2

The Navy's Current Health-Hazard Assessment Process

THIS CHAPTER REVIEWS the Navy's policies, directives, and regulations for handling hazardous materials to determine if the Navy Environmental Health Center (NEHC) is adequately constituted to carry out its mission. This is followed by a review of the Navy's current health-hazard assessment (HHA) process as implemented by NEHC, which includes a discussion of the types of HHAs conducted by NEHC, and the resources, information sources, and quality-control procedures employed.

NAVY POLICIES AND DIRECTIVES RELATED TO HAZARDOUS SUBSTANCES

Because the Navy is a very large organization spread out over the entire marine geography of the earth, it requires an integrated command structure to carry out its duties for sound and responsible handling of hazardous substances. Without a responsive command structure that acts in an effective, efficient, and coordinated manner to handle hazardous materials, the Navy's mission to protect and defend the nation and fulfill treaty agreements with allies could be jeopardized



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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS 2 The Navy's Current Health-Hazard Assessment Process THIS CHAPTER REVIEWS the Navy's policies, directives, and regulations for handling hazardous materials to determine if the Navy Environmental Health Center (NEHC) is adequately constituted to carry out its mission. This is followed by a review of the Navy's current health-hazard assessment (HHA) process as implemented by NEHC, which includes a discussion of the types of HHAs conducted by NEHC, and the resources, information sources, and quality-control procedures employed. NAVY POLICIES AND DIRECTIVES RELATED TO HAZARDOUS SUBSTANCES Because the Navy is a very large organization spread out over the entire marine geography of the earth, it requires an integrated command structure to carry out its duties for sound and responsible handling of hazardous substances. Without a responsive command structure that acts in an effective, efficient, and coordinated manner to handle hazardous materials, the Navy's mission to protect and defend the nation and fulfill treaty agreements with allies could be jeopardized

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS through impaired health of key combat and support personnel, loss of public confidence in its ability to operate effectively, or loss of the good will of those countries that host Navy facilities. The Department of Defense (DOD), the Secretary of the Navy, and the Navy's Bureau of Medicine and Surgery (BUMED) have published many policies, directives, instructions, and military standards that set the framework for control of hazardous substances within the Navy. This section reviews and summarizes those documents to assess whether the Navy's management system for handling hazardous materials clearly states its policies with regard to how such materials should be handled, who is responsible for implementing the policy decisions, and whether NEHC is adequately constituted to carry out its assigned mission. A summary of pertinent policies, directives, instructions, and standards, is presented in Appendix B. DOD and Navy documents clearly set out expectations that Navy managers, whether officers, enlisted, or civilians, are responsible for designing and implementing hazardous materials and that they use procedures that are based on pollution prevention (particularly source reduction) and life-cycle review considerations. The relevant policy statements make it clear that there is an expectation that hazardous chemical materials be fully evaluated prior to use, that the lowest hazard material (subject to consideration of operational acceptability) be selected, that safety is built into the design of systems, and that problem prevention rather than remediation is a significant design and use consideration. The elements of Navy-wide health, safety, and environmental programs that are outlined in those documents include (1) life-cycle assessment, emphasizing pollution prevention and programs to acquire less hazardous materials, and (2) hazardous-material control (including hazard identification and risk assessment) by incorporating elements of occupational safety, industrial hygiene, occupational medicine, and hazard communication. The documents also demonstrate that NEHC is given considerable responsibility for reviewing and assessing the impact of potential hazardous substances on the health of Navy personnel and communicating its findings to the Navy command structure. NEHC is instructed to provide (1) toxicity and related data, (2) guidance on the control of hazardous substances, and (3) recommendations for exposure limits. NEHC is not given responsibility for reviewing or assessing the environmental aspects of hazardous substances, except on an as-requested

