3745-4-05 Level 2 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 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. 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. 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 requirements in this paragraph 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 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 QDC or qualified data collection organization (level 2 or level 3) 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 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 2 QDC shall submit to the director a notification of the level 2 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 study 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 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 or whenever Ohio EPA makes available a generic study plan.

(3) All laboratories that perform analysis under a level 2 study plan must implement a quality assurance program and must 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 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 2 or level 3 QDC;

(e) A statement attesting 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 that 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 QAP that 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 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.

The director from time to time shall publish examples of acceptable level 2 analytical methods for commonly sampled parameters. Appendix C is the published list of such examples as of the effective date of this rule.

Appendix A Guidelines for the preparation of level 2 project study plans.

Persons preparing level 2 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 on this list is missing and there is no other comparable justification for the technical and scientific adequacy of the project study plan.

(1) The name and contact information (affiliation, address, electronic mail address, and phone number) for the qualified data collector designated as the project leader;

(2) If applicable, the names of other persons expected to assist with sample collection, sample analysis, and data entry, including the individuals’ status as qualified data collectors;

(3) If persons who are not level 2 or level 3 qualified data collectors are expected to assist with sample collection, sample analysis, or data entry, the plan must include detailed procedures for the supervision of those persons who are not level 2 or level 3 qualified data collectors;

(4) A clear statement of the objectives of the planned sampling activities, including data quality objectives, a precise delineation of the study area, and the general types of data to be collected (e.g., chemical water quality, stream habitat, stream flow, biological);

(5) A detailed description and map of the overall sampling area, including proposed sampling locations and the spacial relationship to specific point and nonpoint source issues (when applicable) that will be evaluated, and discussion of other factors that may influence water quality conditions within the study area;

(6) A list of the sampling equipment to be used, including model numbers and manufacturers of field meters and probes and flow current meters;

(7) A specific list of all parameters to be sampled and analyzed at each sampling location;

(8) Identification of field collection and data assessment techniques for stream habitat 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;

(9) For all stream flow measurements, identification of the methods used;

(10) A schedule of planned sampling activities, including the anticipated beginning and ending dates for sampling or alternatively, for ongoing sampling programs, the beginning and ending dates for the initial phase of sampling;

(11) Documentation that all project personnel identified as qualified data collectors have successfully demonstrated their qualifications and been approved by the director as level 2 or level 3 qualified data collectors in accordance with rule 3745-4-03 of the Administrative Code;

(12) If a 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 and all laboratory accreditations;

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

(14) A statement attesting that the qualified data collector acting as the lead project manager will maintain and make available to the director, for each sampling location, the name of the water body sampled, sampling location latitude and longitude, sampling location river mile where possible or practicable, general location information, the U.S. geological survey 7.5 minute quadrangle map name, and the purpose for data collection at each sampling location;

(15) A statement attesting that the qualified data collectors will maintain and make available to the director a digital photo catalog of all sampling locations, 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;

(16) A statement attesting that the qualified data collector acting as the lead project manager will provide to the director upon request ten voucher specimens of each identified taxonomic family of macroinvertebrates that are collected at sampling locations. All voucher materials shall be kept for at least ten years; and

(17) A certification from each qualified data collector working on the project attesting 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.

Appendix B Guidelines for laboratory quality assurance plans.

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). 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; and

(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; and

(b) The schedules for performance of routine equipment maintenance;

(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 or certifications, and participation in inter and intra laboratory studies.

(16) 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).

(17) 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.

Appendix C to rule 3745-4-05 of the Administrative Code.

Some examples of acceptable analytical methods for level 1 and level 2 credible data.

See Appendix C at http://www.registerofohio.state.oh.us/pdfs/3745/0/4/3745-4-05_PH_FF_N_APP1_20060310_0811.pdf

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