[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6770 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 6770

To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety 
          of infant and toddler food, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           December 13, 2023

      Mrs. Sykes (for herself, Mr. Pallone, Mr. Cardenas, and Mr. 
 Krishnamoorthi) 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 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 ``Improving Newborns' Food and 
Nutrition Testing Safety Act of 2023'' or the ``INFANTS Act of 2023''.

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 which purports 
to be or is represented as food for children up to 24 months of age, 
including infant formula.''.

SEC. 3. CONTAMINANTS IN FOOD.

    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. SAMPLING AND TESTING FOR CONTAMINANTS IN FOOD.

    ``(a) Sampling and Testing.--
            ``(1) In general.--The owner, operator, or agent in charge 
        of a food facility that manufactures or processes food, 
        including infant and toddler food, in final product form 
        intended for sale to consumers shall--
                    ``(A) collect representative samples of each such 
                food; and
                    ``(B) conduct testing of the samples for 
                contaminants, including toxic elements.
            ``(2) Requirement 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 
                        section; and
                            ``(ii) ensure that all sampling and testing 
                        conducted under this section is conducted in 
                        accordance with the sampling plan.
                    ``(B) Requirements.--A sampling plan under 
                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 this section, the Secretary shall 
                issue guidance to assist food facilities in developing 
                sampling plans. Such guidance may, as determined 
                appropriate by the Secretary, address when samples 
                should be tested for specific species of contaminants.
            ``(3) Contaminants to be tested.--Each sample taken 
        pursuant to a sampling plan under this section shall be tested 
        for levels of lead, cadmium, mercury, arsenic, and any other 
        contaminant, including other toxic elements, that the Secretary 
        may specify by regulation.
            ``(4) Frequency of testing.--The sampling and testing 
        conducted under this section shall be conducted at least once 
        per quarter of each calendar year.
            ``(5) Foods to be tested.--The sampling and testing 
        conducted under this section shall be conducted for--
                    ``(A) infant and toddler foods, in final package 
                form; and
                    ``(B) such other foods as the Secretary may 
                specify, by regulation, as appropriate to protect 
                public health.
    ``(b) Recordkeeping.--
            ``(1) In general.--The owner, operator, or agent in charge 
        of a facility described in subsection (a)(1) shall maintain, 
        for not less than 2 years or the shelf-life of each infant and 
        toddler food manufactured or processed at the facility, 
        whichever is longer, records documenting the sampling and 
        testing conducted under this section with respect to the food.
            ``(2) Requirements.--Records required by paragraph (1) to 
        be maintained shall include a detailed description of the foods 
        sampled and tested, the number of samples and tests performed, 
        the size and number of items in each sample unit, a copy of the 
        facility's sampling plan, identification of the entity 
        conducting the sampling, identification of the entity 
        conducting the testing, and the analytical methods used to 
        perform the sampling and testing.
            ``(3) Applicability.--This subsection applies to all 
        records of sampling and testing conducted under this section, 
        regardless of the findings.
    ``(c) Laboratory Accreditation.--The owner, operator, or agent in 
charge of a food facility described in subsection (a)(1) shall ensure 
that testing conducted pursuant to this section 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 section is not 
subject to the requirements regarding laboratory accreditation 
described in section 422.
    ``(d) Records Availability.--
            ``(1) In general.--The owner, operator, or agent in charge 
        of a food facility described in subsection (a)(1) shall make 
        all records required under this section available promptly to 
        the Secretary, upon request, for inspection and copying. Upon 
        request of the Secretary, such an owner, operator, or agent in 
        charge shall provide within a reasonable time an English 
        translation of records maintained in a language other than 
        English.
            ``(2) Records 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 food 
        facility described in subsection (a)(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 (2), the Secretary shall provide to the person 
        confirmation of receipt.
            ``(4) Authority of the secretary.--Nothing in this 
        subsection supplants the authority of the Secretary to conduct 
        inspections otherwise permitted under this Act in order to 
        ensure compliance with this Act.
    ``(e) Delayed Applicability.--The requirements for sampling and 
testing under this section apply beginning on the date that is 180 days 
after the date on which the Secretary publishes the guidance required 
by subsection (a)(2)(C).''.

SEC. 4. 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 and the owner, operator, or agent 
in charge of a food facility that manufactures or processes such food--
            ``(1) is subject to the requirements of section 425; and
            ``(2) fails to comply with the requirements of such section 
        with regard to that article.''.

