Page:United States Statutes at Large Volume 124.djvu/3953

 124 STAT. 3927 PUBLIC LAW 111–353—JAN. 4, 2011 accredited by a recognized accreditation body, including the name of, contact information for, and other information deemed appropriate by the Secretary about such bodies and laboratories; and ‘‘(C) require, as a condition of recognition or accredita- tion, as appropriate, that recognized accreditation bodies and accredited laboratories report to the Secretary any changes that would affect the recognition of such accredita- tion body or the accreditation of such laboratory. ‘‘(2) PROGRAM REQUIREMENTS.—The program established under paragraph (1)(A) shall provide for the recognition of laboratory accreditation bodies that meet criteria established by the Secretary for accreditation of laboratories, including independent private laboratories and laboratories run and oper- ated by a Federal agency (including the Department of Com- merce), State, or locality with a demonstrated capability to conduct 1 or more sampling and analytical testing methodolo- gies for food. ‘‘(3) INCREASING THE NUMBER OF QUALIFIED LABORA- TORIES.—The Secretary shall work with the laboratory accredi- tation bodies recognized under paragraph (1), as appropriate, to increase the number of qualified laboratories that are eligible to perform testing under subparagraph (b) beyond the number so qualified on the date of enactment of the FDA Food Safety Modernization Act. ‘‘(4) LIMITED DISTRIBUTION.—In the interest of national security, the Secretary, in coordination with the Secretary of Homeland Security, may determine the time, manner, and form in which the registry established under paragraph (1)(B) is made publicly available. ‘‘(5) FOREIGN LABORATORIES.—Accreditation bodies recog- nized by the Secretary under paragraph (1) may accredit labora- tories 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 specified sampling or analytical testing methodology and included in the registry provided for under paragraph (1). In developing the model standards, the Secretary shall consult existing stand- ards for guidance. The model standards shall include— ‘‘(A) methods to ensure that— ‘‘(i) appropriate sampling, analytical procedures (including rapid analytical procedures), and commer- cially available techniques are followed and reports of analyses are certified as true and accurate; ‘‘(ii) internal quality systems are established and maintained; ‘‘(iii) procedures exist to evaluate and respond promptly to complaints regarding analyses and other activities for which the laboratory is accredited; and ‘‘(iv) individuals who conduct the sampling and analyses are qualified by training and experience to do so; and ‘‘(B) any other criteria determined appropriate by the Secretary.