Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO:
KRS
224.1-010,
224.10-100,
224.10-670,
224.70-100,
224.70-110,
40 C.F.R. 136,
33 U.S.C.
1342
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. Requirement for Acceptance of Environmental Data. In accordance
with
KRS
224.10-670(2), environmental
data from analyses and laboratory tests submitted to the cabinet for activities
subject to
33 U.S.C.
1342 shall be performed:
(1) By a certified wastewater laboratory;
and
(2) In compliance with:
(a) An analytical method in 40 C.F.R. Part
136 or as established in the applicable permit;
(b) This administrative regulation;
and
(c) The provisions of the
Commonwealth of Kentucky Wastewater Laboratory Certification Manual.
Section 2. 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, DEP No. DOW0503, and shall include all
information required by that form, and shall be submitted with the applicable
fee as established in Section 6 of this administrative regulation as follows:
(a) If in paper form, to: Kentucky Division
of Water; Attn: Laboratory Certification; 300 Sower Boulevard; 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 3. 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 4.
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 5. Due Date for Certification Renewal
Applications.
(1) If a Kentucky Wastewater
Laboratory Certification Program Application for Kentucky Laboratory
Certification 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 a Kentucky Wastewater Laboratory
Certification Program Application for Kentucky Laboratory Certification 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
6(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 a Kentucky Wastewater Laboratory
Certification Program Application for Kentucky Laboratory Certification 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 6(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 6. 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 8 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 Kentucky Wastewater
Laboratory Certification Program Application for Kentucky Laboratory
Certification.
(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 5(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 a reduction to the administrative fee
established in Table 1 of subsection (2) of this section, based on its maximum
permitted flow value as established in this subsection.
(a) Less than or equal to 0.10 million
gallons per day (MGD) shall indicate a 100 percent reduction (no administrative
fee).
(b) Less than or equal to
0.50 MGD but greater than 0.10 MGD shall indicate 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 shall indicate 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 shall indicate a
twenty-five (25) percent reduction.
(e) Greater than two and zero tenths (2.0)
MGD shall indicate 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
7. Interim Certification.
(1) If
a wastewater laboratory demonstrates that it complies with the requirements
established in subparagraphs (a) through (d) of this subsection 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 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.
(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
8. 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
9. Full Certification Requirements.
(1) If, after an on-site audit and review of
submitted information, all requirements established by 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
established by 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 Kentucky Wastewater
Laboratory Certification Program Application for Kentucky Laboratory
Certification;
(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 10. Provisional
Certification.
(1) The cabinet shall, upon
becoming aware of a failure of a wastewater laboratory to comply with one (1)
or more of the requirements established in Section 9(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 comply with the
requirements of Section 9(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
11. Certification Revocation.
(1)
The cabinet may immediately revoke a wastewater laboratory's certification for:
(a) Failing 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)
Refusing 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 12. Incorporation by Reference.
(1) The following material is incorporated by
reference:
(a) "Commonwealth of Kentucky
Wastewater Laboratory Certification Manual", August 2018; and
(b) "Kentucky Wastewater Laboratory
Certification Program Application for Kentucky Laboratory Certification", DEP
No. DOW0503 (March 2018).
(2) This material may be inspected, copied,
or obtained, subject to applicable copyright law, at the Division of Water, 300
Sower Boulevard, 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.
STATUTORY AUTHORITY:
KRS
224.10-670