Ohio Administrative Code
Title 3745 - Ohio Environmental Protection Agency
Chapter 3745-300 - Voluntary Action Program
Section 3745-300-09 - Property-specific risk assessment procedures
Universal Citation: OH Admin Code 3745-300-09
Current through all regulations passed and filed through September 16, 2024
[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 rule 3745-300-15 of the Administrative Code titled "Incorporation by reference - voluntary action program."]
(A) Applicability. The volunteer may use the property-specific risk assessment procedures 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 volunteer shall conduct the cleanup of the radionuclides or
radioactive material in compliance with requirements of the Ohio department of
health. Remedy approval by the Ohio department of health are 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 (COC), the volunteer shall
use a property-specific risk assessment to develop an applicable standard for
that COC.
(3)
Mandatory application. A volunteer shall conduct a
property-specific risk assessment in accordance with this rule to determine
applicable standards instead of, or in addition to, use of the generic
numerical standards in rule
3745-300-08
of the Administrative Code if any of the following apply to the property:
(a)
The complete
exposure pathways 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 appendices 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 appendices to rule
3745-300-08
of the Administrative Code.
(c)
COCs that
originate from the property, as follows:
(i)
The COCs consist
of hazardous substances or petroleum that do not have generic numerical
standards included in the appendices to rule
3745-300-08
of the Administrative Code.
(ii)
If only some of
the COCs identified have a generic numerical standard listed in the appendices
to rule
3745-300-08
of the Administrative Code, a volunteer may use the applicable generic
numerical standards for the COC that has listed standards, and may conduct a
property-specific risk assessment in accordance with this rule.
(iii)
When a
combination of generic numerical standards and applicable standards determined
by a property-specific risk assessment conducted in accordance with this rule
is used, the volunteer shall 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
COCs in surface water or sediment exceed applicable standards determined in
accordance with rule
3745-300-08
of the Administrative Code.
(e)
There are
complete exposure pathways to important ecological resources (IERs) other than
sediment or surface water, such as soil.
(f)
There are
persistent, bioaccumulative, and toxic (PBT) COCs that are determined to be
from the property that do not have or that exceed applicable standards as
determined in accordance with rule
3745-300-08
of the Administrative Code. A list of PBTs can be found in Ohio EPA's
"Ecological Risk Assessment Guidance."
(B) Applicable risk and hazard levels for human receptors. The volunteer shall 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 COCs which have carcinogenic effects, the cumulative human health
carcinogenic risk shall not exceed the following risk levels based on the
reasonably anticipated use of the property:
(a)
For all
residential and commercial property land uses, the cumulative carcinogenic
risk, which is attributable to the COCs, shall not exceed an excess upper bound
lifetime cancer risk to an individual of one in one hundred thousand (1x10-5).
(b)
For industrial
property land use, the cumulative carcinogenic risk shall not exceed an excess
upper bound lifetime cancer risk to an individual, which is attributable to the
COCs, of one in ten thousand (1x10-4) provided that a
demonstration that the cumulative cancer risk to off-property receptors, which
is attributable to COCs, is less than an excess upper bound lifetime cancer
risk to an individual of one in one hundred thousand (1x10-5):
(2)
Non-carcinogenic hazard. For COCs which have non-carcinogenic effects, the
cumulative human health hazard, which is attributable to the COCs, shall not
exceed a hazard index of one.
(3)
Carcinogenic risk
and non-carcinogenic hazard. For COCs which have both carcinogenic and
non-carcinogenic effects, the concentration of the COCs shall 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 shall 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)
COCs that are required to be evaluated are dependent on the
petroleum fraction of the released product. The volunteer shall evaluate
additional petroleum constituents or typical impurities to ensure applicable
standards are met. The volunteer shall assess and evaluate the risk indicator
compounds for each appropriate petroleum fraction including the
following:
(a)
For light petroleum fractions, such as natural gasoline,
gasohol, or naphtha solvents, the volunteer shall analyze environmental media
for benzene, toluene, ethylbenzene, methyl tert-butyl ether, total xylenes,
naphthalene, and 1,2,4-trimethylbenzene.
