Current through all regulations passed and filed through September 16, 2024
(B) Data submitted by a QDC shall meet the
following minimum requirements to be accepted as level 3 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 to 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 level 3 QDC 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)(f) 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 3 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 expectation
and ability to utilize level 3 credible data in certain regulatory functions of
Ohio EPA give rise to the requirement that all test methods for level 3
credible data be from one of the publications listed in paragraph (C) of this
rule. Test methods published in updates to the publications listed in paragraph
(C) of this rule may be used if approved by the director as part of a project
study plan approval. Explicit approval of the specific methods employed in the
study shall occur when Ohio EPA reviews project study plans.
(3) All laboratories that perform analysis
under a level 3 study plan shall be accredited, successfully participate in
annual proficiency testing, and implement a quality assurance program as
described in this paragraph.
(a) The QDC is
responsible for ensuring that the laboratories used in generating level 3
credible data have current accreditations from one or more of the following
organizations: national environmental laboratory accreditation program;
American industrial hygiene association; international organization for
standardization; or other governmental or private accrediting authorities that
apply accreditation standards consistent with and equivalent to the
organizations listed in this paragraph. An Ohio EPA laboratory audit, with all
issues acceptably resolved, may be substituted for this accreditation (based on
availability and to be scheduled through the credible data program).
(b) Laboratories analyzing level 3 data are
required to successfully participate in annual proficiency testing (PT) studies
administered by providers that are accredited by the national institute of
standards and technology (NIST) national voluntary laboratory accreditation
program (NVLAP). The analyte list should encompass all parameters for which the
laboratory analyzes level 3 data. Laboratories may limit the scope of PT
studies to those analytes that are readily available from the NIST NVLAP
accredited providers.
(c)
Laboratories analyzing level 3 data are required to implement a quality
assurance program and document all elements of the program in a quality
assurance manual (QAM) or quality assurance plan (QAP). Guidelines for these
elements 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 in hard copy or
electronic format:
(a) Habitat and chemistry
sample data using the online credible data database, or in an acceptable format
approved by the director.
(b) Fish
and macroinvertebrate sample data on forms made available by the director, or
on forms developed for the project if part of the approved project study
plan.
(c) Documentation
demonstrating adherence to an approved project study plan.
(d) Copies of the results from all quality
assurance and quality control samples collected during implementation of the
approved project study plan in the same manner as the data submitted in
accordance with paragraph (B)(4) (a) or (B)(4)(b) of this rule.
(e) 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.
(f) 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 which 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 quality assurance
plan which meets the content guidelines presented in appendix B to this
rule.
(6) Data approval process.
The director shall review data submissions to verify that the data submissions
were submitted by a QDC, that appropriate test methods and quality control and
quality assurance practices were used, and that the data reporting requirements
are complete. The review shall 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, unless the QDC demonstrates to the
satisfaction of the director that the discrepancy is valid and defensible for
the purpose for which the data was collected. 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. The
director shall approve or disapprove the data no later than one year from the
submittal of such data to Ohio EPA.
(7)
Adherence to
methods prescribed in Ohio's water quality standards. Analytical methods and
procedures for matters relating to Ohio's water quality standards are listed in
rule 3745-1-03 of the Administrative
Code. Level 3 QDCs conducting studies designed to interpret, apply, or adopt
standards shall use the methods, data collection, and data analysis
requirements cited in rule
3745-1-03 of the Administrative
Code.
(C)
Publications that provide acceptable level 3 test methods for the collection,
analysis and interpretation of surface water quality monitoring data submitted
under the credible data water quality monitoring program established pursuant
to section 6111.53 of the Revised Code are
presented in this paragraph. These references are available on the web at
http://www.epa.ohio.gov/dsw/credibledata/references.aspx
or through public libraries. The director may approve other level 3 methods as
part of a project study plan approval. Any level 3 methods shall have a degree
of accuracy commensurate with the purpose for which the data will be used.
The person submitting data as a level 3 QDC shall be
responsible for the selection and proper execution of the test methods as
described in paragraph (B)(2) of this rule. Test methods published in updates
to the publications listed in paragraphs (C) (1) to (C)(5) of this rule may be
used if approved by the director. Where the published methods allow for
alternative test procedures for chemical or physical parameters and the
appropriate review authority has approved the alternative test method, the
director may approve use of the alternative test procedure through the study
plan approval. Where Ohio EPA has developed, applied and published new
biological or habitat assessment methods, the director may approve the use of
such methods through the study plan approval.
