21 U.S.C. § 384d Accreditation of Third-Party Auditors

• Library: United States Statutes
• Edition: 2023
• Currency: Current through P.L. 118-34 (published on www.congress.gov on 12/26/2023), except for [P. L. 118-31]
• Year: 2023
• Citation: 21 U.S.C. § 384d

(a) Definitions

In this section:

(1) Audit agent

The term "audit agent" means an individual who is an employee or agent of an accredited third-party auditor and, although not individually accredited, is qualified to conduct food safety audits on behalf of an accredited third-party auditor.

(2) Accreditation body

The term "accreditation body" means an authority that performs accreditation of third-party auditors.

(3) Third-party auditor

The term "third-party auditor" means a foreign government, agency of a foreign government, foreign cooperative, or any other third party, as the Secretary determines appropriate in accordance with the model standards described in subsection (b)(2), that is eligible to be considered for accreditation to conduct food safety audits to certify that eligible entities meet the applicable requirements of this section. A third-party auditor may be a single individual. A third-party auditor may employ or use audit agents to help conduct consultative and regulatory audits.

(4) Accredited third-party auditor

The term "accredited third-party auditor" means a third-party auditor accredited by an accreditation body to conduct audits of eligible entities to certify that such eligible entities meet the applicable requirements of this section. An accredited third-party auditor may be an individual who conducts food safety audits to certify that eligible entities meet the applicable requirements of this section.

(5) Consultative audit

The term "consultative audit" means an audit of an eligible entity-

(A) to determine whether such entity is in compliance with the provisions of this chapter and with applicable industry standards and practices; and

(B) the results of which are for internal purposes only.

(6) Eligible entity

The term "eligible entity" means a foreign entity, including a foreign facility registered under section 350d of this title, in the food import supply chain that chooses to be audited by an accredited third-party auditor or the audit agent of such accredited third-party auditor.

(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 chapter; 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 381(q) of this title; or

(ii) whether a facility is eligible to receive a facility certification under section 384b(a) of this title for purposes of participating in the program under section 384b of this title.

(b) Accreditation system

(1) Accreditation bodies

(A) Recognition of accreditation bodies

(i) In general

Not later than 2 years after January 4, 2011, 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.

(ii) Direct accreditation

If, by the date that is 2 years after the date of establishment of the system described in clause (i), the Secretary has not identified and recognized an accreditation body to meet the requirements of this section, the Secretary may directly accredit third-party auditors.

(B) Notification

Each accreditation body recognized by the Secretary shall submit to the Secretary a list of all accredited third-party auditors accredited by such body and the audit agents of such auditors.

(C) Revocation of recognition as an accreditation body

The Secretary shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section.

(D) Reinstatement

The Secretary shall establish procedures to reinstate recognition of an accreditation body if the Secretary determines, based on evidence presented by such accreditation body, that revocation was inappropriate or that the body meets the requirements for recognition under this section.

(2) Model accreditation standards