3745-4-06 Level 3 data requirements and reporting.

(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 3 credible data shall be collected and submitted by level 3 qualified data collectors (QDCs) approved by the director pursuant to rule 3745-4-03 of the Administrative Code. The director shall accept the data as level 3 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. Data submitted by a QDC determined to meet these requirements shall be included in a computerized database maintained by Ohio EPA and made available for sharing with other agencies and interested persons.

(B) Data submitted by a QDC must 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 must prepare and adhere to a project study plan or, alternatively, use a generic study plan as described in this paragraph.

(a) The QDC shall prepare and submit to the director for approval a project study plan using the guidelines presented in appendix A of this rule. Upon completion of the plan review, the director shall send written notification of deficiencies in the plan, if any are found, to the QDC thereby disapproving the plan for use in the credible data program. A plan submitted by a level 3 QDC or qualified data collection organization not disapproved within sixty days shall be considered to have been approved. The director will disapprove a site-specific plan that does not include the certification statement in paragraph (B)(4)(f) of this rule.

(b) Generic study plan. The director may from time to time make available generic study plans suitable for certain project objectives and utilizing appropriate methods. After such time that a generic study plan is available, the QDC may elect to collect data using the generic study plan appropriate to the data quality objectives for the specific study. The level 3 QDC shall submit to the director a notification of the level 3 QDC’s intent to utilize a generic plan or generic plan component under this paragraph. The QDC is encouraged to submit the notification to the director at least ninety days prior to the first anticipated sampling activity. The QDC may submit credible data to the director in accordance with a generic plan without prior approval from the director.

[Comment: QDCs are encouraged to submit notification of intent to use generic study plans at least ninety days prior to sample collection to allow time for consultation with Ohio EPA. The objective of the consultation is to ensure that Ohio EPA and the QDC agree that the generic study plan is suitable for the project and the stated data quality objectives, thereby allowing the data generated to be deemed credible at the level intended by the QDC.]

(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. Explicit approval of the specific methods employed in the study shall occur when Ohio EPA reviews project study plans or whenever Ohio EPA makes available a generic study plan.

(3) All laboratories that perform analysis under a level 3 study plan must be accredited, 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: United States environmental protection agency; Ohio EPA voluntary action program; 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.

(b) Laboratories analyzing level 3 data are required to 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 of this rule.

(4) Data reporting. QDCs choosing to submit their data to Ohio EPA must submit all collected data. Submission of data may be done at any time, but must 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. Additional data reporting requirements are:

(a) Wherever possible, a paper copy of all sample data shall be on forms made available by the director, but may be submitted on forms developed for the project. In lieu of a paper copy, data may be submitted electronically in a format mutually acceptable to the QDC and the director;

(b) Submission of documentation demonstrating adherence to an approved project study plan, generic study plan, or generic plan component;

(c) Copies of the results from all quality assurance and quality control samples collected during implementation of the approved project study plan, generic study plan, or generic plan component;

(d) Documentation of the person’s status as a level 3 QDC;

(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, generic study plan, or generic plan component; and

(f) A certification that the persons conducting data collection have 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, generic study plan, or generic plan component. 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 of 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 and 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 will 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) 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. 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.

(1) References for water quality sampling procedures.

(a) Ohio EPA. 2003. Manual of Ohio EPA Surveillance Methods and Quality Assurance Practices. Ohio Environmental Protection Agency, Division of Surface Water / Division of Environmental Services. Columbus, Ohio. 47 p. This document is available on the web at http://www.epa.state.oh.us/dsw/documents/Field%20Manual%2010-1-03.pdf.

(b) USEPA. 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. This document is available on the web at http://www.epa.gov/clariton/clhtml/pubtitleORD.html.

(c) Ohio EPA. 1998. Sampling Methods for Documentation of a Public Health Nuisance under OAC Rule 3745-1-04 (F) & (G). August 20, 1998. Ohio Environmental Protection Agency, Division of Surface Water. Columbus, Ohio. 7 p. This document is available on the web at http://www.epa.state.oh.us/dsw/guidance/wqs3.pdf.

(d) 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.

(2) References for chemical and microbiological laboratory methods.

