THE PLANNING AND 'MANAGEMENT OF RESEARCH AND DEVELOPMENT ACTIVITIES WITHIN EPA A Report to the President and the Congress U.S. Environmental Protection Agency June 30, 1978 ------- EXECUTIVE SUMMARY This report describes a study conducted by EPA in response to a directive contained in Section 7(c) of the Environmental Research, Develop- ment, and Demonstration Authorization Act of 1978. Specifically, this study has two objectives: 1) to determine the causes of the operational problems identified in recent studies of EPA's research management process; and 2) to develop specific corrective measures to alleviate these problems and assure the most effective use of the Agency's substantial research and development (P.&D) resources. Two intra-Agency groups were formed last year to achieve these two objectives. The first group was a policy-level committee consisting of all the Assistant Administrators, the Executive Director of the Science Advisory Board and key Regional and laboratory representatives. This group was responsible for overall direction and decision-making. The second group consisted of Agency-wide senior staff members, whose function was to provide necessary analysis and support to the policy-level group. The analysis of the causes of the operational problems within EPA's research management process revealed that the Agency lacked the following fundamental components: 1) a coherent research strategy which related program objectives and priorities to research activities; 2) effective communication and decision-making mechanisms between researchers and ------- programs; 3) an adequate program of long term and anticipatory research; 4) adequately responsive research results; and 5) consistent research quality. In order to gain insight into the specific mechanisms which might be used to alleviate these problems, the R&D management systems of the Fish and Wildlife Service, the Nuclear Regulatory Commission, the Food and Drug Administration, and the Occupational Safety and Health Administration were examined. Certain aspects of each of these systems were incorporated into EPA's revised R&D planning and management system. The policy group determined that the Agency's R&D problems have not resulted from the way the R&D program is organized so no provisions for major reorganizations are included in the revised system. The revised R&D planning and management system does, however, contain five major components which differ significantly from previous EPA R&D systems, and which are clearly linked to the five major deficiencies identified above. Specifically, these components are: 1) the identification of distinct research planning units around which coherent regulatory program/research strategies can be developed; 2) the establishment of permanent Research Committees for each research planning unit and a separate Research Oversight Committee composed of top EPA managers who will review strategy develop- ment and provide oversight throughout the R&D planning and imple- mentation cycle; ------- 3) the tying of R&D planning and management processes into Agency- wide management processes with decision rules focused on these connections; 4) a Research Incentive System designed to encourage responsiveness to Program and Regional research needs; and 5) the incorporation of peer review mechanisms throughout the plann- ing and management process to improve research quality. Sines tha revised system for R&D planning and management represents a major departure from previous EPA systems, the policy-level group decided that it should be tested on a pilot-study basis. Five pilot projects were, th*=-"pfore, initiated on March 15 and will be monitored closely for a six month period. The pilot areas include research activities in the areas of drinking water, industrial wastewater control, mobile source air pollutants, pesticides, and respirable particulate matter. A report on the pilot-study results will be provided to the Committee on Environment and Public Works and the Committee on Science and Technology by October 31, 1978. This report will include a description of the experience of each pilot area, recommended changes in the R&D planning and management system based on the pilot experience, and steps undertaken to extend the approach to other EPA research and development activities. ------- THE PLANNING AND MANAGEMENT OF RESEARCH AND DEVELOPMENT ACTIVITIES WITHIN EPA A Report to the President and the Congress I. INTRODUCTION A. Purpose This report has been prepared in response to a directive contained in Section 7(c) of the Environmental Research, Development, and Demonstration Authorization Act of 1978. It also reflects more wide ranging efforts by EPA to improve its research management capabilities. The purpose of the report is twofold: (1) To determine the causes of the operational problems identified in recent studies of EPA's research management process; and (2) To describe the specific corrective measures that are now being implemented in order to alleviate these problems and assure the most effective possible use of the Agency's substantial R&D resources. ------- B. Recent Activities Two intra-Agency groups were formed last year to address the various concerns that have been raised in recent years. The first was a policy level committee consisting of all the Assis- tant Administrators, the Executive Director of the Science Advi- sory Board and key Regional and laboratory representatives with an interest in the coordination of program and research activity. This group was responsible for overall direction and decision- making. The second group was at the working level and consisted of senior Agency staff members, whose function was to provide the necessary analysis and support to the policy-level group. At the direction of the policy group, the staff had three major responsi- bilities: (1) Identify current problems in the planning and management of R&D activities; (2) Examine systems used by selected other agencies to plan and manage their R&D activities; and (3) Develop organization and management options for the conduct of the R&D program at EPA. ------- II. ANALYSIS OF PROBLEMS A. Summary of Problems The problems facing EPA's R&D program have been described and discussed by several Congressional committees, the National Academy of Sciences, and the Office of Technology Assessment and were confirmed by the EPA internal working group in its review. These problems include insufficient attention to long-term anticipatory research, a general lack of responsiveness to the programs' regulatory concerns and the uneven quality of EPA research. An analysis was undertaken of each of these problems to determine the underlyirsn causes, looking particularly at the inadequacies of past EPA research planning and management systems. A summary of this analysis is presented below. B. Causes of Problems 1. Inadequacy of EPA's Program