Sec. 15.
(a) This
section establishes a procedure that is required when developing Tier I
wildlife criteria for BCCs as follows:
(1)
This method may be used for the development of Tier I criteria or Tier II
values for pollutants other than BCCs for which the commissioner determines:
(A) Tier I criteria or Tier II values are
necessary for the protection of wildlife in the Great Lakes basin;
and
(B) that this method is
applicable to the pollutant.
(2) In the event that this procedure is used
to develop criteria for pollutants other than BCCs, the procedure for deriving
bioaccumulation factors under section 13 of this rule must be used. For
chemicals that do not biomagnify to the extent of BCCs, it may be appropriate
to select different representative species that are better examples of species
with the highest exposures for the given chemical. In addition, section 16 of
this rule describes the procedures for calculating site-specific wildlife
criteria.
(b) The
following procedures must be used to calculate wildlife values for Tier I
criteria:
(1) Tier I wildlife values are to
be calculated using the following equation:
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Where: WV = Wildlife value in milligrams of substance per
liter (mg/L).
TD = Test dose (TD) in milligrams of substance per kilograms
per day (mg/kg/d) for the test species. This must be either a NOAEL or a
LOAEL.
UFA = Uncertainty factor (UF) for
extrapolating toxicity data across species (unitless). A species-specific UF
must be selected and applied to each representative species, consistent with
the equation.
UFS = UF for extrapolating from
subchronic to chronic exposures (unitless).
UFL = UF for LOAEL to NOAEL
extrapolations (unitless).
Wt = Average weight in kilograms (kg) for the representative
species.
W = Average daily volume of water consumed in liters per day
(l/d) by the representative species.
FTLi = Average daily amount of food
consumed from trophic level i in kilograms per day (kg/d) by the representative
species.
BAFTLiWL =
Bioaccumulation factor (BAF) for wildlife food in trophic level i in liters per
kilogram (l/kg), developed using the BAF methodology in section 13 of this
rule. For consumption of piscivorous birds by other birds, for example, herring
gull by eagles, the BAF is derived by multiplying the trophic level three (3)
BAF for fish by a biomagnification factor to account for the biomagnification
from fish to the consumed birds.
(2) For bioaccumulative chemicals,
piscivorous species are identified as the focus of concern for wildlife
criteria development in the Great Lakes. This methodology identifies three (3)
avian species (eagle, kingfisher, and herring gull) and two (2) mammalian
species (mink and otter) as representative species for protection. The TD
obtained from toxicity data for each taxonomic class is used to calculate WVs
for each of the five (5) representative species.
(3) The avian WV is the geometric mean of the
WVs calculated for the three (3) representative avian species. The mammalian WV
is the geometric mean of the WVs calculated for the two (2) representative
mammalian species. The lower of the mammalian and avian WVs must be selected as
the GLWC.
(c) The
following procedures must be used to obtain the parameters of the effect
component of the wildlife criteria procedure:
(1) A test dose (TD) value is required for
criterion calculation. To derive a Tier I criterion for wildlife, the data set
must provide enough data to generate a subchronic or chronic dose response
curve for any given substance for both mammalian and avian species as follows:
(A) In reviewing the toxicity data available
that meet the minimum data requirements for each taxonomic class, the following
order of preference must be applied to select the appropriate TD to be used for
calculation of individual WVs:
(i) Data from
peer-reviewed field studies of wildlife species take precedence over other
types of studies, where the studies are of adequate quality. An acceptable
field study must be of subchronic or chronic duration, provide a defensible,
chemical specific dose response curve in which cause and effect are clearly
established, and assess acceptable endpoints as defined in this rule.
(ii) When acceptable wildlife field studies
are not available, or determined to be of inadequate quality, the needed
toxicity information may come from peer reviewed laboratory studies. When
laboratory studies are used, preference must be given to laboratory studies
with wildlife species over traditional laboratory animals to reduce
uncertainties in making interspecies extrapolations.
(B) All available laboratory data and field
studies must be reviewed to corroborate the final GLWC, to assess the
reasonableness of the toxicity value used, and to assess the appropriateness of
any UFs that are applied. When evaluating the studies from which a test dose is
derived in general, the following requirements must be met:
(i) The mammalian data must come from at
least one (1) well-conducted study of ninety (90) days or greater designed to
observe subchronic or chronic effects as defined in this rule.
