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DEPARTMENT OF ENERGY H. Review Under Small Business as nuclear reactor moderators or Regulatory Enforcement Fairness Act of reflectors, and as nuclear reactor fuel 10 CFR Part 850 1996 element cladding. At DOE, beryllium Appendix A to the Preamble—References operations have historically included Appendix B to the Preamble—Questions and [Docket No. EH±RM±98±BRYLM] Answers Concerning the Beryllium melting, casting, grinding, and machine Induced Lymphocyte Proliferation Test tooling of parts. (Be–LPT), Medical Records, and the Inhalation of beryllium dust or RIN 1901±AA75 Department of Energy (DOE) Beryllium particles can cause chronic beryllium disease (CBD) or beryllium Chronic Beryllium Disease Prevention Registry sensitization. CBD is a chronic, often Program I. Introduction debilitating, and sometimes fatal lung AGENCY: Office of Environment, Safety This final rule implements a chronic condition. Beryllium sensitization is a and Health, Department of Energy. beryllium disease prevention program condition in which a person’s immune (CBDPP) for the Department of Energy system becomes highly responsive ACTION: Final rule. (DOE or the Department). This program (allergic) to the presence of beryllium in will reduce the number of workers the body. There has long been scientific SUMMARY: The Department of Energy currently exposed to beryllium at DOE consensus that exposure to airborne (DOE) is today publishing a final rule to facilities managed by DOE or its beryllium is the only cause of CBD. establish a chronic beryllium disease contractors, minimize the levels of, and As of September 1999, among the prevention program (CBDPP) to reduce potential for, exposure to beryllium, 11,266 current and former DOE federal the number of workers currently establish medical surveillance and contractor workers who were exposed to beryllium in the course of requirements to ensure early detection screened for the disease, 130 workers their work at DOE facilities managed by of disease, and improve the state of had been diagnosed with CBD, and DOE or its contractors, minimize the information regarding chronic beryllium another 277 workers had become levels of, and potential for, exposure to disease and beryllium sensitization. sensitized to beryllium. DOE anticipates beryllium, and establish medical On December 3, 1998, DOE published an increase in the number of workers surveillance requirements to ensure a Notice of Proposed Rulemaking who may be exposed to beryllium as early detection of the disease. This (NOPR) for public comment in the DOE moves forward with deactivating program improves and codifies Federal Register (63 FR 66940) and decommissioning former nuclear provisions of a temporary CBDPP proposing regulations for a chronic weapons production facilities. established by DOE directive in 1997. beryllium disease prevention program. The current worker protection EFFECTIVE DATE: This rule is effective The public comment period for the permissible exposure limit (PEL) of 2 January 7, 2000. NOPR ended on March 9, 1999. DOE µg/m3, measured as an 8-hour, time- weighted average (TWA), was adopted FOR FURTHER INFORMATION CONTACT: received 36 comment letters. In by the Occupational Safety and Health Jacqueline D. Rogers, U.S. Department addition, public hearings were held on Administration (OSHA) in 1971 and of Energy, Office of Environment, Safety February 3, 1999, in Oak Ridge, codified in 29 CFR 1910.1000, Tables Z– and Health, EH–51, 1000 Independence Tennessee; February 9, 1999, in Golden, Colorado; and February 11, 1999, in 1, Z–2 and Z–3 by reference to existing Avenue SW, Washington, DC 20585, national consensus standards. DOE’s 301–903–5684. Washington, DC. Comment letters were received from private individuals, DOE predecessor agency, the Atomic Energy SUPPLEMENTARY INFORMATION: contractors, other federal agencies, trade Commission (AEC), had previously I. Introduction associations, academia, public health established the same limit of 2 µg/m3 for A. Background and medical professionals, and application at its facilities in 1949, and B. Chemical Identification and Use attorneys. that limit has remained in effect at C. Health Effects DOE’s facilities up to the present. In 1. Chronic Beryllium Disease On June 3, 1999, DOE published a 2. Beryllium Exposures at DOE Operations notice of limited reopening of the 1977, the National Institute for 3. Epidemiology comment period (64 FR 29811) to solicit Occupational Safety and Health 4. Value of Early Detection public comments on options that DOE (NIOSH), a federal agency, II. Legal Authority and Relationship to Other was considering for the criteria to be recommended to OSHA an exposure Programs used for the release or transfer of limit of 0.5 µg/m3 for beryllium. NIOSH, III. Overview of the Final Rule equipment and other items previously at the same time, classified beryllium as IV. Section-by-Section Discussion of used in DOE beryllium operations, a potential occupational carcinogen. Comments and Rule Provisions Between the 1970s and 1984, there A. Subpart A—General Provisions either to other DOE facilities or to the public. In response to this reopening of appeared to be a significant reduction in B. Subpart B—Administrative the incidence rate of CBD. This, coupled Requirements the comment period, DOE received 15 C. Subpart C—Specific Program additional comments. with the long latency period for the Requirements DOE has carefully considered the disease, led to the assumption that CBD List of Commenters comments and data from interested was occurring only among workers who V. Procedural Requirements parties, as well as reference works, had been exposed to high levels of A. Review Under Executive Order 12866 journal articles, and other information beryllium decades earlier (e.g., in the B. Review Under the Regulatory Flexibility relevant to the subject of the 1940s). However, the number of Act rulemaking. confirmed cases of CBD, more recent C. Review Under the Paperwork Reduction data suggesting the occurrence of CBD Act A. Background among workers with low-level D. Review Under the National Environmental Policy Act DOE has a long history of beryllium exposures, and the expected future E. Review Under Executive Order 13132 use because of the element’s broad increase in the number of workers F. Review Under Executive Order 12988 application to many nuclear operations potentially exposed to beryllium (during G. Review Under the Unfunded Mandates and processes. Beryllium metal and decontamination and decommissioning Reform Act of 1995 ceramics are used in nuclear weapons, activities) all indicate a need for more

VerDate 29-OCT-99 10:58 Dec 07, 1999 Jkt 190000 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\A08DE0.189 pfrm04 PsN: 08DER3 Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 / Rules and Regulations 68855 aggressive workplace controls to exposed to beryllium in the development of a DOE beryllium worker ˜ minimize worker exposure to beryllium performance of these 64 operations or protection rule, Secretary Pena also in the DOE complex. processes. These estimates were established the Beryllium Rule Advisory In December 1998, the American updated in 1999 through a cost survey Committee (BRAC) in June 1997 to Conference of Governmental Industrial conducted by the Office of advise DOE on issues pertinent to the Hygienists (ACGIH) published a Notice Environment, Safety and Health (1999 proposed rulemaking. The BRAC, which of Intended Change for its beryllium Environment, Safety and Health Cost consisted of a diverse set of stakeholders exposure limit. ACGIH is a professional Survey). In this survey, 14 DOE sites and recognized experts from DOE, other organization that develops and indicated that they would be affected by federal agencies, industry, labor, publishes consensus occupational the proposed rule. These sites reported medicine, and academia, explored health standards. In the Notice, ACGIH that 1,634 workers in more than 100 issues and generated recommendations proposed an 8-hour TWA of 0.2 µg/m3 different job categories would be for consideration in the development of to help minimize the occurrence of CBD potentially exposed to beryllium and a CBDPP rule.1 and sensitization. DOE’s NOPR did not 1,236 of these workers (75.6 percent) address ACGIH’s proposed change would be potentially exposed at the B. Chemical Identification and Use because publication of the NOPR proposed action level or PEL. Beryllium (atomic number 4) is a preceded ACGIH’s announcement. The 1996 survey also provided silver-gray, metallic element with a DOE has reviewed current technical information on exposure levels density of 1.85 g/cm3 and a high information and is of the opinion that it experienced by workers at the surveyed stiffness. The second lightest of the is difficult to determine the exposure sites. Although the exposure data were metals, beryllium also has a high level that is necessary to eliminate the not comprehensive, the reported 8-hour melting point (1285° C) and heat risk of contracting CBD. Until OSHA TWA exposure data (personal breathing absorption capacity; a pound of completes its rulemaking, DOE has zone monitoring results) for these beryllium will absorb as much heat as decided to implement an aggressive, workers ranged from nondetectable to 5 pounds of copper. two-pronged exposure reduction and 25 µg/m3. Most of these exposure levels Beryllium occurs naturally in the minimization program that is expected were reported to be below the 2 µg/m3 earth’s surface in about 30 minerals to further protect DOE federal and 8-hour TWA PEL. To control worker found in rocks, coal and oil, soil, and contractor workers from the hazards exposures in the affected processes or volcanic dust. Beryllium used in associated with exposure to beryllium. operations, the surveyed sites reported industry begins as a silicate (BeSiO3) in While DOE acknowledges that this rule the use of various engineering and beryl and bertrandite ores. In very pure may not eliminate the risk of contracting administrative controls, including crystalline form, beryl takes the form of CBD, DOE believes that this rule will ventilation hoods, glove boxes, wet gems, such as blue-green aquamarine significantly decrease the number of machining methods, high-efficiency and green emeralds. Bertrandite is workers exposed and the level of particulate air (HEPA) vacuums, mined in Utah. The United States is the exposure to beryllium, and therefore, is regulated areas, action levels and world’s leading producer, processor, expected to decrease disease. First, DOE administrative warning levels, and and consumer of beryllium products. is establishing an 8-hour TWA action personal protective equipment. The Beryllium, discovered in 1798, was µ 3 level of 0.2 g/m that triggers certain survey showed that beryllium exposure not widely used in industry until the workplace precautions and control controls varied considerably among the 1940s and 1950s. Beryllium can be used measures. Second, DOE is requiring its DOE facilities. as a pure metal, mixed with other contractors and any covered DOE To supplement the data obtained from metals to form alloys, processed to salts employers to establish in their CBDPPs the 1996 survey, the Department that dissolve in water, and processed to exposure reduction and minimization published a Federal Register notice on form oxides and ceramic materials. measures designed to reduce potential December 30, 1996, requesting scientific Beryllium metal has been produced exposure to levels below the action data, information, and views relevant to for various industrial uses, especially in level. This program will enhance and a new DOE beryllium health standard the aerospace and defense industries. supplement existing worker protection (61 FR 68725). This was followed by Both structural and instrument grade programs established under DOE Order two Beryllium Public Forums, one held materials are manufactured, including 440.1A, Worker Protection Management in Albuquerque, New Mexico, and one windshield frames and other structures for DOE Federal and Contractor held in Oak Ridge, Tennessee, in in high-speed aircraft and space Employees. January 1997. vehicles, aircraft and space shuttle This rulemaking initiative was Acting on the information compiled brakes, satellite mirrors and space preceded by several years of information from these various sources, and in view telescopes, inertial guidance systems gathering and data analysis. In 1996, of the time needed to promulgate a rule, ˜ and gyroscopes, neutron moderators or DOE surveyed its contractors to then-Secretary of Energy Pena directed reflectors in nuclear reactors, X-ray characterize the extent of beryllium the Office of Environment, Safety and windows, and nuclear weapons usage, the types of tasks involving Health to publish a new DOE policy to components. beryllium usage, the controls in place protect the workforce while the In alloys, beryllium confers on metal for each task, the estimated number of Department moved forward with its specific properties of resistance to workers exposed during each task, and rulemaking process. DOE Notice 440.1, corrosion, wear, and fatigue; high the estimated exposure levels associated Interim Chronic Beryllium Disease electrical and thermal conductivity; with each task. This survey found that Prevention Program, was signed by ˜ between 1994 and 1996, 10 of the 15 Secretary Pena and issued on July 15, 1 Individual members and groups of members DOE sites surveyed performed 64 1997. This interim Notice established a made BRAC recommendations. The different operations or processes that CBDPP that enhanced and recommendations were generated by the facilitated could expose workers to beryllium. The supplemented worker protection process used during the meetings and were not adopted by the committee as consensus opinions. surveyed DOE sites estimated that programs under DOE Order 440.1A. For convenience of reference these between 518 and 530 workers in 58 Because of the complexity and recommendations are referred to as the ‘‘BRAC different job categories were potentially significance of issues regarding the recommendations.’’

VerDate 29-OCT-99 10:58 Dec 07, 1999 Jkt 190000 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 E:\FR\FM\A08DE0.190 pfrm04 PsN: 08DER3 68856 Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 / Rules and Regulations strength; and hardness. Beryllium- mucosal surfaces. In susceptible require continuous oxygen copper (BeCu) alloys usually contain individuals the beryllium-peptide administration. about 2 percent beryllium, but vary complex initiates an immune response, Individuals sensitized to beryllium greatly in composition to meet different which may progress ultimately to are asymptomatic and not physically industrial and consumer needs. granuloma formation in the pulmonary impaired. Once sensitization has Beryllium is also added to aluminum, interstitium. Data have suggested that occurred, it is medically prudent to nickel, zinc, and zirconium for some CBD can occur at relatively low prevent additional exposure to applications. Beryllium alloys are used exposure levels and, in some cases, after beryllium. Individuals with CBD have a for springs, switches, relays, and relatively brief durations of exposure. clinical illness varying from mild to connectors in automobiles, computers, The International Agency for Research severe. In severe cases, the affected radar and telecommunications on Cancer (IARC) and ACGIH classify individuals may be permanently and equipment, and other instruments; high- beryllium as a human carcinogen. totally disabled. Mortality of the strength non-sparking tools; molds or Frequently reported symptoms sensitized individuals directly casts to make metal, glass, and plastic include one or more of the following: attributable to CBD and its items; sports equipment such as golf dyspnea (shortness of breath) on complications is estimated to be 30 clubs and bicycle frames; and dental exertion, cough, fever, night sweats, and percent (ref. 2). This estimate is based bridges and related applications. chest pain and, less frequently, upon historical data reflecting both the Other beryllium materials include arthralgias (neuralgic pain in joints), higher levels of exposure that occurred soluble salts and oxides. Beryllium fatigue, weight loss, or appetite loss. On in the workplace prior to regulation of soluble salts, such as beryllium fluoride, physical examination, a doctor may find workplace exposure in the late 1940s chloride, and sulfate, are used in signs of CBD results, such as rales and a tracking of the medical history of nuclear reactors, in glass manufacture, (changes in lung sounds), cyanosis (lack subjects of CBD over several decades. and as catalysts for certain chemical of oxygen), digital clubbing, or DOE’s more recent experience with reactions. Beryllium Oxide (BeO) is lymphadenopathy (enlarged lymph improved diagnoses and treatments may used to make ceramics for electronics, nodes). A radiograph (X-ray) of the result in a lower mortality rate for CBD and other electrical equipment. lungs may show many small scars. cases. Patients may also have an abnormal Beneficial properties of BeO include 2. Beryllium Exposures at DOE breathing test, pulmonary function test, hardness, strength, excellent heat Operations conductivity, and good electrical and a blood test, the peripheral blood insulation. beryllium-induced lymphocyte DOE’s medical surveillance programs proliferation test (Be–LPT). Examination are discovering cases of CBD among C. Health Effects of the lung tissue under the microscope workers who were first exposed after DOE received a number of comments may show granulomas, which are signs 1970, when DOE facilities were (Exs. 2, 5, 14, 19, 20, 22, 23, 24, 26, 29, of damage due to the body’s reaction to expected to maintain workers exposure 30) 2 regarding the ‘‘Health Effects’’ beryllium. CBD may be confused with to beryllium below the OSHA PEL. As section of the NOPR. DOE has carefully other lung diseases, especially of June 1999, 119 workers (88 at the considered these comments and has sarcoidosis. In advanced cases, there Rocky Flats facility in Golden Colorado, revised the following health effects may be manifestations of right-sided 29 at the Y–12 Plant in Oak Ridge, discussion as appropriate. heart failure, including cor pulmonale Tennessee, and two at the Hanford (enlarged right ventricle of the heart facility in Richland, Washington) have 1. Chronic Beryllium Disease caused by blockage in the lungs). been diagnosed with CBD, and another Chronic beryllium disease (CBD) is a The Be-LPT is highly specific for 258 workers (197 at the Rocky Flats granulomatous lung disease that is beryllium sensitivity and has a high facility, 59 at the Y–12 Plant, one at the caused by the body’s immune system predictive value for beryllium disease. It Hanford facility, and one at the Mound response (similar to an allergic reaction) is the most definitive means of ruling facility in Miamisburg, Ohio) have been to inhaled dust or fumes containing out beryllium disease as the cause of diagnosed as sensitized to beryllium beryllium metal, alloys, beryllium non-specific lung and other symptoms. from among approximately 10,000 compounds or mixtures, or insoluble Therefore, this measurement of current and former DOE federal and beryllium salts. The body’s immune sensitization to beryllium identifies at- contractor workers who were screened system response to beryllium is often risk individuals, as well as individuals for the disease. called beryllium sensitization. whose lung problems are not beryllium A worker’s exposure is measured by Beryllium sensitization precedes the related (ref. 1). For individuals whose personal monitoring, which is development of CBD. Sensitization can Be-LPT screening results exceed a accomplished by sampling the air occur quickly or many years after certain threshold, an additional Be-LPT within the breathing zone of the worker. exposure to beryllium, progressing into is conducted on cells washed from a Personal monitoring of occupational disease at a rate of approximately 10 segment of the lung. The presence of exposures to beryllium was not widely percent a year (ref. 1) 3. granulomata in the lung of an individual adopted at DOE sites until the 1980s. It is hypothesized that beryllium is a with a positive lung Be-LPT confirms Prior to the 1980s, many sites relied on hapten (a substance that provokes an the presence of CBD. In the absence of area monitoring to assess occupational immune response only when combined granulomata or other clinical evidence exposures to beryllium. However, with another substance, generally a of CBD, individuals with a positive Be- results from area monitoring have been protein) that binds to peptides on LPT are classified as sensitized to shown to significantly underestimate beryllium. actual exposure levels. Since 1984, 2 A list of commenters is included as an appendix The clinical course of CBD is highly personal sampling data have provided to the Section-by-Section Discussion of Comments variable. Some individuals deteriorate more precise information on and Rule Provisions in this Supplementary rapidly; most experience long, gradual occupational exposure to beryllium at Information section. 3 A listing of references is included as an deterioration. Treatment consists of oral DOE sites. appendix to this Supplementary Information corticosteroid therapy. Individuals with Available personal sampling data section. impaired respiratory gas exchange may provides a clear indication of the low

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TABLE 1.ÐOAK RIDGE Y±12 PLANT PERSONAL SAMPLING FOR BERYLLIUM EXPOSURE

1980 to 1989 1990 to 1996

Number of Samples ...... 148 ...... 1448 Estimated Arithmetic Mean Level of Exposure 1 ...... 0.9 µg/m3 ...... 0.3 µg/m3 Percent of Samples Less Than 2 µg/m3,2 ...... 94% ...... 98% 1 The arithmetic mean was estimated from the samples using linear regression. 2 Samples were analyzed using flame spectroscopy with a detection limit of about 0.1 µg/m3.

These Y–12 data are from beryllium the 1990s identified a greater number of Personal sampling data from the operations where cases of CBD have exposures over the existing exposure Rocky Flats Building 444 Beryllium been found. The facilities where these limit. The investigations of these Machine Shop (Table 2) collected in operations take place have not been exposures resulted in changes to work 1984–85 and then again in 1986 after remodeled since the 1970s. Thus the practices that had contributed to the extensive remodeling to the ventilation differences between sampling results high exposures. This focus on system illustrates the impact and measured before and after 1990 are operations with elevated exposure effectiveness of engineering attributed to changing work practices. levels also led to a significant reduction modifications to control exposure. For example, increased monitoring in in average exposure levels.

TABLE 2.ÐROCKY FLATS BUILDING 444 BERYLLIUM MACHINE SHOP PERSONAL SAMPLING DATA (BERYLLIUM EXPOSURE)

1984 to 1985 1986

Number of Samples ...... 99 ...... 279 Estimated Arithmetic Mean Level of Exposure1 ...... 1.19 µg/m3,1 ...... 0.035 µg/m3 Percent of Samples Less Than 2 µg/m3,2 ...... 84% ...... 99.6% 1 The arithmetic mean was estimated from the samples using linear regression. 2 Samples were analyzed using graphite furnace atomic absorption (AA) or Inductively Coupled Plasma (ICP) spectroscopy with a detection limit of about 0.01 µg/m3.

The samples collected in 1984 and TABLE 3.ÐDECONTAMINATION OF investigated and future occurrences can 1985 were the first personal samples ROCKY FLATS BUILDINGS 865 AND be prevented. collected in this shop following the 867 PERSONAL SAMPLINGÐ1995 TO 3. Epidemiology discovery of a case of CBD in 1984. 1996 Controls in that machine shop had Epidemiology is the field of public previously been judged to be adequate Number of Samples ...... 7,673 health that examines relationships based on area monitoring. In addition to Arithmetic Mean Level of Ex- 0.03 µg/m3 between disease in people, and the extensive remodeling of the posure. exposures or events that are related to ventilation system in the shop to Percent of Samples Less 99.8% that disease. Occupational epidemiology µ 3 minimize leakage from ventilation Than 2 g/m . is the study of the effects of workplace hoods, operations performed outside of exposures on the frequency and hoods were eliminated to the extent As can be seen from the foregoing distribution of diseases and injuries. possible. The improved engineering examples, machining and D&D Hardy and Tabershaw (ref. 3) reported controls in this shop reduced average operations at Y–12 and Rocky Flats the first evidence of the existence of exposure levels by a factor greater than achieved an exceptional level of CBD in a 1946 paper. The paper 30, to levels approaching 1% of the exposure control. described ‘‘delayed chemical existing PEL. While the application of controls pneumonitis’’ among fluorescent lamp A final example, taken from personal eliminates predictable sources of workers exposed to beryllium sampling data collected during the exposure, there still can be large day-to- compounds. The differential diagnosis decontamination of Rocky Flats day variations in exposure. The included sarcoidosis (an immune Buildings 865 and 867 in 1995–1996, exposures that remain are likely to disease of unknown etiology) and further demonstrates the low levels of reflect accidents, equipment failures, or tuberculosis. beryllium exposure which can be poor work planning. Meeting exposure There also are reports of CBD in achieved through the implementation of minimization goals will require individuals without known effective controls (Table 3). Each worker planning to limit the potential for such occupational exposure to beryllium. was sampled during each work shift occurrences, and monitoring to detect Under the direction of Dr. Thomas during this time period. those that do occur, so they can be Mancuso, 16 cases of CBD were

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Ten 1960s, and ultimately was relocated to the health status of that of that worker. of these 11 lived within 3⁄4 of a mile of the National Institute for Occupational An article published by Cullen et al. the plant, and exposure from plant Safety and Health (NIOSH) in 1978. At in 1987 reported on an epidemiology discharges into the air was the suggested that time, the Beryllium Case Registry study of CBD among precious-metal cause of their CBD. Measurements of air contained 622 cases of CBD, 224 cases concentrations of beryllium at various of acute beryllium disease, and 44 acute refinery workers (ref. 15). In 1993, distances from the plant provided the cases that developed into CBD. Twenty- researchers at the National Jewish basis for the Environmental Protection three cases were attributed to household Medical and Research Center (NJMRC) Agency’s (EPA’s) community exposures and 42 to air pollution (ref. published two reports on epidemiology permissible exposure limit (24-hour 6). The Beryllium Case Registry, which studies that were designed to determine ambient air limit of 0.01 microgram of is now inactive, was criticized as the incidence of CBD among beryllium beryllium per cubic meter of air [µg/ deficient in acquiring data on cases, workers and the value of the Be-LPT in m3]). identifying populations at risk detecting CBD (refs. 16, 17). One of In addition, CBD has been reported (denominator data), maintaining follow- these two studies was conducted at among family members of beryllium up of questionable cases, and obtaining DOE’s Rocky Flats Environmental workers who were presumably exposed exposure data (ref. 9). Technology Site (Rocky Flats). These to contaminated work clothing during According to criteria utilized by the three epidemiology studies showed that the 1940s and 1950s (refs. 6, 7). The Beryllium Case Registry, the diagnosis CBD incidence among exposed workers virtual disappearance of CBD caused by of CBD included at least four of the was the same as had been reported air pollution or household exposures following six criteria, with one of the among workers exposed in the 1940s, has been attributed to more stringent first two conditions required: (1) the when the disease was first recognized. control of air emissions and improved establishment of beryllium exposure This exposure limit was originally work practices, such as mandatory work based on occupational history or results derived by analogy to other toxic metals clothing exchange. However, as recently of air samples, (2) the presence of (ref. 18). A decline in the number of as 1989, a woman previously diagnosed beryllium in lung tissue or thoracic reports of CBD in the 1970s and up to with sarcoidosis was diagnosed with lymph tissue or in the urine, (3) 1984 led to the assumption that the 2 CBD. She had no occupational evidence of lower respiratory tract µg/m3 limit had been effective in exposure, but her husband was a disease and a clinical course consistent preventing CBD (ref. 6). DOE recognizes beryllium production worker. This is with beryllium disease, (4) pathological that the 1980s–1990s studies used more the first new case of non-occupational changes consistent with beryllium effective screening and diagnostic CBD reported in 30 years (ref. 8). disease upon examination of lung tissue methods than the earlier studies. Sterner and Eisenbud suggested that or thoracic lymph nodes, (5) radiologic Nevertheless, these 1980s–1990s studies CBD was a highly selective evidence of interstitial lung disease, and provide strong evidence that adherence immunologic response. Their (6) decreased pulmonary function tests to the OSHA standard has not prevented conclusion was based on epidemiologic (ref. 10). new cases of disease. evidence that (1) severe cases have The beryllium-induced lymphocyte occurred at low exposure; (2) the level proliferation test (Be-LPT) in blood and In 1991, responding to NJMRC of beryllium contained in tissue did not bronchoalveolar lavage (BAL) fluid have findings, DOE’s Office of Environment, correlate with the extent of the disease; allowed earlier identification of the Safety and Health initiated a beryllium (3) there was a correlation between disease. The BAL Be-LPT now is one of worker health surveillance program at disease and low atmospheric the criteria required for diagnosis (refs. Rocky Flats to provide medical concentration, but not high 11–13). Beryllium has been found to act screening to current and former concentrations; (4) the onset of as a specific antigen, causing beryllium workers who had not symptoms could occur years after the proliferation and accumulation of participated in the NJMRC studies. In termination of exposure; and (5) beryllium-specific helper T addition, the Office of Environment, pulmonary lesions were not easily lymphocytes (CD4∂) in the lung (ref. Safety and Health initiated a study at reproduced in animals (ref. 7). 14). Current data suggest that the the Oak Ridge Y–12 Plant (Y–12) in A registry of production plant CBD peripheral blood Be-LPT is a specific 1991 to learn if the NJMRC findings on cases was started at Columbia and sensitive method for testing CBD incidence and the effectiveness of University in 1947. A second registry of beryllium sensitivity (ref. 11). The the Be-LPT could be replicated. Results phosphor-lamp CBD cases was started presence of granulomatous tissue in the to date confirm NJMRC findings that around the same time. In 1952, a lung along with a positive BAL Be-LPT CBD incidence rates are high and that Beryllium Case Registry was established is considered definitive evidence for the Be-LPT is an effective screening test at the Massachusetts Institute of diagnosis of CBD (ref. 12). When a for CBD as shown in Table 4.

TABLE 4.ÐRESULTS OF MEDICAL SCREENING OF BERYLLIUM-EXPOSED WORKERS AT THREE DOE SITES THROUGH DECEMBER 1997

Rocky Flats Y±12 Mound

Individuals Examined ...... 6,257 ...... 1,949 ...... 632 Abnormal Be-LPT Number (percent) ...... 221 (3.5%) ...... 77 (4%) ...... 1 1 Completed Diagnostic Exams ...... 186 ...... 33 ...... 0

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TABLE 4.ÐRESULTS OF MEDICAL SCREENING OF BERYLLIUM-EXPOSED WORKERS AT THREE DOE SITES THROUGH DECEMBER 1997ÐContinued

Rocky Flats Y±12 Mound

CBD Number (percent) 2 ...... 79 (1.3%) 3 ...... 25 (1.3%) 4 ...... 0 1 The one Mound employee who was found to be consistently positive declined diagnostic testing. Four others had one positive blood test re- sult and were awaiting retesting. 2 Includes 44 cases confirmed through biopsy and testing of lavage cells and 35 presumptive cases in which the pulmonologist diagnosed CBD but biopsy and/or lavage could not be completed. 3 Includes 56 cases found through the surveillance program since 1991, 17 cases through the 1987±1991 NJMRC study, and 6 cases between 1984 and 1987 for a total of 79 CBD cases. Six of the 79 cases had consistently normal Be-LPT results and were identified through lung disease symptoms or abnormal chest X-rays. 4 Includes 17 cases found in the surveillance program since 1993, 2 cases found in 1991 among beryllium workers who had been diagnosed with other lung diseases, and 6 cases found by the site clinic in 1993 among 146 currently exposed beryllium workers who were provided the Be-LPT.