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS basis or as a part of the Defense Environmental Restoration Act or Base Realignment and Closure programs; those requests come from the Naval Facilities Engineering Command. NEHC is also not given the responsibility for reviewing and assessing the intrinsic safety properties of materials for fire hazard or explosivity. Although the responsibilities of NEHC are clearly stated, it is not given authority to require Navy managers in the client commands to use its services, or authority to prohibit the use of certain hazardous materials. In addition, the documents indicate that NEHC is the primary source for review of potentially hazardous substances for the Navy. However, Navy operational units may screen materials – for small on-the-shelf types of purchases – through the safety office at site operations and regional occupational health centers. Only materials that are not cleared during the screening process at the unit level or by regional occupational health centers are sent to NEHC. However, NEHC is the only source for providing HHAs to acquisition commands, such as the Naval Sea Systems Command. HHAs are useful to acquisition commands in making decisions for purchasing large amounts of chemicals that would be used throughout the Navy. Although this process appears to make efficient use of Navy resources at multiple organizational levels, it also provides some challenges for adequate training of operations and regional staff, consistency in hazard evaluation across organizations, and life-cycle assessment (LCA) of hazardous substances across Navy operations. Although DOD and Department of the Navy documents include policy statements requiring the use of LCA, it is not clear that consideration of LCA is actually taken into account in the procedures that the Navy has put into place to handle potentially hazardous materials. DOD Directive 5000.1 (Defense Acquisition Management Policies and Procedures) outlines a DOD acquisition process (See phases and milestones process in Figure 2-1) that is similar to many of the “phases and gates” processes used in civilian industrial product-development processes. Although the process does require identification of “potential environmental consequences” at Phase 0, it is not clear if health effects other than those listed on a material safety data sheet (MSDS) are considered in the process or if milestone approvals require sign-off by qualified and experienced professionals on the NEHC or BUMED staff for health assessments. Comparable civilian processes often require such sign-offs to assure that risk assessments are conducted by

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS FIGURE 2-1 Acquisition phases and milestones.

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS qualified personnel who can act independently from the command structure controlling acquisition. DOD and Navy policies also require that end-of-life considerations must be taken into account during acquisition. From examination of the model presented in DOD Instruction 5000.1, the policy contained in this instruction is not complete because the last phase of the process (Phase IV) deals with operations and support rather than disposal and recycling (required elements of a complete LCA). THE NAVY'S CURRENT HEALTH-HAZARD ASSESSMENT PROCESS The Navy uses large amounts of potentially hazardous materials. Control over use of hazardous materials necessitates a considerable investment in minimizing the number and quantity of hazardous materials purchased and that resulting waste material that might be generated. This effort ranges from major weapons systems procurement to individual off-the-shelf purchases. Navy policy requires, after suitable life-cycle considerations, that the material with the least hazard potential (operationally acceptable) be selected for use. The NEHC health-hazard assessment program provides commanders and commanding officers with technical assistance for evaluating toxicity and other relevant data, identifying appropriate control measures, monitoring the use of hazardous materials in the workplace, and developing authorized hazardous-materials-use lists. NEHC's HHA process depends heavily on the availability and quality of toxicity and use information as well as on individuals capable of understanding and applying that information in an appropriate manner. The HHA process provides for several levels of review for toxicity and of related data to prepare HHAs for various chemicals used by the Navy. A tiered approach to assessment of health risk has been used, with a large number of nonhealth professionals within individual commands using standardized criteria to screen materials. Figure 2-2 shows the process flow for conducting HHAs within the Department of the Navy. Initially, the safety office at site operations (ashore or afloat) screens a substance for operational acceptability and economic feasibility and, based on product information (e.g., an MSDS), evaluates whether it is an occupational health hazard (Level I

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS FIGURE 2-2 Process flow chart for health hazard assessments within the Department of the Navy.

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS review). If the safety office at the site operations cannot determine whether or not the substance is a health hazard, industrial hygienists and occupational medicine physicians at a regional occupational health department then review the material (Level II review) and provide recommendations. If there is still uncertainty about the potential hazards, NEHC is contacted to assess the health-hazard potential (Level III review). If insufficient information exists to complete a Level III review, NEHC might contact the Toxicology Detachment of the Naval Health Research Center (NHRC/TD) to perform a Level IV review which might require toxicological testing and development of quantitative risk assessments. As a matter of DOD and Department of the Navy policy, NEHC uses exposure standards set or recommended by the Occupational Safety and Health Administration (OSHA) and the American Conference of Governmental Industrial Hygienists (ACGIH) for those substances with available values. For Navy-specific substances, exposure standards are developed and recommended by NEHC or the NHRC/TD. The Navy usually asks the National Research Council (NRC) Committee on Toxicology (COT) to review the scientific validity of standards set by NEHC or NHRC/TD. NRC recommendations are reviewed and approved by BUMED and forwarded to the Office of the Chief of Naval Operations for promulgation. In certain circumstances, these might be coordinated across services of the DOD for consistency. Examples of Health-Hazard Assessments Conducted by NEHC To evaluate NEHC's HHA process, the subcommittee requested a description of the work of NEHC's Hazardous Materials Department (HMD), which is the responsible body within NEHC that prepares HHAs. In response, a series of documents were received that covered the efforts of NEHC from December 1997 through January 1998. A total of 98 actions were taken. Table 2-1 provides examples of the types of NEHC documents that were submitted to the subcommittee as well as an estimate of the professional level that was thought to be necessary to complete the project successfully. Table 2-2 lists the types of administrative health-hazard assessments prepared between December 1997 and January 1998. Each HHA contains references to the request

