View all text of Chapter 6 A [§ 138 - § 138i]
§ 138a. National Laboratory Accreditation Program
(a) Establishment of Program
(b) Standards
The Secretary of Health and Human Services, after consultation with the Secretary and the Administrator of the Environmental Protection Agency, shall establish, through regulations, standards for the National Laboratory Accreditation program 1
1 So in original. Probably should be capitalized.
that shall include—(1) standards applicable to laboratories;
(2) qualifications for directors and other personnel; and
(3) standards and procedures for quality assurance programs.
(c) Accrediting bodies
The Secretary of Health and Human Services shall approve State agencies or private, nonprofit entities as accrediting bodies to act on behalf of such Secretary in implementing the certification and quality assurance programs in accordance with the requirements of this section. In making such approvals the Secretary of Health and Human Services shall—
(1) oversee and review the performance of any accrediting body acting on behalf of the Secretary to ensure that such accrediting body is in compliance with the requirements of the certification program under this section; and
(2) have the right to obtain from an accrediting body acting on behalf of the Secretary and from any laboratory that may be certified by such a body all records and materials that may be necessary for the oversight and review required by paragraph (1).
(d) Requirements
To be accredited under this chapter, a laboratory shall—
(1) prepare and submit an application for accreditation to the Secretary; and
(2) comply with such terms and conditions as are determined necessary by the Secretary and the Secretary of Health and Human Services.
(e) Exceptions
This chapter shall not apply to—
(1) a laboratory operated by a government agency;
(2) a laboratory operated by a corporation that only performs analysis of residues on agricultural products for such corporation or any wholly owned subsidiary of such corporation and does not make claims to the public or buyers based on such analysis;
(3) a laboratory operated by a partnership that only performs analysis of residues on agricultural products for the partners of such partnership and does not make claims to the public or buyers based on such analysis; or
(4) a laboratory not operated for commercial purposes that performs pesticide chemical residue analysis on agricultural products for research or quality control for the internal use of a person who is initiating the analysis.
(Pub. L. 101–624, title XIII, § 1322, Nov. 28, 1990, 104 Stat. 3562.)