Evaluating Research Efficiency In The U S Environmental Protection Agency

A new book from the National Research Council recommends changes in how the federal government evaluates the efficiency of research at EPA and other agencies. Assessing efficiency should be considered only one part of gauging a program's quality, relevance, and effectiveness. The efficiency of research processes and that of investments should be evaluated using different approaches. Investment efficiency should examine whether an agency's R&D portfolio, including the budget, is relevant, of high quality, matches the agency's strategic plan. These evaluations require panels of experts. In contrast, process efficiency should focus on "inputs" (the people, funds, and facilities dedicated to research) and "outputs" (the services, grants, publications, monitoring, and new techniques produced by research), as well as their timelines and should be evaluated using quantitative measures. The committee recommends that the efficiency of EPA's research programs be evaluated according to the same standards used at other agencies. To ensure this, OMB should train and oversee its budget examiners so that the PART questionnaire is implemented consistently and equitably across agencies.

The Environmental Protection Agency (EPA) applies scientific results that have been provided by various parts of its own organization and by external organizations. The agency requires substantial high-quality inhouse scientific expertise and laboratory capabilities so that it can answer questions related to regulation, enforcement, and environmental effects of specific chemicals, activities, and processes. It is also usually faced with situations in which research or analytic work is time-critical, so it maintains dedicated laboratory staff and facilities that can respond quickly to such needs. In recent years, EPA has made several changes to improve the efficiency and effectiveness of its laboratories, such as the designation of national program directors to align the work of research laboratories with the needs of the agency's regulatory program offices. The agency is currently undertaking an integrated evaluation of it laboratories to enhance the management effectiveness and efficiency of its laboratory enterprise and to enhance its capabilities for research and other laboratory-based scientific and technical activities. The results of EPA's evaluation are expected to include options for colocation and consolidation of laboratory facilities. Rethinking the Components, Coordination, and Management of U.S. Environmental Protection Agency Laboratories assesses EPA's highest-priority needs for mission-relevant laboratory science and technical support, develops principles for the efficient and effective management of EPA's laboratory enterprise to meet the agency's mission needs and strategic goals, and develops guidance for enhancing efficiency and effectiveness now and during the next 10 years. EPA's laboratories play a vital role in the agency's work. The findings and recommendations of this report will help EPA to develop an implementation plan for the laboratory enterprise.

Environmental research has driven landmark improvements that led to the protection of human and ecosystem health. Recognizing the value of knowledge generated by environmental research and the ingenuity within academic and nonprofit institutions, the US Environmental Protection Agency (EPA) created a program known as Science to Achieve Results, or STAR, in 1995. STAR is EPA's primary competitive extramural grants program. A Review of the Environmental Protection Agency's Science to Achieve Results Research Program assesses the program's scientific merit, public benefits, and overall contributions in the context of other relevant research and recommends ways to enhance those aspects of the program. This report also considers the conclusions and recommendations of a prior National Research Council review of the STAR program (2003), the STAR program's research priorities in light of the nation's environmental challenges, and the effects of recent STAR funding trends on obtaining scientific information needed to protect public health and the environment.

Potential health effects from chemicals that disrupt endocrine function pose an environmental health concern because of their ability to interfere with normal hormone function in human and wildlife populations. The endocrine system regulates biological processes throughout the body and is sensitive to small changes in hormone concentrations. Endocrine-disruptor research has focused primarily on chemicals that affect three hormone pathways that play important roles in reproduction and development - the estrogen, androgen, and thyroid hormone pathways. Some of this research has identified dose-response relationships that have nonmonotonic curves. Nonmonotonic dose-response curves (NMDRs) are of concern because they do not follow the usual assumption made in toxicology that as dose decreases the response also decreases. The existence of NMDRs has been a controversial topic for decades, and there has been considerable debate about their implications for how chemicals are tested and for how risks from such chemicals are assessed. Toxicity tests are designed to identify hazards and to characterize dose-response relationships, so tests are aimed at finding a (high) dose that elicits a response, and dose-response is explored by testing lower doses spaced to identify statistically a no- or lowest-observed-adverse-effect level. The concern for NMDRs is that such studies, as currently designed, might not detect the inflection of the dose-response curve if only a few doses are tested or if the change in inflection occurs below the range of doses tested. Another concern is that some NMDRs are found for biological effects that are not usually evaluated in toxicity tests. If current testing strategies are inadequate to account for NMDRs, changes to risk assessment practices might be necessary. To help address these issues, the U.S. Environmental Protection Agency (EPA) developed a draft State-of-the-Science Evaluation: Nonmonotonic Dose Responses as they Apply to Estrogen, Androgen, and Thyroid Pathways and EPA Testing and Assessment Procedures. EPA asked the National Research Council to conduct an independent review of this evaluation to ensure that it is scientifically sound and of high quality. Review of Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response as they Apply to Endocrine Disrupters evaluates whether EPA's evaluation presents a scientifically sound and high-quality analysis of the literature on NMDRs. This report reviews how well the EPA evaluation described how the assessment was performed, whether consistent methods and criteria were applied in the analysis of different evidence streams, and whether appropriate methods were applied to evaluating the evidence. The report makes recommendations to improve EPA's process and strengthen the evaluation.