(a) Eaton, A.D., L.S. Clesceri, E.W. Rice, A.E. Greenberg, M.A.H. Franson, (editors). 2005. Standard Methods for the Examination of Water and Wastewater: Centennial Edition. 21st Edition. ISBN: 0875530478. American Public Health Association. Washington, D.C. 1368 p. This document is available on the web at http://www.standardmethods.org/.

(b) Clesceri, L.S., A.E. Greenberg, and A.D. Eaton, (editors). 1998. Standard Methods for the Examination of Water and Wastewater. 20th Edition. ISBN: 0875532357. American Public Health Association. Washington, D.C. 1325 p.

(c) APHA. 1995. Standard Methods for the Examination of Water and Wastewater. American Public Health Association. 19th Edition. American Public Health Association. Washington, D.C.

(d) APHA. 1992. Standard Methods for the Examination of Water and Wastewater. American Public Health Association. 18th Edition. American Public Health Association. Washington, D.C.

(e) 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). This document is available on the web at http://www.epa.state.oh.us/dsw/guidance/permit5.pdf.

(f) USEPA. 40 C.F.R. 136. July 1, 2004 edition. This document is available on the web at http://www.epa.gov/docs/epacfr40/chapt-I.info/.

(g) USEPA. 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. This document is available on the web at http://www.epa.gov/epahome/index/sources.htm.

(h) USEPA. 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. This document is available on the web at http://www.epa.gov/epahome/index/sources.htm.

(i) 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. This document is available on the web at http://infotrek.er.usgs.gov/pubs/.

(j) 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. This document is available on the web at http://water.usgs.gov/pubs/twri/.

(k) ASTM. 2005. Annual Book of ASTM Standards, Water and Environmental Technology. Section 11.01: Sampling and Flow Measurement; Inorganic Constituents. Section 11.02. Organic Constituents. American Society for Testing and Materials International. West Conshohocken, PA. This document is available on the web at http://www.astm.org.

(l) AOAC. 2003. Official Methods of Analysis of AOAC INTERNATIONAL. 17th Edition, 2nd Revision. 2003. AOAC INTERNATIONAL. Gaithersburg, Maryland. This document is available on the web at http://www.aoac.org.

(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. This document is available on the web at http://infotrek.er.usgs.gov/pubs/.

(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. This document is available on the web at http://infotrek.er.usgs.gov/pubs/.

(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. This document is available on the web at http://water.usgs.gov/pubs/twri/.

(d) Bureau of Reclamation. 1997. Water Measurement Manual, Third Edition. United States Department of Interior, Bureau of Reclamation, Water Resources Research Laboratory. Denver, Colorado. This document is available on the web at http://www.usbr.gov/pmts/hydraulics_lab/pubs/wmm/index.htm.

(e) International Organization for Standardization (ISO). 2005. Published standards found at 17.120.20. Flow in open channels. This document is available on the web at http://www.iso.org.

(f) ASTM. 2005. Annual Book of ASTM Standards, Water and Environmental Technology, Section 11.01: Sampling and Flow Measurement. American Society for Testing and Materials International. West Conshohocken, PA. This document is available on the web at http://www.astm.org.

(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. This document is available on the web at http://www.epa.state.oh.us/dsw/bioassess/BioCriteriaProtAqLife.html.

(b) 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.

(c) Ohio EPA. 1989. Biological criteria for the protection of aquatic life: volume III: standardized biological field sampling and laboratory methods for assessing fish and macroinvertebrate communities. pp. V-4-18 to V-4-31. This document is available on the web at http://www.epa.state.oh.us/dsw/bioassess/BioCriteriaProtAqLife.html.

(5) References for sediment sampling and constituent testing.

(a) Ohio EPA. 2001. Sediment Sampling Guide and Methodologies. Second edition. Ohio Environmental Protection Agency. Columbus, Ohio. 35 p. This document is available on the web at http://www.epa.state.oh.us/dsw/guidance/guidance.html.

(b) Test Methods for Evaluating Solid Waste, Physical/Chemical Methods, EPA Publication SW-846 [Third Edition (November 1986), as amended by Updates I (dated July 1992), II (dated September 1994), IIA (dated August 1993), IIB (dated January 1995), III (dated December 1996) and IIIA (dated April 1998)]. This document is available on the web at http://www.epa.gov/epaoswer/hazwaste/test/main.htm.

