Collapse to view only § 138d. Application
- § 138. Definitions
- § 138a. National Laboratory Accreditation Program
- § 138b. Accreditation
- § 138c. Samples
- § 138d. Application
- § 138e. Reporting
- § 138f. Fees
- § 138g. Public disclosure
- § 138h. Regulations
- § 138i. Effect of other laws
§ 138. Definitions
As used in this chapter:
(1) Agricultural product
(2) Certificate
(3) Laboratory
(4) Pesticide
(5) Secretary
(Pub. L. 101–624, title XIII, § 1321, Nov. 28, 1990, 104 Stat. 3562.)
§ 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.)
§ 138b. Accreditation
(a) In general
(b) Requirements for accreditation
(c) Failure to meet accreditation standards
(d) Limited accreditation
(Pub. L. 101–624, title XIII, § 1323, Nov. 28, 1990, 104 Stat. 3563.)
§ 138c. Samples
(a) Performance evaluation samples
(1) Provided by Secretary
(2) Analysis by laboratory
(3) Testing methods
(b) Results of testing
(1) Submission of results
(2) Evaluation of tests
(c) Review of accreditation
(Pub. L. 101–624, title XIII, § 1324, Nov. 28, 1990, 104 Stat. 3564.)
§ 138d. Application
(a) Contents of application
An application for accreditation under this chapter shall be prepared and submitted to the Secretary and shall include—
(1) the name and address of the laboratory;
(2) the name and address of the owners and managers of such laboratory;
(3) a statement concerning the type of analysis the laboratory intends to conduct;
(4) a brief history of the laboratory and its previous operations; and
(5) such other information as may be required by the Secretary.
(b) Restrictions on submission of application
(Pub. L. 101–624, title XIII, § 1325, Nov. 28, 1990, 104 Stat. 3564.)
§ 138e. Reporting
(a) In general
Each laboratory or individual that performs, brokers, or otherwise arranges for the performance of a pesticide chemical analysis of food shall prepare and submit a report, simultaneously to the Secretary, the Secretary of Health and Human Services, and to the owner of such food, that shall contain any finding of pesticide chemical residues in such food—
(1) for which no chemical residue tolerance or exemption has been established;
(2) that is in excess of residue tolerances; or
(3) for which the chemical residue tolerance has been revoked or the chemical residue is otherwise not permitted by the Environmental Protection Agency.
(b) Timing of report
(c) Guidelines
(Pub. L. 101–624, title XIII, § 1326, Nov. 28, 1990, 104 Stat. 3565.)
§ 138f. Fees
(a) In general
(b) Amount of fee
(c) Reimbursement of expenses
(d) Adjustment of fees
(e) Appropriations prerequisite
(f) Authorization of appropriations
(Pub. L. 101–624, title XIII, § 1327, Nov. 28, 1990, 104 Stat. 3565; Pub. L. 102–237, title X, § 1017, Dec. 13, 1991, 105 Stat. 1904.)
§ 138g. Public disclosure
The results of the evaluations of laboratories conducted by the Secretary under this chapter shall be made available to the Secretary of Health and Human Services and to the public on request.
(Pub. L. 101–624, title XIII, § 1328, Nov. 28, 1990, 104 Stat. 3565.)
§ 138h. Regulations
The Secretary shall promulgate regulations to carry out this chapter.
(Pub. L. 101–624, title XIII, § 1329, Nov. 28, 1990, 104 Stat. 3565.)
§ 138i. Effect of other laws
Nothing in this chapter shall alter the authority of the Secretary of Health and Human Services under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(Pub. L. 101–624, title XIII, § 1330, Nov. 28, 1990, 104 Stat. 3565.)