Chapter 3745-300 Voluntary Action Program

3745-300-01 Definitions.

[Comment: For dates of non-regulatory government publications, publications of recognized organizations and associations, federal rules, and federal statutory provisions referenced in this rule, see paragraph (B) of this rule titled "Incorporation by reference."]

(A) Except as otherwise provided in this chapter, the following definitions are applicable:

(1) "Acceptance limit" is the numerical range in which an analyte must be quantitated in a proficiency testing sample.

(2) "Active remediation" or "active remedy" is the remedial activities taken to reduce the mass, toxicity, mobility or concentration of a chemical of concern. Active remediation includes but is not limited to the removal of the hazardous substances or petroleum from the property or the design and installation of the following: air sparging; soil washing; pump and treat; steam stripping; soil vapor extraction; and enhancement of bioremediation. Active remediation may include short-term activities, such as soil removal and proper disposal, the construction of an engineering control, such as a cap or cover, or ground water gradient reversal. Alternately, active remediation may involve long-term activities such as ground water pump-and-treat systems.

(3) "Activity and use limitations" are one or more restrictions or obligations created under sections 5301.80 to 5301.92 of the Revised Code with respect to real property. Activity and use limitations eliminate or mitigate exposure to a release of hazardous substances or petroleum. Examples of activity and use limitations include but are not limited to land use limitations and ground water use restrictions. The term is known as institutional controls in rules 3745-300-07 , 3745-300-08 , 3745-300-09 , 3745-300-10 , 3745-300-11 and 3745-300-14 of the Administrative Code.

(4) "Actual costs" are the actual, substantiated direct, indirect and other costs associated with a specific voluntary action program activity.

(5) "Additional certification" is supplemental certification to perform analyses of specific analytes or parameter groups, using designated methods, for which the laboratory is not already certified pursuant to the laboratory's current certification under rule 3745-300-04 of the Administrative Code.

(6) "Affected media" are any environmental media present on or off property that contain concentrations of chemical(s) of concern.

(7) "Affected property" is a property, or portion thereof, for which a variance is being sought under rule 3745-300-12 of the Administrative Code.

(8) "Affiliated" means under common ownership or control.

(9) "Agency" or "Ohio EPA" is the Ohio environmental protection agency.

(10) "Analyte" is a hazardous substance or petroleum, or a constituent of a hazardous substance or petroleum.

(11) "Applicable standards" are standards established in or pursuant to sections 3746.05 , 3746.06 , and 3746.07 of the Revised Code, or rule 3745-300-07 , 3745-300-08 , 3745-300-09 , 3745-300-10 , or 3745-300-11 of the Administrative Code, as applicable.

(12) "Audit findings" means written documentation provided by certified mail to a person who has performed a voluntary action, the current owner of a property that has been the subject of a voluntary action, or a certified professional or certified laboratory, as appropriate, which indicates the results of an audit conducted pursuant to rule 3745-300-14 of the Administrative Code.

(13) "Background levels" are the conditions at a property and areas surrounding a property that are unaffected by any current or past activities involving treatment, storage, or disposal of hazardous substances or petroleum. Background levels include naturally occurring substances.

(14) "Biocriteria manual" means collectively, unless specified otherwise, "Biological Criteria for the Protection of Aquatic Life: Volume II" and "Biological Criteria for the Protection of Aquatic Life: Volume III" as cited in paragraph (B)(2) of this rule.

(15) "Capture zone" means all unsaturated and saturated subsurface areas that presently contribute or will contribute ground water to a well.

(16) "Central tendency value" is a parameter value from a probability distribution of parameter values which is an estimation of the median of that distribution.

(17) "Certificate" is the document issued by the director to an individual laboratory, certified under rule 3745-300-04 of the Administrative Code, that authorizes the laboratory to perform analyses in support of a request for a no further action letter for the specified analytes or parameter groups, and using the methods listed on the document, or the document issued by the director which acknowledges that an individual is a certified professional for the purposes of this chapter and Chapter 3746. of the Revised Code.

(18) "Certified" or "certification" is the authorization of a laboratory to perform analyses in support of a request for a no further action letter for the specific analytes or parameter groups and using the methods for which the director has determined the laboratory meets the requirements as set forth in rule 3745-300-04 of the Administrative Code, or the authorization of an individual to issue no further action letters under rule 3745-300-05 of the Administrative Code.

(19) "Certified laboratory" is a laboratory, either a fixed-base laboratory or mobile laboratory as defined by this rule, and certified by the director pursuant to rule 3745-300-04 of the Administrative Code.

(20) "Certified professional" is a person certified by the director pursuant to rule 3745-300-05 of the Administrative Code to issue no further action letters under section 3746.11 of the Revised Code.

(21) " Chemical of concern" are specific constituents of hazardous substances or petroleum which are on, underlying or emanating from a property, and are identified during a voluntary action.

(22) "Chemical-specific intake" is the measure of exposure of a receptor to the chemical of concern and is equivalent to the administered dose. Chemical specific intake is equal to the mass of a substance in contact with the exchange boundary of a receptor per unit body mass per unit time. For the purposes of this rule, chemical specific intake is expressed in units of milligrams per kilogram (mg/kg) per day.

(23) "Chemical testing method" is a method used for the preparation and analysis of an environmental sample to quantify for hazardous substances or petroleum, or constituents of hazardous substances or petroleum.

(24) "Class C release" means a release of petroleum occurring or identified from an underground storage tank system subject to sections 3737.87 to 3737.89 of the Revised Code for which the responsible person for the release is specifically determined by the fire marshal not to be a viable person capable of undertaking or completing the corrective actions required under those sections for the release. "Class C release" also includes any release designated as a "Class C release" in accordance with rules adopted under section 3737.88 of the Revised Code.

(25) "Complete exposure pathway" is a current or reasonably anticipated exposure pathway determined to be complete after the identification of current and reasonably anticipated property use and receptor populations and as a result of a pathway completeness determination.

(26) "Conflict of interest" is any circumstances which would affect the laboratory's ability to objectively analyze samples in connection with a voluntary action, including circumstances similar to those set forth in paragraph (E)(3) of rule 3745-300-05 of the Administrative Code for certified professionals.

(27) "Consolidated saturated zone" is a saturated zone in bedrock.

(28) "Consumer price index" means the "Midwest Consumer Price Index for All Urban Consumers for the U.S. Average for All Items" - unadjusted, index base period 1982-84 = 100, annual average as of the close of the twelve-month period ending on the thirty-first day of December of that year, as published by the United States department of labor.

(29) "Continuing education unit" is a unit of credit customarily used for professional development courses. One continuing education unit equals ten hours of actual instruction in an approved continuing education course.

(30) "Course" is any educational activity with a clear purpose and objective which will maintain, improve, or expand the skills and knowledge relevant to the investigation, assessment or remediation of hazardous substances or petroleum.

(31) "Covenant not to sue" is a release from civil liability that is issued by the director under section 3746.12 of the Revised Code.

(32) "Cumulative risk" is the estimate of excess lifetime cancer risk attributable to the exposure of a receptor or receptor population to one or more chemicals of concern in one or more environmental media, or through one or more routes of exposure.

(33) "Determination of sufficient evidence letter" is a notification from the director, pursuant to section 3746.02 of the Revised Code and this chapter, that a person or property that is the subject of an enforcement letter may or may not participate in the voluntary action program.

(34) "Diligent inquiry" means conducting a thorough search of all reasonably available information, and making reasonable efforts to interview persons with knowledge regarding current and past uses of the property, waste disposal practices, and environmental compliance history.

(35) "Director" is the director of the Ohio environmental protection agency, or the director's designee.

(36) "Discretionary audit pool" is any no further action letter submitted to the director with a request for a covenant not to sue in the preceding calendar year under section 3746.11 of the Revised Code that was either not included in or was not selected for audit from the random audit pool.

(37) "Document" is any record, device, or item, regardless of physical form or characteristic, including but not limited to, electronic or hard copy records of reports, studies, data, correspondence, and all other information.

(38) "Drinking water source protection area " is the surface and subsurface area surrounding a public water supply well that will provide water to the well within five years as delineated or endorsed by the agency under the wellhead protection program and the source water assessment and protection program.

(39) "Drinking water source protection plan" means the strategies to be implemented by a public water system to prevent, detect, and respond to water quality contamination in a drinking water source protection area, as adopted by the owner of the public water system and endorsed by the agency as meeting the requirements of the wellhead protection program and the source water assessment and protection program.

(40) "Enforcement letter" is a notification that the director intends to pursue enforcement under Chapter 3704., 3734., or 6111. of the Revised Code relating to a release or threatened release of hazardous substances or petroleum, in the form of an invitation to negotiate from the director which includes proposed director's final findings and orders.

(41) "Engineered fill" is soil or aggregate materials derived from on-property or off-property locations which has been placed on the property to meet specific engineering requirements for the construction of buildings, utility lines, roadway sub-grade, or other structures. Engineered fill includes structural fill.

(42) "Engineering control" is any structure, system, or barrier that effectively and reliably eliminates or mitigates human or important ecological resource exposure to hazardous substances or petroleum on, underlying or emanating from a property, which is protective of human health, safety and the environment.

(43) "Environmental covenant" is a servitude that imposes activity and use limitations on property that is the subject of a no further action letter submitted with a request for a covenant not to sue under section 3746.11 of the Revised Code. An environmental covenant meets the requirements established in section 5301.82 of the Revised Code.

(44) "Environmental media" are soil, sediment, surface water, and ground water. Environmental media also include naturally occurring transitional zones between soil, sediment, surface water or ground water, such as bedrock, soil gas, and air.

(45) "Exposure" is contact of a receptor with a chemical of concern that is quantified as the amount of the chemical of concern available for absorption at the exchange boundaries of the organism, such as the skin, lungs or gastrointestinal tract.

(46) "Exposure factor" is a parameter that defines one term in an equation used to quantify the exposure of a receptor to a chemical of concern by means of one exposure pathway. Exposure factors may be represented by point values or by a distribution of values.

(47) "Exposure factor point value" is a single numeric value selected from a distribution of numeric values of the exposure factor, selected on the basis of its representativeness of a central tendency or upper-bound value.

(48) "Exposure pathway" is a mechanism by which a receptor is exposed to chemical of concern.

(49) "Exposure point concentration" is the mass of a chemical of concern per unit quantity of medium which is available for intake by a receptor.

(50) "Exposure route" is the manner in which a chemical or physical agent comes into contact with an organism (for example, ingestion, inhalation, or dermal contact of soil).

(51) "Exposure unit" is a geographic area within which an exposed receptor may reasonably be assumed to move at random and where contact with environmental media is equally likely at all sub-areas.

(52) "Fixed-base laboratory" is a laboratory at a permanent location that provides for the analysis of environmental media.

(53) "Free product" is a separate liquid hydrocarbon phase that has a measurable thickness of greater than one one-hundredth of a foot.

(54) "Gallons" means U.S. gallons.

(55) "Generic direct-contact soil standard" is a generic numerical standard based on a single chemical exposure resulting from ingestion of soil, dermal contact with soil and inhalation of volatile and particulate emissions from soil.

(56) "Generic numerical standard" is a concentration of a hazardous substance or petroleum that exists on a property that ensures protection of public health and safety and the environment for the reasonable exposures associated with a residential, commercial or industrial land use, construction or excavation activities, or potable ground water use. Generic numerical standards include generic direct-contact soil standards, generic unrestricted potable use standards, and surface water standards.

(57) "Good moral character" is such character as will enable an individual to comply with the ethical responsibilities of a certified professional.

(58) "Ground water" for purposes of conducting a voluntary action, is water underlying a property in a saturated zone that meets the following criteria:

(a) Capable of yielding, within eight hours after purging, a minimum of one and one-half gallons of water as determined in accordance with paragraph (F)(2)(b) of rule 3745-300-07 of the Administrative Code.

(b) The in situ hydraulic conductivity is greater than 5.0 X 10-6 centimeters per second as determined in accordance with standards of paragraph (F)(2)(b) of rule 3745-300-07 of the Administrative Code.

This definition only applies to voluntary actions conducted under Chapter 3746. of the Revised Code and this chapter.

(59) "Hazard index" is a numerical value that describes the potential for an adverse non-cancer threshold effect to occur in an individual as a result of exposure of a receptor or receptor population to one or more chemicals of concern in one or more environmental media through one or more routes of exposure over a specific time exposure period. This numerical value is expressed as the unitless sum of the hazard quotient values for each chemical(s) of concern, each environmental medium and for each route of exposure.

(60) "Hazardous substance" includes all of the following:

(a) Any substance identified or listed in rules adopted under division(b)(1)(c) of section 3750.02 of the Revised Code .

(b) Any product registered as a pesticide under section 921.02 of the Revised Code when the product is used in a manner inconsistent with its required labeling .

(c) Any product formerly registered as a pesticide under that section for which the registration was suspended or canceled under section 921.05 of the Revised Code .

(d) Any mixture of a substance described in paragraphs (A)(60)(a) to (A)(60)(c) of this rule with a radioactive material.

(61) "Hazard quotient" is the value which quantifies non-carcinogenic risk for one chemical for one receptor population over a specified exposure period. The hazard quotient is equal to the ratio of a chemical-specific intake to the reference dose.

(62) "Historical records" means sources of information which assist in identifying current or past uses or occupants of a property, including but not limited to the following: aerial photographs, fire insurance maps, property tax files, recorded land title records, U.S. geological survey 7.5 minute topographic maps, local street directories, building department records, zoning or land use records that identify past uses or occupants of the property from its first commercial or industrial use through the present use, and records in the files of an owner or operator of the property.

(63) "Identified area" is a location at a property where a release of hazardous substances or petroleum has or may have occurred.

(64) "Imminent hazard" is any condition which poses a significant immediate risk of harm to public health, safety, or the environment, including, but not limited to, a threat of explosion, any discharge of hazardous substances or petroleum to surface water, any discharge of hazardous substances or petroleum to ground water that threatens to immediately impact drinking water supplies, releases of hazardous substances or petroleum into the air which could result in an exposure at or to a concentration of chemicals that is immediately dangerous to life or health, or any off-site migration or release of hazardous substances or petroleum which would threaten to immediately harm public health, safety, or the environment.

(65) "Important ecological resource" is any specific ecological community, population or individual organism protected by federal, state or local laws and regulations, or ecological resources that provide important natural or economic resource functions and values. Important ecological resources include, but are not limited to: any surface water, as that term is used in Chapter 3745-1 of the Administrative Code; any wetland regulated under federal law and state of Ohio's water quality laws; any dedicated natural area or preserve; any federally-listed or state-listed threatened or endangered species and its associated habitat; any state of Ohio special interest or declining species and its associated habitat; any state or national park; any federally designated wilderness area; any national lakeshore recreational area; any national preserve; any national or state wildlife refuge; any federal, state, local or private land designated for the protection of natural ecosystems; any federally-designated or state-designated scenic or wild river; any federal or state land designated for wildlife or game management; and wildlife populations and their associated important nesting areas and food resources, taking into consideration land use and the quality and extent of habitat on and in the vicinity of the property.

(66) "Incremental sampling" is a technique used to obtain a reproducible estimate of the exposure point concentration. An incremental sample is comprised of randomly collected sub-samples combined to form the sample.

(67) "Individual" is any person, but not a corporation, business trust, estate, trust, partnership, or association, as person is defined in section 1.59 of the Revised Code. Individual is also not this state, any political subdivision of this state, any other body of this state or of a political subdivision of this state, and the United States and any agency or instrumentality thereof.

(68) "Indirect costs" are all costs other than direct costs which may be attributed to a fee source including, but not limited to, administrative overhead, training of personnel, reporting to the legislature, rule development, guidance development, program marketing, database management, and word processing. Indirect costs will be determined by multiplying direct costs by the indirect rate.

(69) "Indirect rate" is the rate or percentage by which direct costs are multiplied to determine the indirect costs for a given fee or activity.

(70) "Industrial fill" is non-soil material that is derived from industrial or manufacturing operations and that has been placed on a property for the purpose of disposal, grading or construction.

(71) "Initial certification" is any first certification issued to a laboratory to perform analyses of specific analytes or parameter groups, using designated methods, under rule 3745-300-04 of the Administrative Code, or issued to an individual who is certified by the director to issue no further action letters under rule 3745-300-05 of the Administrative Code.

(72) "Institutional control" is a restriction that is recorded in the same manner as a deed which limits access to or use of the property such that exposure to hazardous substances or petroleum are effectively and reliably eliminated or mitigated. Examples of institutional controls include land and water use restrictions.

(73) "Interim measures" are remedial activities undertaken to protect public health and safety and the environment until the property complies with applicable standards through a permanent remedy.

(74) "Investigatory auditing activities" means activities conducted prior to the issuance of audit findings, including, but not limited to document review and analysis, field screening or sampling activities, and laboratory analysis.

(75) "Key property personnel" means a person or persons identified by the owner or operator of a property, and confirmed by the volunteer, as having reliable knowledge of the uses or physical characteristics of the property.

(76) "Laboratory" is a fixed-base laboratory or mobile laboratory that provides for the analysis of environmental media.

(77) "Laboratory compliance audit" is an inspection of a certified laboratory to evaluate compliance by the laboratory with its obligations as a certified laboratory under rule 3745-300-04 of Administrative Code and Chapter 3746. of the Revised Code which may include inspection of laboratory technology, operations, facilities, information and documents, and interviews with personnel.

(78) "Method" is the analytical procedure used to identify and calculate the concentration of an analyte or parameter group.

(79) "Method detection limit study" is a procedure with a final spiking concentration not to exceed the laboratory's reporting limit. Further, the procedure is that used by a laboratory to determine its ability to reliably and accurately report to a specific concentration for an analyte or parameter group using the method for which it is applying for certification.

(80) "Mobile laboratory" is a laboratory that is not fixed at a permanent location. Mobile laboratory data provide real-time analysis of environmental media at a location on or near a property.

(81) "Native fill" is soil material derived from the property and transferred from one area of the property and placed in another area in such a manner that the original soil structure and physical properties may be altered from the initial pre-excavation conditions, but the chemical and physical properties remain consistent with other undisturbed native soils at the property.

(82) "Natural attenuation" is the in situ biotic and abiotic processes through which passive remediation occurs. Natural attenuation processes can be non-destructive, including but not limited to the following physical processes: adsorption, absorption, advection, dispersion, diffusion, dilution from recharge, and volatilization. Natural attenuation processes can also be destructive, including but not limited to the following chemical processes: aerobic, hypoxic and anaerobic biodegradation, and chemical degradation, including abiotic oxidation processes, hydrolysis and other reactions.

(83) "Ninety-five per cent upper confidence limit" is the upper limit of an interval within a frequency distribution curve in which the observed mean of a data set will occur ninety-five per cent of the time.

(84) "No further action letter" is a document issued by a certified professional under affidavit upon determination by the person undertaking a voluntary action that either there is no information indicating there has been a release of hazardous substances or petroleum at or upon the property, or there has been a release of hazardous substances or petroleum at or upon the property and applicable standards were not exceeded or have been or will be achieved in accordance with Chapter 3746. of the Revised Code and rules adopted thereunder.

(85) "No further action letter submitted to the director" means those no further action letters submitted to the director for either of the following:

(a) A covenant not to sue has been requested from the director under division (D) of section 122.654 , sections 3746.11 and 3746.12 of the Revised Code and paragraph (H)(1) of rule 3745-300-13 of the Administrative Code .

(b) A covenant not to sue has not been requested from the director, but Ohio EPA is obligated to review the no further action letter under division (C) of section 122.654 of the Revised Code.

(86) "Operation and maintenance plan" is a written plan prepared in accordance with paragraph (E) of rule 3745-300-11 of the Administrative Code. An operation and maintenance plan describes the remedy or remedial activities planned to demonstrate that the property meets and will maintain compliance with applicable standards. As applicable, an operation and maintenance plan also describes the remedial activities planned so that the property will achieve compliance with applicable standards within five years or such other time frame as agreed upon by the director in an operation and maintenance agreement. The operation and maintenance plan must demonstrate that the property meets and will maintain applicable standards and the remedy continues to be protective of public health and safety and the environment.

(87) "Other person responsible for operation and maintenance plan and agreement implementation" is the person responsible for implementation of the operation and maintenance plan and agreement through transfer of the operation and maintenance agreement, by assignment or in conjunction with acquisition of title to the property.

(88) "Owner or operator" includes both of the following:

(a) Any person owning or holding a legal, equitable, or possessory interest in or having responsibility for the daily activities on a property .

(b) In the case of property title or control of which was conveyed due to bankruptcy, foreclosure, tax delinquency, abandonment, or similar means to this state or a political subdivision of this state, any person who owned, operated, or otherwise controlled activities occurring on the property before the conveyance.

(89) "Parameter group" is a group of analytes similar in chemical characteristics quantitated using a specific method and technology.

(90) "Passive remediation" or "passive remedy" is the remedial activities relied upon as in situ natural methods and documented in peer-reviewed scientific literature, which reduce the mass, toxicity, mobility or concentration of a chemical of concern over distance and time through natural attenuation processes as defined in this rule.

(91) "Peer-reviewed" is a document or study that meets the following criteria:

(a) The document or study has been published in a recognized scientific journal or publication .

(b) The document or study is generally-accepted within the scientific community as being accurate and reliable .

(c) The results contained in the document or study have been independently reproduced or the methods described in the document or study have been proven to produce consistent results.

(92) "Performance-based method" is a method designed to quantitate for an analyte or parameter group that is not listed in a method published or endorsed by U.S. EPA or Ohio EPA.

(93) "Person" is defined in section 1.59 of the Revised Code and also includes this state, any political subdivision of this state, any other body of this state or of a political subdivision of this state, and the United States and any agency or instrumentality thereof.

(94) "Petroleum" is oil or petroleum of any kind and in any form, including, without limitation, crude oil or any fraction thereof, petroleum, gasoline, kerosene, fuel oil, oil sludge, oil refuse, used oil, substances or additives utilized in the refining or blending of crude petroleum or petroleum stock, natural gas, natural gas liquids, liquefied natural gas, synthetic gas usable for fuel, and mixtures of natural gas and synthetic gas.

(95) "Phase I property assessment" is all the activities required to evaluate a property in accordance with rule 3745-300-06 of the Administrative Code, Chapter 3746. of the Revised Code and the standards provided in division (B) of section 3746.07 of the Revised Code.

(96) "Phase II property assessment" is all the activities required to evaluate a property in accordance with rule 3745-300-07 of the Administrative Code, Chapter 3746. of the Revised Code and the standards provided in division (C) of section 3746.07 of the Revised Code.

(97) "Point of compliance" is any location on or off the property to which applicable standards must be met and maintained.

(98) "Practically reviewable" means information provided in a manner and in a form that, upon examination, yields information relevant to the property. Records that cannot feasibly be retrieved by reference to the location of the property, the geographic area in which the property is located, or the name of the owner or operator of the property are not practically reviewable.

(99) "Professional development hour unit" is a unit hour for tracking continuing education, as required by paragraph (C) of rule 3745-300-05 of the Administrative Code.

(100) "Professional services" is any conduct in connection with a voluntary action or in rendering a voluntary action opinion.

(101) "Proficiency" is a demonstration of competence in projects similar in type and scope to voluntary actions.

(102) "Proficiency testing provider" is any entity that is accredited to provide proficiency testing samples and evaluate proficiency testing results by a proficiency testing oversight body/proficiency testing provider accreditor designated by the national environmental laboratory accreditation conference institute.

(103) "Proficiency testing result" is the result derived by the laboratory from the analysis of a proficiency testing sample.

(104) "Proficiency testing sample" is a material or matrix spiked with a known concentration of one or more specific analytes representative of the analyte or parameter group, and method for which the laboratory is applying for initial and additional laboratory certification. The proficiency testing sample is used to evaluate a laboratory's ability to identify and quantitate an analyte or parameter group using a specific method or technology.

(105) "Property," except for the purposes of sections 3746.02 , 3746.26 , and 3746.27 of the Revised Code, is any parcel of real property, or portion thereof, and any improvements thereto, the limits of which have been described in writing by the owner of record or a legally appointed representative of the owner and that is or has been the subject of a voluntary action under this chapter and Chapter 3746. of the Revised Code.

(106) "Property-specific risk assessment" is an analysis conducted in accordance with the requirements of rule 3745-300-09 of the Administrative Code. This process includes the following steps:

(a) Selection of chemicals of concern .

(b) Exposure assessment .

(c) Toxicity assessment .

(d) Risk characterization, including uncertainty.

(107) "Publicly available" means the source of the information allows access to the information by anyone upon request.

(108) "Quality assurance program plan" is a written document detailing the data collection, storage, analysis, and quality assurance/quality control procedures used by a laboratory to assure that all data generated are scientifically valid, defensible, and of known precision and accuracy.

(109) "Radioactive material" is a substance that spontaneously emits ionizing radiation.

(110) "Random audit pool" is the pool of all of the no further action letters submitted to the director with a request for a covenant not to sue in the preceding calendar year under section 3746.11 of the Revised Code. Properties with a remedy or a risk assessment that have been issued and submitted after completion of the process and procedures, as defined by the agency, to comply with the "2007 Memorandum of Agreement," between the agency and U.S. environmental protection agency, region 5, are excluded from the random audit pool.

(111) "Reasonably available" is a situation under which information is:

(a) Publicly available or known of and available to the volunteer or owner/operator of the property .

(b) Provided or made available by the source within ninety days of receiving a written request .

(c) Practically reviewable.

(112) "Receptor" or "receptor population" means humans or important ecological resources that are reasonably anticipated to come in contact with chemicals of concern, based on the distribution of the chemicals of concern on the property and the activity patterns of those humans or important ecological resources on or off the property.

(113) "Recognized educational institution" is an institution which is accredited by an appropriate regional board or association of institutions of higher education.

(114) "Reference concentration" is an estimate of a continuous inhalation exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime.

(115) "Reference dose" is a value representative of a daily exposure level for the human population, including sensitive subpopulations, that is not likely to cause an adverse non-cancer health effect during a specified period of time (for example, an acute, short-term, subchronic or chronic exposure period).

(116) "Release" is any spilling, leaking, pumping, pouring, emitting, emptying, discharging, injecting, escaping, leaching, migrating, dumping, or disposing of any hazardous substance or petroleum into the environment, including, without limitation, the abandonment or discarding of barrels, containers, or any other closed receptacle containing any hazardous substance, petroleum, or pollutant or contaminant. "Release" does not include any of the following:

(a) Any release that results solely in the exposure of individuals to hazardous substances or petroleum in the workplace with respect to which those individuals may assert a claim against their employer and that is regulated under the Occupational Health and Safety Act and regulations adopted under that act, or under Chapter 4167. of the Revised Code and rules adopted thereunder.

(b) Emissions from the engine exhaust of a motor vehicle, rolling stock, aircraft, vessel, or pipeline pumping station engine .

(c) Any release of a source, byproduct, or special nuclear material from a nuclear incident, as "source material," "byproduct material," "special nuclear material," and "nuclear incident" are defined in the Atomic Energy Act if the release is subject to financial protection requirements under section 170 of that act unless any such material is mixed with a hazardous substance or petroleum .

(d) Any federally permitted release as defined in section 101(10) of the Comprehensive Environmental Response, Compensation, and Liability Act .

(e) The normal application of a fertilizer material that is intended to improve the quality or quantity of plant growth.

(117) "Relevant professional experience" is experience obtained through conducting or supervising voluntary actions or projects similar in type and scope to voluntary actions. Such experience must indicate that the applicant is competent to conduct voluntary actions or render voluntary action opinions. Relevant professional experience does not include experience involving non-scientific or non-technical activities associated with assessment or remediation projects such as contract management, budget control, or other similar management activities.

(118) "Remedy" or "remedial activities" are actions that are taken at a property to treat, remove, transport for treatment or disposal, dispose of, contain, or control hazardous substances or petroleum, which are protective of public health and safety and the environment, and which are consistent with a permanent remedy, including, without limitation, excavation, treatment, off-property disposal, the use of engineering or institutional controls or measures, the issuance and implementation of a consolidated standards permit under section 3746.15 of the Revised Code, and the entering into and implementation of an operation and maintenance agreement pursuant to section 3746.12 of the Revised Code.

(119) "Renewal certification" is the renewal of a laboratory's current certification under rule 3745-300-04 of the Administrative Code or a certified professional's certification under rule 3745-300-05 of the Administrative Code.

(120) "Risk mitigation measures" are the health and safety precautions and other such remedial activities that mitigate or eliminate human exposure to the chemicals of concern at the property. Risk mitigation measures provide protection to persons working in construction or excavation in environmental media from exposure of chemicals of concern at concentrations above target risk goals, as defined in rule 3745-300-08 or 3745-300-09 of the Administrative Code. Risk mitigation measures also protect persons working in construction or excavation in environmental media from exposure to chemicals of concern where the risk is uncharacterized. Risk mitigation measures reduce potential risks to receptor populations performing excavation or construction activities that may breach the point of compliance for properties having institutional controls that limit land use or that may breach an engineering control, such as a soil cap or other structure.

(121) "Sediment" is unconsolidated inorganic and organic material that has precipitated and deposited below surface waters. Sediment includes the following:

(a) Materials below the water surface under bankfull conditions in streams, lakes and ditches .

(b) Materials below normal pool elevation for reservoirs .

(c) Materials within the federal and state jurisdictional boundaries of wetlands .

(d) Materials below maximum capacity for ponds and lagoons .

(e) Materials found below the ordinary high water mark of lake Erie, as defined by "International Great Lakes Datum."

(122) "Sole source aquifer" is an aquifer designated as a sole source aquifer under section 1424(e) of the Safe Drinking Water Act.

(123) "Source area" is any abandoned or discarded barrels, containers or any other closed receptacle in environmental media, or any affected media originally impacted by a release from which contamination is acting, has acted or has the potential to act as a point of origin for the migration of the release throughout the environment.

(124) "Split sample" is a material or medium that consists of two or more individual samples collected at the same time and location and that are analyzed independently; with each sample analyzed at a different laboratory.

(125) "Standard operating procedures" are a laboratory's written procedures to prepare samples and perform measurements of analytes or parameter groups.

(126) "Suspension period" is the period of time, listed on the final findings and orders issued by the director to a certified laboratory, in which the certified laboratory is suspended for an analyte or parameter group and corresponding method.

(127) "System audit" is an inspection of a laboratory to evaluate its qualifications for certification under rule 3745-300-04 of the Administrative Code and Chapter 3746. of the Revised Code, which may include inspection of laboratory technology, operations, facilities, information and documents, and interviews with personnel.

(128) "Technology" is the laboratory instrumentation used to quantify an analyte or parameter group. Examples include but are not limited to: gas chromatography, gas chromatography / mass spectrometry, and inductively coupled plasma.

(129) "Tier I audit" is a review and analysis of documents pertaining to a no further action letter held or produced by a certified professional, a volunteer, the current owner of the property, or a certified laboratory, as appropriate, and a site walkover of the property, in order to determine compliance with applicable standards, this chapter or Chapter 3746. of the Revised Code.

(130) "Tier II audit" is a physical inspection and investigation of a property upon which a voluntary action was conducted in order to determine compliance with applicable standards, this chapter or Chapter 3746. of the Revised Code, including sampling and analysis of soils, surface water, air, sediments, or groundwater.

(131) "Unconsolidated saturated zone" is any saturated zone that is not in bedrock, including, but not limited to, saturated zones in soil, gravel, sand, silt, clay or fill materials.

(132) "Unrestricted potable use standard" means ground water standards based on the assumption that ground water will be used as a source of water for drinking, cooking, showering, and bathing. Unrestricted potable use standards include generic unrestricted potable use standards based on maximum contaminant levels or other established regulatory criteria in accordance with rule 3745-300-08 of the Administrative Code, generic risk-derived unrestricted potable use standards developed in accordance with rule 3745-300-08 of the Administrative Code, or property-specific risk-derived unrestricted potable use standards developed in accordance with rule 3745-300-09 of the Administrative Code.

(133) "Upper-bound value" is a parameter value from a distribution of such values which is contained within the highest decile (ten per cent) of that distribution.

(134) "Urban setting designation" is an area where the potable use pathway is determined to be incomplete in accordance with paragraph (C) of rule 3745-300-10 of the Administrative Code. An urban setting designation does not eliminate the volunteer's responsibility to address non-potable pathways or to protect ground water meeting unrestricted potable use standards.

(135) "U.S. EPA sediment toxicity test" means "Methods for Measuring the Toxicity and Bioaccumulation of Sediment-Associated Contaminants with Freshwater Invertebrates."

(136) "Voluntary action" is a series of measures that may be undertaken to identify and address contamination and potential sources of contamination of properties by hazardous substances or petroleum and to establish that the property complies with applicable standards. "Voluntary action" may include, without limitation: a phase I property assessment; a phase II property assessment; a sampling plan; a remedial plan; remedial activities; or such other actions the volunteer considers to be necessary or appropriate to address the contamination, followed by the issuance of a no further action letter indicating that the property complies with applicable standards. To demonstrate that applicable standards have been met, the person undertaking such measures must establish either that there is no information indicating that there has been a release of hazardous substances or petroleum at or upon the property or that there has been a release of hazardous substances or petroleum at or upon the property and that applicable standards were not exceeded or have been or will be achieved in accordance with Chapter 3746. of the Revised Code and this chapter.

(137) "Voluntary action opinion" is any of the following:

(a) A no further action letter issued in accordance with this chapter and Chapter 3746. of the Revised Code .

(b) A written notice pursuant to division (B) of section 3746.11 of the Revised Code that the certified professional is not able to issue a no further action letter for a property because the property does not comply with applicable standards .

(c) An application for a variance pursuant to rule 3745-300-12 of the Administrative Code and section 3746.09 of the Revised Code .

(d) A request for an urban setting designation, pursuant to paragraph (C) of rule 3745-300-10 of the Administrative Code .

(e) A summary report prepared pursuant to division (C) of section 3746.11 of the Revised Code.

(138) "Voluntary action program" means the program created under Chapter 3746. of the Revised Code to provide a way to voluntarily investigate and clean up possible environmental contamination.

(139) "Volunteer" is a person conducting a voluntary action and any authorized representative of the person conducting the voluntary action. Volunteer does not include a responsible person, as defined by section 3737.87 of the Revised Code, for a Class C release on the property that is the subject of a voluntary action.

(B) Incorporation by reference. This chapter includes references to certain matter or material. The text of the incorporated materials is not included in the rules contained in this chapter. The materials are hereby made a part of the regulations in this chapter. For materials subject to change, only the specific version specified in this rule is incorporated. Any amendment or revision to a referenced document is not incorporated unless and until this rule has been amended to specify the new dates.

(1) Availability. The materials incorporated by reference are available as follows:

(a) " ASTM International" ASTM international documents are generally available at Ohio public libraries and the state library of Ohio. Information and copies may be obtained by writing to: "ASTM International, 100 Bar Harbor Drive, PO Box C700, West Conshohocken, Pennsylvania 19426-2959." These documents are available for purchase at http://www.astm.org.

(b) Code of Federal Regulations references. These regulations can generally be found in most Ohio public libraries and at the state library of Ohio, electronically at http://www.gpo.gov/fdsyshttp://www.ecfr.gov, or can be purchased from: "U.S. Government Printing, Superintendent of Documents, Mail Stop: SSOP, Washington, DC 20-402-9328."

(c) Federal Register. The Federal Register is available for inspection and copying at most Ohio public libraries and the state library of Ohio, and electronically at http://www.gpo.gov/fdsys. Information and copies may be obtained by writing to: "Superintendent of Documents, Attn: New Orders, PO Box 371954, Pittsburgh, PA 15250-7954."

(d) Government literature. The availability of these documents is provided with the reference to each document contained in paragraph (B)(2) of this rule.

(e) Ohio EPA technical documents. These documents are generally available in most Ohio public libraries and the state library of Ohio. Information and copies may be obtained by writing to: "Voluntary Action Program, Lazarus Government Center, PO Box 1049, Columbus, OH 43216-1049."

(f) Private publications. These publications are generally available at Ohio public libraries and the state library of Ohio. Information and copies may be obtained by writing to: "Voluntary Action Program, Lazarus Government Center, PO Box 1049, Columbus, OH 43216-1049."

(g) USC and USCA. These laws can generally be found in Ohio public libraries and the state library of Ohio, and electronically at http://www.gpo.gov/fdsys. Information and copies can may be obtained by writing to: "U.S. Government Bookstore, 732 N. Capitol Street NW, Washington, DC 20401."

(h) U.S. EPA technical documents. These documents are generally available in Ohio public libraries and the state library of Ohio. Documents listed in paragraph (B)(2) of this rule without an address can be ordered by writing to "Voluntary Action Program, Lazarus Government Center, PO Box 1049, Columbus, OH 43216-1049."

(2) Incorporated materials.

(a) "American Industrial Hygiene Association, Asbestos Analysts Registry, 2700 Prosperity Ave., Suite 250, Fairfax, VA 22031". http://www.aiha.org

(b) Appropriate "Federal Statutes," the statutes listed in this rule are those versions of the laws amended through July 1, 2013, including the following:

(i) Atomic Energy Act, 68 Stat. 919 , 42 U.S.C. 2011 et seq.

(ii) Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. 9601 et seq.

(iii) Federal Water Pollution Control Act, 86 Stat. 886 , 33 U.S.C. 1251 et seq.

(iv) Occupational Health and Safety Act, 84 Stat. 1590 , 29 U.S.C. 651 et seq.

(v) Resource Conservation and Recovery Act, 90 Stat. 2806 , 42 U.S.C. 6921 et seq.

(vi) Safe Drinking Water Act, 42 U.S.C. 300f , et seq.

(vii) Toxic Substances Control Act, 15 U.S.C. 2601 et seq.

(c) "ASTM E1527-13. Standard Practice for Environmental Site Assessments: Phase I Environmental Site Assessment Process ASTM International / 2013."

(d) "CHEMFATE Chemical Search, Syracuse Research Corporation, 7502 Round Pond Road, North Syracuse, NY 13212-2510." http://www.srcinc.com/what-we-do/environmental/scientific-databases.html.

(e) "Comprehensive Environmental Response, Compensation, and Liability Information System" list. http://www.epa.gov/enviro/html/cerclis/cerclis_query.html

(f) "Consumer Price Indexes. United States Department of Labor. Bureau of Labor Statistics, Division of Consumer Prices and Price Indexes, Suite 3130, 2 Massachusetts Avenue, NE, Washington, DC 20212-0001." http://www.bls.gov/cpi/.

(g) Corrective action program. http://www.epa.gov/epawaste/hazard/correctiveaction/index.htm

(h) Gerlach, R. W., and J. M. Nocerino. 2003. "Guidance for Obtaining Representative Analytical Laboratory Subsamples from Particulate Laboratory Samples." U.S. EPA, Washington, DC, EPA/600/R-03/027. http://www.epa.gov/osp/hstl/tsc/Gerlach2003.pdf.

(i) "Hazardous Substances Data Bank. National Library of Medicine's Toxicology Data Network, 8600 Rockville Pike, Bethesda, MD 20894." http://toxnet.nlm.nih.gov/.

(j) "Integrated Risk Information System. Toxicology data file on the National Library of Medicine's Toxicology Data Network." http://toxnet.nlm.nih.gov.

(k) MacDonald, D.D., Ingersoll, C.G. and Berger, T.A. 2000. "Development and Evaluation of Consensus-based Sediment Quality Guidelines for Freshwater Ecosystems. Arch. Environ. Contam. Toxicol. 39, 20-3."

(l) Mason, B. 1992. "Preparation of Soil Sampling Protocols: Sampling Techniques and Strategies." U.S. EPA, Washington, DC, EPA/600/R-92/128. http://www.epa.gov/OUST/cat/mason.pdf.

(m) Method detection limit study. 40 CFR Part 136, Appendix B (effective June 30, 1986).

(n) The national environmental laboratory accreditation conference institute standards. http://www.nelac-institute.org/.

(o) "National Institute of Standards Technology. National Voluntary Laboratory Accreditation Program for Asbestos Fiber Analysis, 100 Bureau Drive, M/S 2140, Gaithersburg, MD 20899-2140." http://ts.nist.gov/Standards/scopes/plmtm.htm.

(p) "National Priorities List." http://www.epa.gov/superfund/sites/index.htm

(q) Ohio department of natural resources. Water well log search. Ground water mapping and technical services. http://www.dnr.state.oh.us/water/maptechs/wellogs/app/.

(r) Ohio EPA. "Biological Criteria for the Protection of Aquatic Life: Volume II: Users Manual for Biological Field Assessment of Ohio Surface Waters. Division of Surface Water." Published in October 1987 and as amended through August 2008. http://www.epa.ohio.gov/dsw/bioassess/BioCriteriaProtAqLife.aspx.

(s) Ohio EPA. "Biological Criteria for the Protection of Aquatic Life: Volume III: Standardized Biological Field Sampling and Laboratory Methods for Assessing Fish and Macroinvertebrate Communities. Division of Surface Water. " Published in October 1989 and as amended through August 2008. http://www.epa.ohio.gov/dsw/bioassess/BioCriteriaProtAqLife.aspx.

(t) Ohio EPA. "Ecological Risk Assessment Guidance Document. Division of Emergency and Remedial Response." Published in February 2003 and as amended through April 2008. http://www.epa.ohio.gov/portals/30/rules/RR-031.pdf.

(u) Ohio EPA. "Manual of Ohio EPA Surveillance Methods and Quality Assurance Practices. Division of Surface Water." Published in 2006 and amended in 2012. http://www.epa.ohio.gov/portals/35/documents/Field_Manual_4_13_12_revision.pdf.

(v) Ohio EPA. "Sediment Sampling Guide and Methodologies, 2nd edition. Division of Surface Water." Published in November 2001. http://www.epa.ohio.gov/portals/35/guidance/sedman2001.pdf.

(w) Ohio EPA. "Support Document for the Development of Generic Numerical Standards and Risk Assessment Procedures. Division of Environmental Response and Revitalization." http://epa.ohio.gov/Portals/30/vap/docs/rules/Risk%20Support%20Document.pdf.

(x) Ohio EPA. "Technical Guidance Manual For Hydrogeologic Investigations and Ground Water Monitoring." Published in February 1995 and as amended through October 2009. http://www.epa.ohio.gov/ddagw/tgmweb.aspx.

(y) Ohio EPA. "Sample Collection and Evaluation of Vapor Intrusion to Indoor Air." Published in May 2010.http://epa.ohio.gov/portals/30/rules/Vapor%20Intrusion%20to%20Indoor%20Air.pdf.

(z) "The Physical Properties Database, Syracuse Research Corporation, 7502 Round Pond Road, North Syracuse, NY 13212-2510." http://www.srcinc.com/what-we-do/environmental/scientific-databases.html.

(aa) Source water assessment and protection program. http://www.epa.ohio.gov/ddagw/swap.aspx.

(bb) State emergency response commission. www.epa.ohio.gov/dapc/serc/index.aspx.

(cc) Underground injection control program. http://www.epa.gov/safewater/uic/

(dd) U.S. department of energy. 2006. "The Risk Assessment Information System. Office of Environmental Management, Oak Ridge National Laboratory." Oak Ridge, TN. http://rais.ornl.gov.

(ee) U.S. EPA. 1989. "Risk Assessment guidance for Superfund, Volume I: Human Health Evaluation manual (Part A). Office of Remedial Response." EPA/540/1-89/002. http://www.epa.gov/oswer/riskassessment/ragsa/pdf/rags_a.pdf

(ff) U.S. EPA. 2009. "Risk Assessment guidance for Superfund, Volume I: Human Health Evaluation manual (Part F). Office of Remedial Response." EPA/540/R-070/002.http://www.epa.gov/swerrims/riskassessment/ragsf/pdf/partf_200901_final.pdf.

(gg) U.S. EPA. 2001. "Risk Assessment guidance for Superfund, Volume III: Process for conducting probabilistic risk assessment (Part A). Office of Remedial Response." EPA/540/R-02/002.http://www.epa.gov/swerrims/riskassessment/rags3adt/pdf/rags3adt_complete.pdf.

(hh) U.S. EPA. 1989. "Risk Assessment guidance for Superfund, Volume II: Environmental Evaluation Manual. Office of Remedial Response." EPA/540/1-89/001. http://rais.ornl.gov/documents/RASUPEV.pdf.

(ii) U.S. EPA. 1991. "Human Health Evaluation Manual, Supplemental Guidance: Standard Default Exposure Factors. Office of Remedial Response. Office of Solid Waste and Emergency Response Directive." 9285.6 -03. http://Rais.ornl.gov/documents/OSWERdirective9285.6-03.pdf.

(jj) U.S EPA. 2009. "Statistical Analysis of Ground Water Monitoring Data at RCRA Facilities. Unified Guidance. EPA/R-09-007. Office of Resource Conservation and Recovery Program Implementation and Information Division. U.S. Environmental Protection Agency."http://www.epa.gov/osw/hazard/correctiveaction/resources/guidance/sitechar/gwstats/unified-guid.pdf.

(kk) U.S. EPA. 1992. "Supplemental Guidance to Risk Assessment Guidance for Superfund: Calculating the Concentration Term. Office of Solid Waste and Emergency Response." Washington, DC. OSWER Directive 9285.7 -081.

(ll) U.S. EPA. 1994. "Statistical Methods for Evaluating the Attainment of Cleanup Standards. Volume 3: Reference-Based Standards for Soil and Solid Media. Office of Policy, Planning and Evaluation." Washington DC. EPA 230-R-94-004. http://www.epa.gov/tio/download/stats/vol3-refbased.pdf.

(mm) U.S. EPA. 1997. "Exposure Factors Handbook. Office of Research and Development, National Center for Environmental Assessment." Washington, DC. EPA/600/P-95/002F. http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=12464.

(nn) U.S. EPA. 2000. "Methods for Measuring the Toxicity and Bioaccumulation of Sediment-Associated Contaminants with Freshwater Invertebrates, Second Edition. Office of Science and Technology, Office of Water." Washington, DC. EPA 600R-99/064. http://water.epa.gov/polwaste/sediments/cs/upload/freshmanual.pdf.

