21 U.S.C. § 384d (FOOD AND DRUGS)
§ 384d. Accreditation of third-party auditors
(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
Not later than 18 months after January 4, 2011, the Secretary shall develop model standards, including requirements for regulatory audit reports, and each recognized accreditation body shall ensure that third-party auditors and audit agents of such auditors meet such standards in order to qualify such third-party auditors as accredited third-party auditors under this section. In developing the model standards, the Secretary shall look to standards in place on January 4, 2011, for guidance, to avoid unnecessary duplication of efforts and costs.
(c) Third-party auditors
(1) Requirements for accreditation as a third-party auditor
(A) Foreign governments
Prior to accrediting a foreign government or an agency of a foreign government as an accredited third-party auditor, the accreditation body (or, in the case of direct accreditation under subsection (b)(1)(A)(ii), the Secretary) shall perform such reviews and audits of food safety programs, systems, and standards of the government or agency of the government as the Secretary deems necessary, including requirements under the model standards developed under subsection (b)(2), to determine that the foreign government or agency of the foreign government is capable of adequately ensuring that eligible entities or foods certified by such government or agency meet the requirements of this chapter with respect to food manufactured, processed, packed, or held for import into the United States.
(B) Foreign cooperatives and other third parties
Prior to accrediting a foreign cooperative that aggregates the products of growers or processors, or any other third party to be an accredited third-party auditor, the accreditation body (or, in the case of direct accreditation under subsection (b)(1)(A)(ii), the Secretary) shall perform such reviews and audits of the training and qualifications of audit agents used by that cooperative or party and conduct such reviews of internal systems and such other investigation of the cooperative or party as the Secretary deems necessary, including requirements under the model standards developed under subsection (b)(2), to determine that each eligible entity certified by the cooperative or party has systems and standards in use to ensure that such entity or food meets the requirements of this chapter.
(2) Requirement to issue certification of eligible entities or foods
(A) In general
An accreditation body (or, in the case of direct accreditation under subsection (b)(1)(A)(ii), the Secretary) may not accredit a third-party auditor unless such third-party auditor agrees to issue a written and, as appropriate, electronic food certification, described in section 381(q) of this title, or facility certification under section 384b(a) of this title, as appropriate, to accompany each food shipment for import into the United States from an eligible entity, subject to requirements set forth by the Secretary. Such written or electronic certification may be included with other documentation regarding such food shipment. The Secretary shall consider certifications under section 381(q) of this title and participation in the voluntary qualified importer program described in section 384b of this title when targeting inspection resources under section 350j of this title.
(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
An accredited third-party auditor shall issue a food certification under section 381(q) of this title or a facility certification described under subparagraph (B) only after conducting a regulatory audit and such other activities that may be necessary to establish compliance with the requirements of such sections.
(ii) Provision of certification
Only an accredited third-party auditor or the Secretary may provide a facility certification under section 384b(a) of this title. Only those parties described in 1 381(q)(3) of this title or the Secretary may provide a food certification under 1 381(q) 2 of this title.
(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
Following any accreditation of a third-party auditor, the Secretary may, at any time, require the accredited third-party auditor to submit to the Secretary an onsite audit report and such other reports or documents required as part of the audit process, for any eligible entity certified by the third-party auditor or audit agent of such auditor. Such report may include documentation that the eligible entity is in compliance with any applicable registration requirements.
(C) Limitation
The requirement under subparagraph (B) shall not include any report or other documents resulting from a consultative audit by the accredited third-party auditor, except that the Secretary may access the results of a consultative audit in accordance with section 350c of this title.
(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
An accredited third-party auditor or audit agent of such auditor may perform consultative and regulatory audits of eligible entities.
(C) Limitations
(i) In general
An accredited third party auditor may not perform a regulatory audit of an eligible entity if such agent has performed a consultative audit or a regulatory audit of such eligible entity during the previous 13-month period.
(ii) Waiver
The Secretary may waive the application of clause (i) if the Secretary determines that there is insufficient access to accredited third-party auditors in a country or region.
(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
The Secretary may withdraw accreditation from an accredited third-party auditor in the case that such third-party auditor is accredited by an accreditation body for which recognition as an accreditation body under subsection (b)(1)(C) is revoked, if the Secretary determines that there is good cause for the withdrawal.
(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
The Secretary shall establish by regulation a reimbursement (user fee) program, similar to the method described in section 1622(h) of title 7,2 by which the Secretary assesses fees and requires accredited third-party auditors and audit agents to reimburse the Food and Drug Administration for the work performed to establish and administer the accreditation system under this section. The Secretary shall make operating this program revenue-neutral and shall not generate surplus revenue from such a reimbursement mechanism. Fees authorized under this paragraph shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriation Acts. Such fees are authorized to remain available until expended.
(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 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 section 1001 of title 18.
(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
The Secretary shall establish a publicly available registry of accreditation bodies and of accredited third-party auditors, including the name of, contact information for, and other information deemed necessary by the Secretary about such bodies and auditors.
(h) Limitations
(1) No effect on section 374 inspections
The audits performed under this section shall not be considered inspections under section 374 of this title.
(2) No effect on inspection authority
Nothing in this section affects the authority of the Secretary to inspect any eligible entity pursuant to this chapter.
(June 25, 1938, ch. 675, § 808, as added Pub. L. 111–353, title III, § 307, Jan. 4, 2011, 124 Stat. 3959.)
heading: References in Text
text: Section 381(q) of this title, referred to in subsec. (c)(2)(C)(ii), was in the original “301(g)”, and was translated as reading “801(q)”, meaning section 801(q) of act June 25, 1938, ch. 675, which is classified to section 381(q) of this title, to reflect the probable intent of Congress, because section 381(q) of this title relates to food certification, whereas section 301(g) of act June 25, 1938, ch. 675, which is classified to section 331(g) of this title, does not relate to food certification.
Section 1622(h) of title 7, referred to in subsec. (c)(8), was in the original “section 203(h) of the Agriculture Marketing Act of 1946”, and was translated as reading “section 203(h) of the Agricultural Marketing Act of 1946”, meaning section 203(h) of act Aug. 14, 1946, ch. 966, which is classified to section 1622(h) of Title 7, Agriculture, to reflect the probable intent of Congress.
heading: Construction
text: Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.