Current through all regulations passed and filed through September 16, 2024
(A) Except as provided by paragraph (D) of
rule 3745-4-01 of the Administrative
Code, all data submitted to the director for consideration as level 2 credible
data shall be collected and submitted by level 2 or level 3 qualified data
collectors (QDCs) approved by the director pursuant to rule
3745-4-03 of the Administrative
Code. Other persons trained and supervised by the QDC may assist with the
collection of data. The director shall accept the data as level 2 credible data
provided the requirements of this rule are met. The director shall have sole
authority in determining whether data meet these requirements. Data reporting
shall be in a format consistent with the requirements listed in this
rule.
(B) Data submitted by a QDC
shall meet the following to be accepted as level 2 credible data:
(1) Adherence to a study plan. Persons
submitting data to Ohio EPA as a QDC under section
6111.53 of the Revised Code
shall prepare and adhere to a project study plan.
(a) The QDC shall prepare and submit to the
director for approval a project study plan using the guidelines presented in
appendix A to this rule. The director may approve an alternative to the
guidelines in appendix A of this rule upon a reasonable and scientifically
supported demonstration by a QDC.
(b) Upon completion of the plan review, the
director shall send written notification of deficiencies in the plan, if any
are found, to the QDC and provide the QDC a reasonable opportunity to address
such deficiencies. If the deficiencies are not addressed, the director may
disapprove the study plan.
(c) A
plan submitted by a QDC (level 2 or 3) not disapproved within sixty days of the
initial submittal or, where a notification of deficiency has been issued,
within sixty days of any revised submittal, shall be considered to have been
approved.
(d) The director shall
disapprove a site-specific plan that does not include the certification
statement in paragraph (B)(4)(e) of this rule.
(2) Use of appropriate test methods. In
preparing the project study plan, the QDC shall be responsible for selecting
the appropriate field and laboratory methods, including quality assurance and
quality control steps, that fit the objectives and purpose of the project. All
methods should be commensurate with the purposes of level 2 and the need for
sufficient rigor and sensitivity to detect relatively small differences in
water quality over time or from sampling site to sampling site. The QDC may
select from parameters and test methods published by the director pursuant to
paragraph (C) of this rule or similar methods published in the scientific
literature. Explicit approval of the specific methods employed shall occur when
Ohio EPA reviews project study plans.
(3) All laboratories that perform analysis
under a level 2 study plan shall implement a quality assurance program and
shall document all elements of the program in a quality assurance manual (QAM)
or quality assurance plan (QAP). Guidelines for the elements that should be
addressed in the QAM or QAP are presented in appendix B to this rule.
(4) Data reporting. QDCs choosing to submit
data to Ohio EPA shall submit all collected data. Submission of data may be
done at any time, but shall be done no later than one year after completion of
the study identified in the project study plan. For ongoing sampling programs,
data submission should begin no later than one year after the initial phase of
study identified in the project study plan. The
timeframe for submission of data may be extended at the director's discretion
for good cause. The following shall be submitted:
(a) Level 2 sample data using the online
credible data database, or in a pre-approved format acceptable to the director.
(b) Documentation demonstrating
adherence to an approved project study plan.
(c) The results from all quality assurance
and quality control samples collected during implementation of the approved
project study plan using the online credible data database.
(d) A certification that, to the best of the
QDC's knowledge and belief, the data were collected in accordance with the
procedures required by the approved project study plan.
(e) A signed statement from each QDC working
on the project certifying that the QDC has not been convicted of or pleaded
guilty to a violation of section
2911.21 of the Revised Code
(criminal trespass) or a substantially similar municipal ordinance within the
previous five years.
(5)
Reporting laboratory quality assurance and quality control plans. In addition
to the information required by paragraph (B)(4) of this rule, the QDC, upon
request of the director, shall provide quality assurance and quality control
documentation for all laboratories that were used to analyze any data collected
pursuant to the approved project study plan. The QDC is responsible for
providing this documentation in the form of a laboratory QAP that meets the
content guidelines presented in appendix B to this rule.
(6) Data approval process. The director shall
review data submissions to verify that they were submitted by a QDC, that
appropriate test methods and quality control quality assurance practices were
used, and that the data reporting requirements are complete. The review will
ensure that all components of the plan for the collection of data were
followed. If substantial discrepancies are found, the director may decide not
to approve the data. The director shall provide written notification to the
person submitting the data as to whether the data have been approved and at
what level the data qualify as credible data.
(C) Publication of acceptable methods.
The director from time to time shall publish examples of
acceptable level 2 analytical methods for commonly sampled parameters. These
can be found online at:
https://www.epa.state.oh.us/dsw/credibledata/parameters_testing_methods.
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Appendix
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Appendix