[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2229 Introduced in House (IH)]
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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. Cardenas) 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.
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 webpage 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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