No official summary available for this bill.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8385 Introduced in House (IH)]
<DOC>
118th CONGRESS
2d Session
H. R. 8385
To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety
of food and limit the presence of contaminants in infant and toddler
food, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 14, 2024
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 ensure the safety
of food and limit the presence of contaminants in 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 2024''.
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:
``(tt) The term `infant and toddler food' means food that purports
to be, or is represented as being, specifically for infants or children
up to the age of 24 months.''.
SEC. 3. CONTAMINANTS IN FOOD, INCLUDING INFANT AND TODDLER FOOD.
(a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 341 et seq.) is amended by adding at the end the
following:
``SEC. 425. CONTAMINANTS IN FOOD, INCLUDING INFANT AND TODDLER FOOD.
``(a) Administrative Orders for Contaminants in Food.--
``(1) In general.--Within the applicable timeframe
specified in paragraph (4), the Secretary, by administrative
order--
``(A) shall establish limits on--
``(i) lead, cadmium, mercury, and total
arsenic in infant and toddler food;
``(ii) lead, cadmium, mercury, and total
arsenic in food pouches made with fruit or
vegetable puree or juice; and
``(iii) lead and arsenic in juice; and
``(B) if the Secretary determines appropriate upon
review of relevant health data and other relevant
available information, may--
``(i) establish limits for additional
contaminants in infant and toddler food;
``(ii) establish limits for additional
contaminants in juice;
``(iii) establish limits for additional
contaminants in food pouches made with fruit or
vegetable puree or juice; and
``(iv) revise limits established pursuant
to subparagraph (A).
``(2) Procedure.--In establishing or revising any limit
under paragraph (1), the Secretary shall--
``(A) evaluate relevant health data and other
information the Secretary considers relevant;
``(B) take into account relevant differences among
food types, groups, and categories, as appropriate,
including the extent to which the presence of a
contaminant cannot be avoided; and
``(C) notwithstanding the requirements of
subchapter II of chapter 5 of title 5, United States
Code, and chapter 6 of title 5, United States Code--
``(i) publish any administrative order
under paragraph (1) in the Federal Register
following--
``(I) publication of a proposed
order in the Federal Register; and
``(II) consideration of comments to
a public docket open for not fewer than
45 calendar days; and
``(ii) set forth in any proposed or final
administrative order under paragraph (1) a
substantive summary of the valid scientific
evidence concerning the proposed or final
limit.
``(3) Additional contaminants; changes to limits.--If the
Secretary determines appropriate after review of relevant data
and available health information, the Secretary may revise any
limit established under this subsection by administrative order
published in the Federal Register in accordance with paragraph
(2)(C).
``(4) Timeframe for initial limits.--
``(A) Proposed orders.--Subject to the requirements
of paragraph (2)(C), the Secretary shall issue proposed
orders for limits under paragraph (1)(A) as follows:
``(i) For lead, not later than December 31,
2025.
``(ii) For total arsenic, not later than
December 31, 2025.
``(iii) For cadmium, not later than April
30, 2026.
``(iv) For mercury, not later than April
30, 2028.
``(B) Final orders.--The Secretary shall issue each
final administrative order for a limit established
pursuant to paragraph (1)(A) not later than the earlier
of--
``(i) the applicable deadline for a final
order specified in paragraph (1); or
``(ii) 18 months after issuance of the
respective proposed order.
``(5) Criteria.--The limits established under this section
shall represent the level at which the Secretary finds
necessary for the protection of public health. In determining
such limits the Secretary shall take into account the extent to
which the use of such substance is required or cannot be
avoided in the production of each such article, and the other
ways in which a consumer may be affected by the same or other
contaminants, taking into consideration relevant information
and data that has been made available.
``(6) Adulterated food.--A food may be determined
adulterated, at the final product stage, under section 402(j),
if such food bears or contains any contaminant in excess of a
limit established under this subsection when considering
variability of the validated method of analysis.
``(7) Periodic review.--The Secretary shall periodically
review the limits established under this subsection, taking
into consideration relevant information and available data to
consider whether such limits should be revised, following the
procedure described in paragraph (2), in accordance with the
criteria specified in paragraph (5).