(b)
For middle
petroleum fractions, such as kerosene, diesel fuel, or jet fuel, the volunteer
shall analyze environmental media 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, the volunteer shall analyze environmental
media 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. Where the heavy petroleum is used motor oil, used
cutting oil, or hydraulic oil, the volunteer shall identify additional COCs
that may be typical impurities of the used heavy petroleum fractions product,
and the volunteers shall include such COCs in the analysis, as
appropriate.
(d)
For releases of automotive gasoline formulated before
January 1, 1996, racing fuel, or aviation gasoline, the volunteer shall analyze
environmental media for the constituents listed in paragraph (C)(1)(a) of this
rule as well as 1,2-dichloroethane and 1,2-dibromoethane (ethylene
dibromide).
(e)
For petroleum from an unknown source, the volunteers
shall analyze environmental media 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. The volunteer shall identify additional COCs that may
be typical impurities of used petroleum fractions, and the volunteer shall
include such additional COCs in the analysis, as appropriate.
(2)
Evaluation of compliance with applicable standards. The concentrations of COCs
evaluated in accordance with paragraph (D)(3)(a) of this rule on or from the
property shall meet applicable standards for the media and exposure pathways
evaluated. As appropriate, the volunteer shall evaluate applicable standards
for petroleum and petroleum's constituents or impurities in the following
manner:
(a)
The
volunteer shall conduct a human health property-specific risk assessment that
includes derivation of applicable standards in accordance with paragraph (D) of
this rule, or shall use generic numerical standards provided in rule
3745-300-08
of the Administrative Code. The volunteer may use generic numerical standards
for the exposure pathways included in rule
3745-300-08
of the Administrative Code. The volunteer shall evaluate other exposure
pathways in accordance with paragraph (D) of this rule. The volunteer shall
conduct an evaluation of cumulative risks in accordance with paragraphs (B) and
(D)(3)(d) of this rule.
(b)
The volunteer shall determine soil saturation
concentrations of total petroleum hydrocarbons 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 shall meet the residual saturation concentration in table I
of this rule.
Table I: Total petroleum hydrocarbon soil saturation concentration (values are in milligrams per kilogram)
|
Residual Saturation Concentrations for: |
|||
|
Sand and Gravel; Unknown Soil Type |
Silty or 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 (C20 - C34) |
5,000 |
20,000 |
40,000 |
|
Where 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 shall
meet the appropriate ground water response requirements in accordance with rule
3745-300-10
of the Administrative Code.
(d)
The volunteer
shall evaluate sediment, surface water, and ecological exposure pathways in
accordance with 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 shall demonstrate that the concentrations of COCs 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 shall 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 COCs and are consistent with rule
3745-300-11 of the
Administrative Code.
(c)
The use of institutional controls including, without
limitation, activity and use limitations in the environmental covenant.
Institutional controls shall meet the following criteria:
(i)
Be effective at
eliminating or mitigating exposures to all receptor populations sufficient to
meet the risk and hazard levels 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 shall 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 is 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 COCs
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)
As identified following the procedures under rules
3745-300-06
and
3745-300-07
of the Administrative Code, the physical characteristics of the property or
properties 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 shall include, at a
minimum, topography, climate, native soils and fill material characteristics,
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 COCs 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 shall include
the relative concentrations of the COCs in identified areas on the
property.
(3)
The
property-specific risk assessment is comprised of four parts: selection of
chemicals of concern, exposure assessment, toxicity assessment, and
characterization of risk. These four parts are as follows:
(a)
Selection of
COCs. Hazardous substances or petroleum identified on or from the property are
considered COCs and the volunteer shall evaluate such COCs pursuant to all the
appropriate risk assessment calculations and methods referenced in paragraph
(D)(3) of this rule if such hazardous substances or petroleum fall into one of
the following categories:
(i)
Do not meet the applicable standards established for
background pursuant to paragraph (H) of rule
3745-300-07
of the Administrative Code.
(ii)
Do not
constitute contamination in de minimis or previously addressed areas pursuant
to paragraph (E) of rule
3745-300-06
of the Administrative Code.
(iii)
Cannot be
removed from the list of COCs pursuant to paragraph (F) (5)(f) of rule
3745-300-07
of the Administrative Code.