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS TABLE 2-1 Examples of Documents Submitted by the Navy Environmental Health Center and Personnel Required to Perform Specific Projects Type of Project Number of Requests/Responses Documented During the Period Specified Below Personnel Required to Perform Specific Projects Department of Defense, Hazardous Materials Information System (HMIS). Technical focal point responsibilities. Forwarding of MSDSs. 638 MSDS (10 December 1997 to 30 January 1998) B.S.-level industrial hygienist Forwarding of technical documentation packet. 2318 technical documentation packages via electronic media (10 December 1997 to 30 January 1998) B.S.-level industrial hygienist Requests from suppliers for information pertaining to the complete chemical content of products undergoing evaluation by the Navy 14 (10 December 1997 to 30 January 1998) B.S.-level industrial hygienist Development of HHAs. Requests received from operational command program managers. 74 (calendar year 1998) 81 (calendar year 1997) B.S.-level/senior B.S.-level/M.S.-level industrial hygienists. Consultation with physicians, toxicologists, environmental protection specialists and preventive medicine specialists as required. HHAs: Special projects related to complex systems (examples: Advanced Amphibious Assault Vehicle-Fire Suppression System) (Does not include submarine materials reviews that are addressed in Table 2-3) 2 (per calendar year) Senior B.S.-level/M.S.-level industrial hygienists. Consultation with physicians, toxicologists, environmental protection specialists, and preventive medicine specialists as required. for information, the source of the information, indications of whether the material meets screening criteria and whether it is believed that the material can be used safely, a list of precautions under which it

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS TABLE 2-2 Health-Hazard Assessment Reports Prepared and Issued Between 10 December 1997 and 30 January 1998. (Selected Sample) Type of Material/Compound or Product Addressed in Health-Hazard Assessments Number of Health-Hazard Assessments Performed during the Period (Selected Sample) and Command Receiving Assessment Lubricants and greases 2 (Naval Surface Warfare Center) Acrylic coating 1 (Naval Surface Warfare Center) Leak detectors for halocarbons 2 (Naval Surface Warfare Center) Solventless varnishes and electric motor applications 2 (Naval Surface Warfare Center) Laboratory chemical for shipboard use 1 Chlorobenzene (Naval Surface Warfare Center) Tapping and cutting fluids 2 (Naval Surface Warfare Center) High-temperature polytetrafluoroethylene tape 1 (Naval Surface Warfare Center) Ion-exchange resin 3 (Naval Surface Warfare Center) Epoxy resin systems 4 (Naval Surface Warfare Center) Adhesive film 1 (Naval Surface Warfare Center) Stain removal materials 2 (Naval Surface Warfare Center) Battery corrosion preventive compound 1 (Naval Surface Warfare Center) Life preserver inflation device 1 (Naval Surface Warfare Center) Metal surface filler 1 (Naval Surface Warfare Center) Desiccant 1 (Naval Surface Warfare Center) Powder coatings 8 (Naval Sea Systems Command) Thermal insulation and coatings/adhesives 4 (Naval Sea Systems Command) Lubricants 1 (Naval Sea Systems Command) Cleaners/degreasers 2 (Naval Sea Systems Command) Epoxy systems and primers 2 (Naval Sea Systems Command) Industrial finishes 1 (Naval Sea Systems Command) Paint strippers 1 (Naval Air Warfare Center) Industrial flooring system 1 (Navy Environmental and Preventive Medicine Unit # 2, Norfolk, VA Industrial solvents 1 (Naval Sea Systems Command) Industrial solvents 1 (Naval Facilities Engineering Command) Industrial solvents 1 (Naval Air Warfare Center)