(6) References for fish tissue collection and contaminant testing.

(a) Ohio EPA. 2004. State of Ohio Cooperative Fish Tissue Monitoring Program Fish Collection Guidance Manual. Ohio Environmental Protection Agency, Division of Surface Water. Columbus Ohio. 20 p. This document is available on the web at http://www.epa.state.oh.us/dsw/fishadvisory/FishCollectionGuidanceManual05.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 http://www.epa.gov/ost/fishadvice/volume1/index.html.

(7) 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. This document is available on the web at http://www.epa.state.oh.us/dsw/bioassess/BioCriteriaProtAqLife.html.

(b) Ohio Environmental Protection Agency. 1987b. 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. This document is available on the web at http://www.epa.state.oh.us/dsw/bioassess/BioCriteriaProtAqLife.html.

(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. This document is available on the web at http://www.epa.state.oh.us/dsw/bioassess/BioCriteriaProtAqLife.html.

(d) Ohio Environmental Protection Agency. 1989b. Biological criteria for the protection of aquatic life: Volume III. Standardized biological field sampling and laboratory methods for assessing fish and macroinvertebrate communities. Div. Water Quality Plan. & Assess., Ecol. Assess. Sect. Columbus, Ohio. This document is available on the web at http://www.epa.state.oh.us/dsw/bioassess/BioCriteriaProtAqLife.html.

(e) 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.

(f) 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.

3745-4-06 Appendix A. Guidelines for the preparation of level 3 project study plans.

Persons preparing level 3 project study plans for the credible data surface water quality monitoring program should consult the following set of guidelines to ensure the adequacy of the project study plan. The director may conclude that the project study plan is deficient if the information requested in this appendix is missing and there is no other comparable justification for the technical and scientific adequacy of the project study plan.

(1) A clear statement of the objectives of the planned activities, including data quality objectives and the types of data to be collected: chemical, stream habitat, fish, or macroinvertebrate;

(2) A detailed explanation and description, including georeferencing, of the specific point and nonpoint source issues (when applicable) that will be evaluated and other sources that may influence ecological conditions within the study area;

(3) A detailed explanation of parameter coverage within each data type (chemical, stream habitat, fish, and macroinvertebrate) for which sampling will be conducted at each sampling location;

(4) Identification of field collection and data assessment techniques for stream habitat, fish, and macroinvertebrate sampling and, for all chemical parameters sampled, identification of the sample collection methods, the field or laboratory analytical methods used, and the detection limits;

(5) A detailed explanation of planned sampling locations, including the name of the water body and each sampling location. For each sampling location the following information shall be included: sampling location latitude and longitude; sampling location river mile; general locational information; the U.S. geological survey 7.5 minute quadrangle map name; and the purpose for data collection at each sampling location;

(6) A detailed schedule of planned sampling activities or criteria for sampling conditions;

(7) A written quality assurance and quality control (QA/QC) plan which adheres to the general quality assurance and quality control principles described in Ohio EPA’s “Manual of Surveillance Methods and Quality Assurance Practices;”

(8) A detailed explanation of all anticipated work products which will be submitted to the director for use by the director in consideration of the data as level 3 credible data. Examples of anticipated work products that shall be submitted to the director include, but are not limited to, the following: measured chemical, stream habitat, and biological data; beneficial use attainment statistics; biological index metrics and scores; water quality criteria exceedences; and stream habitat index metrics and scores;

(9) A list of all qualified data collectors and other persons who will be involved with sample collection, sample analysis, and data entry along with specific procedures outlining how persons not qualified as level 3 data collectors will be supervised to ensure the accuracy of their activities. The list shall include the name, address, electronic mail address, and phone number of all qualified data collectors and shall identify the qualified data collectors designated as the lead project managers;

(10) Documentation demonstrating that each person who will be acting as a lead project manager has been approved by the director as a level 3 qualified data collector in accordance with rule 3745-4-03 of the Administrative Code;

(11) If a contract laboratory will be used for chemical or biological analyses, identify the laboratory and provide a contact name, address, electronic mail address, and phone number for the contact;

