5

Evaluation of Other Issues Related to Improvement of The Toxicology Program

The subcommittee evaluated other issues related to NMRITD's toxicology program by addressing the following questions:

  1. What degree of toxicological expertise is required in the development of health-hazard evaluations and risk assessments, and what type of role is implied for the Navy's sole toxicological research laboratory?

  2. How can the scientific currency and growth of the military and civilian staff be ensured?

  3. Does the coordination of research with the U.S. Air Force toxicology laboratory result in significant scientific benefit? How should coordination be improved?

  4. Does the use of the on-site contractor significantly benefit the Navy's program? How should this relationship be improved?

  5. What relationships should be formed with other DOD sources of expertise?

  6. What role should external contracts play in an expanded Navy toxicology program?

EVALUATION OF RELATED ISSUES

Toxicological Expertise and Role of Naval Laboratory

Risk assessment involves the integration of hazard identification, dose-



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Review of the U.S. Naval Medical Research Institute's Toxicology Program 5 Evaluation of Other Issues Related to Improvement of The Toxicology Program The subcommittee evaluated other issues related to NMRITD's toxicology program by addressing the following questions: What degree of toxicological expertise is required in the development of health-hazard evaluations and risk assessments, and what type of role is implied for the Navy's sole toxicological research laboratory? How can the scientific currency and growth of the military and civilian staff be ensured? Does the coordination of research with the U.S. Air Force toxicology laboratory result in significant scientific benefit? How should coordination be improved? Does the use of the on-site contractor significantly benefit the Navy's program? How should this relationship be improved? What relationships should be formed with other DOD sources of expertise? What role should external contracts play in an expanded Navy toxicology program? EVALUATION OF RELATED ISSUES Toxicological Expertise and Role of Naval Laboratory Risk assessment involves the integration of hazard identification, dose-

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Review of the U.S. Naval Medical Research Institute's Toxicology Program response assessment, exposure assessment, and risk-characterization activities to predict the probability of adverse health effects from exposures to environmental agents. The performance of each part of the risk-assessment paradigm, as well as the integration of the results of the four components into a risk assessment, requires a high level of expertise in each of the areas. That is true whether the information used to complete the risk assessment is developed by the risk-assessment team or is obtained from the literature. Thus, regardless of whether the data are generated internally or externally, the hazard identification and dose-response evaluations would require highly competent and well-trained individuals at the doctoral level in such disciplines as neurotoxicology, immunotoxicology, reproductive and developmental toxicology, pathology, carcinogenicity, inhalation toxicology, general toxicology, and biochemical toxicology. To generate data internally, a team of scientists should be assembled with the ability to organize and conduct research programs. The team should be organized from the toxicological experts associated with the triservices and its contractors. This team should be supported by scientists with doctoral, master's, or bachelor's degrees and technicians trained in the pertinent disciplines. In addition, involvement of epidemiologists might be required to conduct or evaluate the results of epidemiological studies. Epidemiological expertise can be obtained from other units of the Navy, branches of the military, or external sources. The assessment of dose-response relationships would likely involve highly trained toxicologists and statisticians who understand the complex mathematical models used to extrapolate dose-response relationships from animals to humans. Exposure assessment might involve the activities of Navy physicians, competent industrial hygienists, and environmental scientists. The integration of results into a risk assessment will involve qualified personnel from all areas as well as individuals prepared by training and experience to draw conclusions from diverse data sets. The risk assessment presented to the risk manager for implementation will be only as good as the quality of input into the process, and thus, valid and reliable risk assessment can only be produced by highly qualified scientists and risk assessors. The role of the Navy's sole toxicology research laboratory should be

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Review of the U.S. Naval Medical Research Institute's Toxicology Program defined in relation to other health, safety, and environmental functions throughout the Navy. NMRITD's role should fit into the continuum of tasks as presented in Table 1, Chapter 2 of the NRC (1991) report Review of the U.S. Army Environmental Hygiene Agency Toxicology Division. According to its mission, NMRITD is responsible for performing risk assessments for the Navy's health concerns as well as deciding whether toxicological testing is needed as part of the analysis. The mission statement implies a need for the capability to (1) gather information from world-class computerized and library resources; (2) conduct research to gather information needed for risk assessment; (3) determine acute, subacute, and chronic toxicity in animals for selected chemicals either through a literature search or by conducting animal studies when pertinent information is missing; (4) identify chemicals with potential for exposure, determine toxicity, and identify sensitive biological end points and biomarkers of exposure; (5) develop animal models to predict human toxicity; (6) develop a state-of-the-art analytical testing laboratory for chemical identification; (7) define exposure levels and set exposure standards for human exposure; and (8) identify special populations who might be at potential risk because of special sensitivity or other conditions. The mission statement also implies a need for knowledge of the Navy's operations and of the specific needs of its combat missions. To accomplish these goals, the toxicology laboratory should be assured of a basic multiyear budget to fund routine internal and external research and to fund “emergency” toxicological research. Priorities need to be established and adhered to with sufficient flexibility to address unforeseen needs without disrupting “routine” investigations. Laboratory personnel should be available to provide continuing education and training of other Navy personnel, such as corpsmen, on the hazardous aspects of toxic substances. Mechanisms for Scientific Currency and Growth of Military and Civilian Staff It is the subcommittee's understanding that NMRITD can request personnel with a particular expertise. In practice, the classification codes

