As an agency with the mission and regulatory responsibility to protect human health and the environment, the US Environmental Protection Agency (EPA) necessarily relies on science as an integral part of its activities. The agency’s responsibility for regulation and enforcement creates a unique combination of drivers for obtaining scientific information to provide fundamental knowledge to inform policy and rules; for establishing robust and defensible analytic methods to support monitoring, certification, and compliance; and for continually innovating to respond to new environmental agents of concern, forensic needs, terrorism, and natural disasters.
EPA applies scientific results that have been provided by various parts of its own organization and by external organizations. The agency clearly 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 its laboratories to enhance the management, effectiveness, and efficiency of its laboratory enterprise1 and to enhance its capabilities for research and other laboratory-based scientific and technical activities. The results of EPA’s evaluation may include options for colocation and consolidation of laboratory facilities.
THE NATIONAL RESEARCH COUNCIL COMMITTEE’S STUDY
As part of its integrated effort, EPA asked the National Research Council to form a committee to assess the agency’s highest-priority needs for mission-relevant laboratory science and technical support, to develop principles for the efficient and effective management of EPA’s laboratory enterprise to meet the agency’s mission needs and strategic goals, and to develop guidance for enhancing efficiency and effectiveness now and during the next 10 years.2 The committee was not asked to identify the highest-priority needs anew, but to assess needs identified previously and to develop principles that would help EPA meet its scientific obligations over the next 10 years.3 Also, it was asked not to assess the physical space and configuration options of EPA laboratories, because that analysis is being undertaken in a separate effort. EPA indicated that it will consider the findings, principles, and recommendations provided by this committee in developing an implementation plan for the laboratory enterprise. This is the committee’s report.
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1“The EPA laboratory enterprise is the aggregate capability and capacity required by its laboratories and laboratory-based centers to meet the Agency’s high-priority mission needs of its programs and strategic goals” (G. Paulson, US EPA, presentation to the committee, September 17, 2013).
2The full statement of task is presented in Appendix A.
3EPA identifies highest-priority needs based on mission relevance, legislative mandates, and guidance from EPA’s strategic plan, which is revised every 4 years. Also, the NRC report Science for Environmental Protection: The Road Ahead (NRC, 2012a) identified scientific priorities for the agency for the next 10 years.
THE ENVIRONMENTAL PROTECTION AGENCY LABORATORY ENTERPRISE
EPA’s laboratory enterprise consists of a distributed network of three general types of laboratories that have different immediate priorities, are typically in different places, and are required to do different things.
• Regional office laboratories provide scientific data that support the needs of regional environmental programs for informing immediate and near-term decisions on environmental conditions, emergency response, compliance, and enforcement.
• National program office laboratories develop and provide specific programs that support decisions on regulations, compliance, and enforcement related to legislative mandates at a national level.
• Office of Research and Development (ORD) laboratories develop knowledge, assessments, and scientific tools that underpin decisions about EPA’s regulatory standards, risk assessments, and risk-management decisions.
Although there are institutional links (for example the EPA science advisor) and important interactions among the various types of laboratories that make up the enterprise, they do not function as a single entity. Not only do the three types of laboratories do different types of work, but their work typically has different timeframes. ORD laboratories may undertake research over a period of 5 years or more, whereas a regional office laboratory might need an immediate answer for a site-cleanup decision and a program office laboratory may be engaged in technical projects on motor vehicle emissions that last for several years. The different kinds of laboratories need different kinds of scientific and technical expertise and approaches, and they report to different managers and policy officials.
Beyond descriptions of the laboratory enterprise as a general concept, the committee received little information from EPA to describe the operational characteristics of the laboratories at the enterprise level. Rather, EPA’s responses to the committee’s information requests generally focused on specific types of laboratories. On the basis of our examination and review, we have concluded that EPA does not have a comprehensive justification or organizing vision for its current laboratory enterprise. The committee identified various opportunities where EPA laboratories could become more effective and efficient through a rethinking of its system of laboratories from an enterprise perspective. The committee recommends specific actions which, if implemented systematically, could provide additional benefit relative to the current management and function of the agency’s network of laboratories.