In 1996, three studies reported on The article included an analysis of the that excursions above the limit were exposure to beryllium associated with work histories of these 97 current and common. CBD and immunologic sensitization to former workers. A qualitative exposure Kreiss and colleagues studied CBD beryllium (refs. 19–21). Two of the estimate based on the work histories of occurring in a beryllium oxide ceramic studies reported on cases of CBD at individuals who developed CBD manufacturing plant (ref. 21). They Rocky Flats (refs. 19, 20). The third concluded that exposures varied by found that machinists had the highest reported on an epidemiology study of a more than one order of magnitude. private sector beryllium ceramics Extensive air monitoring data were incidence rate of beryllium sensitization fabrication plant that began operating in available for machinists, which were and the highest exposure potential. The 1981 (ref. 21). Both Rocky Flats and the one of the highest exposed groups. area monitoring conducted in this plant ceramics plant were extensively Barnard and colleagues completed an was aimed at estimating exposures monitored for compliance with the extensive analysis of the monitoring associated with job titles and was found current OSHA 8-hour TWA exposure data associated with machining to correlate with personal sampling. The standard of 2 µg/m3. The authors operations at Rocky Flats (ref. 20). Prior authors concluded, ‘‘the existing data concluded that exposures among the to 1984, air monitoring was suggests that the machining exposures highest exposed groups in the plants accomplished with fixed area monitors resulting in the 14.3 odds ratio for were, on average, below the 2 µg/m3 located near the machine tools that were beryllium sensitization were largely limit. At both plants, cases of CBD and thought to be the primary sources of within those permitted by current sensitization to beryllium were found emissions into the work-rooms. In 1984, regulations.’’ This article confirmed the not only among the highest exposed personal sampling was initiated, which findings of a study of CBD in the workers, but also among the lowest was more representative of individual neighborhood of a beryllium extraction exposed workers, including exposure. The article reported a high plant, which showed a correlation administrative and other personnel who degree of uncertainty in exposure between ambient beryllium levels and assessments prior to 1984 due to the did not work directly with beryllium. incidence of CBD (ref. 5). Further Stange and colleagues reported on the lack of correlation between area analyses of CBD incidence at Rocky findings of a health surveillance monitoring and personal monitoring. program at Rocky Flats that used the Be- The authors concluded that machinists, Flats, as yet unpublished, showed a LPT to screen for CBD (ref. 19). Of 97 as a group, shared similar exposure similar higher risk for machinists individuals who tested positive on the potential, that average exposures were compared to that for other workers (See Be-LPT, 28 were found to have CBD. less than but near the 2 µg/m3 limit, and Table 5).

TABLE 5.ÐINCIDENCE RATES OF CBD AT ROCKY FLATS

Incidence Job category Number tested CBD cases rate (per- cent)

Beryllium Machinist ...... 223 21 9.4 Administrative ...... 1,903 23 1.2 Professional ...... 1,396 15 1.1 All Employees Tested ...... 6,254 64 1.0

Cases of CBD have occurred in an exhaust duct that was disconnected. produced pure metal, oxide, alloys, and machinists who worked in the Y–12 No other area measurements above ceramics. Employees in the pebble plant beryllium ceramic machine shop, where 2 µg/m3 were recorded, and the median (producing beryllium metal) had the levels have been quite low. Only a small measurement was at the level of highest prevalence of CBD (6.4%) percentage of samples there have detection. compared with other workers (1.3%). detected beryllium. Continuous area air Kreiss (ref. 22) describes the relative The pebble plant was not associated monitors have operated in the shop hazards in sectors of the beryllium with the highest gravimetric industrial throughout its existence. One area industry, and risk factors for CBD and hygiene measurements, indicating that sample indicated levels above 2 µg/m3 sensitization related to work processes total beryllium was probably not a good when a machine tool was operated with in a beryllium manufacturing plant that indicator for hazard surveillance. The

VerDate 29-OCT-99 18:38 Dec 07, 1999 Jkt 190000 PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 E:\FR\FM\08DER3.XXX pfrm03 PsN: 08DER3 68860 Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 / Rules and Regulations report indicates that particle size or Epidemiologic investigations to date in determining who will develop CBD. other characteristics may be more have failed to show whether the time Recent advances in genetics and important contributors to risk than the course of exposure (dose rate) is immunology have made it possible for total mass of breathing zone particles, biologically significant. High day-to-day researchers to investigate the basis for that daily-weighted averages are poor variation in exposure level and CBD and to identify a genetic estimates of personal exposure, and that excursions above the 2 µg/m3 limit have component (ref. 28). occurred in all groups studied for which methods of exposure assessment may Differences in individual exposure data is available. Excursions poorly reflect actual exposures from susceptibility have made it difficult to make up a significant contribution to accidents. understand the relationship between individuals’ total doses, confounding Several authors have highlighted the attempts to understand if dose rate is an exposure and CBD. Early epidemiology uncertainty that exists in the exposure important risk factor. Beryllium oxide studies detected similar disease rates assessments (refs. 20, 21, 23). The and metal in the lung dissolve slowly among high- and low-exposure chemical composition of the beryllium over a period of months and years (ref. occupational groups (Table 6). The materials used and the particle size 24), producing the beryllium ion that NJMRC researchers detected differences distribution of the aerosol created by the elicits an immune response (ref. 25). in disease rates among the workers they work operation affect the bioavailability The persistent presence of the beryllium studied (Table 7). The DOE surveillance of beryllium, and neither is accounted ion in the lung makes CBD a chronic findings supported this conclusion (See for by current personal sampling and disease (ref. 26). Both intermittent high Table 5). NJMRC researchers have found analytical methods. It is not known and continual low exposures to cases of CBD among those who had been what percentage of measurable airborne insoluble forms of beryllium can create exposed for periods as short as one beryllium is capable of reaching the and maintain a lung burden that will month and those who had unrecognized regions of the lung where health effects not clear for many years, if at all (ref. or seemingly trivial exposure. However, occur. In addition, area monitoring used 27). the NJMRC also found evidence that in the past does not correlate with the Certain individuals are more disease incidence increased with personal monitoring that is thought to susceptible to CBD than others. It has increasing exposure and concluded that be more representative of exposure (refs. long been suspected that genetic exposure to beryllium should be 20, 23). predisposition plays an important role minimized.

TABLE 6.ÐCHRONIC BERYLLIUM DISEASE RATES

Estimated Estimated in- Estimated Exposed during the 1940s exposed Cases cidence per level of expo- 100 exposed sure µg/m 3

Residents Living Within 0.25 Mile of a Beryllium Extraction Plant 1 ...... 500 5 1.0 1 Fluorescent Lamp Manufacturing: 1 Massachusetts ...... 15,000 175 1.16 100 Ohio ...... 8,000 32 0.4 100 Machine Shop 1 ...... 225 11 4.9 500 Beryllium-Copper Foundry 1 ...... 1,000 13 1.3 500 Beryllium Extraction: 1 Lorain, Ohio ...... 1,700 22 1.3 1,000 Painesville, Ohio ...... 200 0 0.0 1,000 Reading, Pennsylvania ...... 4,000 51 1.3 1,000

Study par- Incidence per Estimated Exposed from the 1970s to the 1980s ticipants Cases 100 exposed level of expo- sure µg/m 3

Beryllia Ceramics Plant 2 ...... 505 9 1.8 NA The DOE Rocky Flats Plant 3 ...... 895 15 1.7 1 Second Beryllia Ceramics Plant 4 ...... 709 8 1.1 0.5 1 Eisenbud and Lisson, ``Epidemiologic Aspects of Beryllium-Induced Non Malignant Lung Disease: A 30-Year Update,'' JOM, Vol. 25, pp 196± 202, 1983. 2 Kathleen Kreiss et al., ``Beryllium Disease Screening in the Ceramics Industry,'' JOM, Vol. 35, pp 267±274, 1993. 3 Kathleen Kreiss et al., ``Epidemiology of Beryllium Sensitization and Disease in Nuclear Workers,'' Am. Rev. Res. Dis., Vol. 148, pp 985±991, 1993. 4 Kathleen Kreiss et al., ``Machining Risk of Beryllium Disease and Sensitization with Median Exposures Below 2 µg/m3,'' Am. J. Ind. Med., Vol. 30, pp 16±25, 1996.

TABLE 7.ÐBERYLLIUM SENSITIZATION AND DISEASE RATES AT ROCKY FLATS 1

Workers Sensitiza- Beryllium process title Workers doing tion rate sensitized process (percent)

Cleaning Tools, Machines ...... 7 255 2.7 Machining ...... 6 189 3.2 Inspection ...... 2 138 1.4 Metallurgical Sample Preparation ...... 3 115 2.6 Sawing ...... 5 6 4.7 Trepanning ...... 3 77 3.9 Band Sawing ...... 4 67 6.0

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TABLE 7.ÐBERYLLIUM SENSITIZATION AND DISEASE RATES AT ROCKY FLATS 1ÐContinued

Workers Sensitiza- Beryllium process title Workers doing tion rate sensitized process (percent)

Decanning, Shearing ...... 2 65 3.1 Precision Grinding ...... 2 31 6.5

Rate (per- All participants Number Participants cent)

Sensitized ...... 18 895 2.0 Confirmed CBD Cases ...... 15 895 1.7 1 Kathleen Kreiss et al. ``Epidemiology of Beryllium Sensitization and Disease in Nuclear Workers,'' Am. Rev. Res. Dis., Vol. 148, pp 985±991, 1993.

A recent publication by Eisenbud in with CBD who had been identified associated with CBD can be minimized January 1998 (ref. 29) consolidated the through abnormal chest X-rays or through early detection and treatment. previous epidemiology studies that have clinical symptoms to those of patients Sensitized and early CBD patients can questioned the relevance of the current whose CBD had been identified through be removed from jobs with beryllium PEL after evaluating the effect of the positive Be-LPTs (ref. 30). Twelve out of exposure. level of exposure on disease. In this 21 Be-LPT-identified patients had lung Finally, beryllium sensitization found article, Eisenbud concludes that it abnormalities, including reduced through screening with the Be-LPT is ‘‘appears’’ the current 2 µg/m3 standard exercise tolerance. Fourteen of 15 the earliest indication that working is not protective enough. Rather than patients identified through chest X-rays conditions and work practices are recommend an alternative exposure or clinical symptoms had abnormal lung affecting the health of exposed workers. limit, however, Eisenbud points to the function, and their abnormalities were This allows for an earlier opportunity to need for the development of an animal more severe. The authors concluded initiate corrective actions and possibly model to aid in better understanding the that the Be-LPT was useful because it to prevent cases of CBD. Early detection etiology of CBD and suggests that permitted detection of affected enhances the contribution of medical innovative measures may be needed to individuals earlier in the disease surveillance to the management of the control the disease. process. CBDPP. In summary, evidence suggests higher DOE’s experience is consistent with II. Legal Authority and Relationship to incidence of CBD among workers with this conclusion. The 79 cases of CBD Other Programs higher exposures (e.g., machinists), but, diagnosed among Rocky Flats workers at lower exposure levels, other factors showed a range of severity. Thirty-nine Today’s rule, which establishes may operate to confound a clear dose- individuals had symptoms that required minimum requirements for the response relationship. These factors treatment ranging from inhaled protection of beryllium-associated include: (1) the effect of peak exposures bronchodilators to corticosteroids to workers, is promulgated pursuant to (such that most of the exposure results oxygen. Two individuals died of CBD. DOE’s authority under section 161 of from short-term episodes; (2) the Seventy-three of the 79 cases were the Atomic Energy Act of 1954 (AEA) to inadequacy of area monitoring in identified among individuals who had prescribe such regulations as it deems reflecting actual exposure; (3) the effect abnormal Be-LPT results but normal necessary to govern any activity of chemical composition, size, and chest X-rays or pulmonary function authorized by the AEA, specifically shape on the bioavailability of the screening test results. Clinical including standards for the protection of inhaled particles; (4) inadequate evaluations using computer aided health and minimization of danger to monitoring of the chemical beryllium tomography (CAT) scan, life or property (42 U.S.C. 2201(i)(3) and composition, size, and shape of inhaled bronchoalveolar lavage-BeLPT (BAL Be- (p)). Additional authority for the rule, particles; and (5) the effect of genetic LPT), transbronchial biopsy, and gas insofar as it applies to DOE Federal predisposition on developing beryllium diffusion studies of workers confirmed employees, is found in section 19 of the sensitization and CBD. As a result, the the presence of CBD in these workers. Occupational Safety and Health Act of existing literature does not point to a There is no direct evidence that 1970 (29 U.S.C. 668) and Executive specific tolerance level for exposure to removal from exposure improves the Order 12196, ‘‘Occupational Safety and beryllium. prognosis of patients with CBD, because Health Programs for Federal follow-up studies have not been done. Employees,’’ (5 U.S.C. 7902 note), 4. Value of Early Detection However, beryllium does clear from the which require Federal agencies to Early detection of a disease is of value lung over time, and a reduced level of establish comprehensive occupational if it leads to earlier treatment and a antigen in the lung should reduce the safety and health programs for their better prognosis for the individual being severity of the inflammation and the employees. tested. Screening for CBD with the Be- amount of lung damage (ref. 27). DOE intends this final rule to be LPT can provide earlier detection than Additionally, members of the work force integrated with the existing worker is possible with other tests. In some who are consistently positive on the Be- protection management program for cases this has led to treatment of CBD LPT are those most likely to eventually DOE Federal and contractor employees to reduce lung damage that would not develop CBD. Treating physicians established by DOE Order 440.1A. The have been possible if the CBD remained generally recommend that these requirements in this final rule will undiagnosed by other tests, such as individuals receive more frequent and supersede any conflicting provisions of chest X-ray. Researchers at the NJMRC more extensive pulmonary function DOE Order 440.1A on the effective date compared the lung functions of patients testing so that the lung damage of the rule. On that date the rule also

VerDate 29-OCT-99 18:10 Dec 07, 1999 Jkt 190000 PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 E:\FR\FM\08DER3.XXX pfrm03 PsN: 08DER3 68862 Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 / Rules and Regulations will supersede DOE Notice 440.1, because beryllium generally is not a Hygienist, to manage and supervise ‘‘Interim Chronic Beryllium Disease nuclear material. Any radiological beryllium inventories, hazard Prevention Program,’’ established by implications of the two radioisotopic ˜ assessments, and exposure monitoring. then-Secretary Pena on July 15, 1997. forms of beryllium would be addressed • The final rule establishes the Some comments on the NOPR raised under the provisions of 10 CFR part 835, airborne beryllium concentration action questions about the effect of the rule on Occupational Radiation Protection. collective bargaining and grievance- level, which in this rule triggers key III. Overview of the Final Rule arbitration processes established by worker protection measures, at 0.2 µ 3 µ 3 collective bargaining agreements. One The final rule strengthens the worker g/m , instead of 0.5 g/m as proposed. union urged (Ex. 22) DOE to clarify protection program established under The STEL has been deleted, because the whether the terms of this rule are DOE Order 440.1A, Worker Protection proposed STEL would not provide any subject to negotiation between a union Management for DOE Federal and added protection for workers given that and a contractor. Contractor Employees (or DOE Orders the new action level of 0.2 µg/m3 would DOE has concluded that there is a 5483.1B, 5480.4, 5480.8A, and 5480.10 be exceeded in less than 15 minutes compelling need for the CBDPP for operations not covered by DOE where exposure levels are at 10µg/m3. requirements in this final rule in order Order 440.1A), by supplementing the • The final rule provides that for DOE to meet its obligation under the general worker protection program responsible employers must require AEA to protect the health of its requirements with provisions that are workers to use respirators in areas employees and other workers at DOE specifically designed to manage and where the beryllium exposure level is at control beryllium exposure hazards in facilities. The regulatory requirements or above the action level, rather than at the DOE workplace. These hazard- of this rule will by operation of law or above the PEL as proposed in the specific provisions are derived largely apply to DOE contracts. Therefore, the NOPR, and must provide a respirator to application and enforcement of this rule from DOE Notice 440.1, ‘‘Interim any worker exposed to beryllium who are not subject to the Work Smart Chronic Beryllium Disease Prevention requests one, regardless of the Standards Program or other related Program,’’ but a number of provisions concentration of airborne beryllium. processes. DOE believes that this have been modified as a result of DOE’s mandatory application of the CBDPP consideration of comments received in • The final rule includes criteria and requirements to all DOE beryllium the rulemaking. requirements to govern the release of activities is appropriate given the Consistent with DOE Notice 440.1, beryllium-contaminated equipment and hazardous nature of beryllium-related this final rule establishes a CBDPP that other items at DOE sites for use by other work. is designed to reduce the occurrence of DOE facilities or the public. CBD among DOE federal and contractor While the minimum requirements in • The final rule requires responsible the rule are non-negotiable and may not workers and any other individuals who employers to offer medical surveillance be waived, the rule does not preclude perform work at DOE facilities. The to any ‘‘beryllium-associated worker,’’ all collective bargaining on matters CBDPP will accomplish this disease- defined to include any current worker related to beryllium exposure reduction mission through provisions protections. Some rule provisions, such that: (1) Reduce the number of current who is exposed through beryllium work as the requirement for a beryllium workers who are exposed to beryllium or who had past exposure or potential exposure reduction and minimization by clearly identifying and limiting exposure to beryllium at a DOE facility. provision in an employer’s CBDPP, are worker access to areas and operations • The final rule contains medical performance-based and allow for that contain or utilize beryllium; (2) removal protection and multiple negotiation between the employer and minimize the potential for, and levels physician review provisions that are employee representatives. Other rule of, worker exposure to beryllium by modeled on provisions of three of requirements, however, are stated in implementing engineering and work OSHA’s expanded health standards. specific terms that do not permit any practice controls that prevent the release The provisions of the rule are change. For example, section 850.24(e) of beryllium into the workplace of the rule specifies the accuracy that atmosphere and/or capture and contain presented in three subparts. Subpart A must be achieved by exposure airborne beryllium particles before describes the purpose and applicability monitoring of workers: not less than worker inhalation; (3) establish medical of the rule, defines terms that are critical plus or minus 25 percent, with a surveillance to monitor the health of to the rule’s application and confidence level of 95 percent, for exposed workers and ensure early implementation, and establishes DOE airborne concentrations of beryllium at detection that makes possible early and contractor responsibilities for the action level. DOE’s objectives of treatment of disease; and (4) establish executing the rule. Subpart B establishes controlling worker exposure to airborne continual monitoring of the administrative provisions requiring beryllium and obtaining better exposure effectiveness of the program in responsible employers to develop and data would be defeated if accuracy of preventing CBD and implementing maintain a CBDPP and to perform all monitoring were a subject of collective program enhancements as appropriate. beryllium-related activities according to bargaining. Although today’s rule may Another key purpose of the rule is the the CBDPP. Subpart C establishes incidentally affect collective bargaining, collection of consistent data, which will requirements for the content and it is neutral with respect to the balance improve the information available to implementation of the CBDPP. Some of of bargaining power of organized labor better understand the cause of CBD. the provisions of Subpart C apply only and management. The rule applies to all DOE has made numerous changes in when it is determined that the airborne DOE contractors whether or not they are the final rule after considering the concentration of beryllium in a specific involved in collective bargaining. public comments on the proposed rule. workplace or operation rises above a This final rule is not being The principal changes are as follows: specified limit. Table 8 summarizes promulgated as a nuclear safety • The final rule requires responsible these provisions and indicates the levels requirement under 10 CFR Part 820, employers to assign a qualified of beryllium at which the provisions Procedural Rules for Nuclear Activities, individual, such as a Certified Industrial apply.

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TABLE 8.ÐLEVELS AT WHICH THE PROVISIONS OF THE CBDPP APPLY

Worker exposure or potential exposure levels (8±Hour TWA) Provision Be oper- ≥Action ≥PEL (8-hr ations/loca- level (0.2 TWA) (2.0 tions 1 µg/m 3) µg/m 3)

Baseline Inventory (850.20) ...... X ...... Hazard Assessment (850.21) ...... X ...... Initial Exposure Monitoring (850.24) ...... X ...... Periodic Exposure Monitoring (850.24) ...... X ...... Exposure Reduction and Minimization (850.25) ...... X 2 X3 X4 Regulated Areas (850.26) ...... X ...... Hygiene Facilities and Practices (850.27) ...... X ...... Respiratory Protection (850.28) ...... X 5 X ...... Protective Clothing and Equipment (850.29) ...... X 6 X ...... Housekeeping (850.30) ...... X 7 ...... Release Criteria (850.31) ...... X 8,9 ...... Medical Surveillance (850.34) ...... X 10 ...... Training and Counseling (850.37) ...... X11 ...... Warning Signs (850.38) ...... X ...... 1 Applies to beryllium operations and other locations where there is a potential for beryllium contamination. 2 Responsible employers must implement actions for reducing and minimizing exposures, if practicable. 3 Responsible employers must establish a formal exposure reduction and minimization program, if practicable. 4 Responsible employers must reduce exposures to or below the PEL. 5 Responsible employers must provide respirators when requested by the worker. 6 Responsible employers must provide protective clothing and equipment where surface contamination levels are above 3 µg/100 cm2. 7 Housekeeping efforts must maintain removable surface contamination at or below 3 µg/100 cm2 during non-operational hours. 8 Removable contamination on equipment surfaces must not exceed 0.2 µg/100 cm2 when released to the public or for non-beryllium use. 9 Removable contamination on equipment surfaces must not exceed 3 µg/100 cm2 when released to other beryllium handling facilities. 10 Responsible employers must provide medical surveillance for all beryllium-associated workers. 11 Training is required for all workers who could be potentially exposed. Counseling is required for beryllium-associated workers diagnosed with CBD or beryllium sensitization.

IV. Section-by-Section Discussion of been implemented at DOE facilities; and Employee Occupational Safety and Comments and Rule Provisions (2) to minimize the burden on DOE Health Programs and Related Matters,’’ This section of the Supplementary contractors by clarifying that contractors as well as Executive Order (EO) 12196, Information responds to significant need not establish redundant worker ‘‘Occupational Safety and Health comments on specific proposed rule protection programs to protect workers Programs for Federal Employees.’’ provisions. It also contains explanatory from hazards of exposure to airborne DOE’s intent in section 850.2(a)(1) is to material for some final rule provisions beryllium. supplement these general worker protection requirements with specific in order to provide interpretive Section 850.2—Applicability beryllium-related requirements in the guidance to DOE offices and DOE As in the proposed rule, section 850.2 limited instances where DOE federal contractors that must comply with this specifies that this rule applies to DOE workers may have the potential for rule. All substantive changes from the offices and DOE contractors with beryllium exposure. notice of proposed rulemaking (NOPR) responsibility for operations or activities Section 850.2(a)(2) specifies that the are explained in this section. However, that involve present or past exposure, or rule also applies to DOE contractors some non-substantive changes, such as the potential for exposure, to beryllium with operations or activities involving the renumbering of paragraphs and at DOE facilities. It also applies to any exposure or the potential for exposure to changes to clarify the meaning of rule current DOE employee, DOE contractor beryllium. As clarified in the definition provisions, are not discussed. employee, or any other current worker of ‘‘DOE contractor’’ (section 850.3), DOE has determined that the at a DOE facility who is or was exposed DOE’s intent is that the contractors requirements set forth in this final rule or potentially exposed to beryllium at a covered under this rule include any are those which, based on currently DOE facility, regardless of which entity under contract to perform DOE available data, are necessary to provide organization currently employs the activities at DOE-owned or -leased protection to workers who may be worker. facilities, including contractors awarded exposed to beryllium. Except at the few DOE-operated management and operating contracts, A. Subpart A—General Provisions facilities, DOE federal workers are not integrating contractors, and usually directly involved in production subcontractors. This section further Section 850.1—Scope tasks or other activities in which they clarifies that the requirements of the The CBDPP required by this rule will would be exposed to airborne beryllium. CBDPP apply only to contractors and enhance, supplement, and be integrated However, in performing management subcontractors who work in areas or on into existing worker protection program and oversight duties, DOE federal DOE activities that involve the potential requirements for DOE Federal and workers may enter facilities where for worker exposure to beryllium. contractor employees. DOE has beryllium is handled. Federal agencies The provisions of this rule do not structured the rule this way for two are required to ensure the protection of apply to former DOE workers; to main reasons: (1) to take advantage of federal workers under the health and activities at DOE facilities that do not existing and effective comprehensive safety provisions of 29 CFR Part 1960, involve exposure or potential exposure worker protection programs that have ‘‘Basic Program Elements for Federal to beryllium; or to activities not

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DOE recognizes that because each of these aspects of the practice in many DOE facilities, and is some beryllium-containing beryllium rule is already included in the intended to ensure that the population manufactured items may not pose OSHA Laboratory standard, DOE has of potentially exposed individuals is beryllium hazards where they have been retained the laboratory operations reduced to the lowest possible number formed to specific shapes or designs and exemption in section 850.2(b)(2). and that workers who are granted access their subsequent uses or handling will to regulated areas have the knowledge not result in the release of airborne Section 850.3—Definitions they need to protect themselves and beryllium. This exemption for beryllium Commenters on the proposed rule’s other workers. Under this rule, articles is consistent with the approach ‘‘Definitions’’ section typically authorized individuals are to be trained taken by OSHA in regulating hazardous requested clarification or modification in the hazards of beryllium and in the materials under the Hazard of the proposed definitions. means of protecting themselves and Communication standard at 29 CFR New terms. In response to public those around them against such hazards. 1910.1200. comment, the following additional Training requirements for individuals Section 850.2(c) establishes that the terms have been defined in section working with beryllium are specified in rule does not apply to the DOE 850.3: ‘‘beryllium-associated worker,’’ section 850.37 of the rule. DOE did not laboratory operations involving ‘‘Head of DOE Field Element,’’ receive any comments on this beryllium that are subject to the ‘‘removable contamination,’’ definition, which remains unchanged in requirements of OSHA’s Occupational ‘‘responsible employer,’’ and ‘‘unique the final rule. Exposure to Hazardous Chemicals in identifier.’’ A discussion of each term is Beryllium means elemental beryllium Laboratories standard, 29 CFR included in the alphabetical listing of and any insoluble beryllium compound 1910.1450, commonly called OSHA’s definitions provided below. or alloy containing 0.1 percent Laboratory standard. Three commenters beryllium or greater that may be Terms and definitions deleted. In (Exs. 30, 31, 32) opposed this released as an airborne particulate. This response to public comment, the exemption, stating that lesser protection definition of beryllium reflects the focus following definitions in the NOPR are would be afforded to laboratory workers of this rule on worker exposure to deleted in the final rule: ‘‘accepted than to those workers covered by the airborne beryllium. One commenter (Ex. applicant,’’ ‘‘short term exposure limit rule. One commenter (Ex. 30) suggested 26) questioned whether exposure to that laboratory exposures are difficult to (STEL),’’ and ‘‘surface contamination.’’ naturally occurring beryllium predict and that a lack of sampling The deletions are explained in the compounds in excess of 0.1 percent was resulting from the perception that little section-by-section discussion of the rule covered by the DOE program. However, hazard is present in laboratory settings provisions in which the terms were as correctly noted by the same may lead to incomplete exposure previously used. commenter, sections 850.2(a)(1) and (2) characterizations. Section 850.3 defines key terms using provide that the rule only applies to In establishing its Laboratory traditional industrial hygiene exposures and potential exposures to standard, OSHA clarified its intent that terminology and terminology used by beryllium that occur in connection with 29 CFR 1910.1450 supersede all other OSHA in its regulations. The use of facility operations. Another commenter OSHA regulations for bench-top such terminology is consistent with (Ex. 10) suggested that 0.1 percent laboratory-scale activities, noting that DOE’s increased emphasis on industrial beryllium was too inclusive, and the provisions of the standard were hygiene compliance through the use of suggested that a level of 0.5 percent be more relevant and suitable to the unique accepted occupational safety and health used instead. DOE notes, however, that characteristics of laboratory activities. requirements and procedures. The the concentration specified in the DOE agrees with OSHA’s approach and following discussion explains the definition is consistent with the believes that the provisions of OSHA’s definitions in the rule. Although some criterion that OSHA uses for a Laboratory standard are adequate to of these terms are commonly used, DOE carcinogenic mixture, i.e., one that protect workers from beryllium believes that these definitions will help contains a carcinogenic component at a exposures in facilities that fall within ensure that their meaning as used in the concentration of 0.1 percent (or 1,000 the scope of the standard. context of the rule is clear. parts per million [ppm]) or greater, by DOE notes the laboratory exemption Action level means the level of weight or volume. Therefore, DOE has only applies in instances where airborne concentration of beryllium not changed the definition in the final relatively small quantities of beryllium established pursuant to Subpart C, rule. are used in a non-production activity. In which, if met or exceeded, requires the Beryllium activity means an activity addition, OSHA’s Laboratory standard implementation of certain specified performed for, or by, DOE at a DOE has specific provisions to ensure that provisions of the rule. Using an action facility that can expose workers to protective laboratory practices are level to trigger certain provisions of the airborne concentrations of beryllium. followed. Many of the provisions in rule is consistent with the approach Activities within the scope of this OSHA’s Laboratory standard are the applied in many of OSHA’s substance- definition may involve design, same as, or similar to, those in this final specific standards. The word construction, operation, maintenance, rule. For instance, OSHA’s Laboratory ‘‘exceeded’’ was amended to read ‘‘met and decommissioning. The definition standard establishes provisions for or exceeded’’ in the final rule to clarify further explains that a ‘‘beryllium identifying the presence of hazardous DOE’s intent that worker protection activity’’ may involve one DOE facility chemicals (baseline inventory), provisions must be implemented in or operation, or a combination of establishing a chemical hygiene plan cases where worker exposure levels are facilities and operations. This definition

