Review of the U.S. Navy Environmental Health Center's Health-Hazard Assessment Process (2000)

THE SUBCOMMITTEE was charged with assessing the validity and effectiveness of the Navy Environmental Health Center's (NEHC's) health-hazard assessment (HHA) process and determining whether the process as implemented provides the Navy with state-of-the-art, comprehensive, and defensible evaluations. The subcommittee was also asked to identify any program elements that require improvement.

The subcommittee's assessment of NEHC's HHA process is based on its review of documents submitted by NEHC, presentations made by NEHC personnel at subcommittee meetings, and site visits to NEHC in Norfolk, Virginia, and the aircraft carrier U.S.S. Constellation, while docked at the Naval Air Station North Island in San Diego, California. In addition, the subcommittee reviewed HHA processes used by chemical and pharmaceutical companies for their adaptability and usefulness to the Navy situation.

Based on its assessment, the subcommittee concludes that NEHC's HHA process is adequate for preparing routine HHAs, considering the available resources. There are several deficiencies, however, especially for conducting complex HHAs. To address those deficiencies, the following are needed: (1) formal, written, standard operating procedures (SOPs) for preparing HHAs, (2) staff with expertise in toxicology, epidemiology, and risk assessment for preparing complex HHAs, (3) access to electronic databases, (4) enhanced quality-assurance and

quality-control procedures, (5) increased coordination and information transfer between NEHC and other organizations and stakeholders, (6) enhanced medical surveillance and centralization of medical data, and (7) life-cycle assessments. The subcommittee's conclusions and recommendations with respect to each of these major deficiences are discussed below.

In reviewing NEHC's procedures for Level I and II reviews, it became apparent to the subcommittee that no formal, documented procedures (e.g., SOPs, including flow charts) have been developed as to how Level I and II reviews should be conducted and documented. In addition, the criteria used to defer reviews to a Level III or Level IV review were not developed. Although this ad hoc process provides a great deal of flexibility which may be important (e.g., when ships are away from home port), it presents challenges for: (a) developing a uniform standard for evaluating health hazards among Navy industrial hygienists, (b) having a Navy-wide hazardous substances control and reduction process, and (c) assuring continuity of NEHC's occupational safety and health programs following the rotation of current industrial hygiene personnel to different duty assignments. The subcommittee believes that the efficiency, consistency, and “institutional memory” of NEHC can be enhanced if formal, documented SOPs for preparing HHAs are developed and implemented. Therefore, the subcommittee recommends that NEHC develop (and update regularly) a set of SOPs for the preparation of its HHAs by incorporating the relevant aspects of procedures employed by pharmaceutical and chemical companies, governmental organizations (e.g., U.S. Army Center for Health Promotion and Preventive Medicine [CHPPM], the U.S. Environmental Protection Agency [EPA]), and the National Research Council [NRC]). The subcommittee also recommends that NEHC develop guidelines or criteria for developing HHAs for use by industrial hygiene personnel on ships or at regional naval occupational health departments. The subcommittee recommends that criteria and guidelines be developed for deciding when to defer a review to NEHC.

The effectiveness of NEHC's HHA program is directly dependent on the training and expertise of personnel tasked to prepare the HHAs. For this purpose, the Navy uses experienced professionals who are familiar with Navy operations to provide opinions about potential exposures to hazardous substances.

The professional staff of NEHC's Industrial Hygiene Directorate has extensive experience at the practical level, ranging from 4 to 30 years, in all aspects of hazardous materials evaluation and in the preparation of comprehensive HHAs of new materials and operations contemplated by the Navy prior to introduction. Thus, NEHC has a unique national resource in its staff of 37 professionals who have in excess of 500 years of combined experience in industrial hygiene and environmental health, and in preparing HHAs.

The impression gained from the site visit to NEHC in Norfolk, Virginia, by the subcommittee was that the NEHC staff, from the highest level down, is enthusiastic, hard-working, and intent on making the best possible effort to provide the Navy and Marine Corps with state-of-the-art evaluations of toxicity and potential hazards.