(b)
Exposure
assessment. The exposure assessment shall determine the reasonably anticipated
magnitude, frequency, duration, and routes of exposure. The exposure assessment
shall include consideration of 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 shall evaluate the risk and hazard potential to all receptor
populations as identified in paragraph (E)(6) of rule
3745-300-07
of the Administrative Code that are reasonably anticipated to be exposed to
COCs on or from the property. The exposure assessment shall evaluate
populations for the magnitude and frequency of exposure for each exposure
period.
(ii)
Evaluation of exposure pathways, as follows:
(a)
The
property-specific exposure assessment shall evaluate all complete exposure
pathways in accordance with paragraph (F)(1) of rule
3745-300-07
of the Administrative Code.
(b)
The exposure
assessment shall include a written justification for all exposure pathways
eliminated or mitigated through the use of institutional controls or
engineering controls. The written justification shall include a description of
the efficacy of such controls. The volunteer shall implement the described
institutional controls or engineering controls in accordance with rules
3745-300-11 and
3745-300-13
of the Administrative Code.
(c)
The volunteer
shall evaluate complete exposure pathways in accordance with the procedures in
the following sources, as incorporated by reference in rule
3745-300-15
of the Administrative Code:
(i)
U.S. EPA's "Risk Assessment Guidance for Superfund
(RAGs), Volume I: Human Health Evaluation Manual (Part A)."
(ii)
U.S. EPA's "Risk
Assessment Guidance for Superfund (RAGs), Volume I: Human Health Evaluation
Manual (Part E, Supplemental Guidance for Dermal Risk
Assessment."
(iii)
U.S. EPA's "Risk Assessment Guidance for Superfund
(RAGs), Volume I: Human Health Evaluation Manual (Part F, Supplemental Guidance
for Inhalation Risk Assessment)."
(iv)
U.S. EPA's
"Exposure Factors Handbook," 2011 Edition and 2017 Chapter 5
updates.
(v)
U.S. EPA's "Human Health Evaluation Manual,
Supplemental Guidance: Standard Default Exposure Factors."
(iii)
Quantification of chemical-specific intake. The
volunteer shall calculate chemical-specific intakes 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 COCs 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.
(a)
The volunteer
shall calculate the chemical-specific intakes using formulas identified in the
following sources, as incorporated by reference in rule
3745-300-15
of the Administrative Code:
(i)
U.S. EPA's "Risk Assessment Guidance for Superfund
(RAGs), Volume I: Human Health Evaluation Manual (Part A)."
(ii)
U.S. EPA's "Risk
Assessment Guidance for Superfund (RAGs), Volume I: Human Health Evaluation
Manual (Part E, Supplemental Guidance for Dermal Risk
Assessment."
(iii)
U.S. EPA's "Risk Assessment Guidance for Superfund
(RAGs), Volume I: Human Health Evaluation Manual (Part F, Supplemental Guidance
for Inhalation Risk Assessment)."
(iv)
U.S. EPA's
"Exposure Factors Handbook," 2011 Edition and 2017 Chapter 5
updates.
(v)
U.S. EPA's "Human Health Evaluation Manual,
Supplemental Guidance: Standard Default Exposure Factors."
(vi)
Ohio EPA's
"Support Document for the Development of Generic Numerical Standards and Risk
Assessment Procedures."
(b)
The volunteer
shall determine the numerical values for the exposure factor terms in formulas
in accordance with paragraphs (D)(3)(b)(iii)(c) and (D)(3)(b)(iii)(d) of this
rule.
(c)
Exposure factors.
(i)
The volunteer
shall determine the exposure factor values either as point values or as the
output value from a probabilistic simulation of twenty thousand or more
iterations which solve for the chemical-specific intake equation. A
probabilistic simulation output value for the intake shall be the ninetieth per
centile or greater value.
(ii)
For risk-derived
unrestricted potable use ground water, the volunteer shall obtain exposure
factor values using the reasonable maximum exposure point values 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 appendix A to rule
3745-300-08
of the Administrative Code. Distributions developed by the volunteer shall
adequately describe the parameter in question following U.S. EPA's "Risk
Assessment Guidance for Superfund (RAGs), Volume I: Human Health Evaluation
Manual (Part A)."