of Long-Term and Anticipatory Research Both the Committee on Environment and Public Works and the Committee on Science and Technology have expressed a special concern about the inadequacy of EPA's long-term and anticipa- ------- tory research program. At the heart of this problem is the need for a clear EPA commitment to devote a significant part of its resources to well-thought-out research projects which identify and address potentially significant environ- mental hazards. The appropriate balance between longer-term anticipatory and shorter-term programmatic research is largely a matter of experience and judgement. As described more fully below, EPA's early experience was that of attempting to assimilate pieces of existing programs and organizations while at the same time trying to implement new legislation. The urgency of legislative mandates and the demands of forming a new organizational structure combined to create an atmosphere in which immediate concerns inevitably assumed priority over long-range needs. In the past EPA has tried to improve research management and coordination by reorganizing various elements of its research program and by introducing a number of different planning and control methods. While each of these changes was designed to correct one or more perceived problems, one aggregate result of so much change was to create the sense of continuing instability, which promoted short-term problem solving, but worked against a longer range perspective. ------- Both the Agency and the Congressional Committees with over- sight responsibility are now agreed on the need to correct this imbalance in EPA's research perspective. 2. Unresponsiveness The staff group identified the following causes for allegations that the research program is unresponsive to EPA's "regulatory needs: (1) inadequate future planning by the regulatory programs; (2) inherent differences in perspec- tive between research and program staff; and (3) inadequate communications between the two staffs. Review of Agency program plans and interviews with Agency program and research staff strongly indicate that the Agency simply did not develop its program strategies in enough detail and with specificity sufficient to permit identifi- cation of research needs and priorities. Early research planning was characterized by solicitation of research ideas from the regulatory program offices. Although such a relatively common approach did yield numerous "research needs," it proved impossible to manage, since there was no programmatic framework within which to assess potential utility and to establish relative priorities. ------- The second source of problems relates to the inherent dichotomy between researchers and regulators. Researchers tend to approach problems from a longer-term perspective, whereas regulators must focus on more immediate concerns. Even when attempting to address immediate needs, researchers often require long lead-times, both in conductinr and in redirecting their research efforts. Regu^cors, on the other hand, are faced with immediat".-, often inflexible deadlines which are established in legislation or court decisions or which grow out of the need to address unantic- ipated hazards. Regulators demand a degree of respon- siveness which is antithetical to a stable research environment. Furthermore, researchers, by training and in response to the standards of the research community, are deeply concerned with quality of the research. Their motivation and pro- fessional recognition is based on the quality, not the timing of the work. Regulators, however, are primarily interested in the timeliness and utility of information. They are sometimes forced to make judgments on the basis of the data which is available at the time the decision has to be made. ------- Thus, an inherent set of tensions is created because of different professional experiences of and demands on researchers and regulators. While these tensions can never be fully resolved, they can be brought into a reasonable balance that best supports the Agency's regulatory mission. Finally, and perhaps most significantly, there were few effective communications channels at the appropriate oper- ating levels of the organization. Effective linkages between laboratory directors and their research staffs with relevant program divisions and regional offices often did not exist. The complex, discipline-oriented organizational structure of the Office of Research and Development (CED), with its fifteen laboratories, complicated communications problems. While the discipline orientation is not an insuperable problem itself, the lack of organizational alignment with the structure of the regulatory program offices tends to exacerbate the communications problems. Without a systematic planning and management process to compensate for these organizational complexities, decisions have often been forced to the top of the organization, often to the Assistant Administrator level, for resolution. But ------- 8 because of the limited time of top management to respond to the demand for ad hoc problem solving, many problems are simply never resolved, adding further to perceptions of unresponsiveness and organizational isolation of ORD within the program and regional offices. Because of these long-standing communications problems, there is great skepticism within the Agency as to whether any research management system can function effectively. Fears of paper-intensive planning systems, of undelivered promises from ORD, of the unwillingness or inability of the regulatory . programs to pay sufficient and knowledgeable attention to identifying their research needs, of the conduct of "closet" research by the program offices, and of th>e Continued "isolation" of ORD from the rest of the Agency reflect a history which must be appreciated in order to be overcome. 3. Uneven Quality of Research. Under these circumstances the review, evaluation and quality control of research activities has been extremely difficult. This has resulted in the dissemination of research results of uneven quality. Also complicating the problem of obtaining high quality research are the inter-related problems of attracting and keeping highly qualified staff within the constraints of civil service salaries and rules and requiring that senior staff assume supervisory duties in order to be promoted. ------- This report addresses the research quality issues that can be impacted by the planning and management process. The research personnel issues are being addressed in an associated study of EPA's overall personnel management efforts. C. The Changing Situation A brief look at the history of EPA shows that the atmosphere for program and research coordination has changed significantly over the last seven years. During its early years, EPA tended to operate in a crisis mode. The enactment of a continuous stream of new legislation