401 KAR 5:320. Wastewater Laboratory Certification Program.
RELATES TO: KRS 224.01-010, 224.10-100, 224.10-670,
224.70-100, 224.70-110, 40 C.F.R. 136, 33 U.S.C. 1342
STATUTORY AUTHORITY: KRS 224.10-670
NECESSITY, FUNCTION, AND CONFORMITY: KRS 224.10-670 authorizes the cabinet
to promulgate administrative regulations establishing standards for the
operation of laboratories, fees for certification and competency evaluation of
those laboratories, issuance of certificates of competency, and a certification
program for laboratories that submit environmental data as it relates to
analyses and laboratory tests for activities subject to 33 U.S.C. 1342.
This administrative regulation establishes the wastewater laboratory certification
program, standards for the certification of wastewater laboratories, and fees
for certification and evaluation of wastewater laboratories.
Section 1. Definitions. (1) "Analysis
category" means one (1) of the following analyte groups for which an
analysis can be performed by a wastewater laboratory:
(a) Inorganic general chemistry;
(b) Inorganic metals;
(c) Organic chemistry volatiles;
(d) Organic chemistry semi-volatiles;
(e) Organic chemistry pesticides, herbicides,
or PCBs;
(f) Organic chemistry dioxins;
(g) Microbiology;
(h) Whole effluent toxicity; and
(i) Field analysis.
(2) "Certified" means that the
cabinet has determined that the wastewater laboratory meets the regulatory
performance criteria and the standard of quality established in this
administrative regulation and has issued a certification.
(3) "Equivalency of certification"
means certification of a wastewater laboratory by an entity, other than the
cabinet, whose requirements for certification are determined by the cabinet to
meet the requirements of this administrative regulation.
(4) "Field analysis" means a
measuring of the following:
(a) Dissolved oxygen;
(b) Residual chlorine;
(c) pH;
(d) Temperature;
(e) Conductivity; and
(f) Turbidity.
(5) "Field-only wastewater
laboratory" means a wastewater laboratory that performs a measurement for
only the parameters identified as field analysis, regardless of whether the
measurement takes place outdoors, in an on-site room used as a laboratory, or
in an off-site laboratory.
(6) "General wastewater laboratory"
means a wastewater laboratory that performs an analysis for at least one (1) analysis
category other than field analysis, regardless of whether the general
wastewater laboratory also performs a field analysis measurement.
(7) "Interim certification" means
a certification approved by the cabinet if it determines through documentation
review that the wastewater laboratory meets the requirements of Section 10 of
this administrative regulation. Interim certification is applicable to a
method-analyte pairing until the cabinet has completed an on-site audit for
that method-analyte pairing.
(8) "Primary analyst or technician"
means an analyst or technician who performs a specific method-analyte pairing
analysis more often than any other analyst or technician at that wastewater
laboratory.
(9) "Wastewater laboratory"
means a laboratory that performs an analysis, measurement, or laboratory test
for an activity subject to 33 U.S.C. 1342.
Section 2. Effective Date for this
Administrative Regulation. The effective date for this administrative
regulation shall be:
(1) January 1, 2014, for a general
wastewater laboratory; and
(2) January 1, 2015, for a field-only
wastewater laboratory.
Section 3. Requirement for Acceptance of
Environmental Data. (1) In accordance with KRS 224.10-670(2) and the schedule
established in subsection (2) of this section, environmental data from analyses
and laboratory tests submitted to the cabinet for activities subject to 33 U.S.C.
1342 shall be performed:
(a) By a certified wastewater laboratory;
and
(b) In compliance with:
1. An analytical method in 40 C.F.R. Part
136 or as established in the applicable permit;
2. This administrative regulation; and
3. The provisions of the Commonwealth of
Kentucky Wastewater Laboratory Certification Manual.
(2) The requirements established in
subsection (1) of this section shall begin on:
(a) January 1, 2015, for a general
wastewater laboratory; and
(b) January 1, 2016, for a field-only
wastewater laboratory.
Section 4. Certification Requirements. The
requirements established in this section shall apply to a wastewater laboratory
seeking certification.