(1) References for water quality sampling
procedures.
(a) Ohio EPA.
2019.
"Surface Water Field Sampling Manual for water quality parameters and flows.
Ohio Environmental Protection Agency, Division of Surface Water / Division of
Environmental Services. Columbus, Ohio. 40 p."
(b) Ohio EPA. 2019. "Inland
Lakes Sampling Procedure Manual. Ohio Environmental Protection Agency, Division
of Surface Water. Columbus, Ohio
23 p."
(c) U.S. EPA. 1982. "Handbook for Sampling
and Sample Preservation of Water and Wastewater. EPA 600/4-82-029. United
States Environmental Protection Agency. Environmental Monitoring and Support
Laboratory. Cincinnati, Ohio. 418 p."
(d) Ohio EPA. 1998. "Sampling Methods for
Documentation of a Public Health Nuisance under paragraphs (F) and (G) of rule
3745-1-04 of the Administrative
Code. August 20, 1998. Ohio Environmental Protection Agency, Division of
Surface Water. Columbus, Ohio. 7 p."
(e) For the measurement of visibility using
secchi disk depth when accompanied by measurements of total phosphorus and
chlorophyll a, Lind, O. T. 1985. Handbook of common methods in limnology.
Second edition. Kendal / Hunt Publishing Co., Dubuque, IA. 199 p.
(f) U.S. EPA. 1997. Method 445.0. "In vitro
Determination of Chlorophyll a and Pheophytin a in Marine and Freshwater Algae
by Fluorescence. Revision 1.2. September 1997. United States Environmental
Protection Agency. National Exposure Research Laboratory Office of Research and
Development. 22 p."
(g) U.S.
geological survey, variously dated, "National field manual for the collection
of water-quality data: U.S. Geological Survey Techniques of Water-Resources
Investigations," Book 9, chapters A1-A10, available online at:
http://pubs.water.usgs.gov/twri9A.
(2) References for chemical and
microbiological laboratory methods.
(a) Baird,
R.B., Eaton, A.D., Rice, E.W., (editors). 2017. "Standard Methods for the
Examination of Water and Wastewater: 23rd Edition. ISBN: 9781625762405.
American Public Health Association. Washington, D.C."
(b) Ohio EPA. 1998. "Permit Guidance #5 -
Reporting and Testing Guidance for Biomonitoring Required by the Ohio
Environmental Protection Agency. Ohio Environmental Protection Agency, Division
of Surface Water. Columbus, Ohio. 31 p." (plus six attachments).
(c) U.S. EPA. 40 C.F.R. 136 . July 1, 2017
edition.
(d) U.S. EPA. 1983.
"Methods for Chemical Analysis of Water and Wastes. U.S. Environmental
Protection Agency. EPA 600/4-79-020. United States Environmental Protection
Agency, Office of Research and Development, Environmental Monitoring and
Support Laboratory. Cincinnati, Ohio. 552 p."
(e) U.S. EPA. 1978. "Microbiological Methods
for Monitoring the Environment, Water and Wastes. EPA-600/8-78/017. United
States Environmental Protection Agency, Office of Research and Development,
Environmental Monitoring and Support Laboratory, Cincinnati, Ohio. 356 p."
(f) Fishman, M. J. (editor). 1993.
"Methods of analysis by the U.S. Geological Survey National Water Quality
Laboratory; determination of inorganic and organic constituents in water and
fluvial sediments. Open File report 93-125. United States Department of the
Interior, U.S. Geological Survey. Denver, CO."
(g) Stevens, H.H. et. al. 1975. Water
temperature-influential factors, field measurements and data presentation. "In:
Techniques of Water-Resource Investigations, Book 1, Chapter D1. United States
Department of the Interior, U.S. Geological Survey." Washington, D.C.
(h) ASTM. 2016. "Annual Book of ASTM
Standards, Water and Environmental Technology. Volume 11.01: Sampling and Flow
Measurement; Inorganic Constituents. Volume 11.02. Organic Constituents.
American Society for Testing and Materials International. West Conshohocken,
PA."
(i) AOAC. 2016. "Official
Methods of Analysis of AOAC INTERNATIONAL. 20th Edition. 2016. AOAC
INTERNATIONAL. Gaithersburg, Maryland."
(j) Arar, J.E. and B.G. Collins (U.S. EPA).