(12) If applicable, a copy of an approved scientific collector’s permit issued by the Ohio department of natural resources, division of wildlife;

(13) A statement certifying that a digital photo catalog of all sampling locations will be maintained for ten years including photos of the specific sampling location, riparian zone adjacent to the sampling location, and general land use in the immediate vicinity of the sampling location;

(14) A statement certifying that the qualified data collector acting as the lead project manager will provide to the director upon request two voucher specimens of each taxa or species of fish and macroinvertebrates that are collected at sampling locations. If a specimen is too large to preserve, a large game species, or a legally protected species, diagnostic photographs or the preservation of specific diagnostic material from the specimen, where allowed, may be submitted in lieu of a complete specimen. All voucher materials shall be kept for at least ten years;

(15) A statement from each qualified data collector working on the project certifying that he or she 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.

Except as provided in this appendix, level 3 project study plans that use biological assessment methods shall provide for the collection of both fish and macroinvertebrate data at all sampling locations. If the level 3 project study plan does not include provisions for the collection of both fish and macroinvertebrates at all sampling locations, the project study plan shall include a detailed explanation of the circumstances, issues, and complexities associated with the proposed sampling location which preclude the use of both organism groups. If circumstances during project execution result in the failure to collect both fish and macroinvertebrates, then an explanation should accompany the data submission. Such circumstances may include, but are not limited to, problems with access to the sampling location, vandalism, on-site equipment failure, and extremely high or low stream flows.

3745-4-06 Appendix B. Guidelines for laboratory quality assurance plans.

All laboratories that perform analysis under a level 3 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). The elements covered in the QAM or QAP should, at a minimum, include the items listed in this appendix.

(1) Title page with authorization signatures and dates.

(2) Table of contents.

(3) Statement of quality assurance policy.

(4) Laboratory organization and responsibility, including:

(a) Organizational tables;

(b) Position descriptions for all personnel;

(d) Training procedures; and

(e) Description of records retained by the laboratory on employee training and performance.

(5) Data quality objectives for accuracy, precision, and reporting limits for each test, target analyte, and sample matrix.

(6) Analytical methods variances.

(7) Laboratory equipment and instrument lists.

(8) Sample receipt and chain-of-custody procedures. This section should include procedures for:

(a) Receiving samples;

(b) Sample login;

(d) Sample storage;

(e) Sample tracking; and

(f) Sample disposal.

(9) Laboratory standard operating procedures (SOPs) with dates of last revision. This section should include procedures for:

(a) Glassware preparation;

(b) Sample preparation;

(d) Sample analysis; and

(e) A description of quality control procedures that are required and followed for each method.

(10) Calibration procedures. This section should describe:

(a) The type of calibration used for each method;

(b) The criteria for acceptance or verification; and

(11) Preventive maintenance and documentation. This section should describe:

(a) The location of instrument manuals;

(b) Schedules for performance of routine equipment maintenance;

(d) Maintenance contracts in place.

(12) Internal quality control checks, frequency, and criteria for acceptability. This section may reference laboratory SOPs, and should include the frequency and acceptability of method detection limit (MDL) calculations.

(13) Data reduction, review, and reporting. This section could include discussion of the process used to do data assessment, evaluation of data completeness, comparability, and trends.

(14) Standard corrective action procedures for quality control failures.

(15) External and internal audits, accreditations, and certifications. This section should list all laboratory accreditations and certifications, and participation in inter and intra laboratory studies.

(16) Reports to management. This section should describe the various types of reports and meetings and their frequencies with management.

(17) Document retention and control. In this section, the lab should discuss its document retention schedule, storage, and retrieval procedures, including procedures for review and approval of revised lab documents (i.e., QAP and SOPs).

(18) Procedures for procurement and process control. This section should describe the laboratory’s policy and procedures for the selection and purchasing of equipment and supplies it uses that affect the quality of the environmental tests and calibrations.

(19) Sample handling and analysis.

Effective: 03/24/2006

R.C. 119.032 review dates: 03/24/2011

Promulgated Under: 119.03

Statutory Authority: 6111.51

Rule Amplifies: 6111.50, 6111.51, 6111.52, 6111.53, 6111.54, 6111.55, 6111.56