during EPA's formative years demanded that the top Agency priority be the development and implementation of regulations. This occurred while EPA was simultaneously attempt- "• ing to integrate a diverse set of programs and administrative units into a viable and rational new organization. While the research effort contributed vital information during this era and provided expert witnesses for judicial proceedings, much of OFD became increasingly detached from regulatory concerns and came to be viewed as a bystander while the program and regional offices struggled to put the major regulatory building blocks in place. Today, the legislative mandates of EPA are relatively stable. All parts of the Agency have attained greater organizational maturity. More time can now be devoted to the interaction of ------- 10 research with the regulatory efforts. Furthermore, the exper- ience gained in the early years of the Agency's existence has brought about a change in perspective that will be of great assistance in this effort. A. heightened awareness of the importance of timely, credible research is developing. There is also a recognition of the need to use the Agency's research resources more effectively. Finally, and most importantly, top management now has a commit- ment to manage the Agency. Research management is only one of many activities under careful scrutiny. A wide range of reforms are now being proposed and implemented which include regulatory reforms, ZBB process improvements and personnel management reforms. The reform of the research management process is a significant element in this agenda for action. D. Relating Solutions to Problems In order to have impact, proposed solutions must be directly related to, and able to solve, the problems being addressed. While this seems obvious, organizational solutions are pre- scribed, more often than not, when, in fact, the underlying problems call for quite different remedies. This analysis includes a careful linking of identified problems with proposed solutions. ------- 11 The lack of a programmatic context for environmental research calls for the development of a coordinated program/research strategy. Only then can major goals and objectives be iden- tified, coherent plans developed and implemented, and results evaluated. The lack of adequate communication channels and decision-making procedures underscores the need for structured and meaningful interactions among the appropriate research, program, and regional staff, as well as outside experts. The inadequacy of the current program of exploratory research calls for provisions in the planning and management process to protect and enhance those longer-term efforts which have the potential to help solve future environmental problems. The perceived inadequacy of research findings in terms of usefulness and timeliness calls for innovative approaches through which program and regional offices can assure responsiveness to their regulatory and enforcement needs. Finally, the uneven quality of research results emphasizes the need for qualified peer review of research plans, protocols, and findings—in fact, that quality must be built into each step of the research planning and management process was an inescapable conclusion. ------- 12 The following matrix summarizes the results of our analysis. Problem Corrective Action Lack of research strategy Program context for research management Lack of adequate communi- cations and decision-making Inadequate program of long- term anticipatory research Inadequately responsive research results Communications and problem solving at operational levels Protection of long- term research activi- ties Greater program and regional influence and responsibility Incorporation of peer review throughout planning and management process E. Review of Systems Used in Other Agencies In order to gain insight into the specific mechanisms which might be used to address the problems identified above, the R&D planning and management systems used in four other regulatory agencies were examined: Uneven research quality ------- 13 • Fish and Wildlife Service (FWS) • Nuclear Regulatory Commission (NEC) * Food and Drug Administration (FDA) • Occupational Safety and Health Administration (OSHA) For each agency, the review consisted of two components: 1) interviews with key staff in the research office, in a program office, and in an administrative or planning office; and 2) an examination of relevant agency documentation such as organizational charts, functional statements and planning manuals. As shown in Table A, the missions of these four agencies are quite different. There are also fundamental differences in the way each agency obtains R&D support for its programmatic activi- ties. In FWS, control of R&D funds rests with the program offices while all research is performed by FWS's research office. The NRC, on the other hand, gives funding control for R&D to its research office which in turn "contracts" with the Department of Energy (DOE), where most of the work is performed. At FDA, R&D responsibilities are assigned to the program offices, which have their own research labs. Finally, OSHA, which is part of the Department of Labor, essentially has no research capability. Instead, OSHA relies on HEW's National Institute of Occupational Safety and Health (NIOSH) for the research needed to support its activities. ------- 14 While it was determined that it would be impractical and inappro- priate for EPA to adopt any of these R&D systems j.n toto, there are features of each model which were found to be of significant merit and were therefore incorporated into the design of EPA's new R&D planning and management system. Table B presents a summary of the major features of each agency's R&D planning and management process. Those features which are particularly relevant to EPA's R&D concerns are marked with asterisks. These are the features that best addressed the basic problems identified above. 1. Program/Research Strategies. The review of the four indicated that none of their R&D plcinning and management systems had evolved to the point where future planning such as required for the development of well-coordinated strategies was consistently being performed. Some, however, do have formal planning procedures which show particular promise for EPA. At NIOSH, the Director prepares a yearly research strategy in cooperation with an OSHA-NIOSH policy group. However, the strategy is quite broad in scope. EVJS, on the other hand, requires its program managers to prepare detailed strategy papers during the ZBB year which specify program ------- 15 objectives and required R&D support. These strategies are relatively narrow in scope since they relate only to one program manager's area of responsibility; If a middle ground could be found between these two forms of strategy development, a viable method of preparing well-coordinated program/research strategies could be developed. 