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This definition removal protection benefits.’’ This language to clarify that maintenance clarifies DOE’s intent that the rule proposed definition included DOE operations are within the scope of the applies only to current workers. The Federal or contractor workers, workers term. definition further clarifies that current employed by a subcontractor to a DOE Beryllium article means a workers who have been removed from contractor and visitors performing work manufactured item that is formed to a beryllium exposure as part of the at DOE facilities. Consistent with other specific shape or design during medical removal plan are beryllium- provisions of the proposed rule, DOE manufacture, that has end-use functions associated workers under the rule, but intended this definition to apply only to that depend in whole or in part on the they are not ‘‘beryllium workers’’ (see current workers. DOE specifically stated item’s shape or design, and that does definition of ‘‘beryllium worker’’). in the NOPR that former workers would not release beryllium or otherwise result Beryllium emergency means any not be included in the proposed in exposure to airborne concentrations occurrence such as, but not limited to, ‘‘beryllium worker’’ definition, but of beryllium under normal use equipment failure, container rupture, or instead would be addressed under a conditions. DOE has included this failure of control equipment or separate initiative. definition of ‘‘beryllium article’’ to operations, that unexpectedly releases a DOE received eight comments on the distinguish between forms of beryllium significant amount of beryllium. This definition of ‘‘beryllium worker’’ in the that may result in exposure to airborne definition is particularly important proposed rule. Five commenters (Exs. 2, beryllium and manufactured items when determining appropriate 14, 16, 17, 28) stated that the term containing beryllium that do not release emergency response procedures that fall beryllium worker was too limiting. beryllium or otherwise result in within the scope of OSHA’s Hazardous These commenters argued that the exposure to airborne concentrations of Waste Operations and Emergency proposed definition of beryllium worker beryllium. All of the persons (Exs. 9, 26, Response standard, 29 CFR 1910.120. should not be limited to those workers 30, 31) commenting on this definition This definition is based on OSHA’s exposed to levels of beryllium at or agreed that exempting beryllium articles interpretation of the term ‘‘emergency’’ above the action level, but rather should from the program is a logical approach. as applied in 29 CFR 1910.120 and include all workers with the potential Two of these commenters (Exs. 9, 26) refers to any untoward event, such as a for beryllium exposure. Three stated that an item destined for major spill of powdered beryllium or an commenters (Exs. 2, 14, 28) supported machining should be considered a unexpected upset that releases a this position by noting that current beryllium article up to the time of that significant amount of beryllium into the scientific evidence does not suggest a machining. In response to these workplace atmosphere. Two ‘‘safe’’ level of beryllium exposure, and comments DOE notes that the beryllium commenters (Exs. 24, 31) expressed that CBD has been identified in article definition is consistent with the concern that the term ‘‘significant individuals thought to have only low or approach employed by OSHA in release’’ was open to too much incidental exposure to beryllium. DOE formulating its definition of ‘‘article’’ in interpretation and needed further shares this concern, and has omitted the the Hazard Communication standard (29 clarification. Emergency situations, by reference to the action level from the CFR 1910.1200). The key concept is that their very nature, are difficult to definition of ‘‘beryllium worker’’ in the an article, if used as intended, does not anticipate and describe. DOE believes final rule. DOE has revised the have the potential to result in hazardous that the examples listed provide a definition in the final rule to apply to exposures. However, an item ceases to general indication as to what constitutes each ‘‘current worker who is regularly be an ‘‘article’’ when it is subjected to a significant release. The use of the term employed in a DOE beryllium activity.’’ machining, cutting, drilling, or similar ‘‘beryllium emergency’’ is used in These same five commenters (Exs. 2, action other than its intended end use. section 850.33, which requires DOE 14, 16, 17, 28) also argued that medical Similarly, if an item is manufactured for contractors to develop emergency surveillance should be offered to all the purpose of being machined later, it procedures and training to address individuals with beryllium exposure is not considered an article. Another emergency scenarios. and that the beryllium worker commenter (Ex. 31) suggested that Beryllium-induced lymphocyte definition, therefore, should be examples of activities that could release proliferation test (Be-LPT) means an in expanded to include reassigned and beryllium, such as burning, grinding vitro measure of the beryllium antigen- former workers with prior beryllium and chipping, be included in a specific, cell-mediated immune exposure. These commenters were parenthetical listing in the definition. response. This test measures the extent concerned that restricting medical DOE recognizes that there are many to which lymphocytes, a class of white surveillance to ‘‘beryllium-workers,’’ as activities that could lead to a release, blood cells, respond to the presence of defined in section 850.3 of the proposed and is concerned that providing beryllium by replicating in the rule, would exclude workers with examples could be interpreted to laboratory. Medical personnel use the incidental beryllium exposure who also exclude other activities. To avoid such Be-LPT to identify workers who have may be at risk of contracting CBD. confusion, DOE believes that examples become sensitized to beryllium through Two commenters (Exs. 2, 28) should not be included in the their occupational exposure. DOE did questioned the need for separate definition, but rather should be not receive any comments on this medical surveillance programs for included in a companion proposed definition, which remains former and current beryllium workers. implementation guide for the rule. unchanged in the final rule. These two commenters raised the issues Beryllium-associated worker means a Beryllium worker means a current of increased cost, lack of continuity, and current worker who is or was exposed worker who is regularly employed in a the added confusion to participants or potentially exposed to airborne DOE beryllium activity. Section 850.3 of associated with maintaining separate concentrations of beryllium at a DOE the NOPR defined ‘‘beryllium worker’’ surveillance programs.

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In response to these comments, DOE specified airborne level would surveillance program for all beryllium- added the term ‘‘beryllium-associated unnecessarily limit responsible associated workers (see discussion of worker,’’ which is more inclusive than employers’ options for meeting the section 850.34). the term ‘‘beryllium worker.’’ (See exposure monitoring requirements of Breathing zone is the hemisphere definition of ‘‘beryllium-associated this rule. For instance, if the phrase forward of the shoulders, centered on worker.’’) The term ‘‘beryllium- ‘‘potentially exposed’’ were removed the mouth and nose, with a radius of 6 associated worker’’ is used in provisions from the definition, the use of to 9 inches. This definition is used of the rule where DOE has determined representative sampling would no principally in section 850.24, Exposure that coverage should not be limited to longer be an acceptable option for Monitoring, which requires DOE workers regularly employed in DOE meeting the exposure monitoring contractors to determine worker beryllium activities. Use of the term requirements in the rule. Employers exposures to beryllium by monitoring ‘‘beryllium-associated worker’’ clarifies would be required to determine actual for the presence of contaminants in the DOE’s intent that current employees exposures for all workers to determine worker’s personal breathing zone. One with past beryllium exposures or whether the workers are beryllium- commenter (Ex. 9) stated that this potential exposures, as well as current associated workers. DOE believes that proposed definition was imprecise. DOE individuals who are exposed to airborne such an inflexible requirement would be disagrees and views this definition as beryllium at DOE facilities, be included burdensome and inconsistent with being consistent with sound and under the following rule provisions: sound industrial hygiene practices and accepted industrial hygiene practice. It 850.5 (dispute resolution), 850.10 the provisions of section 850.21 of the will ensure that samples collected for (development and approval of the rule, which requires qualified industrial personal exposure monitoring represent CBDPP), 850.33 (medical surveillance), hygienists to apply their professional the air inhaled by workers while 850.34 (medical removal), 850.35 knowledge and experience in the performing their duties in affected work (medical consent), 850.36 (training and performance of beryllium hazard areas. Therefore, DOE has not revised counseling) and 850.39 (beryllium assessments. Accordingly, the final rule this definition in the final rule. registry). (in the definitions of ‘‘beryllium- DOE means the Department of Energy. DOE contractor means any entity DOE, however, has not expanded the associated worker’’ and ‘‘beryllium under contract with DOE, including a definition to include former workers. activity’’) requires responsible subcontractor, with responsibility for DOE previously established the Former employers to consider potential performing DOE activities at DOE- Beryllium Workers Medical exposures in identifying beryllium owned or -leased facilities. This term Surveillance Program and offers medical workers. examinations to former (retired and does not apply to a contractor or separated) workers who are at risk for Another commenter (Ex.16) stated subcontractor who provides only developing CBD due to their work at that the proposed definition of ‘‘commercial items’’ as defined under DOE. The elements of the Former ‘‘beryllium worker,’’ as applied in the Federal Acquisition Regulations Beryllium Workers Medical determining a worker’s eligibility to (FAR). Such contractors would not be Surveillance Program are: (1) participate in the medical surveillance performing DOE beryllium activities. As identification of beryllium workers who program, could be too narrow in some explained in the discussion of section have retired or separated from respects and too broad in others. This 850.10, subcontractors who are covered employment; (2) notifying workers of commenter favored including current under the rule normally will not be their eligibility to participate in the workers no longer working with designated to prepare the written program, and general announcements to beryllium and those with exposures CBDPP for a site. However, these provide former workers an opportunity below the action level in the definition subcontractors will be included in the to self-identify as a former beryllium of ‘‘beryllium worker.’’ This commenter CBDPP that encompasses all beryllium- worker; (3) informed consent on the recommended allowing the industrial related activities at the site. risks and benefits of participating in the hygiene and medical staff to use a DOE facility means any facility program; (4) screening for CBD using the ‘‘graded approach’’ to determine which operated by or for DOE, whether owned Be-LPT, a standardized questionnaire on workers received medical surveillance, or leased by DOE. respiratory symptoms, and a chest based on the needs of the individual Head of DOE Field Element is the radiograph if indicated by responses to and ‘‘common sense judgement about high-level DOE official in a DOE field or the questionnaire; (5) an offer of cost and benefit.’’ DOE agrees that operations office who has the diagnostic medical examinations to current workers no longer working with responsibility for identifying the individuals found to have either a beryllium and those with exposures contractors and subcontractors covered positive Be-LPT or signs or symptoms of below the action level should be eligible by this part and for ensuring compliance CBD; (6) periodic medical monitoring; for medical surveillance and, thus, has with this part. (7) funds for medical care that is not included such individuals in the final High-efficiency particulate air (HEPA) covered by insurance; and (8) rule’s definition of ‘‘beryllium- filter means a high-efficiency filter epidemiologic surveillance to identify associated workers.’’ DOE does not capable of trapping and retaining at high risk operations where additional agree, however, that determining least 99.97 percent of 0.3-micrometer primary preventative actions are whether a worker should receive monodisperse particles. Such filters are needed. medical surveillance should be left to commonly used in heating and One commenter (Ex. 23) took issue the discretion of the industrial hygiene ventilating systems, respiratory with the phrase ‘‘potentially exposed’’ and medical staff. DOE believes that protection equipment, local exhaust in the proposed definition of ‘‘beryllium such discretionary application of ventilation, etc., to remove toxic or worker,’’ arguing that it is too vague and medical surveillance will result in an hazardous particulates like beryllium. could allow too much room for inconsistent level of protection for Immune response refers to the series individual interpretation. DOE believes workers across the DOE complex. of cellular events by which the immune that limiting the definition to workers Therefore, section 850.34 of the final system reacts to a specific antigen. with actual personal exposure rule requires responsible employers to Types of immune responses include monitoring results at or above a develop and implement a medical acquired immunity and sensitization.

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The body’s immune response to Responsible employer means the DOE ensure compliance with this rule, beryllium is sensitization and is contractor office that is directly including (but not limited to) contract indicated by the results of the Be-LPT. responsible for the safety and health of termination or reduction in fee. Medical removal protection benefits DOE contractor employees while One union commented (Ex. 22) that are employment rights established in performing a beryllium activity or other the proposed enforcement provision section 850.35 for beryllium-associated activity at a DOE facility; or for DOE would be inadequate because DOE is workers temporarily or permanently employees, the DOE office that is not likely to terminate a prime subject to medical removal from directly responsible for the safety and contractor’s contract for failure to working in regulated areas following health of DOE Federal employees while comply with health and safety medical evaluations. These provisions performing a beryllium activity or other requirements, and because award fee give contractors an incentive to make activity at a DOE facility; and any reductions are only useful if the reasonable efforts to find and offer person acting directly or indirectly for contracting officer is aware of, and alternate employment to workers who such office with respect to terms and qualified to investigate, noncompliance. have suffered negative health effects due conditions of employment of beryllium- The union requested that the rule be to exposure to beryllium. The definition associated workers. This definition is enforced under DOE’s nuclear safety of medical removal protection benefits added to clarify DOE’s intent that requirement enforcement procedures in and the requirements in section 850.35 provisions of the final rule apply to both 10 CFR Part 820 or pursuant to section ensure that such workers would suffer DOE Federal and contractor workers at 3131 of the National Defense no reductions in total earnings, DOE facilities. Authorization Act for Fiscal Years 1992 seniority, or other worker rights and Site Occupational Medical Director and 1993 (42 U.S.C. 7274d). The union benefits for two years after permanent (SOMD) means the physician also suggested that while awaiting a medical removal. The two-year period responsible for the overall direction and compliance officer, a worker should for medical removal protection benefits operation of the site occupational have the right to shut down the job after permanent removal will allow the medicine program. DOE intends, without loss of pay. DOE has not adopted the commenter’s contractor to make a reasonable effort to through this definition, to ensure that a recommendation to enforce this rule find alternate employment for a physician administers each DOE under 10 CFR Part 820 or section 3131 removed worker or, through job facility’s occupational medicine of the National Defense Authorization retraining and out-placement programs program. Unique identifier means a number or Act for Fiscal Years 1992 and 1993. Part operated by many sites, to locate alphanumeric code used to identify 820, ‘‘Procedural Rules For DOE alternate outside employment for the each worker individually and Nuclear Activities,’’ contains worker. distinctively while protecting the procedures for enforcement of DOE Regulated area means an area worker’s privacy. Unique identifiers are nuclear safety requirements. Beryllium demarcated and managed by the used in DOE’s health surveillance is not normally considered a nuclear responsible employer where the program to help identify the exposures material, and, therefore, enforcement of airborne concentration of beryllium each worker has experienced in the this rule would not fall within the scope exceeds, or can reasonably be expected course of his or her work in a DOE of Part 820. DOE also cannot enforce to exceed, the action level (see the facility without personally identifying this rule under section 3131 of the definition of ‘‘action level.’’). Employees the worker. The unique identifiers will National Defense Authorization Act working in regulated areas must be allow DOE to link worker’s exposure because that section’s scope is limited, authorized to do so by the responsible and occupational health data. authorizing only the imposition of civil employer, and must be trained and Worker means a person who performs penalties against a DOE contractor for equipped with protective clothing and work at a DOE facility including (but failing to train or certify to DOE the equipment. The purpose of such areas is not limited to) a DOE employee, an adequacy of employee training in to limit potential exposure to beryllium independent contractor, or a DOE hazardous substance response or to as few workers as possible. Regulated contractor employee. As clarified in the emergency response (42 U.S.C. areas are commonly used throughout definition of ‘‘DOE contractor,’’ an 7274d(b)). DOE, particularly with regard to employee of a covered subcontractor is In DOE’s view, the existing radiation protection, and their use is a contractor employee under this part. mechanisms and contractual remedies consistent with OSHA’s expanded Worker exposure means the airborne available for enforcing DOE contractor health standards for toxic particulates. concentration of beryllium in the worker protection programs are Removable contamination means breathing zone of the worker that would adequate for enforcement of this rule. beryllium contamination that can be occur if the worker were not using For instance, under DOE Order 440.1A, removed from surfaces by respiratory protective equipment. This DOE and, to the extent incorporated into nondestructive means, such as casual definition is consistent with accepted contracts, DOE contractors are required contact, wiping, brushing, or washing. industrial hygiene practice and with to implement worker protection This term was adopted from DOE’s OSHA’s definition of the term programs that ensure compliance with Radiological Control Manual, April ‘‘employee exposure’’ as applied in the applicable health and safety 1994. One commenter (Ex. 23) stated OSHA expanded health standards. requirements. The worker protection that ‘‘surface contamination’’, a term program must provide workers with defined in the proposed rule, should Section 850.4–Enforcement certain rights, including, among other refer to contamination that is removable, DOE proposed that enforcement of the things, the right to accompany DOE not simply beryllium on surfaces. DOE CBDPP requirements in Part 850 would worker protection personnel during agrees with this commenter that only be through contractual remedies, workplace inspections on official time; removable surface contamination can including contract termination or the right to express concerns related to become airborne and inhaled by reduction in fee. Section 850.4 of the worker protection; to decline to perform workers, and has replaced the term final rule adheres to this approach. This an assigned task based on a reasonable ‘‘surface contamination’’ with section provides that DOE may take belief that the task poses an imminent ‘‘removable contamination.’’ appropriate steps under its contracts to risk of death or serious bodily harm

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Thus, DOE responsible employers have already indicate they were overexposed to proposed that workers use available developed CBDPPs in response to DOE hazardous materials; and the right to grievance-arbitration procedures for Notice 440.1. DOE expects the receive results of inspections and resolution of disputes related to the additional effort required to refine the accident investigations upon request. subject of this rule. However, DOE existing CBDPPs to meet the These provisions of DOE Order 440.1A agrees with the comment that an requirements of the rule will be continue to apply under the CBDPP. arbitrator deciding a grievance under a minimal. Additionally, a contractor employee is collective bargaining agreement might Section 850.10(a)(2) requires that a protected from retaliation for a refusal to not look beyond the collective single CBDPP be submitted to work under certain circumstances, as bargaining agreement in making a encompass all beryllium-related specified in an interim final rule that decision. Because this rule establishes activities at a site. Because DOE DOE promulgated on March 15, 1999, minimum requirements that are recognizes that one site may encompass which substantially revises 10 CFR part independent of collective bargaining multiple contractors and numerous 708, DOE Contractor Employee agreements, available grievance- work activities, this section clarifies that Protection Program (64 FR 12862 as arbitration procedures may not in some the CBDPP for a given site may include amended at 64 FR 37396). An employee cases be sufficient to ensure compliance specific sections for individual of a contractor (or a subcontractor) may with the rule. contractors, work tasks, etc. DOE file a complaint under the DOE, therefore, has modified the text believes that this allowance for a ‘‘whistleblower’’ regulations if he or she of section 850.5 to permit any adversely segmented CBDPP structure will is subject to retaliation for refusing to affected person to refer a dispute minimize the burden associated with participate in an activity based on a regarding compliance with the rule to the CBDPP update and approval reasonable fear of serious injury (10 CFR the Office of Hearings and Appeals for requirements because it allows 708.5(c)). resolution, but employees who are individual contractors to update and represented by a labor organization are submit for approval only the section of Section 850.5–Dispute Resolution required first to exhaust any grievance- the CBDPP pertaining to their specific In the NOPR, DOE proposed that arbitration procedure that is available activities. If multiple contractors are disputes arising under this part that are for resolving disputes over terms and involved, the DOE contractor designated brought by beryllium workers be conditions of employment. This is the by the Head of DOE Field Element must resolved through applicable grievance- approach DOE took in its interim final take the lead in compiling the overall arbitration processes or, if such rule for the DOE Contractor Employee CBDPP and coordinating the input from processes are not available, through Protection Program, 10 CFR part 708 (64 various other contractors, referral to the DOE’s Office of Hearings FR 12862, March 15, 1999). Consistent subcontractors or work activities. This and Appeals. with section 708.13(a) of the Contractor section further clarifies that in such A union commented (Ex. 22) that the Employee Protection Program rule, DOE cases the designated contractor must proposal to relegate a worker to the has revised section 850.5 in the final review and approve the CBDPPs of other grievance and arbitration provision of rule to provide that a worker will be contractors engaged at the site before a the collective bargaining agreement deemed to have exhausted all applicable consolidated CBDPP can be submitted would be inadequate because it grievance-arbitration procedures if 150 to the Head of DOE Field Element for erroneously assumes that an arbitrator days have passed after the filing of a final review and approval. would find a final rule to be part of the grievance and a final decision on it has One commenter (Ex. 31) stated that collective bargaining agreement. The not been issued. the rule did not clearly designate an union stated that unless DOE required ‘‘ultimate authority’’ responsible for employers to propose this rule, and B. Subpart B—Administrative designating physical areas covered by unions accepted it as a contract Requirements the rule. DOE notes that in sections condition, an arbitrator would decline Subpart B of the final rule establishes 850.20 and 850.21, the responsible to enforce this rule. The same general and administrative requirements employer is assigned the responsibility commenter asked that DOE clarify in the to develop, implement, and maintain a of developing a baseline beryllium final rule that an employee CBDPP and to perform all beryllium- inventory and, where appropriate, representative may file grievances under related activities according to the conducting a beryllium hazard a collective bargaining agreement or CBDPP. assessment. The actions effectively seek other remedies under the labor determine which areas of the facility are laws to compel contractor compliance Section 850.10—Development and covered by the rule. DOE believes that or deter contractor retaliation for Approval of CBDPP the responsible employer is the most seeking enforcement of the rule. Section 850.10 establishes the familiar with activities and operations A DOE contractor (Ex. 23) expressed procedures for the development and that occur on a given DOE site and, concern that proposed section 850.5 approval of the CBDPP. Section thus, is best equipped to make this might interfere with existing dispute 850.10(a)(1) requires a responsible determination through the performance resolution processes, or might violate employer in charge of DOE beryllium of the baseline beryllium inventory and Federal law by imposing an obligation activities to prepare a CBDPP for its hazard assessment. on the employment relationship operations and submit the CBDPP to the Section 850.10(b) requires Heads of between a DOE contractor and its appropriate Head of DOE Field Element DOE Field Elements to review and employees who are subject to the terms for approval. This section establishes a approve CBDPPs. DOE believes that its of a collective bargaining agreement. 90-day time frame from the effective review and approval is necessary to

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DOE strongly local approval of the CBDPPs by DOE and appropriately addresses specific disagrees, and believes that identifying field offices could lead to uneven workplace beryllium exposure hazards. operational tasks within the scope of the enforcement and increased cost of This section also requires that CBDPP at D&D closure sites is practical compliance. DOE does not agree with responsible employers review their and necessary. The non-routine and this assessment, and believes that the written CBDPPs at least annually and unpredictable nature of operations on Head of DOE Field Element is not only revise these programs as necessary to D&D closure sites often makes such responsible for operations within his or reflect any significant changes. Only operations more hazardous than routine her jurisdiction, but is also familiar with those sections of the CBDPP that require production operations involving the operations and any related special a change will have to be resubmitted to beryllium. DOE believes that the circumstances or unique situations that the Head of DOE Field Element for appropriate way to protect workers from may affect implementation or approval. DOE considers the annual this increased hazard potential is effectiveness of the CBDPP. Thus, DOE review cycle to be appropriate and through the implementation of the believes the Head of DOE Field Element necessary to ensure that CBDPPs remain structured assessment, planning, and is the most appropriate DOE approval up-to-date and that they accurately control provisions of the CBDPP. Based authority for CBDPPs. DOE notes, reflect workplace conditions and on experience under the interim CBDPP however, that mechanisms exist to required control procedures. policy, DOE believes the CBDPP is provide independent oversight of DOE’s Section 850.10(d) ensures that feasible for D&D operations. DOE also field organizations. Specifically, the CBDPPs are developed and notes that OSHA’s Hazardous Waste Office of Oversight within the Office of implemented consistent with the Operations and Emergency Response Environment, Safety and Health is requirements imposed by the National standard, 29 CFR 1910.120, requires charged with providing information and Labor Relations Act (NLRA), 29 U.S.C. employers at hazardous waste analysis needed to ensure that DOE’s 141 et seq., on employers in this remediation sites, in addition to top management officials, Congress and context, and not to create obligations in conducting ongoing task-specific hazard the public have an accurate and excess of those that would be found in analyses, to develop a site specific comprehensive understanding of the such circumstances under the NLRA. safety and health plan that addresses effectiveness, vulnerabilities, and trends Section 850.11–General CBDPP existing and planned activities. Thus, of DOE’s environment, safety, health, Requirements DOE has retained this requirement in nuclear safeguards, and security policies the final rule. and programs. DOE believes that this Section 850.11 establishes the general Section 850.11(b) requires responsible independent oversight will help assure requirements of the CBDPP. Section employers to tailor the scope and consistency among CBDPPs across the 850.11(a) specifies that the CBDPP must content of their CBDPPs to the specific complex. address all existing and anticipated hazards associated with the DOE Section 850.10(b)(1) establishes a 90- operational tasks that fall within its beryllium activities being performed. In day period for DOE to review and either scope. In addition, the section requires addition, section 850.11(b)(1) requires approve or reject the CBDPP. During its all responsible employers to develop that these programs include formal review, DOE may direct the contractors and implement a CBDPP that is plans outlining how responsible to modify the CBDPP. If DOE takes no integrated into DOE’s existing worker employers will ensure that occupational action within 90 days, the initial CBDPP protection program. By including this exposures to beryllium are maintained is considered approved. DOE provision, DOE notes the importance of at or below the PEL (8-hour TWA PEL established this 90-day time frame to controlling beryllium hazards within of 2 µg/m3). facilitate timely implementation of the framework of the worker protection Section 850.11(b)(2) further specifies program elements by responsible program established under DOE Order that the responsible employer’s CBDPP employers and to ensure that Heads of 440.1A (or, if applicable, under must, at a minimum, address each DOE Field Elements respond to predecessor orders) and related DOE requirement in Subpart C of the rule. responsible employers’ submissions. health and safety initiatives. The Section 850.11(b)(3) clarifies that the One commenter (Ex.18) stated that existing industrial hygiene and CBDPP provisions must focus on: (i) labor organizations should receive occupational medicine programs Minimizing the number of current initial and updated CBDPPs. DOE notes provide the basis for protecting DOE workers exposed and potentially that proposed section 850.10(b)(2) Federal and contractor workers from exposed to beryllium; (ii) minimizing would require contractors to give health hazards like beryllium exposure. the number of opportunities for workers interested DOE offices, affected workers, DOE believes that establishing a to be exposed to beryllium; (iii) and designated worker representatives a beryllium exposure control program minimizing the disability and lost time copy of the CBDPP, upon request. This outside the framework of this accepted experienced by workers due to CBD, provision is retained in section program may create redundant and beryllium sensitization, and associated 850.10(b)(2) of the final rule. This potentially inconsistent requirements. medical care; and (iv) setting section ensures that workers and their One commenter (Ex. 23) stated that challenging exposure reduction and representatives have access to the proposed requirement to specify in minimization goals to facilitate the information that is related to the the CBDPP existing and planned minimization of worker exposures. DOE protection of their health during the operational tasks within the scope of the believes that the establishment of performance of DOE activities. rule would not be feasible for exposure reduction and minimization Section 850.10(c) requires responsible decontamination and decommissioning goals is essential to the success of the employers to update the written CBDPP (D&D) closure sites. This commenter CBDPP and in moving toward the