The subcommittee believes that the current education and experience level of NEHC staff are adequate for preparing routine HHAs. This conclusion is based on the subcommittee's evaluation of HHAs and other work submitted by NEHC to the subcommittee for review. Much of the work performed by NEHC can be carried out by scientists or industrial hygienists at the bachelor of science level. In some cases, there is a need for personnel with expertise in industrial hygiene at the master of science level. The subcommittee believes that the current senior civilian staff members are well equipped to deal with many of the routine industrial-hygiene problems. However, there were a few complex risk-assessment projects that required personnel who are highly trained in toxicology, epidemiology, human-health risk assessment, and atmospheric modeling. Examples of such complex projects include those that involve determining the health hazards associated with the off-gassing of chemicals in submarine environments and the risk to personnel and their families from exposure to emissions from the Japanese incinerator in Atsugi. The subcommittee recommends that NEHC recruit professional scientists with expertise in toxicology,

epidemiology, and risk assessment for conducting such complex tasks. The subcommittee also recommends that particular attention be given to the qualifications necessary for those personnel exercising key technical oversight and review functions for HHAs.

The Navy's worldwide occupational health program is staffed by professionals in a number of fields. Among these, the Navy's industrial hygiene officers are critical to maintaining the health and safety of all naval personnel and contractors who live and work on board ships and are deployed worldwide in support of operational contingencies. They have important roles in prevention, operational risk management, and emergency response.

During a site visit to the aircraft carrier U.S.S. Constellation, the subcommittee observed that there was only one industrial hygiene officer and no other personnel in the industrial hygiene unit. There were more than 5,000 personnel on that ship performing a variety of industrial and other procedures that included working with a myriad of chemicals and chemical mixtures, as well as with fuels and munitions. It is not possible for one industrial hygienist to ensure that both work practices and the handling of chemicals in such a complex and highly variable environment are performed in a manner that would ensure the least possible risk to the health of all personnel. The work of the local or regional industrial hygienists can be enhanced, however, with more direct access to NEHC. If a formal relationship between NEHC and shipboard industrial hygiene personnel were strengthened, industrial hygiene officers might be in a better position to foster a safer work environment on ships. One practical approach would be to establish direct computer links between ships and NEHC.

However, because all naval operations need to have an adequate level of access to industrial hygienists, commensurate with the size of the facility and the mission (e.g., an aircraft carrier would need several shipboard billets, whereas a submarine would only need periodic access to such officers), the subcommittee recommends that NEHC evaluate whether Navy facilities have sufficient level of support in industrial hygiene. Large facilities, such as aircraft carriers, should have more than one industrial hygienist to support continuous or sustained

operations typical of deploying naval vessels, and in case one of the officers becomes ill, injured, or transferred. In addition, given the unique features of each facility requiring industrial hygiene and hazardous materials/waste officers, there is a need for ongoing training to enable smooth transition when officers are rotated and to provide immediate back up when the primary industrial hygiene officer is not available. Using a “hot fill” approach does not provide the needed expertise for these types of essential operations. The training or cross-training of medical or other officers in basic industrial hygiene and hazardous materials management should be considered.

Another factor necessary to elevate the importance of the industrial hygiene program is to provide NEHC with authority/accountability for mission success. At present, NEHC's HHAs provide advice only. However, delegating authority from BUMED to NEHC for “signing off ” on decisions with health risk implications for product use would make any override decision by users (e.g., Naval Sea Systems Command) more highly visible and accountable.

Because of budget reductions in the Navy, there are decreased numbers of experienced personnel; however, there is an increased demand for greater numbers of HHAs. The combination of decreased personnel and increased demand for HHAs requires a more effective approach for developing HHAs. The subcommittee recommends that NEHC develop a long-term strategy to deal with increasing demand for services in the face of declining resources. This strategy would include elements such as streamlined processes to conserve staff time; increased training of current staff to keep current with advances in toxicology, epidemiology, and risk assessment; and a workforce-planning strategy to replace retiring or relocated staff to ensure the basic quality and quantity of HHAs. This should include a succession plan for NEHC staff, and a projection of future personnel needs.

To streamline the HHA process, the subcommittee recommends that NEHC consider using different levels of review for different levels of potential hazard. In addition, clients should inform NEHC in advance. that they will be submitting requests for HHAs. That will allow NEHC time to plan and assemble the necessary expertise to conduct a quality evaluation.

The subcommittee also recommends that NEHC consider task flow rates to determine whether the number and experience of available staff are sufficient for the workload. If not (and there will be peak activity, regardless of how well the program is managed), the subcommittee recommends that NEHC employ outside contractors (e.g., qualified consultants or other military personnel from Department of Defense 's [DOD] U.S. Army Medical Research Detachment at Walter Reed Army Institute of Research, USAF Institute for Environmental, Safety, and Occupational Health Risk Analysis [IERA], the Navy Toxicology Detachment at Wright-Patterson AFB, or CHPPM) to maintain quality. It might also be feasible to ask large-procurement bidders (manufacturers or suppliers) to provide HHAs (not just MSDS) as part of their bids.