(iii)
For all other pathways, the volunteer shall obtain the
exposure factor values using one of the following methods:
(A)
Exposure factor
values not determined from property-specific information. For exposure factors
represented by a point value, these values shall 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
shall 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 volunteer shall derive the
probability distributions using guidance in U.S. EPA's "Risk Assessment
Guidance for Superfund (RAGs), Volume III Part A: Process for Conducting a
Probabilistic Risk Assessment."
(B)
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 shall reasonably represent the
upper bound value or central tendency value from a distribution of
property-specific data, as appropriate. Exposure factor values shall be
consistent with an estimate of upper-bound exposures as described in U.S. EPA's
"Risk Assessment Guidance for Superfund (RAGs), 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 shall 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 property-specific exposure factor
distributions, shall meet the criteria for property-specific data described in
paragraph (D)(3)(b)(iv) of this rule.
(d)
Exposure point
concentration. The volunteer shall determine exposure point concentrations for
each complete exposure pathway and shall represent the concentration of COCs
from each of the identified areas or exposure units. This representation of
exposure point concentration shall be consistent with concentrations of the
COCs 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)(c) of this rule.
(iv)
Criteria for use of property-specific data.
Property-specific data used in the identification of receptor populations
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, shall meet the following criteria:
(a)
The volunteer
shall collect property-specific physical data 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 populations shall
be representative of the reasonably anticipated land use category and the
actual property characteristics, and shall be included in an institutional
control or engineering control that complies with 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 shall be
consistent with property-specific conditions.
(c)
Toxicity
assessment.
(i)
Information hierarchy. The volunteer shall obtain the
toxicity information used in a property-specific risk assessment from the
following hierarchy:
(a)
U.S. EPA toxicity values [i.e., "Integrated Risk
Information System" (IRIS)]. The volunteer shall obtain the most current
toxicity information from the IRIS for COCs that are 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 in the IRIS, or is not listed in Ohio
EPA's "Support Document for the Development of Generic Numerical Standards and
Risk Assessment Procedures," the volunteer shall consult Ohio EPA to obtain
appropriate toxicity information.
(ii)
Absorption
factors and adjustment of toxicity values, as follows:
(i)
Information
hierarchy. The volunteer shall obtain the toxicity information used in a
property-specific risk assessment from the following hierarchy:
(a)
U.S. EPA toxicity
values [i.e., "Integrated Risk Information System" (IRIS)]. The volunteer shall
obtain the most current toxicity information from the IRIS for COCs that are
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 in the IRIS, or is not listed in Ohio
EPA's "Support Document for the Development of Generic Numerical Standards and
Risk Assessment Procedures," the volunteer shall consult Ohio EPA to obtain
appropriate toxicity information.
(ii)
Absorption
factors and adjustment of toxicity values, as follows:
(a)
The volunteer
shall evaluate 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 COCs 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 (RAGs), Volume I: Human Health Evaluation
Manual (Part A)," and U.S. EPA's "Risk Assessment Guidance for Superfund
(RAGs), Volume I: Human Health Evaluation Manual (Part E, Supplemental Guidance
for Dermal Risk Assessment)."
(b)
The volunteer
shall perform the risk characterization in accordance with the procedures
described in paragraph (D) (3)(d) of this rule so that chemical-specific intake
and toxicity values are both expressed as the absorbed dose or both expressed
as the administered dose.
(c)
The volunteer shall obtain default and
chemical-specific absorption factor and bioavailability values in accordance
with U.S. EPA's "Risk Assessment Guidance for Superfund (RAGs), Volume I: Human
Health Evaluation Manual (Part A)," and U.S. EPA's "Risk Assessment Guidance
for Superfund (RAGs), 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 shall
integrate the exposure and toxicity assessments in order to quantitatively
determine the risk or hazard posed by the COCs on or from the property. The
risk characterization shall evaluate carcinogenic risks and non-carcinogenic
hazard separately.