VerDate 29-OCT-99 10:58 Dec 07, 1999 Jkt 190000 PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 E:\FR\FM\A08DE0.207 pfrm04 PsN: 08DER3 68870 Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 / Rules and Regulations ultimate goal of preventing CBD within activities require additional controls reducing the number of workers the DOE complex. and/or procedures, a change in the exposed to beryllium, minimizing the DOE is sensitive to concerns that exist CBDPP is warranted. Also, when new potential level of beryllium in the within its community regarding the activities are within the range of workplace atmosphere, and continually need to approach exposure reduction potential exposures to beryllium as monitoring worker health to ensure that and minimization objectives in a described in the existing CBDPP, the workplace controls are sufficiently responsible and realistic manner. commenter suggested that no revision protective. DOE expects implementation Accordingly, section 850.11(b)(3)(iv) should be necessary. DOE’s position is of the rule to increase its understanding establishes a performance-based consistent with the views of this of the development and course of CBD, requirement that will allow responsible commenter. In general, only those which may lead DOE, at some future employers to establish their own activities outside the scope of the date, to propose modifications of this exposure reduction and minimization existing CBDPP would require a rule. goals tailored to their unique workplace revision to the CBDPP. needs and conditions, subject to DOE Section 850.12(d) recognizes that, Section 850.20—Baseline Beryllium review and approval pursuant to section depending on the circumstances of the Inventory 850.10(b). DOE intends for responsible work, responsible employers may have Section 850.20(a) requires responsible employers to establish reasonable, but to take other actions to protect their employers to develop a baseline challenging, goals based on sound workers, and DOE does not intend to beryllium inventory. By developing the industrial hygiene principles and the preclude such actions by the provisions baseline inventory, responsible specific circumstances for each affected of the rule. DOE recognizes that employers will accomplish the DOE workplace and location. DOE individuals responsible for following functions that are critical to expects responsible employers to implementing CBDPP activities must the success of the CBDPP: (1) consider, in establishing these goals, the use their professional judgment in Identification of locations and current level of worker exposures, the protecting the health and safety of operations that should be physically number of workers exposed, the existing workers. Nothing in the rule should be isolated from other areas to prevent the controls that are in place, the technical viewed as relieving these individuals of spread of contamination, (2) feasibility and exposure reduction their professional responsibility to take identification of areas in which worker potential of possible additional controls, whatever actions are warranted to access should be restricted to minimize and the cost and operational impact of protect the health and safety of the the number of workers who could be the controls. workforce. exposed, (3) identification of beryllium contamination that must be controlled Section 850.12–Implementation Section 850.13–Compliance in facilities that are scheduled for Proposed in section 850.12 required Section 850.13(a) requires responsible decontamination and decommissioning, responsible employers to manage and employers to conduct DOE activities (4) identification of beryllium control beryllium exposures in all DOE involving beryllium in compliance with contamination in facilities that are being beryllium activities consistent with the their respective CBDPP that has been used for non-beryllium activities, to approved CBDPP, the rule, or any other approved by the Head of DOE Field determine the need for cleanup, and (5) program, plan, schedule or other Element. Through this provision, DOE the determination of which workers process established by this part, as well recognizes that even the best CBDPP should be covered under the CBDPP. as requirements in other applicable will not adequately protect workers if it Section 850.20(b) supplements the Federal statues and regulations. One is not followed at the site. Section generic inventory requirement under commenter (Ex. 16) believed that the 850.13(b) requires that once the rule DOE Order 440.1A by requiring preceding requirement should be takes effect, responsible employers have responsible employers to review current changed to state that DOE and 2 years to fully implement all aspects of and historical records, interview contractor personnel follow the CBDPP the program (written plans, schedules, workers, and sample as necessary to only. This commenter’s concern was and other measures). Although DOE document the characteristics and that including all applicable programs, seeks to lessen the burden on locations of beryllium at DOE sites. plans, etc., was too broad. DOE agrees responsible employers by permitting These supplemental requirements are and has deleted including all applicable them to phase in costly controls over the necessary because those persons who programs, plans, etc., from the final 2-year period, DOE expects employers are responsible for activities at DOE rule. to implement portions of the program as sites may not recognize that activities Section 850.12(c) clarifies DOE’s soon as practical during the 2-year under their supervision involve position that tasks involving potential period. beryllium or are conducted in areas beryllium exposure that are not covered Section 850.13(c) provides that the where beryllium was used in the past. under the CBDPP may not be initiated responsible employer in charge of an Workers often know of past beryllium until the CBDPP has been updated to activity involving a potential for activities for which no records exist. include them and the updated plan has beryllium exposure is responsible for Sampling can identify beryllium been approved by the appropriate Head complying with the rule. When no contamination where the record reviews of DOE Field Element. The rule contractor is responsible for the activity and worker interviews are not provides an exception to this and Federal employees perform the conclusive. These supplemental requirement for urgent and unexpected activity, this section requires DOE to be requirements are particularly necessary situations. In such cases, the task could responsible for compliance. because past beryllium operations at proceed with the written approval from DOE facilities were often conducted in the Head of DOE Field Element prior to Subpart C—Specific Program uncontrolled work areas. the CBDPP being revised and approved. Requirements Section 850.20(b)(3) requires that One commenter (Ex. 16) sought Subpart C of this rule establishes responsible employers conduct air, clarification as to when a change in the performance-based requirements for the surface, and bulk sampling procedures CBDPP was required. This commenter CBDPP. These requirements are to characterize the beryllium. proposed that when new beryllium designed principally to prevent CBD by Characterizing the beryllium is

VerDate 29-OCT-99 10:58 Dec 07, 1999 Jkt 190000 PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 E:\FR\FM\A08DE0.208 pfrm04 PsN: 08DER3 Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 / Rules and Regulations 68871 necessary to assess and control outlined specific training courses that a inventories, hazard assessments, and beryllium workplace hazards. competent person must complete. Two exposure monitoring, and the use of Responsible employers should conduct other commenters (Exs. 3, 31) favored individuals with sufficient industrial the sampling that is appropriate for the the use of OSHA’s ‘‘competent person’’ hygiene knowledge and experience to specific workplace conditions and the definition in lieu of the industrial actually perform these tasks. DOE suspected types and locations of hygiene competencies, but took believes this will provide the level of beryllium contamination. Sampling exception to the last phrase of the consistency required to ensure that techniques could include collecting area definition: ‘‘and who has the hazards are properly identified and and wipe samples and collecting authorization to take prompt corrective workers are appropriately protected personal breathing zone samples. measures to eliminate [hazards].’’ The without being overly prescriptive. In (Sections 850.24(a), (b), and (e)–(g) commenters were concerned that this regard, DOE agrees with the address the personal monitoring that limiting the performance of assessments commenters who stated that the level of may be a component of the baseline and monitoring to individuals with the expertise needed to perform beryllium inventory.) authority to take prompt corrective inventories, hazard assessment, and Section 850.20(c) requires responsible actions would exclude other qualified exposure monitoring does not require a employers to ensure that individuals individuals, such as third-party CIH, and that such a requirement would conducting the baseline beryllium industrial hygienists. cause an unnecessary resource strain on inventory activities have sufficient Nine of the 14 commenters both DOE and its contractors. qualifications in industrial hygiene. recommended that a CIH participate at Five persons commented on other DOE believes that this provision is some level in the performance of provisions of the proposed baseline necessary to ensure that the inventory is beryllium inventories, hazard inventory section. Three of the accurate and complete. DOE requested assessments, and exposure monitoring. commenters (Exs. 9, 21, 28) suggested in the NOPR that interested parties One commenter (Ex. 30) stated that that DOE provide in the final rule submit comments on the need to monitoring and assessments must be greater specificity than DOE proposed provide further specification in the rule performed by a CIH, while the other for baseline inventory requirements. regarding the minimum qualifications commenters (Exs. 3, 11, 13, 16, 19, 26, DOE agrees with these commenters and that an individual must possess to 28, 31) suggested that qualified and in the final rule has modified the perform certain components of the trained persons working under the requirement for reviewing records to CBDPP, such as hazard assessments and direct supervision of a CIH could cover both current and historical exposure monitoring. One alternative conduct these tasks, and that limiting records. The final rule also modifies the approach suggested was use of OSHA’s the actual performance of monitoring requirement for conducting sampling to ‘‘competent person’’ definition to define and assessments to CIHs would be too specify air, surface, and bulk sampling. competency of the individual. Another restrictive and unnecessary. Although DOE believes that these changes clarify alternative was to require that hazard these commenters did not believe that a DOE’s intent, express good industrial assessments and exposure monitoring CIH is needed to actually perform hygiene practice, and continue to allow be performed by a ‘‘certified industrial monitoring and assessments, many did the responsible employer appropriate hygienist’’ (CIH) as defined by the believe that minimum qualifications for flexibility in conducting the baseline American Board of Industrial Hygiene those individuals performing these tasks inventory. One commenter (Ex. 9) (ABIH). must be specified in the final rule. For suggested that DOE also specify in the DOE received 14 comments in instance, one commenter (Ex. 11) final rule that baseline inventories response to this request. Two of the 14 recommended that DOE require that include the locations where beryllium commenters (Exs. 4, 16) agreed with these individuals possess sufficient activities are planned. DOE considers DOE’s approach in proposed sections industrial hygiene experience in locations where beryllium activities are 850.20(c), 850.21(b) and 850.24(a). A addition to knowledge. Another planned to be locations of potential commenter (Ex. 16) noted that if more commenter (Ex. 13) suggested that a beryllium contamination and exposure prescriptive definitions are used to CIH, Industrial Hygienist in Training that must be included in the baseline define personnel qualifications, the (IHIT) as defined by the ABIH, or person inventory under paragraph (a), and, definitions should be appropriate to the with ‘‘demonstrably equivalent therefore, no change is needed. required task. For instance, CIHs should qualifications’’ perform assessments and One commenter (Ex. 18) conduct hazard assessments, while monitoring. Another commenter (Ex. 23) recommended that the final rule individuals possessing a lower level of suggested that the industrial hygienist mandate the disclosure of health and knowledge should conduct exposure definitions in DOE’s ‘‘Functional Area safety documents related to past monitoring. Another commenter (Ex. 4) Qualification Standard,’’ or as defined beryllium emissions and exposures. favored the use of OSHA’s ‘‘competent by AIHA, be used to prescribe the DOE has not included such a provision person’’ definition over requirements for qualifications required to perform in the final rule because the Freedom of a CIH if DOE elected to use one of these monitoring and assessments. Information Act (5 U.S.C. 552) already more prescriptive definitions. DOE agrees with the overwhelming provides for the release of federal Two commenters (Ex. 20, 29) stated majority of commenters who favored a government records, except for specified that the industrial hygiene competency more prescriptive definition. DOE types of records that contain sensitive requirements in proposed sections believes that a more prescriptive information, such as classified 850.20(c), 850.21(b) and 850.24(a) were definition will ensure proficiency and information relating to national defense too subjective and recommended consistency in the conduct of or foreign policy, information in instead, the use of OSHA’s ‘‘competent assessments and monitoring as well as personnel and medical files, and trade person’’ definition. A commenter (Ex. in the overall implementation of the secrets or other confidential business 20) further noted that OSHA’s Asbestos CBDPP. Accordingly, DOE has provided information. Requests to DOE for release Standard, 29 CFR 1926.1101(b), language in sections 850.20(c), 850.21(b) of information related to past beryllium included definitions for ‘‘competent and 850.24(a)(1) of the final rule for the use and exposures may be submitted to person,’’ ‘‘industrial hygienist,’’ and use of qualified individuals such as a the appropriate DOE field office. Such ‘‘certified industrial hygienist’’ and CIH to manage and supervise beryllium requests should follow DOE’s

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Another commenter (Ex. 30) was recommended that the final rule provide Section 850.21(a) requires the concerned about the use of existing for independent review of the responsible employer to conduct an data, such as exposure monitoring responsible employer’s implementation analysis of existing worksite conditions, results, in the hazard assessment. While of the CBDPP. DOE does not think that exposure data, medical surveillance this commenter believed that using such a provision is necessary, because trends, and the exposure potential of existing data is appropriate, the existing mechanisms already provide planned activities. In addition, section commenter warned against the potential independent oversight of DOE’s 850.21(a) specifies that the responsible for errors when relating existing data to contractors and include independent employer must prioritize potential current operations. In particular, this oversight of DOE’s field organizations. exposure activities so that the activities commenter suggested that existing data The DOE Office of Environment, Safety with the greatest risks of exposure are relating to exposure monitoring is often and Health’s Office of Oversight is evaluated first. DOE believes that not well documented or is of poor charged with providing information and prioritizing activities is a logical first quality, thus making it difficult to analysis needed to ensure that DOE’s step in initiating a hazard assessment. determine whether the sampling is top management officials, Congress, and Targeting high-risk beryllium operations representative of current beryllium the public have an accurate and is an effective way to reduce potential operations. DOE agrees that existing comprehensive understanding of the beryllium exposures throughout DOE data can be a valuable tool if collected effectiveness, vulnerabilities, and trends facilities. and documented properly, and in many of DOE’s environment, safety, health, Section 850.21(b) requires responsible cases use of such data will expedite the nuclear safeguards, and security policies employers to ensure that hazard hazard assessment process. At the same and programs. In addition, any assessments are managed by qualified time, DOE also shares this commenter’s interested individual or organization individuals (e.g., a CIH), and that the concerns regarding the accuracy and may conduct a review of a responsible individuals assigned to conduct hazard applicability of existing data and has employer’s compliance with this rule assessments have sufficient knowledge retained in section 850.21(b) the based on information obtained from and experience to perform such requirement for the hazard assessment DOE. activities properly. DOE requested in to be managed by a qualified individual, One commenter (Ex. 14) the NOPR that interested persons such as a CIH. DOE’s intent is that this recommended that the final rule provide submit comments on the need to further requirement will help ensure that the funding for the baseline inventory, and specify in the rule the minimum data considered in the hazard contended that responsible employers qualifications that an individual must assessment accurately reflects current will not conduct the baseline possess to perform certain key site conditions and hazards. inventories unless the funding required components of the CBDPP, such as Another commenter (Ex. 24) favored for this task is explicitly established by hazard assessments. DOE received 14 the triggering of a hazard assessment at the final rule. DOE does not require its comments in response to this request. detectable airborne beryllium levels contractors to perform unfunded tasks, As noted in the preamble discussion of from personal air samples. DOE agrees but funding of DOE programs is section 850.20(c), 10 of the commenters that if such data is available, it must be appropriately handled through the either suggested or supported considered in the hazard assessment. As federal government’s budget process establishing an additional specification another commenter (Ex. 28) pointed out, and not through the regulatory process. that hazard assessments be performed however, a hazard assessment should DOE expects that its program offices under the supervision of a CIH. DOE not be limited to the inhalation risks will request the funds needed to meet generally agrees with these commenters posed by beryllium but must also the obligations and objectives of their about the need for a qualified individual include the presence and characteristics programs and activities, including to manage hazard assessments and of beryllium contamination in a facility. compliance with the CBDPP. certain other tasks required by the rule. Accordingly, the final rule requires the But DOE will not require that person to responsible employer to perform a Section 850.21—Hazard Assessment be in all cases a CIH. Thus, DOE hazard assessment whenever the Because the identification of the provides in section 850.21(b)(1) that a baseline inventory establishes the possible presence of beryllium in a qualified individual, such as a CIH, presence of beryllium in an area. workplace does not, in and of itself, must manage hazard assessments Still another commenter (Ex. 11) suffice to determine whether a hazard performed for the CBDPP. By use of this requested that DOE include a non- exists or whether various control language, DOE leaves open the mandatory appendix to the rule to measures must be employed, section possibility that a responsible employer, provide guidance on how to perform a 850.21 of the final rule requires in a particular case, may determine that hazard assessment. This commenter was responsible employers to conduct a someone who is not a CIH possesses the concerned that inexperienced industrial beryllium hazard assessment to requisite qualifications to manage the hygienists may be called upon to characterize workplace beryllium hazard assessments. perform a hazard assessment, and exposure hazards. This requirement In addition to the comments on the suggested that additional guidance allows each site the flexibility to CIH issue, DOE received only minor would be needed to assure accuracy and determine the appropriate risk-based comments on section 850.21. One consistency. DOE believes this concern approach for assessing beryllium-related commenter (Ex. 21) suggested that the is addressed in section 850.21(b), which hazards in its worksites where the exposure potential of planned activities requires that hazard assessments be baseline inventory has established that should be rank ordered to better focus managed by qualified individuals, such beryllium is present. As noted by one each site’s resources and efforts. DOE as CIHs, and performed by individuals

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DOE Order 440.1A, stating that any new these comments and available scientific Accordingly, DOE has not included the DOE limit should be subject to the data, and continues to believe that its requested appendix to provide guidance rulemaking process (Ex. 16). original conclusion, as outlined in the on how to perform a hazard assessment Five other persons suggested that DOE proposed rule, remains valid. as a part of this rulemaking. adopt one of a variety of lower exposure Specifically, DOE believes that existing limits ranging from the limit of scientific data indicates that there are Section 850.22—Permissible Exposure detection to the NIOSH Recommended reasonable grounds to conclude that the Limit Exposure Limit (REL), which is a ceiling OSHA 8-hour TWA PEL for beryllium In the NOPR preamble, DOE reviewed limit of 0.5 µg/m3. These commenters may not be sufficiently protective of the scientific evidence suggesting that cited the occurrence of CBD among worker health, a conclusion supported the current OSHA 8-hour TWA PEL workers exposed to beryllium at levels by 12 of the 15 commenters that does not sufficiently protect worker below the 8-hour TWA PEL, and some addressed this section of the proposed health. However, DOE also stated that, of these commenters argued that studies rule. DOE is particularly influenced by in its view, it is difficult to determine presented in the Health Effects the published studies (refs. 16–17, 21) from this scientific evidence the discussion of the NOPR provided a indicating that workers exposed below exposure level necessary to eliminate sufficient basis for the establishment of the current PEL are contracting the risk of contracting CBD. For this a new exposure limit. For example, one beryllium disease and exhibiting Be- reason, DOE retained the existing OSHA commenter (Ex. 35) cited two studies LPT sensitivity. A recent article by 8-hr TWA PEL in proposed section that evaluated the occurrence of CBD Eisenbud (ref. 29) also concludes that it 850.22, and proposed other provisions among the general population around a ‘‘appears’’ the current PEL is not to minimize worker exposure to beryllium plant in Lorain, Ohio (refs. 5 protective enough. airborne beryllium in DOE facilities. In and 6). Relying on these studies, this However, DOE also believes, based on addition, DOE included in proposed commenter suggested that the U.S. available scientific data, that it is section 850.22 language providing that Environmental Protection Agency’s difficult to determine the exposure level DOE would adopt a more stringent 8- ambient air criterion for beryllium of necessary to eliminate the risk of hour TWA PEL if OSHA promulgated 0.01 µg/m3 could be used as a basis for contracting CBD and, therefore, that the one through the rulemaking process. a new 8-hour TWA exposure limit. Two best approach to providing improved Finally, DOE requested in the NOPR other commenters (Exs. 14, 24) cited the worker protection is through the that interested persons submit any two Lorain, Ohio community studies, establishment of a conservative 8-hour compelling scientific evidence that the occurrence of CBD among workers TWA action level, coupled with would assist DOE in establishing a new, with beryllium exposures ‘‘well below aggressive exposure reduction and more protective exposure limit for DOE the PEL,’’ a study published in 1997 minimization efforts, and the collection facilities. (ref. 31) which suggests that beryllium of medical surveillance data to better Fifteen persons commented on the 8- sensitization occurs at airborne understand the cause of CBD. hour TWA permissible exposure limit beryllium exposure levels as low as 0.01 Accordingly, DOE has retained the requirements in the proposed rule. Of µg/m3, and the DOE policy to provide a OSHA 8-hour TWA PEL in section these 15 commenters, four supported workplace free of recognized hazards 850.22 of the final rule and has retained DOE’s proposal to retain the OSHA 8- (DOE Order 440.1A) to support their the action level concept of the proposed hour TWA PEL (Exs. 4, 19, 26, 29). One position that workers should not be rule, although at a lower level (see of these four (Ex. 29) took issue with exposed to any detectable level of section 850.23 discussion). Section DOE’s conclusion that the existing beryllium. The remaining two 850.22 has been revised to simply OSHA PEL was not protective. This commenters that offered suggestions for reference 29 CFR 1910.1000, instead of commenter pointed to the inaccuracies an alternative exposure limit agreed specifying the current numerical limit. associated with the use of area with DOE’s conclusion that the OSHA DOE intends this provision to result in monitoring data in referenced studies 8-hour TWA PEL was not sufficiently the automatic incorporation of a more and the fact that most of the referenced protective and recommended adopting stringent PEL that OSHA may studies acknowledged that infrequent limits established by other occupational subsequently promulgate. This does not exposures above the PEL had occurred health groups. One commenter (Ex. 18) represent a substantive change to the within the study group. As a result, this suggested that DOE adopt NIOSH’s REL provision as proposed. commenter felt that the OSHA PEL as a DOE exposure limit while the other In this rule, however, DOE has should be retained as the exposure limit (Ex. 22) suggested that DOE apply a decided not to follow the policy under in DOE work places. safety factor of 4 to the ACGIH 8-hour the more general worker protection Two commenters cited DOE’s policy TLV and use 0.05 µg/m3 as the new DOE program established by DOE Order established in DOE Order 440.1 to adopt limit. 440.1A of adopting the more protective the more protective of either OSHA’s Two other commenters (Ex. 20, 32) of either the OSHA PEL or the ACGIH PEL or ACGIH’s threshold limit value agreed with DOE’s conclusion that the TLV. The incorporation of any new (TLV) and recommended that DOE OSHA 8-hour TWA PEL is not ACGIH TLV in this rule would require adopt the ACGIH’s proposed 8-hour sufficiently protective and that DOE conduct a rulemaking on the TWA TLV of 0.2 µg/m3 as the new DOE recommended that DOE establish a new specific exposure level and present the exposure limit (Exs. 28, 30). One exposure limit. These commenters, scientific basis for public comment. As commenter (Ex. 28) also supported however, did not offer suggestions for stated previously in this SUPPLEMENTARY adopting the proposed ACGIH TLV as alternative new exposure limits. INFORMATION section, DOE believes, an 8-hour TWA action level, which DOE Another commenter did not directly based on the existing scientific has done in the final rule. (See section address DOE’s proposal to retain the evidence, that such a rulemaking is 850.23 in this Section-by-Section OSHA PEL, but instead recommended premature. By contrast, DOE may Discussion for further discussion of the that DOE should consider the possible incorporate an OSHA PEL in this rule action level.) Another commenter effects of particle size on the occurrence because the OSHA PEL is promulgated opposed adopting the proposed ACGIH of CBD. following notice and comment

VerDate 29-OCT-99 10:58 Dec 07, 1999 Jkt 190000 PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 E:\FR\FM\A08DE0.212 pfrm04 PsN: 08DER3 68874 Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 / Rules and Regulations rulemaking, and the rules of the Office µg/m3, which is the same level as the lowest action or trigger level reported by of the Federal Register permit a ACGIH proposed TLV. Most any DOE facility under the interim reference to another part of the Code of commenters believed that this level CBDPP, and a lower level has not been Federal Regulations. would prevent additional cases of demonstrated as being practicable. DOE proposed, in section 850.22(a) of beryllium sensitization and disease. Lowering the action level to 0.2 µg/m3 the NOPR, to adopt the STEL DOE believes that there is reasonable will result in greater protection for the established by the ACGIH of 10 µg/m3, technical basis for selecting 0.2 µg/m3 as affected DOE work force by triggering averaged over a 15-minute sampling an action level, based on the following additional monitoring, surveillance, period. In the final rule the STEL has scientific analyses. respiratory protection, and other been deleted, because the proposed The U.S. Environmental Protection protective measures. STEL would not provide any added Agency’s (EPA) Integrated Risk Benefits of lowering the action level. protection for the worker given that the Information System includes a As specified in this rule, the action level new action level of 0.2 µg/m3 would be Reference Concentration of 0.02 µg/m3 triggers the use of a number of controls exceeded in less than 15 minutes where for beryllium, which is ‘‘an estimate and protective measures designed to exposure levels are at 10µg/m3. DOE did (with uncertainty spanning perhaps an protect employees from exposures to not seek to establish a lower STEL order of magnitude) of a continuous beryllium, including: because, as in the case of a lower PEL, inhalation exposure to the human • Periodic exposure monitoring (10 available scientific data do not provide population (including sensitive CFR 850.24 (c)); a sufficient basis for the establishment subgroups) that is likely to be without • Exposure reduction and of a new STEL. an appreciable risk of noncancer effects minimization measure (10 CFR during a lifetime’’ (ref. 33). This 850.25); 4 Section 850.23—Action Level concentration is based on epidemiology • Regulated areas (10 CFR 850.26); DOE proposed in the NOPR to studies. This continuous 24-hour per • Hygiene facilities and practices (10 establish an 8-hour TWA action level of day, level translates into an 8-hour TWA CFR 850.27); 0.5 µg/m3. In selecting the proposed level of 0.84 µg/m3. • Respiratory protection (10 CFR action level, DOE considered a number Merrill Eisenbud conducted a study of 850.28); and of factors. DOE considered OSHA’s CBD based on air sampling, atmospheric • Protective clothing and equipment substance-specific health standards, dispersion modeling, and analysis of a (10 CFR 850.29). which typically establish action levels beryllium production plant’s past Thus, DOE sites where exposure for hazardous and toxic substances at operations. Eisenbud concluded that the levels exceed the action level would be one-half the 8-hour TWA PEL. Applying lowest beryllium concentration at the 3/ required to implement these controls to this approach to beryllium would have 4-mile boundary, beyond which no provide further protection to workers resulted in a proposed 8-hour TWA community cases of chronic beryllium exposed above the action level. This action level of 1.0 µg/m3. OSHA’s action disease were found, was 0.025 µg/m3 additional protection will reduce the levels are premised on the safety of its during the 7-year period the plant exposure levels experienced by these PELs, and are set to provide an operated at full capacity (ref. 29). This workers, consequently reducing their additional margin of safety. As 24-hour per day level translates into an risk of developing beryllium-related explained in the preceding discussion, 8-hour TWA level of 0.84 µg/m3, which disease and other health effects. Setting however, there is a body of evidence essentially is the same level that the the action level at 0.2 µg/m3, as opposed suggesting that the OSHA PEL for EPA found to be without appreciable to 0.5 µg/m3, does not alter the set of beryllium does not adequately protect risk of causing noncancer effects (i.e., controls that are triggered,5 but does worker health. Therefore, DOE decided CBD). alter the timing of these additional that a lower action level is appropriate The ACGIH, a professional controls. The additional protective for DOE facilities. According to the organization that publishes measures triggered by the action level results of the 1996 DOE survey of DOE occupational health consensus will be put into effect earlier. For facilities which reported potential standards, has proposed to change its 8- example, consider an activity where beryllium exposures, two DOE facilities hour TWA TLV from 2 µg/m3 to 0.2 µg/ airborne concentrations of beryllium (Pantex and Rocky Flats) had already m3, based on its review of recent start very low (below 0.2 µg/m3), but rise employed an action level of 0.5 µg/m3. beryllium epidemiology studies (ref. over time (e.g., over a course of days or Another facility (Lawrence Livermore 32). weeks) in the workplace. Assume also National Laboratory) reported the use of The DOE recognizes that the EPA that airborne concentrations will an ‘‘administrative warning range’’ of (0.84 µg/m3), Eisenbud (0.84 µg/m3), and eventually exceed 0.5 µg/m3. If the 0.2 to 2.0 µg/m3, which triggered a ACGIH (0.2 µg/m3) levels are normally responsible employer recognizes the requirement for an investigation, and six used as exposure limits rather than potential for exposures to exceed the DOE facilities employed an action level action levels. However, based on action level in this activity, this rule (as of 1.0 µg/m3. In light of this experience, limitations of the studies done to date, well as prudent industrial hygiene DOE proposed adopting an action level the difficulties in determining a safe practice) would require the responsible at the lower end of existing DOE threshold level for occupational employer to conduct exposure complex action levels (0.5 µg/m3), rather exposure to beryllium, and DOE’s than follow the typical OSHA practice, decision to implement aggressive 4 The rule does not require that exposure in order to implement aggressive yet exposure reduction and minimization reduction and minimization efforts (e.g., achievable exposure minimization. efforts, DOE has decided that the most engineering controls and work practices) be triggered by the action level. DOE expects, however, The majority of comments received on prudent course is to lower the action that affected sites will specify that some the proposed rule agreed with the DOE’s level to 0.2 µg/m3 rather than set a new engineering controls and work practices be approach of using an action level that is exposure limit. The available science triggered by the action level in their CBDPP plans. lower than the typical OSHA action suggests that this level would be 5 DOE did alter the set of controls that are triggered by the action level between the proposed level, but called for an even lower level protective; is one-quarter of the EPA and and the final rule. This, however, was not done as than DOE had proposed. The most Eisenbud levels and the same as the a result of setting a lower action level, but was in commonly recommended level was 0.2 ACGIH proposed level. This is the response to comments on the proposed rule.

VerDate 29-OCT-99 10:58 Dec 07, 1999 Jkt 190000 PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 E:\FR\FM\A08DE0.213 pfrm04 PsN: 08DER3 Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 / Rules and Regulations 68875 monitoring to determine if and when µg/m3, but who are never exposed above this information, DOE is unable to the action level is exceeded. In this 0.5 µg/m3. DOE estimates that between provide a quantitative estimate of the situation, once the 0.2 µg/m3 threshold 342 and 460 workers may be exposed at benefit of using a lower action level. is crossed, the responsible employer these levels.6 Under an action level of Nevertheless, DOE believes that the use would be required to implement the 0.5 µg/m3, these workers would not be of 0.2 µg/m3 action level as opposed to controls specified above, and workers afforded the protection of controls the 0.5 µg/m3 is justified based on the would benefit from the additional triggered by the action level. Under an benefits discussed above and the protection provided by those controls. action level of 0.2 µg/m3, however, these number of comments that suggested that Under an action level of 0.5 µg/m3, workers are afforded the additional an action level lower than 0.5 µg/m3 is protective measures would not be controls. These additional controls will necessary. implemented until the airborne reduce the exposures faced by these Other issues. This revision to the final concentrations exceeded 0.5 µg/m3. workers, leading to a reduction in their rule does not accommodate the Thus, during the time that exposures are risk of developing beryllium-related comments (Exs. 12, 18, 32) that urged between 0.2 µg/m3 and 0.5 µg/m3, disease and other health effects. Thus, DOE to lower its action level to any workers would not be afforded the the second benefit of using the lower detectable level of beryllium. DOE additional protection of the triggered action level is a reduction in risk among believes it would not be practicable to controls. Thus, the first incremental workers exposed to airborne use any detectable level of beryllium as benefit of setting the action level lower concentrations between 0.2 µg/m3 and its action level because beryllium is is the reduction in risk afforded by the 0.5 µg/m3. ubiquitous; it can be detected virtually controls triggered during the time that Quantitative estimates of the anywhere if a sufficiently large air exposures are between 0.2 µg/m3 and reduction in risk and the consequent sample is taken. Furthermore, according 0.5 µg/m3 (See Table 9). reduction in the incidence of beryllium- to the EPA’s Integrated Risk Information The second benefit from setting the related disease and other health effects System, discussed above, the United action level lower is to expand the are not possible due to a lack of States population is being exposed to number of workers afforded the necessary information. As discussed in detectable background levels of additional controls (See Table 10). DOE this preamble and the Economic beryllium without an appreciable risk of believes there are a number of workers Analysis (Chapter 1, Section 1.1), no contracting CBD in their lifetime. exposed to airborne concentrations of quantitative dose-response relationship Therefore, that level is not supported by beryllium between 0.2 µg/m3 and 0.5 has been defined for beryllium. Without the available science.

