124 STAT. 3960 PUBLIC LAW 111–353—JAN. 4, 2011 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 sec- tion. 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 ‘accred- ited 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 require- ments 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 Act 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 sec- tion 415, 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 Act; and ‘‘(B) the results of which determine— ‘‘(i) whether an article of food manufactured, proc- essed, packed, or held by such entity is eligible to receive a food certification under section 801(q); or ‘‘(ii) whether a facility is eligible to receive a facility certification under section 806(a) for purposes of participating in the program under section 806. ‘‘(b) ACCREDITATION SYSTEM.— ‘‘(1) ACCREDITATION BODIES.— ‘‘(A) RECOGNITION OF ACCREDITATION BODIES.— ‘‘(i) IN GENERAL.—Not later than 2 years after the date of enactment of the FDA Food Safety Mod- ernization Act, 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 recog- nized by the Secretary shall submit to the Secretary a Deadline.