(oo) U.S. EPA. 2002. "Calculating Upper Confidence Limits for Exposure Point Concentrations at Hazardous Waste Sites." OSWER 9285.6 -10. http://www.epa.gov/swerrims/riskassessment/pdf/ucl.pdf.

(pp) U.S. EPA. 2002. "Guidance for Comparing Background and Chemical Concentrations in Soil for CERCLA Sites." EPA 540-R-01-003-OSWER 9285.7 -41. http://www.epa.gov/oswer/riskassessment/pdf/background.pdf.

(qq) U.S. EPA. 2002. "Supplemental Guidance for Developing Soil Screening Levels for Superfund Sites. Office of Solid Waste and Emergency Response." Washington, DC. OSWER 9355.4 -24. http://www.epa.gov/superfund/health/conmedia/soil/pdfs/ssg496.pdf.

(rr) U.S. EPA. 2003. "Region 5 Ecological Screening Levels (ESLs). RCRA Corrective Action." http://epa.gov/region05/waste/cars/pdfs/ecological-screening-levels-200308.pdf.

(ss) U.S. EPA. 2004. "Risk Assessment Guidance for Superfund: Volume I: Human Health Evaluation Manual (Part E, Supplemental Guidance for Dermal Risk Assessment). Office of Superfund Remediation and Technology Innovation." U.S. EPA, Washington, DC. http://rais.ornl.gov/documents/RAGS_E_EPA540R99005.pdf

(tt) U.S. EPA. 2006. "Guidance on Systematic Planning Using the Data Quality Objectives Process. Office of Environmental Information." Washington, DC. EPA/240/B-06/001. http://www.epa.gov/quality/qs-docs/g4-final.pdf.

(uu) "Voluntary Action Program Memorandum of Agreement Between the United States Environmental Protection Agency and the Ohio Environmental Protection Agency."http://epa.ohio.gov/portals/30/vap/docs/OH_MOA.pdf.

(vv) Drinking water source protection.http://epa.ohio.gov/ddagw/swap.aspx.

Effective: 08/01/2014
R.C. 119.032 review dates: 04/24/2014 and 08/01/2019
Promulgated Under: 119.03
Statutory Authority: 3746.04
Rule Amplifies: 3746, 5301
Prior Effective Dates: 12/29/1995, 12/16/1996, 3/4/2002, 4/19/2006, 3/1/2009, 4/23/12

3745-300-02 Eligibility for participation in the voluntary action program.

[Comment: For dates of non-regulatory government publications, publications of recognized organizations and associations, federal rules, and federal statutory provisions referenced in this rule, see paragraph (B) of rule 3745-300-01 of the Administrative Code titled "Incorporation by reference."]

(A) Applicability. Chapter 3746. of the Revised Code and this chapter apply only to the investigation, identification and remediation of hazardous substances or petroleum for property which is eligible for the voluntary action program. All property is eligible for the voluntary action program except as provided in this rule and Chapter 3746. of the Revised Code.

(B) Exceptions to eligibility. A property, that meets the description of one or more of paragraphs (B)(1) to (B)(8) of this rule is ineligible for participation in the voluntary action program. The application of this paragraph to a portion of a property does not preclude the participation under this chapter and Chapter 3746. of the Revised Code, of other portions of a property to which paragraphs (B)(1) to (B)(8) of this rule do not apply.

(1) National priorities list sites. Any property identified on the national priorities list, pursuant to the Comprehensive Environmental Response, Compensation and Liability Act, and regulations adopted thereunder.

(2) Properties subject to the underground injection control program. Any property or portion thereof which is subject to requirements for site assessment, removal, or remediation, pursuant to the Safe Drinking Water Act, 42 U.S.C. 300f - 300j and the regulations adopted thereunder, or Chapter 6111. of the Revised Code and rules adopted thereunder, regarding class I, II, III, and IV underground injection control wells.

Any property or portion thereof on which a class V underground injection control well is located is eligible for the voluntary action program if it is not the subject of an order or permit requiring site assessment, removal, or remediation of hazardous substances or petroleum.

(3) Properties subject to federal or state corrective action permit obligations. Any property or portion thereof which is required to perform corrective action, pursuant to a federal or a state permit issued under the Resource Conservation and Recovery Act (RCRA), and the regulations adopted thereunder, and Chapter 3734. of the Revised Code and rules adopted thereunder.

(4) Properties subject to federal enforcement. Any property that is the subject of a federal enforcement action which requires site assessment, removal, or remedial activities, pursuant to any federal laws and regulations, including, without limitation, the federal laws set forth in division (A) of section 3746.02 of the Revised Code. For the purposes of this paragraph, "federal enforcement action" includes but is not limited to the issuance of administrative or judicial orders, injunctions, and consent decrees.

(5) Closure required under Chapter 3734. of the Revised Code. Any property where closure of a hazardous waste facility or a solid waste facility is required under Chapter 3734. of the Revised Code or rules adopted thereunder.

(a) "Solid waste facility," for purposes of this paragraph, includes any facility as defined in section 3734.01 of the Revised Code, and rules 3745-27-01 and 3745-500-02 of the Administrative Code, including but not limited to sanitary landfill facilities, municipal solid waste disposal facilities, residual waste landfill facilities, industrial solid waste facilities, solid waste transfer facilities, scrap tire facilities, solid waste incinerator or solid waste energy recovery facilities, or composting facilities. "Property where closure of a solid waste facility is required" includes the following:

(i) Any solid waste facility for which a license, plan approval, permit-to-install, registration, or other authorization has been issued pursuant to Chapter 3734. of the Revised Code and rules adopted thereunder .

(ii) Any solid waste facility, for which closure activities have been completed in accordance with Chapter 3734. of the Revised Code, during the term of any applicable post-closure care period required by Chapters 3745-27, 3745-29, 3745-30, and 3745-560 of the Administrative Code.

(b) For the purposes of this rule, "property where closure of a hazardous waste facility is required" includes the following:

(i) Those portions of a property on which hazardous waste generator closure of any accumulation area is required pursuant to Chapter 3745-52 of the Administrative Code .

(ii) Those portions of a property on which "closure" of a "hazardous waste management unit" is required under Chapter 3734. of the Revised Code, as those terms are defined in section 3734.01 of the Revised Code, and rule 3745-50-10 of the Administrative Code, respectively, regardless of whether a hazardous waste facility installation and operation permit has been issued.

Properties on which "hazardous wastes," as defined in section 3734.01 of the Revised Code, were treated, stored, or disposed of, are required to be closed in accordance with Chapter 3734. of the Revised Code and rules adopted thereunder .

(iii) Any hazardous waste management unit described in paragraph (B)(5)(b) of this rule, for which closure activities have been completed in accordance with Chapter 3734. of the Revised Code, during the term of any applicable post-closure care period required by Chapters 3745-55 and 3745-66 of the Administrative Code.

[Comment: Division (H) of section 3734.02 of the Revised Code and rule 3745-27-13 of the Administrative Code require that authorization be received from the director prior to engaging in the filling, grading, excavating, building, drilling, or mining on land where a hazardous waste facility, or a solid waste facility was operated.]

(6) Petroleum underground storage tank systems. Any property that is subject to site assessment, removal, or remediation, pursuant to sections 3737.88 , 3737.882 , and 3737.89 of the Revised Code and rules adopted thereunder regarding underground storage tank systems, including any underground storage tank systems which contain or had previously contained petroleum. However, this paragraph shall not apply to property with either of the following:

(a) A class C release, provided that the volunteer is not a responsible person as defined in section 3737.87 of the Revised Code.

(b) A release other than a class C release, provided the following:

(i) The volunteer is not a responsible person, as determined by the fire marshal pursuant to Chapter 3737. of the Revised Code.

(ii) The voluntary action also addresses hazardous substances or petroleum that are not subject to the rules adopted under division (B) of section 3737.882 of the Revised Code pertaining to a corrective action.

(iii) The fire marshal has not issued an administrative order concerning the release or referred the release to the attorney general for enforcement.

(7) Oil and gas. Any property that is subject to site assessment, removal, or remediation, pursuant to Chapter 1509. of the Revised Code and rules adopted thereunder.

(8) Properties subject to an enforcement letter. Any property that is the subject of an enforcement letter from the director relating to a release or threatened release of hazardous substances or petroleum on, underlying or emanating from the property which poses a substantial threat to public health or safety or the environment, except when sufficient evidence of entry and participation in the voluntary action program is demonstrated, as provided in paragraph (C) of this rule.

(C) Sufficient evidence of entry into the voluntary action program. A property which is the subject of an enforcement letter may be eligible with respect to paragraph (B)(8) of this rule for participation in the voluntary action program upon satisfaction of the requirements of this paragraph.

(1) Following receipt of the enforcement letter, the person seeking to enter the voluntary action program ("proposed volunteer"), must present sufficient evidence to the director that the proposed volunteer has done the following:

(a) Has entered into the voluntary action program prior to receipt of the enforcement letter

(b) Is proceeding expeditiously to address the release or threatened release of hazardous substances or petroleum identified in the enforcement letter.

(i) Entry into the voluntary action program means commencing a voluntary action by completing a phase I property assessment report, retaining a certified professional to conduct the voluntary action, and conducting other activities identified in paragraphs (C)(2) and (C)(3) of this rule.

(ii) Proceeding expeditiously means conducting a voluntary action through the achievement of milestones which address the release or threatened release of hazardous substances or petroleum identified in the enforcement letter with a three year period, unless otherwise established by the director.

(iii) Milestones include, but are not limited to the following:

(a) Assessment of identified areas and releases or threatened releases of hazardous substances or petroleum identified in the enforcement letter.

(b) Completion of a phase II property assessment work plan.

(c) Completion of phase II property assessment activities or a phase II property assessment report.

(d) Completion of a risk assessment.

(e) Completion of a remedial action bench scale, treatability, pilot or similar study.

(f) Completion of a remedial action plan.

(g) Completion of soil and/or ground water remedies.

(h) Submittal of a no further action letter to the director.

(2) Not later than thirty days from the receipt of an enforcement letter, the proposed volunteer must submit to the director, and the director will consider, at a minimum, evidence showing completion of the following requirements:

(a) A phase I property assessment report, which meets the requirements contained in paragraph (G) of rule 3745-300-06 of the Administrative Code, was completed prior to receipt of the enforcement letter for the property for which a no further action letter will be sought .

(b) A detailed summary of planned data collection activities, a schedule for conducting planned data collection activities, a detailed description of how such data will be evaluated, and a general description of and estimation of the time frame for completing each milestone of the phase II property assessment activities and determinations described in paragraph (F) of rule 3745-300-07 of the Administrative Code and any other voluntary activities necessary to address the threat identified in the enforcement letter .

(c) Documentation of recent or ongoing activity at the property, which demonstrates that the proposed volunteer is proceeding expeditiously to achieve milestones which address the threat identified in the enforcement letter. Such documentation shall have been prepared prior to receipt of the enforcement letter. Recent completion of the activities required in paragraphs (C)(2)(a) and (C)(2)(b) of this rule may satisfy the requirements of this paragraph.

(3) Not later than sixty days from receipt of the enforcement letter, or such other time period as approved by the director, the proposed volunteer, through the certified professional, must demonstrate to the director that all existing documentation and data pertaining to the voluntary action have been reviewed by the certified professional and must submit to the director the following documentation:

(a) A copy of the contract between the proposed volunteer and the certified professional to complete the voluntary action, or an affidavit by a certified professional that verifies that the certified professional has been retained to complete the voluntary action and describes the scope of services the certified professional has been retained to provide with respect to the voluntary action .

(b) A schedule for completing a phase II property assessment in accordance with rule 3745-300-07 of the Administrative Code, if applicable .

(c) A schedule for completing the voluntary action in accordance with this chapter that specifies target milestone dates for completing the voluntary action, through submission of a no further action letter to the director.

(4) Upon the submission of all items contained in paragraphs (C)(2) and (C)(3) of this rule, the director will review those items for compliance with paragraph (C)(1) of this rule, determine whether the proposed volunteer has demonstrated sufficient evidence of entry into the voluntary action program and is proceeding expeditiously to address the release or threatened release of hazardous substances or petroleum identified in the enforcement letter, and send a determination of sufficient evidence letter to the proposed volunteer indicating whether the agency intends, at that time, to proceed with enforcement or to consider the proposed volunteer a participant in the voluntary action program.

(5) Upon receipt of the determination of sufficient evidence letter determining that the proposed volunteer has demonstrated sufficient evidence, the proposed volunteer may participate in the voluntary action program, unless otherwise ineligible pursuant to paragraphs (B)(1) to (B)(7) of this rule. In order to remain eligible with respect to paragraph (B)(8) of this rule, the proposed volunteer must do the following:

(a) Substantially comply with any schedule established pursuant to paragraphs (C)(3)(b) and (C)(3)(c) of this rule, as appropriate .

(b) Submit progress reports to the director. The initial report must be submitted within three months after receipt of the director's determination of sufficient evidence letter referenced in paragraph (C)(4) of this rule; thereafter progress reports must be submitted every three months, and must continue until submission to the director of a complete no further action letter for the property. Progress reports must include the following:

(i) A description of the status of the work and actions taken toward achieving compliance with the schedule of work and target milestone dates during the reporting period .

(ii) A description of any difficulties encountered or deviations from the schedule of work and target milestone dates during the reporting period and actions taken to address the difficulties or deviations .

(iii) A description of activities planned and target milestone dates for the next reporting period .

(iv) An identification of any replacement of or addition to the certified professional identified in the contract or scope of services affidavit submitted to the director pursuant to paragraph (C)(3)(a) of this rule .

(v) An indication of any anticipated change in the target or actual completion dates for each milestone of the voluntary action, including project completion, and an explanation for any deviation from any applicable schedules, which shall be subject to Ohio EPA approval.

(6) The requirements of paragraphs (C)(1) to (C)(5) of this rule do not have to be met prior to conducting a voluntary action if Ohio EPA has not taken any of the following actions within any continuous one year period following the issuance of an enforcement letter or a determination of sufficient evidence letter, whichever is later:

(a) Conducted inspections of or other investigation activities concerning the property;

(b) Taken samples at the property .

(c) Sent correspondence to any owners, operators, or other responsible parties concerning activities at or the condition of the property .

(d) Conducted discussions or negotiations with any owners, operators, or other responsible parties concerning activities at or the condition of the property .

(e) Exchanged correspondence, conducted discussions, or engaged in other activities with or on behalf of the U.S.EPA concerning site assessment, removal, or remediation activities in connection with the property.

Upon a submission to the director of a statement that Ohio EPA has not taken any of the foregoing actions contained in this paragraph within a continuous one year period following the issuance of an enforcement letter or a determination of sufficient evidence letter, whichever is later, the director will determine whether the statement of inactivity is true and, in a timely manner, respond in writing to the proposed volunteer as to whether the agency intends to proceed with enforcement or to consider the proposed volunteer a participant in the voluntary action program.

(7) Nothing in this rule precludes the agency from proceeding with an enforcement action at any time if any of the following occur:

(a) The volunteer does not expeditiously proceed with the voluntary action by adhering to the schedules submitted to Ohio EPA pursuant to paragraph (C)(5)(b) of this rule.

(b) The director determines that the volunteer is in violation of any of the requirements of paragraph (C) of this rule.

(c) The property is later determined to be ineligible for the voluntary action program under this chapter.

(8) The director shall provide written notice to a volunteer if the agency intends to proceed with an enforcement action pursuant to paragraph (C)(7) of this rule.

(D) A property which is ineligible for participation in the voluntary action program pursuant to paragraphs (B)(1) to (B)(8) of this rule may become eligible for participation upon a written demonstration to the agency's satisfaction that the property is no longer subject to the laws or regulations which made it ineligible. The demonstration must include a written statement from the applicable state or federal agency or department, which confirms that the property is no longer subject to such requirements.

Effective: 08/01/2014
R.C. 119.032 review dates: 04/24/2014 and 08/01/2019
Promulgated Under: 119.03
Statutory Authority: 3746.04
Rule Amplifies: 3746
Prior Effective Dates: 12/16/1996, 10/21/2002, 3/1/2009, 4/23/2012

3745-300-03 Voluntary action program fees.

(A) Applicability.

Fees shall be derived from the estimated actual costs, as defined in rule 3745-300-01 of the Administrative Code, associated with performing all of the tasks, duties and services related to the relevant application or voluntary action program activity. Fees shall be primarily based upon: the estimated typical time to complete each task, duty or service; the person or persons performing each task, duty or service; the applicable hourly rate plus fringe benefits for the person or persons performing the task, duty or service; and the estimated frequency of each task, duty or service.

(B) The voluntary action program fees for the activities listed below are as follows:

(1) Initial certification of professionals - $2, 500.00.

(2) Annual fee for certified professionals - $2, 000.00.

(3) Initial certification of of a fixed-base laboratory - $5, 000.00.

(4) Annual fee for certified laboratories - $ 500.00.

(5) No further action letter submitted for a covenant not to sue with no environmental covenant - $15,700 .00.

(6) No further action letter submitted for a covenant not to sue that includes an environmental covenant - $18, 200.00.

(7) No further action letter submitted for a covenant not to sue after having completed the voluntary action program memorandum of agreement track -$10, 000.00.

(8) No further action letter submitted for a covenant not to sue after having completed the voluntary action program memorandum of agreement track that includes an environmental covenant - $12, 500.00.

(C) For initial certification fees, a mobile laboratory shall pay the actual costs incurred by the agency relating to reviewing requests for certification pursuant to rule 3745-300-04 of the Administrative Code.

(D) In addition to payment of all applicable initial certification, and renewal certification fees pursuant to paragraph (B) of this rule, a certified laboratory shall pay the following:

(1) The actual costs incurred and invoiced by the agency that are associated with laboratory requests for modification of its certification or proposed revisions to its standard operating procedures or quality assurance program plans pursuant to rule 3745-300-04 of the Administrative Code.

(2) The actual costs, limited to travel costs, incurred by the agency in performing system audits pursuant to rule 3745-300-04 of the Administrative Code;

(3) The actual costs incurred by the agency in performing compliance audits pursuant to rule 3745-300-04 of the Administrative Code.

(4) The actual costs incurred by the agency that are associated with laboratory requests for additional certification for additional parameter groups, analytes or methods pursuant to rule 3745-300-04 of the Administrative Code.

(E) For all activities not addressed by paragraph (B), (C), or (D) of this rule, the actual costs incurred by the agency shall be charged to and paid by the beneficiary or subject, as applicable, of the activity. These activities may include, but are not limited to: providing site-specific technical assistance; reviewing demonstrations of sufficient evidence of entry into the voluntary action program; reviewing urban setting designation requests; reviewing a variance request, or a case-by-case groundwater demonstration; enforcing or administering compliance schedule agreements; monitoring compliance with operation and maintenance agreements, risk mitigation plans, or institutional controls; reviewing and approving remedy changes; and any other activities necessary for the enforcement or administration of this chapter and Chapter 3746. of the Revised Code.

(F) In addition to any applicable existing permit fees, any person requesting a consolidated standards permit shall pay the actual direct and indirect costs related to obtaining and administering the consolidated standards permit.

(G) Full payment of fees shall accompany any application or form, and shall be in the form of either a check or money order which indicates in the memo field the applicable fee or fees being paid. Fees are not refundable, unless specifically provided for in this chapter, and shall be made payable to "Treasurer, State of Ohio."

(H) Any certification, permit, covenant, renewal or other action by the director under this chapter or Chapter 3746. of the Revised Code which requires payment of a fee or cost shall not be made effective until full payment of all applicable fees or costs.

Replaces: 3745-300-03

Effective: 08/01/2014
R.C. 119.032 review dates: 08/01/2019
Promulgated Under: 119.03
Statutory Authority: 3746.04
Rule Amplifies: 3746
Prior Effective Dates: 12/29/1995, 7/1/2006, 3/1/2009, 4/23/2012

3745-300-04 Certified laboratories.

[Comment: For dates of non-regulatory government publications, publications of recognized organizations and associations, federal rules, and federal statutory provisions referenced in this rule, see paragraph (B) of rule 3745-300-01 of the Administrative Code titled "Incorporation by reference."]

(A) Certified data; authority of a certified laboratory, as defined in paragraph (A) of rule 3745-300-01 of the Administrative Code, to perform analyses.

(1) A certified laboratory produces certified data only when the analyses are performed within the laboratory's current certification.

(2) In order to produce certified data to support a voluntary action under this chapter and Chapter 3746. of the Revised Code, the laboratory must be certified for each analyte, parameter group and method, as defined in paragraph (A) of rule 3745-300-01 of the Administrative Code, used at the time it performs the analyses. Further, the laboratory's analyses must remain consistent with the laboratory's standard operating procedures and quality assurance program plan as defined in paragraph (A) of rule 3745-300-01 of the Administrative Code approved by the agency.

(3) Certification pursuant to this rule is applicable to analyses performed in support of a voluntary action, including but not limited to the issuance of a no further action letter under this chapter and Chapter 3746. of the Revised Code. Certification pursuant to this rule does not constitute certification under any other state or federal laboratory certification or accreditation program.

(4) For asbestos analyses performed in support of a no further action letter, the certified laboratory must maintain the accreditation provided in paragraph (B)(1)(c) of this rule.

(5) A volunteer may request that a certified laboratory analyze the constituents of a hazardous substance when a chemical testing method or technology, as defined in paragraph (A) of rule 3745-300-01 of the Administrative Code, does not exist to measure the concentration of the hazardous substance. When a hazardous substance is comprised of more than one constituent, the certified laboratory must obtain certification for each constituent, even if the constituent is not listed as a hazardous substance, as defined in paragraph (A) of rule 3745-300-01 of the Administrative Code.

(B) Methods for the analysis of analytes or parameter groups.

(1) A laboratory may apply for certification pursuant to this rule for any method used for the analysis of any analyte or parameter group that meets the following criteria , except as provided in paragraph (B)(2) of this rule:

(a) Chemical testing methods, as defined in paragraph (A) of 3745-300-01 of the Administrative Code. A laboratory may apply for certification for any chemical testing method published or endorsed by U.S. EPA . For the purpose of this rule, "endorsed" means any method referenced for use in a rule adopted by U.S. EPA . "Published" means any chemical testing method posted on a U.S. EPA web site that indicates the method is approved for public use. A laboratory must only use a published or endorsed method in the manner for which it is designed. A laboratory may apply for performance-based certification under paragraph (B)(1)(b) of this rule if an analyte or parameter group was listed in a published or endorsed method, but the design of the method prohibits the analysis of the analyte or parameter group.

(b) Performance-based methods as defined in paragraph (A) of rule 3745-300-01 of the Administrative Code. At the request of a laboratory, the agency may evaluate whether to certify a laboratory to perform analyses using a performance-based method. A laboratory must demonstrate its ability to perform the method using a proficiency testing sample as provided in paragraph (C)(1) of this rule, if available, and in accordance with the application requirements contained in paragraph (D)(4) of this rule.

(c) Asbestos accreditations. A laboratory applying for certification for the analysis of asbestos must have current accreditation in one or both of the following programs:

(i) American industrial hygiene association, asbestos analysts registry .

(ii) National institute of standards technology, national voluntary laboratory accreditation program for asbestos fiber analysis.

(2) Testing for characteristic hazardous waste or for radioactive materials is not included for certification under this rule.

[Comment: Ohio EPA coordinates with the Ohio department of health for its review of any release of radioactive materials or substances.]

(3) Testing for sediment toxicity is not included for certification under this rule. Testing for sediment toxicity, as required under paragraph (F)(2)(b) of rule 3745-300-09 of the Administrative Code, must follow all of the requirements for the "Hyalella azteca" bioassay and the "Chironomus tentans" bioassay following the methods contained in "Methods for Measuring the Toxicity and Bioaccumulation of Sediment-associated Contaminants with Freshwater Invertebrates."

[Comment: Ohio EPA coordinates the review of sediment toxicity testing results when required under paragraph (F)(2)(b) of rule 3745-300-09 of the Administrative Code.]

(C) Proficiency testing program.

(1) Use of proficiency testing samples; requirement to purchase proficiency testing samples through proficiency testing providers, as defined in paragraph (A) of rule 3745-300-01 of the Administrative Code.

(a) A laboratory applying for certification under this rule must analyze proficiency testing samples representative of the analytes or parameter groups for certification, and receive from the proficiency testing provider acceptable proficiency testing results pursuant to the criteria of this rule.

(b) The proficiency testing samples must be purchased from a proficiency testing provider that is approved to produce the proficiency testing samples and evaluate the proficiency testing results.

(c) For the purposes of this rule, a laboratory must analyze either a non-potable water or drinking water proficiency testing sample that was formulated and evaluated using the criteria established by the national environmental laboratory accreditation conference institute.

(d) This paragraph does not apply to certifications for asbestos or to the circumstances provided in paragraph (C)(2) of this rule.

(2) Criteria for analysis of proficiency testing samples; exceptions; waiver. To demonstrate compliance with this rule for any analyte or parameter group a laboratory must analyze proficiency testing samples, which a proficiency testing provider prepared and evaluated using national environmental laboratory accreditation conference non-potable water criteria, except as follows:

(a) When a non-potable water proficiency testing sample is not available for an analyte or parameter group for which the laboratory applies for certification, proficiency testing samples prepared and evaluated based on drinking water criteria may be used instead.

(b) For mobile laboratories applying for initial or additional certification, each proficiency testing sample must be analyzed while the laboratory is mobilized on location for a project and not at the laboratory's base of operations.

(c) For any analyte or parameter group for which the national environmental laboratory accreditation conference has not published any non-potable water or drinking water proficiency testing criteria or for which proficiency testing samples are not available, the agency may, at its discretion, waive the proficiency testing sample analysis prerequisite under this paragraph. In the case of a waiver, certification for the analyte or parameter group will be limited to the use of a performance-based method as described in paragraph (B)(1)(b) of this rule.

(3) Use of existing proficiency testing results. A laboratory may use the proficiency testing results obtained for another state or federal certification or accreditation program to demonstrate compliance with this rule, provided that the proficiency testing samples meet the requirements of this rule.

(4) Analysis of proficiency testing samples.

(a) The laboratory must analyze proficiency testing samples that include the analyte or parameter group which corresponds to the scope of its certification or application for certification.

(b) The laboratory may analyze a proficiency testing sample on more than one technology to demonstrate proficiency for an analyte or parameter group and method. For example, a laboratory applying for certification for volatile organic compounds by gas chromatography and gas chromatography/mass spectrometry may analyze the same proficiency testing sample on both technologies.

(c) Analysis of proficiency testing samples must be conducted in accordance with the laboratory's standard operating procedures and quality assurance program plan identified in paragraph (D) of this rule, and in accordance with paragraph (C)(2)(b) of this rule if the proficiency testing analysis is being conducted by a mobile laboratory.

(d) Compliance with this rule does not allow a laboratory to analyze more than one concentration level for a proficiency testing sample.

(e) The ordering and analysis of proficiency testing samples is based on a technology. To comply with this rule, a laboratory must order a proficiency testing sample based on the technology that is representative of the certification. For example, to encompass the scope of a certification for volatile organic compounds, the laboratory must ensure that the proficiency testing sample contains both aromatics and halocarbons.

(5) Reporting and time lines for proficiency testing studies.

(a) Reporting proficiency testing results. A laboratory that is certified or applying for certification for multiple technologies for an analyte or parameter group must analyze and report proficiency testing results for each technology, and may use the same proficiency testing sample. For example, the same volatile organic compound proficiency testing sample may be analyzed on gas chromatography and gas chromatography/mass spectrometry with a separate result reported for each technology.

(b) Time lines for the analysis of proficiency testing samples. A laboratory that intends to apply for any initial or additional certification under this rule, must have analyzed the proficiency testing sample within the six months prior to the date the laboratory submits its application to use those proficiency testing results to apply for certification, except as provided in paragraph (C)(2)(c) of this rule.

(6) Providing proficiency testing reports to Ohio EPA. A laboratory must submit proficiency testing reports to the agency as directed by this rule.

(a) Applications for initial or additional certification. A laboratory applying for initial or additional certification must submit to the agency a copy of each required proficiency testing report along with the documentation listed in paragraph (D)(1) of this rule.

(b) Proficiency testing report content. Each proficiency testing report submitted to the agency must include of the following:

(i) Name of proficiency testing provider .

(ii) Laboratory name and address .

(iii) Opening and closing dates of the proficiency testing study .

(iv) Date proficiency testing report was issued .

(v) Analyte or parameter group with units, reported value, assigned value, and acceptance limits .

(vi) Performance evaluation by proficiency testing provider .

(vii) Technology code or method description.

(7) Agency evaluation of proficiency testing results. A laboratory applying for initial or additional certification must meet the proficiency testing requirements provided as follows:

(a) The proficiency testing samples are acceptable for use based on the criteria provided in this rule for the analyte or parameter group for which the laboratory is applying for certification.

(b) The laboratory has obtained acceptable proficiency testing results for each analyte and parameter group using the methods and technologies for which it is applying for certification.

(c) The laboratory has submitted to the agency the proficiency testing report for proficiency testing samples analyzed within the time frame provided in paragraph (C) of this rule.

(d) At the director's discretion, the agency may require a laboratory applying for certification for a performance-based method to analyze non-potable water proficiency testing samples, or drinking water proficiency testing samples. These proficiency testing results will be used to evaluate a laboratory's qualifications to apply for the performance-based method. For example, a laboratory applying for initial or additional certification for n-Hexane by gas chromatography/mass spectrometry must provide acceptable proficiency testing results for a non-potable water volatile proficiency testing sample analyzed using the same technology and method.

(D) Procedures to apply for initial, additional, or renewal certification.

(1) Applications for initial or additional certification. To apply for initial or additional certification, a laboratory must submit to the agency a complete application, which consists of the following:

(a) A hard copy of the completed original application for initial or additional certification, as appropriate, on the form provided by the agency .

[Comment: All applications for certification under this rule may be downloaded from Ohio EPA's web site or are otherwise available upon request from the voluntary action program. In the case of initial certification for mobile laboratories, Ohio EPA may develop an application form that is different from the form designed for fixed-based laboratories.]

(b) A hard copy of the laboratory's quality assurance program plan .

(c) A hard copy of the laboratory's proficiency testing report, in accordance with paragraph (C) of this rule, for the analytes and parameter groups for which it is applying for certification. This requirement does not apply to sediment-toxicity methods and asbestos, or when proficiency testing samples are not required as described in paragraph (C)(2)(c) of this rule .

(d) A hard copy of the standard operating procedures for each analyte, parameter group and corresponding method for which the laboratory is applying for certification .

(e) A hard copy or electronic copy of the laboratory's method detection limit study performed as described by paragraph (A) of rule 3745-300-01 of the Administrative Code for each analyte and parameter group, and corresponding method, except for the analytes or parameter groups provided under paragraph (B)(1)(c) of this rule. The following information must be provided for each analyte and parameter group in spreadsheet format:

(i) Spiking concentration for each analyte or parameter group including units .

(ii) Method numbers for which the laboratory is applying for certification .

(iii) Extraction, digestion, distillation, preparatory, and analysis dates .

(iv) Individual results of the method detection limit study samples as defined in paragraph (A) of rule 3745-300-01 of the Administrative Code along with the calculated standard deviation, calculated method detection limit, and reporting limit for each analyte or parameter group .

(v) The laboratory must digest, extract, or distill all method detection limit study samples using the same procedures included in the standard operating procedures submitted under paragraph (D)(1)(d) of this rule.

(f) A hard copy of an affidavit, signed by a person authorized to submit the affidavit on behalf of the laboratory, affirming based upon knowledge, information, and belief that all information provided in the application and associated documentation is true, accurate, and complete .

(g) For a fixed-base laboratory applying for initial certification, payment of the non-refundable certification fee required by rule 3745-300-03 of the Administrative Code .

(h) For a mobile laboratory applying for initial certification or a certified laboratory applying for additional certification, the actual costs incurred by the agency as required by rule 3745-300-03 of the Administrative Code.

(i) The information listed in paragraph (D)(3) of this rule, if the laboratory is applying for certification for asbestos, or paragraph (D)(4) of this rule, if the laboratory is applying for certification for a performance-based method, as provided in paragraph (B) of this rule.

(2) Applications for renewal certification. A certified laboratory must submit to the agency a complete application at least ninety days prior to the expiration date listed on the laboratory's current certificate. A certified laboratory requesting certification changes must comply with the requirements provided in paragraph (D)(5) of this rule. A complete application consists of the following:

(a) A hard copy of the original completed application for renewal certification on the form provided by the agency .

(b) The payment of the non-refundable annual fee, required by rule 3745-300-03 of the Administrative Code .

(c) A hard copy of an affidavit, signed by a person authorized to submit the affidavit on behalf of the laboratory, affirming based upon knowledge, information, and belief that all information provided in the application and associated documentation is true, accurate, and complete.

(3) Applications for asbestos certification. A laboratory applying for initial or additional certification for the analysis of asbestos under paragraph (B)(1)(c) of this rule must submit a photocopy of a current certificate, or other form of documentation issued by either accreditation program listed in paragraph (B)(1)(c) of this rule. The submission must include the documentation required by paragraph (D)(1), excluding paragraphs (D)(1)(c) and (D)(1)(e) of this rule. A certified laboratory applying for renewal of its asbestos certification must submit a photocopy of a current certificate or other form of documentation issued by either asbestos accreditation program.

(4) Applications for performance-based method certifications. A laboratory applying for initial or additional certification for any performance-based method as provided in paragraph (B)(1)(b) of this rule, must submit the documents listed in paragraph (D)(1) of this rule and pay the fee required by rule 3745-300-03 of the Administrative Code , and provide the following:

(a) Laboratory check sample data. At a minimum, seven data points for each analyte or parameter group and matrix .

(b) Quality control limits derived from the data points collected under paragraph (D)(4)(a) of this rule .

(c) Any other information the agency deems appropriate.

(5) Modifications to certification. A certified laboratory may submit a request for a modification to the laboratory's certification, provided that the requested change is not subject to a requirement for initial, additional or renewal certification. The certified laboratory may only make such requests pursuant to paragraph (Q) of this rule.

(6) Requests for agency review of revised standard operating procedures or a quality assurance program plan must be made in accordance with paragraph (G) of this rule.

(E) Procedures used to evaluate laboratory applications for initial or additional certification.

(1) Ohio EPA's review of a laboratory's application for certification begins within thirty days from receipt of a complete application. An application that contains all of the information listed in paragraph (D) of this rule is considered complete. The agency's review of a complete application includes the following:

(a) A detailed review of the laboratory's standard operating procedures, quality assurance program plan, method detection limit studies, proficiency testing results, and any other information as provided in paragraphs (D)(1), (D)(3), and (D)(4) of this rule .

(b) A system audit, as defined in paragraph (A) of rule 3745-300-01 of the Administrative Code, of the laboratory applying for initial certification. The agency may, at its discretion, conduct a system audit of a certified laboratory applying for additional certification. System audits will be conducted in accordance with paragraph (J) of this rule .

(c) An audit report prepared by the agency within forty-five days from completion of the system audit. The audit report will indicate any deficiencies identified during the audit that require corrective actions by the laboratory in order for the agency to proceed with the laboratory's application for initial or additional certification .

(d) A review of laboratory responses to correct deficiencies identified during the system audit .

(e) A determination that the laboratory has paid the fee or costs as established in rule 3745-300-03 of the Administrative Code.

(2) To be recommended for certification, a laboratory must demonstrate to the director's satisfaction that the laboratory meets the requirements provided for certification under this rule and rule 3745-300-03 of the Administrative Code. The laboratory must also possess the ability to provide reliable, defensible, and representative data that satisfies the requirements for certified data under this rule and Chapter 3746. of the Revised Code using the standard operating procedures and documentation approved for use under this rule.

(3) Following successful completion of the requirements specified in paragraphs (C), (D), (E), and (J) of this rule, the director will provide to the laboratory a certificate identifying the analytes, parameter groups, and methods, for which the laboratory may perform analyses. These analyses may be used to produce certified data for use in support of a voluntary action, including a request for a no further action letter. The certificate automatically expires two years after the date of issuance, unless the laboratory's certificate is suspended, revoked, or renewed prior to the certificate's expiration. The certification expiration date for additional certification is the same as that of the laboratory's initial certification or renewal certification, as applicable. The certificate only applies to the individual laboratory facility identified in the certificate.

(4) Entities that own or operate multiple laboratories must apply for certification for each laboratory that will be performing analyses used in support of a request for a no further action letter.

(F) Procedures used to evaluate certified laboratory applications for renewal certification.

(1) A certified laboratory may only renew its certification under this rule for the analytes, parameter groups, and methods for which the laboratory is currently certified.

(2) As provided in paragraph (D)(2) of this rule, a certified laboratory must submit a complete renewal application at least ninety days prior to the expiration date listed on its current certificate. Any application received by Ohio EPA after the certificate's expiration date may require the laboratory to re-apply for initial certification in accordance with paragraphs (D)(1) and (R) of this rule. The agency's review of the application for renewal certification begins thirty days from receipt of a complete application. An application that contains all of the information listed in paragraph (D) of this rule is considered complete. The agency's review includes the following:

(a) Review of the laboratory's application to ensure that the laboratory is certified for the analytes, parameter groups and methods listed on the application .

(b) Review of agency findings from a system or laboratory compliance audit conducted in accordance with paragraph (J) of this rule .

(c) Review the laboratory's history on payment of its annual fee, as established in rule 3745-300-03 of the Administrative Code.

(3) The director may deny a laboratory's application for renewal certification if the director determines that the laboratory failed to satisfy any of the requirements of paragraph (D)(2), (F), or (H) of this rule.

(G) Procedures on how to request review of revised standard operating procedures or quality assurance program plan.

(1) A certified laboratory must notify the agency of any revisions to approved standard operating procedures or quality assurance program plan that is the subject of a certification under this rule prior to implementing any revision.

(2) A certified laboratory must submit to the agency the revised document along with a summary of any changes made to the document, including deletions and additions. The agency will notify the certified laboratory within fifteen calendar days either of the following:

(a) A technical review of the revised document is not necessary based upon the agency's review of the information submitted in accordance with paragraph (G)(2) of this rule. Upon receiving this notification, the certified laboratory may implement the revised document for use under its certification; or

(b) A technical review of the revised document is required by the agency. Once the technical review is complete, the agency will do either of the following:

(i) Send comments on the revised document to the certified laboratory.

(ii) Notify the certified laboratory that the revised document may be implemented for use under its certification.

(3) Upon receipt of the notification under paragraph (G)(2)(b)(ii) of this rule, the certified laboratory must provide final copies of all documents to the agency.

(4) The certified laboratory may not implement any revised document used in support of a request for a no further action letter until receipt of the agency's notification as provided in paragraphs (G)(2)(a) and (G)(2)(b)(ii) of this rule.

(5) The laboratory may be required to pay for any actual costs that the agency incurred in reviewing the revised standard operating procedures or quality assurance program plans pursuant to rule 3745-300-03 of the Administrative Code.

(H) Standards of performance and conduct for maintaining certification.

To maintain certification under this rule, a certified laboratory must do the following:

(1) Produce results as certified data pursuant to paragraph (A) of this rule whenever the laboratory is requested to provide data in support of a voluntary action under this chapter or Chapter 3746. of the Revised Code .

(2) Disclose when it does not hold certification for a requested analyte, parameter group or method included in a request for analysis. If the requester still requests the analysis to be performed, the laboratory must identify within the analytical report the results for which the laboratory is not providing certified data .

(3) Comply with the methods for which the laboratory is certified .

(4) Notify Ohio EPA, in writing, of any of the following:

(a) A change in managerial or quality assurance personnel .

(b) A change in laboratory operations that affects the laboratory's ability to perform analyses pursuant to this rule .

(c) A change in name or ownership of the laboratory

(d) A relocation of the laboratory, in whole or in part, to a separate location.

(e) A change in personnel responsible for signing affidavits.

(5) Perform acceptably on each laboratory compliance audit and system audit conducted pursuant to this rule, and correct in a timely manner the deficiencies identified by Ohio EPA. Certified laboratories must correct all deficiencies within the timeframe provided by Ohio EPA .

(6) Perform analyses in accordance with the laboratory's standard operating procedures and quality assurance program plan approved by Ohio EPA whenever the laboratory produces certified data .

(7) Disclose when it cannot quantify at or below an applicable standard specified in a request for analysis. The certified laboratory must provide certified data that detects chemicals of concern in environmental media at or below the applicable standards, unless the laboratory discloses that it is incapable of achieving an applicable standard under its certification. For example, if a certified laboratory that performs analyses in support of a no further action letter is not capable of detecting the chemicals of concern in environmental media at or below the applicable standards, the certified laboratory must notify the person requesting the analysis that the laboratory cannot quantify at or below an applicable standard using a method for which it is currently certified. The laboratory may disclose this information in the analytical report or by other means .

(8) Not falsify any information on any application, standard operating procedure, quality assurance program plan, or any proficiency testing result, or any certified data used in support of a no further action letter, or any other submittal to the agency .

(9) Not perform analyses in support of a request for a no further action letter for which the laboratory has a conflict of interest.

(10) Provide the agency access to the laboratory's facility and documents, data, or information related to any voluntary action, or laboratory certification, for the purposes of determining compliance with the requirements of this chapter, and Chapter 3746. of the Revised Code .

(11) Promptly and completely respond to all document and data requests made by the agency under this chapter and Chapter 3746. of the Revised Code .

(12) Pay all costs and fees required by rule 3745-300-03 of the Administrative Code .

(13) Submit, by affidavit, as required by this rule and rule 3745-300-13 of the Administrative Code, all information, data, documents and reports for use in support of a request for a no further action letter .

(14) Conduct laboratory operations in compliance with all applicable federal and state laws, regulations and rules, including but not limited to, requirements for management and disposal of samples that meet the definition of hazardous waste, and other hazardous wastes stored on property in compliance with Chapters 3745-52 and 3745-65 of the Administrative Code.

(I) Procedures for submittals under this rule.

All applications and payment of fees under this rule must be submitted to the agency by certified mail, courier delivery or any other form of mail or delivery accompanied by a receipt.

(J) Compliance and system audits.

(1) The agency will conduct laboratory compliance audits of a certified laboratory and its documentation to determine if the laboratory has performed in compliance with this rule, and Chapter 3746. of the Revised Code. The performance of laboratory compliance audits will be at the discretion of the agency, in accordance with this rule. For a certified mobile laboratory, a laboratory compliance audit will be conducted while the laboratory is mobilized on a project or at its headquarters. The agency will also conduct a laboratory compliance audit of the location where the data undergoes quality assurance review if not performed in the mobile laboratory. The agency may also conduct a laboratory compliance audit of any laboratory relocating its facility to a new location, or when there is a change in laboratory personnel, management personnel, operational procedures, or other functional issue or a complaint received regarding the laboratory's performance under the voluntary action program. A laboratory compliance audit may include, but is not limited to the following:

(a) Review of the laboratory's standard operating procedures, logbooks, sample storage procedures, instrumentation set-up and software programs, equipment calibration and maintenance procedures, data review procedures, record filing and storage, project management and communication procedures, data reporting procedures, record files, and data packages to determine compliance with the requirements of this rule .

(b) Interviews of laboratory personnel to determine knowledge of personnel who perform the analyses for compliance with this rule .

(c) Review of any other documentation that the agency considers appropriate to determine compliance with the requirements established pursuant to this rule.

(2) The agency will conduct system audits to evaluate a laboratory's qualifications to become certified to perform analyses used in support of requests for no further action letters in accordance with the requirements established in this rule. For a mobile laboratory, a system audit will be conducted while the laboratory is either mobilized on a project or at its headquarters. The agency will also conduct a system audit of the location where the data undergoes quality assurance review if not performed in the mobile laboratory. The agency may also conduct a system audit in review of a certified laboratory applying for additional certification. System audits will be conducted in accordance with the criteria established in paragraphs (J)(1)(a) to (J)(1)(c) of this rule.

(3) In order to receive initial or additional certification, the laboratory must correct the deficiencies, if any, identified by the agency during a system audit to the satisfaction of and within the time frame provided by the agency. Prior to applying for renewal certification, the laboratory must correct the deficiencies, if any, identified by the agency during either a compliance audit or system audit to the satisfaction of the agency.

(4) The agency may recover its actual costs for conducting audits pursuant to rule 3745-300-03 of the Administrative Code.

(K) Display of laboratory certificates.

All current certificates must be displayed in a prominent location in the laboratory.

(L) Retention of documents and data.

A laboratory must maintain all documents and data prepared or acquired in connection with a voluntary action for a period of at least ten years after the date that the laboratory's analyses were submitted to a certified professional or volunteer. The laboratory may retain the documents and data using any available technology provided that the laboratory can readily retrieve the documents and data in legible condition, when requested by the agency, during the ten-year retention period. After ten years, if a laboratory does not intend to retain such documents and data, the laboratory must notify the agency by mail or electronic submission of such intent and provide the agency the opportunity to obtain the documents and data. The documents and data must be retained until the notice described above is provided to the agency, and the agency notifies the laboratory in writing that the agency will or will not obtain the documents and data. Notification of the agency pursuant to this paragraph is not required as long as a laboratory continues to retain all documents and data.

(M) Out-of-state laboratories.

As a condition of certification under this rule, laboratories, or companies owning mobile laboratories, located outside the state of Ohio consent to service of process and to personal jurisdiction of any Ohio court or the Ohio environmental review appeals commission in proceedings that adjudicate any rights or obligations under this chapter, and Chapter 3746. of the Revised Code, or in which the cause of action involves, in whole or in part, the laboratory's performance under this chapter or Chapter 3746. of the Revised Code. Out-of-state laboratories also consent to the agency's right of entry for inspection or investigation, and to the service of administrative warrants, inspection warrants, or other appropriate search warrants as a condition of certification under this rule.

(N) Appeal of certification determinations.

The issuance, denial, suspension, or revocation of any laboratory certification is a final action of the director, which is subject to the procedure for appeal set forth in Chapter 3745. of the Revised Code.

(O) Revocation or suspension of certification.

(1) The director may revoke or suspend a laboratory's certification issued pursuant to this rule, for a period to be determined by the director, upon finding that a laboratory failed to comply with any of the requirements set forth in paragraph (H) of this rule, except as provided in paragraph (O)(2) of this rule.