(1) Application for certification shall
be made on the Kentucky Wastewater Laboratory Certification Program,
Application for Kentucky Laboratory Certification, KWLCP Form App, and shall
include all information required by that form, and shall be submitted with the
applicable fee as established in Section 8 of this administrative regulation as
follows:
(a) If in paper form, to:
Kentucky Division of Water
Attn: Laboratory Certification
200 Fair Oaks Lane, 4th Floor
Frankfort, Kentucky 40601; or
(b) If in electronic form, via the
cabinet’s Web site:
www.water.ky.gov.
(2) The wastewater laboratory shall apply
for certification for each analysis category and for each method-analyte
pairing for which the wastewater laboratory intends to perform an analysis.
Section 5. Term of Certification Periods
for a General Wastewater Laboratory. (1) The initial certification period for a
general wastewater laboratory shall be from January 1, 2014, until December 31,
2015, and subsequent certification periods shall be consecutive two (2) year
periods, beginning January 1, 2016.
(2) If, beginning January 1, 2016, a general
wastewater laboratory applies for initial certification of the wastewater
laboratory or for certification for a new method-analyte pairing, the initial
certification period shall be the two (2) year period as established in subsection
(1) of this section, based upon the date of application receipt by the cabinet.
Section 6. Term of Certification Periods
for a Field-Only Wastewater Laboratory. (1) The initial certification period
for a field-only wastewater laboratory shall be from January 1, 2015, until December
31, 2016, and subsequent certification periods shall be consecutive two (2)
year periods, beginning January 1, 2017.
(2) If, beginning January 1, 2017, a
field-only wastewater laboratory applies for initial certification of the
wastewater laboratory or for certification for a new method-analyte pairing,
the initial certification period shall be the two (2) year period as
established in subsection (1) of this section, based upon the date of
application receipt by the cabinet.
Section 7. Due Date for Certification
Renewal Applications. (1) If an application, the Kentucky Wastewater Laboratory
Certification Program, Application for Kentucky Laboratory Certification, KWLCP
Form App, for certification renewal is received by the cabinet by November 15
of the odd-numbered year of the current certification period for a general
wastewater laboratory, or November 15 of the even-numbered year of the current
certification period for a field-only wastewater laboratory, the application shall
be considered timely submitted, and the wastewater laboratory’s certification
shall continue in effect until the cabinet acts upon the application, unless
the certification is otherwise revoked.
(2) If an application, the Kentucky
Wastewater Laboratory Certification Program, Application for Kentucky Laboratory
Certification, KWLCP Form App, for certification renewal is received by the cabinet
after November 15 but on or before December 15 of the odd-numbered year of the
current certification period for a general wastewater laboratory, or after
November 15 but on or before December 15 of the even-numbered year of the
current certification period for a field-only wastewater laboratory, the application
shall not be considered timely submitted, and shall be subject to the surcharge
established in Section 8(4) of this administrative regulation. The wastewater
laboratory’s certification shall continue in effect until the cabinet acts upon
the application, unless the certification is otherwise revoked.
(3) If an application, the Kentucky
Wastewater Laboratory Certification Program, Application for Kentucky
Laboratory Certification, KWLCP Form App, for certification renewal is received
by the cabinet after December 15 of the odd-numbered year of the current certification
period for a general wastewater laboratory, or after December 15 of the
even-numbered year of the current certification period for a field-only
wastewater laboratory, the application shall not be considered timely submitted,
and shall be subject to the surcharge established in Section 8(5) of this administrative
regulation. The wastewater laboratory’s certification shall expire after December
31 of that odd-numbered year for a general wastewater laboratory, or after
December 31 of that even-numbered year for a field-only wastewater laboratory, and
shall not be valid until the cabinet acts upon the renewal application.
Section 8. Annual Certification Fees. (1)
The annual certification fees for wastewater laboratory certification shall be established
in Table 1 of subsection (2) of this section and shall include:
(a) A nonrefundable administrative fee;
and
(b) A fee for each applicable analysis
category.
(2) If a follow-up audit is performed to verify
the correction of a deficiency identified by an audit pursuant to Section 10 of
this administrative regulation, an additional audit fee, established in Table 1,
shall be assessed.