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Review of the U.S. Naval Medical Research Institute's Toxicology Program for military and civilian personnel cover broad areas. For example, a biochemist may be an analytical chemist or someone with experience in kinetics or metabolism. It becomes difficult to hire people within the civil or military services to meet exact qualifications for a given project. Consequently, over time, projects evolve that complement the skills of the staff employed. Amending the personnel request process to allow a more complete description of specialized expertise would help address this problem. Another confounding factor is the short tour length and the current competitive selection process for promotion of Navy officers. At present, a junior officer must demonstrate the ability to assume increasing responsibility to be considered for promotion. Those officers who remain at a single location for a long period might be viewed as less competitive. A long-term assignment within the toxicology program at a single location, such as NMRITD, could result in a lower rank and a career termination after fewer years of service, resulting in a decreased pension in retirement. These conditions are not conducive to developing an exemplary cadre of skilled Navy personnel. They also make it difficult to build and maintain quality staff capable of meeting and anticipating the programs's requirements. A credible, experienced, and stable civilian staff as well as sufficient personnel and resources are necessary to provide the setting for training of junior officers and for scientific growth of these officers and civilian scientists. Stability of the program becomes a key issue. The subcommittee strongly supports the formation of a triservices toxicology program with civilians as key scientists who would provide the continuity necessary for high-quality science and training of junior scientists. Those key scientists would stay abreast of the advances in toxicology and their applicability to the armed services' needs. Each of the civilian scientists would have expertise in a particular area of toxicology, so that collectively they would provide the disciplines needed for a strong, credible program. The key scientists would be responsible for giving the rotating uniformed toxicologists an optimal research environment in which to bring their expertise and experience to bear on field problems. This program would afford military scientists a greater oppommity to produce publishable work during the time limits of their rotations, which in time would enhance their credibility among peers.

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Review of the U.S. Naval Medical Research Institute's Toxicology Program Coordination of Research with the Air Force Toxicology Laboratory Cooperation between NMRITD's and the U.S. Air Force's toxicology laboratories appears to be good and to benefit both groups. There is an outdated Memorandum of Understanding (MOU) between the two parties that is now being revised. The expired MOU primarily relates to services provided to the Navy by the Air Force. As of the date of the subcommittee review, there was no written agreement with the Army. There is an agreement between the Air Force and the Army for using the Army pathology support services. The Navy has access to those services through its MOU with the Air Force. It is understood that the new MOU will include a definition of the role that each of the three armed services will play in the “team” approach that has been initiated. The definition of the team approach in the MOU should include statements about the scientific expertise of each team and the role that NMRITD will play. Synergy undoubtedly exists between the Navy and the Air Force toxicology units because of collocation at WPAFB and a willingness to cooperate. This relationship is enhanced by collocation with the contractor-operated Toxic Hazards Research Unit (THRU) and with the small but growing Army presence at WPAFB. These combined resources are a good beginning in developing the strong scientific base required to support the toxicology needs of not only the Navy but all branches of the services. There is significant room for improvement in the relationship of the Navy, Air Force, and Army toxicology groups. The MOU process is a means by which all three could define a joint organization with the resources to enhance toxicology capability and the quality of the scientific product. Unquestionably, each branch has its unique needs for toxicology studies and would accommodate those separately. For example, toxicology studies related to confined spaces in submarines might be of mission interest to the Navy but not the Air Force or Army. However, the knowledge gained from submarine studies might have application in the logistical operation support activities of the Air Force and Army, as both departments address confined-space issues. The quality of these unique studies would be enhanced by sharing the resources, capabilities,

