Grantee Research Project Results
2002 Progress Report: Development, Testing, and Application of Ecological and Socioeconomic Indicators for Integrated Assessment of Aquatic Ecosystems of the Atlantic Slope in the Mid-Atlantic States
EPA Grant Number: R828684Center: EAGLES - Atlantic Slope Consortium
Center Director: Brooks, Robert P.
Title: Development, Testing, and Application of Ecological and Socioeconomic Indicators for Integrated Assessment of Aquatic Ecosystems of the Atlantic Slope in the Mid-Atlantic States
Investigators: Brooks, Robert P. , Rheinhardt, Rick D. , Weller, Donald E. , O'Connor, Robert E. , Jordan, Thomas E. , Whigham, Dennis F. , Wardrop, Denice Heller , Gallegos, Charles L. , McElfish, James M. , Varnell, Lyle M. , Brinson, Mark M. , Marra, Peter P. , Shortle, James S. , Hines, Anson , Hershner, Carl , Nizeyimana, Egide , Thornton, Kent , Havens, Kirk
Current Investigators: Brooks, Robert P. , Bishop, Joseph A. , Wardrop, Denice Heller , Armstrong, Brian K. , Easterling, Mary M. , Hite, Jeremy T. , Rubbo, Jennifer , Thornton, Kent
Institution: Pennsylvania State University , East Carolina University , Atlantic Slope Consortium , Virginia Institute of Marine Science , Smithsonian Environmental Research Center
Current Institution: Pennsylvania State University , FTN Associates, Ltd
EPA Project Officer: Packard, Benjamin H
Project Period: March 1, 2001 through February 1, 2005 (Extended to February 28, 2006)
Project Period Covered by this Report: March 1, 2002 through February 1, 2003
Project Amount: $6,000,000
RFA: Environmental Indicators in the Estuarine Environment Research Program (2000) RFA Text | Recipients Lists
Research Category: Ecological Indicators/Assessment/Restoration , Water , Aquatic Ecosystems
Objective:
The overall objective of the Atlantic Slope Consortium (ASC) research project is to develop and test a set of indicators in freshwater and coastal systems that are ecologically appropriate, economically reasonable, and relevant to society. The specific objectives of this research project are to: (1) develop and test ecological and socioeconomic indicators of aquatic resource conditions, construct models that use environmental, geographic, and stressor data to predict indicator responses, and use models to link upstream watersheds and downstream estuaries; (2) develop large-scale measures for characterizing landscape attributes and land-use patterns to serve as predictors of a range of environmental conditions; and (3) deliver a nested suite of indicators to managers, where the implications of aggregating models at various scales are considered, and for which reliability is known. These objectives were restated in the project vision statement and developed collaboratively by the project team as stated below.
The ASC uses a universe of watersheds, covering a range of social choices, and asks two questions:
The vision can be expanded to encompass the following tools and concepts:
Following development and articulation of the vision statement, many of the project tasks were oriented to specific portions of this statement. This ensures that a common vision consistently is pursued throughout the project.
Progress Summary:
This is the overall report for the Atlantic Slope Consortium. Individual reports on the subprojects also will be posted on the NCER Web Site.
Preliminary Data Results. Year 2 of the ASC project was characterized by extensive field data collection, additional exploration of landscape-level indicators, socioeconomic surveys and modeling, and continued progress toward integration. These activities will be summarized below and preliminary results will be noted.
Facilitation of All-EaGLes Thematic Meeting, "Moving Towards Integration." In December 2002, the ASC facilitated the annual all-Estuarine and Great Lakes Program (EaGLes) meeting. A theme was established to focus discussions and improve the effectiveness of the annual meeting process. An analytical workshop was developed and held the entire first day of the meeting, and involved presentations on analytical methods appropriate for integration tasks. Both EaGLe members and outside experts from the U.S. Environmental Protection Agency-Science to Achieve Results (EPA-STAR) Statistical Centers were involved, resulting in a body of analytical techniques relevant to integration efforts by various EaGLe projects.
