18 AAC 80.1100 - Laboratory certification
(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
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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