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.