TABLE 9.ÐCOMPARATIVE COST ANALYSIS FOR DIFFERENT ACTION LEVELS

µ 3 µ 3 Annualized 0.5 g/m action level 0.1 g/m Action level cost for 0.2 Difference Difference Category/requirement µg/m3 ac- µ µ tion level Annualized from 0.2 g/ Annualized from 0.2 g/ cost m3 action cost m3 action (final rule) level level

Requirements Triggered By The Action Level in the Final Rule: Periodic exposure monitoring ...... $1,962,620 $1,104,421 ($858,199) $3,574,937 $1,612,317 Notify workers monitoring results ...... 66,932 40,411 (26,521) 82,104 15,171 Exposure reduction and minimization ...... 2,707,636 2 2,707,636 0 3,579,513 871,877 Regulated areas ...... 0 0 0 8,496 8,496 Change rooms and showers ...... 249,730 249,730 0 272,337 22,607 Respiratory protection ...... 9,085 9,085 0 342,495 333,410 Protective clothing ...... 0 0 0 382,528 382,528 Disposal of protective clothing ...... 0 0 0 42,738 42,738

Subtotal ...... 4,996,004 4,111,284 (884,720) 8,285,149 3,289,144 Other Requirements ...... 26,555,397 26,555,397 0 26,555,397 0

Total for all requirements 1 ...... 31,551,401 30,666,680 (884,720) 34,840,545 3,289,144 Note: Column totals may contain some rounding error. 1 For this row, the annualized cost represents the annualized cost of the proposed rule for the specified action level. 2 The costs for exposure reduction and minimization may be lower with a 0.5 µg/m3 action level since fewer requirements would be triggered under the higher action level. The information provided to DOE by the sites, however, did not contain enough information to make an estimate of the reduction in the costs for this category.

6 The lower bound estimate (342) is the difference comparable. In developing the EA for the final rule, estimate of the number exposed above 0.5 µg/m3. between the number of workers exposed above the DOE obtained new data from the sites on the This resulted in an estimated 776 workers exposed µ 3 µ 3 0.5 g/m action level estimated in the Economic number of workers exposed above 0.2 g/m . For above 0.5 µg/m3. The difference between this new Analysis (EA) for the proposed rule (894 workers) some sites, the reported number of workers exposed estimate and the estimated number exposed above and the number of workers exposed above the 0.2 above 0.2 µg/m3 was less than DOE’s previous 0.2 µg/m3 (1,236 workers) provides the upper bound µg/m3 action level estimated in the EA for the final estimate of the number exposed above 0.5 µg/m3. rule (1,236 workers). The estimates contained in the To correct for this inconsistency, DOE used the estimate (460 workers). two versions of the EA are not, however, completely minimum of the two estimates for each site as an

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TABLE 10.ÐESTIMATED NUMBER OF WORKERS BY EXPOSURE LEVEL

Estimated Percent of all Beryllium exposure levels (µg/m3) number of affected work- workers 1 ers

0.0 to 0.1 ...... 0 0 0.1 to 0.2 ...... 398 24.4 0.2 to 0.5 ...... 342 to 460 20.9 to 28.2 Above 0.5 ...... 776 to 894 47.5 to 54.7

Total ...... 1,634 100 Total Above 0.1 ...... 1,634 100 Total Above 0.2 ...... 1,236 75.6 1 The Economic Analysis (EA) for the final rule estimates that 1,236 workers are exposed above the action limit of 0.2 µg/m3 and that a total of 1,634 workers are currently exposed to beryllium. Thus, 398 workers must be exposed below 0.2 µg/m3 (398 = 1,634¥1,236). Given that meas- urements of exposure levels below 0.1 µg/m3 begin to near the detection limits, DOE assumes that all workers exposed below 0.2 µg/m3 would be in the 0.1 to 0.2 group. Next, DOE estimated the upper bound of the above 0.5 group by taking the estimated number of workers exposed above 0.5 µg/m3 from the EA for the proposed rule (i.e., 894 workers). The difference between this number and 1,236 (the number exposed above 0.2 µg/m3) provided the lower bound of the 0.2 to 0.5 group (342 = 1,236+894). To provide the lower bound of the above 0.5 group (776 workers), DOE corrected for an inconsistency between the EA for the proposed rule and the EA for the final rule. In developing the EA for the final rule, DOE obtained new data from the sites on the number of workers exposed above 0.2 µg/m3. For some sites, the reported number of workers exposed above 0.2 µg/m3 was less than DOE's previous estimate of the number exposed above 0.5 µg/m3 (in the EA for the proposed rule). To correct for this inconsistency, DOE used the minimum of the two estimates (i.e., the estimated number of workers exposed above 0.2 µg/m3 in the EA for the final rule and the estimated number of workers exposed above 0.5 µg/m3 in the EA for the proposed rule) for each site as an estimate of the number exposed above 0.5 µg/m3. This resulted in an estimated 776 workers exposed above 0.5 µg/m3 which DOE uses as the lower bound for that group. The difference between this number and the estimated number exposed above 0.2 µg/m3 (1,236 workers) pro- vides the upper bound estimate for the 0.2 to 0.5 group (460 = 1,236¥776). NOTE: Column total may contain some rounding error.

Section 850.24—Exposure Monitoring persons for views or information on the 3, 26, 28, 29) favored representative Section 850.24 establishes CBDPP need for daily exposure monitoring of sampling of the workplace, using worker exposure monitoring all beryllium workers. DOE was statistical analysis to determine the requirements. The exposure monitoring considering whether daily exposure number of samples required. These provisions in this section are necessary monitoring was needed to document commenters asserted that the principal to determine the extent of exposure at and characterize more completely a benefits of a statistically-based the worksite; prevent worker worker’s exposure to beryllium, and to monitoring strategy would be the overexposure; identify the sources of better evaluate the adequacy of existing reduction in the number of samples exposure to beryllium; collect exposure exposure levels or determine needed and resources used. data so that the responsible employer appropriate levels for alternative After considering all of the comments, can select the proper control methods to exposure limits. Of the ten commenters DOE agrees that daily monitoring would be used; evaluate the effectiveness of who responded to this request for be unnecessarily burdensome for selected controls; and provide continual information, three favored a daily responsible employers, and that a feedback on the effectiveness of the monitoring requirement while seven statistically-based approach will ensure program in controlling exposures. These were opposed. the adequate characterization of worker requirements are more specific than the The commenters who favored daily exposures. This position is reflected in provisions of exposure monitoring in monitoring for all workers (Exs. 18, 25, section 850.24(b), as discussed below. DOE Order 440.1A. 30) argued that daily monitoring of each Section 850.24(a) requires that Exposure monitoring is important not worker would more accurately exposure monitoring be managed by a only to determine the level of beryllium document and characterize beryllium qualified individual such as a CIH, and to which workers are exposed and the exposures. One commenter (Ex. 16) conducted by individuals with frequency at which workers should be suggested that initial daily monitoring sufficient industrial hygiene knowledge monitored, but also to determine could be replaced with periodic and experience. DOE requested in the whether other protective provisions of monitoring after sufficient data was NOPR that interested persons submit the rule need to be implemented. The obtained. Another (Ex. 30) noted that comments on the need to further specify employer’s obligation to provide daily exposure monitoring might be the the minimum qualifications that an respiratory protection under section only accurate way to determine individual must possess to perform 850.28, for example, is triggered by exposures during changing workplace certain key functions under the CBDPP, monitoring results showing that a conditions. This commenter suggested including exposure monitoring. Most of worker is exposed at or above the action that daily monitoring is important in the commenters suggested or supported level. Exposure monitoring results also identifying specific work activities that adding a requirement that exposure may help DOE to resolve uncertainties contribute to the worker exposures. monitoring be performed under the regarding the adequacy of the existing The majority of commenters supervision of a CIH. DOE agrees that a beryllium PEL and to refine the responding to this request (Exs. 3, 4, 16, CIH is often best qualified to manage requirements of this rule as needed to 17, 26, 28, 29) objected to daily exposure monitoring activities, and protect worker health. monitoring of all workers to determine provides in section 850.24(a)(1) that Because of the importance of beryllium exposures. These commenters exposure monitoring performed for the adequately characterizing and stated that daily monitoring would CBDPP be managed by a qualified monitoring worker exposures to generate large amounts of data, at great individual, such as a CIH. However, in beryllium, DOE included a specific cost, while producing little or no added keeping with the performance-based request in the NOPR asking interested benefit. Some of these commenters (Exs. philosophy underlying this rule, DOE

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DOE monitoring, under the management of a Accordingly, section 850.24(b)(2) allows does not believe that periodic qualified individual, need sufficient employers to use initial monitoring data monitoring should be mandated for all knowledge and experience but not collected within 12 months before the workers regardless of exposure level, as necessarily the same level of effective date of this rule to satisfy the suggested by the other commenter, but qualification as a CIH. rule’s initial monitoring requirements. rather that the responsible employer Section 850.24(b) requires the One commenter (Ex. 31) cautioned DOE should determine the frequency of responsible employer to perform initial that any sampling performed prior to periodic monitoring where levels are exposure monitoring for all persons who the issuance of the final beryllium rule below the action level. However, DOE work in areas that may have airborne should only be accepted by DOE if the does encourage sites to establish lower concentrations of beryllium, as work conditions during the sampling action levels to trigger components of determined through the baseline period are the same as current their CBDPP, as part of their exposure beryllium inventory and hazard conditions. DOE agrees with this reduction and minimization efforts assessment. The responsible employer commenter, and notes that several required under section 850.25. must employ a statistically-based provisions of the final rule require A third commenter (Ex. 14), monitoring strategy to obtain the responsible employers to ensure that addressing the periodic monitoring number of samples needed to sampling results reflect current requirements of proposed section characterize worker exposures. The workplace conditions. Specifically, 850.24(c), stated that periodic initial exposure information is section 850.24(b) requires that the monitoring on a continuous basis is the necessary to determine the need for responsible employer obtain a sufficient only way to determine worker engineering and work practice controls, number of sample results to adequately exposures. While DOE acknowledges to select appropriate personal protective characterize exposures, and section that certain operations may warrant clothing and respiratory protective 850.24(d) requires that the responsible continuous monitoring due to the dynamic nature of day-to-day equipment where needed, and to employer perform additional monitoring operations, DOE believes that an identify the need to establish regulated if operations, maintenance, or inflexible, one-size-fits all monitoring areas. One commenter (Ex. 28) procedures change, or if the responsible policy is inappropriate due to the wide recommended that sampling should be employer has any reason to suspect a range of beryllium-related operations conducted to determine particle size change has occurred which may result within the DOE complex. Accordingly, and chemical characterization of the in new or additional exposures. Further, DOE believes that the requirement that DOE provides responsible employers potential exposure, and another exposure monitoring be managed by a the flexibility to determine the commenter (Ex. 30) recommended use qualified individual will help assure monitoring frequency that is needed to of particle size-selective personal that exposure monitoring results sufficiently characterize worker monitoring. DOE has decided to leave accurately characterize worker exposures. DOE believes that details of this nature to the qualified exposures. responsible employers are best individual who manages exposure Section 850.24(c) requires the positioned to evaluate the potential monitoring under the CBDPP, rather responsible employer to conduct variability of worker exposures in their than attempt to prescribe them in periodic exposure monitoring of operations and to tailor their periodic regulations. This type of issue also may workers who work in areas where monitoring approaches as appropriate. be addressed in future DOE guidance on airborne concentrations of beryllium are Nevertheless, because slight process or implementing the CBDPP. at or above the action level. Periodic procedural changes may go unnoticed Section 850.24(b)(1) requires the monitoring provides the responsible over time and because equipment responsible employer to determine the employer with assurance that workers maintenance, aging, or deterioration can beryllium exposure of workers by are not experiencing higher exposures affect performance, DOE, in section collecting personal breathing zone that may require the use of additional 850.24(c), is requiring a minimum samples that reflect worker’s exposure controls. In addition, periodic exposure monitoring frequency of every to airborne concentrations of beryllium monitoring reminds workers and 3 months (quarterly) for workers who over an eight-hour period. As specified responsible employers of the continued are exposed to airborne concentrations in the definition of ‘‘worker exposure’’ need to protect against the hazards of beryllium at or above the action level. in section 850.3, this is a measurement associated with exposure to beryllium. DOE recognizes that the minimum of the exposure that would occur if the The collection of exposure monitoring quarterly monitoring of workers worker were not using respiratory data also enables the SOMD to be exposed at or above the action level is protective equipment. Section 850.3 informed of the existence and extent of more frequent than is required in most also includes a definition of ‘‘breathing potential sources of beryllium exposure. OSHA expanded health standards. zone,’’ which means ‘‘a hemisphere Some commenters argued that the However, DOE considers this minimum forward of the shoulders, centered on periodic monitoring requirements in the monitoring frequency to be necessary the mouth and nose, with a radius of 6 rule should be more conservative than due to the uncertainties regarding the to 9 inches.’’ Thus, a breathing zone proposed in the NOPR. For instance, adequacy of the current PEL. To sample is taken as close as practical to one commenter (Ex. 13) recommended supplement this periodic monitoring the nose and mouth of the worker. For that the requirement for periodic requirement, section 850.24(d) requires a full description of breathing zone monitoring be implemented if employee that responsible employers perform samples, see OSHA’s Instruction CPL 2– exposures exceed 10% of the PEL while additional exposure monitoring when 2.20B, CH–1, Nov. 13, 1990. another commenter (Ex. 18) suggested beryllium-related operations or

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This exposure reduction and minimization affect worker exposure to airborne section also provides responsible provisions of the CBDPP that reflect beryllium, to ensure the continued employers with two alternative methods DOE’s goal of achieving aggressive effectiveness of existing engineering and of worker notification: (1) written reduction and minimization of worker work-practice controls, and to identify notification to each affected worker, or exposures to airborne beryllium. the need for additional control measures (2) posting of monitoring results in a Section 850.25(a) establishes the to minimize worker exposure to location or locations readily accessible baseline requirement that responsible beryllium. to affected workers. Two commenters employers ensure that no worker is exposed to airborne beryllium at levels To obtain accurate exposure (Exs. 16, 23) expressed concern about above the exposure limit established in monitoring results, section 850.24(e) the use of personal identifiers in posted section 850.22. requires that responsible employers use monitoring results, citing worker privacy concerns. Section 850.25(b)(1) requires the monitoring and analytical methods that responsible employer to include in the have accuracy, at a confidence level of One commenter (Ex. 26) objected strongly to DOE’s proposal to provide CBDPP a formal exposure reduction and 95 percent, of not less than plus or minimization program to reduce minus 25 percent for airborne notice to workers in a manner that does not identify the worker. This commenter exposure levels that are at or above the concentrations of beryllium at the action argued that not only is there no right to action level to below the action level, if level. The main reason DOE is requiring privacy implicated by posting of practicable. Sections 850.25 (b)(1)(i)-(iv) this degree of accuracy for exposure sampling results, but that anonymous provide that the formal exposure monitoring results is to ensure that notification would not further personal reduction and minimization program exposure monitoring results are accountability for work practices. This must include: (1) exposure reduction sufficiently accurate at the exposure commenter cited the Atomic Weapons and minimization goals, (2) the rationale level that is relevant for the CBDPP. Establishment’s (AWE) experience at its to support the goals and a strategy for Accuracy of measurements is critical, Cardiff (United Kingdom) facility to achieving them, (3) the specific actions since certain central requirements of the show the beneficial effects of peer that the responsible employer plans to rule (e.g., engineering controls, exposure pressure on individual workers’ take to achieve the goals, and (4) a reduction and minimization, respirator adherence to good work practice. DOE means of tracking progress towards use, and regulated areas) are triggered recognizes AWE’s experience and the meeting the goals or demonstrating that by measured worker exposures that benefits of peer pressure on workers’ the goals have been met. Where levels meet or exceed the action level. In adherence to good work practices. are below the action level, section addition, the medical removal provision However, DOE is following the 850.25(b)(2) requires responsible requires that a removed worker not be approach used in OSHA’s substance- employers to include in their CBDPP a placed in a job where exposure levels specific standards that have posting description and rationale for the steps are at or above the action level. requirements, which does not they plan to take to reduce and Section 850.24(f) further ensures the incorporate the principle of applying minimize exposures, if such steps are quality of monitoring results by peer pressure to establish good work practicable. Such steps are applicable requiring that all laboratory analyses of practice procedures. DOE, therefore, when exposures are measured below the air sampling data be performed in a provides in the final rule that when the action level to provide additional laboratory accredited for metals by the posting option is selected, responsible worker protection. This requirement AIHA, or a laboratory that demonstrates employers must post the results without assures responsible employer’s quality assurance for metals that is disclosing the identity of the affected commitment to address and further equivalent to AIHA accreditation. workers. This protection of workers’ reduce exposures, as practicable, below Equivalency to AIHA’s accreditation privacy is consistent with OSHA’s the action level and implementing the means that a laboratory can demonstrate substance-specific standards that have steps included in their CBDPP. that their testing protocols meet the posting requirements. Section 850.25(c) provides that accreditation standards of AIHA. These Sections 850.24(g)(2) and (3) deal responsible employers must apply the accuracy and quality requirements are with cases in which monitoring results hierarchy of industrial hygiene controls, consistent with similar requirements indicate that the worker exposure level as already required under DOE Order that appear in many of OSHA’s meets or exceeds the action level. In 440.1A, to achieve exposure control. expanded health standards for toxic such cases, the responsible employer is This hierarchy dictates that responsible substances. The only commenter (Ex. required by paragraph (g)(2) to include employers first must implement feasible 13) to address this issue agreed with in the notice to workers a description of engineering controls, followed by DOE that the use of an AIHA accredited the corrective actions being taken to administrative controls, in their efforts laboratory will ensure the quality reduce worker exposure to below the to reduce and minimize exposures. control, consistency, and accuracy of action level. Paragraph (g)(3) requires Responsible employers can supplement beryllium sample analyses. DOE has the responsible employer to notify the these controls with personal protective added to the final rule the language ‘‘or SOMD of the results within 10 working clothing and equipment to reduce a laboratory that demonstrates quality days of receipt of the monitoring results. exposures where engineering and assurance for metals analysis that is DOE believes that the SOMD must be administrative controls are not feasible. equivalent to AIHA accreditation,’’ to informed of such exposures in order to In summary, section 850.25 provide responsible employers more refine, as appropriate, the medical establishes a graded approach to flexibility in selecting a laboratory and surveillance protocol for affected reducing and minimizing beryllium to allow the use of an appropriate workers to ensure effective monitoring exposures to levels as low as

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DOE’s requirement that the Another commenter (Ex. 3) recommendation. responsible employer establish a formal questioned the efficacy of enforcing a One of the commenters (Ex. 3) program of setting and tracking rule that allows each site to establish suggested that if engineering or process reduction goals for exposures above the individual exposure reduction and controls bring exposure levels to below action level will result in greater minimization goals. DOE believes that the action level in a regulated area, the management attention to potential high this approach is adequately enforceable area should remain a regulated area to exposures. The requirement that the based on its positive experience using ensure that controls remain in place. responsible employer take steps to contractual mechanisms to enforce DOE does not agree with this comment. reduce and minimize exposures that are similar requirements in radiation While the rule would not prevent below the action level commits DOE to protection regulations. responsible employers from implementing such a practice, requiring continue reducing and minimizing Section 850.26—Regulated Areas exposures, but without the same level of that regulated area provisions remain in management attention since these Section 850.26 establishes the effect after exposures have been reduced exposures are believed to represent a regulated area provisions of the CBDPP. to acceptable levels would impose lower risk to workers. Regulated areas are an effective means additional financial burdens on Six persons commented on the of minimizing the number of workers employers with no corresponding exposure reduction and minimization exposed to airborne concentrations of improvement in worker protection. In requirements of the proposed rule. Two beryllium because they prevent or addition, DOE believes that such a of the commenters (Exs. 18, 23) minimize the spread of beryllium to mandatory provision could undermine recommended that the rule require clean areas. This is consistent with good the incentives this rule creates for responsible employers to initiate industrial hygiene practice whenever employers to implement effective reduction and minimization actions to exposure to a toxic substance can cause engineering or process controls. If maintain exposures below the action serious health effects. employers were required to maintain level, rather than below the exposure The final rule’s requirements for regulated areas regardless of whether limit. DOE would essentially be setting regulated areas are essentially the same they had implemented effective a new DOE exposure limit if it followed as those proposed, with certain good engineering controls, employers might this recommendation. As previously hygiene practices being added in have less motivation to implement the explained, DOE believes that setting a response to a commenter’s (Ex. 1) controls. This commenter’s concern is at new exposure limit would be concern discussed below under section least partly addressed by section inappropriate because the scientific data 850.26(d). 850.24(d), which requires the is not fully developed and does not yet Section 850.26(a) requires the performance of additional exposure provide an adequate basis for responsible employer to establish monitoring if operations or procedures determining an appropriate new limit. regulated areas where, based on change or if the employer suspects a The discussion of section 850.22, breathing zone samples, the employer change that could affect exposure levels. Permissible Exposure Limit, provides determines that workers are exposed to Section 850.26(b) of the rule requires greater detail on the issue of lowering airborne concentrations of beryllium at responsible employers to demarcate the exposure limit. or above the action level. areas where worker exposures are at or Three of the commenters (Exs. 4, 18, Three commenters addressed this above the action level in a manner that 33) made recommendations that relate provision, as proposed, and suggested alerts workers to the boundaries of such to the appropriate trigger for requiring either alternate or supplemental criteria areas. Under section 850.38 of this part, responsible employers to initiate to trigger the establishment of regulated warning signs must be posted, stating reduction and minimization actions areas. One commenter (Ex. 18) that only authorized personnel are where exposure levels are below the suggested that the trigger level be allowed in the area. Due to the serious action level. Two commenters (Exs. 18, lowered to require that regulated areas nature of the adverse health effects 33) recommended that the rule require be established wherever beryllium is associated with exposure to beryllium, responsible employers to initiate detected. DOE believes that the final no one should be in a regulated area reduction and minimization actions rule’s significantly lower action level without proper personal protection. wherever beryllium is detected. One provides a suitable mandatory trigger for Section 850.26(c) requires responsible commenter (Ex. 4) interpreted Table 5 in the establishment of regulated areas. In employers to limit access to regulated the NOPR preamble to mean that DOE addition, DOE believes that the CBDPP areas to authorized persons only. DOE would expect the responsible employer exposure reduction and minimization intends that only individuals who are to undertake actions anywhere exposure provisions will result in the use of an essential to the performance of work in levels are greater than zero. DOE even lower site-specific action level as the regulated area will be authorized to believes that using either the limit of improved controls become feasible enter regulated areas. Responsible detection or greater than zero as the throughout the DOE complex. employers will have to evaluate the trigger is not practicable because trace The two other commenters (Ex. 3, 34) affected operation and determine which levels of beryllium are ubiquitous, and suggested that the proposed provision personnel (including managers, beryllium levels in air can be measured for regulated areas be supplemented supervisors, and workers) are necessary everywhere if a large enough air sample with a surface contamination level limit for the performance of the work and is taken to accumulate sufficient that would trigger the establishment of thus are authorized to enter. Methods beryllium to exceed the lower detection regulated areas. No reliable correlation for preventing unauthorized persons limit of the analytic method being used. has been established between surface from entering a regulated area may DOE believes that final section contamination level and airborne include posting a sign indicating that 850.25(b)(2) best meets DOE’s intention concentrations of beryllium. DOE, only authorized persons may enter, the of establishing an effective performance- therefore, believes that using a surface use of locked access doors, and other

VerDate 29-OCT-99 10:58 Dec 07, 1999 Jkt 190000 PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 E:\FR\FM\A08DE0.220 pfrm04 PsN: 08DER3 68880 Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 / Rules and Regulations security measures as required by provisions are common in OSHA’s areas, in turn, are required wherever a worksite conditions. DOE believes that expanded health standards designed to hazard assessment identifies the employers are best equipped to protect workers from exposures to potential for worker exposures at or determine whether any access control hazardous particulates. above the action level. Thus, the methods are needed in addition to Sections 850.27(a)(1) and (2) requires requirement for change rooms and warning signs specified in section responsible employers to assure that showers is already indirectly triggered 850.38. workers observe prohibitions on the by the results of a hazard assessment. Two commenters (Exs. 1, 31) availability and use of cosmetics, A commenter (Ex. 23) expressed suggested the incorporation of tobacco and chewing products, and food concern that the impact and burden of additional personal hygiene controls, and beverages in areas where beryllium constructing new change rooms for D&D specifically recommending that the rule is above the action level. Section closure sites has not been considered in prohibit smoking, eating, and drinking 850.27(a)(3) requires responsible the development of the change room in regulated areas. DOE agrees with employers to prevent beryllium workers provisions, and argued that alternative these commenters and has included in from exiting areas that contain methods of compliance should be section 850.27 a prohibition on beryllium with contamination on their considered for D&D operations. In fact, smoking, eating, and drinking in areas bodies or their personal clothing. DOE DOE has addressed the economic where beryllium is above the action believes that these provisions promote impact of requiring responsible level (i.e., in regulated areas). sound work place hygiene practices that employers to provide change rooms for Section 850.26(d) requires responsible may protect workers from exposure to workers in the economic analysis employers to keep a record of all other substances present in the prepared for the NOPR and made persons who enter regulated areas. The workplace, as well as beryllium. These available for public review. Based on record must include the name of the provisions are commonly included in that economic analysis, DOE is aware person who entered, the date of entry, OSHA’s substance-specific health that the cost of change rooms may be the time in and time out, and the type standards. substantial for some DOE facilities. of work performed. One commenter (Ex. Section 850.27(b) requires responsible However, DOE believes that providing 26) stated that a log of worker activities employers to provide clean change change rooms and showers for workers is not needed unless DOE is conducting rooms or areas for workers who work in who work in regulated areas is the most a ‘‘prospective risk assessment.’’ This regulated areas. In addition, section effective method for preventing workers commenter believed that a simple log, 850.27(b)(1) requires that separate from carrying beryllium contamination only documenting who entered facilities be provided for workers to on their work clothes and bodies from regulated areas, would be sufficient. The change into and store personal clothing regulated areas to other areas of DOE intended function of these records is and clean protective clothing and facilities and to workers’ private clarified in section 850.39, equipment. DOE believes that such automobiles and homes. DOE is Recordkeeping and Use of Information. provisions are necessary to prevent unaware of any equally effective DOE believes that recordkeeping must cross-contamination between work and alternative method for achieving this be adequate to permit DOE to monitor personal clothing and the subsequent objective and, thus, has retained the the effectiveness of each responsible spread of beryllium into clean areas of change room and shower provisions in employer’s compliance activities and to the facility and into workers’ private the final rule. The economic burden provide information regarding each automobiles and homes. These may be lessened by steps employers worker’s history of potential exposures. provisions also address the need to already have taken to comply with This information will assist the prevent contamination of clean existing hygiene facility requirements. responsible employer’s occupational protective clothing and equipment, For example, 29 CFR 1910.120(n)(7) of medicine staff in establishing ensuring that protective clothing and OSHA’s Hazardous Waste Operations appropriate medical surveillance equipment actually protect workers and Emergency Response standard protocols and will aid in DOE’s efforts rather than contribute to their already requires employers to provide to establish links between working exposures. showers and change rooms for workers conditions and potential health Section 850.27(b)(2) requires that the on D&D operations of six months outcomes. DOE has retained the change-rooms used to remove duration or longer. DOE contractors at proposed regulated area recordkeeping beryllium-contaminated clothing and DOE sites are subject to this requirement requirements in section 850.26(d) of the protective equipment be maintained through their contracts, which require final rule. under negative pressure, or be located in compliance with DOE Order 440.1A or a manner or area that prevents other analogous Orders or standards. Section 850.27—Hygiene Facilities and dispersion of beryllium contamination Consistent with the goal of preventing Practices into clean areas. the spread of contamination into Section 850.27 of the final rule retains DOE received two comments on the adjacent work areas and into affected the NOPR requirements for responsible hygiene facilities and practices workers’ homes, section 850.27(c)(1) employers to provide change rooms or provisions of the NOPR. A commenter requires responsible employers to areas and hand washing and shower (Ex. 25) suggested that the requirement provide shower and hand-washing facilities for beryllium workers. In to provide change rooms, hand washing facilities for workers assigned to addition to these provisions, the final facilities, and showers be based on a regulated areas. In addition to rule also requires responsible employers hazard assessment. DOE believes that controlling the spread of contamination, to provide lunchroom facilities that are requiring responsible employers to showering also reduces the worker’s readily accessible to beryllium workers, perform a separate hazard assessment to period of exposure to beryllium by ensure that tables for eating are free of determine the need for change rooms removing any beryllium that may have beryllium, that no worker is exposed at and showers is unnecessary and overly accumulated on the skin and hair. any time at or above the action level, burdensome to responsible employers. Requiring workers to change out of work and specifies that all of these facilities The requirement for change rooms and clothes, which are segregated from their must comply with the requirements of showers is triggered by the requirement street clothes, and to shower before 29 CFR 1910.141. These hygiene to establish regulated areas. Regulated leaving the plant, leaving work clothing

