40 CFR 60.535 – What procedures must I use for EPA approval of a test laboratory or EPA approval of a third-party certifier?
(a) Test laboratory approval. (1) A laboratory must apply to the Administrator for approval to test under this rule by submitting documentation that the laboratory is accredited by a nationally recognized accrediting entity under ISO-IEC Standard 17025 to perform testing using the test methods specified under § 60.534. Laboratories accredited by EPA prior to May 15, 2015 may have until March 16, 2018 to submit documentation that they have accreditation under ISO-IEC Standard 17025 to perform testing using the test methods specified under § 60.534. ISO accreditation is required for all other laboratories performing testing beginning on November 16, 2015.
(2) As part of the application, the test laboratory must:
(i) Agree to participate biennially in an independently operated proficiency testing program with no direct ties to the participating laboratories;
(ii) Agree to allow the Administrator, regulatory agencies and third-party certifiers access to observe certification testing;
(iii) Agree to comply with calibration, reporting and recordkeeping requirements that affect testing laboratories; and
(iv) Agree to perform a compliance audit test at the manufacturer’s expense at the testing cost normally charged to such manufacturer if the laboratory is selected by the Administrator to conduct the compliance audit test of the manufacturer’s model line. The test laboratory must provide a preliminary audit test report to the Administrator within 14 days of the completion of testing, if the tested wood heater exceeds the applicable emission limit in § 60.532. The test laboratory must provide the Administrator and the manufacturer, within 30 days of the completion of audit testing, all documentation pertaining to the test, including the complete test report and raw data sheets, laboratory technician notes, and test results for all test runs.
(v) Have no conflict of interest and receive no financial benefit from the outcome of certification testing conducted pursuant to § 60.533.
(vi) Agree to not perform initial certification tests on any models manufactured by a manufacturer for which the laboratory has conducted research and development design services within the last 5 years.
(vii) Agree to seal any wood heater on which it performed certification tests, immediately upon completion or suspension of certification testing, by using a laboratory-specific seal.
(viii) Agree to immediately notify the Administrator of any suspended tests through email and in writing, giving the date suspended, the reason(s) why, and the projected date for restarting. The laboratory must submit the operation and test data obtained, even if the test is not completed.
(3) If the EPA approves the laboratory, the Administrator will provide the test laboratory with a certificate of approval for testing under this rule. If the EPA does not approve the laboratory, the Administrator will give written notice to the laboratory setting forth the basis for the determination.
(b) Revocation of test laboratory approval. (1) The Administrator may revoke the EPA laboratory approval if it is determined that the laboratory:
(i) Is no longer accredited by the accreditation body;
(ii) Does not follow required procedures or practices;
(iii) Has falsified data or otherwise misrepresented emission data;
(iv) Has failed to participate in a proficiency testing program, in accordance with its commitment under paragraph (a)(2)(i) of this section; or
(v) Has failed to seal a wood heater in accordance with paragraph (a)(2)(vii) of this section.
(2) Revocation of approval under this paragraph (b) will not take effect until the laboratory concerned has been given written notice by the Administrator setting forth the basis for the proposed determination and an opportunity for a hearing under § 60.539. However, if revocation is ultimately upheld, all tests conducted by the laboratory after written notice was given will, at the discretion of the Administrator, be declared invalid.
(c) Period of test laboratory approval (1) With the exception of laboratories meeting the provisions of paragraph (c)(2) of this section, and unless revoked sooner, a certificate of approval for testing under this rule is valid for 5 years from the date of issuance.
(2) Laboratories accredited by the EPA by May 15, 2015, under the provisions of § 60.535 as in effect prior to that date may continue to be EPA accredited and deemed EPA approved for testing under this subpart until May 15, 2018, at which time the EPA accreditation and approval ends unless the laboratory has obtained accreditation under § 60.535 as in effect on that date.
(d) Third-party certifier approval. (1) A third-party certifier may apply to the Administrator for approval to be an EPA-approved third-party certifier by submitting credentials demonstrating that it has been accredited by a nationally recognized accrediting entity to perform certifications and inspections under ISO-IEC Standard 17025, ISO-IEC Standard 17065 and ISO-IEC Standard 17020.
(2) As part of the application, the third-party certifier must:
(i) Agree to offer to contract with wood heater manufacturers to perform third-party certification activities according to the requirements of this subpart;
(ii) Agree to periodically conduct audits as described in § 60.533(m) and the manufacturer’s quality assurance program;
(iii) Agree to comply with reporting and recordkeeping requirements that affect approved wood heater testing laboratories and third-party certifiers;
(iv) Have no conflict of interest and receive no financial benefit from the outcome of certification testing conducted pursuant to § 60.533;
(v) Agree to make available to the Administrator supporting documentation for each wood heater certification and audit; and
(vi) Agree to not perform initial certification reviews on any models manufactured by a manufacturer for which the third-party certifier has conducted research and development design services within the last 5 years.
(3) If approved, the Administrator will provide the third-party certifier with a certificate of approval. The approval will expire 5 years after being issued unless renewed by the third-party certifier. If the EPA denies the approval, the Administrator will give written notice to the third-party certifier for the basis for the determination.
(e) Revocation of third-party certifier approval. (1) The Administrator will revoke a third-party certifier’s EPA approval if it is determined that the certifier;
(i) Is no longer accredited by the accreditation body;
(ii) Does not follow required procedures or practices; or
(iii) Has falsified certification data or otherwise misrepresented emission data.
(2) Revocation of approval under this paragraph (e) will not take effect until the certifier concerned is given written notice by the Administrator setting forth the basis for the proposed determination and an opportunity for a hearing under § 60.539. However, if revocation is upheld, all certifications by the certifier after written notice was given will, at the discretion of the Administrator, be declared invalid.