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS might be used, first aid instructions (if appropriate), and a contact person. Table 2-3 shows a list of special projects conducted by NEHC. The majority of projects reviewed did not require additional expertise in toxicology, risk assessment, or biological modeling beyond that currently resident in NEHC. In completing these tasks, NEHC appeared to be placed in the position of a “job shop” in that it appeared that requests for work were sent and reports were promptly prepared and sent out, but there was little or no interaction during the process and no feedback to NEHC on the adequacy of its evaluation. NEHC'S PROCESS FOR PREPARING HHA REPORTS The remainder of this chapter reviews the HHA process (Level III review) that is used by NEHC to determine whether the process provides both the Department of Navy and the Marine Corps with state-of-the-art, comprehensive, and defensible HHAs. The subcommittee was not charged with evaluating Levels I, II, and IV reviews or reviewing the approval and the promulgation process of higher authority. The subcommittee 's assessment of NEHC's HHA process was based on documents provided by the Navy and presentations made by Navy personnel, observations and evaluations made during a site visit to NEHC in Norfolk, Virginia, and a site visit to the naval aircraft carrier U.S.S. Constellation while docked at the Naval Air Station, North Island, in San Diego, California. Navy programs involved in research, development, testing, and acquisition forward requests for HHAs via their chain of command to NEHC. Those requests are to be made early enough in the developmental phase of each program to allow sufficient time for the assessments to be performed. The information to be provided to NEHC by the client command includes a description of the material or process under consideration (including composition, physical and chemical characteristics, and other information that might appear on a standard MSDS), description of the intended use of the material, estimates of the numbers and types of personnel who might be required to work with the material, an estimate of the quantities likely to be in use and in storage, information regarding details of a material being replaced, and an outline of the developmental or introduction milestones.

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS TABLE 2-3 Special Projects Conducted by the Hazardous Materials Department, Including Submarine Material Reviews Prepared and Issued Between 10 December 1997 and 30 January 1998. (Selected Sample) Project Type of Project and Comments Refrigerant 404a use aboard submarines Provides HHA of refrigerant, notes restrictions for use and assigns a recommended usage category. Solventless motor varnishes Provides HHA of these varnishes, provides guidance with regard to varnish use, off-gassing of aldehydes, and assigns recommended usage category. Washroom cleaner Provides HHA of washroom cleaner proposed for use on submarines and assigns a recommended usage category. Rubber mounts and adhesives Provides HHA of mount/adhesive use and assigns a recommended usage category. Recommends follow-up off-gas testing and further analysis of these materials. Review/recommendations pertaining to the submarine Materials Test Protocol and Quality-Assurance Program Provides review of protocol, a listing of target compounds and recommendations for revision and incorporation of new target compounds into the program. Molybdenum disulfide antiseize compound Provides review of off-gas testing data from samples analyzed at the National Aeronautics and Space Administration/ White Sands Test Facility (NASA/WSTF), Las Cruces, NM, and assigns a recommended usage category for this antiseize compound. Armaflex insulation Provides a submarine materials review and a proposed usage category for this insulation. Recommends follow-up off-gas testing at NASA/WSTF and further analysis of this insulation. Non-metallic grating Provides review of grating for use in submarine access tubes. Provides additional guidance regarding hazards associated with installation of grating. Battery liner coating Provides review of off-gas data from samples of battery liner coating, which is proposed for use in submarine battery compartments. Recommends usage category. Enzyme digester Provides review of detergent. Provides required precautions for use, and recommends follow-up testing of material. Optical bypass switches Provides review of optical bypass switches for use in missile control centers. Recommends usage category.

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS Adhesive for installing rubber sheeting Provides review of proposed adhesive use, notes potential hazards and control recommendations, and recommends material usage category. Revision to Nuclear Powered Submarine Atmosphere Control Manual Provides confirmation that recommendations provided via five previous letters have been included in the final draft of the Manual. Adhesives Provides review of all known sources of this adhesive and identifies additional requirements for off-gas testing of materials at the NASA/WSTF. Provides health-hazard control recommendations. Battery charger Provides administrative review of battery charger, notes potential hazards and concerns, and recommends a usage category. Open cell foam panels and fabric covers Provides review of off-gas testing data for both systems and recommends usage categories. Also recommends pre-baking of systems to minimize subsequent off-gassing when first placed into service. Development of permissible exposure criteria and health-hazard control guidance for hydroxylammonium nitrate (HAN) Addresses possible use of HAN as the oxidizer for torpedoes and an internal combustion catapult (new programs development). Discusses possible need for COT participation in development of permissible exposure criteria for HAN. Powder coatings Provides HHAs of significant new use of 25 powder coatings. Identifies potential health hazards and control measures. Recommends on-site initial trials prior to final approval for use. Assigns interim submarine material usage categories. In completing a Level III review, industrial hygiene personnel at NEHC use the scientific literature (information provided in MSDS, toxicology books and journals, electronic literature searches, etc.) and their experience relevant to naval operations to evaluate the available toxicological, epidemiological, and related data; judge the nature and degree of the exposures that might occur; assess the potential health hazard from each; and recommend controls needed in a given use situation to minimize the health risk. If necessary, NEHC also provides interim recommendations to the requesting command to ensure that obvious health hazards identified early in the review process are made

