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2 Model Use in the Environmental Regulatory Decision Process
Pages 40-82

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From page 40...
... In spite of the challenges, the use of computational models within the regulatory decision process at EPA is a continually growing practice. This growth is in response to greater demands for quantitative assessment of regulatory activities, including analysis of how well environmental regulatory activities fulfill their objectives and at what cost.
From page 41...
... Moreover, the monitoring networks capable of quantitative description of the state of the environment were rudimentary, and the technology for measurement of pollutant discharges of various kinds and their environmental effects were much less developed than today's technology. It was in this setting that most modern environmental regulatory statutes first appeared, including the Clean Air Act (CAA)
From page 42...
... EPA would come to base these SIP approval decisions on emission-inventory models linked to air quality models. In a similar manner, the CWA specified further regulatory action in "waterquality-limited" waters, where the imposition of the technology-based 1 In 1970, a tax on sulfur emissions as a partial alternative to some of the air quality regulation then under consideration in Congress was proposed by President Nixon.
From page 43...
... REGULATORY MODEL CLASSIFICATIONS There are many ways to classify the regulatory models used by EPA, each with its own perspectives and particular advantages and disadvantages. Two broad categorizations are used here: (1)
From page 44...
... In presenting a science perspective and a regulatory perspective, the committee acknowledges that the user community for environmental regulatory models is diverse, and a single perspective on model classification is not possible. More perspectives provide insights into model use, insights that are not possible from a single perspective.
From page 45...
... Appendix C provides examples of specific models from the model categories. The figure provides an approximate categorization of how computational models used in environmental analysis have historically been grouped, in particular, in economic, environmental, and human health models.
From page 46...
... These environmental regulatory modeling activities typically occur as a subset of the full system summarized in Figure 2-1. The underlying statutory requirements, the regulations implementing the statutory requirements, and the importance of the activity dictate the nature of the modeling analysis.
From page 47...
... Modelgenerated emissions inventories serve as input to regional air quality models and are used to test alternative emission-reduction schemes to see whether they will result in air quality standards being met (e.g., ADEC 2001; TCEQ 2004)
From page 48...
... . The remedial investigation for a mining megasite might include water quality, environmental chemistry, human health risk, and ecological risk assessment modeling (NRC 2005a)
From page 49...
... Incorporating behavior into environmental regulatory models is discussed more generally in Box 2-1. Linkages among the different processes are not seamless.
From page 50...
... A key modeling consideration is the extent to which such models incorporate human behavior. The earliest models used for environmental regulatory purposes had little if any behavioral content.
From page 51...
... . 2 PM2.5 refers to a subset of particulate matter collected by a sampling device with a size-selective inlet that has a 50% collection efficiency for particles with an aerodynamic diameter of 2.5 µm.
From page 52...
... and laid out in Figure 2-2. A major modeling component is the development of dose-response relationships through analysis of epidemiological or toxicological studies (Setzer 2005)
From page 53...
... This standard was initially delayed so that the EPA Science Advisory Board, the National Drinking Water Advisory Council, and a second NRC committee could further examine benefits, costs, and health risks. These reviews supported the proposed 10 µg/L standard, which was subsequently finalized by EPA.
From page 54...
... • Sensitivity and uncertainty analysis. These models may also bring with them many technical and science policy challenges.
From page 55...
... . Integrated Models and Modeling Frameworks Some models tend to fit into a single category, while other regulatory models represent multiple categories of processes, such as modeling emissions and fate and transport together.
From page 56...
... It is intended to make watershed and water quality studies easier by bringing key data and analytical components "under one roof." A further discussion of improvements in integrated model methods is contained in Chapter 6. Regulatory Models from a Regulatory Perspective In this section, we describe the use of models in six phases of the regulatory process.
From page 57...
... was funded for 10 years in the 1980s and produced 27 state-of-the-science and -technology reports on all aspects of the acid rain issue. One of the primary products was the air quality models that are precursors to the models used at EPA today.
From page 58...
... EPA's modeling activities at the rule-making stage can be extensive. For example, the nonroad diesel RIA included the use of activity models, emissions models, air quality models, engineering cost models, energy forecasting models, petroleum refinery models, and human health and agricultural impacts models to assess the benefits and costs of the proposed regulation (EPA 2004b)
From page 59...
... As mentioned, tribal governments have the option of running their own environmental programs, and some tribes have received authorization to run air quality and water quality programs. Private consultants often are engaged to perform part of the modeling analysis required under state delegated programs.
From page 60...
... , are primarily run by the states, although some states have only partial authority. Although many of the requirements under the NPDES program are still driven by technologybased standards, increasingly state and federal permit writers must take into account water quality standards and watershed considerations, which increases modeling needs.
From page 61...
... Model Use in the Environmental Regulatory Decision Process 61 pensation and Liability Act. The damage estimates are generally based on contingent valuation surveys, as well as models that attempt to estimate the costs of restoring or replacing the damaged resources.
From page 62...