1997. Method 445.0. "In Vitro Determination of Chlorophyll a and Pheophytin a
in Marine and Freshwater Algae by Fluorescence. Revision 1.2. September
1997."
(k) Ohio EPA. 2016. "Ohio
EPA Total (Extracellular and Intracellular) Microcystins - ADDA by ELISA
Analytical Methodology. Ohio EPA DES 701.0. Version 2.2. November 2016. Ohio
EPA Division of Environmental Services. Columbus, OH. 6 p."
(l) Ohio EPA. 2016. "Ohio EPA Extracellular
Microcystins - ADDA by ELISA Analytical Methodology. Ohio EPA DES 701.2.
Version 1.0. May 2016. Ohio EPA Division of Environmental Services. Columbus,
OH. 6 p."
(m) Ohio EPA. 2016. "Ohio
EPA Total (Extracellular and Intracellular) Saxitoxin by ELISA Analytical
Methodology. Ohio EPA DES 702.0. Version 2.0. November 2016. Ohio EPA Division
of Environmental Services. Columbus, OH. 6 p."
(n) Ohio EPA. 2016. "Ohio EPA Extracellular
Saxitoxin by ELISA Analytical Methodology. Ohio EPA DES 702.1. Version 1.0.
November 2016. Ohio EPA Division of Environmental Services. Columbus, OH. 6
p."
(o) Ohio EPA. 2016. "Ohio EPA
Total (Extracellular and Intracellular) Cylindrospermopsin by ELISA Analytical
Methodology. Ohio EPA DES 703.0. November 2016. Ohio EPA Division of
Environmental Services. Columbus, OH. 6 p."
(p) Ohio EPA. 2016. "Ohio EPA Quantitative
Polymerase Chain Reaction (qPCR) for Determination of Cyanobacteria and
Cyanotoxin-Producing Genes Analytical Methodology. Ohio EPA DES 705.0. Version
1.0. July 2016. Ohio EPA Division of Environmental Services. Columbus, OH. 7
p."
(q) U.S. EPA. 1995.
"Determination of Organic Compounds in Drinking Water by Liquid-Solid
Extraction and Capillary Column Gas Chromatography/ Mass Spectrometry. Method
525.2. Revision 2.0. 1995. United States Environmental Protection Agency,
Office of Research and Development, National Exposure Research Laboratory.
Cincinnati, OH. 60 p."
(3) References for stream flow measurement
methods.
(a) Rantz, S.E. et al. 1982.
"Measurement and computation of streamflow -- v. 1, Measurement of stage, and
v. 2, Computation of discharge. U.S. Geological Survey Water-Supply Paper 2175.
United States Department of Interior, U.S. Geological Survey. Washington D.C.
631 p."
(b) Lipscomb, S.W. 1995.
Quality assurance plan for discharge measurements using broadband acoustic
Doppler current profilers. "U.S. Geological Survey Open File Report 95-701. 12
p."
(c) "U.S. Geological Survey.
2005. Techniques of Water Resources Investigations Reports. Book 3:
Applications of hydraulics, Section A: Surface-water techniques. (21 chapters).
United States Department of Interior, U.S. Geological Survey." Washington D.C.
(d) "Bureau of Reclamation. 1997
and 2001. Water Measurement Manual, Third Edition. United States Department of
Interior, Bureau of Reclamation, Water Resources Research Laboratory. Denver,
Colorado."
(e) "International
Organization for Standardization (ISO)." 2010. Published standards found at
17.120.20. Flow in open channels.
(f) ASTM. 2005. "Annual Book of ASTM
Standards, Water and Environmental Technology, Volume 11.01: Sampling and Flow
Measurement. American Society for Testing and Materials International." West
Conshohocken, PA.
(4)
References for stream habitat measurement methods.
(a) Rankin, E.T. 1989. The qualitative
habitat evaluation index (QHEI): rationale, methods, and application. "Div.
Water Qual. Plan. & Assess., Ecol. Assess. Sect., Columbus, Ohio."
(b)
Ohio environmental protection agency (Ohio EPA). 2006.
Methods for assessing habitat in flowing waters: using qualitative habitat
evaluation index (QHEI). Prepared by the "Midwest Biodiversity Institute for
the Division of Surface Water, Ecological Assessment Section," Columbus, OH. 23
pp.
(c) Rankin, E. T. 1995.
The use of habitat assessments in water resource management programs. pp.
181-208. In: W. Davis and T. Simon (eds.). "Biological Assessment and Criteria:
Tools for Water Resource Planning and Decision Making. Lewis Publishers. Boca
Raton, FL."
