H.R. 8431

[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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