U.S Code last checked for updates: Jun 21, 2024
§ 384d.
Accreditation of third-party auditors
(a)
Definitions
In this section:
(1)
Audit agent
(2)
Accreditation body
(3)
Third-party auditor
(4)
Accredited third-party auditor
(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
(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
(ii)
Direct accreditation
(B)
Notification
(C)
Revocation of recognition as an accreditation body
(D)
Reinstatement
(2)
Model accreditation standards
(c)
Third-party auditors
(1)
Requirements for accreditation as a third-party auditor
(A)
Foreign governments
(B)
Foreign cooperatives and other third parties
(2)
Requirement to issue certification of eligible entities or foods
(A)
In general
(B)
Purpose of certification
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 381(q) of this title, 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 384b of this title.
(C)
Requirements for issuing certification
(i)
In general
(ii)
Provision of certification
(3)
Audit report submission requirements
(A)
Requirements in general
As a condition of accreditation, not later than 45 days after conducting an audit, an accredited third-party auditor or audit agent of such auditor shall prepare, and, in the case of a regulatory audit, submit, the audit report for each audit conducted, in a form and manner designated by the Secretary, which shall include—
(i)
the identity of the persons at the audited eligible entity responsible for compliance with food safety requirements;
(ii)
the dates of the audit;
(iii)
the scope of the audit; and
(iv)
any other information required by the Secretary that relates to or may influence an assessment of compliance with this chapter.
(B)
Records
(C)
Limitation
(4)
Requirements of accredited third-party auditors and audit agents of such auditors
(A)
Risks to public health
If, at any time during an audit, an accredited third-party auditor or audit agent of such auditor discovers a condition that could cause or contribute to a serious risk to the public health, such auditor shall immediately notify the Secretary of—
(i)
the identification of the eligible entity subject to the audit; and
(ii)
such condition.
(B)
Types of audits
(C)
Limitations
(i)
In general
(ii)
Waiver
(5)
Conflicts of interest
(A)
Third-party auditors
An accredited third-party auditor shall—
(i)
not be owned, managed, or controlled by any person that owns or operates an eligible entity to be certified by such auditor;
(ii)
in carrying out audits of eligible entities under this section, have procedures to ensure against the use of any officer or employee of such auditor that has a financial conflict of interest regarding an eligible entity to be certified by such auditor; and
(iii)
annually make available to the Secretary disclosures of the extent to which such auditor and the officers and employees of such auditor have maintained compliance with clauses (i) and (ii) relating to financial conflicts of interest.
(B)
Audit agents
An audit agent shall—
(i)
not own or operate an eligible entity to be audited by such agent;
(ii)
in carrying out audits of eligible entities under this section, have procedures to ensure that such agent does not have a financial conflict of interest regarding an eligible entity to be audited by such agent; and
(iii)
annually make available to the Secretary disclosures of the extent to which such agent has maintained compliance with clauses (i) and (ii) relating to financial conflicts of interest.
(C)
Regulations
The Secretary shall promulgate regulations not later than 18 months after January 4, 2011, to implement this section and to ensure that there are protections against conflicts of interest between an accredited third-party auditor and the eligible entity to be certified by such auditor or audited by such audit agent. Such regulations shall include—
(i)
requiring that audits performed under this section be unannounced;
(ii)
a structure to decrease the potential for conflicts of interest, including timing and public disclosure, for fees paid by eligible entities to accredited third-party auditors; and
(iii)
appropriate limits on financial affiliations between an accredited third-party auditor or audit agents of such auditor and any person that owns or operates an eligible entity to be certified by such auditor, as described in subparagraphs (A) and (B).
(6)
Withdrawal of accreditation
(A)
In general
The Secretary shall withdraw accreditation from an accredited third-party auditor—
(i)
if food certified under section 381(q) of this title or from a facility certified under paragraph (2)(B) by such third-party auditor is linked to an outbreak of foodborne illness that has a reasonable probability of causing serious adverse health consequences or death in humans or animals;
(ii)
following an evaluation and finding by the Secretary that the third-party auditor no longer meets the requirements for accreditation; or
(iii)
following a refusal to allow United States officials to conduct such audits and investigations as may be necessary to ensure continued compliance with the requirements set forth in this section.
(B)
Additional basis for withdrawal of accreditation
(C)
Exception
The Secretary may waive the application of subparagraph (A)(i) if the Secretary—
(i)
conducts an investigation of the material facts related to the outbreak of human or animal illness; and
(ii)
reviews the steps or actions taken by the third party auditor to justify the certification and determines that the accredited third-party auditor satisfied the requirements under section 381(q) of this title of certifying the food, or the requirements under paragraph (2)(B) of certifying the entity.
(7)
Reaccreditation
The Secretary shall establish procedures to reinstate the accreditation of a third-party auditor for which accreditation has been withdrawn under paragraph (6)—
(A)
if the Secretary determines, based on evidence presented, that the third-party auditor satisfies the requirements of this section and adequate grounds for revocation no longer exist; and
(B)
in the case of a third-party auditor accredited by an accreditation body for which recognition as an accreditation body under subsection (b)(1)(C) is revoked—
(i)
if the third-party auditor becomes accredited not later than 1 year after revocation of accreditation under paragraph (6)(A), through direct accreditation under subsection (b)(1)(A)(ii) or by an accreditation body in good standing; or
(ii)
under such conditions as the Secretary may require for a third-party auditor under paragraph (6)(B).
(8)
Neutralizing costs
(d)
Recertification of eligible entities
An eligible entity shall apply for annual recertification by an accredited third-party auditor if such entity—
(1)
intends to participate in 3
3
 So in original. Probably should be followed by “the”.
voluntary qualified importer program under section 384b of this title; or
(2)
is required to provide to the Secretary a certification under section 381(q) of this title for any food from such entity.
(e)
False statements
Any statement or representation made—
(1)
by an employee or agent of an eligible entity to an accredited third-party auditor or audit agent; or
(2)
by an accredited third-party auditor to the Secretary,
shall be subject to
(f)
Monitoring
To ensure compliance with the requirements of this section, the Secretary shall—
(1)
periodically, or at least once every 4 years, reevaluate the accreditation bodies described in subsection (b)(1);
(2)
periodically, or at least once every 4 years, evaluate the performance of each accredited third-party auditor, through the review of regulatory audit reports by such auditors, the compliance history as available of eligible entities certified by such auditors, and any other measures deemed necessary by the Secretary;
(3)
at any time, conduct an onsite audit of any eligible entity certified by an accredited third-party auditor, with or without the auditor present; and
(4)
take any other measures deemed necessary by the Secretary.
(g)
Publicly available registry
(h)
Limitations
(1)
No effect on section 374 inspections
(2)
No effect on inspection authority
(June 25, 1938, ch. 675, § 808, as added Pub. L. 111–353, title III, § 307, Jan. 4, 2011, 124 Stat. 3959.)
cite as: 21 USC 384d