Training is often the first activity to be reduced in response to budget cuts. Although this would allow more staff time to be devoted directly to the development of HHAs, the subcommittee recommends that specific directives be issued by the Navy to ensure continued HHA-development training for NEHC professionals. Areas of training should include industrial hygiene, toxicology, epidemiology, chemistry, and risk assessment. In addition, the subcommittee recommends that such training be outsourced rather than provided in-house. That is likely to be more cost-effective and productive. In addition, NEHC should make resources available to encourage staff professional development through participation in scientific societies and meetings.

The subcommittee observed that there is an absence, of or limited availability of, computerized hardware for use by key personnel. This impairs access to information for the identification of hazards or human health risks via the internet, intranet, and email and continues to foster reliance on paper records. The absence of a data-management structure precludes meaningful analysis of the vast array of existing data available throughout the Navy on chemicals, exposures, and health outcomes.

During its site visit on board the U.S.S. Constellation, the subcommittee had an opportunity to review information systems available aboard ship. In general, there were a limited number of personal computers that are capable of accessing health-hazard information. Material safety data sheets (MSDSs) were provided to the ship industrial hygienist on CD-ROMs. These were updated periodically. However, there were only a few copies of the CD-ROMs on shipboard and access to them was limited. Work areas received MSDSs in paper form after being printed from the CD-ROM. In all the shipboard work areas visited, paper copies of the MSDSs were readily available to the crew and the crew members appeared knowledgeable about their use and content.

The efficiency of the current system for managing MSDSs is of concern. At present, MSDSs are transferred from NEHC for publication by the DOD on CD-ROM. Ganak (1998) has reported that the process for obtaining MSDSs from NEHC through DOD to Navy sites has not been working well and that a solution is being implemented. According to Ganak, it is not unusual for 8 months to elapse before an MSDS appears on a CD-ROM. Because the use of the MSDS has become a critical element of the HHA process, the subcommittee recommends that industrial hygiene personnel at regional or local occupational offices as well as those aboard Navy ships be provided with MSDSs as soon as possible. However, the subcommittee recommends that ship IH officers not solely rely on MSDSs because they sometimes over-estimate effects or fail to adequately deal with serious clinical effects.

The subcommittee believes that high-efficiency information searches are essential to conserve the valuable time of the hazard assessor and recommends that up-to-date computer hardware and software be provided to NEHC's industrial hygiene staff for electronic searches. The subcommittee also recommends that training for the use of that technology be provided.

There are a number of highly credible information sources on the toxicology of industrial and commercial compounds that could provide valuable technical input in developing HHAs. For example, the subcommittee believes that the NEHC will find it useful and cost-effec-

tive to more directly and routinely use the EPA's Integrated Risk Information System [IRIS] as screening tools. IRIS is now available at no cost on the Internet. However, IRIS and other secondary references need to be used prudently. For example, if the IRIS entry was completed recently, the information is relatively up-to-date. However, if it was completed several years ago, a re-evaluation of the database may be warranted. NEHC needs to implement additional ways to maintain the currency of toxicological databases (particularly in the time intervals between receiving vendor updates) and to systematically verify (at least a sample of) input data from its current toxicological assessment software.

NEHC now relies heavily on the SmartRisk/SmartTox assessment software to develop some of its HHAs. The SmartRisk/SmartTox software appears to be a good guide for the development of HHAs. However, the information it contains might not always be current and must be updated regularly; the subcommittee recommends that updates be performed routinely. EPA's Exposure Factors Handbook (EPA 1997) can be consulted for updated exposure-factors information.

The subcommittee recommends that NEHC not rely heavily on the toxicity information contained within MSDSs in conducting HHAs. The subcommittee believes it is appropriate to begin an assessment with consideration of the MSDS, but all data contained in them should be independently confirmed before use. MSDSs often contain incomplete toxicity information and do not contain the most up-to-date toxicity data available. A cross-check of manufacturer- or vendor-supplied MSDS data for completeness and accuracy is imperative. Information sources available for this purpose include the Hazardous Substances Data Base, Registry of Toxic Effects, the Agrochemicals Handbook (Royal Society of Chemistry 1994), Sax's Dangerous Properties of Industrial Materials (Lewis 1996), Patty's Industrial Hygiene and Toxicology (Clayton and Clayton 1993), the International Agency for Research on Cancer series, and the Air Force toxicology guide (Installation Restoration Program Toxicology Guide, ORNL, 1989, 1990). A number of these sources are already in use by NEHC staff.

