Executive Summary

Over 7 billion pounds of toxic chemicals are released into the air, land, and water of the United States each year, and more than half the U.S. national wildlife refuges are thought to be affected by these contaminants. In response to concerns expressed by the public, Congress, some agencies, and scientists, the U.S. Fish and Wildlife Service (FWS) undertook to develop a comprehensive program for the assessment and monitoring of potentially toxic substances on the trust resources1 for which it is responsible: the Biomonitoring of Environmental Status and Trends Program.

OVERVIEW OF THE FWS BIOMONITORING OF ENVIRONMENTAL STATUS AND TRENDS PROGRAM

Biomonitoring programs are scattered throughout the federal government (e.g., the Environmental Monitoring and Assessment Program, EMAP, at the Environmental Protection Agency; the National Status and Trends Program at the National Oceanic and Atmospheric Administration); however, the proposed Biomonitoring of Environmental Status and Trends Program would be the only monitoring program that specifically addresses contaminant impacts on FWS trust resources. Its purpose is to adopt a comprehensive ecosystem approach2 to identify contaminant problems. According to FWS, when fully operational, the program is to identify the location of contaminant-related ecosystem degradation and provide answers to such common contaminant-related questions as the following:

1  

The FWS trust resources include more than 91 million acres of lands managed by FWS (which are primarily national wildlife refuges), as well as anadromous fish, migratory birds, some marine mammals, and federally listed endangered species. The lands are referred to as “trust lands” and the species as “trust species.”

2  

An ecosystem approach is defined by FWS as a holistic, integrated approach that incorporates the interactions between physical habitats and living resources, rather than focusing on a particular contaminant or species (FWS, 1993).



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A Review of the Biomonitoring of Environmental Status and Trends Program: The Draft Detailed Plan Executive Summary Over 7 billion pounds of toxic chemicals are released into the air, land, and water of the United States each year, and more than half the U.S. national wildlife refuges are thought to be affected by these contaminants. In response to concerns expressed by the public, Congress, some agencies, and scientists, the U.S. Fish and Wildlife Service (FWS) undertook to develop a comprehensive program for the assessment and monitoring of potentially toxic substances on the trust resources1 for which it is responsible: the Biomonitoring of Environmental Status and Trends Program. OVERVIEW OF THE FWS BIOMONITORING OF ENVIRONMENTAL STATUS AND TRENDS PROGRAM Biomonitoring programs are scattered throughout the federal government (e.g., the Environmental Monitoring and Assessment Program, EMAP, at the Environmental Protection Agency; the National Status and Trends Program at the National Oceanic and Atmospheric Administration); however, the proposed Biomonitoring of Environmental Status and Trends Program would be the only monitoring program that specifically addresses contaminant impacts on FWS trust resources. Its purpose is to adopt a comprehensive ecosystem approach2 to identify contaminant problems. According to FWS, when fully operational, the program is to identify the location of contaminant-related ecosystem degradation and provide answers to such common contaminant-related questions as the following: 1   The FWS trust resources include more than 91 million acres of lands managed by FWS (which are primarily national wildlife refuges), as well as anadromous fish, migratory birds, some marine mammals, and federally listed endangered species. The lands are referred to as “trust lands” and the species as “trust species.” 2   An ecosystem approach is defined by FWS as a holistic, integrated approach that incorporates the interactions between physical habitats and living resources, rather than focusing on a particular contaminant or species (FWS, 1993).