2. Communications Between Researchers and Programs. Each agency examined had at least one mechanism in place for resolving problems between program office and research managers. The mechanism employed by NRC appears to us to be the most adaptable to EPA's situation. Specifically, NRC uses standing Research Review Groups which meet on a periodic basis to resolve policy and technical issues encountered in the research program. Each Research Review Group, which consists of high level staff from the program offices, the research office, and DOE laboratories, is responsible for reviewing a particular research area. The Research Group is also assisted by outside experts. 3. Ways to Assure Responsiveness and Protect Long-term Research. Since responsiveness of research to program needs and the maintenance of long-term research capabilities are inter- dependent, both will be discussed here. The mechanism used in EV7S offers one method for ensuring research respon- ------- 16 siveness. PWS gives R&D funding control to its program offices. EWS feels that this arrangement gives the program offices a vested interest in research since they must take responsibility for seeing that R&D funds are spent on research which supports their needs. At the same time, the researcher feels the incentive to be responsive since funding could be withdrawn if he does not perform in accordance with the program's requests. FVJS has no formal mechanism for protecting long-term research. However, agency staff stated that there is an informal under- standing that some of the program offices' R&D funds will, in fact, be spent on long term research. 4. Research Quality. Maintenance of a consistent quality of research is a goal that is not unique t^ *-he four agencies examined or to regulatory agencies in general. Each of the four agencies does have a procedure to be followed in the evaluation of research (Table B). Some of the agencies also have procedures established to ensure transfer of research results. For example, at the NRC following the evaluation of research, a Research Information Letter (RIL) is prepared which includes a brief technical description and identifica- tion of the user need, an executive summary of principal ------- 17 results and their significance to NRC, and a concise descrip- tion of the evaluation of the results including the range of applicability. F. Analysis of "Organizational Solutions" In reviewing the organizational arrangements in other agencies and in EPA, the issue of a possible reorganization of the EPA research program was addressed. Both centralized and decentralized systems were analyzed. While there are advantages and disadvantages to each approach, the critical issue becomes whether or not the problems facing EPA's R&D program have resulted from the way it is organized. The Policy Group reviewed a number of options for R&D in EPA which paralleled the organizational arrangements in other agencies, but ultimately rejected them. The reasons for rejecting options requiring reorganization were: o Current organizational arrangements are not at the core of the problems facing the Agency's R&D effort. o ORD has, in its short existence, already gone through several reorganizations, each with an increasingly severe impact on morale. o A reorganization always disrupts ongoing activity. VJhen that ongoing activity consists of research projects typi- cally lasting two to four years, the potential costs in ------- 18 terms of projects that are aborted or seriously disrupted is considerable. • In examining the possibility of reorganizing EPA's research function along program lines in a manner similar to that of FDAf it was found that: - Such a reorganization would be hindered by EPA's large number of geographically dispersed laboratories and by the fact that many are simultaneously supportive of several different programs. - A decentralized research program such as FDA's may result in duplication of research effort. • EWS's, and to a certain extent NRC's, organizational arrangements are similar to EPA's. e The OSHA/NIOSH arrangement where research and operational programs are located in separate Departments does not seem to offer a useful model for enhancing the responsive- ness of research activities to regulatory needs. The Policy Group, in rejecting solutions which were dependent on major reorganization, asked rather that management system changes be proposed which would bring about the desired improvements in the functioning of the Agency's research program. ------- 19 III. RECOMMENDED SYSTEM The system that is being recommended for implementation in the planning and management of research and development in EPA has five major components: 1) the identification of distinct research planning units based on regulatory programs; 2) the establishment of permanent Research Committees for each research planning unit and of a separate Research Oversight Committee composed of EPA's top management; 3) the tying of R&D planning and management processes to Agency- wide management processes with decision rules focused on those connections; 4) a Research Incentive System designed to assure responsiveness to program and regional research needs; and 5) the incorporation of peer review mechanisms throughout the planning and management process to improve research quality. These design features are directly linked to the five major problem areas identified earlier (See Table C). Each of these features is discussed in detail below. ------- 20 A. Research Planning Units This analysis has shown that many of the problems associated with EPA's R&D program would be alleviated if a set of carefully laid-out regulatory program/research strategies were to be developed around a logical planning framework. The conceptual basis for the EPA R&D planning and management system will be clusters of R&D activities which, because of their inherent interdependencies, should be planned and managed as a unit. The following are examples of possible research planning units: • hazardous air pollutants • toxic pollutant control • nonpoint source pollution control * hazardous waste disposal • safe drinking water In many cases, research planning units will be "multi-media" and will cross program lines or research category and budgetary boundaries. "Toxic pollutant control" is an obvious example since three program offices have a stake in this area of research activity. Within these research planning units, major goals and objectives can be defined and relative roles and responsibilities for the conduct of research clarified. It is expected that 15-20 such research planning units will eventually be identified with each having $10-25 million in resources. ------- 21 B. Research Committees In order to facilitate effective communication between ORD, Program Offices, and Regions in overseeing the planning and