06-096-263 Me. Code R. § 3

Current through 2024-51, December 18, 2024
Section 096-263-3 - METHODS REQUIRED FOR ACCREDITATION
A.Scope
1. The laboratory must use appropriate methods and procedures for all tests within its scope. These methods and procedures include sampling, handling, transport, storage and preparation of samples as well as statistical techniques for analysis of test data.
2. The laboratory must retain instructions on the use and operation of all relevant equipment and on the handling and preparation of samples. All instructions, standards, manuals and reference data relevant to the work of the laboratory must accurately reflect method requirements, must be kept current, and must be made readily available to personnel. Deviations from test methods may occur only if the deviation has been documented, technically justified, authorized, accepted by the client, and allowed by regulation. Deviations from Drinking Water methods are not permitted.
3. Laboratories must observe appropriate methodologies for conducting analyses.
B.Wastewater Program
1. Methods for the Wastewater Program test category are as provided in 40 Code of Federal Regulations (CFR) Part 136, including 40 CFR § 136.3, Tables IA, IB, IC and ID; §136.4; §136.5; §136, Appendices A, B, and C; and 40 CFR Part 503 , updated in the Annual Edition of July 1, 2022. The CFR is available online at the website of the US Government Publishing Office, Code of Federal Regulations (Annual Edition). The Federal Register is available online by searching the citation.
2. Unless prohibited by a federal regulation, alternative methods may be used for Maine-specific testing if the state agency administering the permit, program or rule grants written approval, citing the laboratory's name and the title, revision date and revision number of the procedure that is receiving DEP approval. Alternative methods include any methods approved by EPA after the date of the federal regulations cited in Section 3(B)(1) of this rule.
3. The laboratory must submit a copy of the approval for alternative methods to the accreditation officer, along with an application, as required under Section 4 and fees as required under Section 6.
a. The laboratory must validate standard methods used outside its published scope to confirm that the methods are appropriate for the intended use.
b. Modifications to methods are allowed, only if the modified method produces equivalent performance for the analyte(s) of interest, as determined by the accreditation officer, and the equivalent performance is documented.
C.Drinking Water Program
1. Methods for the Drinking Water Program test category are in 40 CFR Part 141 , including Subpart C, Appendix A and 40 CFR §§ 141.21(f), 141.23(k), 141.24(e), 141.131(b), 141.131(c), 141.131(d), 141.74(a), and 40 CFR § 143.4(b) updated in the Annual Edition of July 1, 2022.
2. Unless prohibited by a federal regulation, alternative methods may be used for Maine-specific testing, if the state agency administering the permit, program or rule grants written approval that cites the laboratory's name and the title, revision date and revision number of the procedure receiving DHHS approval. Alternative methods include any methods approved by EPA after the date of the federal regulations cited in Section 3(C)(1) of this rule.
D.Resource Conservation Recovery Program
1. Methods for the Resource Conservation Recovery Program test category are as provided under 40 CFR Part 261, as amended up to July 1, 2022, and "Test Methods for Evaluating Solid Waste: Physical/Chemical Methods," Publication SW-846 and the Methods Innovation Rule, 40 CFR Parts 63, 258, 260, 261, 264, 265, 266, 268, 270, 271 and 279, updated in the Annual Edition of July 1, 2022.
2. In the absence of an applicable federal regulation, alternative methods may be used for Maine-specific testing if the Maine state agency administering the permit, program or rule grants written approval, citing the laboratory's name and the title, revision date and revision number of the procedure that is receiving DEP approval.
3. The laboratory must submit a copy of the approval of alternate methods to the accreditation officer, along with an application, as required under Section 4 and fees as required under Section 6.
a. The laboratory must validate methods used outside its published scope to confirm that the methods are fit for the intended use.
b. Modifications to methods are allowed only if the modified method produces equivalent performance for the analyte(s) of interest, as determined by the accreditation officer, and the equivalent performance is documented.
E.Oil Program or Leaking Underground Storage Tanks (LUST) Program
1. The laboratory must be accredited under this rule for organic compounds analysis in either the Wastewater Program or Resource Conservation and Recovery Program.
2. In the absence of an applicable federal regulation, alternative methods may be used for Maine-specific testing, if the Maine State agency administering the permit, program or rule grants written approval that cites the laboratory's name and the title, revision date and revision number of the procedure receiving DEP approval.
F.Environmental Lead Program
1. A certificate will be issued to any laboratory providing documentation of accreditation through a program recognized by the EPA's National Lead Laboratory Accreditation Program (NLLAP).
2. In the absence of an applicable federal regulation, alternative methods may be used for Maine-specific testing, if the Maine State agency administering the permit, program, or rule grants written approval that cites the laboratory's name and the title, revision date and revision number of the procedure receiving agency approval.
G.Other required methods

The analytical methods, as well as the verification of preservation procedures used for samples required to be analyzed under a permit, program or rule administered by a Maine State agency must meet the requirements specified by the permit, program or rule.

06-096 C.M.R. ch. 263, § 3