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A Review of the Biomonitoring of Environmental Status and Trends Program: The Draft Detailed Plan What are the major contaminant threats to FWS trust resources? Are contaminant impacts to trust resources increasing or decreasing? Which trust resources are degrading or improving on a national, regional, and local level? What contaminants impact national wildlife refuges and what are the probable contaminant sources and pathways? The Biomonitoring of Environmental Status and Trends Program has three goals as noted in the draft detailed plan of the program: Goal 1: Determine the status and trends of environmental contaminants and their effects on trust resources. Goal 2: Identify and assess the major factors (relative to Goal 1) affecting trust resources and provide current and predictive information to alleviate impacts. Goal 3: Provide summary information in a timely manner to managers and the public to guide conservation efforts. To meet Goal 1, monitoring will be based on analytical chemistry, bioassays and toxicity tests, biological markers, and population-and community-level indicators. The program's data-collection approach has been designed around two major components: FWS lands (primarily national wildlife refuges) and trust species (anadromous fish, migratory birds, some marine mammals, and federally listed endangered species). For FWS trust lands, two sampling approaches have been developed —one to identify specific contaminant problems and the other to measure the status and trends of contaminants. For the trust species, indicator or surrogate species will be used to support two sampling designs focusing on trust-species exposure and response and on status and trends of habitat condition. All data will be subject to a quality-control and quality-assurance program. To meet Goal 2, the Biomonitoring of Environmental Status and Trends Program will use a modern database-management system to organize, store, and retrieve internal and external information. The information will be used to assess current effects and predict potential effects on fish and wildlife. A research component will identify new or emerging problems and provide new data-collection and data-interpretation methods. To meet Goal 3, the Biomonitoring of Environmental Status and Trends Program will present the information developed in meeting Goal 2 in an aggressive outreach effort to natural-resource managers, decision-makers, and the public. At the request of FWS and then the National Biological Survey (NBS), which now includes the program, the National Research Council formed the Committee to Review the Department of Interior's Biomonitoring of Environmental Status and Trends Program in the Board on Environmental Studies and Toxicology. This report constitutes the first phase of the committee's work. Its purpose is to evaluate the overall concept of the program as outlined in the Biomonitoring of Environmental Status and Trends Draft Detailed Plan. This report evaluates the draft detailed plan for the Biomonitoring of Environmental Status and Trends Program proposed by FWS. That plan was developed before the incorporation of the program into the NBS. The NBS asked the National Research Council to address the charge posed to the

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A Review of the Biomonitoring of Environmental Status and Trends Program: The Draft Detailed Plan committee in relation to FWS, not the NBS, at this time. Later, the committee is to review the final version of the plan (should there be one) after the NBS considers the committee's recommendations. THREE KEY ASPECTS OF THE PROGRAM In response to the request to evaluate whether the program is feasible, the committee focused on three aspects: problem identification, causality, and management. In the problem-identification portion of the program, FWS Identifies specific contaminant problems on FWS trust lands at the local level. Determines the magnitude of and response to contaminants that affect key trust species at the regional level. Determines the status and trends of contaminant impacts on FWS trust lands at the ecoregion, habitat, and hydrologic-unit levels. Determines the status and trends of contaminant impacts on the habitats of key species at the regional and national levels. Once this information is determined, the program uses reference sites3 for comparison and ecological action levels (EALs)4 for decision-making. The causality portion of the program assesses and predicts impacts with a two-tiered bioassessment approach that determines the presence and effects of toxic substances on local to global scales. Tier 1 is a general screening for existing and potential contaminants using inexpensive methods. Tier 2 detects toxic substances and diagnoses their effects. Impact assessment and prediction are conducted once a measured effect exceeds the EAL. Ecological indexes, ecological risk assessment, trend analysis, and mathematical models are used for this last step.5 The objective is then to describe the exposure of key trust species6 to toxic substances, to measure changes in exposure and response over time, and to answer such questions as: What toxic substances are causing changes in populations or species? Can the toxic substances be linked to the changes in the population or other species? The third focus of the committee was on management issues of the program—specifically administrative structure and personnel, partnerships, data management, outreach, program phasing, and cost effectiveness. Administratively, the program, under the FWS Division of 3   A reference site is defined by NBS as “an area that approximates ‘natural' or baseline conditions for the variable(s) being studied, often used as a control for comparative studies 4   EALs, according to FWS, are interpretative guidelines or ranges of chemical concentrations in biological tissue, enzyme levels, or biological indexes that identify the magnitude of contaminant threats to trust resources. 5   An ecological index, according to FWS, expresses the “global ecological health” of a site in terms of a single measure. Ecological risk assessment relates toxic substances and observed effects through the use of dose-response studies (when possible). Trend analysis evaluates observed temporal and spatial changes in toxic-substance concentrations. Mathematical models of transport and partition dynamics of toxic substances–including their cumulative impacts on organism population dynamics, genetic diversity, and behavior–supplement impact assessments. 6   According to FWS, a key trust species is “a trust species or a group of trust species with similar habitat requirements and life history” that is used to represent the entirety of a species. Criteria are provided to guide selection of the species.