(2) The director must permanently revoke a laboratory's certification if the laboratory does not comply with a request for documents and data made by the agency, in violation of paragraph (H)(11) of this rule. The director may permanently revoke a laboratory's certification if the laboratory falsifies any information in connection with its certification or any voluntary action, in violation of paragraph (H)(8) of this rule.

(3) Upon revocation or suspension, the laboratory must promptly return to the agency the certificate to which the revocation or suspension applies.

(P) Procedure to request reinstatement of certification.

(1) Procedures to request reinstatement of certification after a suspension period based on audit deficiencies or other noncompliance issues.

(a) A certified laboratory may request to reinstate its certification for a suspension issued because of the laboratory's failure to comply with paragraphs (H)(1) to (H)(7), (H)(9) to (H)(10) and (H)(12) to (H)(14) of this rule.

(b) After the suspension period, the laboratory may request reinstatement of its certification by providing a written request and any documentation to demonstrate that the laboratory has resolved all findings which resulted in the suspension.

(2) The laboratory may be required to pay any costs incurred by the agency in reviewing requests for reinstatement, pursuant to rule 3745-300-03 of the Administrative Code.

(Q) Procedures to request modifications to certificates.

(1) Any laboratory that requests a modification to its certificate to reflect changes in company name, address, or to update or remove methods from a certificate, must submit such requests on its application when applying for renewal certification, or through use of a cover letter when requesting a modification during a non-renewal period.

(2) The laboratory may be required to pay any costs incurred by the agencyin processing a request for modification of certification when such request is not submitted with an application for renewal certification. The agency may recover these costs pursuant to rule 3745-300-03 of the Administrative Code.

(R) Recertification following expiration of certification.

A laboratory whose certification has expired may be required by the director to apply for recertification. The laboratory's application for recertification must comply with the requirements for initial certification set forth in paragraphs (D) and (E) of this rule.

Effective: 08/01/2014
R.C. 119.032 review dates: 04/24/2014 and 08/01/2019
Promulgated Under: 119.03
Statutory Authority: 3746.04
Rule Amplifies: 3746
Prior Effective Dates: 12/29/1995, 7/1/2006, 3/1/2009, 4/23/2012

3745-300-05 Certified professionals.

(A) Criteria for certification.

(1) Individuals applying for certification must provide such information and evidence as the director deems reasonably necessary to enable the director to determine that the individual meets the qualifications set forth in this rule.

(2) The director will issue a certificate to an individual upon a demonstration, to the director's satisfaction, of the following:

(a) The individual has earned a minimum of a bachelor's degree from a recognized educational institution in one of the following areas: biology, chemistry, environmental sciences, geology, hydrogeology, toxicology, scientific subdisciplines of public health or hazardous waste management, appropriate areas of engineering, or in a curriculum determined to be equivalent by the director. The charter or accreditation of the recognized educational institution must have been effective as of the date the individual's degree was granted .

(b) The individual possesses eight years of relevant professional experience three of which are supervisory or project management related. Such experience must consist of an average minimum of twenty hours per week. Relevant professional experience that consists of less than an average minimum of twenty hours per week will be applied toward the satisfaction of this requirement on a pro rata basis .

(c) The individual possesses the professional competence and knowledge to perform the tasks required of a certified professional. This determination will be made by reviewing evidence including, but not limited to, references, agency comments on past work submitted to the agency, the application form and other sources the director deems appropriate. In order to make this determination, the director will consider the following:

(i) The proficiency of the individual;

(ii) The duration of the individual's relevant employment .

(iii) The previous performance of the individual with regard to various investigative methods used, including but not limited to, whether such experience includes work at sites where subsurface investigations involving hazardous substances or petroleum have occurred .

(iv) The previous performance of the individual with regard to the various types of remedial systems designed and monitored .

(v) The performance of the individual with regard to risk and exposure assessments .

(vi) The number of individuals and disciplines of other professionals supervised or coordinated by the individual .

(vii) The nature of conclusions reached and recommendations and opinions presented by the individual .

(viii) Any other factors the director deems relevant.

(d) The individual has completed initial certification training in accordance with this rule. Each individual applying for initial certification must complete initial certification training by attending all sessions of the initial certification training. Initial certification training will consist of at least eight hours of instruction pertaining to the technical implementation of Chapter 3746. of the Revised Code and this chapter and the standards of conduct a certified professional must exercise when providing professional services under Chapter 3746. of the Revised Code and this chapter.

(i) The training may be conducted by Ohio EPA or a third-party who implements the training in a manner and using materials approved by Ohio EPA. Ohio EPA will review, and, with or without modification, approve the training syllabi, and the scope and content of training and training materials used by a third party prior to their use at an initial certification training.

(ii) Ohio EPA or the third party who conducts the initial certification training may charge each person registering for or attending the initial certification training a non-refundable fee, established at a level sufficient to defray the actual costs of the training, the amount subject to Ohio EPA approval.

(iii) Upon the conclusion of each initial certification training, Ohio EPA or the third-party who conducted the training will provide each person who completed the initial certification training a certificate of completion. In the event a third party conducts the initial certification training, the third party must submit to Ohio EPA the name and contact information of each person who completed the initial certification training.

(iv) Initial certification training is valid for one year from the date the individual completes the initial certification training as provided in the certificate of completion. If the individual applying for initial certification does not submit the application within one year of completion of the initial certification training, the training must be retaken .

(e) Possesses good moral character . Evidence of an inability to comply with the ethical responsibilities required of a certified professional with good moral character includes, but is not limited to, acts involving dishonesty, fraud, or deceit.

(3) An individual who has earned advanced degrees from recognized educational institutions in addition to those required to meet the minimum educational requirements may request that the director credit that additional education toward the requirements for relevant professional experience if the individual can demonstrate, to the director's satisfaction, that the advanced degree constitutes relevant experience. Credit may be granted in accordance with the following:

(a) One year credit for each relevant master's degree .

(b) Two years credit for a relevant doctorate degree.

(c) A maximum of two years credit may be granted for such additional education.

(4) Certification will be denied if the director finds the following:

(a) The individual does not meet the requirements set forth in paragraph (A)(2) of this rule .

(b) The individual hascommitted an act involving dishonesty, fraud, or deceit or otherwise lacks sufficient honesty or integrity .

(c) The individual fails to pay the fees and costs as set forth in this chapter.

(5) An individual may be denied certification if the director finds that the individual is or was subject to certification or license denial, revocation, or suspension in this state, another state, or under a federal program.

(6) Except as provided in paragraphs (A)(4) and (A)(5) of this rule, an individual who meets the qualifications of paragraph (A)(2) of this rule and pays the application fee will be issued a certificate.

(B) Procedure for initial certification.

(1) An individual must submit to the director a complete and current application by certified mail, courier delivery or any other form of mail or delivery accompanied by a receipt, on forms provided by the director, and full payment of the non-refundable certified professional application fee, as set forth in paragraph (B)(1) of rule 3745-300-03 of the Administrative Code. The director may require the individual to furnish additional documentation pertaining to this application.

(2) The individual must submit official transcripts from the appropriate educational institutions to verify that the educational qualifications as specified in paragraphs (A)(2)(a) and (A)(3) of this rule are met.

(3) The individual must submit a certificate of completion demonstrating the individual's completion of the initial certification training in accordance with paragraph (A)(2)(d) of this rule.

(4) All documents and information submitted to the director pursuant to this paragraph must be accompanied by an affidavit from the individual affirming that upon knowledge, information, and belief, all information submitted in support of the individual's certification application is true, accurate and complete.

(5) The agency will conduct a completeness review of the application within fourteen days of receipt and will respond to the individual in the event that the application is incomplete. The agency will not consider an incomplete application and will notify the individual of any reasons the application is incomplete and of any additional information required for further consideration. The director will not initiate approval or denial of an application until the agency determines that a complete application has been received. Nothing in this rule prevents the agency from requiring an individual to promptly provide any information necessary to determine whether to approve or deny certification.

(6) Within forty-five days of the agency's determination that an application is complete, the director will either approve or deny certification. The initial certification is valid for one year from the date of approval. If the director denies certification, the director will provide a letter describing the deficiencies upon which the certification denial is based.

(7) Each individual has the burden of demonstrating to the director's satisfaction that the individual meets the requirements for certification. The agency may require an individual to appear for a personal interview for the purpose of answering questions pertaining to an application. If a personal interview is scheduled, the time for approving or denying an application as set forth in paragraph (B)(6) of this rule will be extended to twenty days from the date a personal interview is conducted. If an individual twice fails to appear for a personal interview scheduled with the agency, the application will be denied unless the agency finds such failure to appear was due to circumstances beyond the individual's reasonable control.

(C) Procedure for renewal of certification.

(1) An individual applying for certification renewal must submit to the director a renewal application by certified mail, courier delivery or any other form of mail or delivery accompanied by a receipt, on the form provided by the agency. The complete renewal application must be submitted before certification expires to maintain continuous certification. Submittal of a renewal application after the expiration date will result in a lapse in the individual's certification.

(2) A complete renewal application must include the following:

(a) Full payment of the annual fee set forth in paragraph (B)(2) of rule 3745-300-03 of the Administrative Code.

(b) Compliance with the standards of conduct set forth in paragraph (E) of this rule.

(c) Fulfillment of the continuing education requirements set forth in paragraph (C)(3) of this rule.

(d) Completion of initial certification training, if applicable, in accordance with paragraph (A)(2)(d) of this rule.

(e) All documents and information submitted to the director pursuant to this paragraph must be accompanied by an affidavit from the individual, affirming that upon knowledge, information, and belief, all information submitted in support of the renewal application is true, accurate and complete.

(3) To maintain certification, a certified professional must demonstrate to the director's satisfaction that the certified professional has completed a minimum of twelve professional development hour units in the certification period, as set forth in this rule, of relevant continuing education, or must obtain an excuse or modification of those requirements in accordance with paragraph (C)(10) of this rule. Professional development hour units may be earned as follows:

(a) Attendance at, and successful completion of relevant college courses, relevant continuing education courses, seminars, in-house courses, workshops, meetings, conventions, or conferences pertaining to investigation, assessment or remediation of hazardous substances or petroleum.

(b) Presentation and instruction at any courses, seminars, workshops or other meetings identified in paragraph (C)(3)(a) of this rule or instruction of courses in biology, chemistry, environmental sciences, geology, hydrogeology, toxicology, scientific subdisciplines, hazardous waste management, appropriate areas of engineering or other core courses that themselves do not qualify under paragraph (C)(3)(a) of this rule, but demonstrate the certified professionals knowledge of the subject matter relevant to the investigation, assessment or remediation of hazardous substances or petroleum.

(c) The director has final authority with respect to approval of courses, credit, professional development hour unit value for courses, and other methods of earning credit.

(4) The conversion of other units of credit to professional development hour units is as follows:

(a) Once college or unit semester hour equals twenty professional development hour units.

(b) One college or unit quarter hour equals fifteen professional development hour units.

(c) One continuing education unit equals ten professional development hour units.

(d) One hour of attendance at seminars, in-house courses, workshops, or professional or technical presentations made at meetings, conventions, or conferences equals one professional development hour unit.

(5) A certified professionals initial presentation or instruction of a course, seminar, workshop or other meeting described in paragraph (C)(3) of this rule will be eligible to receive credit for twice the professional development hour units that would be credited for attending the part of the course, seminar, workshop or other meeting presented or instructed by the certified professional. This additional credit is not available to full-time faculty.

(6) Professional development hour units will not be earned for the following:

(a) Any worker health and safety training.

(b) Any course, seminar or workshop designed primarily for hazardous waste facility personnel for training on the requirements of Chapter 3734. of the Revised Code or the rules adopted thereunder. Partial credit may be claimed and earned for the portions of such course, seminar or workshop that relate to the performance of a voluntary action, such as waste characterization and hazardous waste management requirements.

(c) Attendance at a course, seminar or workshop more than once in a certification period.

(7) A certified professional must earn a minimum of six of the twelve professional development hour units in the certification period by attending courses and seminars conducted by Ohio EPA that are approved for professional development hour units.

(8) A certified professional who has not submitted a no further action letter to the director in request of a covenant not to sue within the past four calendar years, must demonstrate having done either of the following:

(a) Attended and completed initial certification training in accordance with paragraphs (A)(2)(d)(i) to (A)(2)(d)(iii) of this rule within the past four calendar years.

(b) Attended and completed an alternative Ohio EPA-sponsored course or third party workshop approved by Ohio EPA pertaining to the technical implementation of Chapter 3746. of the Revised Code and this chapter, and the standards of conduct a certified professional must exercise when providing professional services under Chapter 3746. of the Revised Code and this chapter.

(9) Documents used to support professional development hour units claimed must be submitted with the renewal application and must include the following:

(a) A personal log or attendance verification document showing the date of the activity, type of activity claimed, sponsoring organization and the actual hours of instruction.

(b) Course summaries or conference agendas with details of the sessions attended.

(10) The director may excuse or modify the continuing education requirements of this rule for any certification period if a certified professional is able to demonstrate to the director's satisfaction that the certified professional is unable to complete the minimum requirements due to the following:

(a) Health reasons, as certified by a medical doctor.

(b) Active service in the armed forces of the United States.

(11) The agency will conduct a completeness review of the renewal application and respond to individual's applying for renewal within fourteen days of receipt of an incomplete application. The agency will not consider an incomplete application and will notify the individual of the reason the application is incomplete, and of any additional information required for further consideration. The director will not approve or deny an application until the director determines that a complete application has been received. Nothing in this rule prevents the agency from requiring the individual to promptly provide any information necessary to determine whether to approve or deny certification. If the individual provides the additional information required to complete the application after the expiration date of certification, there will be a lapse between certification periods. Individuals must verify that they have no lapse in certification at the time they issue any voluntary action opinions.

(12) The certified professional has sixty days after notification of an incomplete application to provide additional documentation, such as completion of additional professional development hour units, and submit such documentation as an addendum in accordance with paragraphs (C)(1) to (C)(2) of this rule.

(13) If the director determines that the certified professional has not submitted documentation of a completed application and the director denies renewal of a certification, the director will provide a letter describing the reasons for the denial of certification renewal.

(14) The certified professionals certification expires one year after the date of issuance, unless the certification is suspended or revoked prior to expiration. An individual whose certification has expired and has not been renewed within one year after the expiration date of the certificate cannot apply for renewal certification in accordance with paragraph (C)(1) of this rule, but may apply for certification as set forth in paragraphs (A) and (B) of this rule.

(D) Biocriteria certification.

(1) If the qualitative habitat evaluation index, index of biotic integrity, modified index of well-being, and the invertebrate community index are being used in support of a no further action letter, the certified professional or the certified professional's designated representative must do the following:

(a) Conduct these indices in accordance with the procedures contained in the biocriteria manual only for those indices for which the certified professional or the certified professional's designated representative have received approval for under paragraph (D)(1)(b) of this rule .

(b) Receive approval by the director for status under paragraph (B) of rule 3745-4-03 of the Administrative Code to be a qualified data collector for level 3 credible data for any one or a combination of the following:

(i) Stream habitat assessment.

(ii) Fish community biology.

(iii) Benthic macroinvertebrate biology.

(c) Submit with the no further action letter written documentation from the agency which states that the certified professional or the certified professional's designated representative received approval by the director for status under paragraph (B) of rule 3745-4-03 of the Administrative Code to be a qualified data collector for level 3 credible data.

(2) Qualified data collector level 3 status must be renewed every two years before it automatically expires. In order to be renewed, the certified professional or the certified professional's designated representative must meet the renewal requirements for status as a level 3 qualified data collector under paragraph (C) of rule 3745-4-03 of the Administrative Code.

(E) Standards of conduct.

The following standards apply to a certified professional only when providing professional services under Chapter 3746. of the Revised Code and this chapter:

(1) Professional competency.

(a) A certified professional must act with care and diligence, and must fully apply the certified professional's knowledge and skill at the time professional services are performed.

(b) A certified professional may render a voluntary action opinion only when the certified professional, individually, or together with other persons who are qualified by education, training, and experience in other areas outside the certified professional's area of professional practice, has done either of the following:

(i) Managed, supervised or actually performed the work which is required to render the voluntary action opinion .

(ii) Reviewed the work, performed by other qualified persons, which is required to render the voluntary action opinion.

(2) Professional responsibility.

(a) A certified professional must hold paramount public health, safety, welfare and the environment in the performance of professional services.

(b) If a certified professional identifies an imminent hazard at a property at which the certified professional is providing professional services, the certified professional must do the following:

(i) Immediately notify the volunteer, or the owner or operator of the property, if different from the volunteer, of the imminent hazard and of the need to notify the director .

(ii) Notify the director of the imminent hazard if the volunteer, or the owner or operator of the property, if different from the volunteer, does not submit written confirmation to the certified professional within forty-eight hours of identifying the imminent hazard that the hazard has been addressed or the director has been notified.

(c) If a certified professional discovers the occurrence of a release at or from a property that is subject to the requirements contained in section 3750.06 of the Revised Code, the certified professional must do the following:

(i) Immediately advise the volunteer, or the owner or operator of the property, if different from the volunteer, of the condition and the need to notify the director within the applicable time frame established in section 3750.06 of the Revised Code .

(ii) Notify the director of the condition if the certified professional is not able to notify the volunteer, or the owner or operator of the property, if different from the volunteer, within the applicable time frames established in section 3750.06 of the Revised Code.

(d) In the event that a certified professional knows or has reason to know of an action taken by a volunteer, or any person conducting work in connection with a voluntary action, that significantly deviates from any scope of work, plan, or report developed to meet the requirements of this chapter, or an order of the director issued under division (B)(3) of section 3746.12 of the Revised Code, the certified professional must promptly notify the volunteer in writing of such deviation.

(e) In providing professional services, a certified professional must do the following:

(i) Exercise independent professional judgment and be objective in any professional report, statement, or testimony .

(ii) Follow the requirements and procedures set forth in the applicable provisions of this chapter and Chapter 3746. of the Revised Code .

(iii) Make a good faith and diligent effort to obtain all relevant data, reports, and other available information regarding conditions at a property, and identify and obtain such additional data and other information as the certified professional deems necessary to provide professional services .

(iv) In rendering a voluntary action opinion, disclose and explain in the voluntary action opinion the relevant facts, data, and other information that support the voluntary action opinion, and all qualifications and limitations of the voluntary action opinion.

(f) In the event that, subsequent to the date that a certified professional issues a no further action letter, the certified professional learns that relevant facts, data or other information existed at the time the no further action letter was issued which indicates that applicable standards were not met, the certified professional must do the following:

(i) Promptly notify the volunteer or the owner or operator of the property, if different from the volunteer, that the applicable standards were not met and of the need to notify the director .

(ii) Notify the director that applicable standards were not met if the volunteer, or the owner or operator of the property, if different from the volunteer, does not submit written confirmation to the certified professional within thirty days of learning of the relevant facts, data, or other information, that the director has been notified.

(g) In the event that a volunteer prevents or attempts to prevent a certified professional from acting in accordance with paragraphs (E)(2)(e)(i) to (E)(2)(e)(iv) of this rule, the certified professional must sever the certified professional's relationship with the volunteer.

(h) A certified professional must not engage in fraudulent or dishonest business practices or allow the use of the certified professional's name by, or associate in a business venture with, any person or firm which the certified professional knows or should know is engaging in fraudulent or dishonest business practices.

(i) A certified professional must cooperate fully in the conduct of audits by the director and must promptly furnish such information as the director deems necessary to perform all audits under this chapter and section 3746.17 of the Revised Code.

(j) A certified professional must promptly and completely respond to all document requests made by the director under this chapter and Chapter 3746. of the Revised Code.

(3) Conflicts of interest and contingent fees.

(a) A certified professional must not accept compensation, financial or otherwise from more than one person for professional services regarding a property, unless the circumstances are fully disclosed in writing to, and agreed to by, all persons who contract with the certified professional for professional services with regard to that property.

(b) A certified professional must not render a voluntary action opinion with respect to any property owned, leased, or operated by or in which any of the following persons have an interest:

(i) The certified professional .

(ii) An employer or a person affiliated with an employer of the certified professional .

(iii) A relative or past relative of the certified professional .

(iv) A person, or any affiliated person, with whom the certified professional was employed during the year preceding, or in the year subsequent to, the date at which the certified professional entered into a contract with that person .

(v) Any person whose relationship with the certified professional may impact the certified professional's ability to discharge professional obligations under this chapter.

(c) In the event that a certified professional has, develops, or acquires any business association, direct or indirect financial interest, or other circumstance which could create an impression of influencing the certified professional's judgment in connection with performance of professional services, the certified professional must fully disclose in writing, to the person who has contracted with the certified professional for professional services, the nature of the business association, financial interest, or other circumstance.

(i) If the person who has contracted with the certified professional for professional services objects to such business association, financial interest or circumstance, the certified professional, at the certified professional's discretion, must either terminate the business association, financial interest or circumstances, or terminate the professional services pertaining to the voluntary action.

(ii) If a certified professional believes that a business association, financial interest or other circumstance renders the certified professional incapable of discharging professional obligations under this chapter regarding a voluntary action, the certified professional must terminate the certified professional's involvement regarding that voluntary action and avoid any further involvement regarding such action.

(d) A certified professional must not solicit or accept financial or other consideration from any person in return for specifying or endorsing the products or services of such person in connection with a voluntary action.

(e) A certified professional must not, directly or indirectly, provide professional services under a contingency arrangement whereby the amount of payment of any consideration to the certified professional is dependent upon or related to the attainment or non-attainment of a specified finding or result, or where the payment of any consideration to the certified professional in whole or in part is otherwise dependent upon or related to a specified finding or result of such services.

(f) A certified professional may not advertise or otherwise promise to any person that the certified professional will issue a no further action letter regarding a property, until the certified professional has determined that all requirements of Chapter 3746. of the Revised Code and this chapter have been satisfied.

(4) Affidavit requirement - voluntary action opinions.

Certified professionals must submit each voluntary action opinion by affidavit pursuant to this paragraph except for no further action letters that are subject to the affidavit provisions of paragraph (O) of rule 3745-300-13 of the Administrative Code. The certified professional must submit an affidavit based upon the certified professional's knowledge, information and belief, which includes the following:

(a) The name of the certified professional .

(b) Name and address of the property that is the subject of the voluntary action .

(c) The purpose for which the voluntary action opinion is being submitted .

(d) An identification of the information, data, documents, or reports included with the voluntary action opinion submitted with the affidavit .

(e) A statement attesting the certified professional has read all of the standards of conduct contained in paragraph (E) of this rule and is in compliance with the standards of conduct regarding the voluntary action opinion .

(f) A statement attesting the voluntary action opinion and the associated information, data, documents, or reports submitted by the certified professional are true, accurate and complete.

(F) Suspension or revocation of certification.

(1) The director may suspend or revoke the certification of a certified professional for a period of time to be determined by the director if the director finds any of the following:

(a) The certified professional's performance has resulted in the issuance of a no further action letter that is not consistent with applicable standards contained in this chapter or Chapter 3746. of the Revised Code .

(b) The certified professional has not substantially complied with section 3746.31 of the Revised Code or paragraph (H)(2) of this rule.

(2) The director will revoke the certification of a certified professional for a period of time to be determined by the director if the director finds that any information on the certified professional's application for initial certification or application for renewal or any information in connection with a voluntary action has been falsified.

(3) The director will permanently revoke the certification of a certified professional if the certified professional fails to comply with the director's request to provide documents, data or other information for the purposes of verifying the qualifications of the certified professional or for the purpose of auditing the performance of the certified professional made by the director in connection with an audit under rule 3745-300-14 of the Administrative Code.

(4) The director may suspend for a period of not more than five years, or permanently revoke a certified professionals certification if the director finds any of the following:

(a) The certified professional has violated or failed to comply with the standards of conduct established in paragraph (E) of this rule.

(b) The certified professional has been denied certification for performing environmental work in this state, another state, or under federal programs.

(c) The certified professional's certification for performing environmental work in this state, another state, or under federal programs has been revoked or suspended.

(d) The certified professional has used the certified professional seal described in paragraph (K) of this rule in an unauthorized manner.

(e) The certified professional has committed an act involving dishonesty, fraud, or deceit.

(f) The certified professional has failed to make annual fee payments in accordance with paragraph (C)(1) of this rule and paragraph (B)(2) of rule 3745-300-03 of the Administrative Code.

(g) The certified professional's certification has been suspended or revoked under this chapter on at least two occasions.

(5) A certified professional whose certification has been suspended or revoked must immediately provide notification of the suspension or revocation, by certified mail, to all persons who have contracted with the certified professional for professional services, or who have had a no further action letter prepared by the certified professional. The certified professional must provide to the director a copy of all notifications required by this paragraph within ten days of the date of the certified mailing.

(6) The director will not revoke the certification of a certified professional who conducts voluntary actions only at properties contaminated solely with petroleum, unless the director first consults with the director of the department of commerce.

(7) The director will provide at least thirty days notice to a certified professional of an ensuing suspension or revocation action by the director. The notice will include a general explanation of the suspension or revocation action.

(G) Recertification after suspension or revocation.

(1) An individual whose certification has been suspended, and has not been renewed within one year after the date of expiration, may apply for recertification after termination of the suspension period imposed by the director. Such application must comply with the criteria and procedures for initial certification set forth in paragraphs (A) and (B) of this rule.

(2) An individual whose certification has been revoked may apply for recertification after termination of the revocation period imposed by the director. Such application must comply with the criteria and procedures for initial certification set forth in paragraphs (A) and (B) of this rule.

(H) Document retention and production.

(1) The following criteria are applicable to all voluntary actions for which professional services are rendered:

(a) A certified professional must maintain all documents and data prepared or acquired in connection with a voluntary action for a period of at least ten years. After ten years, if a certified professional does not intend to retain such documents, the certified professional must notify the director by certified mail of such intent and provide the director with the opportunity to obtain all documents. The documents must be retained by the certified professional until the notice described above is provided to the director and the director notifies the certified professional in writing that the director does intend to obtain the documents. If the director notifies the certified professional in writing that the director does not intend to obtain the documents, the certified professional may discard the documents. Notification of the director is not required as long as a certified professional continues to retain all documents.

(b) If a certified professional no longer intends to retain certification, the certified professional may return the certificate with a notice by certified mail to the director indicating the certified professional's intent to withdraw from certification. Upon withdrawal, the certified professional must promptly provide the director the opportunity to obtain all documents maintained under this chapter in the same manner as identified in paragraph (H)(1)(a) of this rule.

(2) The director will, upon the written request of any person for documents not in the possession of the director and described on a list included in a no further action letter submitted to the director, send a written request to the certified professional to submit such documents to the director within a reasonable period of time. Upon receiving the written request from the director, the certified professional must submit the original documents to the director, within the time period specified in the director's request. Within a reasonable period of time after the director receives the requested documents, the director will provide copies of the documents, at cost, to the person who requested the documents and will retain the originals in the agency's files.

Any request for reproduction of documents must be made through the director.

(I) Summary reports.

A certified professional must prepare and retain a voluntary action summary report, detailing the certified professional's findings and conclusions regarding the environmental conditions at each property for which the certified professional was requested to prepare a no further action letter, in accordance with division (C) of section 3746.11 of the Revised Code and paragraph (J) of rule 3745-300-13 of the Administrative Code and in a format prescribed and provided by the agency.

(J) Appeal of certification determinations.

The issuance, denial, suspension, or revocation of certifications are final actions of the director, and are subject to the procedure for appeal set forth in Chapter 3745. of the Revised Code.

(K) Certified professional's seal.

(1) For the purpose of rendering a voluntary action opinion, each certified professional must procure and use an embossing device for a seal. A rubber stamp may be used in addition to the embossing device for purposes of recording the individual's certification dates. The design, arrangement, size and wording of the seal must conform with the specifications as prescribed by the agency.

(2) The certified professional's seal is intended for the certified professional's official use only in connection with voluntary action opinions for which the certified professional is responsible, and is not transferable.

(3) A certified professional must use the seal to attest that, in the certified professional's professional judgment, the voluntary action opinion upon which it appears complies with the provisions of this chapter and Chapter 3746. of the Revised Code.

(4) A certified professional may not allow the official seal to be affixed to any document associated with any project which is not a voluntary action or to any voluntary action opinion not prepared by the certified professional or under the certified professional's personal supervision.

(5) An individual whose certification has expired and has not been renewed, or has been revoked or suspended must not allow the official seal to be affixed to any document associated with a voluntary action opinion unless and until such individual is recertified as a certified professional in accordance with this rule.

(L) Out-of-state certified professionals.

As a condition of certification under this rule, certified professionals located outside the state of Ohio hereby consent to service of process and to personal jurisdiction of any Ohio court or the Ohio environmental review appeals commission in proceedings which adjudicate any rights or obligations under this chapter, and Chapter 3746. of the Revised Code, or in which the cause of action involves, in whole or in part, the certified professional's performance under this chapter or Chapter 3746. of the Revised Code. Out-of-state certified professionals also hereby consent to the agency's right of entry for inspection or investigation, and to the service of administrative warrants, inspection warrants, or other appropriate search warrants as a condition of certification under this rule of the Administrative Code.

Effective: 08/01/2014
R.C. 119.032 review dates: 04/24/2014 and 08/01/2019
Promulgated Under: 119.03
Statutory Authority: 3746.04
Rule Amplifies: 3746
Prior Effective Dates: 12/29/1995, 12/16/1996, 3/4/2002, 4/19/2006, 3/1/2009, 4/23/2012, 4/18/13

3745-300-06 Phase I property assessments for the voluntary action program.

[Comment: For dates of non-regulatory government publications, publications of recognized organizations and associations, federal rules, and federal statutory provisions referenced in this rule, see paragraph (B) of rule 3745-300-01 of the Administrative Code titled "Incorporation by reference."]

(A) The purpose of a phase I property assessment under the voluntary action program is to determine whether there is any reason to believe that any releases of hazardous substances or petroleum have or may have occurred on or from a property including any release from management, handling, treatment, storage, or disposal activities from on or off-property activities. The scope of a phase I property assessment is to characterize a property for the purposes of participation in the voluntary action program and to determine the necessity for and initial scope of a phase II property assessment.

[Comment: If the voluntary action is part of a property transfer or is to be financed in part or in whole by a lending institution, additional requirements for an environmental investigation at the property may be required by the lending institution.]

(B) Upon completion of the phase I property assessment, if the volunteer has information that establishes any reason to believe that any releases of hazardous substances or petroleum, have or may have occurred on or from the property, including any release from management, handling, treatment, storage, or disposal activities from on or off-property activities, the volunteer must conduct, at a minimum, a phase II property assessment that addresses each release in accordance with rule 3745-300-07 of the Administrative Code prior to obtaining a no further action letter from a certified professional, except when paragraph (E)(2) of this rule is applicable.

(C) The volunteer must, at a minimum, perform a review of the historic and current uses of the property, review the environmental history of the property, and review the history of the property pertaining to the treatment, storage, management, or disposal of hazardous substances or petroleum, and the existence of source areas on the property and must conduct a property inspection. Any current owner of a property upon which a voluntary action is being conducted must provide to the volunteer any information known by that owner which may be relevant to determining the existence of source areas on the property or whether treatment, storage, management, or disposal of hazardous substances or petroleum occurred or may have occurred at the property. Any information that is determined not to be reasonably available, as defined in this chapter, must be identified and an explanation must be provided in the phase I property assessment report as to why it was not reasonably available.

(1) Historic and current uses of the property. The objectives of this portion of the phase I property assessment are to establish a continuous history of the uses of the property, to determine if those uses may have included the treatment, management, handling, storage or disposal of hazardous substances or petroleum, which have or may have led to any releases of hazardous substances or petroleum on or from the property.

The volunteer must identify the first industrial or commercial use of the property through and including the present use of the property. To complete the property history portion of the phase I property assessment, a volunteer must perform the following as necessary to provide a continuous history:

(a) History analysis. A diligent inquiry of reasonably available historical records to establish a continuous history of the use of the property, including significant changes in the use of the property, and to determine what, if any, hazardous substances or petroleum are or may be present on or from the property.

(b) Chain of title investigation. A review of the chain of title for the property to evaluate current and previous ownership and identifiable uses of the property. The investigation must include a review of documents pertinent to determining whether there is any reason to believe that any releases of hazardous substances or petroleum have or may have occurred onor from the property. The documents include but are not limited to: deeds, mortgages, easements of record and similar documents that are reasonably available to the volunteer; and

(c) Interviews. Reasonable attempts to locate and conduct interviews with persons who reside or have resided, or who are or were employed at or within the areas surrounding or adjoining the property regarding the current and past uses of the property to determine if there is any reason to believe that a release of hazardous substances or petroleum has or may have occurred on or from the property.

(2) Environmental history review. The objective of this portion of the phase I property assessment is to provide a continuous environmental history to determine whether any management, handling, treatment, storage, or disposal activities at the property have occurred, which have or may have led to any release of hazardous substances or petroleum ator from the property.

(a) To the extent that they are reasonably available, or available through diligent inquiry, a volunteer must review any previous environmental assessments or studies, property assessments or geologic studies for the property.

(b) A diligent inquiry must be conducted of the environmental compliance history of the property and all persons who owned or operated the property. This investigation must relate to releases of hazardous substances or petroleum and to factors which may affect the eligibility of the property to participate in the voluntary action program and must, at a minimum, include a review of reasonably available information from the U.S. EPA, the Ohio EPA, the Ohio department of natural resources, and the bureau of underground storage tank regulations.

(c) Review of records for the property and surrounding properties within a minimum of one half-mile from the property. A review of the following records of information, as they relate to the property and all areas located within a minimum of one half-mile of the property, to the extent necessary to determine if hazardous substances or petroleum may have been released from surrounding properties and could potentially impact the subject property:

(i) Federal national priorities list.

(ii) Federal comprehensive environmental response, compensation and liability information system list.

(iii) Federal Resource Conservation and Recovery Act treatment storage and disposal facility list.

(iv) Federal emergency release notification system list.

(v) Federal Resource Conservation and Recovery Act information data base.

(vi) Ohio EPA, division of emergency and remedial response files.

(vii) Ohio bureau of underground storage tank regulations leaking underground storage tank list.

(viii) Ohio EPA spill data base.

(d) Review of records for the property and adjoining properties. A review of the following records of information, as they relate to the property and all adjoining properties, to the extent necessary to determine if hazardous substances or petroleum may have been released onto the property or are emanating onto the property from adjoining properties:

(i) Federal Resource and Conservation Recovery Act generators list.

(ii) Ohio bureau of underground storage tank regulations registered underground storage tank list.

(e) Review of records for the property only. A review of the following records of information as they relate to the potential release of hazardous substances or petroleum on or from the property:

(i) Community right-to-know inventory report records of the state emergency response commission and the local emergency planning committee.

(ii) Local fire department records.

(iii) Local health department records.

(f) Review of records for the property and surrounding properties. A review of other appropriate federal, state and local agency records and other data bases, such as those referenced in ASTM E1527, paragraph 8.2, when a volunteer has reason to believe that relevant information may be obtained from such records of information. For example, reviews may include Ohio department of natural resources well log information, historical society records, library records or historical newspaper search engines.

(3) Interviews. Interviews with reasonably available key property personnel, residents, or former property personnel who have knowledge relevant to historical uses, operations, and environmental conditions at the property or surrounding properties. A sufficient number and quality of interviews must be conducted so that those persons with relevant knowledge have the opportunity to provide as much meaningful and relevant information about the property or surrounding properties as is reasonably possible. All interview information including interview questions and relevant responses obtained during the interviews must be documented in the phase I property assessment report, as provided in paragraph (G) of this rule.

(4) Property inspection. The objective of this portion of the phase I property assessment is to obtain information from a physical inspection of the property to determine whether any releases of hazardous substances or petroleum have or may have occurred on or from the property. The volunteer must conduct a physical inspection of all areas of the property, including an inspection of the interior and exterior of all buildings and structures on the property and an inspection of all other areas of the property. When conducting the property inspection, the volunteer must, at a minimum, identify and document the following:

(a) Areas containing hazardous substances or petroleum or areas where hazardous substances or petroleum were located, including, but not limited to: underground storage tanks, above-ground storage tanks, wells (including oil and gas wells and underground injection control wells), cans, boxes and other containers, pipes, drains, storm or sanitary sewers, electrical equipment, cables, fuel tanks, oil pans, lagoons, stacks, cooling systems, inventory, pits, piles, landfills, waste or process water treatment systems, equipment and associated structures that contain or previously contained any hazardous substances or petroleum, and areas used for the treatment, storage, management or disposal of any hazardous substances or petroleum. If any of the above sources are identified in the property inspection, the volunteer must determine the condition of the sources.

(b) Evidence that a release of hazardous substances or petroleum occurred or may have occurred on or from the property. This evidence may include but is not limited to the following:

(i) Spilled materials.

(ii) Stressed vegetation.

(iii) Discolored soils.

(c) Any other available evidence of the current and past uses of the property or evidence of practices regarding the management, handling, treatment, storage, or disposal of any hazardous substances or petroleum.

(d) The general topographic conditions of the property and area surrounding the property.

(e) Evidence of current and past uses of adjoining properties which may be observed from the property or which are accessible from public rights of way.

(f) Identifiable migration conduits for hazardous substances or petroleum including but not limited to basements, drains, tiles, wells, and utility lines.

(g) Any physical obstructions which limit the visibility of conditions on the property, including but not limited to buildings, snow or leaf cover, rain, fill, asphalt, or pavement.

(5) Property hazardous substance or petroleum release history. Based on information obtained from paragraphs (C)(1) to (C)(4) of this rule, areas where hazardous substances or petroleum were or are located on or off property must be evaluated to determine which areas have known or suspected releases of hazardous substances or petroleum. The volunteer must identify for each release, to the extent known or suspected the following:

(a) The contaminant type.

(b) The quantity.

(c) The date of release.

(d) The areas of the property impacted by the release.

(e) The environmental media impacted by the release, i.e. soil, soil gas, ground water, surface water and sediments. Releases to dirt floors inside buildings are considered releases to environmental media.

(f) Any measures taken to address the release, including the result of those measures.

(D) Any phase I property assessment performed as part of a voluntary action after December 16, 1996, must meet the requirements of this rule. Any phase I property assessment performed as part of a voluntary action after September 28, 1994 and completed prior to December 16, 1996, must have been performed in accordance with ASTM E1527 and Chapter 3746. of the Revised Code. Any phase I property assessment performed prior to December 16, 1996, and not conducted for purposes of a voluntary action, may be used by the volunteer in support of a no further action letter or to assist in a phase II property assessment under rule 3745-300-07 of the Administrative Code, to the extent the previous phase I property assessment satisfies the requirements of this rule. To the extent the previous phase I property assessment does not satisfy the requirements of this rule it must be supplemented to meet all requirements of this rule.

[Comment: For example, if a phase I property assessment was completed December 1, 1990 and met all of the requirements of this rule except the requirement to provide a property history, including the uses of the property and all adjoining properties and any surrounding areas, the 1990 phase I property assessment must be supplemented to include a continuous property history in accordance with paragraph (C)(1) of this rule, and a new phase I property assessment in accordance with this rule must be performed for the period between December 2, 1990 up to the date of the issuance of the no further action letter or the performance of a phase II property assessment, whichever is applicable to the particular voluntary action.]

(E) Designating identified areas.

(1) The volunteer must identify each area at the property where a release of hazardous substances or petroleum has or may have occurred to environmental media. Each identified area must be detailed in the written phase I property assessment report as provided in paragraph (G) of this rule.

(a) Each identified area may be redelineated or eliminated if data obtained during a phase II property assessment conducted in accordance with rule 3745-300-07 of the Administrative Code supports a redelineation or elimination of the identified area.

(b) If the volunteer has reason to believe a release has or may have occurred, but cannot visually observe or otherwise define the portion of the property that may have been affected by hazardous substances or petroleum, the volunteer shall designate the portion of the property as an identified area, suspected to be affected by the hazardous substances or petroleum.

(c) If the volunteer has knowledge that a release of hazardous substances or petroleum occurred on the property but has no information on the location of the release, the volunteer may designate the whole property as one identified area.

(2) Exceptions to designating identified areas.

(a) De minimis areas. Areas with releases that are de minimis, as determined in accordance with this rule, are not identified areas. De minimis areas are those areas where the following criteria have been demonstrated and documented in the phase I report. The logic and reasoning used when evaluating the information for the de minimis demonstration must consider the following:

(i) Whether the release of hazardous substances or petroleum is confined to surficial soils on the property and that no hazardous substances or petroleum have been released from the de minimis area into surface water, sediments or ground water on or from the property.

(ii) That the release of hazardous substances or petroleum was a small quantity confined to a limited area of shallow depth of the soil surface that generally would not present a threat to human health, safety and the environment.

(iii) That the release of hazardous substances or petroleum was not part of a pattern of disposal or mismanagement.

(iv) There are no more than three de minimis areas per acre at the property.

(b) Areas previously addressed under regulatory programs. Areas previously addressed under a regulatory program, as determined in accordance with this rule, are not identified areas. Areas where a release of hazardous substances or petroleum was previously investigated or remediated to the most stringent standards, without the need for institutional or engineering controls are not identified areas if both of the following apply:

(i) Documentation from the regulatory program is evaluated, and it is determined that the release meets current unrestricted residential standards, or the equivalent. The regulatory program process must have addressed all potential constituents of the release identified under this phase I property assessment, or the additional constituents must be considered an identified area. The size of the area, the environmental media and the pathways investigated under the regulatory program must be consistent with what would have been investigated under this chapter, or the release must be considered an identified area.

(ii) The release was addressed under one or more of the following regulatory jurisdictions, as appropriate:

(A) Closure of an underground storage tank system or corrective action of petroleum releases that are subject to the jurisdiction of the Ohio bureau of underground storage tank regulations of the state fire marshal's office.

(B) Closure, corrective action or other remedial activities that are suject to the jurisdiction of a program administered by the Ohio environmental protection agency.

(C) Closure, corrective action or other remedial activities that are subject to the jurisdiction of of a program administered by the United States environmental protection agency.

(F) Eligibility evaluation. The volunteer must do the following:

(1) Evaluate the property based on each exception to voluntary action eligibility given by rule 3745-300-02 of the Administrative Code.

(2) Document the completion, resolution or non-applicability of the exception as needed to support a demonstration to the agency pursuant to the rule that the property is eligible for the voluntary action program.

(3) Identify any activities that remain to be completed or statements from regulatory agencies that remain necessary to confirm the eligibility of the property as required by that rule.

(G) The volunteer must complete a written phase I property assessment report which, at a minimum, includes the following:

(1) An introduction identifying: the property; the date that the phase I property assessment and the written report were completed; the name and job title of each person conducting the investigation; and a summary of the current use of the property.

(2) A summary of the areas where hazardous substances or petroleum were or are located on or off property and the areas of known or suspected releases of hazardous substances or petroleum. The summary must include all identified areas at the property of known or suspected releases, and include, as applicable, the de minimis areas and the previously addressed areas that have been determined not to be identified areas pursuant to paragraph (E) of this rule. For each designated identified area, the report must include the location and the approximate boundaries of the identified area and the contaminant type known or suspected to be present for evaluation during a phase II property assessment. Any of the identified areas designated in the phase I property assessment report may be redelineated or eliminated as a result of data collected and assessed in accordance with paragraph (E) of rule 3745-300-07 of the Administrative Code.

(3) The results of the eligibility evaluation conducted pursuant to paragraph (F) of this rule.

(4) Asbestos.

(a) A summary of the asbestos in building material at the property, as identified and documented in accordance with paragraph (C)(4)(a) of this rule. An asbestos survey may be included in an appendix of the report completed under this rule to document the presence of asbestos. The completion of an asbestos survey is not a requirement of a phase I property assessment conducted pursuant to this rule.

(b) Documentation of compliance with the standards for asbestos emission control during demolition and renovation activities, as applicable, in accordance with Chapter 3745-20 of the Administrative Code, which may document the absence of an asbestos release under this rule. The standards are also referred to as national emission standards for hazardous air pollutants or "NESHAPs."

(5) Maps.

(a) A property location map using the most currently available 7.5 minute U.S. geological survey topographic map, which includes the property boundary and the surrounding significant features such as roads and other rights of way, surface water bodies, and adjacent properties.

(b) A property map which identifies significant structures and features, including but not limited to property improvements, including all roads, railroads and above and below ground structures and appurtenances, the property's boundaries, and identifies the property which is the subject of the voluntary action.

(c) Identified areas and other areas. A property map which identifies the location and type of all known or suspected releases of hazardous substances or petroleum on the property including areas determined under this rule to be de minimis areas and previously addressed areas in accordance with paragraph (E) of this rule.

(d) A map which identifies all sites within one half-mile surrounding the property which were identified in paragraph (C)(5) of this rule.

(6) An explanation of all procedures used during the phase I property assessment.

(7) A summary of all relevant information used to meet the objectives contained in paragraph (C) of this rule, including: historic and current uses of the property, adjoining properties, and areas surrounding the property; the environmental history; any interviews and property inspections conducted; and the release history on or adjoining the property.

(8) A statement of any limitations or qualifications which impact the phase I property assessment, including an identification and explanation of any records of information which were not reviewed because they were determined not to be reasonably available.

(9) A recommendation stating that either a no further action letter can be issued or that a phase II property assessment would be required in order to obtain a no further action letter for the property.

(10) A bibliography of references which identifies, to the extent available, a description, date, source, and location of any document reviewed as part of the phase I property assessment and include the name, address and telephone number of any persons interviewed in the phase I property assessment.

(11) Sufficient color photograph documentation of the property's current condition. The volunteer must identify the dates that the photographs of the property were taken.

(12) Appendices for all appropriate supporting documentation.

(H) If more than one hundred eighty days has elapsed since the completion of a phase I property assessment, the phase I property assessment must be amended in accordance with paragraph (E)(1)(c) of rule 3745-300-07 and paragraph (D)(1) of rule 3745-300-13 of the Administrative Code.

Effective: 08/01/2014
R.C. 119.032 review dates: 08/01/2019
Promulgated Under: 119.03
Statutory Authority: 3746.04
Rule Amplifies: 3746

3745-300-07 Phase II property assessments.