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS known to the users, and provide recommendations for surveillance and control. When appropriate, other governmental agencies and technical organizations, as well as private consultants, are consulted for their input in preparing HHA reports. NEHC also coordinates with NHRC/TD, located at Wright Patterson Air Force Base near Dayton, Ohio, in performing HHAs. Coordination and interaction between these two groups occurs most frequently when information on the toxicity of the material is limited or when a quantitative risk assessment is required. This interaction generally involves requesting NHRC/TD to review toxicological data, determine possible additional research efforts to fill data gaps, estimate resource availability and project duration, and estimate additional resources that might be required to advance each project to meet the requesting command's deadlines. When additional review is considered necessary, specific questions are then referred to the COT. In addition, NHRC/TD maintains liaison with other sources of pertinent expertise such as the Air Force is Armstrong Aerospace Medical Research Laboratory and the NRC's COT, performs or obtains needed research to fulfill risk characterization requirements, and keeps NEHC informed of the same. NHRC/TD also maintains toxicology databases that are presumably available for use by NEHC. Further, staff guidelines for the preparation of HHAs point out that “if it is considered to be advantageous,” assistance can be sought from the Environmental Programs Directorate or the Occupational Medicine Directorate for comment on the occupational medicine and environmental hazard aspects of a product's use (J. Drewyer, personal commun. Aug 11, 1997). Hazard assessors are also directed, on an as-needed basis, to request additional consultation from the NHRC/TD according to the procedures outlined in BUMEDINST 6270.8. (See Appendix B.) NEHC staff state that NHRC/TD provides an extremely high level of toxicological support for the NEHC program on a daily and continuous basis. Assistance contacts are via phone, email, and official correspondence, and occur at least daily, with some “hot issues” requiring hourly contact, and several days to weeks for completion. NEHC staff estimate that at least 500 contacts per year occur, probably requiring more than 1,000 hours of NHRC/TD staff time to research and provide the needed level of support required.

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS The recommendations contained in HHA reports are incorporated into the requesting cormnand's occupational safety and health program and are used by the requesting command (client) as part of their decision-making to determine whether the development or use of the material should be continued. An outline of the informal procedures for Level III review by NEHC is summarized below: The HHA assessment process is triggered by a request to NEHC for assessment from a Navy operations manager, a program manager, or a safety officer. If necessary, NEHC contacts the requesting agency to obtain additional information, points of contact, or clarification of administrative items. NEHC receives a documentation package from the manufacturer of the product being assessed, including an MSDS. NEHC reviews the manufacturer's documentation package and ensures that the required technical information is complete. Essential information for a review includes a complete description of the product, intended use, technical specification sheets and sales literature, supplier's name, supplier's phone number, a technical point of contact, an MSDS that complies with the OSHA hazard-communication standard (HCS), complete product formula with ingredients totaling 100%, Chemical Abstracts Services (CAS) number for each ingredient, a current MSDS for each ingredient, the temperature to which the product will be subjected during use as well as maximum use temperature, copies of toxicity studies related to the product and its ingredients, and copies of standard operating procedures that relate to the application or use of the product. Desirable information to complete an HHA includes a small sample of the product as sold, copies of any industrial hygiene survey reports that address potential health hazards related to working with the material, copies of laboratory reports that address the composition and magnitude of pyrolysis products emitted from the product when it is involved in a fire or otherwise severely heated or allowed to contact molten metal, and a technical points of contact within the Navy and at major commercial users of the product should additional information pertaining to application or use experience be needed.