... . CONGRESSIONAL AND EXECUTIVE BRANCH INFLUENCES There are some particular influences and constraints on the regulatory process resulting from the enabling statutes passed by Congress and from a series of executive orders that over time have given OMB oversight responsibility over regulations and imposed specific requirements on how regulatory decisions are supported through modeling.
From page 63...
... (A) our Nation's waters." Water quality standards set by statute "shall be such as to protect the public health or welfare…." Resource Conservation and Standards for treatment of hazardous wastes disposed onto land shall specify "those levels or methods Recovery Act, 42 U.S.C.
From page 64...
... 64 TABLE 2-3 Continued General Directions Comprehensive Environmental "The President shall select a remedial action that is protective of human health and the environment, that Response, Compensation, and is cost effective, and that utilizes permanent solutions and alternative treatment technologies or resource Liability Act, 42 U.S.C.
From page 65...
... Legislation also affects how EPA uses model assumptions. For example, under the CAA, EPA is instructed to set NAAQS for criteria pollutants that are "requisite to protect the public health" with an "adequate margin of safety."4 This mandate has been interpreted by the 4 Criteria pollutants are air pollutants emitted from numerous or diverse stationary or mobile sources for which NAAQS have been set to protect human health and public welfare.
From page 66...
... . The impact on regulatory modeling is that control costs, technological feasibility, and cost-benefit comparisons are not included in the analysis used to set NAAQS.
From page 67...
... BOX 2-3 The Development of the Requirement for Regulatory Impact Analysis for Major Federal Rules RIAs are required currently for any regulation whose estimated economic effects (costs) exceed $100 million annually or have important adverse effects on prices, employment, productivity, or other economic consequences.
From page 68...
... Since most of the benefits -- and many of the costs -- of environmental regulation are not traded in markets, econometric models are needed to estimate individuals' willingness to pay for the predicted physical effects of regulations, such as improved air quality.7 The RIAs could result in the estimation of regulatory benefits and costs even for rules where the enabling legislation has expressly forbidden the use of costs to make regulatory decisions. For example, as noted in the preceding section, the CAA prohibits cost to be a criterion in the setting of NAAQS.
From page 69...
... Models used in environmental regulatory programs delegated to the states, such as models used to develop SIPs and TMDLs, can be subjected to public comments and debate, but independent peer reviews of individual model applications are not required. Models used in providing guidance may be subjected to scientific and public review, but generally, this review is done at the agency's discretion.
From page 70...
... Interested parties are also provided with an opportunity to challenge the model to the agency and in court to ensure that the model is reliable. External Review of EPA's Models The first and perhaps most important set of requirements involves subjecting regulatory decisions, including the models underlying them, to review by three layers of outside reviewers.
From page 71...
... In July 1994, EPA published Guidance for Conducting External Peer Review of Environmental Regulatory Modeling (EPA 1994c) , which was a prelude to broader peer review guidance published in 2006 (EPA 2006a)
From page 72...
... This guidance also offers a framework for reviewing model development, model application, and environmental regulatory decision making. It explains that policy decisions resulting from the science and other factors are required by law to be made by EPA decision makers.
From page 73...
... Model Performance Measures • What criteria have been used to assess model performance? • Did the data bases used in the performance evaluation provide an adequate test of the model?
From page 74...
... . Public Review Public review of a regulatory model concerns review and comments by stakeholders during the public comment periods of external peer review activities or during the "notice and comment" period that accompanies rule-making activities.
From page 75...
... . Thus, there is a variety of both formal and informal processes for interagency review of regulatory models and analysis based on these models.
From page 76...
... In some instances, the effect of comments on the regulatory process is not clear. It is understood that not all comments are appropriate or useful, even though all need to be carefully considered.
From page 77...
... If EPA applies a generic air dispersion model to a large power plant located in a meteorologically unusual setting, such as the shores of Lake Erie, EPA might have to test the location to establish that the model provides some reliability in that setting, or it must be prepared to explain why its model should be accepted as is (for example, State of Ohio v.
From page 78...
... A second, more recent opportunity for external challenge to model use in the regulatory process is through the Information Quality Act (Treasury and General Government Appropriations Act for Fiscal Year 2001, Pub.
From page 79...
... When the demands of regulatory accountability, transparency, public accessibility, and technical rigor are added to the challenges typically encountered in modeling, the task becomes much more complex. Although improvements to EPA regulatory modeling efforts are possible, EPA clearly has made important advances in the science of environmental modeling and has been a global leader in using models in the environmental regulatory decision process.
From page 80...
... . Technical Reliability The sometimes contentious environment for regulatory models also creates important impediments for ensuring the technical reliability of EPA's models.
From page 81...
... As a result, these various constituencies and individuals must be able to participate in the model evaluation process through various activities, including producing their own supporting or conflicting model results, and challenging the legitimacy or accuracy of a model in public comments or judicial actions.
From page 82...
... Meaningful stakeholder involvement should be solicited at the model development and model application stages of regulatory activity, when appropriate. EPA could improve model accessibility through a variety of activities, such as requiring an additional interface for each model to help to identify the assumptions and sources of parameters and other uncertainties and providing additional user and stakeholder training.


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