conduct of research during ZBB, planning, and implementation years, Research Committees will be established for each research planning unit. Each Research Committee will be chaired by a Research Manager designated by ORD and will have representatives from relevant client offices (Program Offices and Regions). Regional representatives will be selected by the Regions collectively. The services of experts from other Agencies and from outside the Federal Government will also be used. Each Research Committee will be a permanent body with continuing responsibilities throughout all phases of the R&D cycle. Specifically, the Research Committee will be responsible for: • developing a multi-year research strategy which is based on the relevant regulatory Program strategy, and which identifies Agency research goals and objectives as well as broad Program and Regional research output requirements, • reviewing and suggesting appropriate modifications in related ORD, Program Office and Regional ZBB decision units which include research components in order to assure their respon- ------- 22 siveness to approved research strategies and their consistency with regulatory components of those same and other decision units; • analyzing relevant research decision units in the ZEB process; • monitoring progress during the planning and implementation years against approved strategies and implemention plans and suggesting corrections for significant deviations to the relevant ORD unit; • serving as the primary forum for resolving R&D issues encoun- tered by the Program Offices, the Regional Offices, or ORB during the planning and implementation years, or if unsuccessful, referring the issues to the Research Oversight Committee; • as time allows, reviewing and evaluating research results; and • as time allows, recommending the appropriate timing and means for disseminating specific R&D products. The Research Committees, however, will act in an advisory capacity only and will raise major unresolved issues to the Assistant Adminis- trator for Research and Development, who will negotiate a resolution with the appropriate Assistant and Regional Administrators. Issues still unresolved will be raised to the Research Oversight Committee. Research ------- 23 Committees will not assume the operational responsibilities of ORD, the Program Offices, or the Regional Offices. The development of Program strategies, ZBB decision units, implementation plans, project workplans, routine project evaluation, etc., will remain line management responsi- bilities. Research Committee Purview. Research and development activities in EPA are grouped into three basic categories, not all of which may be relevant to any particular research planning unit. These categories are defined as follows: a. Exploratory R&D* — research which is conducted primarily for the purpose of developing fundamental knowledge and principles appli- cable to the solution of currently intractable problems or scien- tific questions, or research which is aimed at identifying or understanding environmental problems on the horizon for which no specific regulatory activity is currently contemplated. b. Regulatory/Operational Support R&D—research in response to identified program or regional office operational requirements, or research designed to test current Agency, Program or Regional assumptions but which is not immediately required in support of * The Exploratory category will include, but not be limited to, the Anti- cipatory Research activities funded under the Interdisciplinary budget category. ------- 24 planned regulatory actions. It also includes technical assistance support services in response to ad hoc needs or special requirements that cannot be planned in detail during normal budgeting and planning cycles. c. Assigned Mission R&D—research in response to missions speci- fically assigned to EPA by Congress, the White House or OMB beyond the general requirements of the Agency's enabling legislation. Examples include the Interagency Energy/Environment Program and the Biological and Climatic Effects of Radiation (BACER) Program. Most Research Committees will be responsible for research which is primarily regulatory/operational support in nature. Nevertheless, these Committees will be expected to address relevant activities from all research categories that fall within the purview of the Committee's research planning unit. This will include appropriate portions of the Exploratory R&D and Assigned Mission R&D categories. In addition, the Office of Research and Development will establish Research Committees for the Exploratory R&D and Assigned Missions R&D categories. These two Research Committees, which will be chaired by the Assistant Administrator for Research and Development, will include Program and Regional representatives and draw on outside experts for consultation. The jurisdictions of these two committees will partially overlap with those of the other Research Committees. (See Table D). ------- 25 In addition to conducting their own independent deliberations, the Exploratory and Assigned Mission Research Committees will receive recommendations from the other Research Committees and will integrate them into their priorities. The Exploratory R&D Committee will also receive and incorporate recommendations from a "bottom-up" planning process as called for in the report of the National Academy of Sciences, Such a process would allow laboratories and bench-level scientists to propose implementation of specific longer-term research projects. In the case of Assigned Mission R&D, the Research Committee will assure the consistency of its recommendations with priorities set by Congress, the White House, and OMB. As with all Research Committees, the activities and recommendations of these last two Committees will be subject to review by the Research Oversight Committee (see below). The Office of Research and Development will normally be responsible for the detailed planning and implementation of projects in the Exploratory and Assigned Mission categories. However, when changes are made in the programs in either of these categories which might directly or indirectly affect Regulatory Support R&D, it is the responsibility of the Assistant Administrator for Research and Development to inform the affected Research Committees. ------- 26 In addition to the Research Committees, a Research Oversight Committee composed of the Assistant Administrators and of those Regional Adminis- trators named by the Deputy Administrator will also be established. It will be chaired by the Assistant Administrator for Research and Development and have general responsibility for reviewing the activi- ties and recommendations of all Research Committees and for resolving all issues that cannot be resolved at lower levels. Specifically, it will be responsible for: o reviewing and approving multi-year strategies developed