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DOE recognizes that standards, including 29 CFR 1910.134, understanding how to set exposure the installation of such facilities may through contract provisions requiring limits for materials, such as beryllium, take time in some cases. Accordingly, compliance with DOE Order 440.1A and for which the cause of illness is the section 850.13(b) of the final rule allows its predecessor orders. DOE also has body’s immune system reaction; and (3) responsible employers two years to followed OSHA standards in to establish an internally consistent achieve full compliance with the implementing the Federal Employee CBDPP which includes consistent requirements of the rule. Occupational Safety and Health triggers for its protective provisions and, Section 850.27(d) requires responsible Program. DOE Order 440.1A requires therefore, is rational and easy to employers to provide beryllium workers employers to provide, and DOE workers communicate. DOE generally agrees working in regulated areas with readily to use, appropriate respiratory with these comments and has revised accessible lunchroom facilities in which protective equipment necessary to section 850.28 to require the use of tables for eating are free of beryllium protect workers from exposures to respirators when exposures are at or and no worker is exposed at any time hazardous substances. In addition, the above the action level. to a concentration of beryllium at or provisions of 29 CFR 1910.134 include One commenter (Ex. 3) was concerned above the action level. DOE believes a requirement that employers select that using the action level as a trigger for that it is imperative that workers have only NIOSH-approved respirators. DOE respiratory protection would render the a clean place to eat to reduce the Order 440.1A expands this requirement action level a de facto PEL, because likelihood of additional exposure to to allow for the use of DOE-accepted OSHA uses the PEL as the trigger for loose beryllium dust through inhalation respiratory protection if NIOSH- respiratory protection in OSHA or ingestion. approved respiratory protection does substance-specific standards. Similarly, not exist for a specific DOE task. The Responsible employers must also two commenters (Exs. 4, 20) believed provisions of section 850.28 that are that using the action level as a trigger for assure that workers in regulated areas new in this final rule are the respiratory protection signifies that DOE do not enter the lunchroom wearing requirements for the use of respiratory believes that the PEL is not adequately protective clothing unless the clothing protection: (1) at the action level (rather protective. Section I.C., Health Effects, is properly cleaned beforehand. than at OSHA’s PEL); (2) based on the of the Supplementary Information Responsible employers are given analyses of job activities (rather than section provides a detailed explanation discretion to choose any method for only on measured levels); and (3) when of the difficulties of determining a safe removing surface beryllium from the requested by beryllium-associated threshold level for occupational clothing that does not disperse the dust workers regardless of exposure level. exposure to beryllium, given the current into the air. These requirements are DOE does not expect that these new state of knowledge of occupational similar to the hygiene facilities and provisions will greatly increase the practices provisions in a number of number of workers who wear respirators exposures and the etiology of beryllium OSHA’s health standards. at DOE sites. Under current practice, disease. DOE’s strategy is to require a rigorous program to prevent chronic Section 850.28–Respiratory Protection DOE sites require use of respirators at their established action level (ranging beryllium disease by reducing and Section 850.28 establishes the from 0.2 to 1.0 µg/m3) rather than at the minimizing exposures, while studies respiratory protection requirements for PEL (see CBDPP Economic Analysis, continue that may provide the data the CBDPP. Section 850.28(a) requires Chapter 3, Section 3.2.8). needed to establish a safe level of that responsible employers comply with The NOPR (Section V, Request for exposure to airborne beryllium. The OSHA’s Respiratory Protection standard Information) requested comments on preamble discussions of sections 850.22 (29 CFR 1910.134). Section 850.28(b) changing the trigger for requiring and 850.23 explain in greater detail requires that responsible employers respiratory protection from the PEL to DOE’s rationale for continuing to defer provide appropriate respiratory the action level. Seven of the thirteen to OSHA’s PEL, while establishing a protective equipment for all workers commenters on respiratory protection more protective action level for DOE. exposed, or potentially exposed based (Exs. 16, 18, 23, 25, 26, 28, 30) One commenter (Ex. 26) upon task analyses, to airborne recommended that the rule be more recommended that the responsible concentrations of beryllium at or above protective of workers’ health by employer provide respiratory protection the action level. This section also requiring the use of respiratory when warranted based upon an analysis requires the responsible employer to protection at the proposed action level. of the worker’s job activities. DOE ensure that workers use respirators. None of the remaining four commenters recognizes that many tasks involving Section 850.28(c) requires the on this issue (Exs. 3, 4, 20, 31) beryllium may result in high responsible employer to include in the recommended retaining the PEL as a concentrations of airborne beryllium respiratory protection program any trigger. The seven supporters of using due to a procedure error, a work error, beryllium-associated worker who the action level as a trigger represent a or an equipment failure. An analysis of requests to use a respirator, regardless of wide variety of stakeholders. These the worker’s job activities will exposure level. Section 850.28(d) commenters’ predominant reason for determine whether respiratory requires that responsible employers recommending the more protective level protection is necessary for such tasks. select and use only National Institute for as the trigger is the uncertainty about Therefore, DOE added section Occupational Safety and Health the protection afforded by the current 850.28(b)(2) requiring responsible (NIOSH)-approved respiratory PEL. These commenters provided the employers to provide respiratory protective equipment or, if none exist following additional reasons for protection for task involving such for a DOE beryllium activity, DOE- lowering the respiratory protection circumstances.

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Two commenters (Exs. 26, 30) upon OSHA’s requirements in lieu of beryllium compounds apparently were recommended that the responsible making specific changes to the rule. not present within the DOE complex. employer provide respiratory protection One commenter (Ex. 4) recommended Section 850.29–Protective Clothing and when it is not otherwise required if excluding soluble beryllium from Equipment requested by a worker due to the section 850.29 based on that survey uncertainty about what is a safe level Section 850.29 establishes the result. However, as a result of other and uncertainties in monitoring and protective clothing and equipment public comments, DOE learned that that controlling a substance like airborne provisions (other than respirator use) of survey result was incorrect because one beryllium. DOE agrees with these the CBDPP. The objectives of this DOE commenter (Ex. 16) indicated that commenters and has added section section are to provide clothing and its facilities contain soluble beryllium. 850.28(c), which requires the equipment that protects workers against Moreover, other commenters (Exs. 26, responsible employer to provide the hazards of skin and eye contact with 30) pointed out that DOE facilities may respiratory protection upon the request dispersible forms of beryllium and to contain soluble beryllium in the future. of the beryllium-associated worker prevent the spread of contamination Nevertheless, DOE has not changed regardless of measured exposure levels. outside work areas that could occur the definition of ‘‘beryllium’’ in the final One commenter (Ex. 3) recommended from the improper handling of rule to include soluble forms of requiring respiratory protection for beryllium-contaminated clothing and beryllium, because the principal focus exposures at or above the STEL. DOE equipment. of this rule is on preventing CBD, which DOE has clarified the proposed agrees with the commenter that the is caused by exposure to insoluble forms requirement for the responsible STEL would have been an appropriate of beryllium. One commenter (Ex. 26) employer to provide protective clothing trigger for respiratory protection if the correctly pointed out that the skin and µ 3 and equipment where skin or eye action level had remained at 0.5 g/m . eye effects that this section is intended µ 3 contact with beryllium is possible. However, a STEL of 10 g/m for 15 to prevent are different health effects minutes, as proposed in the NOPR, Section 850.29(a) requires that responsible employers provide than CBD. Although another commenter would provide no added protection for (Ex. 25) questioned DOE’s view that workers as a trigger for respiratory protective clothing and equipment to beryllium workers where dispersible soluble beryllium exposure to the lungs protection in the final rule because its does not cause CBD, DOE finds no action level of 0.2 µg/m3 will be forms of beryllium may contact workers’ skin, enter openings in workers’ skin, or evidence in the information on health exceeded in less than 15 minutes where effects presented in section I.C. that exposure levels are at 10 µg/m3. As contact workers’ eyes. exposure of the lungs to soluble forms explained in the discussion of section The openings in workers’ skin could of beryllium causes CBD. DOE expects 850.22, DOE has decided that it would include fissures, cuts, and abrasions. responsible employers to address not be appropriate, given the current DOE recognizes that the potential for the soluble beryllium hazards in existing science, to establish a lower STEL in development of contact dermatitis, worker protection programs under DOE this rule. chronic ulcerations, and conjunctivitis DOE has clarified its expectations on is mainly associated with contact with Order 440.1 or analogous Orders or the use of DOE-accepted respirators in soluble forms of beryllium compounds standards cited in responsible response to one commenter (Ex. 31) who that are not included in the definition employers’ contracts with DOE. questioned the use of DOE-accepted of ‘‘beryllium’’ in this rule. Insoluble Section 850.29(a)(1) requires respirators rather than NIOSH-approved beryllium, however, has also been responsible employers to provide respirators. This requirement as shown to cause chronic ulcerations if protective clothing and equipment to proposed in section 850.28(c) could introduced into or below the skin via beryllium workers, at no cost, where have been interpreted, as it was by this cuts or abrasions (ref. 34). DOE believes airborne beryllium levels are measured commenter, to mean that responsible that it is prudent industrial hygiene or presumed to be at or above the action employers could choose between practice to avoid skin or eye contact level, because elevated airborne levels NIOSH-approved respirators and DOE- with a material that causes chronic are likely to generate elevated surface accepted respirators. This was not ulcerations and, therefore, has included levels which represent a skin and eye DOE’s intent. DOE’s revision in section protecting workers’ skin and eyes from hazard. DOE has included ‘‘presumed to 850.28(d)(2) clarifies that responsible contact with insoluble beryllium in be’’ in section 850.29(a)(1) in response employers may use the DOE-accepted section 850.29(a). The protective to a recommendation that one respirators only if NIOSH-approved equipment required by this section commenter (Ex. 26) made with respect respirators do not exist for particular could include coveralls, overalls, to respiratory protection that applies DOE tasks. This section also references jackets, footwear, headwear, face equally to protective clothing and DOE’s Respirator Acceptance Program shields, goggles, gloves, and gauntlets, equipment. The commenter to clarify that DOE only accepts for use depending on the nature of the recommended that the responsible respirators that DOE deems acceptable operation and the related skin and eye employer provide respiratory protection based upon the results of a formal exposure hazards involved. when warranted based upon task testing and evaluation program. In the NOPR, DOE requested analyses. DOE recognizes that many One commenter (Ex. 31) information regarding the presence of tasks involve beryllium that could recommended that the rule specify that soluble beryllium compounds within readily become airborne in high all respiratory protective equipment be the DOE complex and the concentrations due to a procedure error, furnished at no cost to the worker. appropriateness of the exclusion of such a worker error, or an equipment failure, Section 850.28(a) requires that compounds from the definition of but which will have no measurable responsible employers comply with 29 ‘‘beryllium’’ in the proposed rule. In exposure level unless one or more of CFR 1910.134, Respiratory Protection, addition, DOE requested comments these problems occur. DOE believes that which currently requires in section regarding the need for the protective an analysis of the worker’s job activities 1910.134(c)(4), that employers provide clothing and equipment provisions of would show the need for protective respirators at no cost to the employee. proposed section 850.29(a)(2), given a clothing and equipment, and respiratory Accordingly, DOE will continue to rely DOE survey that had found that soluble protection to perform such activities.

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Another commenter (Ex. 3) worker, regardless of measured property. A recent study (ref. 35) has recommended that DOE add a surface exposure levels. documented the transport from work contamination level that would also Section 850.29(b) incorporates into areas of beryllium on workers’ hands trigger the requirement to provide this rule 29 CFR 1910.132, Personal and inside their personal vehicles. protective clothing and equipment. DOE Protective Equipment General One of DOE’s objectives is to prevent agrees with this commenter because Requirements. This OSHA standard is the spread of beryllium contamination, elevated surface levels represent a skin responsive to a commenter’s (Ex. 31) thereby reducing the number of persons and eye hazard, and, accordingly, DOE recommendation that the rule should exposed and the opportunities for has added paragraphs (a)(2) and (a)(3) to require the responsible employer to potential exposures. Thus, sections this section. Section 850.29(a)(2) furnish the clothing and equipment at 850.29(d) through (f) establish requires responsible employers to no cost to the employee, and covers provisions to control the handling, provide protective clothing and other well-established practices, such as maintenance, cleaning, and disposal of equipment to beryllium workers where the topics to be included in protective beryllium-contaminated protective surface contamination levels are clothing and equipment training, and clothing and equipment. measured to be, or prior to initiating ensuring that protective clothing and Section 850.29(d) requires the work are presumed to be, above the equipment fits properly. This responsible employer to ensure that housekeeping level prescribed in requirement to comply with 29 CFR workers do not remove beryllium- section 850.30. Section 850.29(a)(3) 1910.132 is consistent with the general contaminated protective clothing and requires responsible employers to worker protection provisions of DOE equipment from areas that contain provide protective clothing and Order 440.1A, and analogous Orders or beryllium, except for authorized equipment to beryllium workers where standards cited in the responsible activities such as cleaning and repairing surface contamination level results employer’s contract with DOE. the clothing and equipment. DOE obtained to confirm housekeeping Section 850.29(c)(1) requires the replaced ‘‘site’’ in the proposed rule efforts are above the prescribed responsible employer to establish with ‘‘area that contains beryllium’’ in housekeeping level. procedures for donning, doffing, the final rule to clarify its intent to Section 850.29(a)(2) addresses the handling, and storing protective minimize contamination of other areas situation in which the responsible clothing and equipment that prevent at the site as well as outside the site. employer is planning to conduct a task beryllium workers from exiting areas Section 850.29(e) requires the involving beryllium and has time to that contain beryllium with responsible employer to prohibit the measure or estimate surface levels contamination on their bodies or their removal of beryllium from protective before the task begins. Section personal clothing. DOE added this clothing and equipment by blowing, 850.29(a)(3) addresses the situation in provision because one commenter (Ex. shaking, or other means that may which the responsible employer learns 3) correctly pointed out that it was disperse beryllium into the air. from routine surface monitoring omitted in the proposed rule and is Although DOE generally believes that conducted at the end of a shift that needed to ensure that workers do not responsible employers should have the housekeeping efforts did not reduce track contamination out of areas that flexibility to determine the most surface levels to below the surface contain beryllium. The same commenter appropriate means to clean contamination level specified in section recommended that DOE explicitly contaminated clothes based on their 850.30. DOE recognizes that sampling to require HEPA vacuuming of own specific worksite conditions, DOE confirm the adequacy of housekeeping contaminated protective clothing and has included this well recognized and efforts at the end of shifts, and the equipment as part of the required accepted industrial hygiene control to turnaround time of as much as 24 hours doffing procedure. This final rule does prevent the dispersion of beryllium for sample analysis, could result in not include a requirement to include particles into the workplace workers not using protective clothing HEPA vacuuming in doffing procedure, atmosphere. and equipment for more than a day because DOE believes that this would Section 850.29(f), which was where surface contamination levels not allow the employer sufficient proposed as section 850.29(c), requires exceed the prescribed surface flexibility in selecting cleaning responsible employers to clean, launder, contamination level. However, DOE procedures. repair, and replace protective clothing believes that these situations will be Section 850.29(c)(2) requires that the and equipment as needed to ensure its rare, because routine post-shift cleaning procedures for donning, doffing, continued effectiveness in protecting should keep these surface handling, and storing protective workers. This section allows contractors contamination levels from becoming clothing and equipment include a flexibility in determining the required excessive. Also, DOE believes that requirement that beryllium workers frequency for laundering protective responsible employers will be motivated exchange their personal clothing for clothing based on specific work to reduce turnaround times for analyses full-body protective clothing and conditions and the potential for in their efforts to reduce and minimize footwear (work shoes or booties) before contamination. exposures. DOE selected the term beginning work in regulated areas. This Section 850.29(f)(1), which was ‘‘results’’ in section 850.29(a)(3) to avoid change from personal clothes into proposed as section 850.29(b), creating a situation in which the protective work clothing must occur in paragraphs (1)–(2), requires the responsible employer would violate the a change room that protects the worker’s responsible employer to ensure that rule simply because the employer did personal clothes and clean protective protective clothing and equipment not know that the housekeeping clothing from beryllium contamination. removed for laundering, cleaning, criterion had been exceeded until DOE believes that the use of full-body maintenance, or disposal, is placed in surface monitoring results were protective clothing in lieu of personal containers that prevent the dispersion of available. clothes in regulated areas is necessary to beryllium dust, and that these Section 850.29(a)(4) requires the prevent the spread of beryllium containers are labeled in accordance responsible employer to provide contamination into adjacent work areas with section 850.38. These warning protective clothing and equipment upon and to preclude the possible transport of labels will help ensure appropriate the request of the beryllium-associated beryllium onto affected workers’ private subsequent handling of beryllium-

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In section forms of beryllium compounds at the and re-suspension of dust during 850.29(f)(1) of the final rule, DOE has final rule’s lower action level is likely housekeeping activities. deleted the words ‘‘impermeable’’ and to result in greater use of protective Two commenters (Exs. 26, 28) ‘‘are designed’’ which were in proposed clothing and equipment, including questioned the scientific basis for µ 2 section 850.29(b)(1) in response to a respirators, and consequently greater establishing a 3 g/100 cm surface commenter’s (Ex. 8) recommendation to potential for heat stress. DOE believes removable contamination level. In clarify DOE’s intent. This change that the health benefit from lowering the addition, these two commenters stated eliminates the possible implication that risk of CBD outweighs any increased that the variability associated with wipe DOE expects responsible employers to health risk caused by heat stress that sampling makes surface sampling provide special containers even if results from the requirements of this method an unreliable method for existing containers are capable of section. DOE has not included heat sampling. DOE views wipe sampling as preventing the spread of contamination. stress provisions in this rule because it a useful and accepted method for Section 850.29(f)(2), which was is a potential problem for many DOE providing qualitative information on proposed as section 850.29(d), requires activities that require the use of chemical contamination of work the responsible employer to ensure that protective clothing and equipment; and surfaces, and agrees with the following statement in the OSHA Technical organizations that launder or clean DOE DOE expects heat stress issues to be Manual (Section II: Chapter 2, Sampling beryllium-contaminated protective addressed in the responsible employer’s for Surface Contamination): ‘‘Wipe clothing or equipment are informed that existing worker protection program. sampling is an important tool of work exposure to beryllium is potentially Section 850.30—Housekeeping site analysis for both identifying harmful, and that clothing and hazardous conditions, and in evaluating equipment should be laundered or Section 850.30 establishes the the effectiveness of * * * cleaned in the manner prescribed by the housekeeping provisions of the CBDPP. housekeeping, and decontamination responsible employer to prevent the Good housekeeping practices are programs.’’ Accordingly, this release of airborne beryllium. DOE necessary in operational areas where requirement is intended only as a replaced ‘‘any individual’’ with beryllium is used or handled, to prevent housekeeping performance measure, ‘‘organizations’’ to clarify that DOE’s the accumulation of beryllium and should not be viewed as a objective for this section is to ensure contamination on surfaces throughout mechanism for measuring, or predicting that any organization that launders the workplace. Such accumulations, if airborne concentrations of beryllium. In beryllium contaminated clothing is not controlled, may lead to the spread addition, this requirement only applies informed of the hazards of handling of beryllium contamination on surfaces to removable or loose surface beryllium contaminated items so that and the re-suspension of beryllium contamination, which could become re- the organization can take steps to particles into the air, both in the area suspended in the workplace air or protect its workers. The proposed where beryllium dusts were originally spread to non-controlled areas. wording ‘‘any individual’’ could have generated and in other work areas. In DOE does not intend the requirement been interpreted as establishing a direct addition, the uncontrolled accumulation for surface wipe sampling in this rule to relationship between the responsible of beryllium-contamination on preclude the use of other surface employer that generated the equipment in the workplace increases sampling methods for measuring contaminated clothing and the the potential for worker exposure to beryllium contamination. DOE agrees employee of the laundry or cleaning beryllium during the performance of with comments calling for more organization, which is not DOE’s intent. equipment maintenance, handling, and research (Exs. 16, 28) and encourages Also, DOE clarifies in section disposal tasks. the use, research, and development of 850.29(f)(2) that this section requires DOE in section 850.30(a) has new technologies such as direct reading informing both on-site cleaning and established that the removable instruments, which may provide better laundry services, as well as off-site contamination housekeeping level on results than wipe sampling. cleaning and laundry vendors. On-site surfaces must not exceed 3 µ/100 cm2 Section 850.30(a) requires that cleaning and laundry services are during non-operational periods. responsible employers conduct routine covered by this rule, but may not know Establishing a surface removable surface sampling in operational areas, to about the presence and hazards of contamination limit reduces the ensure the effectiveness of their beryllium on the clothing and potential for spread of beryllium housekeeping efforts. This sampling equipment unless the responsible contamination. Responsible employers would not include the interior of employer informs them. must perform measurements to installed closed systems such as DOE has deleted the words ‘‘at or determine if the operational work area enclosures, glove boxes, chambers, or above the action level or above the is in compliance with the rule. In ventilation systems. Sampling should STEL,’’ which in proposed section addition, monitoring surface not be carried out during a normal work 850.29(a) qualified the requirement to contamination levels is an shift, but rather it should be undertaken inform downstream launderers or indispensable tool for ensuring that after normal clean-up and during non- cleaners of beryllium-contaminated beryllium emissions from operations are operational periods. protective clothing and equipment. This under control. The only practical Affected sites throughout DOE have change is consistent with final section method of monitoring surface levels is already established, under the interim 850.25, which requires reduction and to maintain the surface contamination at CBDPP, allowable beryllium surface minimization, if practicable, where an established housekeeping level so contamination levels to ensure the

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Therefore, immediate environment outside of regulated areas. possible to maintain surface levels of adoption of the NIOSH method at sites Comments on the NOPR called for beryllium in an operational work area across DOE may be impractical and add setting levels ranging from less than 1 below the 3 µg/100 cm2 limit at all no immediate value to worker health µg/100 cm2 (Exs. 14, 18) to 5 µg/100 cm2 times. Again, the surface removable and safety. In the long term, by (Ex. 24). Information collected from the contamination level is intended as a recommending a single method (a wet sites during the development of the post-shift measure of the effectiveness of method) for conducting the surface interim beryllium CBDPP indicated that routine housekeeping efforts. sampling, DOE believes that the the Pantex and Y–12 facilities currently DOE emphasizes that the variability associated with surface have an allowable surface concentration housekeeping concerns addressed by sampling will be reduced without level of 25 µg/100 cm2 for regulated section 850.30 apply to areas where specifying a particular method in the areas. Los Alamos National Laboratory workers may be exposed to beryllium, rule. (LANL) procedures call for re-evaluation not to closed-off rooms or buildings. To One commenter (Ex. 3) suggested that of the operations with additional make this clear, DOE has added the term the term ‘‘routine’’ in section 850.30(a) cleaning of beryllium operations areas at ‘‘operational areas’’ in section 850.30(a). should be more clearly defined, i.e., levels greater than 26 µg/ft2 (2.8 µg /100 If routine surface sampling during non- weekly or monthly. Because DOE cm2). Lawrence Livermore National operational or post-shift periods shows believes that this rule should be as Laboratory (LLNL) indicated those areas that the removable contamination level performance-based as possible, the with surface concentrations greater than has been exceeded, clean-up measures frequency of ‘‘routine’’ monitoring 3 µg/100 cm2 are designated as regulated must be instituted. procedures under this section should be areas. Rocky Mountain Remediation DOE agrees with the comment (Ex. 28) developed by the local health and safety Services (a sub-contractor at Rocky that the meaning of the term specialist (industrial hygienist) based on Flats) indicated that a surface ‘‘removable’’ contamination may not be the specific circumstances at the site. contamination level greater than 25 µg/ clear. Therefore, DOE has added a new Section 850.30(b) prohibits the use of ft (2.7 µg/100 cm2) outside of regulated definition of ‘‘removable compressed air or dry methods and areas triggers clean up actions at its site. contamination’’ and deleted the requires the use of vacuuming, wet or The AWE facility at Cardiff (United definition of ‘‘surface contamination’’ in similar methods for the cleaning of Kingdom) has utilized a surface action section 850.3. The definition of beryllium-contaminated floors and other level of 10 µg/ft2 (1 µg/100 cm2) outside ‘‘removable contamination’’ is taken surfaces. The purpose of using these of regulated areas since 1990. Based on from the U.S. Department of Energy methods is to reduce or eliminate the this range of data, DOE adopted the 3 Radiological Control Manual (DOE/EH– potential for re-suspension of beryllium µg/100 cm2 housekeeping level in the 0256T Revision 1, April 1994). Use of dust into the air and breathing zone of proposed rule and continues to believe this language in this rule maintains a the worker. it is a reasonable surface removable consistent approach with DOE’s One commenter (Ex. 23) requested contamination level that should not be radiological surface sampling program. flexibility in cleaning methods, such as exceeded. Two commenters suggested the use of permitting the use of sticky tack cloths. One commenter (Ex. 3) recommended wet wipes for surface sampling, while DOE agrees with the comment and in that the surface removable another commenter (Ex. 24) indicated the final rule has allowed the use of contamination level be the same level as that there is no basis for the application other cleaning methods, such as sticky the criterion for releasing contaminated of a wet method. NIOSH, in its recent tack cloths, that have the same end equipment for other uses. Another publication on beryllium contamination result as wet vacuuming (i.e., a commenter (Ex. 23) objected to inside worker vehicles, supports the use reduction of dust-producing cleaning establishing a single surface limit for of a wet wipe sampling method to methods). These are appropriate removable beryllium contamination that collect beryllium samples in potentially methods for complying with the would be both a housekeeping and contaminated employee vehicles (ref. housekeeping requirement of the rule. release level, recommending instead a 35). Section 850.30(c) requires the use of tiered approach, with different levels for The use of diverse sampling methods HEPA filters in all vacuuming normal or safe work conditions (and free (e.g., differences in type of sample operations used to clean contaminated release of equipment), for beryllium media, type of solvent (if any) on the or potentially contaminated surfaces, work, and for special work conditions. sample media, area sampled, etc.) may and further requires filter replacement For the reasons discussed under section easily lead to the reporting of as needed, to maintain the capture 850.31, Release Criteria, DOE has inconsistent results. To reduce the efficiency of the vacuum system. The adopted different levels for the release variability in reported surface use of wet methods for reducing or of equipment that depend on the contamination across the DOE complex, minimizing the dispersal of dust during intended future use of the equipment. DOE recommends, but does not require, general housekeeping tasks, such as One commenter (Ex. 24) expressed the use of a single sampling method: sweeping, is a common industrial concern that certain beryllium oxide NIOSH method 9100 (NIOSH Manual of hygiene practice. HEPA filters must be weapons components could not meet Analytical Methods, 4th Edition, August used to prevent the spread of dust by the 3 µg/100 cm2 level, and 15, 1994, Lead in Surface Wipe effectively collecting the dust that is recommended that weapons Samples). This method may have to be collected by vacuum systems. components be exempt from surface modified for surfaces smaller than 100 Responsible employers should have contamination limits. DOE has revised cm2 using a procedure such as that procedures for the cleaning or section 850.30 to clarify that the surface described in Appendix D of 10 CFR part replacement of filters that ensure