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Review of the U.S. Naval Medical Research Institute's Toxicology Program and scientific knowledge available for problem solving. Duplication of resources could be avoided and a stronger cooperative effort could result from a joint agreement similar to the one just described to share resources and facilities. Major equipment purchases could be coordinated with the Air Force and Army to share the costs and, more important, the benefits of the equipment. A significant new cooperative venture was initiated by the three armed services in November 1992 that addresses many of the concerns. This team approach to shared toxicological research and risk assessment offers promise for the creation of a viable, state-of-the-art institution at WPAFB. It is possible that this toxicology unit could be modeled after the Armed Forces Institute of Pathology. The joint resources of the three services could be combined to create a single more effective unit than currently exists. It is possible that coordination of the toxicology and pathology institutes could be pursued to more comprehensively address research problems that each institute attempts to solve. Use of On-Site Contractors The Toxic Hazards Research Unit (THRU) has traditionally been operated at WPAFB by a contractor. This contractor historically performed tasks directed by Air Force and Navy personnel. Much of the earlier work was accomplished in support of inhalation toxicology. The relationship has evolved to the point where the contractor is conducting risk assessments and basic work such as metabolic and kinetic research. The work presented by the contract personnel during the subcommittee 's visit to WPAFB was impressive and demonstrated good scientific approaches to solving problems. The THRU contractor offers a resource base not available within the Navy proper. This process gives the Navy access to a high-quality pool of scientific talent for work on unique issues or to extra technicians at the junior level to assist with more routine tasks. Furthermore, when an issue is resolved, the contractor has the responsibility to assign the personnel elsewhere. Additionally, if the personnel are not satisfactory, they can be reassigned without impeding progress on the Navy's toxicology program.

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Review of the U.S. Naval Medical Research Institute's Toxicology Program The subcommittee members favor the Navy's use of the contractor. It is the subcommittee's understanding that the contractor is available to the Navy on a contractual basis from the Air Force. There appears to be good cooperation between the Navy and the Air Force in the use of the contractor, even though the arrangement might be part of an expired MOU. The Navy's relationship with the contractor will be improved when the three services are integrated into teams along with the contractor. Because several of the scientific teams currently have group leaders who are contractor scientists, participation of Navy personnel in the teams will increase scientific and programmatic interactions between the Navy and the contractor. The subcommittee strongly encourages participation of NMRITD in the teams as a method to increase interactions with the contractor. Relationships with Other DOD Sources of Expertise There is opportunity to combine NMRITD with its counterpart organizations from the Army and Air Force to form a triservice unit. The Armed Forces Institute of Pathology and the triservice combustion toxicology research program provide excellent examples of cooperation among the three services to strengthen scientific capabilities. As described earlier, subcommittee members see numerous advantages to a combined program. The Armed Forces Institute of Pathology has an expert staff addressing such issues as pathology that overlap with the toxicology program of NMRITD, and interactions between the two groups have been excellent although infrequent. The Armed Forces Epidemiology Board, which has focused over the years on infectious diseases, and the Armed Forces Radiobiology Research Institute, which focuses on the effects of radiation, are two other programs that have similar interests and might provide opportunities for interaction with NMRITD. With or without integration of NMRITD's toxicology program with other programs, numerous tools exist to formalize interactions with other agencies, service branches, academia, and industry that have not been used fully. Examples are the MOU, the Bilateral Agreement (BLA), and the Program Objective Memorandum (POM).

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Review of the U.S. Naval Medical Research Institute's Toxicology Program The MOU appears to be a tool used sparingly and primarily within the military services. The subcommittee has encouraged renewal of the MOU with an agreement that will benefit the Navy and Air Force. Similar agreements could be pursued with agencies such as the Environmental Protection Agency, the Occupational Safety and Health Administration, the National Institute for Occupational Safety and Health, the National Institute of Environmental Health Sciences, including the National Toxicology Program, and the new U.S. Agency for International Development 's Environmental Health Program for developing and developed countries. Relationships of this type are particularly valuable for research in areas that not only benefit the Navy but also add to the fundamental base of scientific knowledge. There are also many academic and industrial institutions with research programs in areas of interest to the Navy where interaction would be mutually beneficial. DOD has historically developed and is currently developing BLAs with foreign countries and organizations. For example, an agreement was recently developed with the German Navy to examine medical diving issues. Such BLAs should be encouraged, not only with foreign governments but also with various foreign organizations such as the United Nations Environmental Program, the World Health Organization, the International Labor Organization, and the International Program on Chemical Safety. The MOU and BLA are tools that could be used more effectively to leverage the Navy's research capabilities. The POM provides a mechanism that could be better used to establish long-term funding and personnel support for NMRITD's toxicology program. This process could be accomplished with or without cooperation among the three service branches, but it would likely have greater impact as a coordinated research-planning effort at the DOD level within the Office of the Director of Defense Research and Engineering. Cooperation within the various branches of the military should be encouraged to define both common and unique research requirements. Coordination of effort should be at the DOD level within the Office of the Deputy Undersecretary for Environmental Security. In addition, communication and cooperation should be increased among various military programs, such as those addressing occupational safety and health, life sciences, environmental policy and planning, acquisitions, and engineering. The elevation of environmental policy planning to being a critical element of