by Research Committees; o giving overall policy direction to the Research Committees and to the Agency with regard to research activities and resolving major operational problems regarding the conduct of research or research planning; and o overseeing, with the Science Advisory Board, evaluation by the Research Committees of research products and, as neces- sary, reviewing and approving Research Committee recommen- dations regarding the appropriate timing and means for disseminating research products. C. Integration of R&D Management and Planning with EPA Planning Process It is considered crucial that the planning and management system for R&D be carefully tied to the ongoing management system of EPA and that ------- 27 clear well-defined decision rules be applied. Some of these decision rules will act to foster long-term research and assure its relevance to potentially significant regulatory needs. The following section describes the relationship of the new R&D planning and management System to the Agency strategy formulation and ZBB processes and to planning and implementation activities. 1. Pre-ZBB Strategy Development. Each Research Committee will develop a strategy that addresses all phases of the relevant research activity. The research strategy will delineate the major goals and objectives for the relevant areas of research activity. Such a research strategy will, whenever possible, be developed within the context of a pre-existing program strategy. Outside experts will be asked to play a significant role in the development and evaluation of this strategy. All EPA research funds (e.g., ORD, Program, Regional) will be encompassed in the research strategy document as appropriate. Prior to the development of multi-year research strategies by the Research Committees, it will be necessary for the Program and Regional Offices to have carried out the following preliminary activities: • prepare an inventory of all statutorily mandated or court ordered program requirements and of all other specific program needs, ------- 28 • prepare a timetable of required completion dates for each of the above activities, • identify all technical information needed to carry out the above activities, and • identify all information gaps and the time frame within which these gaps must be filled. This last item will be the major Program/Regional input to the Research Committees' strategy development process. Completed strategies will then be reviewed and approved by the Research Oversight Committee. The Assistant Administrator for Research and Development, with the advice of the Research Oversight Committee and after consultation with the Administrator, will define the general resource levels by planning unit, for the Exploratory R&D and Assigned Mission R&D categories. 2. ZBB. The R&D elements of the ZBB decision units will be based on the specific research planning unit strategies developed by the Research Committees. They must also be consistent with any associated program decision units. Program decision units should, if possible, be drafted prior to the drafting of research decision units. 3. Planning Year. Detailed research planning and execution in response to approved strategies and objectives will normally be the responsibility of ORD. Accomplishment plans for R&D activities will ------- 29 be prepared by ORD or the responsible Program or Regional office and submitted to the Research Committee for review and comment. Reorien- tation of the plans, as appropriate, will be recommended to ORD or the other responsible office by the Research Committee. In the case where Program or Regional Offices wish to implement specific extramural R&D activities independently, ORD will be given the opportunity to review the research proposals to determine if there is any duplication with past, ongoing, or planned ORD activities, and to comment on the technical quality of the proposed activities. Finally, under the Research Incentive System, a portion of the research funds may be allotted to a Program or Regional Office rather than to ORD. When this does occur, ORD will, within agreed-upon time constraints, be given adequate opportunity to negotiate for the opportunity to conduct that research intramurally or to provide contract monitoring services to the sponsoring Program or Regional Office. If the Program or Regional Office accepts ORD's offer, the management details (costs, timing, form of output) will be negotiated between ORD and the client office. 4. Implementation years. The Research Committees will review progress periodically in response to the research strategy and implementation plans during the implementation phase of the R&D cycle, and report on an exception basis to the Research Oversight Committee. ------- 30 As time allows, the Research Committees will also review and evaluate results in terms of technical quality and operational responsiveness. Both Agency and outside experts will be used to conduct such reviews. The Research Committees will also, as time allows, identify the appropriate timing and method of dissemination of specific R&D outputs. D. Research Incentives System The Research Incentives System (RIS) will constitute an important element of the proposed R&D planning and management system. The primary purpose of the RIS is to establish a mechanism to encour- age ORD to be responsive to Program and Regional needs and to encourage Program and Regional Offices to take seriously their responsibilities for clearly articulating their research needs and for following the progress of key research projects. The RIS would establish a client- contractor relationship between ORD and the Program and Regional Offices. It would require ORD and Program and Regional Offices to work together effectively to avoid the results of failure—loss of research resources by ORD, and assumption of day-to-day research management duties by the Programs or Regions. We are now considering a number of variants of the RIS, one of which will be discussed for illustrative purposes. During strategy develop- ment, Program and Regional Offices would identify areas of research ------- 31 that they feel they should more closely manage because those areas are key to the success of their regulatory efforts in the near-term. Program and Regional Offices, with the assistance of ORE), would develop appropriate proposals to incorporate into the ZBB decision units. The ZBB ranking process would then be used to determine the relative priority of such proposals. Based on ZBB decisions and Congressional action, implementation plans for activities assigned to Program or Regional Offices would be developed by those Offices. The Offices would then negotiate with ORD to conduct the research within its laboratories or to provide contract management services for the Program/Regional Office projects. Alternatively, the Program/Regional Offices, after consultation