21 U.S.C. § 384d — Accreditation of third-party auditors

Page 658 TITLE 21—FOOD AND DRUGS § 384c agreements to which the United States is a party, see sections 2251 and 2252 of this title. § 384c. Inspection of foreign food facilities (a) Inspection The Secretary— (1) may enter into arrangements and agree- ments with foreign governments to facilitate the inspection of foreign facilities registered under section 350d of this title; and (2) shall direct resources to inspections of foreign facilities, suppliers, and food types, es- pecially such facilities, suppliers, and food types that present a high risk (as identified by the Secretary), to help ensure the safety and security of the food supply of the United States. (b) Effect of inability to inspect Notwithstanding any other provision of law, food shall be refused admission into the United States if it is from a foreign factory, warehouse, or other establishment of which the owner, oper- ator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or other es- tablishment. For purposes of this subsection, such an owner, operator, or agent in charge shall be considered to have refused an inspection if such owner, operator, or agent in charge does not permit an inspection of a factory, ware- house, or other establishment during the 24-hour period after such request is submitted, or after such other time period, as agreed upon by the Secretary and the foreign factory, warehouse, or other establishment. (June 25, 1938, ch. 675, § 807, as added Pub. L. 111–353, title III, § 306(a), Jan. 4, 2011, 124 Stat. 3958.) Statutory Notes and Related Subsidiaries CONSTRUCTION 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 agree- ments to which the United States is a party, see sec- tions 2206, 2251, and 2252 of this title. § 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 individ- ually 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 au- thority that performs accreditation of third- party auditors. (3) Third-party auditor The term ‘‘third-party auditor’’ means a for- eign government, agency of a foreign govern- ment, foreign cooperative, or any other third party, as the Secretary determines appro- priate 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 enti- ties 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 consult- ative 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 eligi- ble entities to certify that such eligible enti- ties 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 chap- ter 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 im- port 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 chap- ter; and (B) the results of which determine— (i) whether an article of food manufac- tured, processed, packed, or held by such entity is eligible to receive a food certifi- cation under section 381(q) of this title; or (ii) whether a facility is eligible to re- ceive a facility certification under section 384b(a) of this title for purposes of partici- pating 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 sys- tem 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 de- Page 659 TITLE 21—FOOD AND DRUGS § 384d scribed in clause (i), the Secretary has not identified and recognized an accreditation body to meet the requirements of this sec- tion, 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 ac- credited by such body and the audit agents of such auditors. (C) Revocation of recognition as an accredi- tation body The Secretary shall promptly revoke the recognition of any accreditation body found not to be in compliance with the require- ments 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 stand- ards, including requirements for regulatory audit reports, and each recognized accredita- tion body shall ensure that third-party audi- tors and audit agents of such auditors meet such standards in order to qualify such third- party auditors as accredited third-party audi- tors under this section. In developing the model standards, the Secretary shall look to standards in place on January 4, 2011, for guid- ance, to avoid unnecessary duplication of ef- forts 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 accredi- tation body (or, in the case of direct accredi- tation under subsection (b)(1)(A)(ii), the Sec- retary) shall perform such reviews and au- dits of food safety programs, systems, and standards of the government or agency of the government as the Secretary deems nec- essary, including requirements under the model standards developed under subsection (b)(2), to determine that the foreign govern- ment or agency of the foreign government is capable of adequately ensuring that eligible entities or foods certified by such govern- ment or agency meet the requirements of this chapter with respect to food manufac- tured, processed, packed, or held for import into the United States. (B) Foreign cooperatives and other third par- ties 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 accredi- tation body (or, in the case of direct accredi- tation under subsection (b)(1)(A)(ii), the Sec- retary) shall perform such reviews and au- dits 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 sys- tems and standards in use to ensure that such entity or food meets the requirements of this chapter. (2) Requirement to issue certification of eligi- ble 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 ap- propriate, electronic food certification, de- scribed in section 381(q) of this title, or facil- ity 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 