Watershed and Estuarine Data Collection and Analysis. A large amount of effort this year has been devoted to collecting field data that will allow development of a variety of site-level indicators of aquatic ecosystem health. In many cases, these measurements are being supplemented by existing data sets. Information has been collected in both estuarine and upland waters, with emphasis on the former. Sampling includes measurements of biota (e.g., fish and prey communities, benthic macroinvertebrates, birds, amphibians, vegetation) and abiotic condition (e.g., water quality, sediment, in-stream habitat). Shoreline surveys and measurement of optical properties also have been undertaken. In two North Carolina watersheds, beaver ponds are being characterized as a subclass of headwater riverine wetlands because of their importance in this area. All of the above sampling is being conducted as a series of independent but integrated studies, so not all parameters are measured for all locations.
In a separate but related effort, existing biomonitoring data, along with water chemistry and physical habitat data, have been compiled from federal, state, and other sources. Analysis of these data will supplement our ability to make cross comparisons among site-specific biological, chemical, and physical habitat data, and landscape-level geographic information system (GIS) data as predictors of ecological condition.
In a collaborative effort, representatives from each of the core ASC institutions developed and pilot tested a protocol for sampling Stream, Wetland, and Riparian (SWR) areas to yield a rapid, site-level assessment of watershed conditions that can be correlated with water quality discharge models developed for selected watersheds. GIS was used as a tool to overlay the geographic locations of existing biological sample points with a watershed classification system developed in Year 1 of the project for the purpose of selecting 20-30 representative, data-rich watersheds for intensive study. The SWR protocol will be applied in Year 3 of the project to each of the watersheds selected for intensive study. The wetland portion of the SWR assessment is being compared with an alternate, 3-level assessment developed by the Virginia Institute of Marine Sciences.
In addition to site-level indicator development, analysis of geographic data is underway on several fronts. An existing nutrient discharge model and GIS are being used to explore the efficacy of geographic data (beyond physiographic province and land use/land cover) in predicting nutrient discharges. Information about the spatial arrangement of landscape features, particularly source areas and riparian forests, also is being incorporated. This modeling will allow linkages between geographic data and water chemistry data, and ultimately, biological condition.
We continue to pursue unique statistical methodologies to explore relationships between landscape and site-specific data, and how these relationships change across a variety of spatial scales. Collaboration between statisticians and ecologists occurred in a series of weekly meetings during the spring and summer of 2002. One product of this effort was the use of SATScan software to recognize critical areas, or hot spots, of human disturbance and vulnerability of watersheds. The result was a map of statistically derived critical areas, which then can be compared to existing biological data. Refinement of this tool is continuing, and it appears to hold great promise in future indicator testing efforts.
Some examples of preliminary findings/accomplishments of the estuarine and watershed analyses include the following:
Human Dimensions Working Group. The Human Dimensions Working Group's data collection and data analysis activities fell into four areas during the reporting period. In the first period, interviews were conducted with state and federal agency officials to gather information about what indicators are being used by water quality managers in the ASC, what these indicators are used for, and attributes of indicators that make them particularly useful. We expect the results to guide the selection of a suite of indicators that will be useful for water quality management decisions and understandable by stakeholders.
Another line of investigation examines the value of various types of information in aquatic ecosystem management. The Susquehanna Nitrogen Management Model is being used to conduct simulation experiments for estimating the value of alternative information sets required to assess the costs and benefits of controlling nitrogen pollution loads to the Chesapeake Bay from the Pennsylvania portion of the Susquehanna River Basin. The Wetland Monitoring Matrix developed by ASC team members Wardrop and Brooks has been represented in a decision theoretic framework that allows estimation of the value of various indicators in wetlands assessment.
In another project, models were developed for integrated assessment of the quality of life and the quality of environment. The primary goal is to provide methods for ranking the relative efficiency of communities in the region in producing a high quality of life and environment using minimal value judgments, and for explaining differences in their relative efficiency.
The human dimensions group also has been conducting research on the legal aspects of ecological indicator use. State laws from the Atlantic Slope states were collected and analyzed to determine where such laws authorized the use of ecological indicators in decision-making. In addition, a baseline analysis of the status of ecological indicators as a management tool in state programs across the nation, is being conducted.
Interactions With Other EaGLes. Brooks and Wardrop continue to work with the Directors and Coordinators of other institutions involved in EPA's EaGLes Program through monthly conference calls, correspondence, and face-to-face meetings. The ASC hosted the 2nd Annual EaGLe Meeting in Edgewater (Annapolis), MD, in December 2002. Significant progress was made addressing integration and data management issues. Brooks and Wardrop are co-authoring an overview paper with the EaGLe Project Directors and the Coordinator, and have participated in several meetings to accomplish that task. Several avenues of inter-EaGLe collaboration are beginning to emerge, and will be further explored in the coming year.
