[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8431 Introduced in House (IH)]
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119th CONGRESS
2d Session
H. R. 8431
To amend the Federal Food, Drug, and Cosmetic Act to expand a program
under which third-parties are accredited to conduct food safety audits,
and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 22, 2026
Mr. Rulli 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 expand a program
under which third-parties are accredited to conduct food safety audits,
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 ``Third-Party Certification and
Inspection Modernization Act of 2026''.
SEC. 2. EXPANSION OF THE ACCREDITED THIRD-PARTY CERTIFICATION PROGRAM.
(a) Revised Definitions.--Section 808 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 384d) is amended--
(1) by amending subsection (a)(6) to read as follows:
``(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) by amending subsection (a)(7) to read as follows:
``(7) Regulatory audit.--The term `regulatory audit' means
an audit of an eligible entity--
``(A) to determine whether such entity is in
compliance with the provisions of this Act; and
``(B) the results of which determine--
``(i) whether an article of food
manufactured, processed, packed, or held by
such entity is eligible to receive a food
certification under section 801(q);
``(ii) whether a facility is eligible to
receive a facility certification under section
806 for purposes of participating in the
program under section 806; or
``(iii) whether a facility is eligible to
receive a food or facility certification for
other purposes described in subsection
(c)(2)(B)(iii).''.
(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 amending subparagraph (B) to read as follows:
``(B) Purpose of certification.--
``(i) Certifications concerning imported
foods.--The Secretary shall use certification
provided by accredited third-party auditors to
determine, in conjunction with any other
assurances the Secretary may require under
section 801(q), whether a food satisfies the
requirements of such section.
``(ii) Voluntary qualified importer
program.--The Secretary shall use certification
provided by accredited third-party auditors to
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.
``(iii) Analyzing risks and prioritizing
inspections and other regulatory activities.--
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.--
(1) Section 808(b)(1)(A) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 384d(b)(1)(A)) is amended to read as
follows:
``(A) Recognition of accreditation bodies.--Not
later than 2 years after the date of enactment of the
Third-Party Certification and Inspection Modernization
Act of 2026, 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.''.
(2) Section 808(c) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 384d(c)) is amended--
(A) in paragraphs (1)(B) and (2)(A), by striking
``(or, in the case of direct accreditation under
subsection (b)(1)(A)(ii), the Secretary)'';
(B) in paragraph (2)(C)(i), by striking ``food
certification under section 801(q) or a facility
certification described under subparagraph (B)'' and
inserting ``food certification or a facility
certification described under this section'';
(C) in paragraph (6)--
(i) in subparagraph(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''; and
(ii) in subparagraph (C)(ii), 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
(D) in paragraph (7)(B)(i), by striking ``through
direct accreditation under subsection (b)(1)(A)(ii)
or''.
(3) Section 808(d) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 384d(d)) is amended--
(A) in paragraph (1), by striking ``or'' at the
end;
(B) in paragraph (2), by striking the period at the
end and inserting ``; or''; and
(C) by adding the following:; and
``(3) otherwise seeks certification for purposes of
subsection (c)(2)(B)(iii).''.
(d) Identification and Inspection of Facilities.--Section 421(a)(1)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350j(a)(1)) is
amended--
(1) by redesignating subparagraph (F) as subparagraph (G);
and
(2) by inserting after subparagraph (E) the following:
``(F) Whether the facility that manufactured,
processed, packed, or held such food holds a
certification demonstrating compliance with a third-
party food safety standard that has been determined by
the Secretary to be aligned with regulations issued by
the Food and Drug Administration relating to preventive
controls to ensure the safety of human food.''.
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