re- quirements set forth by the Secretary. Such written or electronic certification may be included with other documentation regard- ing such food shipment. The Secretary shall consider certifications under section 381(q) of this title and participation in the vol- untary 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 pro- vided by accredited third-party auditors to— (i) determine, in conjunction with any other assurances the Secretary may re- quire under section 381(q) of this title, whether a food satisfies the requirements of such section; and (ii) determine whether a facility is eligi- ble 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 certifi- cation described under subparagraph (B) only after conducting a regulatory audit and such other activities that may be nec- essary to establish compliance with the re- quirements 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 Page 660 TITLE 21—FOOD AND DRUGS § 384d 1 So in original. Probably should be followed by ‘‘section’’. 2 See References in Text note below. 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 Sec- retary, which shall include— (i) the identity of the persons at the au- dited eligible entity responsible for com- pliance 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 influ- ence 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 docu- ments 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 require- ments. (C) Limitation The requirement under subparagraph (B) shall not include any report or other docu- ments 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 sec- tion 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 accred- ited 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 imme- diately notify the Secretary of— (i) the identification of the eligible enti- ty 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 consult- ative and regulatory audits of eligible enti- ties. (C) Limitations (i) In general An accredited third party auditor may not perform a regulatory audit of an eligi- ble 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 applica- tion of clause (i) if the Secretary deter- mines that there is insufficient access to accredited third-party auditors in a coun- try 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 eli- gible entity to be certified by such audi- tor; (ii) in carrying out audits of eligible en- tities under this section, have procedures to ensure against the use of any officer or employee of such auditor that has a finan- cial conflict of interest regarding an eligi- ble entity to be certified by such auditor; and (iii) annually make available to the Sec- retary disclosures of the extent to which such auditor and the officers and employ- ees of such auditor have maintained com- pliance 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 en- tities 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 Sec- retary disclosures of the extent to which such agent has maintained compliance with clauses (i) and (ii) relating to finan- cial conflicts of interest. (C) Regulations The Secretary shall promulgate regula- tions not later than 18 months after January 4, 2011, to implement this section and to en- sure that there are protections against con- flicts 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 in- clude— (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 eli- gible entities to accredited third-party auditors; and (iii) appropriate limits on financial af- filiations between an accredited third- party auditor or audit agents of such audi- tor and any person that owns or operates an eligible entity to be certified by such auditor, as described in subparagraphs (A) and (B). Page 661 TITLE 21—FOOD AND DRUGS § 384d 3 So in original. Probably should be followed by ‘‘the’’. (6) Withdrawal of accreditation (A) In general The Secretary shall withdraw accredita- tion from an accredited third-party audi- tor— (i) if food certified under section 381(q) of this title or from a facility certified under paragraph (2)(B) by such third-party audi- tor is linked to an outbreak of foodborne illness that has a reasonable probability of causing serious adverse health con- sequences or death in humans or animals; (ii) following an evaluation and finding by the Secretary that the third-party audi- tor 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 en- sure continued compliance with the re- quirements set forth in this section. (B) Additional basis for withdrawal of ac- creditation The Secretary may withdraw accredita- tion 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 ma- terial 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 cer- tification and determines that the accred- ited third-party auditor satisfied the re- quirements under section 381(q) of this title of certifying the food, or the require- ments 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 with- drawn 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 ac- credited 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 ac- credited not later than 1 year after revoca- tion of accreditation under paragraph (6)(A), through direct accreditation under subsection (b)(1)(A)(ii) or by an accredita- tion body in good standing; or (ii) under such conditions as the Sec- retary may require for a third-party audi- tor 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 au- thorized under this paragraph shall be col- lected and available for obligation only to the extent and in the amount provided in advance in appropriation