401 KAR 8:040. Laboratory certification.
RELATES TO: KRS 224.10-100, 40 C.F.R.
141.21,Appendix A-Subpart C, 141.201,Appendices A, B of Subpart Q, EO 2009-538
STATUTORY AUTHORITY: KRS 224.10-100(4),
(5), (28), 224.10-110(2), 40 C.F.R. 141.28, 42 U.S.C. 300f-300j-26, EO 2009-538
NECESSITY, FUNCTION, AND CONFORMITY: KRS
224.10-110(2) requires the cabinet to enforce the administrative regulations
promulgated by the secretary for the regulation and control of the purification
of water for public and semipublic use. EO 2009-538, effective June 12, 2009, establishes
the new Energy and Environment Cabinet. This administrative regulation establishes
procedures for certification of commercial or water system laboratories to test
for drinking water contaminants.
Section 1. Laboratory Certification. (1)
The U.S. Environmental Protection Agency or the cabinet shall evaluate a public
water system laboratory or a commercial laboratory that performs drinking water
analysis for a public water system for certification.
(2) Contracting by the cabinet with a
third party to conduct laboratory evaluations and make recommendations to the
cabinet regarding certification shall be in accordance with the Manual for the
Certification of Laboratories Analyzing Drinking Water; Criteria and Procedures
Quality Assurance.
(3)(a) Certification may be for one (1)
or more analysis categories or for a single drinking water contaminant within an
analysis category.
(b) Each analysis category shall require a
different certification, but qualification for different certifications may be evaluated
during one (1) audit.
Section 2. Application. (1) An initial
certification request may be made at any point during the calendar year.
(2) A laboratory seeking certification
shall submit a written request for certification to the cabinet. The request
shall include:
(a) A statement of the analysis category or
drinking water contaminant for which certification is requested;
(b) A list of the analytic methods for
each analysis for which certification is requested;
(c) Payment of the fee established in 401
KAR 8:050, Section 2(5) for the certification requested; and
(d) Completion of a Performance
Evaluation (PE) study for each analysis category or drinking water contaminant for
which certification is requested.
(3) The cabinet may request other
information necessary to determine eligibility for certification as described
in the Manual for the Certification of Laboratories Analyzing Drinking Water;
Criteria and Procedures Quality Assurance.
(4)(a) An applicant who has been
decertified in accordance with the Manual for the Certification of Laboratories
Analyzing Drinking Water; Criteria and Procedures Quality Assurance for an
analysis category or drinking water contaminant may request recertification in
accordance with this section.
(b) The applicant for recertification
shall pay the fee established in 401 KAR 8:050, Section 2(4).
Section 3. Public Water System Laboratory.
(1) A Public water system may establish a laboratory. Each laboratory shall be certified
annually.
(2) Failure to achieve or maintain annual
certification shall not relieve the public water system of the responsibility to
report results of the required analyses from a certified laboratory.
Section 4. Requirements. Maintenance of
certification shall require the following:
(1) Analysis. Analyses for drinking water
contaminants shall be performed in accordance with the appropriate approved
method established in 40 C.F.R. Subpart C, 141.21 through Appendix A;
(2) Submission of analysis results. The result
of each analysis performed in a certified laboratory by or for a public water system
shall be submitted to the cabinet by the tenth day of the month following the compliance
period for which the analysis was performed and shall be submitted to the
public water system as soon as possible. The public water system shall be responsible
for this reporting requirement; and
(3) Performance evaluation sample. A performance
evaluation (PE) sample shall be analyzed for each analysis category or drinking
water contaminant for which certification is requested, and the results shall
be submitted to the cabinet at times specified in the Manual for the
Certification of Laboratories Analyzing Drinking Water; Criteria and Procedures
Quality Assurance not to exceed twice a year, unless additional results shall
be required in accordance with the Manual for the Certification of Laboratories
Analyzing Drinking Water; Criteria and Procedures Quality Assurance.
Section 5. Deviations. (1) Deviation from
accepted practice specified in the Manual for the Certification of Laboratories
Analyzing Drinking Water; Criteria and Procedures Quality Assurance listed on a
report resulting from an on-site inspection, shall be corrected.
(2) A written explanation of the
deviation and action taken to correct it shall be submitted to the cabinet
within thirty (30) days of the issuance of the inspection report.
Section 6. Violations. (1) A laboratory
shall report any violation of a maximum contaminant level or other violation requiring
Tier 1 public notification pursuant to 401 KAR 8:070 to the public water system
and the cabinet within twenty-four (24) hours of sample analysis, in accordance
with 40 C.F.R. 141.201-141.211, Appendices A and B.
(2) A public water system shall begin
check sampling within twenty-four (24) hours of notification of a violation.
(6) Emergency provision. A laboratory
shall make provisions to receive and test samples twenty-four (24) hours a day
during an emergency.
Section 7. Right of Entry. A certified laboratory
shall permit the cabinet to conduct on-site surveys during normal business
hours, without prior notification.
Section 8. Revocation of certification
and downgrading of certification shall be in accordance with the procedures established
in the Manual for the Certification of Laboratories Analyzing Drinking Water;
Criteria and Procedures Quality Assurance.
(1) A laboratory that has been notified
of a change of certification shall, within seventy-two (72) hours, notify the public
water systems that the laboratory serves of the change in certification status
and any impact that change could have on the public water system.
(2) A laboratory may provide monitoring
reports by subcontracting with a laboratory that is certified by the cabinet.
Section 9. Recognition of an Out-of-state
Laboratory. (1) The cabinet shall recognize a laboratory located outside Kentucky
upon submission of proof by the laboratory that it is certified by the
Environmental Protection Agency, or by a state having primary enforcement responsibility
for the provisions of the Safe Drinking Water Act, 42 U.S.C. 300f through
300j-26, or that is certified pursuant to the Safe Drinking Water Act, 42
U.S.C. 300f through 300j-26, requirements.
(2) A water system located in Kentucky
that has entered into a contract with a certified out-of-state laboratory shall
comply with time intervals and capabilities established in the Manual for the
Certification of Laboratories Analyzing Drinking Water; Criteria and Procedures
Quality Assurance.
(3) If on-site inspection shall be
conducted for certification of an out-of-state laboratory, the laboratory shall
bear the cost.
Section 10. Incorporation by Reference.
(1) "Manual for the Certification of Laboratories Analyzing Drinking Water;
Criteria and Procedures Quality Assurance; Fifth Edition, January 2005",
Publication EPA 815-R-05-004, is incorporated by reference.
(2) This material may be inspected,
copied, or obtained, subject to applicable copyright law, at the Kentucky
Division of Water, 200 Fair Oaks Lane, Frankfort, Kentucky, Monday through
Friday, 8 a.m. to 4:30 p.m. (17 Ky.R. 597;
Am. 1432; eff. 11-15-1990; 20 Ky.R. 3019; eff. 7-27-1994; 33 Ky.R. 1641; 3606;
eff. 6-13-2007; 35 Ky.R. 1844; 2677; eff. 7-6-2009; 36 Ky.R. 1110; 1923; eff.
3-5-2010.)