[Comment: For dates of non-regulatory government publications, publications of recognized organizations and associations, federal rules, and federal statutory provisions referenced in this rule, see paragraph (B) of rule 3745-300-01 of the Administrative Code titled "Incorporation by reference."]

(A) Applicability.

(1) A phase II property assessment must be conducted in accordance with this rule if a phase I property assessment conducted in accordance with rule 3745-300-06 of the Administrative Code reveals any information that establishes any reason to believe that a release of hazardous substances or petroleum has or may have occurred on or from the property; or there is reason to believe that a release from an off-property source area is impacting the property. This rule does not apply when a release is in an area that is demonstrated to be de minimis in accordance with the requirements of paragraph (E)(2)(a) of rule 3745-300-06 of the Administrative Code.

(2) Factors affecting eligibility of a property. The volunteer must utilize information from phase I or phase II property assessments to determine that a property is eligible for the voluntary action program in accordance with rule 3745-300-02 of the Administrative Code at the time of the no further action letter issuance.

(B) Purpose of a phase II property assessment.

The purpose of a phase II property assessment is to conduct an investigation sufficient to determine whether all applicable standards are met or to determine that remedial activities conducted in accordance with rule 3745-300-11 of the Administrative Code demonstrate or result in compliance with applicable standards.

A volunteer may elect to conduct remedial activities at any point during a phase II property assessment without first deriving standards, provided that the remedial activities comply with rule 3745-300-11 of the Administrative Code, and provided that the volunteer completes the activities contained in paragraph (E) of this rule.

(C) Data quality objectives for phase II property assessments.

The volunteer must develop and implement data quality objectives consistent with U.S. EPA's "Guidance on Systemic Planning Using the Data Quality Objectives Process" according to their limitations and intended uses. In order to achieve the purpose contained in paragraph (B) of this rule, the volunteer must, at a minimum, complete one iteration of the following steps:

(1) Identify the goals of the phase II property assessment, including the applicable standards that need to be achieved to demonstrate compliance with the voluntary action program rules .

(2) Identify the data and information necessary to support the objectives of the phase II property assessment. Evaluate historical information from the phase I property assessment and determine if data gaps are present that should be addressed .

(3) Define the boundaries of the phase II property assessment, including spatial and temporal limits. Determine the identified areas that need to be investigated or addressed, factoring in current and reasonably anticipated future use of the property .

(4) Develop an approach to identify contaminants of concern, complete exposure pathways and current and reasonably anticipated future receptors .

(5) Specify how the data and information collected in the phase II property assessment will be used in the decision-making process to assess identified areas. Clarify performance and acceptance/rejection criteria for the data .

(6) Develop a sampling and analysis plan to obtain the data.

(7) Develop a conceptual site model that illustrates the relationships between contaminants, transport media and receptors during various phases of the voluntary action as needed. The final conceptual site model, which represents conditions at the time of the no further action letter issuance, must be submitted in the phase II property assessment report completed in accordance with paragraph (J) of this rule.

The conceptual site model must determine exposure scenarios that identify the environmental media, chemicals of concern, current and reasonably anticipated future land use and receptor populations, and a determination of exposure pathway completeness.

[Comment: The conceptual site model should give consideration to appropriate assessment and sampling relative source areas, identified areas, and exposure units based on current and future land use conditions at the property.]

(D) Sampling and sample analysis.

The volunteer must identify the samples and analytes that the certified laboratory must analyze, and the volunteer must ensure that the following:

(1) The sampling procedures employed at the property are consistent with the sample quality requirements of the certified laboratory.

(2) Data from the certified laboratory are adequate for use in the voluntary action. At a minimum, the volunteer must do the following:

(a) Notify the certified laboratory when samples are to be used for a voluntary action and when certified laboratory data are required. If this communication with the certified laboratory is not provided, a certified laboratory is not required to analyze the samples in accordance with its certification. Therefore, the certified laboratory may not be able to provide the appropriate affidavit certifying the analytical results as certified data .

(b) Ensure that the certified laboratory is certified for and capable of performing the analyses that are required for the property, including those necessary for forming the basis of the no further action letter. In accordance with paragraph (H)(2) of rule 3745-300-04 of the Administrative Code, the certified laboratory must disclose when it is not providing certified data whenever it is not certified for any analyte, parameter group, or method included in a request for analysis. This disclosure may be in the analytical report or by other means .

(c) Communicate to the certified laboratory the applicable standards required for the property and ensure that the certified laboratory is capable of detecting the chemicals of concern in environmental media at or below the applicable standards for the property. Cumulative adjustments for multiple chemicals and pathways must be evaluated when determining the applicable standards that must be achieved when evaluating compliance with applicable standards. In accordance with paragraph (H)(7) of rule 3745-300-04 of the Administrative Code, the certified laboratory must disclose when it is not capable of detecting the chemicals of concern in environmental media at or below the applicable standards for the property. This disclosure may be in the analytical report or by other means. An appropriate detection limit may be used to represent any applicable standard where the certified laboratory is not capable of detecting the chemicals of concern at or below the applicable standard until such time that a lower detection is achieved.

(3) Acceptable quality assurance and quality control procedures have been established and employed when collecting field data during the phase II property assessment. The field quality assurance and quality control procedures must serve to: minimize sources of error; minimize the potential for cross contamination; and maximize the representativeness of the data collected. The field quality assurance and quality control procedures must, at a minimum, include the following:

(a) Review of the laboratory's quality assurance program plan and standard operating procedures for consistency with field quality assurance and quality control procedures .

(b) Development of field quality assurance and quality control procedures including but not limited to the following items:

(i) Equipment decontamination .

(ii) Trip blanks, equipment blanks, field blanks, and duplicates .

(iii) Calibration of field instruments, which includes procedures for instrument correction and re-calibration when necessary .

(iv) Documentation and record maintenance .

(v) Sample handling, preservation and holding times .

(vi) Chain-of-custody.

(4) Data collection, field testing, field screening and sampling techniques are established and used. Data collection, field testing, field screening and sampling techniques must be used in a manner that is consistent with achieving the purpose of the phase II property assessment.

(E) Phase II property assessment data collection activities. The volunteer must collect sufficient data in accordance with the requirements contained in this paragraph to make the determinations contained in paragraphs (F)(1) to (F)(10) of this rule. The sampling activities conducted under this paragraph must be performed in accordance with the sampling procedures contained in paragraph (D) of this rule. Data collection and data evaluation may be conducted iteratively in accordance with the conceptual site model as required by paragraph (C)(7) of this rule.

(1) Use of existing information from phase I assessments and data from laboratories not certified under this chapter.

(a) Phase I property assessment and other existing information. The person conducting a phase II property assessment must utilize all information from a phase I property assessment conducted in accordance with rule 3745-300-06 of the Administrative Code and any other information known to the owner or the volunteer if different from the owner which is relevant to properly characterizing environmental conditions on, underlying, or emanating from the property.

(b) Using data from prior phase I environmental site assessments. Prior phase I environmental site assessments and studies not conducted in accordance with rule 3745-300-06 of the Administrative Code may be relied upon, provided that all of the following are met:

(i) The information gathered and the method used to collect and evaluate the data are consistent with the purposes described in paragraph (A) of rule 3745-300-06 of the Administrative Code .

(ii) The prior phase I environmental site assessment is amended in such a way as to comply with the requirements of rule 3745-300-06 of the Administrative Code .

(iii) The prior phase I environmental site assessment is amended to comply with paragraph (E)(1)(c) of this rule,if more than one hundred eighty days has elapsed since its completion.

(c) Amending phase I property assessments. The volunteer must ensure that all requirements contained in paragraphs (C) and (E) of rule 3745-300-06 of the Administrative Code have been performed within one hundred eighty days before the phase II property assessment begins, or that no change in environmental conditions at the property have occurred since the requirements in paragraphs (C) and (E) of rule 3745-300-06 of the Administrative Code were performed. Changed conditions means new information about known or suspected releases to environmental media resulting in additional identified areas at the property that are subject to phase II property assessment or previous identified areas that need further phase II property assessment due to new information.

(i) When determining whether to re-evaluate requirements in paragraphs (C) and (E) of rule 3745-300-06 of the Administrative Code, best professional judgment must be used to decide which requirements in paragraphs (C) and (E) of rule 3745-300-06 of the Administrative Code must be re-evaluated to determine whether additional phase II property assessment is required.

(ii) If any requirements in paragraphs (C) and (E) of rule 3745-300-06 of the Administrative Code require re-evaluation, documentation of the additional information gathered to comply with this paragraph must be included in an updated phase I property assessment report.

(d) Use of non-certified laboratory data. Data generated by laboratories not certified under this chapter, non-certified data, and studies not conducted in accordance with this rule may be used to partially meet the requirements of this rule, provided that all of the following are met:

(i) The information gathered and the methods used to collect and evaluate the data are consistent with the purposes of this rule .

(ii) The data are evaluated to ensure quality and consistency with the requirements for data collected in a phase II property assessment conducted in accordance with this rule .

(iii) The data are confirmed by samples analyzed using by a laboratory with a current certification under this chapter for the analysis. The confirmatory samples must be collected as follows:

(a) For ground water, surface water, and air, a minimum of ten per cent of the sample population of each data set in the previous study must be confirmed, provided that the samples are collected from the same sampling points that were used in the previous study .

(b) For all environmental media not addressed in paragraph (E)(1)(d)(iii)(a) of this rule, or if the sampling points used in the previous study cannot be used, or are not used, for collecting confirmatory samples, the volunteer must quantitatively compare the non-certified laboratory dataset and the certified laboratory dataset and demonstrate that the two are not significantly different, utilizing any method that is accepted as an academic or industry standard, by collecting a minimum of ten per cent of the sample population, or at least eight samples, whichever is greater, for each data set in the previous study.

[Comment: If prior data or information are used in support of a no further action letter, they should be consistent with existing property conditions.]

(2) A review and evaluation of existing regional and property-specific geologic, hydrogeologic, and physical characteristics of the property and its surrounding area by evaluating characteristics contained in paragraphs (E)(2)(a) to (E)(2)(o) of this rule. The volunteer must review reasonably available information -from previous on-property investigations or other sources of information. Property-specific data must be collected as needed. The collection of additional data or information must be by methods consistent with requirements of this rule. The evaluation of information and collection of additional data must be consistent with the data quality objectives developed in accordance with paragraph (C) of this rule. The review and evaluation must address and include, as necessary, the following:

(a) The characteristics of major stratigraphic units and the associated depositional environments. A description of the continuous profile of the stratigraphic units beneath the property, including the thickness and lateral extent of each unit and the depth to bedrock .

(b) Property-specific physical characteristics of saturated or unsaturated soils or bedrock, including but not limited to: porosity, effective porosity, bulk density, moisture content, grain size analysis, and soil pH. The vertical and horizontal hydraulic conductivity of saturated and unsaturated zones. The contaminant attenuation capacity and mechanisms of attenuation of soil or bedrock, including but not limited to: ion exchange capacity, organic carbon content, mineral content, and soil sorptive capacity .

(c) Identification of regional aquifers and ground water zones beneath the property and determination of their productivity .

(d) Identification of confining units that may separate ground water zones and the ability of the confining units to transmit or retard the movement of ground water, including an evaluation of the hydraulic interconnectedness of such zones in the subsurface.

(e) Identification and characterization of ground water recharge and discharge areas, and the amount of recharge and discharge .

(f) Estimates of infiltration or evapotranspiration rates .

(g) A description, and the potential orientation, of geomorphology and structural geologic features that may influence the ground water flow system or unsaturated flow conditions, including but not limited to: topographical features, geologic stratification, faults, joints, or fractures .

(h) The occurrence, flow direction and gradient of surface water or ground water .

(i) The absence or presence of commingled chemicals of concern from multiple source areas .

(j) The natural quality of ground water and surface water .

(k) Any anthropogenic influences that may affect or alter the natural geology and hydrogeology underlying the property or may provide preferential migration pathways, including but not limited to: utilities, fill material, pavement, buildings and building foundations, or grading activities;

(l) Identification of ground water use, availability or special designations such as "drinking water source protection areas for a public water system using -groundwater" as defined in paragraph (A) of rule 3745-300-01 of the Administrative Code or sole source aquifer designations .

(m) Identification of the presence of legally-enforceable restrictions on the use of ground water including, without limitation, local rules and ordinances .

(n) Identification of regional availability of surface water or ground water and reasonable alternative sources of drinking water .

(o) Any other characteristics or information that may be useful to meet the data quality objectives of the phase II property assessment or to determine compliance with applicable standards or the need for remedial activities.

(3) The volunteer must identify the chemicals of concern in the identified areas by evaluating the following:

(a) Hazardous substances or petroleum identified in a phase I property assessment conducted in accordance with rule 3745-300-06 of the Administrative Code or this rule .

(b) Hazardous substances or petroleum that are or have been commonly used in industrial or commercial activities similar to the activities conducted at the property .

(c) Hazardous substances or petroleum that, based on reasonably available information, may be typical constituents, components, additives, impurities and degradation products of hazardous substances or petroleum identified in paragraphs (E)(3)(a) and (E)(3)(b) of this rule .

[Comment: Naturally occurring hazardous substances or petroleum that occur in one environmental medium are considered potential chemicals of concern if current or past activities involving the treatment, storage, or disposal of hazardous substances or petroleum, are suspected to have caused the transfer of these naturally occurring hazardous substances or petroleum to other environmental media. Examples include, but are not limited to: (i) an acid spill that results in the leaching of metals naturally found in soil to the underlying ground water, or (ii) the mobilization to ground water of metals naturally found in soil when the mobilization is the result of anaerobic ground water associated with the biodegradation of an organic solvent ground water plume.]

(d) Constituents of hazardous substances for which a method or technology of analysis is not available to measure the concentration of the hazardous substance. The volunteer must obtain certified data for each constituent or set of constituents, which are representative of a hazardous substance, even if the constituents are not listed as a hazardous substance.

[Comment: An example is the compound aluminum sulfate whereby a laboratory indicates that it can analyze for aluminum which, by itself is not a hazardous substance; however, aluminum sulfate is a hazardous substance.]

(4) Evaluate identified areas.

(a) The volunteer must evaluate all identified areas and determine within each identified area the following:

(i) All source areas that are present .

(ii) All affected media that are present.

(b) The volunteer must consider information from a phase II property assessment to determine if the existence, location and dimensions of each identified area designated pursuant to a phase I property assessment require adjustment. If the existence, location or dimensions of the identified areas require adjustment or redesignation to reflect the phase II property assessment information, the volunteer must make the appropriate adjustments to the identified areas and redesignate the identified areas in the phase II property assessment.

(5) Sampling environmental media.

(a) The volunteer must collect samples from environmental media affected by a release in accordance with the data quality objectives and sampling procedures developed under paragraphs (C) and (D) of this rule. Sampling objectives must be reliable and representative for the environmental media being sampled, as necessary to make the determinations contained in paragraphs (F)(1) to (F)(10) of this rule.

(b) When determining how to conduct sampling under paragraph (E)(5)(a) of this rule, the volunteer must ensure that the data collected will be sufficient for making the determinations in paragraphs (F)(1) to (F)(10) of this rule as well as meeting the stated data quality objectives. The volunteer must ensure that the data are representative considering:

(i) The spatial distribution of sampling locations .

(ii) Temporal variations in the media or in the concentrations of chemicals of concern contained in the media.

(6) Identification of current and reasonably anticipated property use and receptor populations.

The volunteer must identify the current and reasonably anticipated uses of the property using the data quality objectives as provided in paragraph (C) of this rule. The volunteer must also identify all receptor populations reasonably anticipated to be exposed to chemicals of concern on the property, and all off-property receptor populations reasonably anticipated to be exposed to chemicals of concern from the property. Receptor populations that must be identified for the purpose of making the determinations contained in paragraph (F)(1) of this rule include, at a minimum, the following:

(a) Populations that live on the property .

(b) Populations that work on the property .

(c) Populations on the property as visitors, commercial consumers or recreational participants .

(d) Populations on or off the property that may be exposed to chemical(s) of concern in environmental media as a result of construction or excavation activities .

(e) Populations on or off the property that are reasonably anticipated to be exposed to chemicals of concern from the property through ground water migration, surface water migration, dust emissions, volatilization and other mechanisms which transport chemicals of concern off the property .

(f) Important ecological resources that, considering the land use and the quality and extent of habitat on the property and adjoining properties, would have reasonably been associated with the property or adjacent properties were it not for the presence of chemicals of concern from the property.

(7) The volunteer may need to conduct data collection activities necessary to determine background levels in accordance with paragraph (H) of this rule.

(F) Determinations under the voluntary action program.

(1) Pathway completeness determination.

(a) The volunteer must evaluate the current and reasonably anticipated exposure pathways and must identify the following .

(i) All source areas or affected media contributing to the pathway .

(ii) The receptors identified under paragraph (E)(6) of this rule and any applicable points of compliance .

(iii) The transport mechanisms for the pathway .

[Comment: The points of compliance for a pathway may be a receptor identified in accordance with this rule, or may be determined under other rules contained in this chapter. For example, the ground water response requirements contained in rule 3745-300-10 of the Administrative Code under specific conditions require that the point of compliance is the property boundary.]

(b) The volunteer must determine which current and reasonably anticipated pathways are complete. Exposure pathways must be based on property-specific data collected in accordance with the procedures described in this chapter and must be evaluated in accordance with the procedures described in this chapter. A pathway is considered to be complete if all three of the pathway components contained in paragraphs (F)(1)(a)(i) to (F)(1)(a)(iii) of this rule are present. All exposure pathways determined to be complete under this paragraph must be identified in the phase II property assessment report.

(c) If it is determined that any of the exposure pathways on or adjoining the property are not reasonably anticipated to be complete for the chemicals of concern, the phase II property assessment report must include a written justification for the elimination of those exposure pathways from further consideration.

(2) Determination of ground water zones and confining units.

(a) The volunteer must determine ground water zones and confining units beneath the property, as necessary, for the purposes of ground water protection or classification. The information listed in paragraph (E)(2) of this rule should be used, as necessary, to determine the extent to which saturated zones in the subsurface should be divided or grouped into ground water zones. Further, the volunteer should determine whether any confining units are present, and, if present, how they separate the ground water zones.

(b) When evaluating whether the uppermost saturated zone is a ground water zone, the volunteer may assume that the saturated zone contains ground water or may provide a demonstration that the saturated zone does not contain ground water. If the volunteer chooses to make a demonstration that the uppermost saturated zone does not contain ground water, then the volunteer must bias the following determinations to the area of highest expected outcome of the testing:

(i) Determine the ground water yield in accordance with paragraph (F)(8) of this rule, using a sufficient number of properly developed wells that are constructed to the minimum standards of a two-inch diameter, five-foot long manufactured screen placed in the saturated zone in a six-inch diameter borehole.

(ii) Determine the in situ hydraulic conductivity of the saturated zone using appropriate field test methods. Sampling points must be sufficient in number to represent the hydraulic conductivity of the saturated zone underlying the property.

(3) Determination of whether the provisions for protection of ground water meeting unrestricted potable use standards apply or whether ground water classification is required. If a ground water zone is determined to meet unrestricted potable use standards, the provisions contained in paragraph (F) (4) of this rule and paragraph (D) of rule 3745-300-10 of the Administrative Code apply to the ground water zone underlying the property. If a ground water zone is determined to exceed unrestricted potable use standards, the classification of the ground water zone must be determined in accordance with paragraph (B) of rule 3745-300-10 of the Administrative Code. Either generic or property-specific unrestricted potable use standards may be used when making this demonstration. For each ground water zone underlying the property, the volunteer must demonstrate whether the ground water in the zone meets or exceeds unrestricted potable use standards by one of the following methods:

(a) Sample the ground water within the zone to determine whether the ground water in that zone meets or exceeds unrestricted potable use standards. The volunteer must collect one or more ground water samples to determine the concentration of chemicals of concern in the ground water.

(i) Ground water samples must be collected in accordance with paragraph (F)(6)(d) of this rule from one or more ground water monitoring wells located immediately down-gradient of the source area or down-gradient and as close as possible to the source area. The samples must be analyzed by a certified laboratory for the concentrations of the chemicals of concern at the property. If more than one ground water sample is collected from a well, the second sample must be collected within forty-eight hours to ninety days after collection of the first ground water sample.

(ii) To evaluate whether more than one ground water sample is warranted to determine if the ground water meets or exceeds the unrestricted potable use standards, the volunteer must consider all temporal variations that could impact the determination of whether the provisions apply to the ground water zone. If additional ground water sampling events are warranted due to temporal variations, then a sufficient number of additional ground water samples must be collected over an appropriate time period to adequately characterize a representative concentration of the chemical of concern in ground water. Temporal variations include, but are not limited to, the following:

(a) Seasonal variations resulting in either increased or decreased recharge and thus fluctuations in the water table elevation .

(b) Other variations resulting from the impact of geologic heterogeneity (permeability, fractures, etc.), contaminant source heterogeneity or the transient nature of contaminant transport.

(iii) A minimum of two ground water samples are needed to determine that the ground water in a zone exceeds the unrestricted potable use standards, unless one or both of the following conditions apply:

(a) The concentrations of the first sampling event exceed unrestricted potable use standards by at least one order of magnitude .

(b) The concentrations of the first sampling event exceed unrestricted potable use standards and historical ground water data at the property indicates that releases from source areas have impacted the ground water zone underlying the property in excess of unrestricted potable use standards.

(iv) When demonstrating whether ground water meets or exceeds unrestricted potable use standards, a cumulative adjustment for multiple chemicals must be conducted in accordance with paragraph (A)(2)(b) of rule 3745-300-08 of the Administrative Code. The cumulative adjustment for multiple chemicals is required for both generic and property-specific risk-derived unrestricted potable use standards. However, the generic unrestricted potable use standards for ground water under paragraph (E)(3)(b) of rule 3745-300-08 of the Administrative Code must not be included in the cumulative adjustment for multiple chemicals in the ground water zone. When making this demonstration, the risk for potable use of ground water must not be summed with the risk from exposure pathways other than potable use of ground water.

(b) The volunteer may justify that sampling of a ground water zone underlying the property is not necessary to determine that the ground water in the zone does not contain concentrations of any chemicals of concern exceeding unrestricted potable use standards. Based on this justification, the volunteer may apply the provisions for protecting ground water meeting potable use standards contained in paragraph (F)(4) of this rule and paragraph (D) of rule 3745-300-10 of the Administrative Code. As part of this justification, the volunteer must document that it is reasonable to assume ground water does not exceed the unrestricted potable use standards based on a weight-of-evidence approach using relevant property-specific information, including the following, as necessary:

(i) The nature, type, concentration, and mass of the chemicals of concern released, and the time of release.

(ii) The type, concentration, and mass of chemicals of concern present in the subsurface soil or bedrock above the ground water zone requiring protection or between ground water zones .

(iii) The physical and chemical characteristics of the soil or bedrock beneath the property including, but not limited to, the secondary features, soil or bedrock type, heterogeneity of the subsurface soil or bedrock, or the integrity of any confining units separating ground water zones .

(iv) The separation distance between the source area and the ground water zone, or the separation distance between ground water zones .

(v) The results of modeling conducted in accordance with paragraph (G) of this rule, as applicable .

(vi) The presence or absence of off-property source area that may have impacted ground water on, underlying, or emanating from the property. The impact of off-property source areas must be determined in accordance with paragraph (F)(9) of this rule .

(vii) Any other lines of evidence the volunteer believes support the determination that the ground water in a zone underlying the property does not contain concentrations of any chemicals of concern above unrestricted potable use standards.

[Comment: In general, ground water zones may be considered to meet unrestricted potable use standards when they underlie a ground water zone that meets unrestricted potable use standards, as determined according to paragraph (F)(3) of this rule, and will continue to meet unrestricted potable use standards in the future, as determined according to paragraph (F)(4) of this rule. This generalization may be applied when it is reasonable to assume that hazardous substances or petroleum could not have been introduced into the underlying ground water zones through subsurface disposal (or some other means) and when off-property areas identified in the phase I property assessment have not introduced chemicals of concern into the underlying ground water zones.]

(4) Demonstration of continuing compliance with the provisions for protecting ground water meeting unrestricted potable use standards.

(a) When the provisions for protecting ground water apply to a ground water zone in accordance with paragraph (D) of rule 3745-300-10 of the Administrative Code, the volunteer must demonstrate that chemicals of concern , will not migrate to the ground water zone at concentrations that exceed unrestricted potable use standards. To demonstrate this, the volunteer must do either of the following:

(i) Demonstrate that the chemicals of concern in the subsurface do not exceed values that would result in unrestricted potable use standards being exceeded in the ground water zone .

(ii) Demonstrate that the provisions for protecting ground water meeting potable use standards will not be violated, using a weight-of-evidence approach. As part of this weight-of-evidence approach, the volunteer must document that it is reasonable to assume the ground water zone will not exceed unrestricted potable use standards in the future using relevant property-specific information, including the following, as necessary:

(a) The nature, type, concentration, and mass of the chemicals of concern released, and the time of release.

(b) The type, concentration, and mass of chemicals of concern present in the subsurface soil or bedrock above the ground water zone requiring protection or between ground water zones.;

(c) The physical and chemical characteristics of the soil or bedrock beneath the property including, but not limited to, the secondary features, soil or bedrock type, heterogeneity of the subsurface soil or bedrock, or the integrity of any confining units separating ground water zones .

(d) The separation distance between the source area and ground water, or the separation distance between ground water zones .

(e) The results of modeling conducted in accordance with paragraph (G) of this rule, as applicable .

(f) The presence of man-made structures on the property that reduce or prevent infiltration and leaching of any chemicals of concern to the ground water zone. Man-made structures which inhibit infiltration are considered engineering controls and must be maintained under an operation and maintenance plan in accordance with rule 3745-300-11 of the Administrative Code

(g) Any other lines of evidence the volunteer believes support the determination that the ground water in a zone underlying the property will not exceed concentrations of any chemicals of concern above unrestricted potable use standards.

(b) If it cannot be demonstrated in accordance with paragraph (F)(4) of this rule that chemicals of concern will not leach or otherwise migrate into the ground water zone underlying the property, the volunteer must implement a remedy in accordance with rule 3745-300-11 of the Administrative Code that prevents the ground water zone underlying the property from exceeding unrestricted potable use standards.

(5) Determination of applicable standards. Applicable standards must be determined for all chemicals of concern with respect to all exposure pathways determined to be complete under paragraph (F)(1) of this rule for which the volunteer intends to demonstrate compliance with applicable standards in accordance with paragraph (I) of this rule. The volunteer must determine and derive the applicable standards for each complete exposure pathway in accordance with the requirements specified in this chapter. When an engineering control is implemented under an operation and maintenance plan in accordance with rule 3745-300-11 of the Administrative Code that renders an exposure pathway incomplete the volunteer does not need to derive the applicable standards.

(a) The volunteer must determine the applicability of generic numerical standards at the property in accordance with paragraph (A)(1)(a) of rule 3745-300-08 of the Administrative Code. If generic direct-contact soil standards for restricted land uses are used to meet applicable standards, institutional controls must be used to limit the property's land use as described in paragraphs (B)(2)(d) and (C)(2)(c) of rule 3745-300-08 of the Administrative Code. The institutional controls must be implemented in accordance with rule 3745-300-11 of the Administrative Code.

(b) When a property-specific risk assessment is performed at the property, the volunteer must determine the applicability of standards derived through a property-specific risk assessment conducted in accordance with paragraph (A) of rule 3745-300-09 of the Administrative Code.

(c) The volunteer must determine the applicability of any other standards contained in this rule or in rule 3745-300-08 , 3745-300-09 , 3745-300-10 , or 3745-300-11 of the Administrative Code.

(d) The volunteer must consider the performance of a remedy employed at the property when its use is intended to meet or maintain applicable standards. The remedy must be implemented in accordance with rule 3745-300-11 of the Administrative Code.

(e) The volunteer does not need to determine applicable standards in accordance with rule 3745-300-08 or 3745-300-09 of the Administrative Code for chemicals of concern when the concentrations of the chemicals of concern from the property are at or below background levels determined in accordance with paragraph (H) of this rule.

(f) The volunteer does not need to determine applicable standards for chemicals of concern, if any of the following apply:

(i) The chemicals of concern were the result of a release in a de minimus area or a previously addressed area as determined in accordancewith paragraph (E)(2)(a) of rule 3745-300-06 of the Administrative.

(ii) The volunteer makes the determination that infrequent detections of chemicals of concern are a product of artifacts in the data and may not be related to the site operations or disposal practices. Such a determination must include, at a minimum, the following considerations:

(a) Historical information reported in the phase I property assessment report and other historical data from the property .

(b) The concentrations at which the detections are reported, provided that detection limits are not elevated due to matrix interferences .

(c) The detections do not indicate the presence of previously unknown areas of high concentration (i.e., new "hot spots") .

[Comment: The discovery of new hot spots may indicate the presence of identified areas that require adjustment or redesignation in accordance with paragraph (E)(4) of this rule.]

(d) The chemical of concern is not detected in any other sampled environmental media .

(e) The likelihood that the detected constituents are degradation or by-products of chemicals of concern on the property .

(f) The type of environmental media in which the detections are reported.

(iii) The chemicals of concern are demonstrated to be tentatively identified compounds without an indication of historical use on the property or evidence that they might be degradation compounds or by-products of one or more other chemicals of concern used at the property.

(iv) The chemicals of concern are demonstrated through appropriate quality assurance and quality control data to be the result of contamination due to field sampling activities or laboratory processes.

(v) The chemicals of concern are essential human nutrients that are present in concentrations near naturally occurring levels, and may be toxic only at very high concentrations. These chemicals include iron, magnesium, calcium, potassium and sodium.

(vi) The chemicals of concern are determined to contribute to less than one per cent of the estimated risk and or hazard attributed to a pathway-receptor combination in accordance with the procedures contained in U.S. EPA's "Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation manual (Part A)" following a procedure analogous to section 5.9.5 of the document.

(6) Determination of the concentrations of chemicals of concern in identified areas or exposure units as defined in paragraph (A) of rule 3745-300-01 of the Administrative Code. The volunteer must determine the concentrations of the chemicals of concern in accordance with paragraphs (F)(6)(a) to (F)(6)(e) of this rule as necessary to make the determinations contained in paragraphs (F)(1) to (F)(10) of this rule. Exposure unit determinations must consider current and future land use exposure scenarios in accordance with paragraph (D)(3)(b) of rule 3745-300-09 of the Administrative Code, and sampling must be appropriate for the exposure scenario. All samples collected in accordance with this paragraph must be analyzed by a certified laboratory, and certified data provided, in order to support the determinations.

(a) To determine the concentrations of the chemicals of concern in surface water, the volunteer must follow a sampling and analysis plan developed in accordance with the following:

(i) Ohio EPA's "Biological Criteria For the Protection of Aquatic Life: Volume II: User's Manual For Biological Field Assessment Of Ohio Surface Waters."

(ii) Ohio EPA's "Manual of Ohio EPA Surveillance Methods And Quality Assurance Practices."

(b) To determine the concentrations of the chemicals of concern in sediments for the purposes of comparing the concentrations to the applicable standards identified in paragraphs (G) and (H) of rule 3745-300-08 of the Administrative Code, the volunteer must sample the sediments in the identified areas in accordance with the procedures contained in the "Sediment Sampling Guide and Methodologies." The data collected must be analyzed by a certified laboratory to determine its representative concentration or maximum concentration in the identified area. For purposes of determining representative or maximum concentrations in identified areas, the volunteer must derive the concentrations in accordance with paragraph - (F)(6)(c) of this rule.

(c) To determine the concentrations of the chemicals of concern in soil for the purposes of demonstrating compliance with applicable standards, the samples collected must be analyzed by a certified laboratory, and certified data provided, in order to determine the representative concentrations or maximum concentrations of the chemicals of concern in the identified area or exposure unit. For purposes of determining representative or maximum concentrations of the chemicals of concern in identified areas or exposure units, the volunteer must do one of the following:

(i) Derive the representative concentration by calculating the ninety-five per cent upper confidence limit of the arithmetic mean. The ninety-five per cent upper confidence limit of the arithmetic mean must be calculated for each data set. Data sets must be comprised of a sufficient number and quality of samples as to derive a normal, log-normal, or other applicable frequency distribution. In addition to meeting the requirements of paragraph (D) of this rule, the volunteer must use techniques for sampling normal or log-normal distributions based on appropriate equations contained in U.S. EPA's "Calculating Upper Confidence Limits for Exposure Point Concentrations at Hazardous Waste Sites," or by other peer-reviewed statistical methodology for normal or log-normal distributions. Calculating the representative soil concentration using the ninety-five per cent upper confidence limit is inappropriate for vapor intrusion demonstrations .

(ii) Derive the maximum concentration within the identified area or exposure unit. The volunteer may use the maximum concentration in the data set to represent the identified area concentration, provided that a minimum of three or more samples are collected and analyzed by a certified laboratory, and certified data provided. The volunteer must reliably bias sampling activities both vertically and laterally within the identified area or exposure unit to the point of highest concentration. A sufficient number of samples must be collected in order to evaluate all source areas and exposures for each receptor determined in accordance with paragraph (F)(1) of this rule .

(iii) Derive the representative concentration using the incremental sampling technique based on guidance provided in Mason's "Preparation of Soil Sampling Protocols: Sampling Techniques and Strategies" and Gerlach and Nocerino's "Guidance for Obtaining Representative Laboratory Analytical Subsamples from Particulate Laboratory Samples." The volunteer may use the representative concentration from incremental sampling conducted in the identified area or exposure unit, provided that the samples are analyzed by a certified laboratory.

(d) To determine the concentrations of the chemicals of concern in ground water for the purposes of demonstrating compliance with applicable standards, the volunteer must perform sampling activities in compliance with the following criteria:

(i) The method of sample collection must be capable of producing ground water quality appropriate for evaluating the pathway of concern .

(ii) The volunteer must collect a sufficient number of samples to adequately characterize a representative concentration of the chemicals of concern in ground water. In determining the number and timing of samples collected, the volunteer must consider temporal variations that could result in an exceedance of applicable standards. Temporal variations include, but are not limited to the following:

(a) Seasonal variations resulting in either increased or decreased recharge and thus fluctuations in the water table elevation .

(b) Other variations resulting from the impact of geologic heterogeneity (permeability, fractures, etc.) or contaminant source heterogeneity or the transient nature of contaminant transport .

(iii) Sample locations must be appropriately located to evaluate all reasonably anticipated pathways to ensure applicable standards will not be exceeded at the points of compliance or receptors based upon the following:

(a) The direction of ground water flow .

(b) The size of the plume .

(c) The date of the release .

(d) Field screening techniques and methods .

(e) Other methods or information, as appropriate.

(iv) One or more sampling locations must be biased toward the location that is, or would be anticipated to be, the area of highest concentration of chemicals of concern. If sample locations cannot be reliably biased towards the area of highest concentration, the volunteer must take samples from a number of additional sample locations sufficient to determine the area of highest concentration .

(v) All samples collected in accordance with this paragraph must be analyzed by a certified laboratory .

(vi) For purposes of determining compliance with applicable standards, the volunteer must evaluate the data from each location separately .

(vii) If it is necessary to take a ground water sample directly beneath a source area, the volunteer must use methods for monitoring well installation, construction, sampling and maintenance that will not cause cross-contamination between ground water zones .

(viii) Methods and procedures must be followed, according to their limitations and intended uses, and based on either of the following:

(a) Documents containing data collection, field testing and sampling techniques which conform to the following:

(i) Are field-validated .

(ii) Are documented and peer-reviewed .

(iii) Ensure the representativeness of samples taken following the technique .

(iv) Are proven capable of achieving the data quality objectives identified in paragraph (C) of this rule .

(b) Ohio EPA's "Technical Guidance Manual for Hydrogeologic Investigations and Ground Water Monitoring." If any portion of the "Technical Guidance Manual for Hydrogeologic Investigations and Ground Water Monitoring" document would be inconsistent with the purpose of the phase II property assessment and this chapter then that portion should not be used.

(e) To determine the concentrations of the chemicals of concern for a vapor intrusion exposure pathway to indoor air, the volunteer must perform sampling activities according to their limitations and intended uses based on either of the following:

(i) Documents containing data collection, field testing and sampling techniques which conform to the following:

(a) Are field-validated.

(b) Are documented and peer-reviewed.

(c) Ensure the representativeness of samples taken following the technique.

(d) Are proven capable of achieving the data quality objectives identified in paragraph (C) of this rule.

(ii) Ohio EPA's "Vapor Intrusion to Indoor Air - Sample Collection and Evaluation for the Remedial Response and Voluntary Action Programs guidance document."

(f) Non-intrusive or indirect field testing may be used to assist in selecting sampling locations, but these techniques must not be used to demonstrate that concentrations of of concern meet or exceed applicable standards.

(7) Classify the ground water. To classify ground water zones in accordance with paragraphs (A) and (B) of rule 3745-300-10 of the Administrative Code, the volunteer must conduct the following data collection activities:

(a) The volunteer must determine if the ground water zone is being used. To make the determination, the volunteer must, at a minimum do the following:

(i) Identify any visual evidence of ground water use in areas where ground water has or is reasonably anticipated to have concentrations of chemicals of concern in excess of unrestricted potable use standards .

(ii) Review Ohio department of natural resources water well log information for the properties on which ground water contains or is reasonably anticipated to contain concentrations of chemicals of concern in excess of unrestricted potable use standards.

(b) For the purpose of determining that the yield of a ground water zone falls below the criterion for critical resource ground water, as described in paragraph (B)(1) of rule 3745-300-10 of the Administrative Code, the yield of the ground water zone must be based on one or more of the following sources of information or methods:

(i) The ground water resource maps published by the Ohio department of natural resources or other published and verified data for the ground water zone being classified .

(ii) Determined from a sufficient number of properly developed wells constructed to the minimum standards of an eight-inch diameter manufactured screen in a twelve-inch diameter borehole, in accordance with paragraph (F)(8) of this rule. The well screen must extend through at least eighty per cent of the thickness of the ground water zone or the volunteer must otherwise demonstrate that shorter screen lengths would not produce yield resulting in a different classification of the ground water.

(c) For the purpose of determining that the yield of a ground water zone falls below the criteria for "class A" ground water in paragraph (B)(2) of rule 3745-300-10 of the Administrative Code, the yield of the ground water zone being classified must be determined in accordance with paragraph (F)(8) of this rule and conform to the following:

(i) For an unconsolidated ground water zone, a determination of yield based on a sufficient number of properly developed wells, that are constructed to the minimum standards of a four-inch diameter manufactured screen in an eight-inch diameter borehole or a two-inch diameter manufactured screen in a six-inch diameter borehole. When wells with dimensions of a two-inch diameter manufactured screen in a six-inch diameter borehole are used to determine yield, the yield must be multiplied by a factor of 1.15 for purposes of this paragraph. The well screen must extend through at least eighty per cent of the thickness of the ground water zone or the volunteer must otherwise demonstrate that shorter intake lengths would not produce yield resulting in a different classification of the ground water .

(ii) For a consolidated ground water zone that is monitored using wells with screens, a determination of yield based on a sufficient number of properly developed wells, that are constructed to the minimum of a four-inch diameter manufactured screen in an eight-inch diameter borehole or a two-inch diameter manufactured screen in a six-inch diameter borehole. When wells with dimensions of a two-inch diameter manufactured screen in a six-inch diameter borehole are used to determine yield, the yield must be multiplied by a factor of 1.15 for purposes of this paragraph. The well screen must extend through at least eighty per cent of the thickness of the saturated portion of the ground water zone or the volunteer must otherwise demonstrate that shorter intake lengths would not produce yield resulting in a different classification of the ground water .

(iii) For a consolidated ground water zone that is monitored using wells with open hole intakes, a determination of yield based on a sufficient number of wells that are properly constructed and developed to appropriate minimum standards of an eight-inch diameter borehole or a six-inch diameter borehole. When wells with a six-inch diameter borehole are used to determine yield, the yield must be multiplied by a factor of 1.15 for purposes of this paragraph. The open hole intakes must extend through at least eighty percent of the thickness of the ground water zone or the volunteer must otherwise demonstrate that shorter intake lengths would not produce yield resulting in a different classification of the ground water.

(d) For the purpose of comparing the yield of the ground water zone being classified to another ground water zone present below the property in accordance with the criterion of paragraph (B)(2)(c) of rule 3745-300-10 of the Administrative Code, the yield of the other ground water zone, which is the likely source of water used for potable purposes within one mile of the property, must be determined based on the lowest yield of any wells within one mile of the property. If no wells used for potable purposes exist within one mile of the property, the ground water resources maps published by the Ohio department of natural resources may be used to determine the yield of another ground water zone present under the property, which would likely be the source of water used for potable purposes within one mile of the property should a well be developed.

(8) Determination of ground water yield. Whenever testing is conducted for purposes of determining the yield of a ground water zone underlying a property, the volunteer must conduct sufficient testing to determine the representative yield available from the ground water zone for potable purposes. The determination must be made in accordance with the following criteria:

(a) Temporal considerations. The volunteer must demonstrate either of the following:

(i) The statistical average yield for the ground water zone over a twelve month period .

(ii) The maximum yield for the ground water zone, provided that yield tests are biased towards the period of the highest yield .

(b) Spatial considerations. The volunteer must bias the yield testing locations to the area of highest yield.

(9) Determination of source areas. To determine whether ground water contamination is attributable to source areas located on the property, source areas located off the property, or a combination of the two, the volunteer must conduct ground water sampling sufficient to determine the following:

(a) The releases from source areas located on the property that contribute or contributed to the chemicals of concern in excess of unrestricted potable use standards in ground water .

(b) The extent to which releases from on-property source areas have affected the ground water .

(c) If releases from off-property source areas may have affected the ground .

(d) The extent to which releases from off-property source areas have affected the ground water .

(e) Compliance with rule 3745-300-10 of the Administrative Code.

(10) Determination of contaminant pass-through provision. When a release from an off-property source area has affected the property, the volunteer is not responsible for compliance of applicable standards at or beyond the property boundary due to the excess contribution of chemicals of concern caused by the off-property release, except when any of the following apply:

(a) The owner of the voluntary action property was an owner or operator of any property, other than the voluntary action property, where any source area was located during the owner's ownership of or operation on any such property, and hazardous substances or petroleum have emanated from the off-property source area onto the voluntary action property.

(b) The volunteer, or owner if different from the volunteer, caused or contributed to the source areas or the off-property release.

(c) The volunteer, or owner if different from the volunteer, has entered into an agreement with any person with the purpose or effect of creating a less stringent applicable standard than would otherwise be applicable in this rule.

(d) The volunteer is a parent, subsidiary, or other commonly owned entity of any party identified in paragraphs (F)(10)(a) to (F)(10)(c) of this rule.

(G) Use of modeling.

(1) The volunteer must identify all models relied upon as part of the phase II property assessment activities to determine a property's compliance with applicable standards or used to evaluate remedial activities conducted in accordance with rule 3745-300-11 of the Administrative Code. The modeling must be conducted in accordance with this rule.

(2) The model must conform to the following criteria:

(a) Be either of the following:

(i) Generally accepted within the scientific community and peer reviewed.

(ii) Scientifically valid for the processes being modeled and code-verified. To be code-verified, the model must be shown to produce reliable and mathematically accurate results for all functions of the model.

(b) Be used with assumptions and limitations reasonably consistent with conditions throughout the modeled area. The assumptions and limitations of the computer code, mathematical solution, technology utilized and computer code structure must be consistent with the conditions throughout the modeled area and the application of the model;

(c) Be used in a manner consistent with the model's documentation and intended use; and

(d) Be appropriate for the environmental media and application being modeled.

(3) The modeling must adequately address the intended purpose of the modeling evaluation, such as to show compliance with applicable standards or to evaluate remedial activities conducted in accordance with rule 3745-300-11 of the Administrative Code. Depending on the intended purpose of the modeling evaluation or type of model, the model may need to be calibrated to the geologic, hydrogeologic, or physical conditions throughout the modeled area. The model may need to be field-verified to determine if favorable comparisons exist between the modeled conditions and observed field conditions for the area being modeled. In some cases field verification may require monitoring and evaluation under an operation and maintenance plan.

(4) The modeling must be evaluated to determine its sensitivity to the input parameters or other components of the model (for example, boundary conditions). The volunteer must consider the sensitivity of the input parameters when utilizing a model to determine whether a property meets the applicable standards or when evaluating remedial activities conducted in accordance with rule 3745-300-11 of the Administrative Code. Input parameters or other components of the model determined to be sensitive to the modeling results must conform to either of the following:

(a) Be based on scientifically-valid conservative assumptions. The inputs must be based on property-specific data, or information from peer-reviewed literature and best professional judgment .

(b) Be accounted for through an uncertainty analysis to quantitatively determine compliance with applicable standards or to evaluate remedial activities conducted in accordance with rule 3745-300-11 of the Administrative Code. The inputs for the uncertainty analysis must be based on the following:

(i) Property-specific data collected in accordance with this.

(ii) Scientifically-valid and appropriate assumptions using either best professional judgment or information from peer-reviewed scientific literature or publications.

(5) The modeling evaluation and the results must be documented within the phase II property assessment report or within a separate modeling report addressing paragraphs (G)(1) to (G)(4) of this rule. If a separate modeling report is written it must be attached to the phase II property assessment report.

(H) Determination of background levels. Background levels may be used as the applicable standard after demonstrating the chemicals of concern are not the result of current or past activities involving the treatment, storage, or disposal of a hazardous substance or petroleum. The volunteer must provide a demonstration as part of paragraph (J)(8) of this rule that chemicals of concern for which a background determination is being made meet the requirements of this paragraph. Background levels that are determined in accordance with this paragraph are considered applicable standards under this rule.

(1) Background levels in soil. If the background levels, as determined in accordance with this rule, for a chemical of concern do not meet the applicable standard derived for the property in accordance with rule 3745-300-08 or 3745-300-09 of the Administrative Code, the volunteer can select, as the applicable standard, a comparison demonstrating that the concentration of any such chemical of concern on the property is at or below background levels.

