Page:United States Statutes at Large Volume 124.djvu/3991

 124 STAT. 3965 PUBLIC LAW 111–353—JAN. 4, 2011 ‘‘(ii) reviews the steps or actions taken by the third party auditor to justify the certification and deter- mines that the accredited third-party auditor satisfied the requirements under section 801(q) 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shall establish procedures to reinstate the accreditation of a third-party auditor for which accreditation has been withdrawn under paragraph (6)— ‘‘(A) if the Secretary determines, based on evidence presented, that the third-party auditor satisfies the require- ments of this section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 203(h) of the Agriculture Mar- keting Act of 1946, 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 rev- enue from such a reimbursement mechanism. Fees authorized under this paragraph shall be collected and available for obliga- tion only to the extent and in the amount provided in advance in appropriation Acts. Such fees are authorized to remain avail- able 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 voluntary qualified importer program under section 806; or ‘‘(2) is required to provide to the Secretary a certification under section 801(q) 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, United States Code. ‘‘(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); Deadlines. Applicability. Regulations. Deadline. Procedures.