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A Review of the Biomonitoring of Environmental Status and Trends Program: The Draft Detailed Plan Environmental Contaminants, consists of an implementation steering committee; a program development steering committee; the Technical Resource Center (TRC), a core unit for technical support; and a quality assurance unit. In terms of personnel, data collection is to be performed by field staff trained by the Biomonitoring of Environmental Status and Trends Program and working under protocols developed by the TRC. The TRC is to be the focal point for development of monitoring protocols, analysis methods, and database design. The “partners” with which the program will develop partnerships are federal agencies, other branches of FWS, international institutions, state and local agencies, private environmental and scientific organizations, universities, and private research organizations. In terms of data management, the environmental-contaminants program at FWS does not have programwide database or geographic information system (GIS) capabilities. To remedy that, FWS proposes a centralized database facility that will house national data from the Biomonitoring of Environmental Status and Trends Program and external data (such as GIS data) that are used in analysis. This facility will provide database access to program personnel and outside parties and support relatively sophisticated data queries and analyses. Also included in this facility will be Contaminant Information Management and Analysis System (CIMAS) that includes database hardware and software and connectivity with other federal databases and ecological information systems. The detailed plan acknowledges that an educated public can help to identify and mitigate the damage from toxic substances, so a section in the detailed plan addresses outreach efforts. The program's goal is to accomplish outreach in a manner that encourages public participation achieved through partnerships and raises public toxic-substance awareness with state-of-the-art multimedia techniques. The draft detailed plan proposes a phased implementation of the program as follows: Initiate a program team and management structure. Implement a program review (including this review). Develop the Technical Resource Center. Develop a training program. Complete a pilot methods-testing phase. Complete a larger-scale demonstration phase. Implement data collection. COMMITTEE'S EVALUATION OF THE PROGRAM'S DETAILED PLAN In response to the request to evaluate whether the Biomonitoring of Environmental Status and Trends Program is feasible, the committee excerpted five questions from its overall charge (see Appendix A) as a basis for its report. The first question, on problem identification, was

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A Review of the Biomonitoring of Environmental Status and Trends Program: The Draft Detailed Plan Will the program be able to identify current and future problematic trends on and threats to FWS lands and trust species on national and regional scales in a useful and timely manner? For the program to identify current and future problematic threats and trends, FWS needs to take a hypothesis-testing approach in its problem identification. By this, the committee means that the program should have the ability to conduct short-term diagnosis rapidly with incomplete evidence and to conduct long-term modeling where current data can be collected in such a way that long-term future problems can be predicted and prevented. The program has four elements—local contaminant problems on FWS lands, trust-species exposure-response relationships, status-and-trends program for FWS trust lands, and status and trends of trust species. The committee believes that none of them is ready or appropriate for implementation at this time. The committee sees no evidence that FWS field staff typically have the training or technical support needed to make “professional judgments ” about critical issues of study design as is currently proposed. Both a phased approach and dependable access to other centers of expertise will prove to be required. In the case of identifying local contaminant problems on FWS lands, several methodological questions remain unanswered. For trust-species exposure-response relationships, the committee believes that the best action for FWS to take would be to upgrade the current National Contaminant Biomonitoring Program to include a broader range of contaminant exposure and effect indicators and then fold this program into the Biomonitoring of Environmental Status and Trends Program. The committee also concludes that the status-and-trends trust-lands component is not adequate as proposed in the draft detailed plan. If it is retained, it should include hypotheses or conceptual models, habitat-classification schemes, and specific measures of resource condition. Given the above problems, the phased approach to implementation of the program should be continued. In particular, current pilot studies have focused principally on the evaluation of sampling techniques and not on hypothesis-testing. Additional studies are required to evaluate site-selection procedures, hypothesis development, candidate indicators, and data-analysis procedures. The second question, on causality, was Will the program be able to identify causes (including identification of pathways and sources) of observed changes (trends and threats) to trust resources, whether they are human causes or natural fluctuations? For causality, a fundamental step is to evaluate the likelihood that toxic substances are the cause of an effect, measure the relevant ecological characteristics, and determine how much of an observed effect can be attributed to toxic substances, as opposed to other natural and human causes. Clear statements about analysis pathways, decision criteria, rules of evidence, and methods of drawing inferences are also necessary if this program is to be successful. A classic failing of monitoring programs is a lack of attention to such issues until after data have been collected. Program designers should specify beforehand, as explicitly as possible, how raw data