(ii) The avian data must come from at least
one well-conducted study of twenty-eight (28) days or greater designed to
observe subchronic or chronic effects as defined in this rule.
(iii) In reviewing the studies from which a
TD is derived for use in calculating a WV, studies involving exposure routes
other than oral may be considered only when an equivalent oral daily dose can
be estimated and technically justified because the criteria calculations are
based on an oral route of exposure.
(iv) In assessing the studies that meet the
minimum data requirements, preference should be given to studies that assess
effects on developmental or reproductive endpoints because, in general, these
are more important endpoints in ensuring that a population's productivity is
maintained.
(2) In selecting data to be used in the
derivation of WVs, the evaluation of acceptable endpoints, as defined in this
rule, will be the primary selection criterion. All data not part of the
selected subset may be used to assess the reasonableness of the toxicity value
and the appropriateness of the UFs that are applied as follows:
(A) If more than one (1) TD value is
available within a taxonomic class, based on different endpoints of toxicity,
that TD, which is likely to reflect best potential impacts to wildlife
populations through resultant changes in mortality or fecundity rates, must be
used for the calculation of WVs.
(B) If more than one (1) TD is available
within a taxonomic class, based on the same endpoint of toxicity, the TD from
the most sensitive species must be used.
(C) If more than one (1) TD based on the same
endpoint of toxicity is available for a given species, the TD for that species
must be calculated using the geometric mean of those TDs.
(3) The following exposure assumptions are
made in the determination of the TD:
(A) In
those cases in which a TD is available in units other than milligrams of
substance per kilograms per day (mg/kg/d), clauses (B) and (C) must be used to
convert the TD to the appropriate units prior to calculating a WV.
(B) If the TD is given in milligrams of
toxicant per liter of water consumed by the test animals (mg/L), the TD must be
multiplied by the daily average volume of water consumed by the test animals in
liters per day (L/d) and divided by the average weight of the test animals in
kilograms (kg).
(C) If the TD is
given in milligrams of toxicant per kilogram of food consumed by the test
animals (mg/kg), the TD must be multiplied by the average amount of food in
kilograms consumed daily by the test animals (kg/d) and divided by the average
weight of the test animals in kilograms (kg).
(4) Drinking and feeding rates must be
determined as follows:
(A) When drinking and
feeding rates and body weight are needed to express the TD in milligrams of
substance per kilograms per day (mg/kg/d), they are obtained from the study
from which the TD was derived. If not already determined, body weight and
drinking and feeding rates are to be converted to a wet weight basis.
(B) If the study does not provide the needed
values, the values must be determined from appropriate scientific literature.
When scientific literature does not contain exposure information for the
species used in a given study, either the allometric equations which are
presented in clauses (C) and (D), or the exposure estimation methods presented
in Chapter 4 of the Wildlife Exposure Factors Handbook (U.S. EPA,
EPA/600/R-93/187a and b, December 1993)*, must be applied to approximate the
needed feeding or drinking rates. The choice of the methods described in this
clause is at the discretion of the commissioner.
(C) For mammalian species, the general
allometric equations are:
(i) F =
(0.0687)(Wt)0.82
Where: F = Feeding rate of mammalian species in kilograms per
day (kg/d) dry weight.
Wt = Average weight in kilograms (kg) of the test
animals.
(ii) W =
(0.099)(Wt)0.90
Where: W = Drinking rate of mammalian species in liters per
day (L/d). Wt = Average weight in kilograms (kg) of the test animals.
(D) For avian species,
the general allometric equations are:
(i) F =
(0.0582)(Wt)0.65
Where: F = Feeding rate of avian species in kilograms per day
(kg/d) dry weight.
Wt = Average weight in kilograms (kg) of the test
animals.
(ii) W =
(0.059)(Wt)0.67
Where: W = Drinking rate of avian species in liters per day
(L/d).
Wt = Average weight in kilograms (kg) of the test
animals.