(a) When determining background levels in soils, the samples must be taken in soil media native to the property and may not be taken in areas identified in paragraph (H)(1)(b) of this rule. Native fill may be used for determining background levels when the native fill was not moved from or is not currently in an area described in paragraph (H)(1)(b) of this rule. If no areas on a property are appropriate under this rule to sample for background, to determine background levels, the volunteer may collect samples from a nearby, representative off-property location which would meet the requirements of this paragraph.

(b) The following areas are inappropriate to sample when determining background levels:

(i) The following types of fill areas:

(a) Engineered fill .

(b) Structural fill .

(c) Industrial fill .

(ii) Areas in which management, treatment, handling, storage or disposal activities of any of the following are known or suspected to have occurred:

(a) Hazardous substances or petroleum .

(b) Solid or hazardous wastes .

(c) Waste waters .

(d) Material handling areas .

(iii) Areas within three feet of a roadway. This restriction only applies when the chemicals of concern is one that would normally be associated with the activities conducted on the roadway .

[Comment: For example, a volunteer may not sample within three feet of a roadway when the volunteer is trying to determine a background level for lead.]

(iv) Parking lots and areas surrounding parking lots or other paved areas. This restriction only applies when the chemicals of concern is one that would normally be associated with the activities conducted in the parking lots .

(v) Railroad tracks or railway areas or other areas affected by their runoff. This restriction only applies when the chemicals of concern are those that would normally be associated with the activities conducted on or around the railroad tracks .

(vi) Areas of concentrated air pollutant depositions or areas affected by their runoff .

(vii) Storm drains or ditches presently or historically receiving industrial or urban runoff .

(viii) Spill areas.

(c) Background levels must be representative of the zones or depth intervals to which the background levels may be applied .

(d) The following method must be followed to determine a representative numerical value for background levels in soils at a property:

(i) Collecting background level samples. At a minimum, eight soil sampling points must be taken to represent a background level within each zone, or soil horizon which will be compared to samples taken to determine the concentrations of chemicals of concern in identified areas.

(ii) Determining the numerical value for background concentrations for chemicals of concern at the property. The volunteer may use any statistically valid methodology to determine a background concentration whereby the statistical means of the distribution of background and the impacted area datasets are compared. The volunteer may refer to U.S. EPA's "Guidance for Comparing Background and Chemical Concentrations in Soil for CERCLA sites" and "Statistical Methods for Evaluating the Attainment of Cleanup Standards" for guidance. Alternatively, a statistical method that may be applied to establish background concentrations is as follows:

(a) The background mean, referred to as: Xb must be calculated by dividing the sum of the total background readings by the total number of background readings:


              image: oh/admin/2014/3745-300-07_PH_FF_A_RU_20140701_0812-1.png

(b) The background standard deviation, referred to as: Sb must be calculated by taking the square root of the sum of the squares of each reading minus the mean, divided by the degrees of freedom, which is the total number of background samples minus one (nb-1):


              image: oh/admin/2014/3745-300-07_PH_FF_A_RU_20140701_0812-2.png

(c) The coefficient of variation, referred to as "Cv" must be calculated by dividing the background standard deviation by the background mean:


              image: oh/admin/2014/3745-300-07_PH_FF_A_RU_20140701_0812-3.png

The coefficient of variation is used as a means to evaluate the data distribution. Normally distributed background data should generally have "Cv" less than 0.5 for granular soils, and less than 0.75 for cohesive soils, or an explanation accounting for higher "Cv" values. If the "Cv" exceeds 1.0 and the volunteer determines that the data are not distributed normally, the data may be normalized by an appropriate transformation and a maximum allowable limit may be calculated for the transformed data in accordance with paragraph (H)(1)(d)(ii)(d) of this rule. If "Cv" exceeds 1.0 then the volunteer must conduct a thorough evaluation to account for this variability. If the "Cv" exceeds 1.0 and the volunteer determines that a data point does not accurately represent background conditions or if a quality assurance and quality control problem exists which has invalidated the data point, the invalidated and inaccurate data points may be dropped, or additional samples must be collected and analyzed to ensure a sufficient representative data population is maintained.

(d) For normally distributed data apply: Xb + 2 * Sb of background data as the maximum allowable limit or upper limit, where 2 * Sb represents two times the standard deviation and Xb represents the background mean.

Each sample point from the background dataset must be compared to the calculated maximum allowable limit or upper limit analyzed from background data. If a value from the background dataset is found to be an outlier which is not representative of background conditions, it must be replaced by another sample that is not an outlier to maintain at least eight samples for the background determination for soils.

(2) Determination of soil background levels from off-property investigations. Upon demonstration that it is not possible to find sampling locations in accordance with paragraph (H)(1) of this rule, the volunteer may use information from off-property investigations in accordance with this paragraph to determine the background concentrations of chemicals of concern at the property. When evaluating the applicability of the data collected as part of the off-property investigation, the criteria contained in paragraphs (H)(1)(b) and (H)(1)(c) of this rule must be satisfied in order to consider the data as potentially applicable for determining background levels in soils for the purposes of this rule. In addition, if the information is not representative of conditions at the property, the volunteer cannot use this method to demonstrate background levels in soil. Appropriate off-property investigations that may be used for the purposes of this paragraph include investigations using data demonstrated to be reliable and representative of background levels for the property. At a minimum, to be reliable and representative, the investigations must conform to the following:

(a) Be conducted on soil that is representative of the soil type at the property for which the background level is being determined and are located within the state of Ohio .

(b) Employ data demonstrated to be reliable and representative that at a minimum meet the following criteria .

(i) Employ data quality objectives consistent with paragraph (C) of this rule .

(ii) Employ quality assurance and quality control procedures that serve to minimize sources of error and the potential for cross contamination of field samples, and maximize the representativeness of the data collected .

(iii) Employ data collection and sampling techniques that are consistent with the criteria listed in paragraphs (D)(1) to (D)(4) of this rule .

(c) Employ methods for calculating background levels consistent with the methods described in paragraph (H)(1)(d) of this rule or otherwise use methods that are demonstrated to be statistically verifiable.

[Comment: Appropriate investigations may include: peer-reviewed information; research reports generated or sponsored by local, state, or federal agencies; or college or university research reports including theses and dissertations.]

(3) Ground water background levels.

(a) Property-specific determination of ground water background levels. If the background levels, as determined in accordance with this rule, for a chemical of concern do not meet the applicable standard derived for the property in accordance with rule 3745-300-08 or 3745-300-09 of the Administrative Code, the volunteer can select, as the applicable standard, a comparison demonstrating that the concentration of any such chemical of concern on the property is at or below background levels. To determine background levels in ground water, samples must be taken up-gradient at appropriate locations and depths which are unaffected by anthropogenic sources of contamination. Background sampling points may include points not hydraulically up-gradient of the identified areas where either of the following occurs:

(i) Hydrogeologic conditions do not allow the volunteer to determine which direction is hydraulically up-gradient .

(ii) Sampling at other points will provide an indication of background ground water quality that is representative or more representative than that provided by the up-gradient points.

(b) The number and kind of samples collected to establish background in ground water must meet the following criteria:

(i) Be appropriate for the method used for determining whether concentrations of chemicals of concern exceed background, following generally accepted principles .

(ii) As large as necessary to ensure with reasonable confidence that a contaminant release to the ground water from a property will be detected.

(c) The method chosen must be applied separately for each chemical of concern and must comply with the following performance standards:

(i) Capable of accounting for data below the limit of detection using the lowest practical quantitation limit that can be reliably achieved within specified limits of precision and accuracy during routine laboratory operating conditions that are available to the volunteer. The practical quantitation limit must be below the potable ground water standard .

(ii) Contain procedures to control or correct for seasonal and spatial variability as well as temporal correlation in the data .

(iii) Should a statistical method be chosen, the method must be appropriate for the distribution of chemical parameters or hazardous constituents. If the distribution is shown to be inappropriate for a normal theory test, then the data must be transformed or a distribution-free theory test must be used. If the distributions for the chemicals of concern differ, more than one statistical method may be needed .

(iv) Complies with the performance standards set in U.S EPA's "Statistical Analysis of Ground Water Monitoring Data at RCRA Facilities: Addendum to the Interim Final Guidance."

(4) Determination of ground water background levels from off-property investigations. Upon a demonstration that it is not possible to find sampling locations in accordance with paragraph (H)(3) of this rule, the volunteer may use information from off-property investigations in accordance with this paragraph to determine the background concentrations of chemicals of concern at the property. When evaluating the applicability of the data collected as part of the off-property investigation, the criteria contained in paragraphs (H)(3)(b) and (H)(3)(c) of this rule must be satisfied in order to consider the data as potentially applicable for determining background levels in ground water for the purposes of this rule. In addition, if the information is not representative of conditions at the property, the volunteer cannot use this method to demonstrate background levels in ground water. Appropriate off-property investigations that may be used for the purposes of this paragraph include investigations using data demonstrated to be reliable and representative of background levels for the property. At a minimum, to be reliable and representative, the investigations must meet the following criteria:

(a) Be conducted on soils and ground waters representative of the soil type, ground water conditions, and ground water zone at the property for which the background level is being determined and are located within or immediately adjacent to the state of Ohio .

(b) Employ data demonstrated to be reliable and representative and at a minimum meet the following criteria .

(i) Employ data quality objectives consistent with paragraph (C) of this rule .

(ii) Employ quality assurance and quality control procedures that serve to minimize sources of error and the potential for cross contamination of field samples, and maximize the representativeness of the data collected .

(iii) Employ data collection and sampling techniques that are consistent with the criteria listed in paragraphs (D)(1) to (D)(4) of this rule .

(c) Employ methods for calculating background levels that are demonstrated to be statistically verifiable.

[Comment: Appropriate investigations may include: information from the Ohio EPA division of drinking and ground water regarding ambient ground water quality monitoring; peer-reviewed information; research reports generated or sponsored by local, state, or federal agencies; or college or university research reports including theses and dissertations.]

(5) If background levels in soil or ground water cannot be determined using paragraphs (H)(1) to (H)(4) of this rule, background levels cannot be used as the applicable standards for either the soil or ground water.

(I) Demonstration of compliance with applicable standards.

(1) Data collection. The data collected in accordance with this rule must be sufficient to determine whether applicable standards are met or to determine that remedial activities conducted in accordance with rule 3745-300-11 of the Administrative Code result in compliance with applicable standards.

Data must be sufficient to assess existing exposure pathways and reasonably anticipated exposure pathways determined to be complete in accordance with paragraph (F)(1) of this rule and all points of compliance for soil, ground water, and other environmental media, including the following:

(a) Points of compliance for soil.

(i) Applicable standards based on direct-contact with soils. A volunteer must meet and maintain compliance with the direct-contact soil standards to the following minimum soil depths:

(a) For properties having unrestricted land use or unrestricted residential land use , the point of compliance for applicable standards is from the ground surface to a minimum depth of ten feet. The volunteer must comply with applicable standards at depths below ten feet when soil may be made available for direct-contact through circumstances other than those specified in paragraph (I)(1)(a)(i)(c) of this rule.

The volunteer must also comply with applicable standards at depths greater than ten feet when soils may be made available for chronic, direct-contact exposure through excavation, grading, utilities maintenance or other similar circumstances. In these scenarios, the applicable point of compliance extends from the ground surface to the maximum depth of reasonably anticipated activities.

(b) For properties having institutional controls that limit a property's land use and where the institutional controls have been implemented in accordance with rule 3745-300-11 of the Administrative Code, the point of compliance for applicable standards is from the ground surface to a minimum depth of two feet. The volunteer must comply with applicable standards at depths below two feet when soil may be made available for direct-contact through circumstances other than those specified in paragraph (I)(1)(a)(i)(c) of this rule. The volunteer must also comply with applicable standards at depths greater than two feet when soil may be made available for chronic, direct-contact exposure through excavation, grading, utilities maintenance or other similar circumstances such as when soil below two feet is brought to the surface and left on the surface or otherwise incorporated into the soil remaining within the two foot point of compliance.

(c) For properties where excavation, grading, or other construction activities may occur on the property the volunteer must comply with applicable soil standards for such excavation or construction activities. The point of compliance for applicable standards is from the ground surface to a minimum depth equal to the maximum depth of excavation activities at the property.

[Comment: Applicable standards for excavation or construction activities can be either generic direct-contact soil standards for excavation construction activities, standards derived using a property-specific risk assessment, or background levels determined in accordance with paragraph (H) of this rule.]

(ii) Applicable soil standards based on leaching of chemicals of concern from soils to ground water. The point of compliance for applicable soil standards based on leaching of chemicals of concern from soils to ground water, when such leaching must be prevented in accordance with paragraph (D) of rule 3745-300-10 of the Administrative Code, is the depth from the ground surface to the top of the ground water zone requiring protection in accordance with paragraphs (F)(3) and (F)(4) of this rule.

(iii) Applicable soil standards based on other identified complete exposure pathways. The point of compliance for applicable soil standards developed pursuant to rule 3745-300-08 or 3745-300-09 of the Administrative Code for complete exposure pathways identified in paragraph (F)(1) of this rule, other than those identified in paragraphs (I)(1)(a)(i) and (I)(1)(a)(ii) of this rule, must be determined so that the exposure to receptors is appropriately addressed.

[Comment: Other identified complete exposure pathways for chemicals of concern in soil to receptor populations may include but are not limited to volatile emissions of chemicals of concern in soil to indoor air or the migration of chemicals of concern in soil to surface water or sediments.]

(b) Points of compliance for ground water. The points of compliance for each ground water zone on, underlying or emanating from a property must be determined in accordance with paragraphs (D) and (E) of rule 3745-300-10 of the Administrative Code.

(c) Points of compliance for other environmental media. The points of compliance for each complete exposure pathway identified in paragraph (F)(1) of this rule for each environmental medium other than those identified in paragraphs (I)(1)(a) and (I)(1)(b) of this rule, must be determined in accordance with the procedures in rule 3745-300-08 or 3745-300-09 of the Administrative Code.

(2) Data analysis. The volunteer must verify the assumptions and applicability of models, statistical methods, or any other data analysis methods used for determining compliance with applicable standards, determining the concentration of chemicals of concern, deriving applicable standards, or demonstrating the effectiveness of a remedial activity. At a minimum, the following must be demonstrated:

(a) Models were used in accordance with paragraph (G) of this rule .

(b) Statistical methods used are appropriate and valid for their intended use .

(c) Adjustment of applicable standards for multiple chemicals of concern was conducted in accordance with rules 3745-300-08 and 3745-300-09 of the Administrative Code, if applicable. All final cumulative human health carcinogenic risk and non-carcinogenic hazard levels are based on one significant figure .

(d) If non-certified laboratory data or studies not conducted in accordance with this rule are used to partially meet the requirements of this rule, the data must be confirmed in accordance with paragraph (E)(1)(d)(iii) of this rule. The volunteer must demonstrate in the phase II property assessment report how the non-certified laboratory data was confirmed using certified data; and

(e) If applicable standards were not determined for chemicals of concern on the property because the chemicals of concern meet the criteria of paragraph (F)(5) of this rule, the volunteer must demonstrate in the phase II property assessment report how the criteria are met.

(3) Compliance with applicable standards.

(a) The volunteer must verify compliance with applicable standards for all current exposure pathways and reasonably anticipated exposure pathways determined to be complete in accordance with the procedures described in paragraph (F)(1) of this rule, or the volunteer must implement a remedy pursuant to paragraph (I)(4)(b) of this rule.

(b) To verify compliance with applicable standards, the volunteer must compare the concentration of each chemical of concern determined in accordance with paragraph (F)(6) of this rule to the applicable standard identified in paragraph (F)(5) of this rule. Compliance with an applicable standard is verified if the concentration of each chemical of concern does not exceed the applicable standard. All final cumulative human health carcinogenic risk and non-carcinogenic hazard levels are based on one significant figure.

(c) Applicable standards may include but are not limited to standards derived from generic numerical standards, background levels determined in accordance with paragraph (H) of this rule, a property-specific risk assessment, or a combination of these standards. If generic direct-contact soil standards for a restricted land use are used to meet applicable standards, institutional controls must be used to limit the property's land use as described in paragraph (I) of this rule and paragraph (C)(2)(c) of rule 3745-300-08 of the Administrative Code. The institutional controls must be implemented in accordance with rule 3745-300-11 of the Administrative Code.

(4) Implementation of remedial activities.

(a) If concentrations of chemicals of concern exceed applicable standards for any existing exposure pathway or reasonably anticipated exposure pathway determined to be complete in accordance with paragraph (F)(1) of this rule, the volunteer must implement a remedy in accordance with rule 3745-300-11 of the Administrative Code. If the applicable points of compliance for environmental media at the property cannot be met or maintained, the volunteer must implement a remedy in accordance with rule 3745-300-11 of the Administrative Code.

(b) If compliance with applicable standards cannot be determined or is not determined for an existing exposure pathway or reasonably anticipated exposure pathway determined to be complete in accordance with paragraph (F)(1) of this rule, the volunteer must implement a remedy in accordance with rule 3745-300-11 of the Administrative Code. The volunteer may make a determination of compliance with applicable standards at any time during the voluntary action including and up through assessment and remedial activity implementation. The volunteer must demonstrate that the remedy renders the pathway incomplete as to all potential receptors and that all points of compliance as specified in paragraph (I)(1) of this rule have been addressed.

(5) In cases where applicable standards have not been derived, the applicable standards consist of the standards for each complete exposure pathway identified based on paragraph (F)(1) of this rule and allowable land uses, at the points of compliance identified consistent with paragraph (I)(1) of this rule.

(J) A volunteer must complete a phase II property assessment written report that is in a format prescribed by the Ohio EPA and the report must include at a minimum the following information:

(1) An introduction identifying the property, including the legal description of the property; the dates over which the phase I property assessment and the phase II property assessment were conducted and the date that the written report for each was finalized; and the name and job title of each person conducting the phase II property assessment .

(2) A summary of any amendment to the phase I property assessment required by paragraph (E)(1) of this rule .

(3) A statement of the limitations or qualifications, if any, which impact the phase II property assessment .

(4) A graphic or written representation of the conceptual site model that describes the relationships between contaminants, transport media and receptors at the time of the no further action letter issuance, consistent with paragraph (C) of this rule.

(5) A summary of the sampling procedures employed in accordance with paragraph (D) of this rule and the rationale for the sampling and testing activities conducted in accordance with the requirements of this rule .

(6) A summary of the data collection activities conducted under paragraph (E) of this rule, the data collected as a result of these activities, and a determination of the data usability based on the quality control information. The summary should include a discussion noting if the data meets the data quality objectives as required by paragraph (C) of this rule .

(7) A summary of the determinations made under paragraphs (F)(1) to (F)(10) of this rule and a summary of the rationale for the determinations made under paragraphs (F)(1) to (F) (10) of this rule .

(8) )A summary of the background determination activities, if any, conducted under paragraph (H) of this rule;

(9) A summary of any models used in accordance with paragraph (G) of this rule and inclusion of the documentation required by paragraph (G)(5) of this rule .

(10) A summary of the background determination activities, if any, conducted under paragraph (H) of this rule.

(11) If an urban setting designation is being relied upon in part to address potable use pathway(s), a summary of the activities conducted in accordance with paragraph (C)(3) of rule 3745-300-10 of the Administrative Code .

(12) If a property-specific risk assessment was conducted to derive applicable standards, a copy of the written risk assessment report must be attached to or included in a section of the phase II property assessment report .

(13) A summary of any remedial activities implemented prior to the issuance of the no further action letter as required by paragraph (I)(4) of this rule .

(14) A discussion of whether the property complies with applicable standards for each exposure pathway, and whether remedial activities have been or are being implemented to meet or maintain applicable standards in accordance with rule 3745-300-11 of the Administrative Code, and a summary of the applicable standards demonstration conducted in accordance with paragraph (I) of this rule .

(15) The following property maps and cross-sections, as applicable:

(a) Maps indicating the locations of all borings, monitoring wells, or other sampling locations .

(b) Maps depicting the existing topography with a contour interval of no greater than five feet and delineates on or adjacent to the property any existing streams, swamps, lakes, springs, or other surface water features .

(c) Geologic cross-sections representing the subsurface geologic and hydrogeologic conditions underlying the property including all ground water zones evaluated during the phase II property assessment .

(d) Property maps indicating the locations of the identified areas and exposure units at the property, and the concentration and physical distribution of the chemicals of concern identified in environmental media .

(e) Maps showing the portions of the property where remedial activities have been implemented pursuant to rule 3745-300-11 of the Administrative Code, including the institutional controls, risk mitigation measures, and engineering controls subject to an operation and maintenance plan prepared under that rule. If a remedial activity does not apply to the entire property, include a survey map showing the portion of the property to which the remedial activity applies. Maps may be included in the operation and maintenance plan, written pursuant to rule 3745-300-11 of the Administrative Code, instead of including it in the phase II property assessment report .

(16) A bibliography of references which identifies, to the extent available, the description, date, source, and location of the documents reviewed as part of the phase II property assessment and the identification of all laboratories that performed analyses as part of the phase II property assessment .

(17) Appendices for appropriate supporting documentation.

Effective: 08/01/2014
R.C. 119.032 review dates: 04/24/2014 and 08/01/2019
Promulgated Under: 119.03
Statutory Authority: 3746.04
Rule Amplifies: 3746
Prior Effective Dates: 12/16/1996, 10/21/2002, 3/1/2009, 4/23/12

3745-300-08 Generic numerical standards.

[Comment: For dates of non-regulatory government publications, publications of recognized organizations and associations, federal rules, and federal statutory provisions referenced in this rule, see paragraph (B) of rule 3745-300-01 of the Administrative Code titled "Incorporation by reference."]

(A) Generic numerical standards.

(1) Applicability.

(a) Generic numerical standards listed in this rule for hazardous substances and petroleum may be used to demonstrate compliance with applicable standards provided the exposure scenario for the property comports with land use and activity patterns used to derive the generic numerical standard. Generic numerical standards are provided for complete exposure pathways to petroleum releases (paragraph (B) of this rule), direct contact with hazardous substances in soil (paragraph (C) of this rule), indoor air exposure due to vapor intrusion from environmental media to human receptors (paragraph (D) of this rule), unrestricted potable use for hazardous substances in ground water (paragraph (E) of this rule), and complete exposure pathways to human and ecological receptors from surface water and sediment (paragraphs (G), (H) and (I) of this rule). The appendix to this rule contains the generic numerical standards.

(b) If complete exposure pathways exist on a property that are not considered in the development of a generic numerical standard listed in this rule or if a generic numerical standard is not listed for chemicals of concern on a property, applicable standards must be derived in accordance with rule 3745-300-09 of the Administrative Code. Demonstration of compliance with applicable standards at a property may be made using a combination of generic numerical standards in accordance with this rule and standards developed through a property-specific risk assessment in accordance with rule 3745-300-09 of the Administrative Code or any other applicable standards.

(c) If radioactive materials are identified at a property, the property may be subject to the Atomic Energy Act and regulations adopted thereunder and Chapters 3701. and 3747. of the Revised Code and rules adopted thereunder. If radionuclides or radioactive materials are present at a property, the cleanup of the radionuclides or radioactive material shall be conducted in compliance with requirements of the Ohio department of health. Remedy approval by the Ohio department of health shall be considered sufficient to meet applicable standards for radionuclides or radioactive materials for the voluntary action and may be considered a generic numerical standard.

(2) Assumptions. The following assumptions apply for all generic numerical standards except for the generic direct contact soil standards for petroleum described in paragraph (B) of this rule, direct contact soil standards for lead as described in paragraph (C)(3)(e) of this rule, the generic unrestricted potable use standards based on maximum contaminant levels or other regulatory established criteria as described in paragraph (E) of this rule, and potable use standards for petroleum as described in paragraph (E)(3)(a) of this rule.

(a) Single chemical. The generic numerical standards assume a single chemical of concern is present within an identified area or exposure unit.

(i) The single chemical generic standards set forth in this rule are based on the following risk and hazard levels:

(a) For hazardous substances having carcinogenic effects, the chemical-specific carcinogenic risk must not exceed one excess cancer in a population of one hundred thousand (i.e., 1 x 10-5).

(b) For hazardous substances having non-carcinogenic effects, the chemical-specific risk must not exceed a hazard index of one.

(ii) The concentration of a chemical of concern, as determined in accordance with paragraph (F)(6) of rule 3745-300-07 of the Administrative Code, must not exceed the single chemical generic standard for that chemical.

(b) Cumulative adjustment for multiple chemicals.

When more than one chemical of concern is present in each media within an identified area and an applicable generic standard for each of the chemicals of concern is contained in this rule, the standard for each chemical of concern in must be adjusted for the presence of multiple chemicals in order to meet the risk and hazard levels described in paragraph (A)(2)(a) of this rule. A cumulative adjustment for multiple chemicals within each media must also be made when using a combination of generic standards and applicable standards determined by a property-specific risk assessment in accordance with rule 3745-300-09 of the Administrative Code. The incremental risk and hazard must be added to the incremental risk and hazard from other complete exposure pathways to the same receptor population, in accordance with paragraph (A)(2)(c) of this rule. All final cumulative human health carcinogenic risk and non-carcinogenic hazard levels are based on one significant figure.

(c) Summation of risk and hazard across complete exposure pathways.

If more than one complete exposure pathway exists to each receptor population, the incremental cancer risk and hazard indices determined for each exposure pathway must be summed to calculate a cumulative cancer risk and hazard index to each receptor population. All final cumulative human health carcinogenic risk and non-carcinogenic hazard levels are based on one significant figure.

(d) If the generic numerical standards of this rule are applied to one or more exposure units or identified areas of the property and applicable standards, as determined in accordance with rule 3745-300-09 of the Administrative Code, are applied to one or more other areas of the property, then the volunteer must ensure that the risk and hazard levels for each receptor on the property do not exceed the following:

(i) One excess cancer in a population of 100,000 (1 x 10-5) .

(ii) A hazard index of 1.

All final cumulative human health carcinogenic risk and non-carcinogenic hazard levels are based on one significant figure.

(e) Points of compliance. The volunteer must comply with the applicable standards at all points of compliance at the property, for each environmental media and complete exposure pathway, in accordance with paragraph (I) of rule 3745-300-07 of the Administrative Code.

(3) A property-specific risk assessment must be conducted in accordance with the procedures established in rule 3745-300-09 of the Administrative Code to determine applicable standards instead of or in addition to using the generic numerical standards from this rule, if any of the following apply to the property:

(a) The complete exposure pathways as identified in accordance with paragraph (F)(1) of rule 3745-300-07 of the Administrative Code, include exposure pathways that are not considered in the development of standards listed in this rule.

(b) The exposure factors for the receptors identified in paragraph (E)(6) of rule 3745-300-07 of the Administrative Code are not considered in the development of standards listed in this rule, or the volunteer evaluates compliance with applicable standards for exposure units instead of identified areas in accordance with rule 3745-300-09 of the Administrative Code.

(c) The chemicals of concern on the property consist of hazardous substances or petroleum that do not have generic numerical standards included in this rule. If only some of the chemicals of concern identified have a generic numerical standard listed in this rule, a volunteer may use the applicable generic numerical standards for the chemicals of concern having listed standards and conduct a property-specific risk assessment in accordance with rule 3745-300-09 of the Administrative Code. When using a combination of generic numerical standards and applicable standards determined by a property-specific risk assessment conducted in accordance with rule 3745-300-09 of the Administrative Code, the volunteer must adjust the concentrations of the applicable standards to meet the human health risk and hazard levels described in paragraph (A)(2)(d) of this rule .

(d) Concentrations of chemicals of concern in surface water or sediment exceed applicable standards determined in accordance with this rule .

(e) Complete exposure pathways to important ecological resources other than sediment or surface water exist .

(f) Chemicals of concern have been determined to be originating from the property which are persistent, bioaccumulative, and toxic in animal tissue and the development of the generic standards, other than Ohio-specific sediment reference values contained in "attachment H" of Ohio EPA's "Guidance for Conducting Ecological Risk Assessments," which do not consider bioaccumulative effects.

(B) Generic numerical standards for petroleum.

(1) Applicability.

(a) The generic numerical standards referenced in paragraph (B)(3) of this rule apply to all petroleum releases regardless of the source or how the petroleum was released. After eligibility requirements in accordance with rule 3745-300-02 of the Administrative Code have been met, applicable standards for all petroleum releases on the property must be achieved in accordance with this chapter.

(b) The generic numerical standards referenced in paragraph (B)(3) of this rule apply to the exposure pathways for which rules adopted under division (B) of section 3737.882 of the Revised Code have numerical clean-up standards. If an exposure pathway is not addressed by a generic numerical standard under division (B) of section 3737.882 of the Revised Code, then the exposure pathway must be evaluated in accordance with rule 3745-300-09 of the Administrative Code.

(2) Assumptions.

(a) The points of compliance for generic petroleum standards are those identified in paragraph (I) of rule 3745-300-07 of the Administrative Code. For example, exposure pathways that are encompassed within the generic direct-contact soil standard shall use the points of compliance indicated in paragraph (I)(1)(a)(i) of rule 3745-300-07 of the Administrative Code. The volunteer must comply with the applicable standards at all points of compliance at the property, for each environmental medium and complete exposure pathway, in accordance with paragraph (I) of rule 3745-300-07 of the Administrative Code.

(b) Cumulative adjustment for multiple chemicals and summation of risk across complete exposure pathways that are required for chemicals of concern on the property in order to comply with paragraphs (A)(2) and (F) of this rule may not necessarily apply for generic petroleum standards referenced in paragraph (B)(3) of this rule. Cumulative adjustment for multiple chemicals and summation of risk across complete exposure pathways to meet generic petroleum standards are required only when required by rules adopted under division (B) of section 3737.882 of the Revised Code.

(c) When ground water exceeds unrestricted potable use standards, ground water response requirements in accordance with rule 3745-300-10 of the Administrative Code must be met. Properties with free product exceed applicable standards for unrestricted potable use of ground water.

(d) Restricted residential, commercial and industrial land use categories (as described in paragraph (C)(2) of this rule) require implementation of institutional controls in accordance with paragraph (C)(3) of rule 3745-300-11 of the Administrative Code.

(3) Generic numerical clean-up standards for petroleum.

The generic numerical standards for petroleum at residential, commercial, or industrial properties are the standards established in rules adopted under division (B) of section 3737.882 of the Revised Code, as provided in division (B)(1) of section 3746.04 of the Revised Code. The state fire marshal's bureau of underground storage tank regulations administers the rules adopted under division (B) of section 3737.882 of the Revised Code. Property-specific standards for petroleum may be developed using rule 3745-300-09 of the Administrative Code.

(C) Generic standards for hazardous substances- direct-contact with soils and vapor intrusion to indoor air.

(1) Applicability.

(a) When applying generic direct-contact standards to soils on a property, a volunteer must select the generic land use or activity category which is consistent with the exposure factors for the generic land use or activity category contained in paragraph (C)(2) of this rule. The exposure factors used in the development of generic numerical standards are contained in Ohio EPA's "Support Document For the Development of Generic Numerical Standards and Risk Assessment Procedures." Generic direct-contact soil standards for commercial and industrial land uses are equal unless paragraph (B)(1)(b) of rule 3745-300-09 of the Administrative Code applies.

(b) A property-specific risk assessment must be conducted in accordance with the procedures established in rule 3745-300-09 of the Administrative Code, to determine applicable standards instead of or in addition to using the generic direct-contact soil standards, if any conditions of paragraph (A)(3) of this rule apply.

(c) Generic numerical standards for petroleum releases are identified in paragraph (B)(3) of this rule. The standards identified in paragraphs (C)(3) and (D) and contained in the appendix to this rule apply to releases of hazardous substances.

(2) Land use and activity categories.

The generic direct-contact soil standards and vapor intrusion to indoor standards established in this rule are based upon the intended use of the property after the completion of a voluntary action. Standards applied to restricted residential, commercial, and industrial land use categories require implementation of institutional controls in accordance with rule 3745-300-11 of the Administrative Code. Land use and activity categories must be determined as follows:

(a) Residential land use category.

Residential land use is land use with a high frequency of potential exposure of adults and children to dermal contact with soil, inhalation of vapors and particles from soil, incidental ingestion of soil, and inhalation of volatile compounds due to vapor intrusion from environmental media to indoor air.

(i) Unrestricted residential land use category.

Unrestricted residential land use is considered protective for, and may be applied to, any land use, without further restriction.

(ii) Restricted residential land use catergory.

Restricted residential land use is considered protective for, and may be applied to, residential land uses appropriate for a modified point of compliance supported by institutional or engineering controls.

[Comment: A modified point of compliance consists of any depth less than the minimum depth of ten feet required by rule 3745-300-07 of the Administrative Code.]

(b) Commercial land use category.

Commercial land use is land use with potential exposure of adult workers during a business day and potential exposures of adults and children who are customers, patrons or visitors to commercial facilities during the business day. Commercial land use has potential exposure of adults to dermal contact with soil, inhalation of vapors and particles from soil, ingestion of soil and inhalation of volatile compounds due to vapor intrusion to indoor air. Generic direct contact standards for commercial land use may not be appropriate for properties where a high frequency of potential exposure to children may occur, such as at schools and day care facilities.

(c) Industrial land use category.

Industrial land use is land use with potential exposure of adult workers during a business day and potential exposures of adults and children who are visitors to industrial facilities during the business day. Industrial land use has potential exposure of adults to dermal contact with soil, inhalation of vapors and particles from soil and ingestion of soil and inhalation of volatile compounds due to vapor intrusion to indoor air.

(d) Construction or excavation activities.

Construction or excavation activities include invasive activities that result in potential exposure of adult workers during the business day for a portion of one year. Exposures during construction or excavation activities are of greater intensity and shorter duration than those for the commercial and industrial land use categories. Construction or excavation activities have potential exposures of adults to dermal contact with soil, inhalation of vapors and particles from soil, and ingestion of soil.

(3) Generic numerical direct-contact soil standards.

(a) Standards derivation methods. The generic direct-contact soil standards for carcinogenic and non-carcinogenic chemicals of concern are derived considering the following exposures: ingestion of soil, dermal contact with soil, inhalation of volatile compounds in outdoor air and the inhalation and ingestion of particulate emissions. Any and all applicable exposures not considered within the generic direct-contact soil standards shall be addressed in accordance with rule 3745-300-09 of the Administrative Code.

The soil saturation concentrations are calculated using the U.S. EPA recommended soil saturation equation specified in paragraph (H)(5) of rule 3745-300-09 of the Administrative Code. This equation is not recommended for compounds that are at solid phase at ambient soil temperatures; therefore, no generic soil saturation values were calculated for those chemicals whose melting point is greater than seventeen degrees Celsius. Further, soil saturation values were determined only for those chemicals whose physicochemical parameters used to derive the soil saturation concentrations could be verified. The volunteer may use the soil saturation levels as listed in the appendix to this rule, or maycalculate a property-specific soil saturation concentration in place of the generic soil saturation in accordance with paragraph (H)(5) of 3745-300-09 of the Administrative Code.

(b) Generic direct-contact soil standards for carcinogenic and non-carcinogenic chemicals of concern - residential land use category . The generic direct-contact soil standards for carcinogenic and non-carcinogenic chemicals of concern for residential land use categories are contained in table I of the appendix to this rule.

(c) Generic direct-contact soil standards for carcinogenic and non-carcinogenic chemicals of concern - commercial and industrial land use categories. The generic direct-contact soil standards for carcinogenic and non-carcinogenic chemicals of concern for commercial and industrial land use categories are contained in table II of the appendix to this rule.

(d) Generic direct-contact soil standards for carcinogenic and non-carcinogenic chemicals of concern - construction and excavation activities category. The generic direct-contact soil standards for carcinogenic and non-carcinogenic chemicals of concern for the construction and excavation activities category are contained in table III of the appendix to this rule.


              image: oh/admin/2014/3745-300-08_PH_FF_A_RU_20140701_0812-1.png

Where :

Csat is the soil saturation concentration (mg/kg)

S is the water solubility (mg/L water)

pbis dry soil bulk density (kg/L)

Kd is the soil - water partition coefficient (L/kg) (default is Kd = Koc x f oc )

Koc is the soil organic carbon/water partition coefficient (L/kg)

f oc is the fraction organic carbon of soil (g/g)

[THETA]wis the water-filled soil porosity(Lwater/Lsoil)

H' is the dimensionless Henry's Law constant

[THETA]ais the air-filled soil porosity(Lpore/Lsoil).

  

(e) The lead standards contained in tables I, II and III of the appendix to this rule take into account other factors and assumptions in addition to the carcinogenic or non-carcinogenic risk of lead. Therefore, using the cumulative risk considerations contained in paragraph (A)(2) of this rule is not appropriate and need not be performed for lead.

(D) Generic standards for indoor air due to vapor intrusion from environmental media are derived considering the exposure scenario and the chemical specific inhalation toxicity. Standards apply to indoor air only for chemicals that have volatilized from environmental media to indoor air. Concentrations of chemicals of concern in soil, ground water, or soil gas may be used to approximate indoor air concentrations through modeling conducted in accordance with paragraph (G) of rule 3745-300-07 of the Administrative Code.

(1) Generic indoor air standards for residential land use. The standards for indoor air exposure due to vapor intrusion from environmental media for the residential land use category are contained in table IV of the appendix to this rule.

(2) Generic indoor air standards commercial/industrial land use. The standards for indoor air exposure due to vapor intrusion from environmental media for the commercial or industrial land use categories are contained in table V of the appendix to this rule.

(E) Generic unrestricted potable use standards for hazardous substances in ground water.

(1) -Applicability.

(a) -The generic unrestricted potable use standards contained in paragraph (E)(3) of this rule apply as determined in accordance with rule 3745-300-10 of the Administrative Code.

(b) -A property-specific risk assessment must be conducted in accordance with the procedures established in rule 3745-300-09 of the Administrative Code to determine applicable standards in place of or in addition to using the generic unrestricted potable use standards if any of paragraphs (A)(3)(a) to (A)(3)(c) of this rule apply to the property, and those exposures are required to be evaluated under rule 3745-300-07 of the Administrative Code;

(c) -The standards in paragraph (E)(3) of this rule apply to releases of hazardous substances. Generic numerical standards for petroleum releases are identified in paragraph (B)(3) of this rule.

(2) -Assumptions.

The generic unrestricted potable use standards contained in tables VI and VII of the appendix to this rule were determined using the assumption that the ground water on, underlying and emanating from the property will be used as a source of water for drinking, cooking, showering and bathing.

(3) Generic unrestricted potable use standards for ground water.

(a) Generic unrestricted potable use standards for petroleum only. The generic unrestricted potable use standards for petroleum at commercial, industrial, and residential properties are the standards established in rules adopted under division (B) of section 3737.882 of the Revised Code, as provided by division (B)(1) of section 3746.04 of the Revised Code.

(b) Generic unrestricted potable use standards based on maximum contaminant levels or other regulatory established criteria . The generic unrestricted potable use standards based on maximum contaminant levels or other regulatory established criteria are contained in table VI of the appendix to this rule.

  

  

(c) Generic risk-derived unrestricted potable use standards . The generic risk-derived unrestricted potable use standards are contained in table VII of the appendix to this rule.

(F) Procedures for cumulative adjustment for multiple chemicals.

The following procedures may be used to in order to meet the risk and hazard levels described in paragraph (A)(2)(d) of this rule when more than one chemical of concern is present in environmental media within an identified area or exposure unit:

(1) Several procedures may be used to adjust for the presence of multiple carcinogenic chemicals of concern in an identified area or exposure unit to comply with paragraph (A)(2)(b) of this rule. One method is to divide the exposure point concentration (chema) for each chemical of concern in the affected media by the "Single Chemical Carcinogenic Standard" (SCCSa) in the appendix to this rule. The resultant ratios are summed as an expression of estimated risk (see the equation below). When the summed ratios result in a value less than one, carcinogenic risk levels have been met on the property for exposure to that media. When the summed ratios result in a value greater than one the carcinogenic risk levels are not met and remedial action is required.


              image: oh/admin/2014/3745-300-08_PH_FF_A_RU_20140701_0812-2.jpg

(b)

(2) Several procedures may be used to adjust for the presence of multiple non-carcinogenic chemicals of concern in an identified area or exposure unit to comply with paragraph (A)(2)(b) of this rule. One method is to divide the exposure point concentration (chema) for each chemical of concern in the affected media by the ''Single Chemical Noncarcinogenic Standard'' (SCNSa)in the appendix to this rule. The resultant ratios are summed as an expression of estimated hazard index (see the equation below). When the summed ratios result in a value less than one, non-carcinogenic risk levels have been met on the property. When the summed ratios result in a value greater than one the non-carcinogenic risk levels are not met and remedial action is required.


              image: oh/admin/2014/3745-300-08_PH_FF_A_RU_20140701_0812-3.jpg

Non-cancer risk ratios for non-carcinogenic chemicals of concern which do not exhibit the same toxic endpoint may be excluded from the calculation of the cumulative non-cancer risk ratio described above if a written justification for such exclusion is submitted. The consideration of all major toxic endpoints and mechanisms of action must include, at a minimum, those identified with the critical effect upon which the reference dose or reference concentration for each non-carcinogenic chemical of concern is based. The source for each reference dose and reference concentration for each non-carcinogenic chemical for which generic direct-contact soil standards have been derived, are cited in Ohio EPA's "Support Document for the Development of Generic Numerical Standards and Risk Assessment Procedures." It may be necessary to calculate more than one cumulative non-cancer risk ratio for a property resulting from the segregation of non-carcinogenic chemicals of concern on the basis of toxic endpoints or mechanisms of action.

(3) For situations where a chemical of concern poses both carcinogenic and non-carcinogenic risks and a value for the chemical of concern is listed in both the "Standard for a Single Chemical Carcinogens" column and the "Standard for a Single Chemical Non-Carcinogens" column contained in the appendix to this rule or an applicable single chemical carcinogen and non-carcinogen standard has been determined in accordance with rule 3745-300-09 of the Administrative Code, the chemical of concern must be included in the multiple carcinogenic chemical adjustment calculation under paragraph (F)(1) of this rule and the adjustment calculation for multiple non-carcinogenic chemicals under paragraph (F)(2)of this rule. The applicable standard for the chemical of concern will be the lowest of the values determined by using the equations in this paragraph or, if appropriate, the soil saturation concentration.


              image: oh/admin/2014/3745-300-08_PH_FF_A_RU_20140701_0812-4.jpg


              image: oh/admin/2014/3745-300-08_PH_FF_A_RU_20140701_0812-5.jpg

(G) Generic numerical standards for surface water.

(1) Applicability.

(a) The generic numerical standards for surface water in paragraph (G)(2) of this rule apply to a property as determined in accordance with paragraph (F) of rule 3745-300-07 of the Administrative Code.

(b) For all releases of petroleum on underlying or emanating to surface water of the state, the generic petroleum standards are contained within paragraph (B) of this rule.

(2) Generic surface water standards.

(a) For all releases or source areas of hazardous substances on, underlying or emanating from the property to surface waters of the state, surface water chemical concentrations must be compared to the chemical criteria pursuant to Chapter 3745-1 of the Administrative Code. The outside mixing zone average criteria for human health and aquatic life and wildlife should be compared against ambient samples averaged over a thirty-day period. Single ambient samples are not to exceed the outside the mixing zone maximum. If all chemical constituents are below their corresponding chemical criteria, then the surface water may be eliminated as an exposure medium. If chemical constituents exceed their corresponding chemical criteria, then the surface water shall be further assessed in accordance with rule 3745-300-09 of the Administrative Code.

For the purposes of this rule, the generic numerical standards for surface water apply regardless of whether the release or source area of hazardous substances is a point source or nonpoint source.

(b) All regulated point source discharges of pollutants to surface waters of the state and any other regulated discharges that occur from or on the property must comply with all permit and other applicable requirements of the Federal Water Pollution Control Act and Chapter 6111. of the Revised Code, and the regulations adopted thereunder.

The permit and other applicable requirements of point source discharges include but are not limited to: (i) the national pollutant discharge elimination system permit issued pursuant to Chapter 3745-33 of the Administrative Code (also referred to as Ohio NPDES permits), and (ii) the water quality certification issued pursuant to Chapter 3745-32 of the Administrative Code. A volunteer may obtain a consolidated standards permit for activities conducted in connection with a voluntary action which require permits from the director.

(c) Storm water associated with industrial activity that is discharged to surface waters of the state or is discharged through a separate municipal storm sewer system must comply with the applicable requirements contained in 40 C.F.R. 122.26 .

(H) Generic numerical standards for human exposure to sediments.

(1) Applicability.

(a) For purposes of this rule and rule 3745-300-07 of the Administrative Code, human health exposure pathways to sedimentsare considered complete when the surface water which contains the sediments:

(i) Produces or can produce a consistent supply of edible-sized fish and the chemicals of concern in the sediment are persistent, bioaccumulative and toxic; or

(ii) Is reasonably anticipated to support recreational activities such as wading, swimming, or boating.

(b) For all releases of petroleum on or from the property to surface waters of the state which contain sediments, the generic petroleum standards are contained in paragraph (B) of this rule.

(c) If the concentrations of chemicals of concern in sediment exceed the generic numerical standards for human exposure to sediment, the volunteer must conduct a human health property-specific risk assessment following the methodology outlined in paragraph (D) of rule 3745-300-09 of the Administrative Code or conduct a remedy in accordance with the 3745-300-11 of the Administrative Code.

(2) Generic numerical standards for human exposure to sediment.

(a) Generic direct-contact standards for sediments are the generic direct-contact soil standards for residential land use specified in table I of the appendix to this rule. Cumulative adjustment for multiple chemicals must be evaluated in accordance with paragraph (A)(2)(b) of this rule.

(b) If chemicals of concern in sediment are persistent, bioaccumulative and toxic and the surface water containing the sediments produces or can produce a consistent supply of edible-sized fish, the volunteer must conduct a human health property-specific risk assessment in accordance with rule 3745-300-09 of the Administrative Code to evaluate fish consumption.

(I) Generic numerical standards for exposure of important ecological resources to sediments.

(1) Applicability. The volunteer may do either of the following:

(a) Sample sediments directly and apply the applicable standards in accordance with paragraphs (I)(2)(a) and (I)(2)(b) of this rule .