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To prevent the criterion for release to the public and items, the nature of the beryllium potential spread of contamination from DOE non-beryllium facilities and to contamination, and whether exposure to the performance of housekeeping beryllium-handling facilities because it beryllium is foreseeable. activities required by this rule, section would be simpler to administer. DOE In the notice of reopening, DOE 850.30(d) requires that cleaning does not agree with these comments, referenced a comment by the AWE (Ex. equipment used in areas where surfaces because the workers in operational areas 1) which reported that the housekeeping are contaminated or potentially where beryllium is used have been surface action level in its Cardiff, Wales contaminated with beryllium be labeled, trained in the hazards of beryllium and facility had been reduced to 1 µg/ft2 controlled, and not used for other, non- the proper use of protective equipment (about 0.1 µg/100 cm2) in 1990. DOE hazardous materials. These procedures that is required to be worn in those reasoned that, based on the AWE are similar to those required under areas. DOE does not believe that the experience and release limits included OSHA’s asbestos standard for general population or DOE non- in DOE facilities’ interim CBDPPs, a equipment used during cleanup or beryllium workers should be exposed to public release limit as low as 0.1 µg/100 removal of asbestos from buildings. the same level of a hazardous material cm2 would be achievable. Several as workers who have been trained in the commenters (Exs. 41, 43, 46, 47, 51) Section 850.31—Release Criteria safe handling of that material. DOE, argued that this level would be difficult Section 850.31 establishes beryllium therefore, has included in the rule and costly to achieve, and that there is contamination levels and other separate requirements for the release of no technical basis for concluding that it requirements that must be met before beryllium-contaminated equipment and would be more beneficial than a higher equipment and other items used in other items to facilities engaged in level. AWE (Ex. 38) commented that it beryllium work areas may be released or beryllium work and for releases to the is not using 0.1 µg/100 cm2 as a release transferred to the general public and general public or DOE non-beryllium level; its current policy is to dispose of non-beryllium areas of DOE facilities, or facilities. contaminated items in a landfill site. Section 850.31(a) requires the to facilities engaged in work involving The Pantex Plant (Ex. 46) stated that its responsible employer to clean beryllium. DOE requested comments on reported use of 0.1 µg/100 cm2 as a beryllium-contaminated equipment and the setting of ‘‘beryllium free-release’’ release criterion was incorrect, possibly other items to a contamination level that public contamination levels in the due to a typographical error, and it is as low as practicable, but not to NOPR. After considering the comments recommended using 3 µg/100 cm2 for exceed the removable contamination received in response to this broad the public release limit. Rocky Flats (Ex. levels specified in section 850.31(b), for request for views and information, DOE 47) pointed out significant differences release to the general public or to non- reopened the comment period on June between the AWE Cardiff facility, which beryllium areas of DOE facilities, and 3, 1999, to invite public comment on section 850.31(c), for release to facilities is a stable work environment, and the specific options for release criteria that performing work with beryllium. In Rocky Flats facility, which is engaged in were being considered by DOE (64 FR addition, DOE has included in these decontamination and decommissioning 29811). Section 850.31 reflects DOE’s sections other requirements that are work. Two commenters (Exs. 43, 46) consideration of the substantial number designed to protect workers and others argued that a surface removable µ 2 of comments received from from the hazards associated with contamination level of 0.1 g/100 cm organizations and individuals on this exposure to beryllium. DOE uses the could easily be exceeded by background topic. words ‘‘and other items’’ after levels of beryllium. In the notice of reopening of the ‘‘equipment’’ in section 850.31(a) to Other commenters (Exs. 44, 45, 48, comment period, DOE suggested that a cover tools, supplies, documents, etc., 49) took the position that any detectable reasonable contamination level for and any personal property in beryllium- level of beryllium on the surface of an release of equipment and other items to handling areas that may not be item should be presumed to present a the public for non-beryllium uses would encompassed by the term ‘‘equipment.’’ health risk and, therefore, that no item µ 2 be 0.1 g/100cm . This level was based The phrase ‘‘equipment and other having a detectable level of beryllium on the housekeeping and release levels items’’ does not include real property or should be released to anyone for any believed to be in effect at various DOE buildings. purpose. One commenter (Ex. 48) stated facilities and the AWE facility in the Release to the public and for use in that the correlation between surface United Kingdom. DOE also stated that it DOE non-beryllium areas. Section beryllium levels and associated health was inclined to adopt a contamination 850.31(b)(1) sets the removable hazards is unknown, and the possibility level of 3 µg/100 cm2 for release of items contamination level for equipment and exists for fixed or inaccessible beryllium for beryllium work in other facilities. other items to be released to the general to be liberated when equipment is This level was based principally on the public or for use in DOE non-beryllium worked on or repaired. Another practice at the Rocky Flats. work areas at 0.2 µg/100cm2 or the commenter (Ex. 49) stated that DOE Ten organizations and individuals concentration level of beryllium in soil should take a cautious stance because of submitted comments that recommended at the point of release, whichever is the current lack of information release level values. These values higher. The equipment also must be regarding the nature of the exposure- ranged from non-detectable to 3 µg/100 labeled, in accordance with section response relationship and the factors cm2 for public release and non- 850.38(b), to warn recipients of that underlie individual sensitization detectable to 10 µg/100 cm2 for release potential beryllium hazards. The towards beryllium. Two commenters to beryllium facilities. responsible employer must condition (Exs. 49, 52) recommended life-cycle

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Section considers the downstream user’s Hazardous Air Pollutants (NESHAP) 850.31(c)(1) sets the contamination level exposure potential, the history and type limit of 0.01 µg/m3 and therefore, at safe for equipment or other items released of equipment, and the nature of the levels. EPA’s NESHAP is the national for use in other facilities engaged in contamination, in order to decide standard for community air that the beryllium work at 3 µg/100 cm2. The whether and how to release equipment population continuously breathes. equipment or item also must be labeled and other items for non-beryllium uses. DOE has addressed the concerns of in accordance with section 850.38(b). As recognized by DOE in the reopening commenters (Exs. 46, 50) that it may not Section 850.31(c)(3) requires the notice, surface or wipe sampling is not be possible to clean equipment and responsible employer to ensure that a an adequate means of characterizing other items to below the natural released item is enclosed or placed in potential exposure risk. For example, a background of beryllium in local soil. It sealed, impermeable bags or containers lathe or other piece of equipment is highly unlikely that this rule would to prevent exposure to beryllium during released because it is determined to be apply to soil because soils generally handling and transportation to its beryllium-free on the surface may contains less than 0.1 percent beryllium destination. Enclosure of equipment and contain internal beryllium dust that and, therefore, is not considered other items to be released to other could become airborne and present a beryllium for the purposes of this rule. beryllium operations can be health hazard during future Nonetheless, DOE included in section accomplished by any practical means, maintenance. On the other hand, other 850.31(b)(3) the words ‘‘or the such as wrapping in plastic. types of equipment may contain internal concentration level of beryllium in local Several commenters recommended beryllium that is combined with other soil at the point of release’’ to eliminate that DOE establish a higher surface substances (e.g., grease) which would the possibility that the rule would contamination release level for make it unlikely that the beryllium compel a responsible employer to clean equipment and other items to be would ever become airborne. The local soil off of equipment and other transferred to another facility for presence of this type of suspended items before release. beryllium work than is allowed for contamination, even at levels above the DOE does not agree with the view of items released to the public or for use surface release criterion, would not some commenters that, in the absence of in DOE non-beryllium work (Exs. 38, 41, necessarily present a health hazard. scientific evidence of a threshold or 42, 46, 51). Surface contamination levels Accordingly, an assessment of potential ‘‘safe’’ level of exposure to beryllium, recommended by the commenters (see risk of exposure should be undertaken the surface contamination release level Table 9) for release of equipment and before the release of any equipment or should be at the limit of detection or other items to be used in beryllium other item to either the general public zero. Although one commenter (Ex. 45, areas range from 0 and non-detectable to or to DOE for non-beryllium uses. Based 45B) submitted information indicating 10 µg/100 cm2. Rocky Flats (Ex. 47) upon the assessment, the decision that re-suspension of beryllium in the previously established a release level for should be made as to ultimate air is possible on surfaces with less than equipment and other items to be disposition of the equipment and any 1.0 µg/100 cm2 of beryllium, there transferred to other DOE facilities for conditions that should be placed on its currently is no scientific evidence that beryllium work at 2.5 µg/100 cm2. future use. surfaces cleaned to that level would Several commenters (Exs. 41, 42, 51) After considering the comments, DOE result in airborne concentrations of and a number of the DOE sites reporting is persuaded that it would be costly, if beryllium at levels that would be release levels support the use of 3 µg/ not infeasible, to implement a harmful to workers. 100 cm2 or less as a release level for contamination level of 0.1 µg/100 cm2 DOE has addressed the concern about equipment and other items that will be or lower as the public release criterion. the potential for exposure to re- used for beryllium work. Section 850.31(a)(1) requires suspended beryllium by requiring a Based upon current surface sampling responsible employers to clean case-by-case assessment of risk before technology, DOE sees no appreciable equipment and other items to the lowest equipment and other items are released difference between 2.5 µg/100 cm2 and contamination level practicable and to for non-beryllium uses. There is likely 3 µg/100 cm2 and, therefore, has ensure that removable contamination on to be wide variation in these situations, adopted the 3 µg 100 cm2 value for surfaces does not exceed 0.2 µg/100 cm2 and DOE is not prepared at this time to release of equipment and other items to or the concentration level of beryllium prescribe uniform management controls. other facilities for beryllium work. in local soil. This removable However, this is an area for which DOE Adoption of this value also maintains a contamination criterion is based, in may develop guidance to assist field consistency with the housekeeping large measure, on information provided elements, as experience is gained under requirements for operational beryllium in comments submitted by the this rule. areas, which will simplify contractor that manages the Rocky Flats One commenter (Ex. 43) implementation by DOE facilities. facility (Ex. 47). To comply with the recommended establishing a general Other issues. One commenter (Ex. 51) interim CBDPP established by DOE surface release level of 1 µg/100 cm2, recommended that the rule specify that Notice 440.1, Rocky Flats conducted an plus labeling of items. The commenter an industrial hygienist should extensive site characterization (over suggested the use of labels to shift determine the number and location of 6000 samples) using 0.2 µg/100 cm2 as responsibility for controlling future swipe samples. DOE views the the target contamination level. Rocky exposures to the recipients of the determination of the number and Flats reported that they found the 0.2 equipment or items. DOE does not location of swipe samples to be part of µg/100 cm2 to be an achievable level believe that simply cleaning the outside the hazard assessment, which must be and determined (using recently of the equipment and other items and managed by a qualified individual such published re-suspension factors) that providing warning to the new user is as a CIH (see discussion for section any airborne beryllium generated from adequate because some recipients, 850.21).

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Two commenters (Exs. 49, 50) were waste disposal provisions are necessary for protection of such equipment and concerned with dermal exposures to to prevent the re-suspension of items. Accordingly, beryllium- beryllium. DOE agrees that there is a beryllium contamination into the contaminated materials that are potential health hazard associated with workplace atmosphere. Warning labels classified must be handled in dermal exposure to beryllium, and has are necessary to ensure that workers are accordance with the governing national imposed requirements under sections aware that bags, containers, or security regulations, standards, and 850.29 and 850.37 to protect workers enclosures contain beryllium so that policies. Responsible employers also handling beryllium. The hazards they can take appropriate precautions. must dispose of such materials in associated with dermal exposures also Furthermore, responsible employers accordance with the provisions of this are dealt with in the DOE facilities’ must comply with applicable Federal, rule. health and safety programs under DOE state, and local regulations governing Section 850.33—Beryllium Emergencies Order 440.1A or, analogous Orders or the management, transportation, and standards cited in responsible disposal of waste that contain Section 850.33 (proposed as section employers’ contract with DOE. beryllium. 850.32) establishes the beryllium-related DOE received two comments emergency provisions of the CBDPP. Section 850.32—Waste Disposal regarding the waste disposal provisions Such provisions are particularly Section 850.32 (proposed as section of the NOPR. One commenter (Ex. 31) important in light of the possibility, 850.31) establishes the waste disposal applauded DOE for including waste suggested by several commenters, that a provisions of the CBDPP. Like many of minimization principles as a control single, high-level beryllium exposure the provisions of the rule (e.g., regulated measure for reducing beryllium may have been the cause of CBD areas, protective clothing and exposures. This commenter suggested occurring among several workers equipment, and housekeeping), the that DOE consider developing a non- thought to have had no exposure or only waste disposal provisions are designed mandatory appendix to the rule or incidental, low-level exposures to to minimize the spread of beryllium stand-alone guidance to illustrate waste beryllium. contamination throughout the facility or minimization principles and provide Proposed section 850.32 would have beyond the sites boundaries. ideas for workers and employers. DOE established broad performance-based DOE believes that the most effective recognizes the utility of non-mandatory provisions requiring responsible way to control the spread of guidance in assisting responsible employers to develop procedures for contamination resulting from waste employers in implementing certain responding to and alerting workers to disposal activities is to prevent or mandatory requirements of the CBDPP. beryllium emergencies, to ensure the minimize the generation of beryllium DOE notes, however, that the U.S. availability and use of appropriate waste. Accordingly, section 850.32(a) of Environmental Protection Agency and protective equipment during related the final rule requires responsible other Federal agencies have already cleanup operations, and to provide employers to employ waste developed a wide variety of guidance emergency response workers with minimization principles in conducting materials addressing waste appropriate training on proper response beryllium activities. Good housekeeping management, waste minimization, and procedures. practices, required by section 850.30, pollution prevention principles and Two commenters (Exs. 11, 31) aid in this effort by continually practices. Not only are these guides responded to the proposed beryllium removing beryllium dust accumulations readily available to the DOE emergencies section, and both requested from work surfaces, thereby reducing community, but many DOE sites have that DOE provide additional guidance the level of contamination of workplace used these guides to develop their own regarding beryllium emergency equipment. The performance of hazard hazardous waste management plans. For procedures, training, and personal analyses on operations with the this reason, DOE believes that the protective equipment requirements. One potential to generate wastes, as required development of an additional guidance commenter (Ex. 31) suggested that this by section 850.21, can help responsible document to address waste guidance was needed to ensure a employers identify potential sources of minimization principles for the final consistent and coordinated response to wastes and evaluate possible controls CBDPP rule is not necessary. DOE is beryllium emergencies in cases in that could be implemented to prevent or developing an implementation guide for which workers from different employers reduce waste generation. Other waste the CBDPP rule that will provide respond to the same event. Both minimization practices, such as general guidance for disposal of commenters suggested that DOE minimizing the equipment and material beryllium waste. consider incorporating elements of the that is exposed to beryllium The other commenter (Ex. 18) emergency response provisions of contamination, will also assist in suggested that the waste disposal OSHA’s Hazardous Waste Operations reducing the amount of material that provisions should address the and Emergency Response standard (29 must be disposed of as beryllium or declassification of beryllium parts that CFR 1910.120) in the CBDPP rule. beryllium-contaminated waste, thus are classified for national security DOE agrees with the commenters, and reducing the potential beryllium purposes at certain DOE sites. This notes that the beryllium emergencies exposure hazards. section of the final rule requires provisions of the NOPR were not Section 850.32(b) of the final rule responsible employers to control the intended to supersede the applicable requires responsible employers to generation of beryllium-containing provisions of 29 CFR 1910.120. dispose of beryllium-containing waste, waste, and beryllium-contaminated Accordingly, to avoid confusion and and beryllium-contaminated equipment equipment and other items that are duplicative efforts and to ensure and other items that are disposed of as disposed of as waste and to dispose of consistent and coordinated responses to waste, in sealed impermeable bags, this equipment and other items in a safe beryllium emergencies at DOE facilities, containers, or enclosures that are manner. DOE does not intend for these DOE has revised the beryllium labeled in accordance with section provisions to alter or affect the emergencies section (renumbered 850.38. Enclosure can be any practical classification of beryllium-contaminated section 850.33 in the final rule) to mechanism for sealing, such as equipment and other items, nor to require responsible employers to wrapping in plastic. DOE believes these supersede the applicable requirements comply with 29 CFR 1910.120(l) for

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Accordingly, responding to, emergencies involving participation in the medical provisions for anonymous testing are beryllium in the DOE implementation surveillance program, DOE in the NOPR not included in the final beryllium rule. guide for this rule. requested interested parties to comment Section 850.34(a)(1) requires on the feasibility and utility of responsible employers to establish and Section 850.34—Medical Surveillance including anonymous testing as a implement a medical surveillance Section 850.34 (proposed as section provision in the final rule. In requesting program for beryllium-associated 850.33) establishes the medical public comment, DOE noted two workers. DOE adheres to its view that surveillance provisions of the CBDPP. concerns it had regarding the use of participation in the medical These provisions are aimed at: (1) anonymous testing; specifically, surveillance program should not be Identifying workers at higher risk of concern about DOE’s inability to mandatory for workers. The responsible adverse health effects from exposure to correlate collected exposure data to employer’s obligation is to offer to beryllium; (2) preventing beryllium- health outcomes for workers choosing provide the medical tests and induced disease by linking health anonymous testing, and concern about procedures as required. DOE expects outcomes to beryllium tasks; and (3) the effect of anonymous testing on that where worker confidence in the making possible the early treatment of DOE’s ability to conduct follow-up tests medical program exists, refusal to beryllium-induced disease. to confirm positive Be-LPT results. participate will be minimal. Several changes have been made to Eight commenters (Exs. 4, 16, 17, 23, The term ‘‘beryllium-associated the medical surveillance provisions as 26, 28, 30, 31) responded to DOE’s worker’’ is used in the final rule where proposed. These changes include request for information regarding DOE has determined that coverage of enlarging the scope of the covered anonymous testing. Most commenters provisions should not be limited to population to include former beryllium stated that anonymous testing would current workers regularly employed in workers who are still employed at DOE not provide significant additional DOE beryllium activities. Use of the facilities in non-beryllium work; adding benefits or protection for workers. In term ‘‘beryllium-associated worker’’ will the term ‘‘beryllium-associated worker,’’ addition, all of the commenters shared increase the population eligible to which includes all current workers who DOE’s concerns regarding the resulting receive medical surveillance by have or had the potential for exposure inability to correlate collected exposure including current workers with past to beryllium; adding a multiple and data to health outcomes, and the beryllium exposures or potential for alternate physician review process; difficulty of tracking employees for exposures. deleting the requirement that exposure follow-up testing to confirm positive Numerous commenters (Exs. 2, 3, 4, be at or above the action level before results. The commenters believed that 14, 16, 17, 28, 30, 29, 31) made initiating medical surveillance; and these two drawbacks overshadow any recommendations regarding the level of deleting the requirement for Office of potential increase in worker employee exposure that should trigger Environment, Safety and Health review participation. worker participation in the medical of the written medical surveillance One commenter (Ex. 17) expressed surveillance program. Two of these program. In addition, DOE has made concern that the use of anonymous commenters (Exs. 3, 4) objected to editorial changes to clarify various testing would limit the employer’s offering medical surveillance to all provisions. ability to provide support to workers workers potentially exposed to The medical surveillance program is receiving medical surveillance. This beryllium. However, their reasons for designed to ensure the prompt commenter noted that ongoing support not wanting to include all potentially identification, and makes possible the and reassurance is essential for those exposed workers differed. One proper treatment, of workers who workers with positive or inconclusive commenter (Ex. 3) stated that placing all become sensitized to beryllium or test results. Three commenters (Exs. 16, potentially exposed employees in the develop CBD. In addition to 23, 26) stated that medical surveillance medical surveillance program would be determining the incidence of CBD in the should be used to determine workplace inconsistent with the permissible workforce, the medical surveillance exposures and evaluate the effectiveness exposure limit. The other commenter program fulfills a critical information of workplace controls. These (Ex. 4) was concerned with the costs development function, including commenters believe that anonymous associated with such a strategy, and the identifying the risk factors associated testing would hamper this effort by potential for causing worker anxiety with the development of CBD and preventing responsible employers from from false-positive Be-LPT test results beryllium sensitization. This rule identifying specific jobs or tasks that for workers with limited exposure requires that medical surveillance be lead to beryllium-related health effects. potential. While these commenters given to workers who are at the greatest For reasons stated in the NOPR and agreed that some level of worker risk from continued exposure. This expressed by all eight commenters, DOE beryllium exposure should trigger the determination should be made on the has decided against the use of medical surveillance program, neither basis of the air monitoring results, the anonymous testing. However, DOE has provided recommendations for an SOMD’s recommendation, and any taken steps in the final rule to protect appropriate trigger level. other relevant information the the privacy of beryllium-associated One commenter (Ex. 16) suggested responsible employer may possess, such workers, e.g., by requiring the use of that DOE use a graded approach to the as past medical or air monitoring unique identifiers (see discussion of medical surveillance program which records, workers’ job tenure, etc. section 850.39). DOE cannot responsibly would include current beryllium DOE realizes that some workers may accomplish the tasks of ameliorating the workers and other workers with elect not to participate in the medical effects of exposure to beryllium and exposures or potential exposures at or surveillance program because they developing needed data on the cause above the action level. DOE has

VerDate 29-OCT-99 10:58 Dec 07, 1999 Jkt 190000 PO 00000 Frm 00037 Fmt 4701 Sfmt 4700 E:\FR\FM\A08DE0.232 pfrm04 PsN: 08DER3 68890 Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 / Rules and Regulations determined that a graded approach to former workers at the same time as final rule to require responsible linked to exposure at or above the action the program for current workers. employers to ensure that all medical level would not ensure the necessary Another commenter argued that evaluations and procedures are surveillance of all DOE and contractor maintaining two separate databases and performed by or under the supervision workers who may have had exposure to programs was not practical. of a licensed physician who is familiar beryllium, whether current or past. DOE has revised the final rule to with the health effects of beryllium. Several commenters (Exs. 2, 14, 16, require responsible employers to Although a licensed physician is the 17, 28, 29, 30, 31) favored the inclusion provide medical surveillance for all appropriate person to supervise and of all potentially exposed workers in the beryllium-associated workers. DOE evaluate a medical evaluation, certain medical surveillance program regardless based this revision on the beryllium required elements of the evaluation may of the measured exposure level. These cases suggesting that low and even be performed by another, appropriately commenters argued that medical incidental exposure to beryllium can qualified person under the supervision surveillance should not be limited to lead to sensitization or beryllium of the physician. The licensed physician workers exposed to levels of beryllium disease. This approach will ensure the is required to be familiar with the health at or above the action level, but rather early identification of workers at risk of effects of beryllium. DOE expects that should include all workers with the health effects from exposure to the medical evaluations and procedures potential for any beryllium exposure. beryllium, provide the greatest required to diagnose CBD will be Three of these commenters stated that protection of worker health, and provide performed or validated by a specialist in current scientific evidence does not a more complete documentation of pulmonary medicine, occupational indicate a ‘‘safe’’ level of beryllium beryllium exposures. Beryllium- medicine, or other physician with exposure, and that CBD has been associated workers eligible for medical specialized equipment and examination identified in individuals thought to surveillance include any current worker protocols required to definitively have only low or incidental exposure to who is exposed or was exposed or differentiate between CBD and other beryllium. Their concern was that potentially exposed to airborne lung diseases. DOE believes that this is restricting medical surveillance to concentrations of beryllium at a DOE necessary due to the unusual nature of ‘‘beryllium workers,’’ as defined in facility. Thus medical surveillance will CBD and the fact that not all physicians proposed section 850.3, would exclude be available to a beryllium worker (as are familiar with the evaluation of such workers, who in their view are also defined in section 850.3), a current beryllium-associated patients. at risk of contracting CBD. In addition, worker whose work history shows that Three commenters (Exs. 15, 18, 22) two of the commenters (Exs. 28, 30) the worker may have been exposed to expressed concern about certain noted that allowing workers exposed at airborne concentrations of beryllium at language in the NOPR preamble that any level to participate in the medical DOE facilities, a current worker who they interpreted to mean that workers surveillance program would act as an exhibits signs and symptoms of would be limited to an evaluation incentive for employers to minimize the beryllium exposure, and a worker who performed by an employer’s physician. number of individuals who work in is receiving medical removal protection One commenter (Ex. 22) suggested that beryllium areas. benefits. DOE adopt OSHA’s Lead Standard as a Similarly, three commenters (Exs. 28, Section 850.34(a)(2) requires model for selecting physicians. DOE 29, 31) argued that current workers with responsible employers to designate a never intended to limit an employee’s past beryllium exposures should be Site Occupational Medical Director choice of physicians. To clarify this offered the opportunity to participate in (SOMD) who will be responsible for point, DOE has included in section the medical surveillance program. One administering the medical surveillance 850.34, paragraphs (c) and (d), commenter (Ex. 31) noted that, based on program. One commenter (Ex. 18) stated provisions for a multiple physician and the proposed definition of ‘‘beryllium that a panel comprised of individuals alternate physician review. These worker,’’ medical surveillance would representing management, labor, the provisions are explained in the not be made available to current public, and the local medical discussion that follows. workers with past beryllium exposure community should select the SOMD. DOE views medical surveillance as a unless they were covered under the DOE has not adopted this primary tool for determining the extent medical removal provisions of proposed recommendation because DOE believes of CBD risk within the worker section 850.34. Another commenter that the responsible employer must have population. Therefore, section (Ex.15) suggested that all employees at ultimate responsibility for ensuring 850.34(a)(4) requires responsible DOE facilities, even those with no compliance with this requirement. employers to maintain and give to the exposure to beryllium, should be given A number of commenters (Exs. 12, 14, SOMD a list of beryllium-associated the option of participating in the 20, 23) were concerned about the workers who may be eligible for medical medical surveillance program. quality of health care for workers with surveillance. The list must be based on Several commenters (Exs. 2, 16, 28, CBD and, more specifically, whether or hazard assessments, exposure records, 31, 19) raised the issue of medical not workers would have a choice of and any other information that will surveillance for former workers with physicians. One commenter (Ex. 20) identify beryllium-associated workers past beryllium exposures who no longer pointed out that OSHA no longer (section 850.34(a)(4)(i)). In addition, work at a DOE facility. The commenters restricts the performance of medical section 850.34(a)(4)(ii) requires stated that former DOE workers should evaluations to licensed physicians responsible employers to regularly also be provided the opportunity to because this requirement is too update the list based on the information participate in medical monitoring. They prescriptive and fails to recognize the from the periodic evaluations performed acknowledged DOE’s proposed realities of today’s health care system. pursuant to paragraph (b)(2) of this establishment of a separate, directly This commenter suggested adding a section. funded program that offers medical provision to include other licensed One commenter (Ex. 16) questioned examinations to former workers at risk health care professionals among those why DOE proposed to give the SOMD of developing CBD. However, two of the who may perform medical evaluations. the task of identifying working commenters (Exs. 16, 31) argued that DOE agrees with this commenter and conditions that contribute to the risk of this program should be made available has revised section 850.34(a)(3) of the CBD and determining the need for

VerDate 29-OCT-99 10:58 Dec 07, 1999 Jkt 190000 PO 00000 Frm 00038 Fmt 4701 Sfmt 4700 E:\FR\FM\A08DE0.234 pfrm04 PsN: 08DER3 Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 / Rules and Regulations 68891 additional exposure controls. This because it would expand the scope of CBD, this commenter states, might have commenter believed that this task the rule. no positive effect on the course of the should be performed by an industrial Section 850.34(b) requires responsible disease. hygienist. Similarly, another commenter employers to provide, without cost to DOE disagrees with this comment. (Ex. 23) stated that the SOMD should beryllium-associated workers, all Early identification and intervention are not be responsible for performing data medical evaluations and procedures important for identifying workers at analysis to determine which workers performed to comply with these higher risk of exposure to beryllium, should be included in the medical regulations. This section also requires and for preventing and minimizing the surveillance program, or for maintaining that all evaluations and procedures be effects of beryllium-induced disease. the list of beryllium workers at a site. performed at a time and place that are DOE’s position is supported by a The commenter argued that both of convenient for the worker. This commenter (Ex. 29) who stated that these tasks are management functions provision is consistent with similar while spirometry and X-rays may not be that should be carried out by the provisions in OSHA’s expanded health predictive, X-rays have in some responsible employer based on standards. This section also requires instances identified CBD cases in technical guidance provided by the responsible employers to provide the individuals who had a normal Be-LPT. industrial hygiene department and the SOMD with a list of beryllium- This commenter stated that these cases SOMD. DOE agrees with both of these associated workers who may be eligible are likely to be missed if spirometry and commenters. The responsible employer, for protective measures under the rule. X-rays are not required, and also not the SOMD, should have the function Section 850.34(b)(1) requires recommended X-ray screening for Be- of identifying working conditions and responsible employers to provide a LPT negative individuals with evaluating the need for workplace baseline medical evaluation to persistent chest problems. Another controls. Consequently, DOE has revised beryllium-associated workers. The commenter (Ex. 19) emphasized the the final rule to require that responsible purpose of the baseline medical benefits of good data collection to employers identify beryllium-associated evaluation is to: (1) Establish the current determine if early removal of beryllium workers. However, medical judgments health status of the worker and sensitized workers prevents the that are requisite to management determine whether it is appropriate to progression to CBD. decisions are the SOMD’s responsibility. assign the worker to jobs with beryllium One commenter (Ex. 33) suggested exposure; (2) initially determine what that, if available, recent chest X-rays be Section 850.34(a)(5) requires the level of medical surveillance the utilized for the baseline medical responsible employer to provide the responsible employer must provide to evaluation to reduce X-ray exposure. SOMD with the information needed to the worker; and (3) establish essential DOE agrees that if previous chest X-rays operate and administer the medical baseline data for the worker which is have been conducted, for a baseline surveillance program. This information used to assess subsequent health beryllium evaluation, additional X-rays includes, but is not limited to, the changes attributable to beryllium should not be used unless specified by baseline beryllium inventory, hazard exposure. a physician. However, to ensure that the assessment results, and exposure DOE received a number of comments chest X-ray correlates with other monitoring data, as well as information regarding baseline medical evaluations diagnostic and historical information, regarding the identity and nature of and medical testing. One commenter only those X-rays taken for the purpose activities or operations on the site that (Ex. 25) requested clarification as to the of a baseline beryllium evaluation or are covered under the CBDPP, the differences between pre-placement equivalent evaluation should be used to related duties of beryllium workers, and exams, as specified in DOE Notice establish a baseline. the types of personal protective 440.1, ‘‘Interim Chronic Beryllium Section 850.34(b)(1)(vi) requires equipment employed in the Disease Prevention Program,’’ and the responsible employers to provide a Be- performance of these duties. baseline exams specified in the NOPR. LPT as part of the baseline evaluation. Section 850.34(a)(6) requires the The final rule will supersede DOE The Be-LPT is the only available responsible employer to provide the Notice 440.1, and the interim medical laboratory test for determining SOMD and the examining physician surveillance program requirements will individual immune response to with (1) A copy of this rule and its be replaced with those of the final rule. beryllium in vitro. Its use in a preamble; (2) a description of the The final rule does not refer to pre- surveillance program will permit workers’ duties as they pertain to placement exams. Another commenter detection of beryllium-related health beryllium exposure; (3) records of the (Ex. 23) recommended that the meaning effects at a pre-clinical stage. A positive workers’ beryllium exposure; and (4) a of spirometry be clarified to ensure Be-LPT would indicate the need for description of personal protective and consistency. DOE agrees and has further evaluation to determine the respiratory protective equipment in specified the measurement of forced presence of CBD. The use of the Be-LPT current or anticipated use. DOE believes vital capacity (FVC) and forced as an evaluation tool provides an early that this information is necessary to expiratory volume at 1 second (FEV 1) in opportunity for diagnosis and treatment ensure that the physician can make section 850.34(b)(1)(v) of the final rule. of CBD. informed decisions regarding the A commenter (Ex. 19) questioned the Finally, section 850.34(b)(1)(vii) required content of the medical value of baseline pulmonary function authorizes the examining physician to evaluation and the subsequent tests and x-rays. This commenter make available to the worker any development of recommendations suggested that baseline studies cannot additional tests deemed medically related to each beryllium-associated be used to determine which health necessary. DOE believes that it is worker. changes are related to work hazards and important that the examining physician Several commenters (Ex. 8, 17, 18, 19) which are related to other activities or have such discretion because suggested including provisions for disease processes. This commenter individuals may exhibit different providing beryllium education and favored the approach of following responses to beryllium. In this regard, training programs to physicians and patients clinically and using Be-LPT one commenter (Ex. 16) expressed other health care providers in the rule. and other studies, to augment clinical concern regarding proposed section DOE has not adopted this suggestion, impressions. Early identification of 850.33(i), which provided that workers