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS If information in the documentation package is missing, incomplete, or suspected to be erroneous, NEHC will consult with the point of contact at the manufacturer or the Navy requestor for supplemental information. NEHC will review the MSDS for the chemical material and for the constituents of the material, making special note of the presence of known or suspected human carcinogens. These include International Agency for Research or Cancer (ARC) Groups 1, 2A, 2B; the National Toxicology Program (NTP) list of known or suspected carcinogens, and processes that NTP lists as known to be carcinogenic; U.S. Environmental Protection Agency (EPA) assessments on the Integrated Risk Information System (IRIS); or OSHA regulated carcinogens. Previous experience by NEHC staff has demonstrated that a number of noncancer decision criteria serve as useful determinants of toxicity and allow identification of problematic compounds. As a consequence, special consideration is given to chemicals with an oral LD50 of less than 500 mg/kg of body weight (rats); an LC50 of less than 2,000 ppm by volume of gas or vapor, or 20 mg/liter of mist, fume, or dust; a dermal LD50 of less than 1,000 mg/kg of body weight (albino rabbits, 24 continuous hours skin contact); Navy occupational chemical reproductive hazards and sensitizers (dermal, respiratory, and systemic); caustics and corrosives; and highly flammable items and dangerously reactive or explosive materials. The data required by OSHA's HCS on an MSDS are reviewed. Non-HCS data are reviewed for additional information. NEHC reviews the manufacturer's product data sheet, technical data sheet, product use sheet, and any other adjunct information that might contribute to better understanding of the materials being assessed. NEHC then reviews chemical and toxicological reference materials and computerized databases that are readily available and can provide information on the products or constituents being assessed. Among the most frequently used references are the CCINFO CD-ROM series (Canadian Center for Occupational Health electronic MSDS database), Casarett and Doull'sToxicology (Klaassen et al.1996), Micromedex Toxicology, Occupational Medicine and Environmental Services (TOMES), Compendium of Safety Data Sheets for Research and Industrial Chemicals (Keith and Walters 1986), CRC Handbook of Chemistryand Physics (Lide 1999), Hawley's Condensed Chemical Dictionary (Lewis

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS 1993), Chemical Hazards of the Workplace (Proctor et al. 1988), Handbook of Emergency Chemical Management (Quigley 1994), Dorland's Medical Dictionary (W.B. Saunders Co. 1994), IARC Monographs, NTP Reports, and federal regulations (29 CFR Part 1910 and 42 CFR Part 84). As considered necessary, searches are performed by the NEHC library staff. The databases most commonly used by the library staff are CHEMID or CHEMLINE, CANCERLIT (Cancer Literature Database), EMIC (Environmental Mutagenesis Information Center Database), TOXLINE or TOXLIT (Toxicology Literature Information Database), CCRIS (Chemical Carcinogensis Research Information System), IRIS, DART (Developmental and Reproductive Toxicology Bibliography File), and the Chemical Abstracts Registry File. NEHC personnel then integrate the information acquired in the review process. Consideration is given to items such as material percentages, the degree of toxicity, the general severity of the hazard (chemical or physical), the presence of carcinogenic or suspected carcinogenic materials, the presence of reproductive hazards, the presence and potency of sensitizers, and the presence of any undesirable or exotic manifestations reported by users of the material being evaluated. NEHC formulates an assessment of the potential for safe use of the material for the intended purpose, provided all the precautions listed by the manufacturer are followed explicitly. NEHC then compares the safe-use assessment to the manufacturer's MSDS sheet and resolves any significant differences with the manufacturer. As needed, NEHC seeks assistance from the Environmental Programs Directorate or the Occupational Medicine Directorate on the product 's environmental and occupational hazards. If additional consultation is warranted, a request is forwarded to the NHRC/TD following procedures outlined in BUMEDINST 6270.8. (See Apendix B.) An interim response is prepared if a backlog of assessments exists. This response might indicate that the initial assessment was performed, that the material can be safely used for the intended purpose provided the safety and health provisions in the manufacturer's MSDSs are followed explicitly, and that a comprehensive assessment will follow within a prescribed period of time. A comprehensive response is prepared either initially or following the interim response. This response will include the adverse health effects that might be encountered from exposure primarily through the