with ORD, could contract directly with outside firms to conduct the desired research. Through judicious use of the RIS, all managers - Assistant Administra- tors, Deputy Assistant Administrators, and Division Directors - can be given a greater say in project direction for those projects that will contribute significantly to meeting their program needs. The effect of establishing a Research Incentive System will therefore be to enhance the impact of the Research Committee System in promoting openess and responsiveness in communications between research managers and program managers at all three management levels. ------- 32 In order not to overshadow the positive effects of increased research responsiveness which would grow out of this system, however, it is necessary to build in safeguards against potentially negative conse- quences. To avoid undue instability in ORD research efforts, it could be specified that a percentage of research funds managed by ORD in the previous year would continue to be managed by that organization. For example, the Program/Regional Offices could be required to spend 90% of those funds within ORD. Further limits could be placed on the extent of reprogramming of ongoing projects by the Program or Regional Offices without the concurrence of the Assistant Administrator for ORD. Since the Research Incentive System would be operated within the context of agreed-upon research strategies, ZEE decision units and implementation plans, changes in program emphasis or direction would not be made beyond those necessitated by unanticipated needs. Such an approach to the Research Incentive System would have obvious benefits for the Program and Regional Offices which depend upon research findings for their regulatory efforts. These Offices could participate as they chose in the development and approval of research protocols, thereby enhancing the likelihood that the outputs will be specifically tailored to their needs. ------- 33 ORD also has much to gain from a Research Incentive System. Under the current arrangement, requests for new research support are often made to ORD without regard to the relative priority of those requests and without a sense of what research activities are delayed or disrupted by the new requests. The new system instead requires that the Programs/ Regions articulate and set priorities among the requests that they make of ORD. By allowing ORD to choose whether or not to "bid" on key projects, the RIS will allow ORD to set its prices competitively in order to develop in-house research capability, especially in emerging areas. Clearly, whatever variants are selected by the pilot studies, the RIS will have to be applied flexibly in order to meet the special condi- tions of each research planning unit. In general, however, growth areas or those with many short-term projects can probably respond most effectively to such a system. E. Research Quality. The incorporation of peer review mechanisms throughout the planning and management process is fundamental to the success of the proposed R&D planning and management system. Each research committee will use such mechanisms during the planning, implementation, evaluation and dissemination stages of research. Committees will address the following questions: ------- 34 How should "technical quality" be measured? What is the appropriate mechanism•for making the trade-off between timeliness of response and thoroughness of analysis? How and by whom should the product of research be presented to the client/user? What mechanisms should be used to ensure that researchers receive feedback on the timeliness, quality, and utility of the products of ongoing or completed research efforts? IV. ACTIVITIES UNDERWAY TO IMPLEMENT THE SYSTEM The Policy Group, after agreeing to the R&D planning and management approach decribed above, concluded that it would be prudent to test the system in several pilot projects. In this way, the many facets of the system can be thoroughly tested and modified or possibly rejected in order to increase the prospect for the system to work effectively as it is applied to other parts or all of EPA's R&D program. Five pilot areas have been selected. They represent five "natural" areas of research planning which are of major importance in EPA's regulatory and research efforts. They include one area (respirable particulates) which both is specific to a regulatory program (air quality) and cuts across all areas of research disciplines. The ------- 35 other four are also specific to a single regulatory program but are concentrated in only one or two research disciplines (drinking water, industrial wastewater control, mobile source air pollutants and pesticides). The jurisdiction of each of the five pilots falls within the boun- daries of a single Program Office but this need not always be the case. When the pilot project is completed and additional Research Committees are established to cover the bulk of EPA's research activity, some Committees may have responsibilities which cross program boundaries. During the pilot period, the recommended R&D planning and manage- ment system is being applied within each of the five pilot areas. The Research Committee established for each pilot is composed of relevant ORD, Program, and Regional staff and will be assisted by outside experts. Each Research Committee will develop a brief research strategy, participate in the 1980 ZBB process, and review and, where appropriate, make recommendations for reprogramming of research activities planned for FY-79 and of research underway in FY-78. To the extent possible, variants of the Research Incentives System will be tested. The pilot projects were formally initiated on March 15, and will be monitored closely for a six-month period. A report on the pilot experience will be provided to the Congress by October 31, 1978. ------- 36 This report will include a description of the experience of each pilot study, recommended changes in the R&D planning and management system based on the pilot experience, and steps taken to extend the system to other parts of EPA's research and development activities. ------- AGENCY Table B. STRATEGY DEVELOPMENT ling Features of R&D Planning and Management Systems Used in Target Agencies R&D PLANNING AND MANAGEMENT PROCESS ZBB PLANNING IMPLEMENTATION EVALUATION III. FDA O Program managers within the bureaus recommend program goals and objec- tives. Subject to concurrence by the bureau management, the plans are prepared and presented to the Commission during the planning process as the Bureau's Proposed Accompli slime nt Objec- tives. o PMS updated annually to assure coverage of problem areas o Level of effort for R&D defined during the Accomplishment Objective phase of the Planning Process prior to ZBB. o Program managers prepare decision units. o "Bottom -up" mechanism for surfacing and ranking R&D proposals. along with all