EPA should approach management of its laboratory enterprise not so much as separate types of laboratories but as a system of the various laboratory efforts in EPA in which science and technical support activities are undertaken to support and advance the agency’s mission–in other words, as an organized composition of diverse components. (Recommendation 4-1)
EPA should develop a vision for its laboratory enterprise that maintains the strengths of the individual components but provides synergy through systematic collaboration and communication throughout the agency. (Recommendation 4-2)
There are several possibilities for structuring the systematic communication and collaboration, and thus implementing the vision of the laboratory enterprise, as discussed in this report. The committee recommends that the means of implementing the vision for the laboratory enterprise be determined by the EPA administrator with a view to meeting the functional criteria set forth in this report for enhancing the efficiency and effectiveness of the enterprise. (Recommendation 4-11)
To implement this vision, we are not recommending that the entire laboratory enterprise be directed or managed by a single person, nor are we recommending that it be operated as a single entity. Those approaches would not reflect a full awareness of the benefits derived from the three different types of EPA laboratories and their ability to contribute to the agency’s mission in different ways. Instead, we envision that the enterprise would seek to preserve the strengths of the different types of laboratories but provide for more systematic communication and coordination among them. Existing lines of communication can be enhanced. Similarly, coordination of existing networks and processes can be enhanced.
ANALYTIC FRAMEWORKS
The committee developed an analytic framework for each type of laboratory and the entire enterprise to help EPA align its laboratory facilities, functions, and capabilities with the highest-priority scientific needs related to the agency’s strategic goals, such as addressing climate change, improving air quality, and protecting America’s waters. The output of the laboratories supports decisions about regulatory standards, policies, risk management, emergency response, compliance, and enforcement. The frameworks are also applicable for addressing persistent or future challenges expected over the next 10 years, such as the need for better knowledge of the environmental and human health risks of low-dose exposures to metals and organic chemicals.4Figure S-1 represents a framework for the entire laboratory enterprise. In developing the frameworks, the committee considered efficiency and effectiveness criteria to guide EPA’s investment, planning, and implementing actions and to establish formal and systematic arrangements for communication and coordination. We encourage EPA to develop and strengthen its management processes by using the frameworks to enable the individual types of laboratories to perform better and to synchronize with each other.
FIGURE S-1 The overall EPA laboratory enterprise, with an emphasis on lines and directions of communication that should be institutionalized. Other communication directions are not intended to be prohibited. In addition to communication, the dashed red lines represent coordination within the enterprise. The dotted green lines under “Implementation” indicate where EPA should reach outside the agency to other agencies, academe, and other research organizations to inquire about what is going on with respect to a given science need. Note: ORD = Environmental Protection Agency Office of Research and Development; PO = program office; RO = regional office.
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4Science for Environmental Protection: The Road Ahead (NRC, 2012a) indicated that advances in analytic chemistry capabilities will continue to enable chemicals to be detected at ever lower concentrations in, for example, the blood of humans and in environmental media (air, water, and soil). This will give rise to questions about what the concentrations mean.
PRINCIPLES FOR EFFICIENT AND EFFECTIVE MANAGEMENT OF THE LABORATORY ENTERPRISE
The 2012 National Research Council report Best Practices in Assessment of Research and Development Organizations (NRC 2012b) provided a list of attributes that characterize an effective research and development (R&D) organization and are considered to be good indicators of the eventual impact and relevance of the organization and the R&D that it performs. Using those attributes, the present committee developed the following principles for the effective and efficient management of EPA’s laboratory enterprise to meet the agency’s mission needs and strategic goals:
1. Every science institution is more effective if it has a vision of how its scientists, technicians, and other professionals can best contribute to the organization’s mission and goals.
2. Essential laboratory capabilities are the ones that are relevant to the current mission and the ones that anticipate future mission needs. Priorities for laboratory capabilities should focus on work that is central to the agency’s mission rather than on small peripheral efforts.
3. Laboratories should avoid internal redundancy or duplication of capabilities that are readily available externally.
4. Recruiting, developing, and retaining an outstanding, committed scientific and technical workforce is crucial for maintaining outstanding laboratory capabilities.