``(b) Sampling and Testing for Contaminants in Food, Including
Infant and Toddler Food.--
``(1) In general.--Beginning not later than 180 days after
the date of enactment of the Baby Food Safety Act of 2024, the
owner, operator, or agent in charge of a facility engaged in
manufacturing or processing infant and toddler food, food
pouches made with fruit or vegetable puree or juice, or juice
for consumption in the United States shall--
``(A) have a control program pursuant to section
418 in place for contaminants subject to ordered limits
under subsection (a), or be in compliance with the
Juice Hazard Analysis Critical Control Points Program
of the Food and Drug Administration, as applicable;
``(B) be in compliance with regulations promulgated
under section 420(b);
``(C) collect representative samples of each such
food in final product form in accordance with a
sampling plan described in paragraph (2); and
``(D) conduct testing of the samples collected from
the final food product for contaminants, in accordance
with such sampling plan.
``(2) Requirements for sampling plan.--
``(A) In general.--The owner, operator, or agent in
charge of a facility described in paragraph (1) shall--
``(i) prepare a written sampling plan for
all sampling and testing required under this
subsection; and
``(ii) ensure that all sampling and testing
conducted under this subsection is conducted in
accordance with the sampling plan.
``(B) Sampling plan.--A sampling plan required by
subparagraph (A) shall identify--
``(i) the number of sampling units and
sample unit size based upon appropriate
criteria for identifying, in a representative
fashion, the levels of contaminants in each
food; and
``(ii) one or more appropriate test methods
and procedures to be used to analyze the
samples.
``(C) Guidance.--Not later than 18 months after the
date of enactment of the Baby Food Safety Act of 2024,
the Secretary shall issue guidance to assist facilities
described under paragraph (1) with developing sampling
plans. Such guidance may, as the Secretary determines
appropriate, address when samples should be tested for
specific species of contaminants.
``(3) Contaminants to be tested.--In carrying out the
sampling and testing under this subsection, the owner,
operator, or agent in charge of a facility described in
paragraph (1) shall ensure that each sample is tested for
levels of--
``(A) lead, cadmium, mercury, and total arsenic;
and
``(B) any other contaminant that the Secretary may
specify by regulation, and in accordance with the
sampling plan under paragraph (2).
``(4) Foods to be tested.--The sampling and testing
conducted under this subsection shall be conducted for--
``(A) infant and toddler foods, in final product
form;
``(B) pouches made with fruit and vegetable puree
or juice;
``(C) juice; and
``(D) such other foods in final product form as the
Secretary may specify, by regulation, as appropriate to
protect the public health.
``(5) Recordkeeping.--
``(A) In general.--The owner, operator, or agent in
charge of a facility described in paragraph (1) shall
maintain, for not less than 2 years or the shelf-life
of each food product manufactured or processed by the
facility, whichever is longer, records documenting the
sampling plan and results of testing conducted under
this subsection with respect to the food. The owner,
operator, or agent in charge of such a facility shall
make such records available for inspection by the
Secretary upon request by the Secretary.
``(B) Requirements.--The records maintained as
required under subparagraph (A) shall include--
``(i) a detailed description of the foods
sampled and tested;
``(ii) the number of samples and tests
performed;
``(iii) the size and number of items in
each sample unit;
``(iv) a copy of the sampling plan required
under paragraph (2);
``(v) identification of the entity
conducting the sampling;
``(vi) identification of the entity
conducting the testing; and
``(vii) identification of the analytical
methods used to perform the sampling and
testing.
``(C) Applicability.--The requirements of this
paragraph shall apply to all records of sampling and
testing conducted pursuant to this subsection,
regardless of the findings.
``(6) Laboratory accreditation.--The owner, operator, or
agent in charge of a facility described in paragraph (1) shall
ensure that testing required pursuant to this subsection is
performed in accordance with international standards by a
laboratory that is accredited by an accreditation body that
conforms to international accreditation standards. Testing
conducted under this subsection is not subject to the
requirements regarding laboratory accreditation described in
section 422.
``(7) Sampling and testing program.--The Secretary shall
develop and implement a sampling and testing program for infant
and toddler food for sale to consumers that is sufficient to--
``(A) support the periodic review under subsection
(a)(7) of limits on lead, cadmium, mercury, and arsenic
in infant and toddler food; and
``(B) independently verify the effectiveness of the
sampling and testing conducted pursuant to this
subsection by the owner, operator, or agent in charge
of a food facility.
``(8) Guidance.--The Secretary shall issue guidance to
assist food facilities in complying with this subsection.