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Review of the U.S. Naval Medical Research Institute's Toxicology Program military-planning activities, including acquisitions, and strategic-systems development will enhance the ability of the military to properly address and resolve environmental problems. Role of External Contracts The subject of contractual programs and their benefits has already been dealt with in response to other questions. In the opinion of the subcommittee, contractual projects are an indispensable tool that can be used by NMRITD to fully accomplish its goals. The proper conduct of a risk assessment involves the analysis of a large data base on the chemical or the mixture of interest. Many of these data can and will be generated internally at NMRITD. However, certain very specialized techniques of toxicological investigation might not be immediately available there. Also, many highly specialized techniques require the commitment of considerable manpower or highly sophisticated and expensive technical equipment before they become fully functional and operable. It might not always be possible to generate the necessary resources at NMRITD to deal with such specific technical issues. In those situations, contracts issued to organizations that specialize in those techniques will be an expedient and cost-effective means to accomplish the work and to collect the necessary data. An additional advantage of this approach will be that the ongoing scientific research at NMRITD will be complemented with additional state-of-the-art expertise. Much of this expertise will be available in academic settings. Thus, contractual projects offer the possibility of integrating research carried out at NMRITD and the most current research conducted in academia. In the present climate of sparse research funding, such cooperation would be advantageous for all the parties involved. Outside contracts can also help the Navy address urgent toxicological problems that require immediate action. For example, a situation might arise where it is imperative that a chemical or a mixture of chemicals be tested as soon as possible for carcinogenic potential. The facilities to conduct such studies do not exist at NMRITD. However, there exist many highly qualified commercial laboratories that have the capabilities to conduct such studies on a contractual basis. An additional advantage

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Review of the U.S. Naval Medical Research Institute's Toxicology Program to this approach is that most of these laboratories conduct their studies under good laboratory practice regulations and provide adequate quality assurance. NMRITD will also benefit from regularly conducted reviews and audits by independent outside advisors. Such reviews should be conducted yearly. It would be advantageous for the external review process to be organized and supervised by a group who has no direct association with NMRITD's toxicology program. If an external audit is conducted, NMRITD assures itself that this vital process will be performed with the utmost objectivity. In other words, the review process should be organized by an external group, preferably an academic institution or an arm of the National Research Council, such as the Committee on Toxicology. RECOMMENDATIONS ON RELATED ISSUES The subcommittee made the following recommendations on issues related to improving NMRITD's toxicology program: Highly competent individuals with expertise in various subspecialty fields of toxicology are essential to conducting health-risk assessments. To meet this need, access to a multidisciplinary group of scientists should be provided. To satisfy its mission, NMRITD should Develop a world-class biomedical data base on the toxicity of materials of interest to the Navy. Identify chemicals with potential for exposure to naval personnel and determine the toxicity of those chemicals. Identify biomarkers of exposure, effect, and susceptibility relevant to the same chemicals. Develop a state-of-the-art analytical testing laboratory for chemical identification. Conduct research to produce data and information for risk-assessment purposes to meet the Navy's needs. Serve as a resource to conduct occupational and environmental

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Review of the U.S. Naval Medical Research Institute's Toxicology Program health-hazard evaluations and risk assessments for chemicals and exposure scenarios particular to the Navy. The scientific awareness and professional development of staff can be enhanced by Improved access to information resources, such as libraries and electronic data banks, and data bases. Improved opportunities and encouragement to publish in the scientific open literature. Participation in professional scientific activities (meetings, advisory committees, etc.). Recognition by the Navy that longer assignments of its scientific personnel at NMRITD would enhance the efficiency of the detachment and the development of its scientists. Establishment of a triservice toxicology program (comprising the Navy, Army, and Air Force) would be cost effective. Air Force and Army participation in a team effort would ensure a more viable and dynamic toxicology unit. Use of an on-site contractor as an integral part of the team is highly encouraged. The contractor could provide expertise and facilities that are lacking in the Navy or other branches of the armed services. Coordination and communication between contractor scientists and military scientists could substantially improve the overall productivity of the toxicology unit, which should eventually become a prototypical institute at WPAFB. The triservice program would provide resources for the military in the areas of applied and basic toxicology. NMRITD should continue to expand its relationships with other sources of scientific knowledge, such as other DOD organizations (e.g., the Armed Forces Institute of Pathology, the Armed Forces Epidemiology Board, the Army Corps of Engineers), federal agencies (e.g., the Environmental Protection Agency, the National Institutes of Health, and the Occupational Safety and Health Administration), industry, foreign governments, and international organizations (e.g., the World Health Organization's International Program for Chemical Safety). Through these relationships, NMRITD should take advantage of professional re-

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Review of the U.S. Naval Medical Research Institute's Toxicology Program sources while benefiting from research data on current health and environmental issues that might be of interest to the Navy. These contacts might also lead to participation in new areas of research and new program development. External contracts should be used to complement internal projects where additional, highly specialized information is required. External contracts could ensure that work products from NMRITD represent state-of-the-art scientific toxicological information. Contracts should also be funded to support external scientific review processes.