Source: https://www.law.cornell.edu/cfr/text/40/appendix-D_to_part_132
Timestamp: 2017-01-19 22:02:21
Document Index: 649495555

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40 CFR Appendix D to Part 132, Great Lakes Water Quality Initiative Methodology for the Development of Wildlife Criteria | US Law | LII / Legal Information Institute
CFR › Title 40 › Chapter I › Subchapter D › Part 132 › Appendix D_to_part_132 40 CFR Appendix D to Part 132, Great Lakes Water Quality Initiative Methodology for the Development of Wildlife Criteria
Appendix D to Part 132 - Great Lakes Water Quality Initiative Methodology for the Development of Wildlife Criteria
D. The term “wildlife value” (WV) is used to denote the value for each representative species which results from using the equation presented below, the value obtained from averaging species values within a class, or any value derived from application of the site-specific procedure provided in procedure 1 of appendix F of this part. The WVs calculated for the representative species are used to calculate taxonomic class-specific WVs. The WV is the concentration of a substance which, if not exceeded, should better protect the taxon in question. E. “Tier I wildlife criterion,” or “Tier I criterion” is used to denote the number derived from data meeting the Tier I minimum database requirements, and which will be protective of the two classes of wildlife. It is synonymous with the term “GLWC,” and the two are used interchangeably. II. Calculation of Wildlife Values for Tier I Criteria Table 4 of Part 132 and Table D-1 of this appendix contain criteria calculated by EPA using the methodology provided below. A. Equation for Avian and Mammalian Wildlife Values. Tier I wildlife values for the pollutants designated BCCs pursuant to part 132 are to be calculated using the equation presented below.
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. BAF
WLTLi = Bioaccumulation factor (BAF) for wildlife food in trophic level i in liters per kilogram (L/kg), developed using the BAF methodology in appendix B to part 132, Methodology for Development of Bioaccumulation Factors. For consumption of piscivorous birds by other birds (e.g., herring gull by eagles), the BAF is derived by multiplying the trophic level 3 BAF for fish by a biomagnification factor to account for the biomagnification from fish to the consumed birds.
B. Identification of Representative Species for Protection. For bioaccumulative chemicals, piscivorous species are identified as the focus of concern for wildlife criteria development in the Great Lakes. An analysis of known or estimated exposure components for avian and mammalian wildlife species is presented in the Wildlife TSD. This analysis identifies three avian species (eagle, kingfisher and herring gull) and two 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 representative species. C. Calculation of Avian and Mammalian Wildlife Values and GLWC Derivation. The avian WV is the geometric mean of the WVs calculated for the three representative avian species. The mammalian WV is the geometric mean of the WVs calculated for the two representative mammalian species. The lower of the mammalian and avian WVs must be selected as the GLWC. III. Parameters of the Effect Component of the Wildlife Criteria Methodology A. Definitions. The following definitions provide additional specificity and guidance in the evaluation of toxicity data and the application of this methodology. Acceptable endpoints. For the purpose of wildlife criteria derivation, acceptable subchronic and chronic endpoints are those which affect reproductive or developmental success, organismal viability or growth, or any other endpoint which is, or is directly related to, parameters that influence population dynamics. Chronic effect. An adverse effect that is measured by assessing an acceptable endpoint, and results from continual exposure over several generations, or at least over a significant part of the test species' projected life span or life stage. Lowest-observed-adverse-effect-level (LOAEL). The lowest tested dose or concentration of a substance which resulted in an observed adverse effect in exposed test organisms when all higher doses or concentrations resulted in the same or more severe effects. No-observed-adverse-effect-level (NOAEL). The highest tested dose or concentration of a substance which resulted in no observed adverse effect in exposed test organisms where higher doses or concentrations resulted in an adverse effect. Subchronic effect. An adverse effect, measured by assessing an acceptable endpoint, resulting from continual exposure for a period of time less than that deemed necessary for a chronic test. B. Minimum Toxicity Database for Tier I Criteria Development. A 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. In reviewing the toxicity data available which 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. 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 document. 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. 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 which are applied. When evaluating the studies from which a test dose is derived in general, the following requirements must be met:
a. F = 0.0687 × (Wt)
b. W = 0.099 × (Wt)
a. F = 0.0582 (Wt)
b. W = 0.059 × (Wt)
F. LOAEL to NOAEL Extrapolations (UFL). 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 and should not exceed 10, depending on the dose-response curve and any other available data, and is represented by UFL in the equation expressed in Section II.A of this appendix. Guidance for selecting an appropriate UFL, based on a review of available wildlife toxicity data, is available in the Wildlife TSD.
G. Subchronic to Chronic Extrapolations (USS). 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 and should not exceed 10, and is represented by UFS in the equation expressed in Section II.A of this appendix. This factor is to be used when assessing highly bioaccumulative substances where toxicokinetic considerations suggest that a bioassay of limited length underestimates chronic effects. Guidance for selecting an appropriate UFS, based on a review of available wildlife toxicity data, is available in the Wildlife TSD.
H. Interspecies Extrapolations (UFA). 1. 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. Guidance for selecting an appropriate UFA, based on a review of available wildlife toxicity data, is available in the Wildlife TSD. Additional discussion of an interspecies UF located in appendix A to the Great Lakes Water Quality Initiative Technical Support Document for Human Health Criteria may be useful in determining the appropriate value for UFA.
Table D-1 - Tier I Great Lakes Wildlife Criteria
Substance Criterion (µg/L) DDT & Metabolites
Table D-2 - Exposure Parameters for the Five Representative Species Identified for Protection
Trophic level of prey (percent of diet) Mink
Fish: 90 - TL3: 80; TL4: 20.
Fish: 92 - TL3: 80; TL4: 20.
Birds: 8 - PB: 70; non-aquatic: 30.
Note: TL3 = trophic level three fish; TL4 = trophic level four fish; PB = piscivorous birds; Other = non-aquatic birds and mammals.