``(c) Record Availability.--
``(1) In general.--Upon request by the Secretary, the
owner, operator, or agent in charge of a facility described in
subsection (b)(1) shall--
``(A) make all records required under this section
available promptly to the Secretary for inspection and
copying; and
``(B) provide within a reasonable time an English
translation of such records maintained in a language
other than English.
``(2) Record availability in lieu of an inspection.--Any
records that the Secretary may inspect under this section
shall, upon the request of the Secretary, be provided to the
Secretary by the owner, operator, or agent in charge of a
facility described in subsection (b)(1), in advance of or in
lieu of an inspection, within a reasonable timeframe, within
reasonable limits, and in a reasonable manner, and in either
electronic or physical form, at the expense of such owner,
operator, or agent. The Secretary's request shall include a
sufficient description of the records requested.
``(3) Confirmation.--Upon receipt of records requested
under paragraph (1) or (2), the Secretary shall provide to the
owner, operator, or agent described in paragraph (2)
confirmation of the receipt.
``(4) Authority of the secretary.--Nothing in this
subsection supplants the authority of the Secretary to conduct
sampling, testing, or inspections otherwise permitted under
this Act in order to ensure compliance with this Act.
``(d) Delayed Applicability.--The requirements for sampling and
testing under this section shall apply beginning on the date that is 2
years after the date of enactment of this subsection.
``(e) Preemption of State and Local Requirements Regarding Food
Ingredients and Contaminants in Food, Including Infant and Toddler
Food.--No State or political subdivision of a State may establish or
continue in effect with respect to contaminants in food, including
infant and toddler food, food pouches made with fruit or vegetable
puree or juice, and juice, any requirement that is different from, or
in addition to, or not identical with any requirement under this
section, and relates to contaminant sampling and testing, contaminant
limits, disclosure of contaminant test results, contaminant labeling,
contaminant warnings, or any other matter related to contaminants in
food.''.
(b) Importer Requirements.--Section 805(c)(4) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 384a(c)(4)) is amended, by inserting
``, including as described in section 425(b)'' before the period at the
end.
(c) Enforcement.--
(1) Adulteration.--Section 402 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 342) is amended by adding at the
end the following:
``(j) If it is an article of food in final product form that is an
infant and toddler food, a food pouch made with fruit or vegetable
puree or juice, or juice and--
``(1) such food bears or contains any contaminant in excess
of limits established under section 425(a); or
``(2) the owner, operator, or agent in charge of a facility
that manufactures or processes the food is not in compliance
with subsection (b) or (c) of section 425.''.
(2) Prohibited act.--Section 301 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331) is amended by adding at the
end the following:
``(jjj) The failure of an owner, operator, or agent in charge of a
facility that manufactures or processes food to comply with applicable
requirements under subsection (b) or (c) of section 425.''.
SEC. 4. IMPLEMENTATION OF FOOD TRACEABILITY PLAN; STUDY ON INSPECTIONS;
REPORTING ON INSPECTIONS.
(a) Implementation Plan.--The Secretary of Health and Human
Services (referred to in this section as the ``Secretary''), acting
through the Commissioner of Food and Drugs, in coordination with the
FDA Human Foods Program and the Center for Food Safety and Applied
Nutrition, shall finalize an implementation plan for the Food and Drug
Administration to achieve its goal of compliance, not later than
January 20, 2026, with the rule issued by the Food and Drug
Administration titled, ``Requirements for Additional Traceability
Records for Certain Foods'' (87 Fed. Reg. 70910 (November 21, 2022)).
Such plan shall include a description of--
(1) any resource needs of the Food and Drug Administration;
(2) strategies for facilitating compliance with the rule;
and
(3) detailed plans for communicating with and educating
regulated entities, non-Federal regulatory partners, and
regulatory staff of the Food and Drug Administration about the
requirements under the rule.
(b) Study on Inspections.--The Secretary shall--
(1) conduct a study to--
(A) determine the annual number of facility
inspections that is sufficient to determine that
imported foods are held to the same safety standards as
domestic food; and
(B) identify whether such inspection targets are
consistent with the targets in the most recent annual
report regarding food conducted under section 1003(h)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
393(h)); and
(2) not later than 1 year after the date of enactment of
this Act, submit a report to Congress on the findings of such
study, and, if applicable, any factors preventing the Secretary
from meeting its goal for the number of inspections and a plan
to ensure that such goal is met in the next 2 years.