Project Management and Integration within the ASC. The large number of ASC investigators poses unique integration challenges, and we continue to address them in a number of ways, including: (1) collaborative development of a project vision statement and document; (2) biannual "all-hands" meetings that emphasize integration; (3) additional subgroup meetings and conference calls, as needed, to focus on more specific issues; (4) creation of functional working groups that cross institutional boundaries; (5) inclusion of one investigator (Kent Thornton of FTN Associates) whose primary role is to facilitate integration of the project; and (6) creation of a new and improved Web site that will facilitate communication among team members.
Interinstitutional coordination has occurred on many aspects of the project, including watershed classification, estuarine sampling, shoreline assessment, development of bird community indices, and geographic data acquisition and analysis. Collaborative products produced thus far include a new watershed classification scheme that subsequently was used as the basis for the experimental design; a new protocol for rapid assessment of stream, riparian, and wetland areas; and a paper describing a new hierarchical classification framework for all wetlands in the Atlantic Slope. Inclusion of the Human Dimensions Working Group in the ASC has added a perspective to indicator development that is unique among EaGLe projects, and which has provided much "food for thought" among more traditionally trained natural scientists in the group.
We also are working toward integrating three main areas of our analyses. These are: (1) integration of upstream watersheds with downstream estuaries, (2) integration across geographic scales, and (3) integration of scientific and human dimensions evaluations of indicators. Specific activities are documented in each of the institutional reports.
Future Activities:
Future activities for Year 3 of the project include continued field sampling by ASC members, with increased emphasis on using these data for indicator development and evaluation. EPA's approach described in Methods for Evaluating Ecological Indicators (Jackson, et al., 2000) will be applied for this latter purpose. There also will be increased attention given to integration across scales, and from upstream watersheds to downstream estuaries. Projected activities of specific working groups include:
Estuary Group. Sampling of the physical, chemical, and biological components of near-shore areas of estuarine segments and the non-tidal stream, wetland, and riparian portions of estuarine watersheds will continue. Continued refinement of the nutrient discharge model with geographic data will be undertaken. The resulting improved statistical models will be used to provide expectations for the Smithsonian Environmental Research Center (SERC) estuarine study.
Watershed Group. Additional field sampling using the revised SWR protocol will take place during spring/summer 2003 in approximately 20 watersheds. Integrated analysis will be undertaken of existing biological, chemical, and habitat data, and new data collected as part of the SWR sampling. These analyses will be coordinated with those of SERC's watershed team, and with those of the Estuarine Working Group, to examine linkages between upstream and downstream conditions. The relationship between site-level and landscape-level indicators also will be explored.
Human Dimensions Group. The major activity in Year 3 of the project will be to conduct focus groups and random sample surveys of stakeholders about diverse indicators in selected ASC watersheds. Efforts will continue on projects underway on the value of information modeling and quality of life/quality of environment. Investigation of the legal aspects of ecological indicators will continue, including targeted research linking state and local laws in selected case study watersheds.
GIS Team. Acquisition of data will continue, including the National Wetland Inventory, time series of census of population and housing, and specific data attributes for selected watersheds in the study region. In conjunction with the watershed group, analyses of landscape metrics will be performed. The GIS group also will represent the ASC project on the EaGLe data committee.
