21 U.S.C. § 350j — Targeting of inspection resources for do-

Page 150 TITLE 21—FOOD AND DRUGS § 350j § 350j. Targeting of inspection resources for do- mestic facilities, foreign facilities, and ports of entry; annual report (a) Identification and inspection of facilities (1) Identification The Secretary shall identify high-risk facili- ties and shall allocate resources to inspect fa- cilities according to the known safety risks of the facilities, which shall be based on the fol- lowing factors: (A) The known safety risks of the food manufactured, processed, packed, or held at the facility. (B) The compliance history of a facility, including with regard to food recalls, out- breaks of foodborne illness, and violations of food safety standards. (C) The rigor and effectiveness of the fa- cility’s hazard analysis and risk-based pre- ventive controls. (D) Whether the food manufactured, proc- essed, packed, or held at the facility meets the criteria for priority under section 381(h)(1) of this title. (E) Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as de- scribed in section 381(q) or 384b of this title, as appropriate. (F) Any other criteria deemed necessary and appropriate by the Secretary for pur- poses of allocating inspection resources. (2) Inspections (A) In general Beginning on January 4, 2011, the Sec- retary shall increase the frequency of in- spection of all facilities. (B) Domestic high-risk facilities The Secretary shall increase the frequency of inspection of domestic facilities identified under paragraph (1) as high-risk facilities such that each such facility is inspected— (i) not less often than once in the 5-year period following January 4, 2011; and (ii) not less often than once every 3 years thereafter. (C) Domestic non-high-risk facilities The Secretary shall ensure that each do- mestic facility that is not identified under paragraph (1) as a high-risk facility is in- spected— (i) not less often than once in the 7-year period following January 4, 2011; and (ii) not less often than once every 5 years thereafter. (D) Foreign facilities (i) Year 1 In the 1-year period following January 4, 2011, the Secretary shall inspect not fewer than 600 foreign facilities. (ii) Subsequent years In each of the 5 years following the 1- year period described in clause (i), the Sec- retary shall inspect not fewer than twice the number of foreign facilities inspected by the Secretary during the previous year. (E) Reliance on Federal, State, or local in- spections In meeting the inspection requirements under this subsection for domestic facilities, the Secretary may rely on inspections con- ducted by other Federal, State, or local agencies under interagency agreement, con- tract, memoranda of understanding, or other obligation. (b) Identification and inspection at ports of entry The Secretary, in consultation with the Sec- retary of Homeland Security, shall allocate re- sources to inspect any article of food imported into the United States according to the known safety risks of the article of food, which shall be based on the following factors: (1) The known safety risks of the food im- ported. (2) The known safety risks of the countries or regions of origin and countries through which such article of food is transported. (3) The compliance history of the importer, including with regard to food recalls, out- breaks of foodborne illness, and violations of food safety standards. (4) The rigor and effectiveness of the activi- ties conducted by the importer of such article of food to satisfy the requirements of the for- eign supplier verification program under sec- tion 384a of this title. (5) Whether the food importer participates in the voluntary qualified importer program under section 384b of this title. (6) Whether the food meets the criteria for priority under section 381(h)(1) of this title. (7) Whether the food or the facility that manufactured, processed, packed, or held such food received a certification as described in section 381(q) or 384b of this title. (8) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources. (c) Interagency agreements with respect to sea- food (1) In general The Secretary of Health and Human Serv- ices, the Secretary of Commerce, the Sec- retary of Homeland Security, the Chairman of the Federal Trade Commission, and the heads of other appropriate agencies may enter into such agreements as may be necessary or ap- propriate to improve seafood safety. (2) Scope of agreements The agreements under paragraph (1) may in- clude— (A) cooperative arrangements for exam- ining and testing seafood imports that lever- age the resources, capabilities, and authori- ties of each party to the agreement; (B) coordination of inspections of foreign facilities to increase the percentage of im- ported seafood and seafood facilities in- spected; (C) standardization of data on seafood names, inspection records, and laboratory testing to improve interagency coordina- tion; Page 151 TITLE 21—FOOD AND DRUGS § 350k 1 So in original. Probably should be ‘‘subsection’’. (D) coordination to detect and investigate violations under applicable Federal law; (E) a process, including the use or modi- fication of existing processes, by which offi- cers and employees of the National Oceanic and Atmospheric Administration may be duly designated by the Secretary to carry out seafood examinations and investigations under section 381 of this title or section 203 of the Food Allergen Labeling and Consumer Protection Act of 2004; (F) the sharing of information concerning observed non-compliance with United States food requirements domestically and in for- eign nations and new regulatory decisions and policies that may affect the safety of food imported into the United States; (G) conducting joint training on subjects that affect and strengthen seafood inspec- tion effectiveness by Federal authorities; and (H) outreach on Federal efforts to enhance seafood safety and compliance with Federal food safety requirements. (d) Coordination The Secretary shall improve coordination and cooperation with the Secretary of Agriculture and the Secretary of Homeland Security to tar- get food inspection resources. (e) Facility For purposes of this section, the term ‘‘facil- ity’’ means a domestic facility or a foreign facil- ity that is required to register under section 350d of this title. (June 25, 1938, ch. 675, § 421, as added Pub. L. 111–353, title II, § 201(a), Jan. 4, 2011, 124 Stat. 3923.) Editorial Notes REFERENCES IN TEXT Section 203 of the Food Allergen Labeling and Con- sumer Protection Act of 2004, referred to in subsec. (c)(2)(E), is section 203 of Pub. L. 108–282, Aug. 2, 2004, 118 Stat. 906, which amended sections 321, 343, and 343–1 of this title and enacted provisions set out as notes under sections 321 and 343 of this title. 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. ADVISORY COMMITTEE CONSULTATION Pub. L. 111–353, title II, § 201(c), Jan. 4, 2011, 124 Stat. 3926, provided that: ‘‘In allocating inspection resources as described in section 421 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 450j] (as added by sub- section (a)), the Secretary may, as appropriate, consult with any relevant advisory committee within the De- partment of Health and Human Services.’’ § 350k. Laboratory accreditation for analyses of foods (a) Recognition of laboratory accreditation (1) In general Not later than 2 years after January 4, 2011, the Secretary shall— (A) establish a program for the testing of food by accredited laboratories; (B) establish a publicly available registry of accreditation bodies recognized by the Secretary and laboratories accredited by a recognized accreditation body, including the name of, contact information for, and other information deemed appropriate by the Sec- retary about such bodies and laboratories; and (C) require, as a condition of recognition or accreditation, as appropriate, that recog- nized accreditation bodies and accredited laboratories report to the Secretary any changes that would affect the recognition of such accreditation body or the accreditation of such laboratory. (2) Program requirements The program established under paragraph (1)(A) shall provide for the recognition of lab- oratory accreditation bodies that meet cri- teria established by the Secretary for accredi- tation of laboratories, including independent private laboratories and laboratories run and operated by a Federal agency (including the Department of Commerce), State, or locality with a demonstrated capability to conduct 1 or more sampling and analytical testing meth- odologies for food. (3) Increasing the number of qualified labora- tories The Secretary shall work with the labora- tory accreditation bodies recognized under paragraph (1), as appropriate, to increase the number of qualified laboratories that are eligi- ble to perform testing under subparagraph 1 (b) beyond the number so qualified on January 4, 2011. (4) Limited distribution In the interest of national security, the Sec- retary, in coordination with the Secretary of Homeland Security, may determine the time, manner, and form in which the registry estab- lished under paragraph (1)(B) is made publicly available. (5) Foreign laboratories Accreditation bodies recognized by the Sec- retary under paragraph (1) may accredit lab- oratories that operate outside the United States, so long as such laboratories meet the accreditation standards applicable to domestic laboratories accredited under this section. (6) Model laboratory standards The Secretary shall develop model standards that a laboratory shall meet to be accredited by a recognized accreditation body for a speci- fied sampling or analytical testing method- ology and included in the registry provided for under paragraph (1). In developing the model standards, the Secretary shall consult existing standards for guidance. The model standards shall include— (A) methods to ensure that— (i) appropriate sampling, analytical pro- cedures (including rapid analytical proce- dures), and commercially available tech-