In the three decades since the U.S. Environmental Protection Agency (EPA) was created, the agency's scientific and technical practices and credibility have been independently assessed many times in reports from the National Research Council (NRC), EPA Science Advisory Board, General Accounting Office, and many other organizations; in congressional oversight and judicial proceedings; and in countless criticisms and lawsuits from stakeholders with interests in particular EPA regulatory decisions. As a previous independent panel put it in the 1992 report Safeguarding the Future: Credible Science, Credible Decisions, EPA's policy and regulatory work receives a great deal of public attention, but the agency's scientific performance typically receives a similar degree of attention only when the scientific basis for a decision is questioned. Thus, strong scientific performance is important not only to enable EPA to make informed and effective decisions, but also to gain credibility and public support for the environmental protection efforts of EPA and the nation. This report is the fourth and final one in a series prepared by two independent expert committees convened by the NRC in response to a request from Congress and to subsequent, related requests from EPA. The Committee on Research Opportunities and Priorities for EPA-the companion committee in this study-was charged to provide an overview of significant emerging environmental issues, identify and prioritize research themes most relevant to understanding and resolving those issues, and consider the role of EPA's research program in the context of research being conducted or supported by other organizations. That committee published an interim report in 1996 and a final report, Building a Foundation for Sound Environmental Decisions, in 1997. The Committee on Research and Peer Review in EPA was charged to evaluate research management and scientific peer-review practices in the agency. The committee published an interim report in 1995 and this final report.

The U.S. Environmental Protection Agency (EPA) has a mission and regulatory responsibility to protect human health and the environment. EPA's pursuit of that goal includes a variety of research activities involving human subjects, such as epidemiologic studies and surveys. Those research activities also involve studies of individuals who volunteer to be exposed to air pollutants intentionally in controlled laboratory settings so that measurements can be made of transient and reversible biomarker or physiologic responses to those exposures that can indicate pathways of toxicity and mechanisms of air-pollution responses. The results of those controlled human inhalation exposure (CHIE) studies, also referred to as human clinical studies or human challenge studies, are used to inform policy decisions and help establish or revise standards to protect public health and improve air quality. Controlled Human Inhalation-Exposure Studies at EPA addresses scientific issues and provides guidance on the conduct of CHIE studies. This report assesses the utility of CHIE studies to inform and reduce uncertainties in setting air-pollution standards to protect public health and assess whether continuation of such studies is warranted. It also evaluates the potential health risks to test subjects who participated in recent studies of air pollutants at EPA's clinical research facility.

Formaldehyde is ubiquitous in indoor and outdoor air, and everyone is exposed to formaldehyde at some concentration daily. Formaldehyde is used to produce a wide array of products, particularly building materials; it is emitted from many sources, including power plants, cars, gas and wood stoves, and cigarettes; it is a natural product in come foods; and it is naturally present in the human body as a metabolic intermediate. Much research has been conducted on the health effects of exposure to formaldehyde, including effects on the upper airway, where formaldehyde is deposited when inhaled, and effects on tissues distant from the site of initial contact. The U.S. Environmental Protection Agency (EPA) released noncancer and cancer assessments of formaldehyde for its Intergated Risk Information System (IRIS) in 1990 and 1991, respectively. The agency began reassessing formaldehyde in 1998 and released a draft IRIS assessment in June 2010. Given the complexity of the issues and the knowledge that the assessment will be used as the basis of regulatory decisions, EPA asked the National Research Council (NRC) to conduct an independent scientific review of the draft IRIS assessment. In this report, the Committee to Review EPA's Draft IRIS Assessment of Formaldehyde first addresses some general issues associated with the draft IRIS assessment. The committee next focuses on questions concerning specific aspects of the draft assessment, including derivation of the reference concentrations and the cancer unit risk estimates for formaldehyde. The committee closes with recommendations for improving the IRIS assessment of formaldehyde and provides some general comments on the IRIS development process.

Tetrachloroethylene is a volatile, chlorinated organic hydrocarbon that is widely used as a solvent in the dry-cleaning and textile-processing industries and as an agent for degreasing metal parts. It is an environmental contaminant that has been detected in the air, groundwater, surface waters, and soil. In June 2008, the U.S. Environmental Protection Agency released its draft Toxicological Review of Tetrachloroethylene (Perchloroethylene) (CAS No. 127-18-4) in Support of Summary Information on the Integrated Risk Information System (IRIS). The draft IRIS assessment provides quantitative estimates of cancer and noncancer effects of exposure to tetrachloreothylene, which will be used to establish airquality and water-quality standards to protect public health and to set cleanup standards for hazardous waste sites. At the request of EPA, the National Research Council conducted an independent scientific review of the draft IRIS assessment of tetrachloroethylene from toxicologic, epidemiologic, and human clinical perspectives. The resulting book evaluates the adequacy of the EPA assessment, the data and methods used for deriving the noncancer values for inhalation and oral exposures and the oral and inhalation cancer unit risks posed by tetrachloroethylene; evaluates whether the key studies underlying the draft IRIS assessment are of requisite quality, reliability, and relevance to support the derivation of the reference values and cancer risks; evaluates whether the uncertainties in EPA's risk assessment were adequately described and, where possible, quantified; and identifies research that could reduce the uncertainty in the current understanding of human health effects associated with tetrachloroethylene exposure.