Journal Articles: 44 Displayed | Download in RIS Format
Other center views: | All 166 publications | 51 publications in selected types | All 44 journal articles |
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Baker ME, Weller DE, Jordan TE. Improved methods for quantifying potential nutrient interception by riparian buffers. Landscape Ecology 2006;21(8):1327-1345. |
R828684 (Final) R831369 (Final) |
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Baker ME, Weller DE, Jordan TE. Comparison of automated watershed delineations: effects on land cover areas, percentages, and relationships to nutrient discharge. Photogrammetric Engineering & Remote Sensing 2006;72(2):159-168. |
R828684C003 (Final) |
not available |
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Baker ME, Weller DE, Jordan TE. Effects of stream map resolution on measures of riparian buffer distribution and nutrient retention potential. Landscape Ecology 2007;22(7):973-992. |
R828684 (Final) R831369 (2006) R831369 (Final) |
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Baker M, King R. A new method for detecting and interpreting biodiversity and ecological community thresholds. METHODS IN ECOLOGY AND EVOLUTION 2010;1(1):25-37. |
R828684 (Final) |
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Bason C, King R, Baker M, Kazyak P, Weller D. How novel is too novel? Stream community thresholds at exceptionally low levels of catchment urbanization. ECOLOGICAL APPLICATIONS 2011;21(5):1659-1678. |
R828684 (Final) |
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Bason C, Kroes D, Brinson M. The Effect of Beaver Ponds on Water Quality in Rural Coastal Plain Streams. SOUTHEASTERN NATURALIST 2017;16(4):584-602. |
R828684 (Final) |
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Bilkovic DM, Roggero M, Hershner CH, Havens KH. Influence of land use on macrobenthic communities in nearshore estuarine habitats. Estuaries and Coasts 2006;29(6):1185-1195. |
R828684 (Final) |
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Borisova T, Shortle JS, Horan RD, Abler DG. The value of information for water quality protection. Water Resources Research 2005;41(6):W06004. |
R828684C004 (2003) R828684C004 (2004) R828684C004 (Final) |
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Brooks B, Brinson M, Havens K, Hershner C, Rheinhardt R, Wardrop D, Whigham D, Jacobs A, Rubbo J. Proposed Hydrogeomorphic Classification for Wetlands of the Mid-Atlantic Region, USA. WETLANDS 2011;31(2):207-219. |
R828684 (Final) |
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Brooks R, McKenney-Easterling M, Brinson M, Rheinhardt R, Havens K, O'Brien D, Bishop J, Rubbo J, Armstrong B, Hite J. A Stream-Wetland-Riparian (SWR) index for assessing condition of aquatic ecosystems in small watersheds along the Atlantic slope of the eastern U.S. Environmental Monitoring and Assessment 2009;150(1-4):101-117. |
R828684 (Final) |
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DeLuca WV, Studds CE, Rockwood LL, Marra PP. Influence of land use on the integrity of marsh bird communities of Chesapeake Bay, USA. Wetlands 2004;24(4):837-847. |
R828684C001 (2004) R828684C001 (Final) |
not available |
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DeLuca WV, Studds CE, King RS, Marra PP. Coastal urbanization and the integrity of estuarine waterbird communities: threshold responses and the importance of scale. Biological Conservation 2008;141(11):2669-2678. |
R828684 (Final) |
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Gallegos CL, Biber PD. Diagnostic tool help set water quality targets for restoring submerged aquatic vegetation in Chesapeake Bay. Ecological Restoration 2004;22(4):1441-1451 |
R828684C002 (2004) R828677C004 (2004) |
not available |
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Gallegos CL, Jordan TE, Hines AH, Weller DE. Temporal variability of optical properties in a shallow, eutrophic estuary: seasonal and interannual variability. Estuarine Coastal and Shelf Science 2005;64(2-3):156-170. |
R828684 (Final) R828684C002 (2003) |
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Goetz S, Fiske G. Linking the diversity and abundance of stream biota to landscapes in the mid-Atlantic USA. Remote Sensing of Environment 2008;112(11):4075-4085. |
R828684 (Final) R831369 (Final) |
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Goetz SJ. Remote sensing of riparian buffers: past progress and future prospects. Journal of the American Water Resources Association 2006;42(1):133-143. |
R828684 (Final) R831369 (2006) R831369 (Final) |
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Hershner C, Havens K, Bilkovic DM, Wardrop D. Assessment of Chesapeake Bay program selection and use of indicators. EcoHealth 2007;4(2):187-193. |
R828684 (Final) |
