits; periodic review.--The 
        Secretary shall--
                    ``(A) not later than 3 years after the date of 
                enactment of the Baby Food Safety Act of 2021, by 
                regulation set regulatory limits lower than the action 
                levels established by paragraphs (2) and (3) to levels 
                protective of infant and toddler neurological 
                development, taking into account the most sensitive 
                testing available; and
                    ``(B) every 5 years thereafter--
                            ``(i) review the levels established under 
                        this subsection to consider whether such levels 
                        should be lowered further consistent with the 
                        standard described in subparagraph (A); and
                            ``(ii) if so, by regulation so lower such 
                        levels.
            ``(5) Toxic elements.--The Secretary may by guidance or 
        regulation, as applicable, establish interim action levels and 
        regulatory limits for toxic elements in infant and toddler food 
        in addition to the toxic elements specified in the table in 
        paragraph (2) if determined by the Secretary to be appropriate 
        upon review of relevant health and dietary data.
            ``(6) Progress reports.--Not later than 1 year, 2 years, 
        and 3 years after the date of enactment of the Baby Food Safety 
        Act of 2021, the Secretary shall submit a report to the 
        Congress containing--
                    ``(A) a summary of progress towards establishing 
                the required levels under this subsection;
                    ``(B) an evaluation of the effectiveness of 
                preventive controls for infant and toddler food based 
                on monitoring results and verification results under 
                section 418 of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 350g) compared to levels under this 
                subsection; and
                    ``(C) an estimate of progress in reducing the 
                cumulative exposure of children to toxic elements in 
                infant and toddler food.''.
    (c) Definition.--Section 104 of the FDA Food Safety Modernization 
Act (21 U.S.C. 2201(b)), as amended by subsections (a) and (b), is 
further amended by adding at the end the following:
    ``(f) Infant and Toddler Food Defined.--In this section, the term 
`infant and toddler food' has the meaning given to such term in section 
201(ss) of the Federal Food, Drug, and Cosmetic Act.''.
    (d) Mandatory Recall Authority.--Section 423(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 350l(a)) is amended--
            (1) by striking ``(other than infant formula)''; and
            (2) by inserting after ``animals,'' the following: ``or the 
        Secretary determines that an article of infant and toddler food 
        contains a toxic element that meets or exceeds the action level 
        applicable under subsection (e) of section 104 of the FDA Food 
        Safety Modernization Act,''.
    (e) Public Awareness Campaign.--Section 1009 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 399) is amended--
            (1) by redesignating subsection (h) as subsection (i); and
            (2) after executing the amendment made by paragraph (1), by 
        inserting after subsection (g) the following:
    ``(h) Baby Food Public Awareness Campaign.--The Secretary, acting 
through the Director of the Centers for Disease Control, shall carry 
out a public awareness campaign to highlight the risks posed by toxic 
elements in infant and toddler food and make recommendations to the 
public with respect to such toxic elements and food.''.
    (f) Grants for Farming Research.--Section 401 of the FDA Food 
Safety Modernization Act (Public Law 111-353; 124 Stat. 3967) is 
amended by adding the end the following:
    ``(c) Grants for Farming Research.--
            ``(1) In general.--The Commissioner of Food and Drugs shall 
        commission the National Academy of Sciences (or, if the 
        National Academy declines, another appropriate entity) to 
        conduct research on agricultural methods of minimizing levels 
        of toxic heavy metals in crops.
            ``(2) Authorization of appropriations.--To carry out this 
        subsection, there is authorized to be appropriated 
        $50,000,000.''.
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