(c) Annual Report Regarding Food.--Section 1003(h)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(h)(1)) is amended--
(1) in subparagraph (E), by striking ``and'' at the end;
(2) in subparagraph (F), by striking the period and
inserting ``; and''; and
(3) by adding at the end the following:
``(G) the nature of domestic facility and foreign
facility inspections described in subparagraph (C), the
aggregate inspection findings of such inspections, and
the compliance rate of foreign food importers with
certification standards;''.
SEC. 5. RECORDS FOR OR IN LIEU OF CERTAIN INSPECTIONS.
Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 374(a)(4)) is amended--
(1) by redesignating subparagraphs (B) through (D) as
subparagraphs (C) through (E), respectively;
(2) by inserting after subparagraph (A) the following new
subparagraph:
``(B)(i) Any records or other information that the Secretary may
inspect under authority of this Act from a person that owns or
operates, or is an agent in charge of, an establishment that is engaged
in any of the activities described in clause (ii) shall, upon the
request of the Secretary, be provided to the Secretary by such person,
in advance of or in lieu of an inspection, within a reasonable
timeframe, within reasonable limits, and in a reasonable manner, and in
either electronic or physical form, at the expense of such person. The
Secretary's request shall include a sufficient description of the
records requested.
``(ii) The activities described in this clause are records relating
to--
``(I) the manufacturing, processing, packing, transporting,
distributing, receiving, holding, or importing of an article of
food; or
``(II) the distribution or use of animal feed bearing or
containing a veterinary feed directive drug, or the issuance of
a veterinary feed directive.''; and
(3) by adding at the end the following:
``(F) Section 703 does not apply to records or other information
obtained pursuant to a request made under this section.''.
SEC. 6. MANDATORY RECALL AUTHORITY.
Section 423(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 350l(a)) is amended by inserting after ``animals,'' the
following: ``or if the Secretary determines through any means that an
article of infant and toddler food (other than infant formula) bears or
contains a contaminant that renders the product adulterated under
section 402(a)(1),''.
SEC. 7. ENVIRONMENTAL MONITORING.
Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
341 et seq.), as amended by section 3, is further amended by adding the
following:
``SEC. 426. ENVIRONMENTAL MONITORING OF INFANT AND TODDLER FOOD.
``(a) In General.--A manufacturer of infant and toddler food shall
establish and implement an environmental monitoring program to verify
the effectiveness of sanitation and hygiene controls where the food has
the potential to be exposed to environment pathogens during the
manufacturing and packing process. The environmental monitoring program
shall be written and include procedures for determining sample
location, number of samples to be taken, and timing and frequency of
sample collection and testing.
``(b) Organisms Sampled.--The environmental monitoring program
under subsection (a) shall include testing for environmental pathogens,
lead, arsenic, mercury, or a reliable indicator organism.
``(c) Sampling Location and Number of Samples.--A manufacturer of
infant and toddler food shall ensure that the sampling locations from
which samples will be taken, and the number of sites to be tested
during routine environmental monitoring are adequate to determine
whether sanitation and hygiene controls are effective.
``(d) Timing and Frequency.--The timing and frequency for
collecting and testing samples shall be adequate to determine whether
sanitation and hygiene controls are effective.
``(e) Records.--
``(1) Availability to the secretary.--A manufacturer shall
make all the records required under this section available
promptly to the Secretary, upon request, for inspection and
copying.
``(2) Maintenance.--Records of environmental monitoring
conducted pursuant to this section shall be established and
maintained by the manufacturer for not less than 2 years or the
shelf-life of the food, whichever is longer.
``(3) Conditions of inspection.--Any records that the
Secretary may inspect under this section shall, upon the
request of the Secretary, be provided to the Secretary by the
manufacturer, in advance of or in lieu of an inspection, within
a reasonable timeframe, within reasonable limits, and in a
reasonable manner, and in either electronic or physical form,
at the expense of such manufacturer. The Secretary's request
shall include a sufficient description of the records
requested.
``(4) Confirmation of receipt.--Upon receipt of the records
requested under paragraph (3), the Secretary shall provide to
the manufacturer confirmation of receipt.
``(f) Authority of the Secretary.--Nothing in this section
supplants the authority of the Secretary to conduct inspections
otherwise permitted under this Act in order to ensure compliance with
this Act.
``(g) Effective Date.--The requirements of this section shall apply
beginning on the date that is 2 years after the date of enactment of
the Baby Food Safety Act of 2024.
``(h) Rule of Construction.--Nothing in this section shall be
construed to exempt any manufacturer from the requirements of this Act,
including the requirements under section 418.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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