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Horan RD, Shortle JS, Abler DG. The coordination and design of point-nonpoint trading programs and agri-environmental policies. Agricultural and Resource Economics Review 2004;33(1):61-78. |
R828684 (Final) R828684C004 (2003) |
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Horan RD, Shortle JS. When two wrongs make a right: second-best point-nonpoint trading ratios. American Journal of Agricultural Economics 2005;87(2):340-352. |
R828684 (Final) R828684C004 (2003) |
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Hychka KC, Wardrop DH, Brooks RP. Enhancing a landscape assessment with intensive data: a case study in the Upper Juniata watershed. Wetlands 2007;27(3):446-461. |
R828684 (Final) |
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King RS, Richardson CJ. Integrating bioassessment and ecological risk assessment: an approach to developing numerical water-quality criteria. Environmental Management 2003;31(6):795-809. |
R828684 (2002) R828684C001 (2002) R828684C001 (Final) R828684C003 (2003) |
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King RS, Beaman JR, Whigham DF, Hines AH, et al. Watershed land use is strongly linked to PCBs in white perch in Chesapeake Bay subestuaries. Environmental Science & Technology 2004;38(24):6546-6552. |
R828684C001 (2004) R828684C001 (Final) |
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King RS, Baker ME, Whigham DF, Weller DE, Jordan TE, Kazyak PF, Hurd MK. Spatial considerations for linking watershed land cover to ecological indicators in streams. Ecological Applications 2005;15(1):137-153. |
R828684 (2002) R828684C001 (2004) R828684C001 (Final) R828684C003 (2003) |
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King RS, Hines AH, Craige FD, Grap S. Regional, watershed, and local correlates of blue crab and bivalve abundances in subestuaries of Chesapeake Bay, USA. Journal of Experimental Marine Biology and Ecology 2005;319(1-2):101-116. |
R828684C001 (2003) R828684C001 (2004) R828684C001 (Final) |
not available |
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King RS, Deluca WV, Whigham DF, Marra PP. Threshold effects of coastal urbanization on Phragmites australis (common reed) abundance and foliar nitrogen in Chesapeake Bay. Estuaries and Coasts 2007;30(3):469-481. |
R828684 (Final) |
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Marshall E, Shortle J. Using DEA and VEA to evaluate quality of life in the mid-Atlantic states. Agriculture and Resource Economics Review 2005;34(2):185-203. |
R828684C004 (Final) |
not available |
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McElfish Jr. JM, Varnell LM. Designing environmental indicator systems for public decisions. Columbia Journal of Environmental Law 2006;31(1):45-86. |
R828684C004 (2004) R828684C004 (Final) |
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Myers WL, McKenney-Easterling M, Hychka K, Griscom B, Bishop JA, Bayard A, Rocco GL, Brooks RP, Constantz G, Patil GP, Taillie C. Contextual clustering for configuring collaborative conservation of watersheds in the Mid-Atlantic Highlands. Environmental and Ecological Statistics 2006;13(4):391-407. |
R828684 (Final) |
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Myers WL, Kurihara K, Patil GP, Vraney R. Finding upper-level sets in cellular surface data using echelons and saTScan. Environmental and Ecological Statistics 2006;13(4):379-390. |
R828684 (Final) |
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Niemi G, Wardrop D, Brooks R, Anderson S, Brady V, Paerl H , Rakocinski C, Brouwer M, Levinson B, McDonald M. Rationale for a new generation of indicators for coastal waters. Environmental Health Perspectives 2004;112(9):979-986. |
R828684 (Final) R828675 (2004) R828675 (Final) R828677C001 (Final) R829458C003 (2003) R829458C008 (2003) R829458C008 (2004) |
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Patil GP, Brooks RP, Myers WL, Rapport DJ, Taillie C. Ecosystem health and its measurement at landscape scale: toward the next generation of quantitative assessments. Ecosystem Health 2001;7(4):307-316. |
R828684 (2002) R828684 (Final) R828684C003 (2002) |
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Patil GP, Bishop JA, Myers WL, Taillie C, Vraney R, Wardrop D. Detection and delineation of critical areas using echelons and spatial scan statistics with synoptic cellular data. Environmental and Ecological Statistics 2004;11(2):139-164. |
R828684 (Final) R828684C003 (2003) |
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Patil GP, Taillie C. Multiple indicators, partially ordered sets, and linear extensions:multi-criterion ranking and prioritization. Environmental and Ecological Statistics 2004;11(2):199-228. |
R828684 (Final) |
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Patil GP, Taillie C. Upper level set scan statistic for detecting arbitrarily shaped hotspots. Environmental and Ecological Statistics 2004;11(2):183-197. |
