Page:United States Statutes at Large Volume 124.djvu/3990

 124 STAT. 3964 PUBLIC LAW 111–353—JAN. 4, 2011 ‘‘(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 main- tained 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 the date of enactment of the FDA Food Safety Modernization Act to implement this section and to ensure that there are protec- tions 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 con- flicts 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 801(q) 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 ACCREDITA- TION.—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 sub- section (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 Waiver authority. Deadline. Deadline.