No official summary available for this bill.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9105 Introduced in House (IH)]
<DOC>
118th CONGRESS
2d Session
H. R. 9105
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
July 23, 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 OR 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 or toddler food' means food that purports
to be, or is represented as being, for infants or children up to the
age of 24 months. Such term does not include infant formula.''.
SEC. 3. CONTAMINANTS IN FOOD, INCLUDING INFANT OR 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 OR TODDLER FOOD.
``(a) Administrative Orders for Contaminants, Including Toxic
Elements, in Food.--
``(1) In general.--
``(A) Required limits.--The Secretary, by
administrative order, shall establish limits on the
toxic elements of lead, cadmium, mercury, and arsenic
(or a species of any such toxic element) in--
``(i) any infant or toddler food; and
``(ii) food predominantly composed of a
fruit or vegetable puree or juice;
``(B) Additional limits.--If the Secretary
determines appropriate upon review of relevant health
data and other relevant available information, the
Secretary, by administrative order, may--
``(i) establish limits for contaminants,
including toxic elements, in infant or toddler
food, in addition to the limits for toxic
elements described in subparagraph (A); and
``(ii) establish limits for contaminants,
including toxic elements, in food predominantly
composed of a fruit or vegetable puree or
juice, in addition to the limits for toxic
elements described in subparagraph (A).
``(2) Procedure.--In establishing or revising any limit
under paragraph (1), the Secretary shall--
``(A) evaluate relevant health data and
assessments, data from State and local health
departments, 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 use of such
substances cannot be avoided in the production of the
applicable food and its ingredients, based on an
evaluation of alternative ingredients, use of best
manufacturing and agricultural practices, and full
compliance with section 418; 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) Changes to limits.--If the Secretary determines
appropriate after review of relevant data and assessments and
other available and relevant 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).
``(4) Timeframe for initial limits.--
``(A) Proposed orders.--Subject to the requirements
of paragraph (2), 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 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 subparagraph (A) or (B) of paragraph (1)
not later than 18 months after issuance of the
respective proposed order.
``(5) Criteria.--The limits established under this section
shall represent the level at which the contaminant may render
the infant or toddler food injurious to health. In determining
such limits the Secretary shall take into account the extent to
which the use of such substance cannot be avoided in the
production of each such food and its ingredients, based on an
evaluation of alternative ingredients, use of best
manufacturing and agricultural practices, and compliance with
section 418.
``(6) Adulterated food.--A food may be determined
adulterated, at the final product form, under section 402(j),
if such food bears or contains any contaminant (including any
toxic element) in excess of a limit established under this
subsection.
``(7) Periodic review.--The Secretary shall review, not
less frequently than every 4 years, 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 Toxic Elements and 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 or toddler food; food
predominantly composed of a fruit or vegetable puree or juice;
or such other food as the Secretary may specify by regulation,
for consumption in the United States, shall--
``(A) have a control program in place for toxic
elements and contaminants subject to limits under
subsection (a)(1);
``(B) collect representative samples of each such
food in final product form in accordance with a
sampling plan described in paragraph (2); and
``(C) conduct testing of the samples collected from
the final food product for toxic elements and
contaminants, in accordance with a sampling plan
described in paragraph (2).
``(2) Requirements for sampling and testing plan.--
``(A) In general.--The owner, operator, or agent in
charge of a facility described in paragraph (1) shall--
``(i) prepare a written 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 plan described in clause
(i).
``(B) Sampling plan.--A sampling and testing 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 toxic elements and
contaminants in each food;
``(ii) one or more appropriate test methods
and procedures to be used to analyze the
samples; and
``(iii) appropriate testing frequencies not
less frequently than every quarter and whenever
a significant change in the product or process
necessitates such testing.
``(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
and testing plans. Such guidance shall address the
standards for adequate and appropriate sampling and
testing of each toxic element and contaminant as
required by the Secretary, the minimum frequency at
which samples should be tested for toxic elements and
contaminants or specific species of toxic elements or
contaminants, and standards for compliance.
``(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 arsenic; and
``(B) any other contaminant that the Secretary may
specify, 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) foods predominantly composed of a fruit or
vegetable puree or juice; and
``(C) such other foods in final product form as the
Secretary has specified, as appropriate for the
protection of 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 and copying
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;
``(vii) identification of the analytical
methods used to perform the sampling and
testing;
``(viii) analytical findings of the
sampling and testing; and
``(ix) such other data and information as
the Secretary may require.
``(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--
``(A) is in compliance with the requirements
regarding laboratory accreditation described in section
422; or
``(B) if the requirements described in subparagraph
(A) do not apply to the laboratory, is accredited by an
accreditation body that conforms to international
accreditation standards.
``(7) Sampling and testing program.--The Secretary shall
develop and implement a sampling and testing program for infant
and toddler food that is sufficient to--
``(A) support the periodic review under subsection
(a)(7) of limits on toxic elements in infant and
toddler food; and
``(B) independently verify that products are
compliant with the limits proscribed pursuant to 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.--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.''.
(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
``monitoring and verifying the accuracy of records described in section
425(b)'' after ``for shipments,''.
(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 predominantly composed of a fruit or
vegetable puree or juice, or such other food as the Secretary may
specify and--
``(1) such food bears or contains any toxic element or
contaminant in excess of a limit 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))
(or any successor rule). 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
remotely inspect or copy 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, at the time of, or in the case in which an in-
person inspection would be unsafe, in lieu of, an in-person, on-site
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 or other information requested.
``(ii) The activities described in this clause are records relating
to--
``(I) the manufacturing, processing, sampling, testing,
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 obtained or copied, or
other information obtained or copied 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 that an article of food is adulterated under paragraph
(a)(1) or (j) of section 402,''.
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 (other
than infant formula) shall establish and implement an environmental
monitoring program to verify the effectiveness of sanitation and
hygiene controls during the manufacturing and packaging process where
the food has the potential to be exposed to pathogens. 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
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, and shall occur not less
frequently than every 3 years.
``(e) Records.--
``(1) Availability to the secretary.--A manufacturer of
infant and toddler food shall make all the records required
under this section available promptly to the Secretary, upon
request by the Secretary, for inspection and copying.
``(2) Maintenance of records pertaining to environmental
monitoring.--Records of environmental sampling, testing, and
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 or other
information 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, at the time of,
or in the case in which an in-person inspection would be
unsafe, in lieu of, an in-person, on-site 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.
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