Table 1: Wastewater Laboratory Certification
Fee
Fee Category
Annual Fee
Administrative Fee
$1,000
Analysis Category Fee
Inorganic general chemistry
$500
Inorganic metals
$500
Organic chemistry volatiles
$500
Organic chemistry semi-volatiles
$500
Organic chemistry pesticides, herbicides, PCBs
$500
Organic chemistry dioxins
$750
Microbiology
$500
Whole effluent toxicity
$1,000
Field analysis only
$250
Follow-up Audit Fee
$500
(3) The applicable certification fee
shall be due by November 15 of each year. In odd-numbered years of the certification
period for a general wastewater laboratory, or in even-numbered years of the
certification period for a field-only wastewater laboratory, the applicable certification
fee shall be submitted concurrent with the renewal certification application,
the Kentucky Wastewater Laboratory Certification Program, Application for
Kentucky Laboratory Certification, KWLCP Form App.
(4)(a) If a fee is received by the cabinet
after November 15 but on or before December 15, the wastewater laboratory shall
incur a surcharge of fifteen (15) percent of the applicable certification fee
(administrative fee plus analysis category fee).
(b) Payment of this surcharge shall be due
thirty (30) days after notice is provided by the cabinet.
(5) If a fee is received by the cabinet after
December 15, the wastewater laboratory shall incur a surcharge of twenty-five
(25) percent of the applicable certification fee.
(a) The wastewater laboratory’s
certification shall expire after December 31 of that year and shall not be valid
until the applicable certification fee and the surcharge are received by the
cabinet.
(b) Payment of this fee and surcharge
shall not reinstate certification for failure to timely submit an application
for certification renewal pursuant to the expiration established in Section 7(3)
of this administrative regulation.
(6) A wastewater laboratory seeking or
obtaining equivalency of certification shall receive a twenty (20) percent reduction
of the certification fee.
(7) An in-state laboratory that is also
certified for drinking water analysis, as established in 401 KAR 8:040, shall
receive a twenty (20) percent reduction of the certification fee.
(8) A wastewater laboratory that provides
only field analysis shall be exempt from the annual administrative fee
established in Table 1 of subsection (2) of this section.
(9) A wastewater laboratory operated by a
facility that has been issued a Kentucky Pollutant Discharge Elimination System
permit and that is providing only field analysis for only its own facility
shall be exempt from all fees established in this administrative regulation.
(10) A wastewater laboratory operated by
a municipality that provides analysis for only its own facility shall receive
the following reduction to the administrative fee established in Table 1 of
subsection (2) of this section, based on its maximum permitted flow value:
(a) Less than or equal to 0.10 million
gallons per day (MGD), a 100 percent reduction (no administrative fee);
(b) Less than or equal to 0.50 MGD but
greater than 0.10 MGD, a seventy-five (75) percent reduction;
(c) Less than or equal to one and zero
tenths (1.0) MGD but greater than zero and five tenths (0.5) MGD, a fifty (50)
percent reduction;
(d) Less than or equal to two and zero
tenths (2.0) MGD but greater than one and zero tenths (1.0) MGD, a twenty-five
(25) percent reduction; and
(e) Greater than two and zero tenths (2.0)
MGD, a ten (10) percent reduction.
(11) If more than one (1) reduction
pursuant to subsections (6) through (10) of this section applies, only the
greatest reduction shall be taken.
Section 9. Interim Certification. (1) If
a wastewater laboratory demonstrates that the following requirements are met
for a method-analyte pairing, the cabinet shall approve interim certification
for that method-analyte pairing:
(a) All information required by the Kentucky
Wastewater Laboratory Certification Program, Application for Kentucky
Laboratory Certification, KWLCP Form App, shall be submitted to the cabinet;
(b) The appropriate fee shall be submitted
to the cabinet;
(c) A method, including instrumentation,
established in 40 C.F.R. Part 136 or the applicable permit shall be used; and
(d) A proficiency test study sample shall
be analyzed by the primary analyst or technician within the last year and the
results shall be within the acceptance limits specified by a proficiency test
study provider approved by the American Association for Laboratory Accreditation.