Acts. Such fees are author- ized to remain available until expended. (d) Recertification of eligible entities An eligible entity shall apply for annual recer- tification 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 en- tity 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 de- scribed in subsection (b)(1); (2) periodically, or at least once every 4 years, evaluate the performance of each ac- credited third-party auditor, through the re- view of regulatory audit reports by such audi- tors, the compliance history as available of el- igible 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 audi- tor present; and (4) take any other measures deemed nec- essary by the Secretary. (g) Publicly available registry The Secretary shall establish a publicly avail- able registry of accreditation bodies and of ac- credited third-party auditors, including the name of, contact information for, and other in- formation deemed necessary by the Secretary about such bodies and auditors. Page 662 TITLE 21—FOOD AND DRUGS § 384e (h) Limitations (1) No effect on section 374 inspections The audits performed under this section shall not be considered inspections under sec- tion 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.) Editorial Notes REFERENCES IN TEXT Section 381(q) of this title, referred to in subsec. (c)(2)(C)(ii), was in the original ‘‘301(g)’’, and was trans- lated 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 Con- gress, 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, Ag- riculture, to reflect the probable intent of Congress. Statutory Notes and Related Subsidiaries CONSTRUCTION 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 agree- ments to which the United States is a party, see sec- tions 2206, 2251, and 2252 of this title. § 384e. Recognition of foreign government in- spections (a) Inspection The Secretary— (1) may enter into arrangements and agree- ments with a foreign government or an agency of a foreign government to recognize the in- spection of foreign establishments registered under section 360(i) of this title in order to fa- cilitate preapproval or risk-based inspections in accordance with the schedule established in paragraph (2) or (3) of section 360(h) of this title; (2) may enter into arrangements and agree- ments with a foreign government or an agency of a foreign government under this section only with a foreign government or an agency of a foreign government that the Secretary has determined as having the capability of conducting inspections that meet the applica- ble requirements of this chapter; and (3) shall perform such reviews and audits of drug safety programs, systems, and standards of a foreign government or agency for the for- eign government as the Secretary deems nec- essary to determine that the foreign govern- ment or agency of the foreign government is capable of conducting inspections that meet the applicable requirements of this chapter. (b) Results of inspection The results of inspections performed by a for- eign government or an agency of a foreign gov- ernment under this section may be used as— (1) evidence of compliance with section 351(a)(2)(B) of this title or section 381(r) of this title; and (2) for any other purposes as determined ap- propriate by the Secretary. (c) Periodic review (1) In general Beginning not later than 1 year after Decem- ber 29, 2022, the Secretary shall periodically assess whether additional arrangements and agreements with a foreign government or an agency of a foreign government, as allowed under this section, are appropriate. (2) Reports to Congress Beginning not later than 4 years after De- cember 29, 2022, and every 4 years thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Rep- resentatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report describing the findings and conclu- sions of each review conducted under para- graph (1). (June 25, 1938, ch. 675, § 809, as added Pub. L. 112–144, title VII, § 712, July 9, 2012, 126 Stat. 1072; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(X), Dec. 13, 2016, 130 Stat. 1156; Pub. L. 115–52, title VII, § 701(b), Aug. 18, 2017, 131 Stat. 1055; Pub. L. 117–328, div. FF, title III, § 3613(c), Dec. 29, 2022, 136 Stat. 5872.) Editorial Notes AMENDMENTS 2022—Subsec. (a)(1). Pub. L. 117–328, § 3613(c)(1), in- serted ‘‘preapproval or’’ before ‘‘risk-based inspec- tions’’. Subsec. (c). Pub. L. 117–328, § 3613(c)(2), added subsec. (c). 2017—Subsec. (a)(1). Pub. L. 115–52 substituted ‘‘para- graph (2) or (3) of section 360(h)’’ for ‘‘section 360(h)(3)’’. 2016—Subsec. (a)(2). Pub. L. 114–255 substituted ‘‘con- ducting’’ for ‘‘conduction’’. § 384f. Strengthening FDA and CBP coordination and capacity (a) In general The Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’), acting through the Commissioner of Food and Drugs, shall coordinate with the Secretary of Homeland Security to carry out activities re- lated to customs and border protection and in response to illegal controlled substances and drug imports, including at sites of import (such as international mail facilities), that will pro- vide improvements to such facilities, tech- nologies, and inspection capacity. Such Secre- taries may carry out such activities through a memorandum of understanding between the Food and Drug Administration and the U.S. Cus- toms and Border Protection. (b) FDA import facilities and inspection capacity (1) In general In carrying out this section, the Secretary shall, in collaboration with the Secretary of