(b) Demonstrate compliance with applicable standards in accordance with paragraph (F)(5) of rule 3745-300-09 of the Administrative Code.

(2) Generic numerical standards for exposure of important ecological resources to sediments. The volunteer must do one of the following:

(a) Compare the concentration of chemicals of concern in sediments on the property to the Ohio-specific sediment reference values contained in "attachment H" of Ohio EPA's "Guidance for Conducting Ecological Risk Assessments."

(b) For each chemical of concern for which the volunteer does not compare the sediment concentrations to the Ohio-specific sediment reference values, use the ecotoxicologically-based benchmarks from the following hierarchy :

(i) Consensus-based threshold effects concentration values contained in MacDonald, Ingersoll and Berger's "Development and Evaluation of Consensus-based Sediment Quality Guidelines for Freshwater Ecosystems."

(ii) U.S. EPA, region 5 ecological screening levels.

(3) If concentrations of chemicals of concern do not exceed Ohio-specific sediment reference values or appropriate ecotoxicologically-based benchmarks and the provisions in paragraph (A)(3)(f) of this rule do not apply, then the applicable standards have been met.

(4) The volunteer shall evaluate the sediments in accordance with paragraph (F) of rule 3745-300-09 of the Administrative Code or conduct a remedy in accordance with rule 3745-300-11 of the Administrative Code if any of the following apply:

(a) The sediments exceed applicable standards in accordance with this rule .

(b) The sediment samples were not compared to the sediment values in accordance with paragraph (I)(2) of this rule.

(J) Developing soil standards for leaching of chemicals of concern from soil to ground water.

(1) Applicability.

(a) Soil standards for leaching may be developed when one or more ground water zones are determined to meet unrestricted potable use standards and the potential for leaching of chemicals of concern from soil to ground water is determined to be a complete exposure pathway.

(b) Soil standards for leaching may be developed when one or more ground water zones are determined to exceed unrestricted potable use standards and the potential for leaching of chemicals of concern from soil to ground water is a complete exposure pathway that must be evaluated in accordance with either of the following:

(i) Applicable ground water response requirements contained in paragraph (E) of rule 3745-300-10 of the Administrative Code .

(ii) A pathway completeness determination in paragraph (F)(1) of rule 3745-300-07 of the Administrative Code.

(2) Soil standards for leaching.

(a) Soil standards for leaching when the underlying ground water zone meets unrestricted potable use standards.

Soil standards for leaching are the soil concentrations determined to be protective of the applicable ground water zone and will not cause unrestricted potable use standards to be exceeded in the ground water zone as demonstrated in accordance with paragraph (F)(4)(a) of rule 3745-300-07 of the Administrative Code.

(b) Soil standards for leaching when the underlying ground water zone exceeds unrestricted potable use standards.

(i) Soil standards for leaching are the soil concentrations determined to be protective of the applicable ground water response requirements for the ground water zone as determined by rule 3745-300-10 of the Administrative Code.

(ii) Soil standards for leaching are the soil concentrations determined to be protective of any other applicable standard in ground water that must be met in accordance with a pathway completeness determination and the demonstration of compliance with applicable standards.

Click to view Appendix

Effective: 08/01/2014
R.C. 119.032 review dates: 04/24/2014 and 08/01/2019
Promulgated Under: 119.03
Statutory Authority: 3746.04
Rule Amplifies: 3746
Prior Effective Dates: 12/16/1996, 10/21/2002, 3/1/2009

3745-300-09 Property-specific risk assessment procedures.

[Comment: For dates of non-regulatory government publications, publications of recognized organizations and associations, federal rules, and federal statutory provisions referenced in this rule, see paragraph (B) of rule 3745-300-01 of the Administrative Code titled "Incorporation by reference."]

(A) Applicability.

The volunteer may use the property-specific risk assessment procedures set forth in this rule to determine applicable standards in place of, or in addition to, generic numerical standards in accordance with rule 3745-300-08 of the Administrative Code.

(1) If radioactive materials are identified at a property, the property may be subject to the Atomic Energy Act and regulations adopted thereunder and Chapters 3701. and 3747. of the Revised Code and rules adopted thereunder. If radionuclides or radioactive materials are present at a property, the cleanup of the radionuclides or radioactive material shall be conducted in compliance with requirements of the Ohio department of health. Remedy approval by the Ohio department of health shall be considered sufficient to meet applicable standards for radionuclides or radioactive materials for the voluntary action.

(2) Elective application.

If a volunteer elects not to apply one or more of the generic numerical standards established under rule 3745-300-08 of the Administrative Code to a chemical of concern, a property-specific risk assessment must be used to develop an applicable standard for that chemical of concern.

(3) Mandatory application.

A property-specific risk assessment must be conducted in accordance with the procedures established in this rule to determine applicable standards instead of or in addition to using the generic numerical standards in accordance with rule 3745-300-08 of the Administrative Code, if any of the following apply to the property:

(a) The complete exposure pathways as identified in accordance with paragraph (F)(1) of rule 3745-300-07 of the Administrative Code, include exposure pathways that are not considered in the development of standards listed in the appendix to rule 3745-300-08 of the Administrative Code.

(b) The exposure factors for the receptors identified in paragraph (E)(6) of rule 3745-300-07 of the Administrative Code are not considered in the development of standards listed in the appendix to rule 3745-300-08 of the Administrative Code .

(c) The chemicals of concern originating from the property consist of hazardous substances or petroleum that do not have generic numerical standards included in the appendix to rule 3745-300-08 of the Administrative Code. If only some of the chemicals of concern identified have a generic numerical standard listed in the appendix to rule 3745-300-08 of the Administrative Code, a volunteer may use the applicable generic numerical standards for the chemicals of concern having listed standards and conduct a property-specific risk assessment in accordance with this rule. When using a combination of generic numerical standards and applicable standards determined by a property-specific risk assessment conducted in accordance with this rule, the volunteer must adjust the concentrations of the applicable standards to meet the human health risk and hazard levels described in paragraph (B) of this rule .

(d) Concentrations of chemicals of concern in surface water or sediment exceed applicable standards determined in accordance with rule 3745-300-08 of the Administrative Code .

(e) Complete exposure pathways to important ecological resources other than sediment or surface water exist .

(f) Chemicals of concern that are determined to be on or from the property are persistent, bioaccumulative, and toxic in animal tissue and the development of the generic standards, other than Ohio-specific sediment reference values contained in "attachment H" of Ohio EPA's "Guidance for Conducting Ecological Risk Assessments," which do not consider bioaccumulative effects.

(B) Applicable risk and hazard levels for human receptors.

The volunteer must determine the applicable standards for human receptors developed from a property-specific risk assessment in accordance with the following risk and hazard levels:

(1) Carcinogenic risk.

For chemicals of concern which have carcinogenic effects, the cumulative human health carcinogenic risk must not exceed the following risk levels based on the reasonably anticipated use of the property:

(a) For residential and commercial property land use, the cumulative carcinogenic risk, which is attributable to the chemicals of concern, must not exceed an excess upper bound lifetime cancer risk to an individual of one in one hundred thousand (1 x 10-5) .

(b) For industrial property land use, the cumulative carcinogenic risk must not exceed the following:

(i) An excess upper bound lifetime cancer risk to an individual, which is attributable to the chemicals of concern, of one in ten thousand (10-4) provided that a demonstration that the cumulative cancer risk to off-property receptors, which is attributable to chemicals of concern, is less than an excess upper bound lifetime cancer risk to an individual of one in one hundred thousand (1 x 10-5) .

(ii) An excess upper bound lifetime cancer risk to an individual, which is attributable to the chemicals of concern, of one in one hundred thousand (1 x 10-5).

(2) Noncarcinogenic hazard.

For chemicals of concern which have noncarcinogenic effects, the cumulative human health hazard, which is attributable to the chemicals of concern, must not exceed a hazard index of one.

(3) Carcinogenic risk and noncarcinogenic hazard.

For chemicals of concern which have both carcinogenic and noncarcinogenic effects, the concentration of the chemicals of concern must not exceed the risk and hazard levels established in paragraphs (B)(1) and (B)(2) of this rule. If more than one complete exposure pathway exists to each receptor population, the incremental cancer risk and hazard indices determined for each exposure pathway must be summed to calculate a cumulative cancer risk and hazard index to each receptor population. All final cumulative human health carcinogenic risk and non-carcinogenic hazard levels are based on one significant figure.

(C) Petroleum standards.

(1) Chemicals of concern that must be evaluated are dependent on the petroleum fraction of the released product. The volunteer may need to evaluate additional petroleum constituents or typical impurities to ensure applicable standards are met. At a minimum, the volunteer must assess and evaluate the indicator compounds for each petroleum fraction including the following:

(a) For light petroleum fractions, such as natural gasoline, gasohol or naphtha solvents, environmental media must be analyzed for benzene, toluene, ethylbenzene, methyl tert-butyl ether and total xylenes.

(b) For middle petroleum fractions, such as kerosene, diesel fuel or jet fuel, environmental media must be analyzed for benzene, toluene, ethylbenzene, total xylenes, acenaphthene, anthracene, chrysene, benzo[a]anthracene, benzo[a]pyrene, benzo[b]fluoranthene, benzo[k]fluoranthene, dibenzo[a,h]anthracene, fluoranthene, fluorene, indeno[1,2,3-cd]pyrene, naphthalene, and pyrene.

(c) For heavy petroleum fractions, such as hydraulic oil, lube oil, or residual fuel oils, environmental media must be analyzed for acenaphthene, anthracene, chrysene, benzo[a]pyrene, benzo[a]anthracene, benzo[b]fluoranthene, benzo[k]fluoranthene, dibenzo[a,h]anthracene, fluoranthene, fluorene, indeno[1,2,3-cd]pyrene, naphthalene, and pyrene. In addition, where the heavy petroleum is used motor oil, used cutting oil, or hydraulic oil, additional chemicals of concern that may be typical impurities of the used heavy petroleum fractions product must also be identified and included in the analysis, as appropriate.

(d) For petroleum from an unknown source, environmental media must be analyzed for benzene, ethylbenzene, toluene, total xylenes, methyl tert-butyl ether, acenaphthene, anthracene, chrysene, benzo[a]anthracene, benzo[a]pyrene, benzo[b]fluoranthene, benzo[k]fluoranthene, dibenzo[a,h]anthracene, fluoranthene, fluorene, indeno[1,2,3-cd]pyrene, naphthalene, and pyrene. In addition, additional chemicals of concern that may be typical impurities of used petroleum fractions must also be identified and included in the analysis, as appropriate.

(2) Evaluating compliance with applicable standards. The concentrations of chemicals of concern evaluated in accordance with paragraph (D)(3)(a) of this rule on or from the property must meet applicable standards for the media and exposure pathways evaluated. As appropriate, the volunteer must evaluate applicable standards for petroleum and its constituents or impurities in the following manner:

(a) A human health property-specific risk assessment must be conducted that includes derivation of applicable standards in accordance with paragraph (D) of this rule or use of generic numerical standards contained in rule 3745-300-08 of the Administrative Code. Generic numerical standards may be used for the exposure pathways included in rule 3745-300-08 of the Administrative Code. Other exposure pathways must be evaluated in accordance with paragraph (D) of this rule. Evaluation of cumulative risks in accordance with paragraphs (B) and (D)(3)(d) of this rule must be conducted.

(b) Soil saturation concentrations of total petroleum hydrocarbons must be determined utilizing the vertical hydraulic conductivity of the unsaturated soil or otherwise demonstrate the soil type most representative of the soils impacted by petroleum. The corresponding petroleum fraction must meet the residual saturation concentration contained in table I of this rule.

Table I: total petroleum hydrocarbon soil saturation concentration (values are in mg/kg).

  

Residual Saturation Concentrations for:

Residual Saturation Concentrations for:

Residual Saturation Concentrations for:

  

Sand and Gravel; Unknown Soil Type

Silty/Clayey Sand

Glacial Till and Silty Clay

Petroleum Fraction

KV: 10-3 - 10-4 cm/s

KV: 10-4 - 10-5 cm/s

KV: < 10-5 cm/s

Light (C6 -C12)

1,000

5,000

8,000

Middle (C10 -C20)

2,000

10,000

20,000

Heavy (C 20-C34

5,000

20,000

40,000

Where: mg/kg means milligrams per kilogram, Kv means vertical hydraulic conductivity of the unsaturated soil, cm/s means centimeters per second, and Cx means carbon chain length.

(c) Free product exceeds applicable standards for unrestricted potable use of ground water. Ground water with free product must meet the appropriate ground water response requirements in accordance with rule 3745-300-10 of the Administrative Code.

(d) Evaluation of sediment, surface water, and ecological exposure pathways must be determined in accordance with requirements in this rule and rule 3745-300-08 of the Administrative Code as appropriate.

(D) Procedures for human health risk assessments.

(1) For a human health property-specific risk assessment conducted in accordance with this rule the volunteer must demonstrate that the concentrations of chemicals of concern on or from a property meet the applicable risk and hazard levels under paragraph (B) of this rule.

(2) Voluntary action activities affecting the property-specific risk assessment.

For the property-specific risk assessment the volunteer must take into account the following:

(a) The classification and use of the ground water determined in accordance with rule 3745-

300-10 of the Administrative Code .

(b) The implementation of remedial activities other than institutional controls or engineering controls, that address the chemicals of concern and are consistent with the requirements contained in rule 3745-300-11 of the Administrative Code .

(c) The use of institutional controls including, without limitation, activity and use limitations contained in the environmental covenant. Institutional controls must meet the following criteria:

(i) Be effective at eliminating or mitigating exposures to all receptor populations sufficient to meet the risk and hazard levels contained in paragraph (B) of this rule .

(ii) Be capable of being monitored, maintained and enforced by the owner or operator of the property during the period of time which the control is used to achieve and maintain applicable standards .

(iii) Be transferrable with the property and recorded with the county recorder, during the period of time which the control is used to achieve and maintain applicable standards.

(d) The existence of engineering controls including, without limitation, fences, cap systems, cover systems, and landscaped controls. Engineering controls must meet the following criteria:

(i) Be effective at eliminating or mitigating exposures to all receptor populations sufficient to meet the risk and hazard levels or applicable standards in this rule .

(ii) Be effective and reliable for the climatic conditions and activities at the property to which the control will be applied .

(iii) Be reliable during the period of time which the control is used to achieve and maintain applicable standards .

(iv) Be capable of being monitored and maintained as required by an operation and maintenance plan or agreement developed in accordance with rule 3745-300-11 of the Administrative Code in order to ensure that the control remains effective.

(e) The physical and chemical characteristics of the chemicals of concern at the property, identified under rules 3745-300-06 and 3745-300-07 of the Administrative Code, as either individual chemicals or as chemical mixtures whenever such chemical mixture data are available .

(f) Relevant exposure pathway information for a property. Property-specific information includes the following:

(i) The physical characteristics of the property or properties, identified following the procedures under rules 3745-300-06 and 3745-300-07 of the Administrative Code, that describe and define complete exposure pathways determined in accordance with paragraph (F)(1) of rule 3745-300-07 of the Administrative Code. Physical characteristics must include, at a minimum: topography; climate; native soils and fill materials; consolidated and unconsolidated geological units; hydrogeological conditions and zones of saturation; surface water bodies; engineered structures (e.g., buildings, roads, retaining walls, constructed fills); and subsurface utilities .

(ii) The spatial distribution of the chemicals of concern in identified areas or exposure units on the property, which are determined in accordance with the procedures under rule 3745-300-07 of the Administrative Code. The physical distribution information must include the relative concentrations of the chemicals of concern in identified areas on the property.

(3) The property-specific risk assessment is comprised of four parts: the selection of chemicals of concern, the exposure assessment, the toxicity assessment, and the characterization of risk. These four parts are as follows:

(a) Selection of chemicals of concern.

Hazardous substances or petroleum identified on or from the property thatdo not meet the applicable standards established for background pursuant to paragraph (H) of rule 3745-300-07 of the Administrative Code, do not constitute contamination in de minimis or previously addressed areas pursuant to paragraph (E) of rule 3745-300-06 of the Administrative Code, or cannot be removed from the list of chemicals of concern pursuant to paragraph (F)(5)(f) of rule 3745-300-07 of the Administrative Code, must be considered chemicals of concern and must be evaluated pursuant to all the appropriate risk assessment calculations and methods referenced in paragraph (D)(3) of this rule.

(b) Exposure assessment.

The exposure assessment must determine the reasonably anticipated magnitude, frequency, duration and routes of exposure . The exposure assessment must consider the information obtained or activities performed under paragraph (D)(2) of this rule for the known and reasonably anticipated land use.

(i) Identification of receptor populations.

The exposure assessment must evaluate the risk and hazard potential to all receptor populations as identified in accordance with paragraph (E)(6) of rule 3745-300-07 of the Administrative Code that are reasonably anticipated to be exposed to chemicals of concern on or from the property. Populations must be evaluated for the magnitude and frequency of exposure for each exposure period.

(ii) Evaluation of exposure pathways.

The property-specific exposure assessment must evaluate all complete exposure pathways in accordance with paragraph (F)(1) of rule 3745-300-07 of the Administrative Code. A description of the efficacy of each institutional control or engineering control used to eliminate or mitigate any complete exposure pathways must be included in the written justification. Those institutional controls or engineering controls described must be implemented in accordance with rules 3745-300-13 and 3745-300-11 of the Administrative Code. Complete exposure pathways must be evaluated in accordance with the procedures contained in U.S. EPA's "Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation Manual (Part A);" "Exposure Factors Handbook;" "Human Health Evaluation Manual, Supplemental Guidance: Standard Default Exposure Factors;" "Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation Manual (Part E, Supplemental Guidance for Dermal Risk Assessment) ;" and "Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation Manual (Part F, Supplemental Guidance for Inhalation Risk Assessment)."

(iii) Quantification of chemical-specific intake.

Chemical-specific intakes must be calculated to quantify the exposure of each receptor population as identified in accordance with paragraph (E)(6) of rule 3745-300-07 of the Administrative Code, to chemicals of concern on or from the property as identified in accordance with paragraph (D)(3)(a) of this rule, and for each medium identified in a phase II property assessment. The volunteer must calculate the chemical-specific intakes using formulas identified in U.S. EPA's "Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation Manual (Part A);" "Exposure Factors Handbook;" "Human Health Evaluation Manual, Supplemental Guidance: Standard Default Exposure Factors;" "Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation Manual (Part E, Supplemental Guidance for Dermal Risk Assessment) ;" "Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation Manual (Part F, Supplemental Guidance for Inhalation Risk Assessment)"; and Ohio EPA's "Support Document for the Development of Generic Numerical Standards and Risk Assessment Procedures." The numerical values for the exposure factor terms in formulas must be determined in accordance with the requirements in paragraphs (D)(3)(b)(iii)(a) and (D)(3)(b)(iii)(b) of this rule.

(a) Exposure factors.

The exposure factor values must be determined either as point values or as the output value from a probabilistic simulation of five thousand or more iterations which solve for the chemical-specific intake equation. A probabilistic simulation output value for the intake must be the ninetieth percentile or greater value.

For risk-derived unrestricted potable use ground water, the exposure factor values must be obtained using the reasonable maximum exposure point values contained in Ohio EPA's "Support Document for the Development of Generic Numerical Standards and Risk Assessment Procedures," which are the basis for the development of the generic unrestricted potable use standards listed in the appendix to rule 3745-300-08 of the Administrative Code. Distributions developed by the volunteer must adequately describe the parameter in question following "Risk Assessment Guidance for Superfund, Volume III Part A: Process for Conducting a Probabilistic Risk Assessment"; For all other pathways, the exposure factor values must be obtained using one of the following methods:

(i) Exposure factor values not determined from property-specific information.

For exposure factors represented by a point value, these values must be upper bound or central tendency with an estimate of upper-bound exposures obtained in accordance with U.S. EPA's "Human Health Evaluation Manual, Supplemental Guidance: Standard Default Exposure Factors;" and Ohio EPA's "Support Document for the Development of Generic Numerical Standards and Risk Assessment Procedures" for the complete exposure pathway which contributes most substantially to risk, and for any other complete exposure pathways for which upper-bound exposures are deemed likely. For all other complete exposure pathways, exposure factor point values must be the values representative of central tendency, upper bound or other appropriate exposures as defined in Ohio EPA's "Support Document for the Development of Generic Numerical Standards and Risk Assessment Procedures." When exposure factor values are represented by probability distributions as input for a probabilistic simulation, the probability distributions must be derived using guidance outlined in "Risk Assessment Guidance for Superfund, Volume III Part A: Process for Conducting a Probabilistic Risk Assessment."

(ii) Exposure factor values determined from property-specific information.

For the complete exposure pathway which contributes most substantially to risk, and for any other complete exposure pathways for which upper-bound exposures are deemed likely, the property-specific exposure factor value must reasonably represent the upper bound value or central tendency value from a distribution of property-specific data, as appropriate. Exposure factor values must be consistent with an estimate of upper-bound exposures as described in U.S. EPA's "Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation Manual (Part A)," and Ohio EPA's "Support Document for the Development of Generic Numerical Standards and Risk Assessment Procedures." For all other complete exposure pathways, the property-specific exposure factor values must reasonably represent either an upper-bound or central tendency value from a distribution of property-specific data for that exposure factor term. Property-specific exposure factor distributions and, if used, the upper bound or central tendency values derived from them, must meet the criteria for property-specific data as described in paragraph (D)(3)(b)(iv) of this rule.

(b) Exposure point concentration .

Exposure point concentrations must be determined for each complete exposure pathway and must represent the concentration of chemicals of concern from each of the identified areas or exposure units . This representation of exposure point concentration must be consistent with concentrations of the chemicals of concern determined in accordance with paragraph (F)(6) of rule 3745-300-07 of the Administrative Code, and the exposure factor values as determined in accordance with paragraph (D)(3)(b)(iii)(a) of this rule.

(iv) Criteria for use of property-specific data.

Property-specific data used in the identification of receptor populations as described in paragraph (D)(3)(b)(i) of this rule, the identification of exposure pathways as described in paragraph (D)(3)(b)(ii) of this rule, or the quantification of chemical-specific intake as described in paragraph (D)(3)(b)(iii) of this rule, must meet the following criteria:

(a) Property-specific physical data must be collected in accordance with paragraph(E) of rule 3745-300-07 of the Administrative Code .

(b) Property-specific information used to define any parameter which requires the prediction of human use and activity patterns on a property, or the physical, physiological and behavioral characteristics of the receptor population(s) must be representative of the reasonably anticipated land use category and the actual property characteristics, and must be included in an institutional control or engineering control that meets the requirements of rule 3745-300-11 of the Administrative Code .

(c) Peer-reviewed literature sources may be used for the express intent to define property-specific data for paragraphs (D)(3)(b)(i), (D)(3)(b)(ii), and (D)(3)(b)(iii) of this rule. Literature based data must be demonstrated to be consistent with property-specific conditions.

(c) Toxicity assessment.

(i) Information hierarchy.

The toxicity information used in a property-specific risk assessment must be obtained from the following hierarchy:

(a) Integrated risk information system. The most current toxicity information must be obtained from the integrated risk information system for chemicals of concern being evaluated in the property-specific risk assessment.

(b) Ohio EPA toxicity information. If the toxicity information required to be used in a property-specific risk assessment is not contained in the integrated risk information system, or is not listed in Ohio EPA's "Support Document for the Development of Generic Numerical Standards and Risk Assessment Procedures," the volunteer must consult with Ohio EPA to obtain appropriate toxicity information.

(ii) Absorption factors and adjustment of toxicity values.

The toxicity values selected for use in the property-specific risk assessment as described in paragraph (D)(3)(c)(i) of this rule for each of the chemicals of concern must be evaluated in conjunction with the quantification of chemical-specific intake as described in paragraph (D)(3)(b)(iii) of this rule for each complete exposure pathway, in accordance with the procedures described in U.S. EPA's "Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation Manual (Part A)," and "Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation Manual (Part E, Supplemental Guidance for Dermal Risk Assessment)." Risk characterization performed in accordance with the procedures described in paragraph (D)(3)(d) of this rule must be performed so that chemical-specific intake and toxicity values are both expressed as the absorbed dose or both expressed as the administered dose. Default and chemical-specific absorption factor values must be obtained in accordance with U.S. EPA's "Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation Manual (Part A)," and "Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation Manual (Part E, Supplemental Guidance for Dermal Risk Assessment)" or from Ohio EPA's "Support Document for the Development of Generic Numerical Standards and Risk Assessment Procedures."

(d) Risk characterization.

Risk characterization must integrate the exposure and toxicity assessments in order to quantitatively determine the risk or hazard posed by the chemicals of concern on or from the property. The risk characterization must evaluate carcinogenic risks and noncarcinogenic hazard separately.

(i) Cancer risk characterization.

Cancer risks must be estimated as an incremental probability of an individual member of a receptor population developing cancer over a lifetime as a result of exposure to carcinogenic chemicals of concern on or from the property; this estimation of cancer risk will hereafter be referred to as incremental cancer risk. An incremental cancer risk must be calculated separately, at a minimum, for each receptor population identified in accordance with the procedures described in paragraph (D)(3)(b)(i) of this rule. An estimate of incremental cancer risk for each receptor population must not exceed the applicable carcinogenic risk goal contained in paragraph (B)(1) of this rule. An estimate of incremental cancer risk is calculated as follows:

(a) Determination of incremental cancer risk must be performed in accordance with the procedures described in this rule and in U.S. EPA's "Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation Manual (Part A)" for each carcinogenic chemical of concern and for each complete exposure pathway identified in accordance with paragraphs (D)(3)(a) and (D)(3)(b)(ii) of this rule, respectively .

(b) If incremental cancer risk is determined for a receptor population for more than one carcinogenic chemical of concern, the cumulative incremental cancer risk posed by these multiple chemicals of concern must be calculated separately, as appropriate, for each complete exposure pathway in accordance with the procedures described in U.S. EPA's "Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation Manual (Part A)."

(c) If incremental cancer risk is determined for a receptor population for more than one complete exposure pathway, the cumulative incremental cancer risk posed by an estimate based on the complete exposure pathways must be calculated in accordance with the procedures described in paragraph (D)(3)(d) of this rule and in U.S. EPA's "Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation Manual (Part A)."

(ii) Noncancer hazard characterization.

A hazard index value is calculated to determine the exposure which will be not likely to cause noncancer adverse health effects posed by chemicals of concern to each receptor population at a property for the duration of that exposure in accordance with the applicable noncancer hazard goals described in paragraph (B)(2) of this rule. A hazard index must be calculated separately for each receptor population over a specified exposure period (i.e., chronic or sub-chronic exposure) identified in accordance with the procedures described in paragraph (D)(3)(b)(ii) of this rule, as follows:

(a) A hazard quotient must be calculated for each chemical of concern with noncancer effects described by a reference dose or reference concentration for each complete exposure pathway in accordance with the procedures described in this rule and in U.S. EPA's "Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation Manual (Part A) ."

(b) If hazard quotient values representing noncancer hazards for one receptor population over a specified exposure period have been determined for more than one chemical of concern as described in paragraph (D)(3)(d)(ii)(a) of this rule, the cumulative noncancer hazards posed by these chemicals of concern must be calculated, as appropriate, as a hazard index value for each complete exposure pathway in accordance with the procedures described in U.S. EPA's "Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation Manual (Part A)." Separate hazard index calculations may be performed based on the consideration of major noncarcinogenic toxic endpoints, which must include, at a minimum, those toxic endpoints identified with the critical effect upon which the reference dose or reference concentration is based, for each noncarcinogenic chemical of concern. A written justification for separate hazard index calculations must be submitted in the property-specific risk assessment report .

(c) If the hazard index values representing noncancer hazard for one receptor population over a specified exposure period have been determined for more than one complete exposure pathway the cumulative noncancer hazard posed by one or more complete exposure pathways must be calculated, as appropriate, as a hazard index value in accordance with the procedures described in this rule and in U.S. EPA's "Risk Assessment Guidance for Superfund, Volume I:

Human Health Evaluation Manual (Part A)." Additionally, exclusion of one or more noncarcinogenic chemicals of concern from the hazard index calculations performed in accordance with paragraph (D)(3)(d)(ii)(b) of this rule may be reconsidered with respect to the toxic endpoints, (including as available, target organ, modes of action or mechanisms of action) identified for the noncarcinogenic chemicals of concern associated with each complete exposure pathway considered in accordance with this paragraph.

(iii) Uncertainty analysis.

Uncertainty associated with the property-specific risk assessment may be evaluated. The uncertainty analysis may include a qualitative description or quantitative evaluation of uncertainty associated with the following: selection of chemicals of concern and the exposure point concentration; estimates of chemical-specific intake factors; complete exposure pathways; toxicity criteria; additive or antagonistic effects of exposure to multiple chemicals of concern through one or more complete exposure pathways; or evaluation of site-specific, epidemiological, or health studies.

(E) Procedures for ecological risk assessment.

(1) For each complete exposure pathway to important ecological resources from environmental media containing chemicals of concern that are persistent, bioaccumulative and toxic, the volunteer must evaluate the environmental media using a food web model in accordance with Ohio EPA's "Guidance for Conducting Ecological Risk Assessments," unless the concentrations of the chemicals of concern in sediment do not exceed either of the following:

(a) Ohio-specific sediment reference values contained in "attachment H" of Ohio EPA's "Guidance for Conducting Ecological Risk Assessments ."

(b) The values listed in paragraph (I)(2)(b) of rule 3745-300-08 of the Administrative Code and those values consider bioaccumulative effects.

(2) A qualitative property-specific ecological risk assessment may be appropriate and may be conducted in order to demonstrate that chemicals of concern on or from a property are not harmful to important ecological resources in cases where toxicity is likely to be low based on the concentrations of chemicals of concern, the land use, the habitat quality and the areal extent of the habitat.

(3) A quantitative property-specific ecological risk assessment must be conducted in accordance with Ohio EPA's "Guidance for Conducting Ecological Risk Assessments" if complete exposure pathways from environmental media other than surface water or sediment exist to important ecological resources and the provisions in paragraph (E)(2) of this rule do not apply.

(4) Data collection to assess ecological risk for both qualitative and quantitative ecological property-specific risk assessments must be performed in accordance with rule 3745-300-07 of the Administrative Code.

(F) Procedures for assessment and remediation of sediments.

(1) For each complete exposure pathway from source areas on the property to sediments the volunteer must determine if concentrations of chemicals of concern in sediments meet applicable standards in accordance with paragraph (H) of rule 3745-300-08 of the Administrative Code, or conduct a human health property-specific risk assessment following the methodology outlined in paragraph (D) of this rule. For purposes of this rule and rule 3745-300-07 of the Administrative Code, an exposure pathway to humans is considered to exist if the surface water which contains the sediments produces or can produce a consistent supply of edible-sized fish and chemicals of concern that are persistent, bioaccumulative and toxic are present in the sediment or the surface water or if the surface water which contains the sediments is reasonably anticipated to support recreational activities such as wading, fishing, swimming, and boating.

(2) For each complete exposure pathway from sediments to important ecological resources where applicable standards determined in accordance with paragraph (I)(2) of rule 3745-300-08 of the Administrative Code have not been met or sediment samples were not compared to the appropriate values in accordance with paragraph (I) of rule 3745-300-08 of the Administrative Code, the volunteer must evaluate the sediment toxicity according to the following methodology:

(a) For all surface waters that have an aquatic life use designation of warm-water habitat, exceptional warm-water habitat (excluding lakes and reservoirs), modified warm-water habitat, or cold-water habitat assigned under Chapter 3745-1 of the Administrative Code, a biological survey must be conducted. The biological survey must include the following:

(i) A fish and physical habitat survey must be used to calculate the qualitative habitat evaluation index, the index of biotic integrity and, where applicable, a modified index of well-being for the surface water following the procedures contained in the biocriteria manual and Ohio EPA's "Surveillance Methods and Quality Assurance Practices." The sampling locations for the fish and physical habitat survey must include the same locations where sediment samples were collected, if possible .

(ii) A quantitative macroinvertebrate survey must be used to calculate the invertebrate community index for the surface waters following the biocriteria manual unless the waterbody does not have sufficient depth and flow to conduct a quantitative macroinvertebrate study. If the waterbody does not have sufficient depth and flow to conduct a quantitative macroinvertebrate study, a qualitative macroinvertebrate study must be conducted following the biocriteria manual and the instruction provided by the biocriteria certification and qualified data collector approval obtained in accordance with paragraph (D) of rule 3745-300-05 and paragraph (B) of rule 3745-4-03 of the Administrative Code. The sampling locations for the quantitative macroinvertebrate survey must include the same locations established where sediment samples were collected, if possible.

[Comment: If a qualitative macroinvertebrate study is to be conducted, it is highly recommended that an Ohio EPA, division of environmental response and revitalization representative be consulted regarding appropriate steps to perform the study.]

(b) For all surface waters with an aquatic life use designation of limited resource water assigned under Chapter 3745-1 of the Administrative Code, or that are a lake, reservoir, wetland or pond, sediment bioassays using sediment samples taken from the surface waters must be conducted to evaluate sediment toxicity. Sediment bioassay sampling locations must be determined in accordance with this rule and rule 3745-300-07 of the Administrative Code. Sediment bioassays must include, at a minimum, the ten-day survival and growth test for "Hyalella Azteca" and "Chironomus tentans" following the procedures in the U.S. EPA sediment toxicity test . "Chironomus riparius" may be substituted for "Chironomus tentans" if needed.

(c) For all surface waters with an aquatic life use designation of limited warm water habitat, or with no aquatic life use designation assigned under Chapter 3745-1 of the Administrative Code, a volunteer must either conduct a use attainability analysis as detailed in the biocriteria manual to assign the appropriate aquatic life use designation, or apply biocriteria for warm-water habitat. The volunteer must consult with an Ohio EPA division of environmental response and revitalization representative for assistance in making a determination on an aquatic life use designation for an unlisted waterbody.

(3) Unless concentrations of chemicals of concern in sediments meet applicable standards in accordance with paragraph (I) of rule 3745-300-08 of the Administrative Code, applicable standards for sediments and surface water are as follows:

(a) For surface water that has an aquatic life use designation of warmwater habitat, exceptional warmwater habitat (excluding lakes and reservoirs), modified warmwater habitat, or coldwater habitat assigned under Chapter 3745-1 of the Administrative Code, the applicable standards must be determined in accordance with the water quality standards established or developed under the federal Water Pollution Control Act, and Chapter 6111. of the Revised Code, and the regulations adopted thereunder.

[Comment: The applicable standards for releases or source areas of hazardous substances or petroleum include the water quality standards established or developed in accordance with Chapter 3745-1 of the Administrative Code. Examples of such standards include but are not limited to: (i) the general water quality criteria; (ii) water use designations and statewide water quality criteria; (iii) the criteria provided for the applicable drainage basin; (iv) the site-specific modifications to criteria and values; and (v) the methodologies for the development of criteria and values.]

(b) For surface water with an aquatic life use designation of limited resource water assigned under Chapter 3745-1 of the Administrative Code and for surface waters which are wetlands, ponds, lakes, or reservoirs, the applicable standards are the absence of toxic effects to both organism groups as defined in the U.S. EPA sediment toxicity test.

(4) The volunteer must take the following actions when, in accordance with paragraphs (F)(3)(a) and (F)(3)(b) of this rule, applicable standards for sediments have not been met:

(a) Submit a written demonstration to be contained in a risk assessment report or a section of the phase II property assessment under paragraph (I) of this rule substantiating the determination that hazardous substances or petroleum on or from the property are not contributing to the failure to meet the applicable standards set forth in paragraph (F)(3) of this rule. Applicable standards for sediment are met if the volunteer can demonstrate that hazardous substances or petroleum on or from the property are not contributing to the failure to meet the applicable standards set forth in paragraph (F)(3) of this rule .

(b) Implement a remedy, conducted in accordance with rule 3745-300-11 of the Administrative Code, to meet applicable standards.

(5) The volunteer may conduct a bioassay or biosurvey in accordance with paragraph (F) of this rule instead of applying paragraph (I)(1) of rule 3745-300-08 of the Administrative Code. If sediment bioassay or biosurvey does not demonstrate full compliance with applicable standards, sediment sampling according to rule 3745-300-07 of the Administrative Code must be conducted in order to determine the concentrations of chemicals of concern in sediments.

(6) A volunteer may use historical biological data collected and interpreted by Ohio EPA, or certified professionals approved as level 3 qualified data collectors in accordance with paragraph (D) of rule 3745-300-05 of the Administrative Code, as part of the demonstration that applicable standards have been met provided the data have not been collected more than ten years prior to the issuance of the no further action letter. Volunteers must consider any changes in the watershed, release history, property characteristics or knowledge of recent data collection prior to the inclusion of historical data within an applicable standards demonstration.

(G) Surface water assessment.

If concentrations of chemicals of concern in surface water exceed applicable standards in accordance with paragraph (G)(2)(a) of rule 3745-300-08 of the Administrative Code, then applicable standards for surface water are those found in paragraphs (E) and (F)(3) of this rule.

(H) Determination of applicable standards from a property-specific risk assessment.

If the volunteer elects or is required to apply risk derived standards determined in accordance with this rule, applicable standards from a property-specific risk assessment are one or more of the following:

(1) Concentrations of chemicals of concern which meet the risk and hazard levels for human health in accordance with the requirements contained in paragraphs (B) and (C) of this rule and in accordance with the procedures described in paragraphs (D) and (F) of this rule .

(2) Concentrations of chemicals of concern that protect important ecological resources in accordance with the procedures contained in paragraph (E) of this rule .

(3) The applicable standards for sediments under paragraphs (F) of this rule .

(4) The applicable standards for surface water under paragraph (G) of this rule .

(5) The soil saturation concentrations, for all compounds which are not at solid phase at ambient soil temperatures, if such concentration are lower than the applicable standard concentrations determined in accordance with paragraphs (H)(1) to (H)(4) of this rule. The volunteer must use the following equation , along with property-specific information, to calculate a property-specific soil saturation concentration :


              image: oh/admin/2014/3745-300-09_PH_FF_A_RU_20140701_0812-1.jpg

(a) All chemical-specific values for the above equation must be obtained from one of the following sources:

(i) U.S. EPA's "Supplemental Guidance for Developing Soil Screening Levels for Superfund Sites".

(ii) Ohio EPA's "Support Document for the Development of Generic Numerical Standards and Risk Assessment Procedures ."

(iii) Hazardous substances data bank .

(iv) The physical properties database .

(v) CHEMFATE chemical search .

(vi) Risk assessment information system .

(vii) If chemical-specific values for the above equation are not available in the sources listed above, contact an Ohio EPA division of environmental response and revitalization representative to determine other appropriate values.

(b) Physical values must be obtained from one of the following sources:

(i) U.S. EPA's "Supplemental Guidance for Developing Soil Screening Levels for Superfund Sites ."

(ii) Property-specific data that meet the criteria contained in paragraph (D)(3)(b)(iv) of this rule.

(I) Risk assessment information.

Upon completion of a property-specific risk assessment conducted in accordance with this rule, the volunteer must present the information in a risk assessment report or in a section of the phase II property assessment. The risk assessment must be prepared and must contain, at a minimum, the following information:

(1) The circumstances under which the property-specific risk assessment was conducted with respect to paragraphs (A)(2) and (A)(3) of this rule .

(2) A list of the institutional controls and engineering controls implemented upon which the property-specific risk assessment is based. Pursuant to rule 3745-300-11 of the Administrative Code, the volunteer must demonstrate the efficacy of those controls .

(3) A list of the chemicals of concern on or from the property which were not considered in the property-specific risk assessment because the chemicals of concern meet the criteria under paragraph (D)(3)(a) of this rule and a written demonstration, including, supporting data, of how those criteria are met .

(4) A list of the receptor populations and exposure pathways identified under paragraphs (D)(3)(b)(i) and (D)(3)(b)(ii) of this rule respectively and a written justification for the selection or elimination of those receptor populations and exposure pathways .

(5) All appropriate documentation which supports the derivation and application of exposure factors used to quantify intake as described in paragraph (D)(3)(b)(iii) of this rule and meets the criteria contained in paragraph (D)(3)(b)(iv) of this rule .

(6) A list of all the toxicity values that are used in the property-specific risk assessment, in accordance with paragraph (D)(3)(c) of this rule, and the sources for those values .

(7) Characterization of risk, as described in paragraph (D)(3)(d) of this rule .

(8) Ecological risk report, in accordance with paragraph (E) of this rule .

(9) Sediment assessment report, in accordance with paragraph (F) of this rule .

(10) Surface water assessment report, if surface waters were required to be assessed, in accordance with paragraph (G) of this rule .

(11) A summary of compliance with applicable standards, in accordance with paragraph (H) of this rule.

Effective: 08/01/2014
R.C. 119.032 review dates: 04/24/2014 and 08/01/2019
Promulgated Under: 119.03
Statutory Authority: 3746.04
Rule Amplifies: 3746. 5301
Prior Effective Dates: 12/16/1996, 10/21/2002, 3/1/2009, 4/18/2013

3745-300-10 Ground water classification and potable use response requirements, and urban setting designations.

(A) Obligation to classify ground water zones identified in paragraph (F)(2) rule 3745-300-07 of the Administrative Code. Ground water underlying a property must be classified in accordance with the criteria of this rule and paragraphs (F)(7) and (F)(8) of rule 3745-300-07 of the Administrative Code unless one of the following conditions apply:

(1) The ground water zone does not contain concentrations of chemicals of concern in excess of unrestricted potable use standards as determined in accordance with a phase II property assessment conducted in accordance with paragraph (F)(3) of rule 3745-300-07 of the Administrative Code.

(2) The response requirements consistent with critical resource ground water under paragraph (E) of this rule are implemented for ground water zones exceeding unrestricted potable use standards underlying and emanating from the property.

(B) Ground water classification system. A ground water zone is not classified when the ground water contained within does not exceed unrestricted potable use standards.

(1) Critical resource ground water. A ground water zone that meets any of the following criteria is classified as critical resource ground water:

(a) The ground water zone is being used by a public water system and is in a "drinking water source protection area for a public water system using ground water."

(b) The ground water zone is located in an unconsolidated saturated zone that is capable of yielding water at a time-weighted average rate greater than one hundred gallons per minute over a twenty-four hour period as determined in accordance with paragraph (F)(8) of rule 3745-300-07 of the Administrative Code.

(c) The ground water zone is in a consolidated saturated zone that is part of a sole source aquifer.

(2) Class A ground water. A ground water zone that does not meet any of the criteria for critical resource ground water and meets any of the following criteria is classified as a "Class A" ground water zone:

(a) The ground water zone is currently utilized as a source of potable water on the property or within one-half mile of the boundary of the property.

(b) The ground water within the zone has a background level of total dissolved solids of less than three thousand milligrams per liter, and except as provided in paragraph (B)(2)(c) of this rule, the ground water zone is capable of yielding water at a time-weighted average rate greater than one-tenth of a gallon per minute over a twenty-four hour period. The ground water yield must be determined in accordance with paragraph (F)(8) of rule 3745-300-07 of the Administrative Code.

(c) The ground water zone is not a "Class A" ground water if the zone meets either of the following criteria:

(i) The zone to be classified yields less than three gallons per minute as determined in accordance with paragraph (F)(8) of rule 3745-300-07 of the Administrative Code, and another ground water zone underlies the property that is a potential source of potable water within one mile of the property. The ground water zone used for comparison must be present both beneath the property and the surrounding area off-property, be capable of yielding three or more gallons per minute, and produce at least twice as much ground water as the zone being classified.

(ii) The ground water zone to be classified yields less than three gallons per minute over a twenty-four hour period and all parts of the zone are wholly contained within fifteen feet below ground surface.

(3) Class B ground water. A ground water zone that does not meet any of the criteria for either critical resource or a "Class A" ground water zone is classified as "Class B" ground water.

(C) Urban setting designation criteria and process.

An urban setting designation may only be used for purposes of eliminating the potable use pathway for areas surrounding the property and may only be requested through a certified professional. An urban setting designation does not impact ground water response requirements for on property or off-property pathways unrelated to the potable use of ground water.

(1) Threshold criteria. A certified professional may request an urban setting designation from the director for a property meeting the following threshold criteria:

(a) Location. The property is entirely within the boundaries of a community; for the purposes of this rule, community means any one of the following:

(i) A township with a population of twenty thousand or more residents in the unincorporated area of the township.

(ii) The unincorporated portion of a township that has an average population density of six hundred fifty people per square mile within the unincorporated area of the township.

(iii) The corporation boundaries of a city.

(iv) The boundaries of a former township that is entirely composed of municipal corporations.

(v) An area that is completely surrounded by areas that are otherwise eligible as described in paragraphs (C)(1)(a)(i) to (C)(1)(a)(iv) of this rule.

(b) Community water supply connectability - ninety per cent or greater. A community water system must be present and one of the following must be demonstrated:

(i) Ninety per cent of the parcels within the communities, as described in paragraph (C)(1)(a) of this rule, for which the designation is requested are connected or capable of being connected to the community water system. Parcels in unincorporated areas that are wholly surrounded by the community must also be considered in the calculation of parcels connected.

(ii) Ninety per cent of the parcels within a minimum of one-mile from the proposed boundary of the urban setting designation are connected or capable of being connected to the community water system. Parcels in unincorporated areas that are wholly surrounded by communities, as described in paragraph (C)(1)(a) of this rule, must also be considered in the calculation of parcels connected.

(c) Community water supply connectability - less than ninety per cent. If the evaluation conducted under paragraph (C)(1)(b) of this rule indicates that less than ninety per cent of the parcels are connected or are capable of being connected to a community water system, an urban setting designation for the property may still be requested provided that one or both of the following apply:

(i) The parcels that are not connected or capable of being connected to a community water system would be unaffected by hazardous substances or petroleum on or emanating from the properties within the urban setting designation.

(ii) Installation of wells used for potable water supply purposes at the parcels that are not connected or capable of being connected to a community water system would be impractical for reasons other than ground water quality or the presence of the community water system. The following criteria may be considered when demonstrating that well installation would be impractical:

(A) Land use patterns (e.g., the parcel is on the right-of-way of a highway).

(B) Topography.