(2) A wastewater laboratory with interim
certification may analyze samples for that method-analyte pairing for
compliance purposes.
Section 10. Audits. (1) A certified
wastewater laboratory shall allow a cabinet auditor to conduct, and shall
participate in, an on-site audit during normal business hours.
(2) Wastewater laboratory certification
records and supporting documentation shall be retained for five (5) years or
until the next on-site audit, whichever is longer.
(3) If the cabinet identifies a
deficiency, the certified laboratory shall correct or otherwise address the
deficiency within thirty (30) days of receipt of notice of the deficiency.
(4)(a) If an on-site audit of a
wastewater laboratory located outside of Kentucky is conducted by the cabinet,
the wastewater laboratory shall bear the reasonable cost of the audit.
(b) Payment shall be due thirty (30) days
after notice of this cost is provided by the cabinet.
Section 11. Full Certification Requirements.
(1) If, after an on-site audit and review of submitted information, all
requirements of this administrative regulation for a method-analyte pairing have
been met, the cabinet shall approve full certification for that method-analyte
pairing.
(2) To maintain full certification for
the method-analyte pairing, the wastewater laboratory shall:
(a) Maintain compliance with the
requirements of this administrative regulation, based upon the cabinet’s review
of requested documentation, on-site audit inspection, or both;
(b) Analyze a proficiency test study
sample at least annually by the primary analyst or technician and the results
shall be within the acceptance limits specified by a proficiency test study
provider approved by the American Association for Laboratory Accreditation. If
the wastewater laboratory fails a proficiency test study, the wastewater
laboratory shall, within ninety (90) days after receiving notice of the failed
proficiency test study, analyze a second proficiency test study with the results
within the acceptance limits specified by an approved proficiency test study
provider;
(c) Notify the cabinet within thirty (30)
calendar days of a change in the personnel, equipment, analytical method, or
laboratory location identified in its application, Kentucky Wastewater Laboratory
Certification Program, Application for Kentucky Laboratory Certification, KWLCP
Form App;
(d) Submit documentation or data required
by this administrative regulation; and
(e) Submit to the cabinet all fees by the
deadlines established in this administrative regulation.
Section 12. Provisional Certification.
(1) The cabinet shall, when becoming aware of a failure of a wastewater
laboratory to comply with one (1) or more of the requirements established in Section
11(2) of this administrative regulation, provide written notice to the wastewater
laboratory of the deficiency and of the cabinet’s intent to change the
certification status to provisional certification.
(2) If the deficiency relates to a
specific method-analyte pairing, the cabinet may change the status of the wastewater
laboratory’s certification to provisional certification. If the status is
changed to provisional certification, this changed status shall be for only the
analyte that failed to meet the requirements of Section 11(2) of this
administrative regulation, unless the cabinet had certified a group of related analytes
based on a limited number of analytes in the group.
(3) The wastewater laboratory shall submit
to the cabinet a written corrective action plan to address this deficiency within
thirty (30) days of receipt of the notice of intent from the cabinet,
specifying the immediate and long-term corrective actions that shall be taken.
(4) The wastewater laboratory shall
correct this deficiency as soon as reasonably possible. If the deficiency is
not corrected within thirty (30) days of receipt of the notice of intent, the
cabinet shall change the certification status to provisional certification, and
shall provide written notice to the wastewater laboratory of this action.
(5) A wastewater laboratory with
provisional certification may continue to analyze a sample for compliance
purposes, but shall notify its client of the wastewater laboratory’s
provisional certification status prior to conducting an analysis for that
client and shall provide that information in writing to the client.
(6) A wastewater laboratory with
provisional certification shall correct the deficiency as soon as is reasonably
possible, but within three (3) months of written notification from the cabinet
of the change to provisional certification status.
(7) The cabinet shall restore the
wastewater laboratory’s provisional certification status to full certification
upon making a determination that the deficiency resulting in the provisional
certification status has been corrected and shall provide written notice to the
wastewater laboratory of this action.
