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Indiana Administrative Code (Last Updated: December 20, 2016) |
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Title 327. WATER POLLUTION CONTROL DIVISION |
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Article 327IAC2. WATER QUALITY STANDARDS |
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Rule 327IAC2-1.5. Water Quality Standards Applicable to All State Waters Within the Great Lakes System |
Section 327IAC2-1.5-15. Determination of wildlife criteria
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(a) This section establishes a procedure that is required when developing Tier I wildlife criteria for bioaccumulative chemicals of concern (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 shall be used to calculate wildlife values for Tier I criteria:
(1) Tier I wildlife values are to be calculated using the following equation:
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 shall be either a NOAEL or a LOAEL.
UFA
=
Uncertainty factor (UF) for extrapolating toxicity data across species (unitless). A species-specific UF shall 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.
BAFi
=
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 Great Lakes wildlife criteria (GLWC).
(c) The following procedures shall 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 shall provide enough data to generate a subchronic or chronic dose response curve for any given substance for both mammalian and avian species.
(A) In reviewing the toxicity data available that meet the minimum data requirements for each taxonomic class, the following order of preference shall 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 such 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 shall 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 shall 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.
(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, shall 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 shall 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 shall 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) shall 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 shall 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 shall 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 shall 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 shall 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, 1993), shall 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 shall be divided by an UF to estimate a NOAEL for use in deriving WVs. The value of the UF shall 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 such cases, the TD shall be divided by an UF to extrapolate from subchronic to chronic levels. The value of the UF shall 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 shall be used to determine an uncertainty factor for interspecies extrapolations (UFA):
(A) The selection of the UFA shall 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 an UF that is intended to account for differences in toxicological sensitivity among species.
(B) For the derivation of Tier I criteria, a UFA shall not be less than one (1) and should not exceed one hundred (100), and shall 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 shall 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 shall 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 shall 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
Other: 0.0177
TL3: 90%
Other: 10%
Otter
7.4
0.600
TL3: 0.977
TL4: 0.244
TL3: 80%
TL4: 20%
Kingfisher
0.15
0.017
TL3: 0.0672
TL3: 100%
Herring gull
1.1
0.063
TL3: 0.192
TL4: 0.0480
Other: 0.0267
Fish: 90%
TL3: 80%
TL4: 20%
Other: 10%
Bald eagle
4.6
0.160
TL3: 0.371
TL4: 0.0929
PB: 0.0283
Other: 0.0121
Fish: 92%
TL3: 80%
TL4: 20%
Birds: 8%
PB: 70%
nonaquatic: 30%
TL3
=
trophic level three fish
TL4
=
trophic level four fish
PB
=
piscivorous birds
Other
=
nonaquatic birds and mammals
(Water Pollution Control Division; 327 IAC 2-1.5-15; filed Jan 14, 1997, 12:00 p.m.: 20 IR 1404; errata filed Aug 11, 1997, 4:15 p.m.: 20 IR 3378)