5. State-of-the-art facilities and equipment are essential if a laboratory enterprise is to be able to meet current and future mission needs.
6. Effective management with appropriate flexibility enables an efficient and effective laboratory enterprise.
7. Communication and coordination among the laboratories within an organization are essential for efficiency and effectiveness.
8. Outstanding research and other science-related activities are the foundation for meeting current and future mission needs and for sustaining leadership in environmental science and applied research.
9. A strong linkage to universities, industry, research institutions, and other federal and state government organizations enhances the laboratory enterprise and prepares it for the future.
MANAGEMENT PROCESSES FOR THE LABORATORY ENTERPRISE
Various management processes could be strengthened to tie the components of the laboratory enterprise together and maintain the strengths of the individual types of laboratories without sacrificing the decided advantages that come from the in-depth experience, strong relationships, and proximity that have been the hallmark of laboratories that are dedicated to research, program offices, and regional offices. We looked specifically at planning and budgeting, plan implementation, assessment processes, and, perhaps most important, communication.
Planning
The committee commends EPA on its progress in aligning its research efforts with the needs of its regulatory program and regional offices and ultimately with its strategic goals through ORD’s four-year strategic research planning process, which includes multiple reviews and outreach activities. However, it is possible that more can and should be done. Greater systematic involvement in the planning process by all of the agency’s laboratories would probably yield a stronger and more efficient laboratory enterprise. At the very least, it would allow the various contributors to see how their efforts might connect to work done by others in moving toward its strategic goals. Greater systematic involvement of the laboratories in the planning process also would make it evident to EPA senior management where there are duplicative or overlapping resources that can be eliminated or redirected to other, more pressing needs of the agency. EPA should ensure that its laboratory planning process includes cross–regional office and cross–
program office laboratory input and that it is more transparent within the agency and to outsiders. (Recommendation 4-3)
Budgeting
In recognizing the need to move toward more efficient and more effective management of its laboratory enterprise, EPA may be hampered by a lack of critical budget information related to its laboratories. It appears that EPA does not currently assemble all the financial data needed to produce a budget for the entire laboratory enterprise. That may be in part because EPA has not traditionally viewed its laboratory systems as an overall enterprise and therefore has not considered it important to know how much was actually budgeted for the entire enterprise or for the individual laboratories wherever they are on an organization chart. However, if one views the laboratory enterprise as a system of various components that operate together at some level, such information could be valuable in enabling EPA to manage it.
Having such data would enable EPA not only to ensure that its available resources are being allocated to projects of the highest priority but also to make comparisons among laboratories. It would enable EPA to determine more easily the marginal cost of new laboratory capacity, equipment, or capabilities. It would enable EPA to determine more easily whether the budget provides for long-term laboratory needs, especially emerging issues, such as population growth and water and energy consumption. Equally important, it would enable outsiders to understand and evaluate the choices that EPA makes. Indeed, as resources become even more constrained and the scientific issues related to the environment become more complex and demanding, it may well be critical for EPA to have data to use in defending its need for resources if the laboratories are to carry out their functions. EPA should conduct an annual internal accounting of the cost of the entire laboratory enterprise as a basis for assessing efficiency and assisting in planning. (Recommendation 4-4)
Funding Allocations
The committee observed that EPA does not have a process whereby the entire portfolio of laboratory projects can be arrayed to enable an evaluation of whether available funds are being allocated to activities in a manner that is best aligned with advancing the agency’s mission. EPA should produce fairly accurate estimates of the costs of implementing various types of laboratory activities before undertaking projects and be able to provide final costs at the completion of projects. It can use such data to compare the costs of similar projects that are undertaken in different laboratories, to benchmark for outsourcing that is contemplated for similar kinds of projects, or to assess benefit:cost ratios for different kinds of projects undertaken in various laboratories. EPA should compile adequate data regarding the costs of individual activities in the various laboratories so that it can manage the laboratory enterprise appropriately. (Recommendation 4-6)
Systematic Internal Collaboration
Collaborations among personnel in different components of EPA’s laboratory enterprise currently appear to be mostly ad hoc rather than the result of a systematic process. The committee was encouraged to learn of various undertakings in EPA laboratories that illustrate approaches to efficient use of the capabilities of all its laboratories’ personnel. Examples include the National Center for Computational Toxicology and the National Homeland Security Research Center. The approaches draw on the skills, expertise, and experience of the scientists, technicians, and engineers that work in the various types of laboratories. The committee commends EPA for developing these centers in the laboratory enterprise. EPA should continue to look for innovative ways to address emerging problems and opportunities that create synergies among agency personnel who might encounter similar problems or opportunities within different EPA laboratories within ORD, program offices, and regional offices. (Recommendation 4-5)
Assessment
Most successful organizations use both internal and external mechanisms for assessment. It is important for managers to focus on such specific questions as, Are the results of sufficient quality to be useful? Do the research and other laboratory-based scientific and technical activities address the problem, and are the results ready for implementation? Does the work continue to reflect current program or compliance priorities?