Section 13. Certification Revocation. (1)
The cabinet may immediately revoke a wastewater laboratory’s certification for any
of the following reasons:
(a) Failure to use an analytical method
established in 40 C.F.R. Part 136 or in the applicable permit;
(b) Reporting proficiency test study data
from another laboratory as its own data;
(c) Engaging in falsification of data or another
deceptive practice;
(d) Endangering public health or the
environment through an operation associated with the wastewater laboratory;
(e) Refusal to allow or participate in an
on-site audit conducted by the cabinet; or
(f) Persistent failure to report accurate
compliance data to the cabinet.
(2) If the cabinet revokes a wastewater
laboratory’s certification pursuant to subsection (1) of this section, the
cabinet shall immediately notify the wastewater laboratory of this action and provide
written notice to the wastewater laboratory of this action.
(3) If a wastewater laboratory has not
corrected the deficiency resulting in the provisional certification status
within three (3) months of written notification from the cabinet of the change to
provisional certification, the cabinet shall provide written notice to the
wastewater laboratory of the cabinet’s intent to revoke the wastewater laboratory’s
certification for any method-analyte pairing involved in the deficiency.
(4) The wastewater laboratory may request,
in writing, a redetermination of the cabinet’s intent to revoke certification
pursuant to subsection (3) of this section.
(a) If a redetermination is requested,
the request shall be made within thirty (30) days of receipt of the notice of
intent to revoke.
(b)1. This request shall be submitted to
the cabinet and shall explain the basis for the redetermination request and, if
appropriate, include a written corrective action plan to address the deficiency
identified in the cabinet’s notice of intent to revoke.
2. The request shall be signed by a
responsible official of the wastewater laboratory.
(5) The cabinet, having received a request
for redetermination pursuant to subsection (4) of this section, shall make a final
determination whether or not to continue provisional certification, approve
certification, or revoke certification, and shall provide written notice to the
wastewater laboratory of this action.
(6) If, within thirty (30) days of
receipt of the notice of intent to revoke pursuant to subsection (3) of this
section, the wastewater laboratory does not request a redetermination, the
cabinet shall revoke the wastewater laboratory’s certification and provide
written notification to the wastewater laboratory of this action.
Section 14. Cabinet to Develop Templates.
(1) The cabinet shall develop templates to assist wastewater laboratories in
preparing a quality assurance plan (QAP) and standard operating procedures
(SOPs) applicable for field analysis measurements.
(2) The templates developed by the cabinet
shall address all applicable requirements for a QAP and common device SOPs, but
will require the inclusion of site-specific information to be provided by the
wastewater laboratory.
(3) The cabinet shall provide public
notice and at least a thirty (30) day opportunity for public review and comment
on the proposed templates before finalizing these templates.
(4) These templates may be used by a
field-only wastewater laboratory or for the field analysis portion by a general
wastewater laboratory. A wastewater laboratory is not required to use these
templates, and may independently develop its own QAP and SOPs.
(5) The cabinet shall make the final
templates available on its Web site.
Section 15. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "Commonwealth of Kentucky
Wastewater Laboratory Certification Manual", June 2013;
(b) "Kentucky Wastewater Laboratory
Certification Program, Application for Kentucky Laboratory Certification",
KWLCP Form App, March 2013;
(c) "Short-term Methods for
Estimating the Chronic Toxicity of Effluents and Receiving Waters to Freshwater
Organisms", Fourth Edition, U.S.EPA-821-R-02-013, October 2002; and
(d) "Methods for Measuring the Acute
Toxicity of Effluents and Receiving Waters to Freshwater and Marine Organisms",
Fifth Edition U.S. EPA-821-R-02-012, October 2002.
(2) This material may be inspected,
copied, or obtained, subject to applicable copyright law, at the Division of
Water, 200 Fair Oaks Lane, Frankfort, Kentucky 40601, Monday through Friday, 8
a.m. to 4:30 p.m. This material may also be obtained through the Division of
Water’s Web site at http://water.ky.gov. (27 Ky.R. 2603; Am. 3122; 3239; eff.
6-8-2001; 35 Ky.R. 2337; 2768; 36 Ky.R. 25; eff. 7-31-2009; T.Am. 4-4-2011; 39
Ky.R. 2094; 40 Ky.R. 33; 282; eff. 9-5-2013.)