(i)
Cancer risk
characterization. The volunteer shall estimate cancer risks as an incremental
probability of an individual member of a receptor population developing cancer
over a lifetime as a result of exposure to carcinogenic COCs on or from the
property; hereafter, this estimation of cancer risk is referred to as
incremental cancer risk. The volunteer shall calculate separately an
incremental cancer risk, 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 shall
not exceed the applicable carcinogenic risk goal in paragraph (B)(1) of this
rule. An estimate of incremental cancer risk is calculated as follows:
(a)
A volunteer shall
determine incremental cancer risk in accordance with the procedures described
in this rule and in U.S. EPA's "Risk Assessment Guidance for Superfund (RAGs),
Volume I: Human Health Evaluation Manual (Part A)" for each carcinogenic COC
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 COC, the volunteer shall calculate separately, as appropriate, the
cumulative incremental cancer risk posed by these multiple COCs, for each
complete exposure pathway in accordance with the procedures described in U.S.
EPA's "Risk Assessment Guidance for Superfund (RAGs), 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 volunteer shall calculate the cumulative incremental
cancer risk posed by an estimate based on the complete exposure pathways 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 (RAGs), Volume I:
Human Health Evaluation Manual (Part A)."
(ii)
Noncancer hazard
characterization. The volunteer shall calculate a hazard index value to
determine the exposure which is not likely to cause noncancer adverse health
effects posed by COCs 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. The volunteer shall calculate
a separate hazard index 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)
The volunteer shall calculate a hazard quotient for each COC 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 (RAGs), Volume
I: Human Health Evaluation Manual (Part A)."
(b)
If the volunteer
determines hazard quotient values representing noncancer hazards for one
receptor population over a specified exposure period for more than one COC as
described in paragraph (D)(3)(d)(ii)(a) of this rule, the volunteer shall
calculate separately, as appropriate, the cumulative noncancer hazards posed by
these COCs 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 (RAGs), Volume I: Human Health Evaluation Manual (Part
A)." The volunteer may perform separate hazard index calculations based on the
consideration of major non-carcinogenic toxic endpoints, which shall include,
at a minimum, those toxic endpoints identified with the critical effect upon
which the reference dose or reference concentration is based, for each
non-carcinogenic COC. The volunteer shall submit a written justification for
separate hazard index calculations in the property-specific risk assessment
report.
(c)
If the volunteer determines hazard index values
representing noncancer hazard for one receptor population over a specified
exposure period for more than one complete exposure pathway, the volunteer
shall calculate cumulative noncancer hazard posed by one or more complete
exposure pathways, 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 (RAGs), Volume I: Human Health Evaluation Manual (Part
A)." Exclusion of one or more non-carcinogenic COCs 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 non-carcinogenic COCs associated with each complete exposure pathway
considered in accordance with this paragraph.
(iii)
Uncertainty
analysis. The volunteer shall evaluate uncertainty associated with the
property-specific risk assessment. The uncertainty analysis shall include a
qualitative description or quantitative evaluation of uncertainty associated
with any of the following:
(a)
Selection of COCs and the exposure point
concentration.
(b)
Estimates of chemical-specific intake
factors.
(c)
Complete exposure pathways.
(d)
Toxicity
criteria.
(e)
Additive or antagonistic effects of exposure to
multiple COCs through one or more complete exposure pathways.
(f)
Evaluation of
site-specific, epidemiological, or health studies.
(E) Procedures for ecological risk assessment.
(1)
For each complete exposure pathway to IERs from
environmental media that contain COCs that are persistent, bioaccumulative, and
toxic, the volunteer shall evaluate the environmental media using a food web
model in accordance with Ohio EPA's "Ecological Risk Assessment Guidance
Document," as incorporated by reference in rule
3745-300-15
of the Administrative Code. Further assessment is not needed if concentrations
of COCs in sediment or surface water do not exceed the following:
(a)
Ohio-specific
metal sediment reference values by ecoregion in table I of appendix B to rule
3745-300-08
of the Administrative Code.
(b)
Consensus-based
threshold effect concentrations in "Development and Evaluation of
Consensus-based Sediment Quantity Guidelines for Freshwater Ecosystems," as
incorporated by reference in rule 3745-300-15 of the Administrative Code. These
values are in table II of appendix B to rule
3745-300-08
of the Administrative Code.
(c)
Surface water
standards provided in Chapter 3745-1 of the Administrative Code, in accordance
with paragraph (F)(2)(a) of rule
3745-300-08
of the Administrative Code, for all releases or source areas of hazardous
substances on or from the property to surface waters of the
state.