Although the ORD planning process seeks internal comments on the relevance and utility of the outputs of the ORD laboratories, the committee understands that the program office and regional office laboratories do not undertake systematic internal assessments. EPA’s program office laboratories and regional office laboratories should undergo regular internal reviews of their efficiency and effectiveness. (Recommendation 4-7)
ORD not only has an internal assessment process but uses external reviews for assessment.5 Requests for such external reviews are ad hoc, and there is no similar process for external review of the outputs of the program office and regional office laboratories. EPA should expand the use of external reviews to cover all components of its laboratory enterprise. (Recommendation 4-8)
Communication
Communication is perhaps the most important aspect of laboratory management in that it facilitates coordination among the three types of laboratories within the enterprise. We recognize that there has been substantial progress in establishing and maintaining channels of communication throughout EPA and between ORD and the program offices and regional offices. For example, each regional office serves, on a rotating basis, as the lead regional office for designated responsibilities in EPA. In addition, we have seen several examples of various kinds of efforts at communication between program office and regional office laboratories, such as participation in weekly staff calls with the administrator’s office. However, they do not appear to constitute systematic lines of communication among laboratories.
Communication is too important to be left to happenstance and informal arrangements. Difficult issues can arise as the components of the laboratory enterprise seek to coordinate their work. The challenge for EPA is to determine precisely what lines of communication are needed, which ones already exist, and which ones must be established. It should then clearly articulate the need for those lines. EPA should determine precisely what lines of communication are needed, which ones already exist, and which ones should be established. It should then clearly articulate the need for these avenues and the mechanisms by which they will be sustained. (Recommendation 4-9)
WORKFORCE
The most reliable predictor of laboratory performance is the quality of the workforce. It is essential that the workforce be experienced and knowledgeable and that it possess creative scientific and technical capabilities. For a laboratory to be effective, it has to have employees with sufficient expertise for major projects that provide policy-relevant information or data to support regulatory action. The workforce should be nimble and adaptable to address new challenges. The current complexity and pace of the emergence of new challenges facing EPA, such as exposure to new chemicals and nanomaterials, makes the need for a highly capable workforce all the greater. Recruiting, developing, and retaining an outstanding, committed scientific and technical workforce are crucial for maintaining outstanding laboratory capabilities.
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5In particular, the Board of Scientific Counselors, a committee convened under the Federal Advisory Committee Act, is charged with providing technical and management advice regarding ORD’s research program and program plan development.
A critical issue facing EPA is the state of its scientific personnel. The number of full-time-equivalent laboratory staff has decreased over the last 15–20 years, and many senior scientists are approaching retirement age. EPA staff has been augmented by on-site contractors and postdoctoral associates, but there is a potential for loss of critical institutional knowledge as key staff members retire without hiring people to replace them and the time to transfer the senior staff members’ knowledge to junior personnel. This concern applies throughout the laboratory enterprise, from regional laboratories to ORD research facilities.
