1. (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. (1) full certification under (c)(1) of this section;
   2. (2) interim certification under (c)(2) of this section;
   3. (3) provisional certification under (c)(3) of this section;
   4. (4) certification, under (d) of this section, of a laboratory holding certification by another certifying agency.

2. (b) Except as provided in (d) of this section, the department will certify a laboratory for an analytical method if the laboratory

   1. (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. (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, including supplements, as adopted by reference in 18 AAC 80.010(b);

   3. (3) submits to the department the results of required 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; the results of required proficiency testing must be submitted to the department on the following schedule:

      1. (A) for all analytical methods except as Iisted in (B) of this paragraph, once every 12 months within the 12-month certification period set out in (f) of this section;
      2. (B) for Cryptosporidium methods, once every six months within the 12-month certification period set out in (f) of this section; and
   4. (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, including supplements, as adopted by reference in 18 AAC 80.010(b).

3. (c) The department will give a laboratory that meets the requirements of (b) of this section

   1. (1) certification for one or more methods, if

      1. (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, including supplements, as adopted by reference in 18 AAC 80.010(b); and
      2. (B) the laboratory has passed an onsite inspection under 18 AAC 80.1105;

   2. (2) interim certification for one or more methods, if

      1. (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, including supplements, as adopted by reference in 18 AAC 80.010(b); and
      2. (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. (3) provisional certification for one or more methods, if

      1. (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, including supplements, as adopted by reference in 18 AAC 80.010(b); and
      2. (B) the department determines that the laboratory is capable of consistently producing data within the limits specified under this chapter.

4. (d) Notwithstanding (b) of this section, the department will certify a laboratory located outside this state and holding a current certification from another EPA-approved certifying agency if the laboratory satisfies the requirements of (1) - (3) of this subsection. 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. To apply for certification, the laboratory must submit to the department an application, in a format specified by the department, that includes, in addition to the documentation required under (b)(2) - (4) of this section,

   1. (1) each applicable fee under 18 AAC 80.1110;
   2. (2) verification from the certifying agency, in a form acceptable to the department, that the laboratory holds the specific 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; and
   3. (3) verification from the certifying agency, in a form acceptable to the department, that the laboratory has received and satisfactorily passed any required onsite inspections by that certifying agency; those inspections must be equivalent to the onsite inspection requirements of 18 AAC 80.1105.
5. (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.

6. (f) The certification period begins on July 1 and ends on June 30 of the following year. A laboratory may get certification under this section at any time. A certification may become invalid before June 30 if a condition described in (h) of this section occurs. The certification is not valid after June 30 unless the laboratory renews the certification in accordance with this subsection as follows:

   1. (1) to request renewal of a certification under (b) and (c) of this section, the laboratory must

      1. (A) submit a complete application for renewal;
      2. (B) submit payment for each applicable fee under 18 AAC 80.1110; and
      3. (C) satisfy the requirements of (b)(2) - (4) of this section; and

   2. (2) to request renewal of a certification under (d) of this section, the laboratory must

      1. (A) submit a complete application for renewal;
      2. (B) submit payment for each applicable fee under 18 AAC 80.1110;
      3. (C) satisfy the requirements of (b)(2) - (4) of this section; and
      4. (D) 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, and has received and passed onsite inspections that may be required as set out in (d)(3) of this section;
   3. (3) for a complete renewal application that the department receives on or before May 30 and processes and approves on or before July 1 under (b) and (c) of this section or under (d) of this section, as applicable, the renewed certification is valid as of July 1 for the new 12-month certification period that ends on June 30 of the following year;
   4. (4) for a complete renewal application that the department receives after May 30 and processes and approves on or before July 1 under (b) and (c) of this section or under (d) of this section, as applicable, the renewed certification is valid as of July 1 for the new 12-month certification period that ends on June 30 of the following year;
   5. (5) for a complete renewal application that the department receives after May 30 and processes and approves after July 1 under (b) and (c) of this section or under (d) of this section, as applicable, the renewed certification is valid on the date that the department approves the application for the new 12-month certification period that ends on June 30 of the following year, regardless of the date on which the department approves the renewal application;
   6. (6) if for any reason the department does not approve the certification renewal on or before July 1, the certification has expired, and the laboratory must comply with (g) of this section.

7. (g) If a laboratory's certification becomes invalid for any reason, including expiration, revocation, or being downgraded, the laboratory shall provide notice to clients and the department as follows:

   1. (1) not later than seven days after the first day that the certification is no longer valid, the laboratory shall give written notice of the expiration, revocation, or downgrade to each affected client; the notice must include a statement that the laboratory may not submit data to the department under an invalid certification;
   2. (2) not 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 under (1) of this subsection.

8. (h) The department may downgrade or revoke, as follows, a certification under this section for unacceptable laboratory practices or for one or more methods, for reasons described in the Manual for the Certification of Laboratories Analyzing Drinking Water: Criteria and Procedures, Quality Assurance, including supplements, as adopted by reference in 18 AAC 80.010(b), or as set out in (1) of this subsection:

   1. (1) under (d) of this section,

      1. (A) if another EPA-approved certifying agency revokes or downgrades the certification upon which the department based a certification, the department will revoke the department's certification or downgrade the department's certification to a classification corresponding to the classification by the other certifying agency;
      2. (B) if the certification upon which the department based a certification by another EPA-approved certifying agency becomes invalid for any reason, the department's certification becomes invalid on the same date that the other certifying agency's certification becomes invalid;
   2. (2) additional fees under 18 AAC 80.1110 may be applicable for a laboratory to regain certification if a certification is revoked or otherwise becomes invalid.
9. (i) 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).

(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; am 5/3/2019, Register 230)

Authority: AS 46.03.020, AS 46.03.050, AS 46.03.710, AS 46.03.720