(C) Legally enforceable and reliable restrictions.

(d) Water supply - future needs. The community, as described in paragraph (C)(1)(a) of this rule, has a community water system that the community considers capable of meeting its future water supply needs.

(e) Drinking water source protection areas. The property for which the designation is requested is not located within a "drinking water source protection area for a public water system using ground water." An urban setting designation for a property located within a "drinking water source protection area for a public water system using ground water," where the public water supply is a community system, may still be requested if the owner of the community water system has a "drinking water source protection plan," and the owner consents in writing to the designation.

(f) Potable use wells. Wells connected for potable water supply purposes must not be located in or within one-half mile of the defined boundary of the property or properties for which designation is requested. The existence of potable wells must be determined in accordance with the criteria of paragraph (F)(7)(a) of rule 3745-300-07 of the Administrative Code. If potable wells are located in or within one-half mile of the defined boundary, the property may still be designated, if either of the following occurs:

(i) The wells are part of a community water system with a "drinking water source protection plan" and the owner of the community water system consents in writing to the designation.

(ii) The certified professional requesting the designation demonstrates that the "capture zones" of any wells connected for potable water supply purposes in or within one-half mile of the defined boundary do not extend under the property for which the designation is requested.

(g) Other ground water resource considerations. When the property for which designation is requested is located over either a "sole source aquifer" in a consolidated saturated zone or an unconsolidated ground water zone capable of sustaining a yield greater than one hundred gallons per minute, as determined in accordance with paragraph (F)(7)(b) of rule 3745-300-07 of the Administrative Code, the certified professional must provide additional lines of evidence to demonstrate that there is not a reasonable expectation that there will be any wells installed or used for potable water supply purposes within one-half mile of the property boundary. The certified professional must consult with the owner of the community water system and the appropriate legislative authority or its authorized representative, and at a minimum, consider all of the following criteria to make this demonstration:

(i) The presence of legally enforceable, reliable restrictions on ground water use, other than those imposed for wellhead protection or ground water protection purposes.

(ii) Whether current land use patterns in or within one-half mile of the property being designated or ground water quality make development of a well impractical.

(iii) Whether ninety per cent or more of the parcels in or within one-half mile of the property being designated is connected to a community water system.

(iv) Whether the capture zones of any wells that can reasonably be expected to be installed or connected in or within one-half mile of the property boundary would not extend under the property for which designation is requested.

(2) Approval or denial of a request for an urban setting designation. An urban setting designation may not be used for purposes of classifying ground water and determining applicable standards under this chapter and Chapter 3746. of the Revised Code until the director approves the urban setting designation in accordance with this paragraph.

(a) Request for approval of designation. A certified professional must send a written request to the director for approval of an urban setting designation. The request for approval must include, at a minimum, the following:

(i) The requested urban setting designation must be based upon a defined property boundary consisting of one or more of the following:

(A) The area described by a survey completed (signed and sealed) by a professional surveyor under Ohio law.

(B) The entirety of a city as may be established by that municipality and Chapter 709. of the Revised Code; or the entirety of a township as may be established by Chapter 503. of the Revised Code (i.e., by certified copy of the recorded plat or map establishing the legal boundary of the entire city or the entire township at the time of the request).

(C) The area described by complete and adjacent parcels of real property shown on a plat or other recorded documents maintained by the county or political subdivision. Any urban setting designation boundary that divides a parcel shall be determined by a survey completed by a professional surveyor under Ohio law.

(ii) The name and address of each applicant seeking the designation requested by the certified professional, a description of the location and size of the property , and if known, whether the legislative authority of the communities, as described in paragraph (C)(1)(a) of this rule, which the property is located is in favor of or in opposition to the proposed designation;

(iii) An affidavit by the certified professional which affirms the following:

(A) The urban setting designation threshold criteria contained in paragraphs (C)(1)(a) to (C)(1)(g) of this rule are met.

(B) A true and accurate copy of all documents which form the basis of the certified professional's determination that the urban setting designation threshold criteria in paragraph (C)(2) of this rule have been met is attached.

(C) An "11 x 17" inch or smaller reproducible figure that is an aerial photo or topographic map that identifies the defined boundary for the requested designation and a one-half mile radius around the boundary is attached.

(D) Notice, in accordance with paragraph (C)(2)(b) of this rule, was provided.

(iv) The documents identified in paragraphs (C)(2)(a)(ii)(b), (C)(2)(a)(iii)(b), (C)(2)(a)(ii)(c) and (C)(2)(a)(iii)(c) of this rule.

(b) Notice. Notification of a request for the director's approval of an urban setting designation must be provided to the legislative authority or authorized representative of any county, township and municipality in which the property for which the designation is sought is located, and to the legislative authority of any county, township and municipality whose boundaries are in or within one-half mile of the property for which the designation is sought. The notice must be made contemporaneously with a request for approval under paragraph (C)(2)(a) of this rule. The notice must include, at a minimum, the following:

(i) An explanation of the voluntary action program.

(ii) The purpose of an urban setting designation.

(iii) The threshold criteria for a designation and the fact that the director must approve of the designation after consulting with the community in which the property is located.

(iv) A copy of the documents outlined in paragraph (C) of this rule.

(v) The location of and a description of the defined boundary of the property for which the designation is sought.

(vi) The applicable standards that apply to the ground water and source areas of ground water contamination and the point of compliance, if approval for the designation is not received.

(vii) The applicable standards that apply to the ground water and source areas of ground water contamination and the point of compliance, if approval for the designation is received.

(viii) A statement which advises the legislative authority that the director will consult with it regarding the designation and it is encouraged to provide written comments or any information relevant to the director's consideration of the designation.

(ix) A statement that a decision may be made by the director within ninety days after the director has consulted with the community where the property is located.

(c) Information. After receipt of a complete request for approval of an urban setting designation, the director may request any additional information from the certified professional, the applicant, local jurisdictions or residents, which may be relevant to determining whether or not to approve of the designation. Failure by a certified professional or applicant to cooperate with any request under this paragraph may result in the director's refusal to consider the request for approval. At the director's discretion, a public meeting may be held on the request for approval.

(d) Consultation. No later than ninety days after receipt of a complete request for approval of an urban setting designation the director will complete consultation with the legislative authority or authorized representative of the community in which the property is located, or any other persons which the director deems appropriate, to obtain sufficient information for determining whether to approve or deny the request, as provided in paragraph (C)(2)(e) of this rule.

(e) Criteria for approval or denial. The director may approve or deny the request for approval of an urban setting designation, after consulting with the legislative authority or authorized representative of the community where the property for which the designation is sought is located. The director may approve or deny a request for approval under this paragraph upon consideration of one or more of the following factors, as relevant:

(i) Whether all of the applicable threshold criteria contained in paragraph (C)(1)of this rule have been met for the property for which the designation is being sought.

(ii) The potential impact of the designation on surrounding jurisdictions or communities.

(iii) The potential impact of the intended designation on regional water resource needs and the consistency of the designation with any existing regional water resource obligations of the community where the property for which the designation is sought is located, including any "drinking water source protection plans" for ground water in the area.

(iv) Whether the ground water in the region or area where the property for which the designation is sought is not currently being used by residents as a source of water used for potable purposes such that the risk of exposure to humans of contaminated ground water as a result of the designation is not likely.

(v) Whether the ground water in the region or area where the property for which the designation is sought is located is not reasonably expected to be used as a future source of water used for potable purposes by residents such that a risk of exposure to humans of contaminated ground water as a result of the designation is not likely. For purposes of this evaluation, the director shall consider but is not limited to considering the following:

(A) The likelihood of future water use by local residents in light of the existence of regional, commingled contamination in the area surrounding the property for which the designation is sought.

(B) The existence of reasonably available alternative potable water sources, other than the ground water proposed for designation, to satisfy the future needs of local residents.

(C) The existence of reliable, legally enforceable local laws which restrict or prohibit the use of the ground water proposed for designation, such that the risk of exposure of humans to contaminated ground water as a result of the designation is not likely.

(vi) The availability and feasibility of treatment systems at community water systems that are capable of preventing exposures to ground water with concentrations of chemicals of concern in excess of unrestricted potable use standards.

(vii) Any other factors pertaining to the request for approval that the director considers relevant to determine whether the designation will be protective of public health and safety and the environment.

(f) Costs. The applicant seeking the urban setting designation is responsible for reimbursing the agency for all of the costs incurred to review and consider the request for the urban setting designation. A statement of costs will be sent to the applicant after the request is approved, denied, or withdrawn. The applicant must pay the costs, in full, within sixty days of receipt of the statement of costs.

(g) Timing. The director will approve or deny a request for an urban setting designation within ninety days after the following:

(i) Receiving a complete request, as set forth in paragraph (C)(2)(a) of this rule.

(ii) Consultation with the each community, as provided in paragraph (C)(2)(d) of this rule.

The director may extend the time for approving or denying a request for approval if the director determines that an extension of time is necessary to properly consider the request. If the director extends the time for considering the request for approval the agency will notify the applicant, and other interested persons, of the extended deadline for denying or approving the request.

(3) Use of an urban setting designation to support a no further action letter. An urban setting designation approved by the director may be used to determine the appropriate ground water response requirements in paragraph (E) of this rule. The certified professional must verify in accordance with this rule that the urban setting designation remains protective of the potable use pathway for property that is the subject of a no further action letter. The certified professional must make the verification at the time of and as part of issuance of the no further action letter for the property. Verification is not required when there is reason to believe that the urban setting designation remains protective of the potable use pathway because conditions are unchanged since the urban setting designation request or most recent verification of record. When a certified professional determines that verification is not required for a property pursuant to this rule, the certified professional must provide written justification for the determination in the phase II property assessment report for the property.

(a) To verify the urban setting designation, the certified professional must consider the criteria included in paragraph (C)(3)(b) of this rule and determine that the criteria are still protective of the potable use pathway.

(b) Criteria for verifying that an urban setting designation is protective. To verify, the certified professional must evaluate the following criteria:

(i) Whether additional wells have been installed in or within one-half mile of the defined urban setting designation boundary or the geographic area that are or will be impacted by the chemicals of concern at or from the property. This evaluation must be accomplished at a minimum by doing the following:

(A) Reviewing the ground water well logs submitted to the Ohio department of natural resources since the request for, or most recent verification of, the urban setting designation. If wells have been installed, the certified professional must determine whether the wells are being or are reasonably anticipated to be used for potable purposes.

(B) Contacting the county health department or other local authorities with jurisdiction over installation of wells used for potable purposes to determine if any residential wells are or are reasonably anticipated to be used for potable purposes.

(ii) If a determination, in accordance with paragraph (C)(3) of this rule, is made that new potable wells have been installed or if previously unknown potable wells are discovered, the urban setting designation may be verified to be protective of the potable use pathway as long as either of the following criteria are met:

(A) The wells are part of a community water system with a "drinking water source protection plan" and the owners of the community water system consents in writing to the use of the urban setting designation in support of the no further action letter.

(B) The capture zones of any wells installed or used for potable water supply purposes in or within one-half mile of the property boundary do not extend under the property for which the urban setting designation applies.

(iii) If ordinance or other imposed restrictions on the potable use of ground water were used as part of the urban setting designation, determine whether the restrictions are still valid.

(iv) Whether any new "drinking water source protection areas for a public water system using ground water" have been delineated that incorporate areas within the urban setting designation.

(v) Evaluate whether the ground water in the region or area within or surrounding the urban setting designation is or is reasonably anticipated to be used as a source of potable water by doing the following:

(A) Contacting the owner or operator of each public water system in the region or area and communities, as described in (C)(1)(b) of this rule, and their planners to determine:

(i) Whether the public water systems are meeting the current water use demands.

(ii) If there are any plans to develop ground water either within or in the vicinity of the urban setting designation as a source of potable water.

(B) As applicable to the property that is the subject of the no further action letter, contacting the surrounding communities to determine whether there are any plans to develop the ground water in the vicinity of the urban setting designation.

(c) In verifying an urban setting designation, the certified professional may rely upon the certified professional's evaluation of the criteria contained in paragraph (C)(3)(b) of this rule or the director's evaluation, if any, of the urban setting designation provided for in paragraph (C)(4) of this rule. Use of the director's evaluation of the urban setting designation in accordance with paragraph (C)(4) of this rule to meet the requirements of this paragraph is acceptable if the urban setting designation has been recently approved by the director or the criteria contained in paragraph (C)(3)(b) of this rule have been recently evaluated and determined to be protective of the potable use pathway. In this situation, the certified professional do not need to verify the urban setting designation where changed conditions do not otherwise exist. However, the director reserves authority to evaluate the protectiveness of the urban setting designation as it applies to a submitted no further action letter in determining whether a covenant not to sue may be issued.

(4) Periodic protectiveness verification. The director may implement a program to periodically verify the protectiveness of an urban setting designation at eliminating a potable use pathway. Based on an evaluation of the criteria in paragraph (C)(3)(b) of this rule, the director may determine that the urban setting designation is still valid or that it is no longer valid . The director may decrease the size of the urban setting designation so that the decreased area remains protective of the potable use pathway.

(a) The director will make available any determinations regarding urban setting designations to certified professionals.

(b) If the director determines that an urban setting designation is no longer valid or decreases its size in accordance with this rule, the agency will notify certified professionals and the original applicants of the urban setting designation. In addition, the director's determination will be public noticed in any affected county.

(D) Protection of ground water meeting unrestricted potable use standards.

(1) When any ground water zone underlying the property complies with unrestricted potable use standards , the remedial activities must ensure that contamination will not result in unrestricted potable use standards being exceeded anywhere within any ground water zone underlying the property that otherwise meets the standards. However, when the contamination exceeding standards is entirely the result of source areas from off-property releases, this provision for protection of ground water does not apply for protection of another ground water zone, except when any of the criteria in paragraphs (E)(1)(b)(i) to (E)(1)(b)(iv) of this rule are applicable.

(2) Except as provided in rule 3745-300-12 of the Administrative Code, no provision of this chapter modifies the requirements of this paragraph.

(E) Response requirements for ground water zones exceeding unrestricted potable use standards.

(1) Assigning responsibility for purposes of this rule for chemicals of concern in ground water zones.

(a) The requirements of paragraphs (E)(2) to (E)(6) of this rule apply to the volunteer when chemicals of concern released to ground water originate from a source area on the voluntary action property or when chemicals of concern released to ground water originate from an off-property source area and the volunteer is responsible for addressing the release, as specified in paragraph (E)(1)(b) of this rule.

(b) The volunteer is responsible for addressing requirements of paragraph (E)(3)(a), (E)(3)(b), or (E)(4) of this rule for chemicals of concern originating from a release from an off-property source area when any of the following apply:

(i) The owner of the voluntary action property was an owner or operator of any property, other than the voluntary action property, where any source area was located during the owner's ownership of or operation on any such property, and hazardous substances or petroleum on or from the off-property source area onto the voluntary action property.

(ii) The volunteer, or owner if different from the volunteer, caused or contributed to the source areas or release.

(iii) The volunteer, or owner if different from the volunteer, has entered into an agreement with any person with the purpose or effect of creating a less stringent ground water standard than would otherwise be applicable in this rule.

(iv) The volunteer is a parent, subsidiary, or other commonly owned entity of any party identified in paragraphs (E)(1)(b)(i) to (E)(1)(b)(iii) of this rule.

(2) Response requirements that apply to all ground water classifications.

For all ground water classifications the volunteer must implement institutional controls or engineering controls that reliably prevent human exposure on the property to ground water with concentrations of chemicals of concern in excess of unrestricted potable use standards, or restore the ground water underlying the property to those unrestricted potable use standards.

[Comment: Engineering controls may include the use of water treatment systems.]

(3) Response requirements that apply to "Class A" ground water zones without an urban setting designation or critical resource ground water zones with or without an urban setting designation.

Ground water on or from the property must not exceed unrestricted potable use standards at the point of compliance, except as described in paragraph (E)(3)(c) or (E)(3)(d) of this rule.

Unless the volunteer demonstrates that the conditions in paragraph (E)(1)(b) of this rule do not apply, the volunteer must comply with or implement remedial activities that reliably bring the property into compliance with the following:

(a) Unrestricted potable use standards must be met at the property boundary, unless the volunteer chooses to demonstrate an alternative point of compliance under the following circumstances:

(i) If the property is in an urban setting designation and the ground water zone is critical resource, the point of compliance is the urban setting designation defined boundary or one-half mile from the property boundary, whichever is greater.

(ii) If ground water discharges to an off-property surface water body that is in close proximity to the property and there is no complete exposure pathway for potable use off-property, as determined in accordance with paragraph (F)(1) of rule 3745-300-07 of the Administrative Code, the point of compliance is the surface water body. The applicable standards established in paragraph (F) of rule 3745-300-08 of the Administrative Code or paragraph (G) of rule 3745-300-09 of the Administrative Code for the receiving surface water body must be met instead of unrestricted potable use standards.

(iii) If the property's down gradient boundary is adjacent to an established transportation corridor, such as a public road or railroad, the point of compliance is the most distant edge of the transportation corridor.

(iv) If there is an activity and use limitation in an environmental covenant pursuant to sections 5301.80 to 5301.92 of the Revised Code that restricts the potable use of ground water on an adjacent down gradient property, the point of compliance is the down gradient edge of the adjacent property.

(v) If the property boundary bisects a landfill, the point of compliance is the down gradient edge of the lateral extent of the landfill.

(b) A volunteer must meet either of the following requirements for ground water containing chemicals of concern that have impacted any off property potable use wells above unrestricted potable use standards:

(i) Restore the contaminated ground water to unrestricted potable use standards.

(ii) Provide a reliable alternate potable water supply or water treatment system that does the following:

(A) Provides a volume of potable water sufficient for the intended use.

(B) Is provided for a period of time no shorter than the time that the ground water supply of off-property ground water users exceeds unrestricted potable use standards due to sources for which the volunteer is responsible.

(c) If the contamination is due to off-property sources in whole or in part, then the volunteer must implement remedial activities to prevent leaching of chemicals of concern from source areas on the property that are reasonably anticipated to result in unrestricted potable use standards being exceeded at the point of compliance determined from paragraph (E)(3)(a) of this rule. This paragraph does not apply if any of the provisions in paragraphs (E)(1)(b)(i) to (E)(1)(b)(iv) of this rule are applicable.

(d) When ground water emanates from the property into a surface water body immediately adjoining the property boundary, the applicable standards established in paragraph (F) of rule 3745-300-08 of the Administrative Code or paragraph (G) of the rule 3745-300-09 of the Administrative Code for the receiving surface water body must be met.

(4) Notification and evaluation of ground water use requirements for critical resource ground water zone.

The following paragraphs are applicable where ground water has or is reasonably anticipated to have contamination in excess of unrestricted potable use standards, except when in an urban setting designation. If the property is within an urban setting designation, the following paragraphs are applicable where ground water has or is reasonably anticipated to have contamination in excess of unrestricted potable use standards beyond the urban setting designation boundary or beyond a distance of one-half mile from the property boundary, whichever is greater.

(a) Prior to issuance of the no further action letter, the volunteer must send a written notification by certified mail to the applicable local health department and all owners of properties in areas where ground water has or is reasonably anticipated to have concentrations of chemicals of concern in excess of unrestricted potable use standards that includes the following:

(i) The location and a description of the property where the voluntary action has taken place.

(ii) A summary of the releases or type of chemicals of concern that were assessed as part of the voluntary action and the remedial activities that were taken or are being taken in response to the releases.

(iii) A description of the concentrations of chemicals of concern in ground water that has or may migrate onto or under the properties in areas where ground water has or is reasonably anticipated to have concentrations of chemicals of concern in excess of unrestricted potable use standards.

(iv) A summary of the unrestricted potable use standards for the chemicals of concern that have emanated from the property.

(v) A description of the requirements contained in paragraph (E)(4)(b) of this rule that the volunteer, or subsequent owners relying on a no further action letter, that address exposures of humans to ground water with concentrations of chemicals of concern in excess of applicable standards.

(vi) A request for information concerning any current or intended use of ground water in areas where ground water has or is reasonably anticipated to have concentrations of chemicals of concern in excess of unrestricted potable use standards, along with the name, address and phone number of a representative of the volunteer, or subsequent owner relying on a no further action letter who can be notified of any current or intended use of ground water or contacted for further information.

(b) Ongoing obligations after issuance of a covenant not to sue.

The volunteer or other person responsible for compliance with applicable standards must, beginning in the year following the issuance of the covenant not to sue for the property, conduct the following activities:

(i) At least annually, review Ohio department of natural resources water well log and applicable health department information for the properties where ground water has or is reasonably anticipated to have concentrations of chemicals of concern in excess of unrestricted potable use standards to determine whether new ground water wells have been installed. If any new potable use wells are discovered, implement remedial activities consistent with requirements in paragraph (E)(3)(b) of this rule as needed for compliance with applicable standards.

(ii) At least annually, identify any known changes and inquire of changes in ownership of properties in areas where ground water has or is reasonably anticipated to have concentrations of chemicals of concern in excess of unrestricted potable use standards. If there is any change in ownership, provide the new owners with the notification prescribed in paragraph (E)(4)(a) of this rule.

(5) The volunteer must implement the applicable requirements of paragraphs (E)(3)(b) and (E)(4)(b) of this rule through an operation and maintenance plan, prepared in accordance with rule 3745-300-11 of the Administrative Code or through another method prescribed by that rule.

(6) All remedial activities, including institutional controls or engineering controls, must be implemented in accordance with rule 3745-300-11 of the Administrative Code or other applicable law.

Replaces: 3745-300-10

Effective: 08/01/2014
R.C. 119.032 review dates: 08/01/2019
Promulgated Under: 119.03
Statutory Authority: 3746.04
Rule Amplifies: 3746.
Prior Effective Dates: 12/16/1996, 10/21/2002, 3/1/2009

3745-300-11 Remediation.

[Comment: For dates of non-regulatory government publications, publications of recognized organizations and associations, federal rules, and federal statutory provisions referenced in this rule, see paragraph (B) of rule 3745-300-01 of the Administrative Code titled "Incorporation by reference."]

(A) Applicability and identification of when remedial activities are required.

(1) Remedial activities as defined in division (N) of section 3746.01 of the Revised Code and in of rule 3745-300-01 of the Administrative Code must be conducted to meet applicable standards when a phase II property assessment conducted in accordance with rule 3745-300-07 of the Administrative Code reveals that concentrations of chemicals of concern in any environmental media fail to comply with any of the following:

(a) Applicable standards as determined from the generic numerical standards in accordance with rule 3745-300-08 of the Administrative Code.

(b) Applicable standards as determined from a property-specific risk assessment conducted in accordance with rule 3745-300-09 of the Administrative Code.

(c) Background levels as determined in accordance with rule 3745-300-07 of the Administrative Code, when background levels are the applicable standards.

(d) Any other applicable standard of this chapter.

(2) Each complete exposure pathway for environmental media determined in accordance with paragraph (F)(1) of rule 3745-300-07 of the Administrative Code must comply with an applicable standard determined in accordance with this chapter. For complete exposure pathways which fail to comply with an applicable standard, the volunteer must implement a remedy in accordance with this rule, unless the volunteer can demonstrate that a pathway to an off-property receptor from contamination that has emanated from the property could not be remedied through diligent efforts by the volunteer. Such pathways may be omitted from the voluntary action in accordance with paragraph (D) of this rule.

(3) An institutional control in the form of a use restriction, or activity and use limitation, as applicable, must be established in accordance with this rule to apply applicable standards to a restricted land use, pursuant to paragraph (F)(4) of rule 3745-300-07 of the Administrative Code.

(4) An operation and maintenance plan is required as part of a no further action letter issued under this chapter and Chapter 3746. of the Revised Code for a property for which the no further action letter relies on one or more of the following:

(a) Engineering controls that involve operation or maintenance, or both, necessary to maintain applicable standards at the property following issuance of the no further action letter.

(b) An on-going active or passive remedy employed at a property that does not yet meet applicable standards at the time that a no further action letter is issued. Such remedial activities must achieve applicable standards within five years, inclusive of verification, or such other time frame agreed to by the director in accordance with an operation and maintenance agreement.

(c) The evaluation, response and other activities related to critical resource ground water response requirements that are required by paragraph (E)(5) of rule 3745-300-10 of the Administrative Code, as applicable, that are implemented to maintain compliance with applicable standards.

(B) Compliance with other laws. Remedial activities conducted under this chapter and Chapter 3746. of the Revised Code must be conducted in compliance with all applicable laws, regulations, rules, resolutions and ordinances, including but not limited to the following: Chapter 3734. of the Revised Code; Chapter 6111. of the Revised Code; Chapter 3704. of the Revised Code; the Safe Drinking Water Act, including the requirements applicable to class V underground injection control wells; and compliance with the laws and regulations administered by the occupational safety and health administration.

(C) Remedial activities. If remedial activities are required to be conducted at a property pursuant to paragraph (A) of this rule, one or more of the following remedial activities must have been conducted and documented in the no further action letter, prior to issuance of a no further action letter for the property.

(1) Passive remediation. Passive remediation must be capable of attaining applicable standards. If passive remediation has not achieved applicable standards prior to issuance of the no further action letter for the property, an operation and maintenance plan prepared in accordance with this rule for continued implementation of the passive remediation must be included with the no further action letter. If the passive remediation has not achieved applicable standards upon issuance of the no further action letter, the no further action letter must demonstrate the passive remediation is capable of attaining the applicable standards, inclusive of verification, within five years or other time frame agreed upon by the director in an operation and maintenance agreement, in accordance with this rule.

(2) Active remediation. Active remediation must be capable of attaining applicable standards. If active remediation has not achieved applicable standards prior to issuance of the no further action letter for the property, an operation and maintenance plan prepared in accordance with this rule for implementation of the active remediation must be included with the no further action letter. If the active remediation has not achieved applicable standards upon issuance of the no further action letter, the no further action letter must demonstrate the active remediation is capable of attaining applicable standards, within five years, inclusive of verification, or other time frame agreed upon by the director in an operation and maintenance agreement, in accordance with this rule.

(3) Institutional controls. Institutional controls (use restrictions or activity and use limitations), as applicable pursuant to this chapter, must meet the following criteria:

(a) Establish restrictions or limitations on use of the property that mitigate or eliminate risk or an exposure pathway to human receptors in order to achieve applicable standards.

(b) Be transferable with the property and recorded with the county recorder in the same manner as a deed to the property during the period of time relied upon to comply with applicable standards.

(c) Be consistent with the criteria contained in paragraph (D)(3)(b)(iv)(b) of rule 3745-300-09 of the Administrative Code, as applicable.

(d) Be recorded with the county recorder in the same manner as a deed to the property, consistent with the requirements for recording contained in rule 3745-300-13 of the Administrative Code, as applicable.

(e) Be effective at eliminating or mitigating exposures to receptor populations sufficient to meet the risk goals contained in rule 3745-300-08 or 3745-300-09 of the Administrative Code, as applicable.

(f) Be capable of being monitored, maintained and enforced by the owner or operator of the property during the period of time which the control is used to comply with applicable standards.

(g) In the case of activity and use limitations, be established through an environmental covenant pursuant to Chapter 5301. of the Revised Code.

(4) Engineering controls. Engineering controls must meet the following criteria:

(a) Be effective and reliable for the climatic conditions and activities at the property to which the control will be applied.

(b) Be consistent with the criteria contained in paragraph (D)(3)(b)(iv)(b) of rule 3745-300-09 of the Administrative Code, as applicable.

(c) Be effective at eliminating or mitigating exposures to receptor populations sufficient to meet the risk goals of rule 3745-300-08 or 3745-300-09 of the Administrative Code, as applicable.

(d) Be reliable during the period of time the control is used to achieve or maintain applicable standards.

(e) Be capable of being monitored and maintained as required by an operation and maintenance plan developed and implemented in accordance with this rule.

(5) Critical resource ground water activities. The evaluation, response and other activities required to protect off-property receptors when concentrations of chemicals of concern in critical resource ground water exceed unrestricted potable use standards must be implemented in accordance with rule 3745-300-10 of the Administrative Code. The activities are provided in paragraphs (E)(3) to (E)(5) of rule 3745-300-10 of the Administrative Code.

(6) Interim measures. Interim measures must be in place for a property when a remedy has not yet achieved applicable standards prior to issuance of a no further action letter and must, at a minimum, mitigate the risks associated with complete exposure pathways to human receptor populations until a remedy has achieved applicable standards.

(7) Risk mitigation measures. Risk mitigation measures must effectively eliminate or reduce the current or reasonably anticipated risk to persons working in areas where concentrations of chemicals of concern in environmental media exceed applicable standards or the risk is uncharacterized.

(a) Risk mitigation measures shall only be utilized to protect workers during construction or excavation activities.

(b) Risk mitigation measures are necessary when excavation or construction activities do any of the following:

(i) Breach the point of compliance for direct contact with soil for properties relying on institutional controls to achieve the applicable standard.

(ii) Breach an engineering control, such as pavement or a soil cap, intended to eliminate direct-contact exposure to chemicals of concern in environmental media.

(iii) Result in direct contact with ground water which has not been demonstrated to meet applicable standards for this exposure pathway.

(c) If the risk mitigation measures are necessary for the property to meet applicable standards after issuance of the no further action letter for the property, the risk mitigation measures must be implemented through a risk mitigation plan in accordance with paragraph (G) of this rule.

(8) Ground water use limitations. Restrictions limiting the extraction or use of ground water for any purpose, potable or otherwise, established in accordance with paragraph (E)(2) of rule 3745-300-10 of the Administrative Code in order to achieve applicable standards for ground water, when one or more ground water zones has been demonstrated to exceed unrestricted potable use standards, must be applied to all ground water zones beneath the property, unless a property-specific investigation conducted in accordance with rule 3745-300-07 of the Administrative Code demonstrates the following:

(a) The ground water zone subject to the use limitation has not demonstrated interconnection to the ground water zone to which the use limitation does not apply.

(b) Selective use restrictions will be implemented for each ground water zone, as necessary, to reliably restrict the use of each ground water zone for all purposes, except the specific permissible uses that have been demonstrated to ensure the following:

(i) The continued protection of all ground water zones that otherwise meet unrestricted potable use standards in accordance with paragraph (F)(4) of rule 3745-300-07 and paragraph (D) of rule 3745-300-10 of the Administrative Code.

(ii) Applicable standards are met for all complete exposure pathways for the resulting groundwater use.

(D) Pathway omission process for pathways to off-property receptors that cannot be remedied after a volunteer has applied diligent efforts.

(1) An exposure pathway that is otherwise complete pursuant to rule 3745-300-07 of the Administrative Code may be omitted from the voluntary action for contamination that has emanated from the property, when the following process has been followed and the volunteer has employed diligent efforts to remedy that pathway. The omission of the pathway may only be requested through a certified professional. A certified professional may request a pathway omission from the director for a complete exposure pathway that meets the following threshold criteria:

(a) The property or properties where the receptor is located are different from the voluntary action property.

(b) The volunteer can demonstrate they have completed reasonable measures to do the following:

(i) Determine the potential off property receptors in accordance with paragraph (E)(6) of rule 3745-300-07 of the Administrative Code.

(ii) Determine the potential complete exposure pathways to those receptors in accordance with paragraph (F) of rule 3745-300-07 of the Administrative Code.

(iii) Contact each receptor property owner. Inform each owner of each potential complete pathway and potential risks associated with the pathway. Explain to each owner the activities that might be reasonably employed to investigate and address that pathway.

(iv) Offer to the owners to pay all costs associated with installation of the remedy, including fair and reasonable compensation for repair of aesthetic impacts to the property resulting from the activities.

(v) Document discussions or correspondence with the owners that indicate the refusal to have a reasonable remedy installed.

(vi) Document, if applicable, any other reason that might prevent installation of a resonable remedy.

(c) Notice the receptor property owners. The volunteer or certified professional must provide a written notice to each receptor property owner prior to submitting a request for approval pursuant to paragraph (D)(2) of this rule. The notice to each owner must include, at a minimum, the following:

(i) An explanation of the voluntary action program.

(ii) A description of the pathway for which omission would be requested and reason for requesting its omission.

(iii) The location of and a description of all property for which the omission is sought.

(iv) A summary of the threshold criteria under this rule for requesting a pathway omission and the fact that the director must approve any omission request.

(v) An explanation that pathway omission, if approved, would exclude coverage of the pathway from any covenant not to sue issued pursuant to Chapter 3746. of the Revised Code pertaining to the voluntary action property.

(2) Content and timing of a request for pathway omission. A certified professional may not rely upon a pathway omission in a no further action letter until the director has approved a request for a pathway omission that is documented and submitted in accordance with the following process:

(a) Request for approval for omission of a pathway from a voluntary action.

A certified professional must send a written request to the director for approval of a pathway omission. The request for approval must include, at a minimum, the following:

(i) A cover letter requesting the director's approval of a pathway omission, which includes the name and address of the volunteer, a description of the location and size of the voluntary action property, the pathway in question, and the receptor property or properties.

(ii) An affidavit by the certified professional which affirms the following:

(A) The pathway omission threshold criteria contained in paragraphs (D)(1)(b)(i) to (D)(1)(b)(vi) of this rule are met.

(B) A copy of all documents which form the basis of the certified professional's determination that the pathway omission threshold criteria in paragraph (D)(1)(b) of this rule have been met is attached.

(C) A description of the receptor property or properties for which the pathway omission is requested is attached.

(iii) Documentation of the notice provided to each receptor property owner, as required by paragraph (D)(1)(c) of this rule.

(b) Information. After receipt of a complete request for approval of a pathway omission, the director may request any additional information from the certified professional, the volunteer, local jurisdictions or residents, which may be relevant to determining whether or not to approve the pathway omission. Failure by a certified professional or volunteer to cooperate with any request under this paragraph may result in the director's refusal to consider the request for approval.

(c) Criteria for approval. The director may approve a request for pathway omission if all applicable threshold criteria contained in paragraph (D)(1)(b) of this rule have been met. The director may also consider whether approving the requested pathway omission would result in improved environmental conditions.

(d) Costs. The volunteer seeking the pathway omission is responsible for reimbursing the agency for all of its costs incurred to review and consider the request for approval of the pathway omission. A statement of costs will be sent to the volunteer after the request for approval is approved, denied, or withdrawn. The volunteer must pay the costs, in full, within sixty days of receipt of the statement of costs, pursuant to paragraph (E) of rule 3745-300-03 of the Administrative Code.

(e) Timing. The director will approve a request for approval of a pathway omission within ninety days after receiving a complete request, as set forth in paragraph (D)(2)(a) of this rule. The director may extend the time for approving a request if the director determines that an extension of time is necessary to properly consider the request. If the director extends the time for considering the request for approval the agency will notify the volunteer, and other interested persons, of the extended deadline.

(E) Verification of completion of remedial activities and determination that the applicable standards are met. When remedial activities are completed under this chapter and Chapter 3746. of the Revised Code, the volunteer must verify that the remedial activities have been implemented in accordance with this rule and have resulted in compliance with applicable standards. Such verification must describe the remedy or remedial activities implemented that are a part of the voluntary action. Verification must include an identification of the data used to demonstrate the compliance with applicable standards, and must include the following, as applicable:

(1) A demonstration of compliance with applicable standards in accordance with paragraph (I) of rule 3745-300-07 of the Administrative Code through implementation of the remedial activities. The demonstration also requires the following, when applicable:

(a) A demonstration that each institutional control relied upon in the no further action letter has been developed in accordance with paragraph (C) of this rule, and implemented in accordance with rule 3745-300-13 of the Administrative Code, and division (C)(3)(a) or (C)(3)(b) of section 3746.10 of the Revised Code, as applicable.

(b) A demonstration that each engineering control or remedy requiring operation or maintenance under this rule is made the subject of an operation and maintenance plan and agreement, as applicable, developed in accordance with paragraph (F) of this rule.

(c) A demonstration that each risk mitigation measure under this rule is made the subject of a risk mitigation plan, as applicable, in accordance with paragraph (G) of this rule.

(2) Termination of remedial activities. To document that a remedial activity is no longer necessary for compliance with applicable standards and may be terminated, the volunteer or other person responsible for remedy implementation must demonstrate that the criteria set forth in this rule have been met. The demonstration must include the following, at a minimum:

(a) A description of the remedial activity that is no longer necessary to maintain compliance with applicable standards.

(b) Identification of the information relied upon to demonstrate the continued compliance with applicable standards without further implementation of the remedial activity.

(c) Information that supports the verification necessary to document the termination of the remedial activity in accordance with this rule and other criteria governing the remedial activity, such as the criteria set forth in an operation and maintenance plan or agreement, environmental covenant or risk mitigation plan.

(d) An affidavit from a certified professional, certifying that applicable standards are met without further implementation of the remedial activity.

(e) An affidavit from the volunteer or other person responsible for remedy implementation that attests to the completion of the remedy, demonstration of compliance with applicable standards or understanding that the remedy may be terminated based on criteria in this rule and any other applicable criteria, as applicable.

(F) Operation and maintenance plan and agreement.

(1) Content of operation and maintenance plan. When a remedy is required to have an operation and maintenance plan in accordance with this rule, the volunteer must develop and implement an operation and maintenance plan that includes the following components as applicable, for each of the remedial activities subject to the operation and maintenance plan:

(a) A summary of the applicable standards for the property and the purpose of the remedial activities;

(b) A plan for implementing the remedial activities, including normal operation and maintenance and a description of tasks that will be done to implement the normal operation and maintenance of the remedial activities, including, but not limited to the following:

(i) A description of the tasks for operation of the remedial activities.

(ii) A description of the tasks and procedures for maintaining the remedial activities, including but not limited to a plan for periodic preventive measures.

(iii) A description of prescribed treatment or operating conditions for the remedial activities.

(iv) Schedules for implementing remedial activities and for operation and maintenance tasks.

(c) A plan for evaluating the effectiveness of the remedial activities. A plan for evaluating the effectiveness of each remedial activity must be included in the operation and maintenance plan. The plan must include, at a minimum, the following:

(i) The purpose and objective of the activities planned to evaluate the effectiveness of the remedy.

(ii) A description of the activities that will be performed to determine the effectiveness of the remedial activities in meeting or maintaining compliance with applicable standards.

(iii) A description of the activities that will be performed to evaluate or confirm assumptions and predictions of a property-specific risk assessment conducted in accordance with rule 3745-300-09 of the Administrative Code, if a property-specific risk assessment was conducted.

(iv) A description of the activities that will be conducted, to comply with the response requirements for critical resource ground water in accordance with paragraphs (E)(3) to (E)(5) of rule 3745-300-10 of the Administrative Code, as applicable.

(v) If data collection, field testing, sampling or data analyses activities are appropriate for the monitoring activities, a summary of these procedures developed in accordance with paragraph (F) of rule 3745-300-07 of the Administrative Code.

(vi) A description of the anticipated length and planned frequency of each monitoring activity that will be performed to evaluate the effectiveness of the remedial activities.

(d) Equipment requirements. A description of equipment required to operate and maintain the remedial activities, including the following:

(i) A description of the monitoring and remedial equipment that has been installed, and the criteria for installation.

(ii) A schedule for the maintenance and replacement of monitoring and remedial equipment, as appropriate for each remedial activity.

(e) A plan for adjustments to normal operation and maintenance. A description of reasonably anticipated adjustments and criteria establishing when the adjustments will be taken to normal operation and maintenance of the remedial activities so that the remedial activities remain effective.

(f) A plan for addressing potential problems with the remedial activities.

(g) Records and reporting mechanisms. The operation and maintenance plan must contain a description of all records that will be kept for the purpose of documenting the requirements of paragraphs (F)(1) and (F)(2) of this rule are met.

(h) A plan for termination of the remedial activities, including, but not limited to the following:

(i) An identification and description of the data and information that will be collected to support the criteria for termination of the remedial activities subject to the operation and maintenance plan to verify completion of the remedial activities in accordance with paragraph (E)(2) of this rule.

(ii) An identification and description of the criteria for termination, as appropriate, of the monitoring activity to verify completion of the remedial activity in accordance with paragraph (E)(2) of this rule.

(2) Reporting evaluation of the effectiveness of remedial activities subject to an operation and maintenance plan and agreement. At least once annually following issuance of a covenant not to sue pursuant to Chapter 3746. of the Revised Code, or at such other interval as agreed upon in an operation and maintenance plan or agreement regarding the property, the volunteer or other person responsible for operation and maintenance plan and agreement implementation, must submit a letter, statement or report to the agency, under affidavit, that includes the following:

(a) The results from all evaluation activities performed in accordance with paragraph (F)(1)(c) of this rule.

(b) A description of the activities, conducted to address remedy problems encountered, if any.

(c) A demonstration of the performance of all remedial activities subject to the operation and maintenance plan.

(d) A demonstration of how compliance with applicable standards will be met or maintained, including the measures used to maintain the remedy's protectiveness of public health and safety and the environment, until the property achieves compliance with applicable standards through a remedy within five years, or other time frame as agreed upon by the director in an operation and maintenance agreement.

(3) When an operation and maintenance plan is required in accordance with this rule, the operation and maintenance plan must be prepared and, as appropriate to maintain applicable standards, implemented, prior to issuance of the no further action letter. The no further action letter must include the operation and maintenance plan. If an operation and maintenance plan is required for an engineering control or other remedy following the receipt of a covenant not to sue issued pursuant to Chapter 3746. of the Revised Code, the operation and maintenance plan may be included in a remedy revision notice perpared pursuant to paragraph (H) of this rule.

(4) Operation and maintenance agreement. When requesting a covenant not to sue from the director pursuant to this chapter and Chapter 3746. of the Revised Code for a property subject to a remedial activity that requires an operation and maintenance plan pursuant to this rule, the volunteer must enter into an operation and maintenance agreement with the director.

(a) At a minimum, the operation and maintenance agreement must include the following:

(i) An operation and maintenance plan for the property developed in accordance with paragraphs (F)(1) and (F)(2) of this rule and approved by the director.

(ii) A provision that the volunteer agrees to implement the operation and maintenance plan.

(iii) A provision requiring periodic reporting to the director of monitoring results and evaluation of the effectiveness of the remedial activities subject to the operation and maintenance plan, in accordance with paragraph (F)(2) of this rule, to the extent the operation and maintenance plan does not provide for such periodic reporting to the director.

(iv) A provision requiring notification to the director within a specified time of all adjustments made to normal operation and maintenance as specified in the operation and maintenance plan, and of implementation of the contingency plan activities specified in the operation and maintenance plan.

(v) A provision requiring that proposed modifications to a remedial activity, other than adjustments or plan activities developed in accordance with paragraphs (F)(1)(e) to (F)(1)(f) of this rule and contained in the operation and maintenance plan, must be submitted to the director for review and approval prior to implementation of the proposed modification. The provision must be written in such a manner consistent with paragraph (H) of this rule.

(vi) A provision requiring that prior notification, within a specified reasonable time frame, be provided to the prospective buyers or transferees of the property of the remedy subject to the operation and maintenance plan and agreement.

(vii) A provision requiring notice to the director within a specified reasonable time frame of each transfer of the property subject to the operation and maintenance plan and agreement.

(viii) A provision requiring notice to the director within a specified reasonable time frame of the transfer of the operation and maintenance plan and agreement, and of the terms and conditions of the transfer.

(ix) The establishment and description of financial assurances that the remedy subject to the operation and maintenance plan and agreement will remain operational and functional.

(x) A provision for inspection of the property by Ohio EPA or its representatives to determine compliance with the operation and maintenance plan and agreement.

(xi) Mechanisms for providing reports to Ohio EPA, including, but not limited to the following:

(A) Daily operating logs.

(B) Laboratory analytical data and supporting records.

(C) A procedure for reporting emergencies.

(D) Maintenance records.

(E) A description of the reports that will be provided to Ohio EPA and the frequency for reporting.

(xii) Other provisions necessary to protect public health and safety and the environment or to demonstrate effectiveness of the remedial activities subject to the operation and maintenance plan or agreement.

(b) The operation and maintenance agreement may specify a reasonable time frame within which the property must attain applicable standards through the remedial activities specified in the operation and maintenance plan or agreement.

(c) Operation and maintenance agreements may be transferred by the volunteer to another person by assignment or in conjunction with the acquisition of title to the property that is the subject of the agreement. The volunteer may choose to but is not required to transfer its operation and maintenance agreement to another person (e.g., the subsequent property buyer). The "other person responsible for operation and maintenance plan and agreement implementation" is defined in rule 3745-300-01 of the Administrative Code for this purpose.

(G) Risk mitigation plans.

When risk mitigation measures are to be employed after issuance of a no further action letter, a risk mitigation plan must be developed and implemented.

(1) The risk mitigation plan must contain, at a minimum, the following components:

(a) A description of the purpose of the risk mitigation plan.

(b) A summary of the potential health risks associated with the chemicals of concern at the property.

(c) A description of the specific precautions against exposure to be taken at the property.

(d) Directions on how to handle environmental media at the property that may contain chemicals of concern.

(e) Provisions for when the risk mitigation plan will be implemented at the property, consistent with the results of a property-specific risk assessment, if applicable, conducted in accordance with rule 3745-300-09 of the Administrative Code.

(f) Provisions for the locations at the property where the risk mitigation plan will be implemented, consistent with the results of a property-specific risk assessment in accordance with rule 3745-300-09 of the Administrative Code. If, based on the results of the property-specific risk assessment, the entire property is not subject to the risk mitigation plan, a legal description of that portion of the property subject to the risk mitigation plan must be attached to and incorporated by reference in the risk mitigation plan.

(g) A property map showing that portion of the property subject to the risk mitigation plan.

(h) Provisions for giving notice of the risk mitigation plan to contractors and subcontractors and their employees, and other persons working in areas where risk mitigation measures are necessary.

(i) A summary explanation of the precautions that each contractor must require of and communicate to its employees and subcontractors.

(j) For property where a covenant not to sue is requested, provisions for annually notifying the director as to whether implementation of the risk mitigation plan occurred; and if implemented, of the events that required implementation of the risk mitigation plan, the exposures to hazardous substances or petroleum that may have occurred, and the risk mitigation measures undertaken in accordance with the risk mitigation plan.

(k) The criteria for termination of the risk mitigation plan, as appropriate.

