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September 28, 2026
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Download official Senate Record PDFReturn to issue contextMr. LEE. Mr. President, I ask unanimous consent that the Senate proceed to the immediate consideration of Calendar No. 530, S. 4974.
The PRESIDING OFFICER. The clerk will report the bill by title.
The legislative clerk read as follows:
A bill (S. 4974) to amend the Federal Food, Drug, and
Cosmetic Act with respect to food safety.
which had been reported from the Committee on Health, Education, Labor, and Pensions with an amendment to strike all after the enacting clause and insert in lieu thereof the following:
SECTION 1. SHORT TITLE.
This Act may be cited as the “Making America's Food Safer
Act”.
SEC. 2. EXPANSION OF THE ACCREDITED THIRD-PARTY CERTIFICATION
PROGRAM.
(a) Revised Definitions.—Section 808(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 384d(a)) is amended—
(1) by striking paragraph (6) and inserting the following:
“(6) Eligible entity.—The term `eligible entity' means a
foreign or domestic entity, including a foreign or domestic
facility subject to registration under section 415, in the
food supply chain that chooses to be audited by an accredited
third-party auditor or the audit agent of such accredited
third-party auditor.”; and
(2) in paragraph (7)(B)—
(A) in clause (i), by striking “; or” and inserting a
semicolon;
(B) in clause (ii), by striking the period and inserting
“; or”; and
(C) by adding at the end the following:
“(iii) whether a facility is eligible to receive a food or
facility certification for other purposes described in
subsection (c)(2)(B)(ii).”.
(b) Removing Limitations on the Use of Certifications.—
Section 808(c)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 384d(c)(2)) is amended—
(1) in subparagraph (A), by striking “food certification,
described in section 801(q), or facility certification under
section 806(a), as appropriate, to accompany each food
shipment for import into the United States from an eligible
entity” and inserting “food certification or facility
certification for purposes described in subparagraph (B), as
appropriate,”; and
(2) by striking subparagraph (B) and inserting the
following:
“(B) Purpose of certification.—
“(i) In general.—The Secretary shall use certification
provided by accredited third-party auditors to—
“(I) determine, in conjunction with any other assurances
the Secretary may require under section 801(q), whether a
food satisfies the requirements of such section; and
“(II) determine whether a facility is eligible to be a
facility from which food may be offered for import under the
voluntary qualified importer program under section 806.
“(ii) Other considerations.—The Secretary may consider
the results of regulatory audits and food or facility
certifications provided by accredited third-party auditors
under this section in analyzing risks and prioritizing
inspections and other regulatory activities, as appropriate
for the protection of public health.”.
(c) Technical and Conforming Amendments.—Section 808 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384d) is
amended—
(1) in subsection (b)(1)(A)—
(A) by striking “accreditation bodies” in the
subparagraph heading and all that follows through “Not later
than” in clause (i) and inserting the following:
“accreditation bodies—Not later than”; and
(B) by striking clause (ii);
(2) in subsection (c)—
(A) in paragraphs (1) and (2), by striking “(or, in the
case of direct accreditation under subsection (b)(1)(A)(ii),
the Secretary)” each place it appears;
(B) in paragraph (2)(C)(i), by striking “food
certification under section 801(q) or a facility
certification described under this subparagraph (B)” and
inserting “food certification or a facility certification
described in this section”;
(C) in paragraph (6)(A)(i), by striking “food certified
under section 801(q) or from a facility certified under
paragraph (2)(B)” and inserting “food or a facility
certified under this section”;
(D) in paragraph (6)(C), by striking “requirements under
section 801(q), of certifying the food, or the requirements
under paragraph (2)(B) of certifying the entity” and
inserting “requirements for certifying the food or facility
under this section”; and
(E) in paragraph (7)(B)(i), by striking “, through direct
accreditation under subsection (b)(1)(A)(ii) or”; and
(3) in subsection (d)—
(A) in paragraph (1), by striking “or”; and
(B) at the end of paragraph (2), by striking the period and
inserting “; or”; and
(C) by adding at the end the following new paragraph:
“(3) otherwise seeks certification for purposes of
subsection (c)(2)(B)(ii).”.
SEC. 3. SHARING FOOD SAFETY INFORMATION WITH STATE, LOCAL,
TRIBAL, AND TERRITORIAL AUTHORITIES.