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS nose, eyes, and skin; the potential for causing cancer in exposed populations; the presence (in any amount) of a Navy occupational chemical reproductive hazard; the first aid actions required as a result of accidents; the personal protective devices necessary to reduce exposure risk; general precautionary statements; training requirements; industrial hygiene and medical department review recommendations; information on what the review did not cover; and information on the procedures for obtaining a submarine-use review. Some reports specifically address certain chemcial stressors of concern (e.g., crystalline silica in nonskid surfaces). Ingestion hazards are not normally addressed due to the unlikelihood of occupational exposure via the ingestion route. Nevertheless, users must be cautioned to review the ingestion hazard statements on the MSDS and be prepared to respond as required by the circumstances. As needed, replies to follow-up requests are made for amplification or clarification regarding either the interim or the comprehensive HHA. NEHC files and maintains the report and all associated documentation indefinitely in a safe and secure area. Information concerning proprietary elements of an assessment is not divulged to any party without the manufacturer's written permission. Requests for information from vendors and other sources besides the client command are addressed by the client command. NEHC does not give HHAs to vendors. SPECIAL CONSIDERATIONS FOR RISK ASSESSMENTS: POPULATIONS AT RISK The Navy is concerned about three populations that might be at risk for adverse health effects from exposure to hazardous materials that are used or encountered in its operations. The first and most restrictive population at risk would include only active military personnel. This at-risk population could be expanded to include family members, especially if there is any possibility that the exposure might be transported outside the occupational setting. A second population would include civilians employed in various capacities at naval facilities or on ships and who have the potential for

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS indirect or direct exposures to hazardous materials in the course of performing their duties. Depending upon the exposures of concern, this definition could be expanded to include dependents and civilian personnel. The third and most comprehensive population at risk includes the community residing in the vicinity of the naval base. In addition to the aforementioned populations, this population includes all residents in a specified geographical area with susceptible subgroups such as pregnant women, infants, children, the elderly, and persons with preexisting diseases. EXPOSURE INFORMATION FOR HEALTH-HAZARD ASSESSMENTS Many occupational exposures to Navy personnel are similar to those that occur among civilian workers. Exposures are expected to be by inhalation or dermal contact in the vast majority of instances. Oral exposures would be expected to occur only under accidental conditions or with poor personal hygiene. Unlike many civilian exposure conditions, the Navy must deal with work locations on board ships or aircraft as well as at shore facilities. Particularly on board ship and aircraft, serious considerations have to be given to addressing the inability of crews to avoid accidental exposures in certain circumstances. Therefore, although emergency evacuation of a facility might be seen as a way to control accidental exposures in a civilian workplace, evacuation of ships at sea or aircraft in flight are not options for handling many accidental exposures during Navy operations. Unlike civilian operations, exposures in the Navy occur under “normal workplace conditions” or under “operational conditions,” that is, under exposure conditions driven by military mission performance requirements and under constraints very different from civilian exposure conditions. This subset of occupational exposures encompasses a continuum from training through combat. Exposures to many materials during normal operations can be similar to that of civilian populations (8 hr/d, 5 d/wk, 50 wk/yr). However, to maintain operational effectiveness, frequent personnel training

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS is conducted. Although exposures during training assignments are of relatively short duration, exposure intensity might be much higher than for civilian personnel using similar materials. The trainers might have routine exposures. In addition, exposures might be continuous for some Navy personnel. Continuous exposure to low levels of hazardous materials are most likely to occur either in undersea operations, where submarine crews live in a self-contained environment, or during sustained operations in contaminated environments. Risher et al. (1995) have characterized typical Navy personnel as being a young workforce (a mean age of 27 years) as compared with the civilian workforce (35 years old on average) and generally in better physical condition due to Navy physical- readiness requirements. Under peacetime conditions, Navy tour-of-duty rotations (typically 2 to 3 years) and career development pathways reduce the overall duration of workplace exposure. The shorter tours (2 to 12 months) are almost exclusively training assignments; a “normal” tour is generally about 3 years. Current personnel assignment trends are fostering longer stays in a geographical area, but the rotations among commands are still about 3 years in length. A notable exception is that many enlisted functions aboard ship require the individual to stay with the ship for longer than 3 years–about 4 to 5 years for certain specialties. These factors, however, are not likely to be relevant for civilian employees of the Navy who are expected to have employment characteristics similar to that of the civilian workforce in the private sector. HUMAN RESOURCES AVAILABLE TO CONDUCT HEALTH-HAZARD ASSESSMENTS HHAs are conducted in whole or in part by professional and technical staff both the Industrial Hygiene Directorate and Environmental Programs Directorate, which are located at NEHC in Norfolk, Virginia. At the time of the subcommittee's evaluation, those directorates were composed of approximately 37 people, of which 5 were military officers and 32 were civil service personnel (administrative and clerical personnel were not counted). Additionally, the Occupational Medicine Directorate had 5 military personnel (4 officers, 1 enlisted) and 7 civil