(2)
If COCs are present for which there are no reference
values in accordance with paragraph (E)(1) of this rule, then the volunteer
shall determine such values in consultation with Ohio EPA.
(a)
If concentrations
of COCs do not exceed reference values, then no further evaluation is
necessary.
(b)
If concentrations exceed reference values, then the
following apply:
(i)
A qualitative property-specific ecological risk
assessment may be appropriate, and the volunteer may conduct a qualitative
property-specific ecological risk assessment in order to demonstrate that COCs
on or from a property are not harmful to IERs in cases where toxicity is likely
to be low based on the concentrations of such COCs, the land use, the habitat
quality, contributions from upstream anthropogenic inputs, and the areal extent
of the habitat.
(ii)
The volunteer shall conduct a quantitative
property-specific ecological risk assessment in accordance with Ohio EPA's
"Ecological Risk Assessment Guidance Document" if complete exposure pathways
from environmental media other than surface water or sediment exist to IERs and
the provisions in paragraph (E) (1) or (E)(2) of this rule do not
apply.
(3)
The volunteer
shall collect data to assess ecological risk for both qualitative and
quantitative ecological property-specific risk assessments in accordance with
rule
3745-300-07
of the Administrative Code.
(F) Procedures for assessment and remediation of sediments.
(1)
For each complete
human health exposure pathway from source areas on the property to sediments,
the volunteer shall determine if concentrations of COCs in sediments meet
applicable standards in accordance with paragraph (G) of rule
3745-300-08
of the Administrative Code, or shall conduct a human health property-specific
risk assessment following the methodology provided in paragraph (D) of this
rule.
(2)
For purposes of this rule and rule
3745-300-07
of the Administrative Code, an exposure pathway to humans is considered to
exist if both of the following apply:
(a)
The surface water
which contains the sediments produces or can produce a consistent supply of
edible-sized fish.
(b)
COCs that are persistent, bioaccumulative, and toxic
are present in the sediment or the surface water.
(3)
An exposure
pathway to humans is considered to exist if the surface water which contains
the sediments is reasonably anticipated to support recreational activities such
as wading, fishing, swimming, and boating.
(4)
For each complete
exposure pathway from sediments to IERs where applicable standards determined
in accordance with paragraph (H)(2) of rule
3745-300-08
of the Administrative Code are not met or sediment samples are not compared to
the appropriate values in accordance with paragraph (H) of rule
3745-300-08
of the Administrative Code, the volunteer shall 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, the volunteer shall conduct a biological survey. The
biological survey shall include the following:
(i)
The volunteer
shall use a fish and physical habitat survey 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. To accomplish this, the
volunteer shall follow the procedures in "Biological Criterial for the
Protection of Aquatic Life" (hereinafter in this rule referred to as the
"biocriteria manual") and Ohio EPA's division of surface water "Manual of Ohio
EPA Surveillance Methods and Quality Assurance Practices," as both documents
are incorporated by reference in rule
3745-300-15
of the Administrative Code. If possible, the sampling locations for the fish
and physical habitat survey shall include the same locations where sediment
samples are collected.
(ii)
The volunteer shall use a quantitative
macroinvertebrate survey to calculate the invertebrate community index for the
surface waters. To accomplish this, the volunteer shall follow the biocriteria
manual unless the water body does not have sufficient depth and flow to conduct
a quantitative macroinvertebrate study. If the water body does not have
sufficient depth and flow to conduct a quantitative macroinvertebrate study,
the volunteer shall conduct a qualitative macroinvertebrate study using 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. If possible, the sampling locations for the
quantitative macroinvertebrate survey shall include the same locations
established where sediment samples are collected.
[Comment: If the volunteer conducts a qualitative macroinvertebrate study, Ohio EPA recommends that the volunteer consult Ohio EPA 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, the volunteer shall conduct sediment bioassays using sediment
samples taken from the surface waters to evaluate sediment toxicity. The
volunteer shall determine sediment bioassay sampling locations in accordance
with this rule and rule
3745-300-07
of the Administrative Code. At a minimum, sediment bioassays shall include the
ten-day survival and growth test for Hyalella azteca and Chironomus tentans
following the procedures in U.S. EPA's "Methods for Measuring the Toxicity and
Bioaccumulation of Sediment-associated Contaminants with Freshwater
Invertebrates," as incorporated by reference in rule
3745-300-15
of the Administrative Code. Chironomus riparius may be substituted for
Chironomus tentans if necessary.