(a) In General.—Section 708 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379) is amended by adding at the end
the following:
“(d) Sharing Food Safety Information With State, Local,
Tribal, and Territorial Authorities.—
“(1) Authorization.—Notwithstanding section 301(j) and
any other law, regulation, or policy, the Secretary may
share, with a State, local, Tribal, or territorial authority
with counterpart functions related to the protection of
public health, unredacted information in the possession of
the Food and Drug Administration relating to any of the
following:
“(A) Foodborne illness surveillance data.
“(B) Laboratory sampling testing information.
“(C) Inspectional information and results.
“(D) Distribution lists for recalls and outbreaks.
“(E) Consumer complaints.
“(F) Any other information the Secretary determines will
assist such authority in protecting the public.
“(2) Timing.—The Secretary may share information pursuant
to paragraph (1) as soon as is reasonably practicable.
“(3) Limitation on further disclosure.—A State, local,
Tribal, or Territorial authority in receipt of information
provided by the Secretary under this subsection shall not
further disclose such information without permission of the
Food and Drug Administration unless such authority determines
that disclosure of such information is necessary to contain a
foodborne illness outbreak, carry out a recall, or carry out
other State enforcement activities.
“(4) Effect of subsection.—Nothing in this subsection
affects the authority of the Secretary to enter into any
written agreement authorized by other provisions of law to
share confidential information.
“(e) Information Disclosure During Food Safety
Incidents.—The Secretary is authorized to disclose
commercial information obtained from a person that is
protected under section 1905 of title 18, United States Code,
when the disclosure of such information advances public
health protection during a food safety incident, including a
foodborne illness outbreak, an investigation related to
contaminated food, or a food recall.”.
(b) Conforming Amendment.—The first sentence of section
301(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
331(j)) is amended—
(1) by inserting “to a State, local, Tribal, or
territorial authority as specified in section 708(d),” after
“of the Department,”; and
(2) by striking the second period at the end.
SEC. 4. DESTRUCTION OF CERTAIN REFUSED ARTICLES.
Section 801 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 381) is amended by adding at the end the following:
“(v) Order To Destroy Certain Refused Articles.—
“(1) In general.—For any article that has been refused
admission and is in violation of this Act, the Secretary of
Health and Human Services may issue to the owner or consignee
an order that the article shall be destroyed, without the
opportunity to export, if the Secretary of Health and Human
Services finds that the article presents a significant public
health concern. Before issuing an order to destroy an article
under this subsection, the Secretary of Health and Human
Services shall provide for notice and an opportunity to
appear before the Secretary of Health and Human Services and
introduce testimony on the order to destroy. The Secretary of
Health and Human Services may combine the opportunity to
appear before the Secretary and the opportunity to introduce
testimony into a single proceeding with respect to an
article. The regulations under paragraph (2) shall provide
that prior to the destruction of any such article,
appropriate due process is available to the owner or
consignee seeking to challenge the decision of the Secretary
of Health and Human Services to order destruction. Such
process may be combined with the notice and opportunity to
appear before the Secretary and introduce testimony on the
refusal as long as appropriate notice is provided to the
owner or consignee about the potential order to destroy. The
Secretary of the Treasury shall cause the owner or consignee
to complete the destruction of any such article within 90
days of the order for destruction and the owner or consignee
shall be responsible for the costs of such destruction.
“(2) Regulations.—
“(A) Proposed.—Not later than 18 months after the date of
enactment of the Making America's Food Safer Act, the
Secretary of Health and Human Services shall issue proposed
regulations to implement paragraph (1), including a framework
for due process, allowing for notice and comment on such
proposed regulations.
“(B) Final.—Not later than 1 year after the issuance of
the proposed regulations under subparagraph (A), the
Secretary of Health and Human Services shall promulgate final
regulations to implement paragraph (1).
“(3) Exceptions.—With respect to importation by an
individual of a prescription drug that is not a controlled
substance pursuant to section 804(j) and in a manner that is
consistent with personal or household use, the authority
provided under paragraph (1) shall not apply.
“(4) Clarification.—For purposes of this section, a
prescription drug described in paragraph (3) that is imported
as described in such paragraph shall not be considered a
`significant public health concern'.”.
Mr. LEE. I ask unanimous consent that the committee-reported substitute amendment be agreed to; that the bill, as amended, be considered read a third time and passed; and that the motion to reconsider be considered made and laid upon the table.
The PRESIDING OFFICER. Without objection, it is so ordered.
The bill (S. 4974), as amended, was ordered to be engrossed for a third reading, was read the third time, and passed.