21 U.S.C. § 384b — Voluntary qualified importer program

Page 657 TITLE 21—FOOD AND DRUGS § 384b 2 So in original. Probably should be ‘‘title’’. (2) The Juice Hazard Analysis Critical Con- trol Points Program of the Food and Drug Ad- ministration. (3) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Con- tainers standards of the Food and Drug Ad- ministration (or any successor standards). The exemption under paragraph (3) shall apply only with respect to microbiological hazards that are regulated under the standards for Ther- mally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers under part 113 of chapter 2 21, Code of Federal Regulations (or any successor regulations). (f) Additional exemptions The Secretary, by notice published in the Fed- eral Register, shall establish an exemption from the requirements of this section for articles of food imported in small quantities for research and evaluation purposes or for personal con- sumption, provided that such foods are not in- tended for retail sale and are not sold or distrib- uted to the public. (g) Publication of list of participants The Secretary shall publish and maintain on the Internet Web site of the Food and Drug Ad- ministration a current list that includes the name of, location of, and other information deemed necessary by the Secretary about, im- porters participating under this section. (June 25, 1938, ch. 675, § 805, as added Pub. L. 111–353, title III, § 301(a), Jan. 4, 2011, 124 Stat. 3953.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective 2 years after Jan. 4, 2011, see section 301(d) of Pub. L. 111–353, set out as an Effective Date of 2011 Amendment note under section 331 of this title. 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. § 384b. Voluntary qualified importer program (a) In general Beginning not later than 18 months after Jan- uary 4, 2011, the Secretary shall— (1) establish a program, in consultation with the Secretary of Homeland Security— (A) to provide for the expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate in such program; and (B) consistent with section 384d of this title, establish a process for the issuance of a facility certification to accompany food offered for importation by importers who have voluntarily agreed to participate in such program; and (2) issue a guidance document related to par- ticipation in, revocation of such participation in, reinstatement in, and compliance with, such program. (b) Voluntary participation An importer may request the Secretary to pro- vide for the expedited review and importation of designated foods in accordance with the pro- gram established by the Secretary under sub- section (a). (c) Notice of intent to participate An importer that intends to participate in the program under this section in a fiscal year shall submit a notice and application to the Secretary of such intent at the time and in a manner es- tablished by the Secretary. (d) Eligibility Eligibility shall be limited to an importer of- fering food for importation from a facility that has a certification described in subsection (a). In reviewing the applications and making deter- minations on such applications, the Secretary shall consider the risk of the food to be im- ported based on factors, such as the following: (1) The known safety risks of the food to be imported. (2) The compliance history of foreign sup- pliers used by the importer, as appropriate. (3) The capability of the regulatory system of the country of export to ensure compliance with United States food safety standards for a designated food. (4) The compliance of the importer with the requirements of section 384a of this title. (5) The recordkeeping, testing, inspections and audits of facilities, traceability of articles of food, temperature controls, and sourcing practices of the importer. (6) The potential risk for intentional adul- teration of the food. (7) Any other factor that the Secretary de- termines appropriate. (e) Review and revocation Any importer qualified by the Secretary in ac- cordance with the eligibility criteria set forth in this section shall be reevaluated not less often than once every 3 years and the Secretary shall promptly revoke the qualified importer status of any importer found not to be in compliance with such criteria. (f) False statements Any statement or representation made by an importer to the Secretary shall be subject to section 1001 of title 18. (g) Definition For purposes of this section, the term ‘‘im- porter’’ means the person that brings food, or causes food to be brought, from a foreign coun- try into the customs territory of the United States. (June 25, 1938, ch. 675, § 806, as added Pub. L. 111–353, title III, § 302, Jan. 4, 2011, 124 Stat. 3955.) Statutory Notes and Related Subsidiaries CONSTRUCTION Nothing in this section to be construed to alter juris- diction and authorities established under certain other Acts or in a manner inconsistent with international 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-