R828684 (Final) |
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Ranjan R, Marshall L, Shortle J. Optimal renewable resource management in the presence of endogenous risk of invasion. Environmental and Resource Economics 2008;89(4):273-283. |
R828684C004 (2003) |
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Rheinhardt RD, Brinson MM, Christian RR, Miller KH, Meyer GF. A reference-based framework for evaluating the ecological condition of stream networks in small watersheds. Wetlands 2007;27(3):524-542. |
R828684 (Final) |
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Rheinhardt RD, McKenney-Easterling M, Brinson MM, Masina-Rubbo J, Brooks RP, Whigham DF, O'Brien D, Hite JT, Armstrong BK. Canopy composition and forest structure provide restoration targets for low-order riparian ecosystems. Restoration Ecology 2009;17(1):51-59. |
R828684 (Final) |
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Rheinhardt R, Brinson M, Brooks R, McKenney-Easterling M, Rubbo JM, Hite J, Armstrong B. Development of a reference-based method for identifying and scoring indicators of condition for coastal plain riparian reaches. Ecological Indicators 2007;7(2):339-361. |
R828684 (Final) |
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Rheinhardt R, Brinson M, Meyer G, Miller K. Integrating forest biomass and distance from channel to develop an indicator of riparian condition. ECOLOGICAL INDICATORS 2012;23:46-55. |
R828684 (Final) |
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Studds C, DeLuca W, Baker M, King R, Marra P. Land Cover and Rainfall Interact to Shape Waterbird Community Composition. PLOS ONE 2012;7(4). |
R828684 (Final) |
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Theobald DM, Goetz SJ, Norman JB, Jantz P. Watersheds at risk to increased impervious surface cover in the conterminous United States. Journal of Hydrologic Engineering 2009;14(4):362-368. |
R828684 (Final) |
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Wardrop DH, Bishop JA, Easterling M, Hychka K, Myers W, Patil GP, Taillie C. Use of landscape and land use parameters for classification and characterization of watersheds in the mid-Atlantic across five physiographic provinces. Environmental and Ecological Statistics 2005;12(2):209-223. |
R828684 (2002) R828684 (Final) R828684C003 (2003) R828684C003 (2004) |
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Weller D, Baker M, Jordan T. Effects of riparian buffers on nitrate concentrations in watershed discharges:new models and management implications. ECOLOGICAL APPLICATIONS 2011;21(5):1679-1695. |
R828684 (Final) |
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Weller D, Baker M, King R. New methods for quantifying the effects of catchment spatial patterns on aquatic responses. LANDSCAPE ECOLOGY 2023; |
R828684 (Final) |
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Supplemental Keywords:
indicators, integrated assessment, aquatic ecosystem, wetland, stream, estuary, watershed, biological integrity, landscape ecology, scaling, socioeconomic, decision-making, GIS, Mid-Atlantic., RFA, Scientific Discipline, Geographic Area, Waste, Water, Ecosystem Protection/Environmental Exposure & Risk, Hydrology, Nutrients, Contaminated Sediments, Wastewater, Ecosystem/Assessment/Indicators, Ecosystem Protection, Economics, Ecological Effects - Environmental Exposure & Risk, Mid-Atlantic, Ecological Risk Assessment, Ecology and Ecosystems, Biology, Ecological Indicators, bioindicator, coastal ecosystem, degradation, remote sensing, aquatic ecosystem, ecological exposure, aquatic biota , ecosystem assessment, watersheds, contaminated sediment, socioeconomics, biomonitoring, ecological assessment, ecosystem indicators, estuarine ecosystems, integrated assessment, Atlantic Slope Consortium, nutrient stress, aquatic ecosystems, environmental stress, integrative indicators, bioindicators, water quality, ecosystem stressRelevant Websites:
http://www.asc.psu.edu Exit
https://cfpub.epa.gov/ncer_abstracts/index.cfm/fuseaction/display.files/fileID/7680 (PDF) (8 pp., 3.4MB) about PDF)
Progress and Final Reports:
Original Abstract Subprojects under this Center: (EPA does not fund or establish subprojects; EPA awards and manages the overall grant for this center).
R828684C001 Integrated Assessment of Estuarine Ecosystems
R828684C002 Development of an Optical Indicator of Habitat Suitability for Submersed Aquatic Vegetation
R828684C003 Integrated Assessment of Watersheds
R828684C004 Socioeconomic and Institutional Research
The perspectives, information and conclusions conveyed in research project abstracts, progress reports, final reports, journal abstracts and journal publications convey the viewpoints of the principal investigator and may not represent the views and policies of ORD and EPA. Conclusions drawn by the principal investigators have not been reviewed by the Agency.