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A Review of the Biomonitoring of Environmental Status and Trends Program: The Draft Detailed Plan will be turned into usable information. FWS must be able to ensure that they are able to make its own partners' current and future monitoring data available. The process that the committee recommends to implement this inference-based procedure is ecological risk assessment. By undertaking the use of ecological risk assessment, FWS would improve its problem formulation, analysis, risk characterization, verification and monitoring, and uncertainty assessment. The result will provide information on the nature, magnitude, extent, and likelihood of effects that can be used by refuge or resource managers in making environmental-management decisions, e.g., on such matters as the environmental benefits of remediation and restriction of use of a chemical. The next questions address several management issues: Will the program be able to set priorities among issues of concern and determine where action is needed? Will the program provide information to support activities to reduce and prevent impacts of toxic substances? Will the program maintain sufficient consistency to ensure development of a useful, long-term database? The committee found these questions difficult to answer. Given the effects of changing policy environments, administrative priorities, and budget constraints on the intent and effectiveness of programs similar to this program, the questions cannot be answered with any precision (particularly over the long term). A program of this scale and complexity tests managerial, as well as scientific and technical, capabilities. The draft detailed plan recognizes and promises attention to many urgent management issues. It also recognizes the need for flexibility and adaptability in response to changing contaminant problems. The program constitutes a start toward strengthening understanding of status and trends in toxic-substance effects on FWS trust resources. It also begins to strengthen both the rationale and the information base for policies and actions to prevent and correct harm to these valued resources. Missing is the administrative and budgetary context of an integrated program for reducing effects of toxic substances on FWS trust resources. Because human and financial resources are limited, priorities need to be set among components of the program. The results of deductive inference are needed to set program priorities and to make decisions regarding program support and prevention and intervention activities. Commitment to partnerships in data collection and management appears to be genuine, and concern for quality appropriate. The detailed plan presents a proposed outreach component in a coherent strategy. The emphasis on strengthening internal and partner communication in a technically demanding program is particularly welcome. The external-outreach component is ambitious and inclusive. However, the draft overlooks broad arenas for official and unofficial participation in various forms. The program is strongly oriented to data-gathering, with scant attention to identification of users and uses or to data analysis and synthesis at any level. In addition, there is not a clear presentation of how data will flow or be used by various interested parties at local, regional, and