(2) For a covenant not to sue issued pursuant to Chapter 3746. of the Revised Code, the risk mitigation plan is developed as a separate plan for implementation as a condition of a covenant not to sue.

(H) Post covenant not to sue remedy changes.

(1) A volunteer, including persons responsible for compliance with applicable standards, may revise an existing remedy or remedies relied upon to meet applicable standards. In order to ensure a covenant not to sue issued pursuant to Chapter 3746. of the Revised Code remains effective, the volunteer shall do the following:

(a) Continue to comply with all existing institutional controls, operation and maintenance plan activities, risk mitigation measures, and other remedies required for compliance, until they are replaced or terminated under this chapter.

(b) Collect any data necessary to scope and support the remedy revision in accordance with rule 3745-300-07 of the Administrative Code.

(c) Implement the remedy revision in accordance with this chapter.

(d) Take any steps necessary to ensure that the property will comply with all applicable standards prior to, during, and after the remedy revision.

(2) The volunteer may choose to demonstrate that revised remedial activities have been implemented in accordance with this rule and have resulted in compliance with applicable standards, and submit a remedy revision notice to the director under an affidavit from a certified professional. Should the volunteer choose to submit a remedy revision notice to the director, the notice shall include the following:

(a) A description of the remedial activity necessary to achieve or maintain compliance with applicable standards.

(b) A statement from the certified professional that the property complies with applicable standards through implementation of the remedial activities in accordance with paragraph (I) of rule 3745-300-07 of the Administrative Code.

(c) A list of the data, information, records and documents relied upon by the certified professional to determine and verify that the property complies with applicable standards.

(d) A description of any remedial activity that will no longer be relied upon for compliance with applicable standards.

(e) If compliance with applicable standards requires a new or revised institutional control, each such institutional control must be developed in accordance with paragraphs (C) and (E) of this rule, and consistent with rule 3745-300-13 of the Administrative Code and division (C)(3)(b) of section 3746.10 of the Revised Code, as applicable.

(f) If compliance with applicable standards relies on an engineering control, a new or revised operation and maintenance pland and agreement, as applicable, must be developed in accordance with paragraph (F) of this rule.

(g) A request for either a remedy revision acknowledgment or a remedy revision approval.

(3) Request to the director for remedy revision approval. A volunteer who submits a remedy revision notice and requests a remedy approval letter shall do the following:

(a) Include copies of all relevant data, information, records and documents referenced in paragraph (H)(2)(c) of this rule.

(b) Respond to questions or requests from the director sufficient for the director to issue a remedy approval letter.

(c) Reimburse the agency for its costs incurred to review the remedy revision notice and prepare and process the remedy approval letter. The applicant must establish a direct billing schedule for receipt of such costs charged pursuant to paragraph (E) of rule 3745-300-03 of the Administrative Code. A statement of costs will be sent to the applicant after the request is approved, denied, or withdrawn. The applicant must pay the costs, in full, within sixty days of receipt of the statement of costs.

(4) Request to the director for remedy revision acknowledgment. A volunteer who submits a remedy revision notice and requests a remedy acknowledgment letter shall include copies of all relevant data, information, records and documents referenced in paragraph (H)(2)(c) of this rule. To the extent the remedy revision requires a new or modified operation and maintenance agreement, operation and maintenance plan, or institutional control, the volunteer must open a technical assistance account with the agency for the preparation and approval of those documents.

(5) A remedy revision that includes the modification or establishment of institutional controls for a resticted land use must apply the criteria of paragraph (F)(5) of rule 3745-300-07 of the Administrative Code. The institutional control must be developed in accordance with paragraphs (C) and (E) of this rule, and consistent with rule 3745-300-13 of the Adminsitrative Code and division (C)(3)(b) of section 3746.10 of the Revised Code, as applicable.

(6) A remedy revision that requires the establishment or modification of an operation and maintenance agreement must have the agreement established or modified in accordance with paragraph (F)(4) of this rule.

(7) A remedy revision that involves a land use change that cannot be supported by data gathered for the original no further action letter requires issuance of a new no further action letter in support of the land use change.

Replaces: 3745-300-11

Effective: 08/01/2014
R.C. 119.032 review dates: 08/01/2019
Promulgated Under: 119.03
Statutory Authority: 3746.04
Rule Amplifies: 3746. 5301
Prior Effective Dates: 12/29/1995, 7/1/2006, 3/1/2009, 4/23/2012

3745-300-12 Variances and case-by-case determinations.

(A) Authority and scope for variances. Pursuant to section 3746.09 of the Revised Code, a volunteer may apply to the director for a variance from any applicable standard that otherwise applies to a property on which a voluntary action is being conducted.

(1) Approval criteria. The director shall issue a variance from those applicable standards only if the volunteer makes all of the following demonstrations to the director's satisfaction:

(a) Either or both of the following:

(i) Compliance with the applicable standards otherwise established at the property named in the application is technically infeasible.

(ii) The costs of complying with the applicable standards otherwise established at the property substantially exceed the economic benefits.

(b) The proposed alternative standard or set of standards and terms and conditions set forth in the application will result in an improvement of environmental conditions at the property and ensure that public health and safety will be protected.

(c) The establishment of and compliance with the alternative standard or set of standards and terms and conditions are necessary to promote, protect, preserve, or enhance employment opportunities or the reuse of the property named in the application.

(2) Application contents. An application for a variance shall be prepared and submitted by a certified professional, on behalf of the volunteer, on a form provided by the agency. The application shall include, but is not limited to, the following information:

(a) The name of the person requesting the variance.

(b) A copy of the certified professional's certificate or an indication of the certified professional's identification number assigned by the agency.

(c) A copy of the certified laboratory's certificate or an indication of the certified laboratory's identification number assigned by the agency for any data submitted to support the variance request.

(d) A statement that identifies the applicable standard that is the focus of the variance request.

(e) A statement of the proposed alternative standard or set of standards proposed to be applicable to the affected property and any terms and conditions thereof, including a detailed description or explanation, and the supporting rationale for the new alternative standard.

(f) A summary of the technology, methods or controls used to achieve the alternative standard or set of standards and terms and conditions.

(g) A description of the affected property.

(h) All information obtained from a phase I or phase II property assessment that is relevant to the affected property.

(i) A written demonstration that the proposed variance meets the requirements of paragraph (A)(1) of this rule.

(j) The names and addresses of all adjacent property owners.

(3) Application review process.

(a) The director shall determine whether a variance application is complete and contains all of the items required pursuant to paragraph (A)(2) of this rule within fourteen days of receiving the application, and shall notify the applicant of this determination in a letter sent by certified mail.

(b) After determining whether a variance application is complete, the director may request additional information. The variance applicant, through their certified professional, shall promptly respond to any requests from the director for additional information.

(c) Upon determining that a variance application is complete the director shall follow the public notice and public meeting requirements described in paragraph (C) of this rule.

(d) In accordance with paragraph (C) of this rule, the applicant for a variance, or a representative of the applicant who is knowledgeable about the affected property and the application, shall attend the public meeting for the variance application, shall present information regarding the application and the basis of the request for the variance, and shall respond to questions from the public regarding the affected property and the variance application.

(4) Issuance or denial of the variance application.

(a) Within ninety days after conducting the public meeting on a variance application, the director shall issue a proposed action to the applicant in accordance with section 3745.07 of the Revised Code. The proposed action shall include the director's intent with regard to the issuance or denial of the variance application, and shall include the findings upon which that action is based. When considering whether to issue or deny the variance application or whether to impose terms and conditions on the variance that are in addition or alternative to those proposed by the applicant, the director shall consider any comments on the variance application made by the public at the public meeting and any written comments on the application received.

(b) The director shall issue a variance from standards established in accordance with the rules adopted pursuant to division (B)(1) or (B)(2) of section 3746.04 of the Revised Code only if the variance application makes all of the demonstrations required under paragraph (A)(1) of this rule to the director's satisfaction.

(c) A variance issued under this rule shall state the specific standards whose terms are being varied and shall set forth the specific alternative standards or set of standards to be applicable to the affected property and any terms and conditions thereof imposed on the affected property and the variance applicant. The variance shall include only standards and terms and conditions proposed by the applicant in the variance application, except that the director may impose any additional or alternative terms and conditions that the director determines to be necessary to ensure that public health and safety will be protected.

(d) The director shall deny a variance application if the director finds that the applicant does not meet the requirements of paragraphs (A)(1) and (A)(2) of this rule. If the variance application fails to propose applicable standards which are protective of public health and safety, as required in paragraph (A)(1)(b) of this rule, the director shall deny the variance application, unless the imposition of additional or alternative terms and conditions, pursuant to paragraph (A)(4)(c) of this rule, will ensure that public health and safety will be protected.

(e) Whether an approval or denial of the variance application, the director shall issue an order to the applicant in accordance with the procedure contained in paragraph (A)(4)(a) of this rule. Variances shall be approved or denied in accordance with this rule, section 3746.09 of the Revised Code, and Chapter 3745. of the Revised Code.

(B) Authority and scope for case-by-case determinations. Pursuant to division (B)(12) of section 3746.04 of the Revised Code, a volunteer may apply to the director for a case-by-case determination that renders a generic numeric ground water standard or risk-derived ground water standard inapplicable to a property on which a voluntary action is being conducted. If the no further action letter relies on a case-by-case determination, then the case-by-case determination must be approved by the director prior to issuance of the no further action letter for that property.

(1) Approval criteria. The director shall issue a case-by-case determination from those applicable standards for remediating contaminated ground water only if the volunteer demonstrates that doing so will ensure that public health and safety is and will continue to be protected. The director shall consider public comments made during the public comment period conducted in accordance with paragraph (C) of this rule.

(2) Application contents. An application for a case-by-case determination shall be prepared and submitted by a certified professional, on behalf of the volunteer, on a form provided by the agency. The application shall include, but is not limited to, the following information:

(a) The name of the person requesting the determination.

(b) A copy of the certified professional's certificate or an indication of the certified professional's identification number assigned by the agency for any data submitted to support the case-by-case request.

(c) A copy of the certified laboratory's certificate or an identification number assigned by the agency for any data submitted to support the case-by-case request.

(d) A description of the affected property.

(e) A statement that identifies the applicable ground water standard that is the focus of the case-by-case request.

(f) A statement of the proposed alternative standard or set of standards proposed to be applicable to the affected property and any terms and conditions thereof. Include a detailed description or explanation, and the supporting rationale for the new alternative standard, if any.

(g) All information obtained from a phase I or phase II property assessment that is relevant to the determination and the affected property.

(h) The names and addresses of all adjacent property owners.

(3) Application review process.

(a) The director shall determine whether the case-by-case application is complete and contains all of the items required pursuant to paragraph (B)(2) of this rule within fourteen days of receiving the application, and shall notify the applicant in a letter sent by certified mail.

(b) After determining whether a case-by-case application is complete, the director may request, at the director's discretion, additional information.

The applicant, through their certified professional, shall promptly respond to any requests from the director for additional information.

(c) Upon determining that a case-by-case application is complete the director shall follow the public notice and public meeting requirements described in paragraph (C) of this rule.

(d) In accordance with paragraph (C) of this rule, the applicant for a case-by-case, or a representative of the applicant who is knowledgeable about the affected property and the application, shall attend the public meeting, shall present information regarding the application and the basis of the request for the case-by-case determination, and shall respond to questions from the public regarding the affected property and the application.

(4) Issuance or denial of the case-by-case application.

(a) Within ninety days after conducting the public meeting on a case-by-case application, the director shall issue a proposed action to the applicant in accordance with section 3745.07 of the Revised Code. The proposed action shall include the director's intent with regard to the issuance or denial of the case-by-case application, and shall include the findings upon which that action is based. When considering whether to issue or deny the application or whether to impose terms and conditions on the determination that are in addition or alternative to any proposed by the applicant, the director shall consider any comments on the case-by-case application made by the public at the public meeting and any written comments on the application.

(b) The director shall deny a case-by-case application if the director finds that the application fails to be protective of public health and safety, as required in paragraph (B)(1) of this rule. The director shall consider public comments made during the public comment period.

(c) Whether an approval or denial of the case-by-case application, the director shall issue an order to the applicant in accordance with the procedure contained in paragraph (B)(4)(a) of this rule. Case-by-case determinations shall be approved or denied in accordance with this rule, section 3746.04 of the Revised Code, and Chapter 3745. of the Revised Code.

(C) Public notice and public meeting requirements. Upon determining that a variance or case-by-case determination application is complete, the director shall do all of the following:

(1) Mail notice of the application to each owner of each parcel of land that is adjacent to the affected property.

(2) Schedule a public meeting for the application and publish notice of the public meeting. The public meeting shall be held between thirty and ninety days after the date of the letter specified in paragraph (A)(3)(a) or (B)(3)(a) of this rule. The public meeting shall be held in the county where the affected property or the greatest portion of that affected property is located.

(3) At least thirty days before the date scheduled for the public meeting on an application, the director shall publish public notice of the public meeting. The public notice shall be published in a newspaper of general circulation in the county in which the affected property is located. If the affected property is located in close proximity, as determined by the director, to the boundary of that county with an adjacent county, the director shall also publish the public notice in a newspaper of general circulation in the adjacent county. The public notice shall, at a minimum, contain all of the following information:

(a) Notification that the director will receive written comments on the application for a period of forty-five days commencing on the date of publication of the public notice.

(b) The address of the property to which the application pertains.

(c) A brief summary of the alternative standards or set of standards and any terms and conditions proposed by the applicant.

(d) The date, time, and location of the public meeting.

(4) Concurrently with the publication of the public notice required in paragraph (C)(3) of this rule, the director shall mail notice by certified mail of the application, comment period, and public meeting to the owner of each parcel of land that is adjacent to the affected property and to the legislative authority of the municipal corporation or township, and county, in which the property is located. The notices mailed to the adjacent land owners and legislative authorities shall contain the same information as the public notice described in paragraph (C)(3) of this rule.

(5) A representative of the Ohio EPA who is familiar with the affected property and the application shall attend the public meeting to receive comments from the public and to respond to questions from the public regarding the affected property and the application.

(6) A stenographic record of the proceedings at the public meeting shall be kept and shall be made a part of the administrative record regarding the application. The agency shall conduct a public meeting and shall maintain all records produced by or for that meeting.

(D) Administrative fees. An applicant seeking a variance or case-by case determination is responsible for reimbursing the agency for actual costs incurred to review the application and accompanying information. The applicant must establish a direct billing schedule under paragraph (E) of rule 3745-300-03 of the Administrative Code. A statement of costs will be sent to the applicant after the application is approved, denied, or withdrawn. The applicant must pay the costs, in full, within sixty days of receipt of the statement of costs.

(E) Application withdrawal. Upon receipt of a written request by the applicant, an application for variance or a case-by-case determination made in accordance with this rule may be withdrawn from consideration by the director. A request for withdrawal must be submitted prior to approval or denial of the application. Upon withdrawal, the director may cease review of the application and discontinue the public notice and public meeting processes. Any fees levied under paragraph (D) of this rule for administrative costs prior to withdrawal are non-refundable.

Replaces: 3745-300-12

Effective: 08/01/2014
R.C. 119.032 review dates: 08/01/2019
Promulgated Under: 119.03
Statutory Authority: 3746.04
Rule Amplifies: 3746
Prior Effective Dates: 12/29/1995, 3/1/2009

3745-300-13 Content and scope of no further action letters.

(A) For the purposes of this chapter and Chapter 3746. of the Revised Code, a no further action letter may be issued pursuant to this rule by a certified professional for a property under one or a combination of the following circumstances:

(1) After completion of a phase I property assessment conducted in accordance with rule 3745-300-06 of the Administrative Code, a certified professional determines that there is no information establishing any reason to believe a release of hazardous substances or petroleum has or may have occurred at or upon a property.

(2) After completion of a phase I property assessment conducted in accordance with rule 3745-300-06 of the Administrative Code, a certified professional determines a release of hazardous substances or petroleum occurred on the property, with the release being demonstrated in writing to be within a de minimis or previously addressed area determined in accordance with paragraph (E) of rule 3745-300-06 of the Administrative Code.

(3) After completion of a phase II property assessment conducted in accordance with rule 3745-300-07 of the Administrative Code, a certified professional determines the concentrations of chemicals of concern pertaining to the property do not exceed the applicable standards.

(4) After completion of a phase II property assessment conducted in accordance with rule 3745-300-07 of the Administrative Code, a certified professional determines the concentrations of chemicals of concern pertaining to the property exceed the applicable standards but those applicable standards have been achieved through remedial activities or will be achieved in accordance with an operation and maintenance plan if required under rule 3745-300-11 of the Administrative Code, or a consolidated standards permit issued under section 3746.15 of the Revised Code and any rules adopted thereunder.

(B) In order to support a request for a no further action letter, a volunteer, and other persons performing work to support the request as described in paragraph (O) of this rule, must submit to a certified professional, by affidavit, all relevant investigatory and remedial information pertaining to the property including, but not limited to the following:

(1) Information demonstrating there is no contamination of hazardous substances or petroleum of soil, sediments, surface water, or ground water released on or from the property exceeding applicable standards. The demonstrations must be based upon the findings of a phase I property assessment in accordance with rule 3745-300-06 of the Administrative Code or a phase II property assessment in accordance with rule 3745-300-07 of the Administrative Code, as applicable.

(2) Information demonstrating compliance with rule 3745-300-02 of the Administrative Code regarding the eligibility of the property to participate in the voluntary action program.

(3) If remedial activities were conducted in connection with a voluntary action, data demonstrating that any or all remedies meet or will meet applicable standards in accordance with paragraph (E) of rule 3745-300-11 of the Administrative Code.

(4) If a remedy relies on institutional controls restricting the use of the property to achieve applicable standards, a demonstration that all institutional controls on the property have been recorded in the office of the county recorder of the county in which the property is located, or have been entered as a memorial in the appropriate register for registered land as defined in section 5309.01 of the Revised Code, in compliance with section 3746.14 of the Revised Code, except as provided by paragraphs (B)(4) and (E)(8)(e) of this rule.

(5) If the remedy relies on activity and use limitations to achieve applicable standards, a demonstration that the activity and use limitations have been developed in accordance with this chapter, and are contained in a proposed environmental covenant that meets the requirements established in section 5301.82 of the Revised Code. This requirement applies when the volunteer intends to request a covenant not to sue from Ohio EPA or when the volunteer does not intend to request a covenant not to sue but Ohio EPA will be obligated to review the no further action letter pursuant to division (C) of section 122.654 of the Revised Code.

(6) An operation and maintenance plan and a proposed operation and maintenance agreement, for the remedies that require an operation and maintenance plan and operation and maintenance agreement, in accordance with rule 3745-300-11 of the Administrative Code.

(7) The affidavits required by paragraphs (O) and (P) of this rule.

(C) A person, with the purpose to deceive a certified professional, certified laboratory or a contractor thereof, or the agency or a contractor thereof, may not withhold, conceal, or destroy any data, information, records, or documents relating to a voluntary action.

(D) After receiving the information which is required to be submitted by a volunteer under paragraph (B) of this rule, a certified professional must review the information to determine whether the property complies with the applicable standards, or must ensure that the information has been reviewed by persons with experience and competence in areas other than the certified professional's expertise and competence, as necessary for the issuance of the no further action letter. The certified professional must conduct an eligibility evaluation and a determination that the property meets all eligibility requirements in accordance with rule 3745-300-02 of the Administrative Code. The following activities must be performed or completed within one hundred-eighty days prior to the issuance of the no further action letter:

(1) All requirements contained in paragraphs (C) and (E) of rule 3745-300-06 of the Administrative Code have either been performed within one hundred-eighty days prior to the issuance of a no further action letter, or that in the best professional judgment of the certified professional no change in environmental conditions at the property has occured since the requirements contained in paragraphs (C) and (E) of rule 3745-300-06 of the Administrative Code were performed. Changed conditions means new information about known or suspected releases to environmental media resulting in additional identified areas at the property that are subject to phase II property assessment or previously identified areas that need further phase II property assessment due to new information.

(a) When determining whether to re-evaluate requirements in paragraphs (C) and (E) of rule 3745-300-06 of the Administrative Code, the certified professional must use best professional judgment to decide which requirements in paragraphs (C) and (E) of rule 3745-300-06 of the Administrative Code must be re-evaluated to determine whether additional phase II property assessment is required.

(b) If any requirements in paragraphs (C) and (E) of rule 3745-300-06 of the Administrative Code require re-evaluation, documentation of the additional information gathered to comply with this paragraph must be included in an updated phase I property assessment report.

(2) A walk-over of the property by the certified professional.

(E) After performing a review of documents and other activities in accordance with paragraph (D) of this rule, if the certified professional concludes on the basis of best available knowledge, information and belief that a property meets or will meet applicable standards, a certified professional may prepare a no further action letter for the property. The certified professional must prepare the no further action letter in the format prescribed by paragraph (I) of this rule and electronic copies of the document must be indexed appropriately in a format prescribed by the agency. The no further action letter must contain, at a minimum, the following information:

(1) A statement that the property is eligible to participate in the voluntary action program pursuant to rule 3745-300-02 of the Administrative Code.

(2) A statement of whether a risk assessment was performed pursuant to rule 3745-300-09 of the Administrative Code.

(3) The name and qualifications of each person who performed work, other than the certified professional, to support the no further action letter and the nature and scope of the work performed by that person.

(4) A list of all documents, and the date such documents were prepared, which were reviewed by the certified professional in preparing the no further action letter; a summary of the information required to be submitted by the volunteer to the certified professional preparing the no further action letter, as described in paragraph (B) of this rule; all other affidavits required under paragraphs (O) and (P) of this rule, and any other relevant information that the certified professional relied upon for the no further action letter.

(5) A summary table which provides a description of all chemicals of concern identified in environmental media on or from the property, their source if known, and their locations and concentration levels prior to any remediation.

(6) An affidavit prepared in connection with the voluntary action in accordance with paragraph (Q) of this rule and as required by rule 3745-300-05 of the Administrative Code.

(7) Administrative information of the no further action letter shall include the following:

(a) Identification of the tax parcel numbers and the taxing districts for the property. If any portion of the property includes less than an entire tax parcel, the no further action letter must include a map indicating the affected tax parcel numbers, and the included and excluded portions.

(b) Payment and fees information based on the current fee structure defined by the agency.

(c) Eligibility determination of "Class C Releases" and "Non-Class C Releases" of underground storage tank systems regulated by the bureau of underground storage tank regulations.

(d) Property information including the volunteer's name and contact information; the certified professional's name and contact information; and the property owner's name and contact information.

(e) Remedy information, such as environmental covenants, operation and maintenance plan, and risk mitigation plan information.

(8) An executive summary of the no further action letter, prepared in accordance with a format prescribed by the agency, as follows:

(a) A legal description of the property subject to the no further action letter.

(b) For each of the maps described in paragraphs (E)(2)(a) and (E)(2)(b) of this rule, the no further action letter must include, in addition to a hard copy on " 8.5 x 11" inch-sized paper, an electronic file as available containing the map data formatted in a manner recommended by the agency. The property maps must include, but are not limited to the following:

(i) Property location map, as required by paragraph (G)(5)(a) of rule 3745-300-06 of the Administrative Code.

(ii) The property's boundaries, as determined by a professional surveyor licensed under Ohio law.

(iii) The locations of all borings, monitoring wells, and other sampling locations, as required by paragraph (J)(1)(a) of rule 3745-300-07 of the Administrative Code.

(iv) The existing topography delineating the streams, swamps, lakes, springs, and other surface waters, with a contour interval of no greater than five feet, as required by paragraph (J)(1)(b) of rule 3745-300-07 of the Administrative Code.

(v) The locations where remedial activities have been implemented or will be implemented pursuant to rule 3745-300-11 of the Administrative Code, as required by paragraph (J)(1)(e) of rule 3745-300-07 of the Administrative Code.

[Comment: The agency recommends electronic formats for map data on its web site. The electronic data will facilitate the entry of property information in an agency graphic view system.]

(c) Identification of the applicable standards for the property that reflects the certified professional's conclusion that the property complies with the applicable standards for each complete exposure pathway identified in accordance with paragraph (F)(1) of rule 3745-300-07 of the Administrative Code. The no further action letter must also provide this information in a summary table format.

(d) Verification that the demonstration of compliance with the applicable standards is based on certified data generated by a certified laboratory pursuant to rule 3745-300-04 of the Administrative Code, if such data is required by rule 3745-300-07 of the Administrative Code.

(e) If the remedy relies on institutional controls (use restrictions or activity and use limitations) to achieve applicable standards, a demonstration that the institutional controls have been implemented in accordance with division (C)(3)(a) or (C)(3)(b) of section 3746.10 of the Revised Code, as applicable. This demonstration must include one of the following:

(i) If the volunteer does not intend to request a covenant not to sue from the director and the director is not obligated to review the no further action letter pursuant to division (C) of section 122.654 of the Revised Code, a copy of the institutional controls (use restrictions) bearing the mark of recordation of the county recorder's office of the county in which the property is located, or have been entered in the appropriated register for registered land, as defined in section 5309.01 of the Revised Code. The institutional controls must be consistent with requirements in rule 3745-300-11 of the Administrative Code and other applicable laws.

(ii) If the volunteer intends to request a covenant not to sue from Ohio EPA or the volunteer does not intend to request a covenant not to sue but Ohio EPA will be obligated to review the no further action letter pursuant to division (C) of section 122.654 of the Revised Code, a copy of the proposed environmental covenant for the property that meets the requirements established in section 5301.82 of the Revised Code. The proposed environmental covenant must contain activity and use limitations that are developed in accordance with rule 3745-300-11 of the Administrative Code and other applicable laws. If the entire property is not subject to the activity and use limitations, the environmental covenant must include the additional legal description and survey map of the portion of the property that is subject to the limitations. The recordation of the environmental covenant in accordance with sections 3746.14 and 5301.88 of the Revised Code will be required as a condition of a covenant not to sue issued for the property in order for the covenant to become effective.

(f) A copy of the operation and maintenance plan and proposed operation and maintenance agreement prepared in accordance with rule 3745-300-11 of the Administrative Code, if the plan and agreement is required pursuant to that rule.

(g) A copy of the risk mitigation plan prepared in accordance with rule 3745-300-11 of the Administrative Code, if the plan is required pursuant to that rule.

(h) A copy of the consolidated standards permit and supporting documents issued pursuant to section 3746.15 of the Revised Code, if any of the following apply, if any.

(i) A copy of the approval of a variance or case-by-case determination obtained pursuant to rule 3745-300-12 of the Administrative Code, if any.

(j) Identification of the tax parcel number(s) and the taxing district(s) for the property. If any portion of the property includes less than an entire tax parcel, the no further action letter must include a map indicating the affected tax parcel number(s), and the included and excluded portions.

(9) A copy of the consolidated standards permit and supporting documents issued pursuant to section 3746.15 of the Revised Code, if any.

(10) Any other information the certified professional considers relevant.

(F) Upon completion of a no further action letter, the certified professional must send a copy of the no further action letter to the volunteer. The no further action letter must be accompanied by the following:

(1) A written request that the volunteer notify the certified professional as to whether the volunteer wishes to submit the no further action letter to the director.

(2) A written notice informing the volunteer that the original no further action letter may be submitted to the director only by a certified professional and that the volunteer may receive a covenant not to sue from the director in connection with the voluntary action only if the original no further action letter for the voluntary action is submitted to the director on behalf of the volunteer by the certified professional.

(3) The certified professional's affidavit, prepared in accordance with paragraph (Q) of this rule.

(G) Promptly after receipt of the no further action letter and the request described in paragraph (F)(1) of this rule, the volunteer must do the following:

(1) Send written notice to the certified professional which indicates whether or not the volunteer wishes the certified professional to submit the no further action letter to the director in a manner prescribed by the agency.

(2) Send a copy of the written notice to the director in a manner prescribed by the agency.

[Comment: To prepare the written notice pursuant to paragraph (G) of this rule the volunteer may use the template letter attached to the no further action letter form, which is available on the agency's web site.]

(H) Promptly after receipt of the written notice pursuant to paragraph (G) of this rule, the certified professional must do either of the following:

(1) Submit the original no further action letter to the director, in a manner prescribed by the agency, by certified mail on behalf of the volunteer, if the volunteer's notice indicates that the volunteer wishes to have the no further action letter submitted to the director. The original no further action letter must include the certified professional's original affidavit, executed prior to volunteer notice, prepared in accordance with paragraph (Q) of this rule.

(2) Send the original no further action letter to the volunteer promptly after receiving the notice, if the notice indicates that the volunteer does not wish the certified professional to submit the no further action letter to the director in a manner prescribed by the agency.

(I) The certified professional must prepare the no further action letter in a format prescribed and provided by the agency.

[Comment: The prescribed format is available by contacting the voluntary action program at Ohio EPA or by accessing the agency's web site. This prescribes the format of how the no further action letter and supporting documentation should be assembled for submitting to the agency and also specifies, for example, the preparation of a summary table showing analytical data results relied upon to support an applicable standards demonstration.]

(J) The certified professional must prepare an executive summary of the no further action letter in the format prescribed and provided by the agency for purposes of meeting the recording requirement of paragraph (L) of this rule. The executive summary must include the legal description of the property and the certified professional's affidavit for the executive summary, in the format prescribed by the agency pursuant to paragraph (I) of this rule.

[Comment: The formats for the executive summary and the certified professional's executive summary affidavit are included with the prescribed format for the no further action letter, and is accessible by contacting the voluntary action program at Ohio EPA or by accessing the agency's web site.]

(K) The volunteer may, through the certified professional, withdrawal the submittal of a no further action letter for the property and request for a covenant not to sue from the director.

(L) If a covenant not to sue is issued by the director as a result of the submission of a no further action letter prepared pursuant to this rule, the volunteer who is issued the covenant not to sue must ensure that the certified professional's executive summary of the no further action letter, in the format described in paragraph (J) of this rule, the covenant not to sue and the environmental covenant for the property, if any, are recorded, in the same manner as a deed to the property, in the office of the county recorder of the county in which the property is located. No further action letters submitted to the agency will be made available by the agency as public records.

(M) Upon receipt of the covenant not to sue by the volunteer, the certified professional, must provide the following supporting documentation evaluated by the certified professional in accordance with paragaraph (D) of this rule to determine that the property meets or will meet applicable standards and that the property was eligible to participate in the voluntary action program, as applicable:

(1) The phase I property assessment report completed in accordance with rule 3745-300-06 of the Administrative Code and any updates to the phase I property assessment report.

(2) Any sampling plans, remediation reports, closure reports, laboratory reports with dates, and compliance reports.

(3) The phase II property assessment report completed in accordance with 3745-300-07 of the Administrative Code.

(4) A description of all chemicals of concern identified in environmental media, their source, if known, and their locations and concentration levels prior to and after any remediation. The no further action letter must also provide this information in a summary table format.

(5) A property-specific risk assessment report completed in accordance with rule 3745-300-09 of the Administrative Code, if such a property-specific assessment was used in lieu of, or in addition to, using generic numerical standards established in rule 3745-300-08 of the Administrative Code.

(6) Information demonstrating that the property conforms with each of the exposure assumptions used to calculate the applicable standards for the property, including all exposure assumptions used to calculate the generic numerical standards established in rule 3745-300-08 of the Administrative Code and all exposure assumptions used to determine the applicable standards under rule 3745-300-09 of the Administrative Code, as applicable to the property.

(7) All affidavits prepared in connection with the voluntary action in accordance with paragraphs (O) to (Q) of this rule and as required by rules 3745-300-04 and 3745-300-05 of the Administrative Code.

(8) Any other information the certified professional considers relevant.

(N) A no further action letter, a covenant not to sue and any agreement authorized to be entered into under Chapter 3746. of the Revised Code and this chapter may be transferred by the recipient to any other person by assignment or in conjunction with the acquisition of title to the property to which such document applies.

(O) Affidavit requirement - volunteers and persons who performed work to support a request for a no further action letter. When a volunteer or a person who performed work to support a request for a no further action letter submits information, data, documents, or reports to a certified professional, a certified laboratory or the agency, the volunteer or person must provide the submission under affidavit. The affidavit must be based on the knowledge, information and belief of that volunteer or person, and include the following:

(1) The name of the affiant.

(2) A statement that the affiant is authorized to submit the affidavit on behalf of the volunteer, with the name of the entity with whom the affiant is employed or retained if not employed or retained by the volunteer.

(3) The name and address of the property subject to the voluntary action.

(4) The purpose for which the information, data, documents, or reports are being submitted.

[Comment: For example, when a person performs work to support a request for a no further action letter, such as a consultant who completes a phase I property assessment or a property-specific risk assessment report, the consultant's affidavit would identify the submission purpose and the report name.]

(5) An identification of all information, data, documents, or reports submitted with the affidavit.

(6) When information, data, documents, or reports are submitted to a certified professional to support a request for a no further action letter, a statement that the work indicated by the submission was conducted in compliance with all applicable local, state and federal laws and regulations.

(7) A statement attesting all information, data, documents, or reports submitted by the affiant are true, accurate and complete.

[Comment: Paragraph (O) of this rule does not apply to information, data, documents, or reports provided by any federal, state, or local governmental entity in response to a public records request.]

[Comment: If a person interviewed by a volunteer or certified professional for purposes of a phase I property assessment does not submit an affidavit attesting, in accordance with paragraph (O) of this rule, to the information the person provided during the interview, the interviewer may submit an affidavit attesting to the information received during the interview and that the interviewed person did not submit an affidavit.]

(P) Affidavit requirement - certified laboratories. The information, data, documents, or reports submitted by a certified laboratory to a volunteer, a certified professional, the director, or any other person to support a request for a no further action letter must be submitted by affidavit. Each time that information, data, documents or reports are submitted by a certified laboratory for the purposes of conducting or completing a voluntary action, an authorized representative of the certified laboratory must submit an affidavit based upon the certified laboratory's knowledge, information and belief, which includes the following:

(1) The name of the affiant.

(2) A statement attesting the affiant is authorized to submit the affidavit on behalf of the certified laboratory.

(3) Name and address of the property that is the subject of the voluntary action.

(4) A statement attesting the purpose for which the information, data, documents, or reports are being submitted is to support a request for a no further action letter.

(5) An identification of all information, data, documents, or reports submitted with the affidavit.

(6) A statement attesting the certified laboratory performed the analyses documented in the submission in accordance with the laboratory's current certificate issued under the voluntary action program and the laboratory was certified for each analyte, parameter group and method used at the time it performed the analyses.

(7) A statement attesting that, at the time of analysis, the analyses were performed pursuant to the certified laboratory's standard operating procedures and quality assurance program plan for which the laboratory has received prior approval from the agency.

(8) A statement attesting all information, data, documents, or reports submitted by the certified laboratory in support of the request for a no further action letter are true, accurate and complete.

(Q) Affidavit requirement - certified professional. For each no further action letter issued to a volunteer or submitted to the director for a covenant not to sue, the certified professional must submit an affidavit based upon the certified professional's knowledge, information and belief, which includes the following:

(1) The name of the certified professional.

(2) The name and address of the property that is the subject of the no further action letter, and the name and address of each volunteer and property owner.

(3) A statement attesting the certified professional has read all standards of conduct contained in paragraph (E) of rule 3745-300-05 of the Administrative Code and met the standards of conduct while the certified professional rendered professional services regarding the voluntary action at the property.

(4) A statement attesting the property is eligible for the voluntary action program pursuant to rule 3745-300-02 of the Administrative Code and section 3746.02 of the Revised Code.

(5) A statement attesting the voluntary action has been conducted and the no further action letter issued in accordance with this chapter and Chapter 3746. of the Revised Code.

(6) A statement attesting the voluntary action was conducted in compliance with all applicable local, state, and federal laws and regulations.

(7) A statement attesting the no further action letter, and any information, data, documents, or reports submitted with the no further action letter, are true, accurate and complete. The certified professional may use the same affidavit prepared in accordance with paragraph (Q) of this rule for both the issuance of a no further action letter to the volunteer and the submission of the no further action letter to the director.

[Comment: The agency provides example affidavit language for use in complying with this rule. The examples are attachments to the no further action letter form, available on the agency's web site.]

Replaces: 3745-300-13

Effective: 08/01/2014
R.C. 119.032 review dates: 08/01/2019
Promulgated Under: 119.03
Statutory Authority: 3746.04
Rule Amplifies: 3746
Prior Effective Dates: 12/29/1995, 12/16/1996, 4/19/2006/ 3/1/2009

3745-300-14 Audits.

(A) The director shall conduct audits in connection with no further action letters issued under section 3746.11 of the Revised Code for any one or any combination of the following purposes:

(1) To determine whether, after completion of voluntary actions conducted pursuant to this chapter and Chapter 3746. of the Revised Code, the properties upon which the voluntary actions were conducted meet applicable standards .

(2) To review the qualifications of and work performed by certified professionals under this chapter and Chapter 3746. of the Revised Code to determine whether they possess the qualifications required for certification pursuant to rule 3745-300-05 of the Administrative Code and whether their performance in the voluntary action program has resulted in the issuance of no further action letters that are not consistent with applicable standards .

(3) To review the qualifications of and work performed by certified laboratories to determine whether they possess the qualifications required for certification pursuant to rule 3745-300-04 of the Administrative Code and whether their performance under this chapter and Chapter 3746. of the Revised Code has resulted in the issuance of no further action letters that are not consistent with applicable standards.

(B) Audits selected from the random audit pool shall be conducted in accordance with the procedures described in paragraph (F) of this rule. The director shall select no further action letters for audit from the random audit pool by any method the director deems necessary.

(C) The director may select no further action letters for audit from the discretionary audit pool by any method the director deems necessary. Audits of no further action letters selected from the discretionary audit pool may be conducted in accordance with the procedures described in paragraph (F) of this rule, or by any other means by the director. The director may conduct a discretionary audit for any reason including, but not limited to, any no further action letters that meet any of the following criteria:

(1) Was prepared by an individual who was certified under division (D) of section 3746.07 of the Revised Code, but not certified pursuant to rule 3745-300-05 of the Administrative Code.

(2) Relied upon analyses by a laboratory certified under division (E) of section 3746.07 of the Revised Code, but not certified under rule 3745-300-04 of the Administrative Code for the analyte, parameter group, and method used in support of the no further action letter.

(3) The director has reason to believe the no further action letter was submitted fraudulently.

(4) Was prepared by a certified professional whose certification was subsequently revoked in accordance with rule 3745-300-05 of the Administrative Code.

(5) Relied upon analyses by a certified laboratory whose certification was subsequently revoked in accordance with rule 3745-300-04 of the Administrative Code.

(6) Was the basis for a covenant not to sue which was subsequently revoked under this chapter and Chapter 3746. of the Revised Code.

(7) The certified professional, volunteer or owner of the property has notified the director, in compliance with paragraph (E)(2)(f) of rule 3745-300-05 of the Administrative Code, that relevant facts, data or other information existed at the time the no further action letter was issued which indicates applicable standards were not met.

(8) Pertains to a voluntary action for which a risk assessment was conducted in accordance with rule 3745-300-09 of the Administrative Code.

(9) Pertains to a voluntary action that included, as a remedial activity, either an engineering control as described in rule 3745-300-11 of the Administrative Code or institutional control which restricts access to or use of the property pursuant to rule 3745-300-11 of the Administrative Code.

(D) At a minimum, the director shall select no further action letters to be audited such that the total number of no further action letters selected for audit from both the random and discretionary audit pools will result in the following:

(1) The selection of no less than twenty-five per cent of all no further action letters involving remedial activities, submitted to the director during the previous calendar year.

(2) The selection of no less than twenty-five per cent of all no further action letters not involving remedial activities, submitted to the director during the preceding calendar year.

(E) Compliance audits may be conducted in accordance with the procedures described in paragraph (F) of this rule, or by any other means selected by the director. The director may conduct a compliance audit for any purpose or combination of purposes described in paragraph (A) of this rule.

(F) Audits may be conducted for any purpose or combination of purposes described in paragraph (A) of this rule in accordance with one or both of the following procedures:

(1) Tier I audit.

(a) Prior to commencing a tier I audit of a no further action letter, the director shall provide reasonable advance notice of the audit to the volunteer for whom the no further action letter was prepared, the certified professional who prepared the no further action letter, the current owner of the property, if different from the volunteer and, as appropriate, any certified laboratory which performed analyses which formed the basis for the no further action letter, and any other parties deemed necessary. The notice shall contain a request that the certified professional who prepared the no further action letter make available all documents relied upon by the certified professional and required to be itemized on the document list contained in the no further action letter pursuant to rule 3745-300-13 of the Administrative Code, and any other documents which the director determines are necessary to perform an audit pursuant to this rule.

(b) Following receipt of the notice provided pursuant to paragraph (E)(1)(a) of this rule, the certified professional shall deliver the requested documentation to the agency not more than thirty days following the request.

(c) When conducting a tier I audit, the director may do the following:

(i) Request that a certified professional, a certified laboratory, a volunteer or a person responsible for maintaining compliance with applicable standards at a property submit any or all documents pertaining to the no further action letter being audited .

(ii) Visit a property or place of business, following reasonable advance notice and during the normal operating hours of the business, to perform a review of the documents stored at that property or place of business .

(iii) Conduct a site walkover of the property upon which the voluntary action was conducted.

(d) All documents requested pursuant to paragraph (E)(1)(c)(i) of this rule shall be submitted to the director not later than thirty days following the request.

(2) Tier II audit.

(a) If the documents produced and reviewed pursuant to paragraph (E)(1) of this rule are inadequate to substantiate the no further action letter, or if the director has a reasonable belief that the no further action letter has been based on fraudulent or inaccurate information or documentation, the director may do the following:

(i) Inspect a property, following reasonable advance notice, investigate or inspect conditions, equipment or practices and conduct sampling to determine compliance with applicable standards, this chapter or Chapter 3746. of the Revised Code .

(ii) Take any other action the director deems necessary to determine whether the no further action letter was prepared in compliance with applicable standards, this chapter or Chapter 3746. of the Revised Code.

(b) In addition to tier II audits conducted pursuant to paragraph (E)(2)(a) of this rule, the director may, at the director's discretion, randomly perform tier II audits on any no further action letter selected for audit.

(c) Nothing in this rule shall diminish the director's ability to conduct criminal or other investigations under Chapter 3704., 3714., 3734., 3746., 3750., 3753., 6109. or 6111. of the Revised Code.

(G) The director shall complete all investigatory auditing activities by the thirty-first of December of the year in which an audit is conducted pursuant to paragraphs (B) to (E) of this rule and division (B) of section 3746.17 of the Revised Code, and the director shall issue all audit findings by the first of March of the year following that in which an audit is conducted.

(H) The person responsible for maintaining compliance with applicable standards at a property subject to an audit may request one informal meeting with the Ohio EPA to discuss the technical aspects of that audit. The Ohio EPA shall be available for such meeting following the conclusion of all investigatory auditing activities and prior to the issuance of audit findings.

(I) The time limits required by this rule shall not prevent the director, at the director's discretion, from granting one thirty day extension to any person subject to this rule. The director may also extend any time limits imposed upon the director under this rule for a period not to exceed thirty days.

(J) If requested by the director, upon proper identification and stating the necessity and purpose of the inspection, the volunteer or current owner of a property shall allow the director access to the property to conduct all audit activities pursuant to this rule. Nothing in this rule shall limit the authority of the director provided in section 3746.21 of the Revised Code.

(K) The Ohio EPA shall provide the person responsible for maintaining compliance with applicable standards at a property with a split sample of any soil, water or sediment sample obtained or removed from a property, if prior to sampling, a written request is made by the person responsible for maintaining compliance with applicable standards at a property. With sufficient prior notice, the Ohio EPA shall provide, at cost, appropriate sampling containers to the person making such a request.

(L) The director shall issue audit findings pursuant to this rule which include a determination of whether applicable standards, and all other requirements established under this chapter or Chapter 3746. of the Revised Code have been met and whether additional actions are required to attain compliance. After an audit is completed:

(1) If the director finds that a certified professional or certified laboratory either did not possess the required qualifications for certification or that work performed by the certified professional or certified laboratory in connection with a voluntary action has resulted in the issuance of a no further action letter that is not consistent with the applicable standards, the director may either suspend or revoke the certification of the certified professional or certified laboratory .

(2) If the director finds that the performance of a certified professional or certified laboratory has resulted in the issuance of no further action letters that are not consistent with applicable standards, the director shall notify persons for whom the certified professional or certified laboratory has performed work in connection with a voluntary action of the audit findings .

(3) If the director finds that a property no longer complies with the applicable standards upon which issuance of a covenant was based, the director shall, by certified mail, return receipt requested, notify the person responsible for maintaining compliance with those standards of that finding and of the requirements of division (B)(3) of section 3746.12 of the Revised Code .

(4) Unless the recipient of a notice provided under paragraph (L)(3) of this rule and division (B)(2) of section 3746.12 of the Revised Code, within thirty days after the mailing of the notice, notifies the director of the recipient's intention to return the property to compliance with the applicable standards upon which the covenant was based and enters into a compliance schedule agreement with the director, the director, by issuance of an order as a final action under Chapter 3745. of the Revised Code, shall revoke the covenant not to sue issued for the property. The compliance schedule agreement shall establish a reasonable period of time for returning to compliance with those applicable standards .

(5) If the director finds that a person with whom the director has entered into a compliance schedule agreement under this rule and division (B)(3) of section 3746.12 of the Revised Code has failed to return the property to which the agreement pertains to compliance with the applicable standards within the time established in the agreement, the director, by issuance of an order as a final action under Chapter 3745. of the Revised Code, shall revoke the covenant not to sue issued for the property.

(M) Nothing in this rule shall diminish the director's ability to conduct criminal or other investigations under Chapter 3704., 3714., 3734., 3745., 3746., 3750., 3751., 3752., 3753., 6109., or 6111. of the Revised Code.

Effective: 08/01/2014
R.C. 119.032 review dates: 04/24/2014 and 08/01/2019
Promulgated Under: 119.03
Statutory Authority: 3746.04
Rule Amplifies: 3746
Prior Effective Dates: 12/29/1995, 3/4/2002, 3/1/2009

3745-300-15 Remediation. [Rescinded].

Rescinded eff 3-1-09