Title 18 . Environmental Conservation

Chapter 78 . Administrative Enforcement

Section 800. Approval requirements

18 AAC 78.800. Approval requirements

(a) Laboratory chemical analyses of soil and water required to be conducted under this chapter must be performed by a laboratory approved by the department under 18 AAC 78.800 - 18 AAC 78.815. If an owner or operator submits samples of soil or water under 18 AAC 78.090, 18 AAC 78.235, or 18 AAC 78.600 - 18 AAC 78.620, the manager of the laboratory that performs the chemical analysis shall include with each analysis the current state laboratory UST identification number. The department will assign a laboratory number if the department receives an application and fee under this section from the laboratory. The department will not accept the submission of a soil or water sample analysis without that number.

(b) To obtain approval of the laboratory, the laboratory manager must

(1) submit a complete application on a form supplied by the department and pay a nonrefundable $800 annual fee for department review of the laboratory's application, quality assurance (QA) manual, and performance evaluation audit (PE) sample results;

(2) submit a notarized statement signed by the laboratory manager, certifying that, for purposes of AS 46.03.360 - 46.03.450 and this chapter, the laboratory will adhere to the methods listed in Table 1 in the UST Procedures Manual and will include the standard operating procedures (SOP) for those methods in its QA manual;

(3) unless waived under (f) of this section, submit for approval a QA manual or similar document that assures generation of quality data by the laboratory; the QA manual must contain the methods referred to in (2) of this subsection and must include the minimum elements described in EPA's Guidance on Preparation of Laboratory Quality Assurance Plans, Revision No. 1, dated October 9, 1992 (EPA 910/9-92-032), adopted by reference; and

(4) pass the performance evaluation audits for gasoline range organics, diesel range organics, residual range organics, and BTEX required under (c) and (d) of this section.

(c) A laboratory manager seeking an initial approval or renewal of approval under this section and 18 AAC 78.810 shall demonstrate the laboratory's ability to analyze samples for the parameters listed in Table 1 of the UST Procedures Manual by successfully analyzing PE samples, using one or more of the methods specified in Table 1, for gasoline range organics, diesel range organics, residual range organics, and BTEX in solids and waters. The laboratory manager shall submit the analysis of the PE samples to the department no earlier than 90 days before the application is submitted and no later than 30 days after the application is submitted. If the PE result falls outside the acceptable range, the laboratory manager shall submit to the department, within 30 days after the laboratory manager receives notice of the failure, a corrective action report that identifies the cause of failure and includes a remedial action plan. If the department

(1) approves the corrective action report, the department will place the laboratory on provisionally approved status; within six months, the laboratory manager shall have the laboratory reanalyze a PE sample of the regulated analyte for which the previous analysis was unacceptable; if the laboratory

(A) passes the PE, the department will approve the laboratory; or

(B) fails the PE, the department will remove the laboratory from provisionally approved status and deny approval;

(2) does not approve the corrective action report, the department will deny approval.

(d) In the analysis of PE samples under (c) of this section, the laboratory shall use the required methods listed in Table 1 of the UST Procedures Manual. The laboratory manager shall obtain PE samples from a supplier listed by the American Association for Laboratory Accreditation unless the department, after receiving a written request from the laboratory manager, approves use of another supplier. The department will approve the use of another supplier if the laboratory manager demonstrates that a national or international accreditation body has accredited the supplier, based on evaluation of the supplier's technical qualifications, competence for conducting specific test methods, measurements, and services in specified fields of calibration or testing, and an onsite audit. To pass a PE, the analysis of each sample analyzed must be accurate to a minimum confidence interval of 95 percent.

(e) If a change in the laboratory operations affects the minimum elements described in the QA manual under (b)(3) of this section, the laboratory manager shall report the change to the department within 30 days after the change occurs. Laboratory approval is valid only if the QA manual reflects the minimum elements currently in effect at the laboratory.

(f) If a laboratory is accredited, certified, or approved for organic and inorganic analytical methods for purposes of another chapter in this title, the department, upon request, will waive the requirement to submit a QA manual for approval under (b)(3) of this section, unless the department determines that compliance with (b)(3) is necessary to assure generation of quality data. A laboratory manager requesting a waiver under this subsection shall submit a written request and the laboratory's current EPA identification number to the department.

(g) To renew an approval, a laboratory manager must submit an application with the required $800 annual fee no more than 90 days and no less than 30 days before approval expires, and must perform the demonstration required in (c) of this section. Failure to submit a completed renewal application and fee when due results in lapse of approval.

(h) Approval under 18 AAC 78.800 - 18 AAC 78.815 constitutes a certification for purposes of AS 44.46.025 .

History: Eff. 11/3/95, Register 136; am 1/22/99, Register 149; am 6/25/99, Register 150

Authority: AS 44.46.020

AS 44.46.025

AS 46.03.020

AS 46.03.365

Editor's note: 1. The EPA's Guidance on Preparation of Laboratory Quality Assurance Plans, Revision No. 1, adopted by reference in 18 AAC 78.800, may be reviewed at the department's offices in Anchorage, Fairbanks, Juneau, and Soldotna, or may be obtained from the United States Environmental Protection Agency, 1200 Sixth Avenue, Seattle, Washington 98101, phone: (360) 871-0748, fax: (360) 871-8747.

2. The American Association for Laboratory Accreditation may be contacted at 5301 Buckeystown Pike, Suite 350, Frederick, MD 21704-8307, phone: (301) 644-3248.

3. Application materials are available upon request from the State Chemistry Lab, 10107 Bentwood Street, Juneau, Alaska 99801, phone: (907) 790-2169, fax: (907) 790-2451. Application materials include the names and addresses of suppliers listed by the American Association for Laboratory Accreditation. The department's list of suppliers is updated on a periodic basis and may not reflect recent changes.