(d) Ohio EPA. 2015.
Biological criteria for the protection of aquatic life: volume III:
standardized biological field sampling and laboratory methods for assessing
fish and macroinvertebrate communities. Div. of Surface Water, Eco. Assess.
Secti. Columbus, Ohio.
(e)
Ohio EPA. 2020. "Field Methods for
Evaluating Primary Headwater Streams in Ohio. Version 4.1. Ohio EPA Division of
Surface Water, Columbus, Ohio. 130 pp."
(f) Ohio EPA. 2010. "Methods of Assessing
Habitat in Lake Erie Shoreline Waters Using the Qualitative Habitat Evaluation
Index (QHEI) Approach (Version 2.1). 35 p."
(g) Thoma, R. F. 2006. "Development and
Assessment of a Qualitative Habitat Evaluation Index For Application In Coastal
Wetlands of the Great Lakes. pp. 171-194. In: T. P. Simon and P. M. Stewart
(eds.). Coastal Wetlands of the Laurentian Great Lakes. Health Habitat and
Indicators. AuthorHouse. Bloomington, IN."
(5) References for fish tissue collection and
contaminant testing.
(a) Ohio EPA. 2012.
"State of Ohio Cooperative Fish Tissue Monitoring Program Fish Collection
Guidance Manual. Ohio Environmental Protection Agency, Division of Surface
Water. Columbus Ohio. 21 p." This document is available on the web at
http://epa.ohio.gov/portals/35/fishadvisory/FishCollectionGuidanceManua112.pdf.
(b) USEPA. 2000. "Guidance for Assessing
Chemical Contaminant Data for Use in Fish Advisories. Volume 1, Fish Sampling
and Analysis. Third edition. EPA 823/B-00-007. Office of Science and
Technology, Office of Water, United States Environmental Protection Agency.
Washington, D.C." This document is available on the web at
https://www.epa.gov/sites/production/files/2015-06/documents/volume1.pdf.
(6) References for fish and macroinvertebrate
community measurement methods.
(a) "Ohio
Environmental Protection Agency. 1987a. Biological criteria for the protection
of aquatic life: Volume I. The role of biological data in water quality
assessment. Div. Water Qual. Monit. & Assess., Surface Water Section.
Columbus, Ohio."
(b) "Ohio
Environmental Protection Agency. 1988b. Biological criteria for the protection
of aquatic life: Volume II. Users manual for biological field assessment of
Ohio surface waters. Div. Water Qual. Monit. & Assess., Surface Water
Section. Columbus, Ohio."
(c) "Ohio
Environmental Protection Agency. 1989a. Addendum to Biological criteria for the
protection of aquatic life: Volume II. Users manual for biological field
assessment of Ohio surface waters. Div. Water Qual. Plan. & Assess.,
Ecological Assessment Section. Columbus, Ohio."
(d) "Ohio Environmental Protection Agency.
2015. Biological criteria for the protection of aquatic life: Volume III.
Standardized biological field sampling and laboratory methods for assessing
fish and macroinvertebrate communities. Div. of Surface Water, Ecol. Assess.
Sect. Columbus, Ohio."
(e) "Ohio
Environmental Protection Agency. 2006. 2006 Updates to Biological Criteria for
the Protection of Aquatic Life: Volume II and Volume II Addendum. Users Manual
for Biological Field Assessment of Ohio Surface Waters. Division of Surface
Water. Columbus, Ohio. 14 p."
(f)
DeShon, J.D. 1995. Development and application of the invertebrate community
index (ICI). pp. 217-243. In: W.S. Davis and T. Simon (eds.). "Biological
Assessment and Criteria: Tools for Risk-based Planning and Decision Making.
Lewis Publishers. Boca Raton, FL."
(g) Thoma, Roger. 1999. "Biological
Monitoring and an Index of Biotic Integrity for Lake Erie's Nearshore Waters.
Chapter 16 in Assessing the Sustainability and Biological Integrity of Water
Resources Using Fish Communites. Edited by Thomas P. Simon. 672 p. CRC Press.
Boca Raton, FL."
(h) Yoder, C.O.
1995. Policy issues and management applications for biological criteria. pp.
327-344. In: W. Davis and T. Simon (eds.). "Biological Assessment and Criteria:
Tools for Water Resource Planning and Decision Making. Lewis Publishers. Boca
Raton, FL."
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Appendix
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Appendix