Staffing high-quality scientists who have relevant expertise and who can embrace problems by drawing on information in many disciplines will require continued attention so that EPA can maintain and enhance its leadership in environmental science and technology. To “sustain leadership capabilities of its laboratory enterprise for environmental science and research”, per this committee’s Statement of Task, EPA will need individuals with excellent, high-quality expertise in science, engineering, and other related fields. To the extent practicable under budget constraints, three tools that would provide EPA flexibility in achieving continuing workforce excellence are the agency’s training grant and fellowships programs, postdoctoral program, and Title 42 program. An important component of implementing each of these tools is periodic independent review to assess whether the efforts are meeting their intended objectives.
Training Grants and Fellowships
EPA is offering Greater Research Opportunities (GRO) undergraduate fellowships for environmental study. In the past, it has also offered Science to Achieve Results (STAR) graduate fellowships to support master’s and doctoral candidates in environmental studies. However, STAR fellowships are not being offered in 2014. The potential transfer of the STAR graduate fellowship program to the National Science Foundation (NSF) illustrates a failure to recognize the differences in training between an EPA fellowship program focused on environmental science and technology and the NSF emphasis on the basic Earth-science or physical-science fellowship. EPA should continue, enhance, and expand its student training grant programs, such as GRO. The STAR fellowship program should be reinstated in EPA to support research programs that are specific to EPA’s mission and goals. (Recommendation 3-5)
Postdoctoral Program
By using the federal postdoctoral research program, EPA can hire early career scientists to address critical research problems. The program also provides postdoctoral scientists with a deeper understanding that may enhance their research futures, wherever their next professional positions may be. EPA should continue its planned hiring of postdoctoral researchers by the Office of Research and Development (ORD) and expand it to other types of laboratories as appropriate. (Recommendation 3-6)
Title 42
EPA needs the highest-quality scientific and engineering expertise if it is to protect health and the environment effectively and efficiently, so it needs personnel tools to hire and attract the best and the brightest. The Title 42 program is one of the most important tools for EPA to use to achieve success.6 Through Title 42, EPA can recruit and retain world-class scientists and engineers who can strengthen the agency’s research and improve the application of science to address its regulatory responsibilities. In 2010, NRC reviewed EPA’s use of temporary Title 42 authority and concluded that the program was
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6Title 42 refers to an administrative provision in §209(f)–(h) of the US Code that gives federal agencies the authority to appoint highly qualified consultants, scientists, and engineers at a pay scale outside civil-service laws described under Title 5. Through the Title 42 hiring program, federal agencies can compete with industry and academe to fill critical senior-level positions.
working well, hiring and retaining top scientists that helped the agency achieve its mission.7 It recommended that permanent Title 42 authority be granted to EPA and the number of Title 42 positions at EPA be expanded on the basis of program needs and available budget.
In the FY 2014 appropriation, Congress provided the EPA administrator with the authority, for FY 2006–2015 and after consultation with the Office of Personnel Management, to employ up to 50 persons at any one time in ORD. The committee notes, however, that the number of Title 42 appointments is not so limited in several other federal agencies that fill scientific positions by using Title 42 authority. According to the US Government Accountability Office, in 2010, the Centers for Disease Control and Prevention had 929 Title 42 employees, the US Food and Drug Administration had 862, and the National Institutes of Health had 4,879.8 The committee agrees with the 2010 NRC report on Title 42. EPA should be granted permanent Title 42 authority and the expanded authority to define the number of Title 42 positions on the basis of its program needs and available budget. In addition, EPA should use an independent body to review the Title 42 program every 5 years to ensure that it is being used for its intended purposes. (Recommendation 3-7)
SYNERGIES WITH OTHER ORGANIZATIONS