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), (C), and (D) as 
        subparagraphs (C), (D), and (E), respectively;
            (2) by inserting after subparagraph (A) the following:
    ``(B)(i) Any records or other information that the Secretary may 
inspect under authority of this Act from a person that owns or operates 
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 the following:
            ``(I) The manufacturing, processing, packing, transporting, 
        distributing, receiving, holding, or importing of an article of 
        food.
            ``(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 requests for records or other 
information when those requests are 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 ``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),'' after 
``animals,''.

SEC. 7. REPORT FINAL PRODUCT POSITIVE TEST RESULTS FOR RELEVANT 
              PATHOGENS IN INFANT FORMULA.

    Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
350a) is amended--
            (1) in subsection (e)--
                    (A) in paragraph (1)--
                            (i) in the first sentence, by striking 
                        ``promptly'' and inserting ``, within 24 hours 
                        of acquiring such knowledge,''; and
                            (ii) in the second sentence, by striking 
                        ``the infant formula'' and inserting ``an 
                        infant formula'';
                    (B) by redesignating paragraph (2) as paragraph 
                (4);
                    (C) in paragraph (4), as so redesignated, by 
                striking ``paragraph (1)'' and inserting ``paragraphs 
                (1) and (2)''; and
                    (D) by inserting after paragraph (1) the following:
    ``(2) If the result of any in-process or finished product testing 
of an infant formula that has been processed by the manufacturer is 
confirmed as a positive analytical result for any environmental 
pathogen (as defined in section 117.3 of title 21, Code of Federal 
Regulations (or any successor regulation)), the manufacturer shall--
            ``(A) within 24 hours of acquiring such confirmation, 
        notify the Secretary of such confirmation regardless of whether 
        such infant formula has left an establishment subject to the 
        control of the manufacturer;
            ``(B) consult with the Secretary for proper disposal and 
        properly dispose of the affected product; and
            ``(C) provide to the Secretary results and isolates from a 
        positive sample of such infant formula.
    ``(3) Not later than 90 days after receipt of a notification under 
paragraph (1) or (2), the Secretary shall confirm through the 
collection of documentation that the manufacturer submitting the 
notification performed, or is performing, appropriate corrective 
action. The manufacturer shall make such documentation available to the 
Secretary during an inspection and, upon request of the Secretary, 
electronically or by other means.''.

SEC. 8. ENVIRONMENTAL MONITORING.

    Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
350a) is amended by adding at the end the following:
    ``(n) Requirements for Environmental Monitoring for Cronobacter Spp 
and Salmonella.--
            ``(1) In general.--A manufacturer of powdered infant 
        formula 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 Cronobacter spp. or Salmonella. The environmental 
        monitoring program shall be written and include procedures for 
        determining sampling location, number of samples to be taken, 
        and timing and frequency of sample collection and testing.
            ``(2) Sampling location and number of samples.--A 
        manufacturer of powdered infant formula shall ensure that the 
        sampling locations from which samples will be taken, and the 
        number of sites to be tested during routine environmental 
        monitoring pursuant to an environmental monitoring program 
        under paragraph (1), are adequate to determine whether 
        sanitation and hygiene controls are effective.
            ``(3) Timing and frequency.--A manufacturer of powdered 
        infant formula shall ensure that the timing and frequency for 
        collecting ant testing samples pursuant to an environmental 
        monitoring program under paragraph (1) are adequate to 
        determine whether sanitation and hygiene controls are 
        effective.
            ``(4) Records.--
                    ``(A) Availability to the secretary.--A 
                manufacturer of powdered infant formula shall make all 
                records required under this subsection available 
                promptly to the Secretary, upon request, for inspection 
                and copying.
                    ``(B) Maintenance.--Records of environmental 
                monitoring conducted pursuant to this subsection shall 
                be maintained for not less than 2 years or the shelf-
                life of the infant formula, whichever is longer.
                    ``(C) Conditions of inspection.--Any records that 
                the Secretary may inspect under this subsection shall, 
                upon the request of the Secretary, be provided to the 
                Secretary by the manufacturer of powdered infant 
                formula, 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.
                    ``(D) Confirmation of receipt.--Upon receipt of 
                records requested under subparagraph (C), the Secretary 
                shall provide to the person confirmation of receipt.
            ``(5) Authority of the secretary.--Nothing in this 
        subsection supplants the authority of the Secretary to conduct 
        inspections otherwise permitted under this Act in order to 
        ensure compliance with this Act.
            ``(6) Delayed applicability.--The requirements of this 
        subsection apply beginning on the date that is 180 days after 
        the date of enactment of this subsection.
            ``(7) Rule of construction.--Nothing in this subsection 
        shall be construed to exempt an infant formula manufacturer 
        from the requirements of this Act, including the requirements 
        of this section and section 418.''.
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