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A Review of the Biomonitoring of Environmental Status and Trends Program: The Draft Detailed Plan national levels. Furthermore, there is a lack of adequate explication of formal structure for integration of laboratory and field data and for data analysis and synthesis in general, including hypothesis generation and hypothesis-testing that use program and related data. Thus, a data-management plan is a critical part of the overall management of this program. A vital portion of the overall program will be a thorough data-management program for the data-gathering component. There is a clear distinction between a database system, made up of hardware and software, and a data-management plan, which defines data paths, procedures, responsibilities, and data manipulations. The program proposes to coordinate and integrate the collection and analysis of data from a wide network of practitioners—its partners in the program. Such an activity has no chance of succeeding without a data-management plan that is as fully developed as the data-gathering plan itself. The processes of program evaluation, validation, and refinement should include external peer reviewers with specialized skills relevant to key program components. The role of the TRC is crucial as a focal point for scientific quality control and should be more rigorously thought through and specified. In terms of cost effectiveness, better protection of valued biological resources is the core benefit. Early identification of potential problems will reduce costs through avoidance of postcontamination remediation expense. SUMMARY OF RECOMMENDATIONS The committee has made a number of recommendations for improving the Biomonitoring of Environmental Status and Trends Program and its implementation. These recommendations are outlined below. Problem Identification A more general procedure should be developed for detecting problems affecting FWS trust resources through the use and observations of volunteers, nongovernment organizations, and field personnel. The program should be directed toward characterization of existing conditions, natural biological variability, and the effects of human perturbations. The tiered bioassessment indicator scheme used to assess the presence and effects of toxic substances on trust resources should be revised to distinguish clearly between general-condition indicators (Tier 1) and diagnostic indicators (Tier 2). Suitable indicators should be developed for trust resources other than wetlands or aquatic ecosystems, such as uplands. The draft detailed plan should be revised to incorporate sound monitoring-program design principles, including Testing of specific hypotheses regarding contaminant exposures and effects. Definition and characterization of reference sites.

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A Review of the Biomonitoring of Environmental Status and Trends Program: The Draft Detailed Plan Development of statistical-power criteria for determining sample sizes, spatial sampling intensities, and temporal sampling frequencies Specification of statistical methods The Biomonitoring of Environmental Status and Trends Program should be implemented through a phased approach that thoroughly tests all aspects of the program at a few sites before adding new sites. A rigorous research program should be implemented for development and validation of ecological action levels of biological indicators, such as biochemical markers and population and community indexes. A support infrastructure should be developed that will provide FWS personnel with training in critical study-design issues—such as indicator selection, analytical-methods selection, toxicity-data evaluation, and statistical design—and offer specialized technical support to refuge managers charged with implementing the program. The current National Contaminant Biomonitoring Program should be upgraded to include a broad range of contaminant-exposure and -effect indicators, which should then be folded into the Biomonitoring of Environmental Status and Trends Program. A detailed sampling network plan for the status and trends of contaminants on trust lands should be developed. In particular, the plan should describe the habitat-classification scheme used to stratify the sampling program, the specific measures of resource condition to be used, and the criteria to be used to distinguish between acceptable and unacceptable resource conditions. Before full implementation, pilot studies of all program components should be conducted to confirm technical feasibility and to develop implementation-cost estimates. Before implementation of the sampling network for the status and trends of key-species habitats, specific measurements and statistical-design criteria for data to be obtained from partners should be identified. Implementation should proceed only if partners are willing to provide data according to specifications provided to them by the Biomonitoring of Environmental Status and Trends Program. The program needs to integrate its data collection so that both short-and long-term diagnostic needs can be addressed. Causality The cause-effect portion of the detailed plan should be framed in the context of ecological risk assessment and should use a relevant paradigm and terminology based on the EPA framework. To demonstrate causality, analytical procedures need to be used to distinguish between alterations resulting from changes in natural conditions, changes due to toxic substances, and other anthropogenic changes. The strategy for assessing causal relationships should follow the well-developed strategy for ecological risk assessment and should involve hypothesis-testing.