The subcommittee recommends that NEHC independently confirm key information presented in HSDB, RTECs, and IARC documents.

To avoid duplication, the subcommittee recommends that NEHC thoroughly evaluate existing information from other governmental agencies, other organizations, and the open literature prior to conduct-

ing its own HHAs. Cooperative information exchange arrangements should be developed with those agencies and organizations. The Air Force Installation Restoration Program Toxicology Guides are an excellent source of toxicity information for chemicals used by the military; they also contain handling precautions. Although these guides were originally designed to address contaminants in drinking water, they also address inhalation and dermal exposures and environmental fate. They cover many chemical compounds that are likely to be used by the Navy. Similarly, the Defense Technical Information Center (DTIC) database is an additional source of toxicity information for chemicals that are of interest to the military.

The subcommittee also recommends that NEHC consider using acute exposure guideline levels (AEGLs) in the preparation of HHAs as an objective source of inhalation toxicology data. AEGLs for a number of hazardous chemicals have been developed by the National Advisory Committee on Acute Exposure Guideline Levels for Hazardous Substances. The AEGL documents are also reviewed by NRC's Committee on Toxicology (COT). Spacecraft maximum allowable concentrations and emergency exposure guidance levels developed by COT should also be used or considered in developing HHAs (NRC 1984 a,b,c, 1985 a, b, 1986 b, 1987, 1988, 1994, 1996 a, b, 2000 b). The subcommittee also recommends that NEHC consider using exposure limits recommended by other governmental and nongovernmental organizations, such as those recommended by the Occupational Safety and Health Administration, National Institute for Occupational Safety and Health, American Conference of Governmental Industrial Hygienists, and American Industrial Hygiene Association. A number of these sources are already in use by the NEHC Staff.

NEHC's procedures for awarding contracts were not clear to the subcommittee. The subcommittee recommends that NEHC establish a quality-assurance/quality-control (QA/QC) program to assist in the development of contracts for services and establish a means for ensuring the quality of such services.

NEHC's selection criteria for the identification of institutions and staff necessary for the performance of internal or external reviews were

also not completely evident to the subcommittee. It is the subcommittee 's impression that low-visibility, routine HHAs in particular do not systematically receive internal review at NEHC. The subcommittee recommends that a system for regular peer review of NEHC's HHAs by qualified internal and external reviewers be developed and documented. Such a system should include criteria for determining which reports will undergo internal or external review. For example, a report would undergo external review if it deals with a health hazard that might be encountered by thousands of Navy personnel and co-located civilians. HHAs of commonly used low-hazard chemical materials would bypass this external review process but would receive some internal review to validate the assessment of low hazard. HHAs associated with an intermediate hazard would be subject to systematic internal reviews.

The subcommittee believes that periodic external review of NEHC's HHA process would assure scientific rigor and objectivity of the program and provide an opportunity for staff to obtain additional perspective, overview and consultation, and access to evolving technologies from scientists working in the field outside the Navy. The subcommittee recommends that NEHC establish a peer review advisory board to assist it in carrying out its mission of providing credible and consistent HHAs. The board should be an independent body comprised of scientists with expertise in broad areas such as industrial hygiene, toxicology, epidemiology, and risk assessment. The subcommittee believes that the U.S. Army Center for Health Promotion and Preventive Medicine 's (CHPPM) Peer Review Board on Toxicology is a good model and recommends that it be tailored to the needs and available resources of NEHC. The CHPPM peer review board was convened in response to COT's recommendation that such a review board be assembled as part of COT's review of the Army Environmental Hygiene Agency's (now known as CHPPM) Toxicology Program (NRC 1991).

NEHC receives requests from client commands for HHAs and these are promptly completed and returned to the client command in a time-

ly manner. However, it appears that there is little or no interaction between NEHC and the client during the process and there is no feedback from the client as to the adequacy of NEHC's HHAs and recommendations. In addition, there were no examples provided of anticipatory or “proactive” efforts by NEHC staff to identify and mitigate potential hazards, or to develop improved processes for HHA. The subcommittee recommends that NEHC develop a formal system or process to collaborate with other military organizations, such as CHPPM in developing HHA reports and distribute report findings to them. Specifically, the subcommittee recommends that the following procedures be followed:

• Findings and recommendations of NEHC's HHA reports should be made available to all NEHC clients of HHAs and to the staffs of the health, safety, and environmental programs. In addition, the basic HHA information should also be made available to all naval personnel and civilian and contract workers, and to the lay public.