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS service personnel who could also provide support for conducting HHAs. NHRC/TD employed approximately 40 persons. NHRC/TD has the capability of conducting experimental studies to determine the toxicological hazard of chemicals used by the Navy and to perform risk assessments for chemicals that involve complex issues. Staff experience and training in the Industrial Hygiene and Environmental Programs Directorates are predominately in industrial hygiene; however, some staff are trained in environmental engineering, environmental sciences, and chemistry. About one-half of the staff had earned master of science degrees in a relevant field and the rest of the staff had earned bachelor of science degrees in a relevant field of study. Only one staff member in those two directorates has a doctorate-level degree in a relevant scientific discipline. However, several persons at NHRC/TD hold doctorate degrees and are available to provide help to NEHC. INFORMATION SYSTEMS USED FOR HAZARD ASSESSMENTS Within NEHC, information searches are conducted primarily by the on-site library staff. The kinds and quality of databases and literature sources in use by NEHC staff for use in performing health risk assessments are primarily those available through the National Library of Medicine (NLM) network of databases and the CAS databases. The first search is the CHEMID database for substance identification. CHEMID provides a list of all NLM databases that contain information on the CAS number or name. Each listed database is then searched individually. These include CHEMID, CANCERLIT, CCRIS, DART, IRIS, MEDLINE, Hazardous Substances Data Bases, TOXLINE, and Registry of Toxic Effects. If clarification or expansion is necessary during the search process, there would be an exchange between the NEHC requestor and the librarian performing the search. This exchange would serve to clarify what was desired and amplify or expand on a provided product, as necessary. Storage of NEHC completed reports and their distribution to NEHC clients appeared to be largely a manual process, rather than an electronic process. Currently, the Navy does not have a computerized

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS database-management structure in place that would permit the identification, evaluation, and control of health hazards for populations at risk. PEER REVIEW OF REPORTS In the preparation of an HHA for a chemical material, NEHC is directed by BUMED (BUMEDINST 6270.8, 4.c. (1), p. 5; 6 Jun 90) to seek review of its HHA reports by credible groups. Those requests for review were the mechanisms employed to obtain external review of the Jinkanpo Incineration Complex draft health risk analysis and the “Human Health Risk Evaluation for Past Firefighters' Activities at Naval Air Station Alameda California.” The Naval Air Station Alameda assessment is highly visible due to potential occupational exposures from PCBs, dioxins, and lead incurred during training exercises by fire fighters. The Jinkanpo assessment addresses a highly visible public health issue involving exposure of Navy staff, dependents, and facility tenants to industrial waste incinerator emissions generated by a privately owned, off-site firm regulated by a host country. NEHC's criteria for determining which assessments undergo external review, and the degree of external review to which the assessment is to be subjected, are discussed below. NEHC policies and procedures require that all HHAs undergo an internal review. External reviews are sought when the HHA or health risk assessments are performed to resolve a controversial issue for which a review by independent groups such as the National Research Council of the National Academy of Sciences would be beneficial when dealing with low-trust and high-concern situations, such as for the Jinkanpo Incinerator Complex at Atsugi, Japan, and the Alameda Fire-fighter risk assessments. Criteria for significant external review appear to be high-visibility subjects involving international differences in the interpretation of regulatory compliance (e.g., Jinkanpo Incineration Complex at Atsugi, Japan); regulatory issues involving unique occupational exposure scenarios (e.g., Past Firefighters' Activities at Naval Air Station Alameda);

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS the introduction of novel compounds (e.g., hydrofluoroether (HFE)-7100 and hydrofluorocarbons (HFC)-236 fa) in the naval supply system. Selection criteria for identifying which institutions and staff qualifications are needed to perform a given review are not known to the subcommittee. The routine NEHC criterion is to select external reviewers who have risk-assessment experience and are associated with the governmental regulatory sector. If potential external reviewers are from other than the regulatory sector, they are selected because of the basis of their expertise in the primary issue of concern (e.g., PCBs, dioxins). In the case of Atsugi, NEHC also sought reviews from the NRC's COT and the University of Florida. At present, the subcommittee's impression is that the current review of low-visibility tasks is not systematic and might not be sufficiently supported.