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A Review of the Biomonitoring of Environmental Status and Trends Program: The Draft Detailed Plan Toxicological theory should be used to choose which substances to investigate and to establish causal hypotheses. Monitoring programs should be designed to address hypotheses and not merely be “surveillance” programs. Pilot studies should be used to assess whether the methods for establishing causality will succeed; they should be designed on the basis of lessons gleaned from previous studies of causality. Management Administrators of this kind of program should develop and offer for comment to internal and external scientists and managers a description and analysis, in an administrative and budgetary context, of all components of a toxic-substances program. The administrative and programmatic features of this program must be redesigned as necessary to reflect reorganization within FWS and other Department of the Interior agencies after the establishment of the NBS. A human-resources evaluation should be conducted to clarify the range and magnitude of skills needed and to support phased training and recruitment strategies. Strong partnerships documented in formal agreements with other federal agencies and other appropriate institutions should be established as needed to implement the plan in a cohesive science-based collaboration. Such agreements need to be detailed and tested in the process of implementation of pilot studies. Systematic input from the NBS and potential federal, state, and other collaborative programs in initial program design should be solicited. A data-management plan needs to be developed that establishes a general framework and guidelines for data collection, transfer, exchange, and dissemination. A distributed model for data management should be developed that provides linkages to existing relevant databases, rather than attempting to centralize all needed data. The computing plan should be revisited and reconciled with new NBS initiatives. Monitoring design should be continually reviewed so that information-gathering and information analysis are harmonized. Initial efforts should be concentrated on collection, storage, and analysis of program-generated data on contaminants on refuges and in trust species. Field staffs concerned with toxic-substance effects should be encouraged to participate in forums established to seek integration of government and private natural-resource management of such regions as watersheds and ecosystems. The role and specifications of the TRC should be carefully coordinated with the developing needs of the program. Pilot projects should be extended to test methods of data integration and synthesis. There should be a strong commitment to a hypothesis-driven program-design strategy so that the cost effectiveness of the program is enhanced.

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A Review of the Biomonitoring of Environmental Status and Trends Program: The Draft Detailed Plan CONCLUSION On the basis of its analysis, the committee concludes that there is a need for a program to evaluate the presence and impact of contaminants potentially affecting the nation's trust lands and species. However, a great deal of work remains to be done before implementation of the Biomonitoring of Environmental Status and Trends Program can be expected to be successful. In particular, FWS should re-evaluate the fundamental nature of the program, take a more hypothesis-driven approach, and be more responsive to clearly stated questions than is indicated in the current draft of the detailed plan. The Fish and Wildlife Service should begin its revision of the program 's detailed plan by starting with the fundamentals. It can do this by asking itself the following questions: What specific question do we expect this monitoring to answer? (I.e., rather than focusing on nonspecific terms, such as “status and trends, ” what answer will actually drive a contemplated decision?) What budget are we considering allocating to this monitoring? Does the monitoring address a question that justifies this budget? Why do we think that the monitoring will be capable of delivering a convincing answer to the question? Why do we think that the monitoring is an efficient way to answer this question? The program should be far more hypothesis-driven and more responsive to clearly stated questions than is indicated in the detailed plan. That is true for all the components reviewed: problem-identification, status-and-trends analysis, causality analysis, and management decision-making. In an ideal world, monitoring programs would always be based on clearly stated hypotheses. The committee, however, understands that not all problems are necessarily amenable to expression in such a formal way. Thus, by “hypothesis-driven,” the committee does not mean that the program should be a laboratory exercise that takes place in the absence of monitoring data. Rather, FWS needs to design the program and plan for the interpretation of data in the light of the need to ask relevant questions, eliminate unlikely answers, and use the most likely answers as a basis for further investigation. Once a problem is detected, further work should be designed to allow comparisons that help the researcher to sort out the multiple causes of the perceived problem via field experiments or some other experimentally designed activity. By reviewing the fundamental nature of the program and its need to be hypothesis-driven, FWS should be able to evaluate the program 's ability to distinguish genuine ecological change from background fluctuation, to assign ecological change to a specific cause, and to distinguish and evaluate the impacts of contaminants and other causes of detrimental ecological changes, and it should be able to evaluate the ability of monitoring and the other suggested techniques, such as “weight of evidence” and “ecological health indicators,” to provide the answers to its questions.

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A Review of the Biomonitoring of Environmental Status and Trends Program: The Draft Detailed Plan Additional key themes in the report include the need for A phased approach to implementation with initial emphasis on problem identification on FWS trust lands. Pilot studies and methods-testing, especially in defining ecological action levels. Outreach and especially partnerships with other federal agencies involved in contaminant assessment and monitoring and with state and local government agencies. Thus, a revision of the detailed plan that keeps in mind the key concept of fundamentals and hypothesis-testing, and management needs, plus the other recommendations in this report, will lead to the development of a scientifically defensible program that will provide the answers that FWS needs to make its decisions appropriately.