• NEHC's HHA reports should be entered into some form of an information system that is likely to be carried on an Intranet (restricted access) or the Internet (wide access).

• NEHC should establish and implement systematic customer survey and feedback mechanisms as to the utility and timeliness of NEHC analyses in decision-making, and obtain suggestions for improvement to better serve customer needs.

The subcommittee also believes that there is a need for greater coordination and information transfer between NEHC and other DOD, Navy, or governmental agencies that also perform HHAs. This interaction could provide insight for addressing issues and solving problems that might be common between institutions. NEHC would benefit by interacting more with CHPPM at Aberdeen Proving Ground, Maryland; the U.S. Air Force's Institute for Environment Safety and Occupational Health Risk Analysis at Brooks Air Force Base, Texas; Triservice Toxicology Research Laboratories (particularly the Naval Health Research Center's Toxicology Detachment) at Wright Patterson Air Force Base in Ohio, and the Armed Forces Institute of Pathology in Washington, D.C.; EPA; and the U.S. Department of Energy.

The Navy's Bureau of Medicine and Surgery (BUMED) collects medical data on Navy personnel. A centralized medical-data management structure is being developed for the entire DOD, which will incorporate data relevant to occupational and environmental health hazard assessment.

This centralized approach will also facilitate communication between various commands within the Navy and permit data entry from numerous remote sites (e.g., shipboard) with immediate feedback on quality control (e.g., valid response codes). It will provide NEHC with greater increased ability to access medical data to conduct surveillance to detect possible adverse health outcomes related to potential chemical exposures.

For the interim, the subcommittee recommends that data from the existing medical surveillance program be analyzed by NEHC to evaluate the effectiveness of HHAs on a regular basis. This is a key element of a properly functioning occupational health program, and is essential to verify the effectiveness of the HHA program and its recommendations. For example, data on the occurrence of adverse health effects in workers should be used to indicate need for additional toxicological testing.

Although the DOD and Navy documents include policy statements requiring the use of life-cycle assessment (LCA), it is not clear to the subcommittee that LCA is considered and applied at all levels of the acquisition process, including development or purchase, use, storage, and disposal of potentially hazardous materials.

DOD Directive 5000.1 (Defense Acquisition Management Policies and Procedures) outlines a DOD acquisition process (See Figure 2-1) that is similar to many of the “phases and gates'” processes used in civilian industrial product-development processes. The HHA process requires identification of “potential environmental consequences” at Phase 0.

However, it is not clear that either occupational safety and health

program costs or end-of-life considerations for various procurement alternatives are taken into account during acquisition as required by DOD and Navy policy. Both disposal and recycling of hazardous materials and hazardous waste, which are required elements of a complete LCA, are missing. The subcommittee recommends that questions related to these issues be considered in developing HHAs.

NEHC's HHA program performs a function that is basic to the occupational medicine and industrial hygiene programs of the entire Navy and Marine Corps. It is primarily designed to protect the health of naval and civilian personnel. In a reduced-size Navy, the preventive functions of NEHC can be an important factor in reducing costs associated with naval health care and readiness. At present, NEHC's HHAs provide advice only. The subcommittee recommends that the Navy elevate the importance of the HHA program by delegating authority to NEHC for “signing off” on decisions to use or not use products and by increasing support for the HHA program throughout the Navy command structure.

The subcommittee concludes that the development of formal, written SOPs; the addition of senior scientists with expertise in toxicology, epidemiology, risk assessment, and industrial hygiene; increased training of the current staff; better QA/QC procedures, including the formation of a peer review board; improvements in data acquisition and management; better coordination between NEHC and other organizations and stakeholders; the development of a centralized medical-data management system; and consideration of life-cycle issues would lead to a more effective HHA process that would stand up to critical and objective scrutiny.

The subcommittee recognizes that many of its recommendations will require significant resources to implement; however, the subcommittee believes that such investments to improve NEHC's HHA program would be cost effective and would result in significant and long-term benefits to naval readiness and mission fulfillment.