[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4974 Reported in Senate (RS)]
<DOC>
Calendar No. 530
119th CONGRESS
2d Session
S. 4974
To amend the Federal Food, Drug, and Cosmetic Act with respect to food
safety.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 14, 2026
Mr. Tuberville (for himself, Mr. Cassidy, and Mr. Kaine) introduced the
following bill; which was read twice and referred to the Committee on
Health, Education, Labor, and Pensions
July 28, 2026
Reported by Mr. Cassidy, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to food
safety.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Making America's Food Safer
Act''.</DELETED>
<DELETED>SEC. 2. EXPANSION OF THE ACCREDITED THIRD-PARTY CERTIFICATION
PROGRAM.</DELETED>
<DELETED> (a) Revised Definitions.--Section 808(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 384d(a)) is amended--</DELETED>
<DELETED> (1) by striking paragraph (6) and inserting the
following:</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (2) in paragraph (7)(B)--</DELETED>
<DELETED> (A) in clause (i), by striking ``; or''
and inserting a semicolon;</DELETED>
<DELETED> (B) in clause (ii), by striking the period
and inserting ``; or''; and</DELETED>
<DELETED> (C) by adding at the end the
following:</DELETED>
<DELETED> ``(iii) whether a facility is
eligible to receive a food or facility
certification for other purposes described in
subsection (c)(2)(B)(ii).''.</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (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</DELETED>
<DELETED> (2) by striking subparagraph (B) and inserting the
following:</DELETED>
<DELETED> ``(B) Purpose of certification.--
</DELETED>
<DELETED> ``(i) In general.--The Secretary
shall use certification provided by accredited
third-party auditors to--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (c) Technical and Conforming Amendments.--Section 808 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384d) is amended--
</DELETED>
<DELETED> (1) in subsection (b)(1), by amending subparagraph
(A) to read as follows:</DELETED>
<DELETED> ``(A) Recognition of accreditation
bodies.--Not later than 2 years after the date of
enactment of the Making America's Food Safer Act, the
Secretary shall establish a system for the recognition
of accreditation bodies that accredit third-party
auditors to certify that eligible entities meet the
applicable requirements of this section.'';</DELETED>
<DELETED> (2) in subsection (c)--</DELETED>
<DELETED> (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;</DELETED>
<DELETED> (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'';</DELETED>
<DELETED> (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 facility certified under this
section'';</DELETED>
<DELETED> (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</DELETED>
<DELETED> (E) in paragraph (7)(B)(i), by striking
``, through direct accreditation under subsection
(b)(1)(A)(ii) or''; and</DELETED>
<DELETED> (3) in subsection (d)--</DELETED>
<DELETED> (A) in paragraph (1), by striking
``or'';</DELETED>
<DELETED> (B) at the end of paragraph (2), by
striking the period and inserting ``; or'';
and</DELETED>
<DELETED> (C) by adding at the end the following new
paragraph:</DELETED>
<DELETED> ``(3) otherwise seeks certification for purposes
of subsection (c)(2)(B)(ii).''.</DELETED>
<DELETED>SEC. 3. SHARING FOOD SAFETY INFORMATION WITH STATE, LOCAL,
TRIBAL, AND TERRITORIAL AUTHORITIES.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(d) Sharing Food Safety Information With State, Local,
Tribal, and Territorial Authorities.--</DELETED>
<DELETED> ``(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:</DELETED>
<DELETED> ``(A) Foodborne illness surveillance
data.</DELETED>
<DELETED> ``(B) Laboratory sampling testing
information.</DELETED>
<DELETED> ``(C) Inspectional information and
results.</DELETED>
<DELETED> ``(D) Distribution lists for recalls and
outbreaks.</DELETED>
<DELETED> ``(E) Consumer complaints.</DELETED>
<DELETED> ``(F) Any other information the Secretary
determines will assist such authority in protecting the
public.</DELETED>
<DELETED> ``(2) Timing.--The Secretary may share information
pursuant to paragraph (1) as soon as is reasonably
practicable.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (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 by striking the second period at the end.</DELETED>
<DELETED>SEC. 4. DESTRUCTION OF CERTAIN REFUSED ARTICLES.</DELETED>
<DELETED> Section 801 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 381) is amended by adding at the end the
following:</DELETED>
<DELETED> ``(v) Order To Destroy Certain Refused Articles.--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 issue regulations
providing for notice and an opportunity to appear before the Secretary
of Health and Human Services and introduce testimony on the order to
destroy. The regulations 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 Secretary of Health and Human
Service's decision 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.''.</DELETED>
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'.''.
Calendar No. 530
119th CONGRESS
2d Session
S. 4974
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to food
safety.
_______________________________________________________________________
July 28, 2026
Reported with an amendment