(5) In those cases in which a NOAEL is
unavailable as the TD and a LOAEL is available, the LOAEL may be used to
estimate the NOAEL. If used, the LOAEL must be divided by the UF to estimate a
NOAEL for use in deriving WVs. The value of the UF must not be less than one
(1) and should not exceed ten (10), depending on the dose-response curve and
any other available data, and is represented by UFL in
the equation expressed in subsection (b)(1).
(6) In instances where only subchronic data
are available, the TD may be derived from subchronic data. In these cases, the
TD must be divided by the UF to extrapolate from subchronic to chronic levels.
The value of the UF must not be less than one (1) and should not exceed ten
(10), and is represented by UFS in the equation
expressed in subsection (b)(1). This factor is to be used when assessing highly
bioaccumulative substances where toxicokinetic considerations suggest that a
bioassay of limited length underestimates chronic effects.
(7) The following procedure must be used to
determine an uncertainty factor for interspecies extrapolations
(UFA):
(A) The
selection of the UFA must be based on the available
toxicological data and on available data concerning the physicochemical,
toxicokinetic, and toxicodynamic properties of the substance in question and
the amount and quality of available data. This value is the UF that is intended
to account for differences in toxicological sensitivity among
species.
(B) For the derivation of
Tier I criteria, a UFA must not be less than one (1) and
should not exceed one hundred (100), and must be applied to each of the five
(5) representative species, based on existing data and best professional
judgement. The value of UFA may differ for each of the
representative species.
(C) For
Tier I wildlife criteria, the UFA must be used only for
extrapolating toxicity data across species within a taxonomic class, except as
provided in this clause. The Tier I UFA is not intended
for interclass extrapolations because of the poorly defined comparative
toxicokinetic and toxicodynamic parameters between mammals and birds. However,
an interclass extrapolation employing a UFA may be used
for a given chemical if it can be supported by a validated biologically-based
dose response model or by an analysis of interclass toxicological data,
considering acceptable endpoints, for a chemical analog that acts under the
same mode of toxic action.
(d) The following procedures must be used to
determine the parameters of the exposure component of the wildlife criteria
procedure:
(1) The body weights (Wt), feeding
rates (FTli), drinking rates (W), and trophic level
dietary composition, as food ingestion rate and percent in diet, for each of
the five (5) representative species are presented in Table 15-1 in subsection
(e).
(2) The procedure for the
determination of bioaccumulation factors is contained under section 13 of this
rule. Trophic levels three (3) and four (4) BAFs are used to derive WVs because
these are the trophic levels at which the representative species
feed.
(e) The following
exposure parameters for the five (5) representative species identified for
protection must be used:
Table 15-1
Exposure Parameters for the Five Representative Species
Identified for Protection
| Species |
Adult Body Weight (kg) |
Water Ingestion Rate (L/day) |
Food Ingestion Rate of Prey in Each Trophic Level
(kg/day) |
Trophic Level of Prey (Percent of Diet) |
| Mink |
0.80 |
0.081 |
TL3: 0.159 |
TL3: 90% |
| Other: 0.0177 |
Other: 10% |
| Otter |
7.4 |
0.600 |
TL3: 0.977 |
TL3: 80% |
| TL4: 0.244 |
TL4: 20% |
| Kingfisher |
0.15 |
0.017 |
TL3: 0.0672 |
TL3: 100% |
| Herring gull |
1.1 |
0.063 |
TL3: 0.192 |
Fish: 90% |
| TL4: 0.0480 |
TL3: 80% |
| Other: 0.0267 |
TL4: 20% Other: 10% |
| Bald eagle |
4.6 |
0.160 |
TL3: 0.371 |
Fish: 92% |
| TL4: 0.0929 |
TL3: 80% |
| PB: 0.0283 |
TL4: 20% |
| Other: 0.0121 |
Birds: 8% |
| PB: 70% |
| nonaquatic: 30% |
TL3 = trophic level three fish
TL4 = trophic level four fish
PB = piscivorous birds
Other = nonaquatic birds and mammals
*This document is incorporated by reference. Copies are
available from the U.S. Environmental Protection Agency, Office of Water
Resource Center, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, or are
available for review at the Indiana Department of Environmental Management,
Office of Legal Counsel, Indiana Government Center North, 100 North Senate
Avenue, Thirteenth Floor, Indianapolis, Indiana
46204.
