18 AAC 80.1100 - Laboratory certification

Current through April 6, 2022

(a) To meet the applicable analytical requirements of this chapter, analyses for inorganic, organic, radioactive, and microbiological contaminants must be performed by a laboratory holding, for the analytical method to be employed, valid certification from the department in one of the following classifications:
(1) full certification under (c)(1) of this section;
(2) interim certification under (c)(2) of this section;
(3) provisional certification under (c)(3) of this section;
(4) certification under (d) of this section of a laboratory holding certification by another certifying agency.
(b) Except as provided in (d) of this section, the department will certify a laboratory for an analytical method if the laboratory
(1) submits, in a format specified by the department, a complete application for certification specifying each method for which the laboratory wishes to be certified, along with each applicable fee under 18 AAC 80.1110;
(2) demonstrates to the department that the laboratory meets the minimum standards listed in the Manual for the Certification of Laboratories Analyzing Drinking Water: Criteria and Procedures, Quality Assurance, adopted by reference in 18 AAC 80.010(b);
(3) submits to the department the results of annual proficiency testing showing that the laboratory correctly analyzed proficiency testing samples for each method being certified; the testing samples shall be purchased by that laboratory from a supplier acceptable to the department; and
(4) submits to the department for review and approval a quality assurance plan that complies with the Manual for the Certification of Laboratories Analyzing Drinking Water: Criteria and Procedures, Quality Assurance, adopted by reference in 18 AAC 80.010(b).
(c) The department will give a laboratory that meets the requirements of (b) of this section
(1) certification for one or more methods, if
(A) the department determines that the laboratory meets each applicable criterion for that method in the Manual for the Certification of Laboratories Analyzing Drinking Water: Criteria and Procedures, Quality Assurance, adopted by reference in 18 AAC 80.010(b); and
(B) the laboratory has passed an onsite inspection under 18 AAC 80.1105;
(2) interim certification for one or more methods, if
(A) the department determines that the laboratory meets each applicable criterion for that method in the Manual for the Certification of Laboratories Analyzing Drinking Water: Criteria and Procedures, Quality Assurance, adopted by reference in 18 AAC 80.010(b); and
(B) the laboratory has not passed an onsite inspection under 18 AAC 80.1105, the laboratory has not received an initial onsite inspection under 18 AAC 80.1105(a), or more than three years have elapsed since the date of the last onsite inspection under 18 AAC 1105(b) or (c); or
(3) provisional certification for one or more methods, if
(A) the department determines that the laboratory has not met one or more of the applicable criteria for that method in the Manual for the Certification of Laboratories Analyzing Drinking Water: Criteria and Procedures, Quality Assurance, adopted by reference in 18 AAC 80.010(b); and
(B) the department determines that the laboratory is capable of consistently producing data within the limits specified under this chapter.
(d) Notwithstanding (b) of this section, the department will certify a laboratory holding a current certification from another EPA-approved certifying agency if the laboratory submits each applicable fee under 18 AAC 80.1110 and verification from the certifying agency, in a form acceptable to the department, that the laboratory holds that certification and has satisfied the requirements of (b)(2) - (4) of this section with the other certifying agency, with respect to each method for which the laboratory seeks department recognition of certification by the other certifying agency. A certification under this subsection is subject to the same requirements of 18 AAC 80.1100 - 18 AAC 80.1103 and 18 AAC 80.1109 - 18 AAC 80.1110 as a certification under (b) and (c) of this section.
(e) A laboratory holding provisional certification shall notify its clients of the laboratory's provisionally certified status on any analysis report of samples to which the provisional certification pertains.
(f) Certification under this section may be obtained at any time, and is not valid after June 30, unless the laboratory renews the certification in accordance with this subsection. To request renewal of a certification under (b) and (c) of this section, the laboratory must submit a complete application for renewal, along with each applicable fee under 18 AAC 80.1110, and must satisfy the requirements of (b)(2) - (4) of this section. To request renewal of a certification under (d) of this section, the laboratory must submit a complete application for renewal, along with each applicable fee under 18 AAC 80.1110, and must submit verification from the other certifying agency, in a form acceptable to the department, that the laboratory holds that certification and has satisfied the requirements of (b)(2) - (4) of this section with the other certifying agency. If the department receives a complete application no later than May 30 for renewal, and approves that application under (b) and (c) of this section or under (d) of this section, as applicable, the renewed certification is valid on July 1. If the department receives a complete application after May 30 for renewal, and approves that application under (b) and (c) of this section or under (d) of this section, as applicable, the renewed certification is valid on July 1 or on the date that the department approves the application, whichever date is later. A renewed certification is not valid after the following June 30.
(g) No later than seven days after the first day that the certification is no longer valid, a laboratory whose certification has expired shall give written notice of the expiration to each client. The notice must include a statement that the laboratory may not submit data to the department under an expired certification. No later than 14 days after the first day that the certification is no longer valid, the laboratory shall certify to the department in writing, subject to 18 AAC 80.1900, that the notice has been given.
(h) The department may downgrade or revoke a certification under this section for one or more methods, for reasons described in the Manual for the Certification of Laboratories Analyzing Drinking Water: Criteria and Procedures, Quality Assurance, adopted by reference in 18 AAC 80.010(b). If another EPA-approved certifying agency revokes or downgrades the certification upon which the department based a certification under (d) of this section, the department will revoke its certification or downgrade it to a classification corresponding to the classification by the other certifying agency. If the certification upon which the department based a certification under (d) of this section expires, the department's certification under (d) of this section becomes invalid on the same date that the other certification becomes invalid. A person aggrieved by a department certification decision under this section may request a review under 18 AAC 80.1920. This subsection does not affect a person's rights under AS 44.62 (Administrative Procedure Act).

Notes

18 AAC 80.1100
Eff. 10/1/99, Register 151; am 3/25/2001, Register 157; am 9/28/2001, Register 159; am 8/19/2006, Register 179; am 4/24/2009, Register 190; am 7/25/2010, Register 195

Information about how to review or obtain the reference materials referred to in 18 AAC 80.1100 is in the editor's note to 18 AAC 80.010.

Authority:AS 46.03.020

AS 46.03.050

AS 46.03.710

AS 46.03.720

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