other programmatic proposals. o Office of Planning and Evaluation and Office of Administration identify allocation decisions for Commissioner o Commissioner designates fiscal year priorities and deter- mines needs for real loca- tion of finds. o Detailed plan- ning performed by program managers. o All research implemented by program office labs, one or more of the 20 field labs, or NCTR. Face-to-face brief ing of Commissione and his top staff by prog ran manager on program accom- plishments. ------- Table B. Features of R&D Planning and Management Systems Used in Target Agencies R&D PLANNING AND MANAGEMENT PROCESS STRATEGY AGENCY DEVELOPMENT IV. OSHA/ * Research development NIOSH performed by NIOSH Director with inputs from OSHA-NIOSH Policy Group ZBB Management Commit- tee chaired by NIOSH Director and composed of top NIOSH officials appoints members of Program Commit- tee for Coordinat- ing Research (PCCRs) PCCRs surface research needs, and "weed out" duplicative research NIOSH Division Directors pre- pare decision units PLANNING o Appropriate NIOSH Research Division Directors do detailed plan- ning but must get PCCR agreement on outputs for allocation of funds and positions IMPLEMENTATION o All research implemented by appropr iate NIOSH Research Division o PCCR reviews interim outputs and progress reports o OSHA representatives are also invited to participate in PCCR reviews EVALUATION *OSHA-NIGSH workit Groups evaluate quality and responsiveness of research prod- ucts and brief OSHA officials. ------- Table B. Features of R&D Planning and Management Systems Used in Target Agencies R&D PLANNING AND MANAGEMENT PROCESS AGENCY STRATEGY DEVELOPMENT ZBB PLANNING IMPLEMENTATION EVALUATION NRG/DOE O Coordinators designated by program offices to oversee identification of research needs Coordinators "weed out" unnecessary duplication and coordinate actions required to arrive at agreement on proposed research Research proposals submitted to Office of Nuclear Research (RES) RES rules on validity of pro- posals; Programs have appeal rights to Execu- tive Director RES prepares decision units * RES does all planning but must have pro- gran office "sponsor" before plans can be final- ized * Standing Re- search Review Groups, (RRGs) of high-level staff from pro- gram offices, RES labs, other agencies and outside experts act as over- sight panels on technical problems encountered dur- ing the planning year o RES manages all research projects * RRGs reviews interim outputs and progress reports o RES Assistant Director chairs committee conpos- ed of prograu offices and RES representation and which may include members of RRG and out- side experts to review respon- siveness of research ------- Table B. Features of R&D PlannH^ and Management Systems Used in Target Agencies R&D PLANNING AND MANAGEMENT PROCESS AGENCY STRATHGY. DEVELOPMENT ZBQ PLANNING IMPLEMENTATION EVALUATION I. FWS Program strategy state- ments prepared by program managers on a year-to- year basis * "Bottom up" and "top down" mechanisms for surfacing R&D proposals to support strategy * Program Manager Strategy Papers prepared by program to show which R&D projects support program objectives. * Associate Director for Research "costs out" proposals * Decision units prepared by area and regional offices o Detailed project planning performed by Research Office with from program offices *A11 research funds assigned to Program Managers o Program advice pre- pared by Program Managers which makes funds available to Research Office o Formal program reviews every 6 months o Progran review of completed research every 6 to 12 months ------- Table A. Target Agencies^ for R&D Program Analysis AGENCY MISSION AGENCY ORGANIZATION R&D PROGRAM CHARACTERISTICS FUND CONTROL IMPLEMENTATION RESPONSIBILITY Fish and Wildlife Service (FWS) To conserve the Nation's fish and wildlife resources Three Program Offices, Six Regions and the Alaska Area Office (which include approx- mately 600 field stations) report directly to the Director of FWS in Headquarters. Assigned to operating progran managers in Headquarters Centralized under the direct control of the Associate Director for Research in Headquarters I. Nuclear Regulatory Commission (NRC) To regulate all civilian nuclear activities Five Program Offices: o Office of Nuclear Material Safety and Safeguards o Office of Nuclear Reactor Regulation o Office of Nuclear Regulatory Research (RES) o Office of Standards Development o Office of Inspection and Enforcement All report to the Execu- tive Director of NRC Assigned to RES Centralized management responsibility in RES. Centralized implementation responsibility in Department of Energy (mandated by legis- lation) ------- Table A. Target Agencies for R&D Program Analysis AGENCY MISSION AGENCY ORGANIZATION R&D PROGRAM CHARACTERISTICS FUND CONTROL IMPLEMENTATION RESPONSIBILITY III. Food and Drug Administration (FDA) IV. Occupational Safety and Health Adminis- tration (OSHA) To regulate the safety of the Nation's foods, cosmetics, drugs, medical devices, biologies, and electronic radio- logical products To assure that no worker suffers diminished health, reduced function capacity, or decreased life expectancy as a result of his work experience. Six Agency Bureaus: o Foods o Drugs o Veterinary Medicine o Radiological Health o Biologies o Medical Devices o Diagnostic Products report directly to the Commissioner. Also reporting directly to the Com- missioner are the National Center for Toxicological Research (NCTR) and the Executive Director of Regional Operations (EDRO) OSHA located organiz- ationally within the Department of Labor and has no research capability. OSHA gets research support from the National Institute for Occupational Safety and Health (NIOSH) which is a part of the Department of Health, Education, and Welfare. Assigned to Bureaus and EDRO Centralized in program office labs Assigned to NIOSH Centralized implemen- tation responsibility in NIOSH ------- TABLE D: RELATIONSHIPS AMONG THE PROPOSED RESEARCH COMMITTEES REGULATORY/ OPERATIONAL RESEARCH COMMITTEES EXPLORATORY RESEARCH COMMITTEE ASSIGNED MISSION RESEARCH COMMITTEE ------- Table C: RELATIONSHIP OF PROPoSR) SYSTEM TO DEFINED PROBLEMS AND SOLUTION? PROBLEMS APPROACH SYSTEM FEATURES LACK OF RESEARCH STRATEGY PROGRAM CONTEXT FOR RESEARCH NATURAL MODULES FOR RESEARCH PLANNING INADEQUATE COMMUNICATIONS AND DECISION-MAKING MECHANISMS COMMUNICATIONS AND PROBLEM SOLVING AT OPERATIONAL LEVELS RESEARCH COMMITTEES INADEQUATE LONG-TERM RESEARCH PROGRAM PROTECT LONG-TERM RESEARCH R&D PLANNING TIED TO EXPLORATORY RESEARCH COMMITTEE; AGENCY SYSTEMS IN DECISION RULES AND SAFEGUARDS INSUFFICIENTLY TIMELY/USEFUL RESEARCH FINDINGS GREATER PROGRAM AND REGIONAL INFLUENCE AND RESPONSIBILITY RESEARCH INCENTIVES SYSTEM UNEVEN RESEARCH QUALITY MORE QUALITY REVIEW THROUGHOUT PLANNING AND MANAGEMENT PROCESS PEER REVIEW THROUGH RESEARCH COMMITTEES ------- |