(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 shall either conduct a use attainability
analysis as detailed in the biocriteria manual to assign the appropriate
aquatic life use designation, or shall apply biocriteria for warm-water
habitat. The volunteer shall consult Ohio EPA for assistance to make a
determination on an aquatic life use designation for an unlisted water
body.
(5)
Unless concentrations of COCs in sediments meet
applicable standards in accordance with paragraph (H) 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 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, the volunteer shall
determine the applicable standards in accordance with the water quality
standards established or developed under the 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, the general water quality criteria, water use designations and statewide water quality criteria, the criteria provided for the applicable drainage basin, the site-specific modifications to criteria and values, and 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 U.S. EPA's
"Methods for Measuring the Toxicity and Bioaccumulation of Sediment-associated
Contaminants with Freshwater Invertebrates."
(6)
The volunteer
shall take the following actions when applicable standards for sediments are
not met in accordance with paragraphs (F)(5)(a) and (F)(5)(b) of this
rule:
(a)
Submit a written demonstration to be in a risk assessment report or a section
of the phase II property assessment under paragraph (I) of this rule that
substantiates the determination that hazardous substances or petroleum on or
from the property did not cause the failure to meet the applicable standards in
paragraph (F)(5) of this rule, taking into consideration upstream sources not
related to releases from the property. Applicable standards for sediment are
met if the volunteer demonstrates that hazardous substances or petroleum on or
from the property are not contributing to the failure to meet the applicable
standards in paragraph (F)(5) of this rule.
(b)
Implement a
remedy conducted in accordance with rule
3745-300-11 of the
Administrative Code to meet applicable standards.
(7)
The volunteer may
conduct a bioassay or biosurvey in accordance with paragraph (F) of this rule
instead of applying paragraph (H)(1) of rule
3745-300-08
of the Administrative Code. If sediment bioassay or biosurvey does not
demonstrate full compliance with applicable standards, the volunteer shall
conduct sediment sampling according to rule 3745-300-07 of the Administrative
Code in order to determine the concentrations of COCs in sediments.
(8)
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 are met, provided that the data are not collected more than ten years
prior to the issuance of the no further action letter. Prior to the inclusion
of historical data within an applicable standards demonstration, volunteers
shall consider any changes in the watershed, release history, property
characteristics, or knowledge of recent data collection.
(G) Surface water assessment. If concentrations of COCs in surface water exceed applicable standards in accordance with paragraph (F)(2)(a) of rule 3745-300-08 of the Administrative Code, then the standards for surface water in paragraphs (E) and (F)(5) of this rule are applicable.
(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 COCs which meet the risk and hazard
levels for human health in accordance with paragraphs (B) and (C) of this rule
and in accordance with paragraphs (D) and (F) of this rule.
(2)
Concentrations of
COCs that protect IERs in accordance with 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 shall use the following equation, along with
property-specific information, to calculate a property-specific soil saturation
concentration:
(a)
The volunteer shall obtain all chemical-specific values
for the above equation from one of the following sources:
(i)
Ohio EPA's
"Support Document for the Development of Generic Numerical Standards and Risk
Assessment Procedures."
(ii)
If chemical-specific values for the above equation are
not available in the sources listed above, contact Ohio EPA to determine other
appropriate values.
(b)
The volunteer
shall obtain physical values 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 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 shall present the information in a risk assessment report or in a section of the phase II property assessment. The volunteer shall prepare a risk assessment and shall include, 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 shall demonstrate the efficacy of those
controls.
(3)
A list of the COCs on or from the property which are
not considered in the property-specific risk assessment because the COCs meet
the criteria under paragraph (D)(3)(a) of this rule and a written
demonstration, which includes 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 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 are 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.
Replaces: 3745-300-09
Disclaimer: These regulations may not be the most recent version. Ohio may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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