USC Chapter 6a

in effect

7 U.S.C. § 138 Definitions

As used in this chapter: (1) Agricultural productThe term “agricultural product” means any fresh fruit or vegetable or any commodity or product derived from livestock or fowl, that is marketed in the United States for human consumption. (2) CertificateThe term “certificate” means a certificate of accreditation issued under this chapter. (3) LaboratoryThe term “laboratory” means any facility or vehicle that is owned by an individual or a public or private entity and is equipped and operated for the purpose of carrying out pesticide residue analysis on agricultural products for commercial purposes. (4) PesticideThe term “pesticide” means any substance that alone, in chemical combination, or in any formulation with one or more substances, is defined as a pesticide in section 136(u) of this title. (5) SecretaryThe term “Secretary” means the Secretary of Agriculture.

7 U.S.C. § 138a National Laboratory Accreditation Program

(a) Establishment of ProgramThe Secretary shall administer a National Laboratory Accreditation Program under which laboratories that request accreditation and conduct residue testing of agricultural products, or that make claims to the public or buyers of agricultural products concerning chemical residue levels on agricultural products, shall be determined to meet certain minimum quality and reliability standards. (b) StandardsThe 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 11 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 bodiesThe 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) RequirementsTo 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) ExceptionsThis 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.

7 U.S.C. § 138b Accreditation

(a) In generalThe Secretary shall issue certificates of accreditation to laboratories that meet the requirements of this chapter, as determined by the Secretary. (b) Requirements for accreditationTo receive accreditation under this chapter, a laboratory shall prepare and submit an application for accreditation to the Secretary and shall complete such required tests, and meet such standards as established under section 138a of this title. (c) Failure to meet accreditation standardsThe Secretary shall deny an application for accreditation or shall revoke any existing accreditation with respect to any laboratory that fails to meet the requirements for accreditation under this chapter. (d) Limited accreditationThe Secretary may issue certificates of accreditation to laboratories that are limited to specific fields of testing.

7 U.S.C. § 138c Samples

(a) Performance evaluation samples(1) Provided by SecretaryThe Secretary shall ensure that performance evaluation samples are provided to any laboratory that has applied for accreditation under this chapter. (2) Analysis by laboratoryA laboratory described in paragraph (1) shall analyze such performance evaluation samples and submit the results of such analysis to the Secretary, as provided for in section 138a of this title. (3) Testing methodsSamples shall be tested by the laboratory according to methods specifically approved for such purpose by alternate methods of demonstrated adequacy or equivalence, as determined in regulations established under this chapter. (b) Results of testing(1) Submission of resultsThe laboratory shall submit the results of the tests conducted under subsection (a) to the Secretary on forms provided by the Secretary, on or before the date determined by the Secretary. (2) Evaluation of testsThe Secretary shall evaluate the results of such tests achieved by the laboratory and shall determine whether such laboratory is capable of undertaking an accurate analysis of chemical residues in agricultural products. (c) Review of accreditationThe Secretary shall ensure that performance evaluation samples for analysis are provided to laboratories accredited under this chapter not less than two times a year.

7 U.S.C. § 138d Application

(a) Contents of applicationAn 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 applicationA laboratory that has been denied, or has lost, accreditation under this chapter shall not reapply for accreditation until the expiration of at least 6 months after such denial or loss of accreditation. Corrective actions taken by the laboratory to address deficiencies upon which the denial or loss of accreditation was based must accompany the reapplication.

7 U.S.C. § 138e Reporting

(a) In generalEach 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 reportA laboratory shall submit the report required under subsection (a) to the Secretary, the Secretary of Health and Human Services, and the owner of such food as soon as practicable after the completion of the analysis of such food. (c) GuidelinesThe Secretary shall adopt standardized reporting guidelines to be applied to laboratories under this section and shall provide such guidelines to laboratories accredited under this chapter, as well as other sources of information regarding applicable pesticide chemical tolerances.

7 U.S.C. § 138f Fees

(a) In generalAt the time that an application for accreditation is received by the Secretary and annually thereafter, a laboratory seeking accreditation by the Secretary under the authority of this chapter, the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), or the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) shall pay to the Secretary a nonrefundable accreditation fee. All fees collected by the Secretary shall be credited to the account from which the expenses of the laboratory accreditation program are paid and, subject to subsection (e), shall be available immediately and remain available until expended to pay the expenses of the laboratory accreditation program. (b) Amount of feeThe fee required under this section shall be established by the Secretary in an amount that will offset the cost of the laboratory accreditation programs administered by the Secretary under the statutory authorities set forth in subsection (a). (c) Reimbursement of expensesEach laboratory that is accredited under a statutory authority set forth in subsection (a) or that has applied for accreditation under such authority shall reimburse the Secretary for reasonable travel and other expenses necessary to perform onsite inspections of the laboratory. (d) Adjustment of feesThe Secretary may, on an annual basis, adjust the fees imposed under this section as necessary to support the full costs of the laboratory accreditation programs carried out under the statutory authorities set forth in subsection (a). (e) Appropriations prerequisiteNo fees collected under this section may be used to offset the cost of laboratory accreditation without appropriations made under subsection (f). (f) Authorization of appropriationsThere are authorized to be appropriated each fiscal year such sums as may be necessary for laboratory accreditation services under this section.

7 U.S.C. § 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.

7 U.S.C. § 138h Regulations

The Secretary shall promulgate regulations to carry out this chapter.

7 U.S.C. § 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.).