An effective EPA laboratory enterprise should be fully cognizant of the array of research conducted outside EPA laboratories, should have mechanisms and programs to capitalize on that scientific work, and should have plans and staffs in its own laboratories not only to accomplish work necessary for its mission but to complement efforts of other agencies and to provide a means of collecting, sorting, and analyzing the results of those efforts to serve EPA’s mission. Data needed to address environmental issues are being generated globally at an enormous rate. To supplement the work of its laboratory enterprise and to use its laboratory facilities and scientific staff efficiently, it is critical for EPA to have a strong capability for accumulating, managing, and mining extremely large and relevant datasets from diverse sources outside EPA. These sources include other federal agencies (such as the Department of the Interior and Department of Agriculture), state agencies (such as departments of health and environment), and private industry (such as motor vehicle manufacturing) in the United States and abroad. EPA should develop more explicit plans for partnering with other agencies (federal and state), academia, industry, and other organizations to clarify how it uses other federal and nonfederal knowledge resources, how it maintains research capabilities that are uniquely and critically needed in the agency, and how it avoids unnecessary duplication of the efforts or capabilities of the other agencies. (Recommendation 4-12)
State-of-the-art facilities and equipment are essential for an outstanding laboratory enterprise to be able to meet current and future mission needs. ORD, program office, and regional office laboratories have various processes for managing and acquiring laboratory equipment, but the processes and inventory tools throughout the agency are not connected. EPA should link inventories of equipment over $500,000 in all laboratories, without regard to mission, to an agencywide accessible process. Before investing in large capital equipment, laboratory equipment in other parts of EPA, other agencies, and universities that could be available for shared use should be explored. (Recommendation 3-9)
ADDRESSING FUTURE CHALLENGES
Examples of important emerging environmental challenges include human and environmental exposure to toxic chemicals, loss of native biodiversity, and new stressors from climate change that affect human health, the built infrastructure, social institutions, and natural ecosystems. A variety of informal and formal approaches that EPA can use for identifying emerging issues and possible solutions are available,
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7NRC, 2010. The Use of Title 42 Authority at the U.S. Environmental Protection Agency.
8GAO. 2012. Human Capital: HHS and EPA Can Improve Practices Under Special Hiring Authorities. GAO-12-692.
including ongoing interactions with state and local governments and formal analyses of future societal scenarios and their ramifications. Advisory groups, such as EPA’s Science Advisory Board (SAB) and advisory bodies established to provide independent expert advice to specific types of EPA laboratories, can also contribute to the process of identifying and evaluating emerging issues.
When faced with a serious emerging issue or important opportunity to take advantage of new knowledge or technologies, the agency could marshal the various institutional research tools that it has already developed into a small E-ARPA (an Environmental Advanced Research Projects Alliance).9 The agency could involve universities and the private sector through its ability to develop cooperative agreements, issue contracts and grants through its STAR grants program, and coordinate the different departments of the government and the different elements of its own scientific expertise. EPA should consider creating an Environmental Advanced Research Projects Alliance (E-ARPA) and also consider how and under what circumstances E-ARPA efforts could be managed to address the agency’s scientific and technical needs. (Recommendation 5-2) Although it did not attempt to estimate the funding requirements for this alliance, the committee does not anticipate that E-ARPA would involve a programmatic effort of comparable magnitude to DOD’s and DOE’s programs.
EPA’s workforce, makeup of expertise among workforce personnel, and management are important elements of its efforts to identify and address emerging issues. A focused commitment by career managers and political appointees is essential for sound decision-making and for maintaining a workforce that is capable of identifying and dealing with emerging issues.
CONCLUDING REMARKS
Given the principles and recommendations provided in this report, we believe that EPA has the tools to design and implement a plan for enhancing its network of laboratories. The actions that the agency takes to improve the effectiveness and efficiency of its laboratory enterprise should be organized around the concept of a system that maintains the strength of the individual laboratory types while providing systematic collaboration and communication throughout the agency. The committee recognizes that some of the recommendations may be difficult to undertake, and that sufficient resources may not be available to undertake them all in the near term. Therefore EPA will need to set priorities and develop a strategy for addressing them as part of its integrated evaluation of agency laboratories.
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9The Department of Defense’s Defense Advanced Research Projects Agency (DARPA) and the Department of Energy’s (DOE’s) Advanced Research Projects Agency–Energy (ARPA-E) program are examples of robust programs that are used to anticipate developments and possible responses. The name of the suggested EPA program is patterned after, but different from, DOE’s ARPA-E.
