21 U.S.C. § 350k — Laboratory accreditation for analyses of

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- Page 152 TITLE 21—FOOD AND DRUGS § 350l niques are followed and reports of analyses are certified as true and accurate; (ii) internal quality systems are estab- lished and maintained; (iii) procedures exist to evaluate and re- spond promptly to complaints regarding analyses and other activities for which the laboratory is accredited; and (iv) individuals who conduct the sam- pling and analyses are qualified by train- ing and experience to do so; and (B) any other criteria determined appro- priate by the Secretary. (7) Review of recognition To ensure compliance with the requirements of this section, the Secretary— (A) shall periodically, and in no case less than once every 5 years, reevaluate accredi- tation bodies recognized under paragraph (1) and may accompany auditors from an ac- creditation body to assess whether the ac- creditation body meets the criteria for rec- ognition; and (B) shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section, specifying, as appropriate, any terms and conditions necessary for labora- tories accredited by such body to continue to perform testing as described in this sec- tion. (b) Testing procedures (1) In general Not later than 30 months after January 4, 2011, food testing shall be conducted by Fed- eral laboratories or non-Federal laboratories that have been accredited for the appropriate sampling or analytical testing methodology or methodologies by a recognized accreditation body on the registry established by the Sec- retary under subsection (a)(1)(B) whenever such testing is conducted— (A) by or on behalf of an owner or con- signee— (i) in response to a specific testing re- quirement under this chapter or imple- menting regulations, when applied to ad- dress an identified or suspected food safety problem; and (ii) as required by the Secretary, as the Secretary deems appropriate, to address an identified or suspected food safety prob- lem; or (B) on behalf of an owner or consignee— (i) in support of admission of an article of food under section 381(a) of this title; and (ii) under an Import Alert that requires successful consecutive tests. (2) Results of testing The results of any such testing shall be sent directly to the Food and Drug Administration, except the Secretary may by regulation ex- empt test results from such submission re- quirement if the Secretary determines that such results do not contribute to the protec- tion of public health. Test results required to be submitted may be submitted to the Food and Drug Administration through electronic means. (3) Exception The Secretary may waive requirements under this subsection if— (A) a new methodology or methodologies have been developed and validated but a lab- oratory has not yet been accredited to per- form such methodology or methodologies; and (B) the use of such methodology or meth- odologies are necessary to prevent, control, or mitigate a food emergency or foodborne illness outbreak. (c) Review by Secretary If food sampling and testing performed by a laboratory run and operated by a State or local- ity that is accredited by a recognized accredita- tion body on the registry established by the Sec- retary under subsection (a) result in a State re- calling a food, the Secretary shall review the sampling and testing results for the purpose of determining the need for a national recall or other compliance and enforcement activities. (d) No limit on Secretarial authority Nothing in this section shall be construed to limit the ability of the Secretary to review and act upon information from food testing, includ- ing determining the sufficiency of such informa- tion and testing. (June 25, 1938, ch. 675, § 422, as added Pub. L. 111–353, title II, § 202(a), Jan. 4, 2011, 124 Stat. 3926.) 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. § 350l. Mandatory recall authority (a) Voluntary procedures If the Secretary determines, based on informa- tion gathered through the reportable food reg- istry under section 350f of this title or through any other means, that there is a reasonable probability that an article of food (other than infant formula) is adulterated under section 342 of this title or misbranded under section 343(w) of this title and the use of or exposure to such article will cause serious adverse health con- sequences or death to humans or animals, the Secretary shall provide the responsible party (as defined in section 350f of this title) with an op- portunity to cease distribution and recall such article. (b) Prehearing order to cease distribution and give notice (1) In general If the responsible party refuses to or does not voluntarily cease distribution or recall such article within the time and in the man- ner prescribed by the Secretary (if so pre- scribed), the Secretary may, by order require,