VerDate 29-OCT-99 10:58 Dec 07, 1999 Jkt 190000 PO 00000 Frm 00039 Fmt 4701 Sfmt 4700 E:\FR\FM\A08DE0.235 pfrm04 PsN: 08DER3 68892 Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 / Rules and Regulations would be referred for further diagnostic the appropriate medical surveillance for and to conduct such examinations, evaluation if there were two or more each individual. Accordingly, DOE has consultations, and laboratory tests as the positive Be-LPTs. The commenter decided to include appropriate second physician may deem necessary interpreted this provision as a standardized forms as non-mandatory to facilitate this review. The responsible mandatory requirement. DOE’s intent is guidance in an implementation guide to employer’s obligation to provide that workers have the opportunity for accompany the final rule. Another information to the examining physician additional testing if recommended by commenter (Ex. 29) was concerned that extends to other physicians involved in the examining physician. A worker is the NOPR required a respiratory the multiple physician review or not required by the rule to undergo symptom questionnaire for periodic alternate physician review process so additional medical evaluation and medical evaluations, but not for the that all of the physicians involved will treatment. baseline evaluation. DOE acknowledges have an equal opportunity to assess the One commenter (Ex. 29) this oversight and has included the beryllium-associated worker’s health recommended clinical referral for respiratory symptom questionnaire as status. additional diagnostic tests after one part of both the periodic and baseline Section 850.34(c)(2) requires that after positive Be-LPT, instead of two or more medical evaluations in sections an initial physician conducts an as proposed by DOE. DOE believes that 850.34(b)(1)(ii) and (b)(2)(I)(B) of the examination or consultation, the the examining physician is in the best final rule. responsible employer must promptly position to determine which additional Section 850.34(c) requires responsible notify the worker of his or her right to tests, if any, would be useful in employers to establish a multiple seek a second medical opinion. This evaluating the health of an individual physician review process for affected notification must be in writing. worker. Therefore, DOE has removed beryllium-associated workers. DOE has Section 850.34(c)(3) requires that after the requirement for follow-up testing identified three benefits of providing a the worker is notified of this right, the based on two or more positive Be-LPT multiple physician review process: (1) responsible employer may condition its tests, relying instead on the examining to strengthen and broaden the bases for participation in, and payment for, physician’s discretion under section medical decisions made pursuant to this multiple physician review upon the 850.34(b)(1)(vii) to order follow-up tests rule when a beryllium-associated worker, within 15 days after receipt of when appropriate. worker questions the findings, the notification or the initial physician’s Section 850.34(b)(2) requires recommendations, or determinations of written opinion, whichever is later, both responsible employers to provide an initial physician retained by the (1) informing the responsible employer medical evaluations to beryllium responsible employer; (2) to increase that the worker intends to seek a second workers annually, and to other beryllium-associated workers’ medical opinion, and (2) initiating steps beryllium-associated workers every 3 confidence in the soundness of medical to make an appointment with a second years. Responsible employers must findings, recommendations and physician. provide the periodic medical evaluation determinations made under this rule; The rule contains no limitation on a elements described in section and (3) to increase beryllium-associated beryllium-associated worker’s choice of 850.34(b)(2)(i) to detect, at an early worker’s acceptance of, and a second physician, except the stage, any pathological changes that participation, in the medical requirement in section 850.34(a)(3) that could lead to CBD or be aggravated by surveillance program. the second physician must be a licensed beryllium exposure. By detecting Given the shortage of trained and physician who is familiar with the abnormalities early, workers may be experienced occupational physicians, it health effects of beryllium. medically removed to prevent further is possible that some physicians If the second physician’s findings, beryllium exposure. performing examinations or determinations, and recommendations Section 850.34(b)(2)(ii) requires consultations under the beryllium rule are the same as those of the initial responsible employers to provide to will misdiagnose CBD. However, rather physician, then the multiple physician beryllium-associated workers a chest than requiring multiple medical review process comes to an end. radiograph (X-ray) every 5 years. DOE opinions in all cases, which would be However, as provided in section includes this requirement for periodic expensive and potentially wasteful, 850.34(c)(4), if the opinions of the two X-rays because X-rays have been shown DOE is providing to beryllium- physicians are in conflict, then the to be effective in the early detection of associated workers an opportunity to responsible employer and the beryllium-related health effects (Ex. 29). obtain an independent review of the beryllium-associated worker must Following an emergency in which a findings, determinations or undertake to encourage the two worker, who is not already participating recommendations of the physician physicians to resolve any disagreement. in the beryllium medical surveillance selected by the responsible employer. DOE expects that the two physicians program, is exposed to an elevated Over time, this independent review is will communicate with each other to amount of beryllium, the responsible likely to show either that a perceived resolve their differences, but the rule employer is required by section low level of confidence in the physician requires the responsible employer and 850.34(b)(3) to provide a medical retained by the responsible employer is worker to encourage such a resolution. evaluation as soon as possible. unwarranted, or that the responsible In most cases, this professional A commenter (Ex. 23) suggested that employer should improve the quality of interaction should resolve any a standard respiratory symptom the medical surveillance being differences of opinion. questionnaire, medical work history provided. In either case, the multiple In cases where differences remain, form, and physical examination form be physician review process will have these differences of opinion are likely to used at all DOE sites for consistency. served a beneficial purpose. be genuine and substantial. If the first DOE agrees that such standardized In section 850.34(c)(1), a beryllium- two physicians are unable to resolve forms may help ensure consistency associated worker may designate a expeditiously any differences of opinion across the DOE complex, but is second physician to review any with respect to a beryllium-associated concerned that mandating the use of findings, determinations, or worker, then it is necessary for a third standardized forms may limit the recommendations of the physician qualified physician to resolve the discretion of the SOMD in determining chosen by the responsible employer, dispute. It is critical that this third

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Consequently, section procedures in which all parties have beryllium sensitization, CBD, or any 850.34(c)(5) requires that the trust and confidence. other abnormal condition or disorder of responsible employer and the Section 850.34(e)(1) requires the workers caused or aggravated by beryllium-associated worker together, SOMD to provide to responsible occupational exposure to beryllium. through their respective physicians, employers, within two weeks after Although not included in the proposed must designate the third physician. receipt of results, a written and signed rule, this provision reflects current Under section 850.34(c)(5) the third medical opinion after each medical practices and does not impose a new physician will have a full opportunity to evaluation of a beryllium-associated burden on employers. Reporting review the findings, determinations, and worker. The purpose of requiring the abnormal conditions and disorders that recommendations of the two prior SOMD to give the responsible employer are occupationally caused and physicians, and to conduct such a written opinion is to inform the beryllium-related will contribute to the examinations, consultations and responsible employer of the medical development of occupational health laboratory tests as the third physician basis for determining the job placement statistics that eventually may lead to deems necessary. DOE’s expects that the of the examined worker. This written improved disease prevention and third physician will consult with the medical opinion, as described in section medical intervention for beryllium- other two physicians. The third 850.34(e)(i–iii), must contain any associated workers. It will also provide physician should provide a written diagnosis of the worker’s condition DOE with information and data helpful medical opinion to the SOMD which related to occupational exposure to in assessing the effectiveness of the will be used to resolve the disagreement beryllium; any other detected medical CBDPP rule and in considering what, if between the other two physicians. conditions relevant to further beryllium any, modification should be made to the Section 850.34(c)(6) requires the SOMD exposure; any recommended restrictions rule in the future. to act in a manner consistent with the on the worker’s exposure to beryllium Section 850.34(h)(1) requires findings, determinations, and or on the use of protective clothing or responsible employers to establish a recommendations of the third equipment; and a statement indicating routine and systematic analysis of physician, unless the SOMD and the that the SOMD or the examining medical, job, and exposure data. The beryllium-associated worker reach an physician has provided to the worker purpose of this requirement is to collect agreement that is otherwise consistent the results of the test, the medical and analyze information so that the with the recommendations of at least evaluation, including all tests results prevalence of disease can be accurately one of the other two physicians. and any medical condition related to described and conclusions reached on Since the multiple physician review beryllium exposure that requires further causes or risk factors for the disease. process will be a means by which evaluation or treatment. This data analysis is an effective means medical surveillance is provided to a Section 850.34(e)(2) requires the of measuring performance under the beryllium-associated worker, SOMD to withhold from the responsible CBDPP, and for correcting and responsible employers must bear the employer, orally or in the written improving the CBDPP. Section expense of this process when it is used. medical opinion, specific findings or 850.34(h)(2) requires the responsible Based on OSHA’s practice and diagnoses not related to occupational employer to use the results of these experience with multiple physician exposure to beryllium. analyses to determine which workers review in its health standards, DOE does Two commenters (Ex. 23, 28) should be offered medical surveillance not expect the costs of this process to be expressed concern regarding proposed and the need for additional exposure burdensome to the responsible section 850.33(j)(2), which stipulated controls. employers. If responsible employers that the physician’s written medical establish and administer medical reports be delivered within 15 calendar Section 850.35—Medical Removal surveillance programs that engender days after the completion of a medical Section 850.35 (proposed as section worker confidence, workers should have evaluation. The commenters noted that 850.34) requires responsible employers little or no need to seek second medical Be-LPT tests are time-consuming and to establish medical removal protection opinions. may exceed the 15-day time frame, and (MRP) and medical removal protection The requirement for multiple suggested that the 15-day period should benefits (MRPB) as part of the CBDPP. physician review is not intended to begin after receipt of the test results. Medical surveillance can only be preclude responsible employers from DOE agrees, and has revised section effective in detecting and preventing establishing and implementing alternate 850.34(f) to require the SOMD to give disease if beryllium-associated workers: medical protocols. DOE has included beryllium-associated workers a written (1) voluntarily seek medical attention language in section 850.34(d) to provide medical opinion containing the results when they feel ill; (2) refrain from for alternate physician determination. of all medical tests or procedures, an efforts to conceal their true health Under that section, the responsible explanation of any abnormal findings, status; and (3) fully cooperate with employer and beryllium-associated and any recommendation that the examining physicians to facilitate worker, or the worker’s designated worker be referred for additional testing accurate medical diagnoses and representative, may agree upon the use within 10 working days after the effective treatment. This sort of worker of any expeditious alternate physician SOMD’s receipt of test results. participation and cooperation cannot be determination process, instead of the In section 850.34(f)(2), upon request evoked by coercion; it will occur only multiple physician review process. The by the beryllium-associated worker, the where no major disincentives to only condition is that the alternate responsible employer is required to meaningful worker participation exist. process be no less protective of the provide the worker with a copy of the Without such participation, it would be worker’s health than the multiple information the responsible employer is much more difficult, if not impossible, review process. For example, a jointly required to provide to the examining to adequately monitor workers’ health agreed upon physician might be used in physician. and to identify workers who need the first instance without recourse to Section 850.34(g) requires the temporary or permanent medical other physicians. DOE encourages responsible employer to report on the removal.

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MRP is a logical result of medical Cadmium, Lead and Benzene standards, Section 850.35(a)(3) is intended to surveillance. Without MRP, responsible 29 CFR 1910.27, 1910.1025 and ensure that beryllium-associated employers would be free to maintain 1910.1028, respectively. DOE’s rationale workers are given the information high-risk workers in their current jobs, for each provision of section 850.35 in needed to make an informed decision which would not be sufficiently the final rule is discussed below. on whether to accept temporary or protective of their health. Alternatively, Section 850.35(a) requires responsible permanent removal from a job with a responsible employers could choose to employers to offer a beryllium- potential for beryllium exposure. terminate workers or transfer them from associated worker medical removal from Section 850.35(a)(4)(i) prohibits the higher-paying, beryllium-exposed jobs exposure to beryllium on each occasion responsible employer from returning a to lower-paying, non-beryllium jobs. that the SOMD determines in a written beryllium-associated worker who has This might be protective, but it would medical opinion that medical removal is been permanently removed to the impair the workers’ standards of living. required. The SOMD’s determination worker’s former job status, unless the In either case, the effectiveness and must be based upon one or more SOMD has determined in a written integrity of the medical surveillance positive Be-LPT results, CBD diagnosis, medical opinion that removal is no program would be compromised. an examining physician’s longer necessary to protect the worker’s With MRP, beryllium-associated recommendation, or any other signs or health, or the exception in section workers are assured of being removed to symptoms the SOMD deems medically 850.35(a)(4)(ii) applies. Under section jobs where exposure to beryllium is low sufficient to show that the worker has a 850.35(a)(4)(ii), if there are special if such removal is determined to be medical condition that places the circumstances that make medical necessary to protect their health. With worker at increased risk of material removal an inappropriate remedy, or if MRPB, workers are assured that, if they impairment to health from further the SOMD’s professional opinion is that fully participate in medical surveillance exposure to beryllium. continued exposure will not pose an and if the results of medical Section 850.35(a)(1) deals with increased risk to the worker’s health surveillance require removal from their temporary removal. It requires the (e.g., the potential decrements to the beryllium exposed jobs, their normal responsible employer to offer temporary worker’s lung function are not projected earnings and job status will be protected medical removal to a beryllium- to be any greater if the worker were for a pre-determined period. associated worker whenever the SOMD permitted to continue on the job than Thirty-two commenters (Ex. 12 is a determines in a written medical opinion they would be if the worker were form letter submitted by 16 beryllium removed), the SOMD must fully discuss that the worker should be removed workers) commented on the proposed the matter with the worker and, in a pending a final medical determination MRP and MRPB provisions in the written medical determination, may on the worker’s health. The responsible NOPR. They addressed a wide variety of recommend returning the worker to his employer must offer to temporarily issues and frequently expressed or her former job status. The purpose of remove a worker regardless of whether opposing viewpoints. For instance, two this exception is to provide some a job is available into which the commenters (Exs. 16, 26) stated that the flexibility where it is reasonably clear removed worker may be transferred. If proposed MRP provisions went too far that returning the worker to his or her no such job is available, the responsible (e.g., two years of protection is too long; normal job is unlikely to adversely employer must pay medical removal accepted applicants should not be affect the worker’s health. For example, included under the provisions), while protection benefits to the worker for up a return to work may be justified if a others (Exs. 3, 8, 12, 14, 17, 18, 22, 24, to one year. Section 850.35(a)(1) (iii) worker who is not experiencing a 28, 29, 31) stated that the provisions did and (iv) require that for each time a decrease in lung function, has been on not go far enough (e.g., two years of beryllium-associated worker is medical removal for 2 years and is about protection is not long enough; one temporarily removed, the responsible to retire, and the time that the worker follow-up examination is not enough; employer must maintain the worker’s will continue to be occupationally the training costs limits are too total normal earnings, seniority and exposed at or above the action level is restrictive; the rule should provide other employment rights as if the very limited. If the SOMD recommends provisions for multiple physician worker were not removed, either by return of the worker in such cases, the reviews). Several commenters (Exs. 20, providing an appropriate alternative job SOMD may require the responsible 22, 31) argued against the voluntary or by paying MRPB, for one year. employer to provide the worker with nature of the proposed provisions, If a final medical determination is additional protection, such as a stating that it would be unethical to made that the worker does not have a supplied air respirator operated in a allow a worker with CBD to continue to medical condition which places the positive pressure mode. In any event, a be exposed to beryllium, and suggesting worker at increased risk of material decision to return the worker should be that workers could be wrongfully impairment to health from exposure to made only after the SOMD has fully pressured into staying in beryllium- beryllium, the temporary MRP must be explained the relevant facts and related jobs. Other commenters (Exs. 29, lifted so that the affected worker may prognoses to the worker. 30) agreed with DOE’s proposal to return to his or her normal duties. Section 850.35(b) establishes the require employee consent, and Section 850.35(a)(2) requires the MRPB that must be provided to requested that DOE provide additional responsible employer to offer beryllium- removed workers. DOE believes that the guidance to help workers make more associated workers permanent medical establishment of MRPB is critical to informed decisions regarding their removal whenever the SOMD minimize the disability associated with medical removal. DOE has decided, determines in a written medical opinion CBD. Removal from exposure and consistent with some of the comments, that the beryllium-associated worker effective job-placement efforts, coupled to use the provisions of OSHA’s should be permanently removed from with early diagnosis and treatment, will expanded health standards as the basis exposure to beryllium. Once a worker is increase the likelihood that affected for the MRP and MRPB provisions of the permanently removed, the worker will beryllium-associated workers will final rule. DOE has modeled the MRP receive the medical removal protection continue as productive members of the and MRPB provisions of this final rule benefits specified in section 850.35(b) of DOE workforce. In addition, MRPB will upon similar provisions in OSHA’s this rule. encourage worker participation in the

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Section 850.36(a) requires responsible a finding of sensitization or diagnosis of In section 850.35(b)(4), the employers to provide beryllium- CBD will not lead to the loss of their responsible employer’s obligation to associated workers with a summary of employment. provide MRPB is reduced by the amount the medical surveillance program, the Under section 850.35(b)(1), the of any compensation the beryllium- type and purpose of data to be collected, responsible employer is required to associated worker receives from any how the data will be maintained, and provide up to two years of MRPB to a other source for earnings lost during the protections for ensuring the beryllium-associated worker on each period of removal. This provision is confidentiality of medical records. occasion that he or she is medically necessary to ensure that MRPB does not Responsible employers must provide removed from exposure to beryllium in result in a ‘‘windfall’’ to the worker who this information at least one week before accordance with this part. collects other compensation, including any medical evaluation or tests, or when Section 850.35(b)(2) requires the salary from another job, while the requested by the worker. responsible employer to provide the worker is on medical removal from Section 850.36(b) requires responsible ‘‘total normal earnings, seniority, and all exposure to beryllium. employers to provide beryllium- other workers rights and benefits’’ of a Section 850.35(b)(5) provides that the associated workers with information on removed beryllium-associated worker as requirement that a responsible employer the benefits and risks of the medical if the worker had not been removed. provide MRPB is not intended to tests and examinations offered as part of The purpose of this requirement is to expand upon or restrict any rights a medical surveillance. This information ensure that a removed worker does not worker has or would have had, absent must be provided at least one week suffer economic loss due to the removal. medical removal, to a specific job prior to any examination or test. DOE Thus, if a removed worker routinely classification or position under the expects responsible employers to make earned overtime pay on the job from terms of a collective bargaining reasonable efforts to help workers which he or she was removed and agreement. understand the material. Accordingly, would have continued to do so during Section 850.35(b)(6) provides that a section 850.36(b) requires responsible the removal period, then MRPB must responsible employer may condition the employers to give beryllium-associated include the amount of expected provision of MRPB upon the beryllium- workers an opportunity to ask questions overtime as part of the worker’s ‘‘total associated worker’s participation in and receive answers before a medical normal earnings.’’ DOE selected 2 years medical surveillance. Thus, although evaluation is performed. as the maximum period during which the rule does not require worker Section 850.36(c) requires responsible the responsible employer is required to participation in medical surveillance, it employers to have the SOMD obtain the pay MRBP to a worker who accepts permits the responsible employer to beryllium-associated worker’s signature removal instead of the 18 month deny economic protection to workers on the informed consent form found in protection period established in OSHA’s who are unwilling to participate in Appendix A to this part, before medical Lead and Cadmium standards. DOE has medical surveillance. Since the evaluations or tests are performed. established a different protection period responsible employer must bear the Section 850.37—Training and for beryllium because of the financial burden of medical removal, Counseling toxicological differences between the employer has a legitimate interest in beryllium and the two metals covered in minimizing the need for medical Section 850.37 (proposed as section the OSHA standards. Specifically, the removal. Unless workers participate in 850.36) establishes requirements for early stages of the health impairments medical surveillance, the responsible training and counseling workers associated with exposure to lead or employer may not be able to identify regarding exposure to beryllium, and cadmium will reverse in time with no workers whose exposure to beryllium the potential health effects associated additional exposure, but beryllium should be reduced to avoid the need for with such exposure. This worker sensitization and CBD will not. The medical removal. training is necessary because the objective of OSHA’s 18 month period is In providing the responsible employer appropriate implementation of the to provide workers with sufficient the authority to condition provision of required workplace procedures of the recovery time so that they can return to MPRB upon a beryllium-associated CBDPP ultimately rests upon the front- their job. The objective of DOE’s 24 worker’s participation in medical line workers who will be performing month period, however, is to allow surveillance, DOE does not intend to work on, with, or near beryllium or beryllium-associated workers who permit an employer to deny MRPB for beryllium-contaminated materials. accept permanent medical removal insignificant lapses in such These workers cannot be expected to sufficient time to be retrained and participation. The worker’s actions implement the required CBDPP placed in different job. DOE believes should be assessed reasonably, in light procedures if they are not aware or fully that this period should be long enough of the goal of prevention of disease and appreciative of the significance of these to enable the majority of removed the employer’s interest in minimizing procedures. beryllium-associated workers to be the need for medical removal. DOE expects that responsible retrained and placed in another job or, employers will conduct training in a for those workers who can be returned Section 850.36—Medical Consent manner that is easy to understand. to their former job status, to be returned Section 850.36 (proposed as section Training material should be appropriate before their MRPB expire. 850.35) establishes the medical consent in content and vocabulary to the Under section 850.35(b)(3), if a provisions of the CBDPP. Because education level, and language removed worker files a claim for worker participation in the medical background of affected workers. The workers’ compensation payments for a surveillance program established by this goal of training is to ensure that all beryllium-related disability, the rule is voluntary, this section is workers, regardless of cultural or responsible employer must provide necessary to ensure that beryllium- educational background, have the MRPB pending disposition of the claim. associated workers receive adequate knowledge necessary to reduce and The responsible employer receives no information to make an informed minimize their exposure to beryllium.

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Section 850.37(a)(1) requires program for family members of actually subject to exposure or potential responsible employers to develop and beryllium workers. Commenters exposure hazards. Periodic training is implement a worker training program generally agreed on the need to inform necessary to reinforce and update initial for beryllium-associated workers and all workers’ families about beryllium training, especially with regard to the other individuals who work at a site hazards, but had different views about protective actions workers must take at where beryllium activities are how it should be accomplished. Two their current jobs to reduce their conducted, and ensure their commenters (Exs. 16, 26) recommended potential for exposure to beryllium. participation in the program. DOE that an outreach requirement not be DOE has established the frequency of recognizes that OSHA’s Hazard included in the rule and, instead, that two years as a minimum requirement, Communication standard (29 CFR workers be relied upon to relay rather than the proposed one year. 1910.1200) already requires that beryllium information to their families. Section 850.37(e) requires the employers provide their workers with Several other commenters (Exs. 17, 28, responsible employer to provide training regarding the risks associated 30, 31) recommended that DOE include additional training when the employer with all hazardous materials in the an outreach requirement in the rule, and has reason to believe that a beryllium workplace. DOE does not intend that require employers to provide beryllium worker lacks the proficiency, employers would implement separate information without relying on the knowledge, or understanding needed to and redundant training and information workers. After considering all of the work safely with beryllium. This programs to comply with both this rule comments, DOE has added section situation could occur because of and the Hazard Communication 850.37(b)(3), which requires the changes in workplace operations, standard. Accordingly, sections responsible employer to provide to its controls, or procedures or the 850.37(b)(1) and (2) require responsible workers information about risks to availability of new or updated employers’ CBDPP training and family members. This section relies information regarding the health risk information programs to comply with upon the workers to relay the relevant associated with exposures to beryllium. the Hazard Communication standard as beryllium hazard information to their Also, a worker’s performance may show well as address the contents of the families. DOE encourages responsible that the worker has not retained the CBDPP. Through this provision, DOE employers to provide beryllium- requisite proficiency. DOE used the intends for responsible employers to associated workers with information retraining requirements of the OSHA integrate their CBDPP training and about beryllium risks that is readily scaffold standard (29 CFR 1926.454(c)) information efforts into their existing understandable to family members and as a model for section 850.37(e). Hazard Communication training others, as well as to the workers. Section 850.37(f) requires the program. This will minimize the burden One commenter (Ex. 4) recommended responsible employer to develop and on responsible employers and provide that the requirement for outreach not be implement a worker counseling program for a consistent approach to worker included as part of the rule, but that to assist beryllium-sensitized workers training and the communication of DOE provide outreach information from and workers diagnosed with CBD. The workplace hazards. a central point in DOE. The commenter purpose of the counseling program is to DOE added ‘‘contents of the CBDPP’’ felt that this approach would be more communicate to workers information to the training requirements in section efficient than having each responsible that may help them make important 850.37(b) because this information is employer develop and provide its own health-and work-related decisions and essential for a worker to understand outreach information. DOE disagrees perform administrative activities, such how to effectively participate in the with this comment, and is of the view as filing workers’ compensation claims. CBDPP. OSHA’s Hazard that more effective outreach will be This section also requires the Communication standard (29 CFR provided if responsible employers responsible employer to communicate 1910.1200) does not explicitly refer to include information about beryllium information concerning the following anything like a CBDPP. In the final rule, risks to families and others as part of the topics: the medical surveillance DOE has removed specific mention of detailed training provided to beryllium- program; medical treatment options; several subjects (beryllium health risk, associated workers and those who use medical, psychological, and career exposure reduction, and safe handling protective clothing and equipment. counseling; medical benefits; of beryllium and medical surveillance) One commenter (Ex. 3) recommended administrative procedures and worker that were specifically identified in the general awareness training for workers rights under applicable workers’ proposed rule. These subjects are who are not beryllium-associated compensation laws and regulations; adequately covered in the Hazard workers but who, at some time, may be work practices aimed at limiting worker Communication standard. at risk because they work at a site where exposure to beryllium; and the risk of One commenter (Ex. 3) recommended beryllium activities are conducted. DOE continued exposure after sensitization. detailed training for workers who have agrees with this recommendation, and One commenter (Ex. 23) cautioned had, or are likely to have, exposures to section 850.37(c) requires the that the proposed language dealing with beryllium because their assigned tasks responsible employer to provide general workers’ compensation counseling may have involved beryllium. DOE awareness training about beryllium could have been interpreted as imposing generally agrees with the commenter hazards and controls to these workers. obligations that exceed employer and in the final rule has used a Section 850.37(d) requires that the obligations under states’ workers’ performance-based approach to responsible employer provide training compensation statutes. DOE has identifying the workers to be trained. to workers prior to initial assignment included in section 850.37(f) the Section 850.37(b), paragraphs (1) and and at least every two years thereafter to qualifying language ‘‘administrative (2), require detailed training for ensure that workers are appropriately procedures and worker rights’’ and beryllium-associated workers. prepared to deal with the hazards and ‘‘under applicable workers’ In the NOPR (Section V, Request for risks of working with beryllium. The compensation laws and regulations’’ to Information), DOE stated that it was initial training requirement of this make clear that DOE does not intend to considering including a requirement paragraph is important to ensure that establish any new workers’ that responsible employers develop and workers have the information they need compensation obligations. DOE implement an outreach education to protect themselves before they are understands that responsible employers

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This is long as the information is presented in recommended that beryllium training be especially important when regulated English as well. DOE agrees with this provided by organizations or persons areas are established on a temporary approach. Thus, section 850.38(c) who receive grants from DOE. This basis, such as during cleanup requires that all warning signs and commenter asserted that it is operations. In such cases, workers who labels comply with 29 CFR 1910.1200. inappropriate for DOE contractors, who typically work in or travel through the Another commenter (Ex. 23) noted are responsible employers, to conduct area may not be aware of the new that the warning signs provisions beryllium training because these potential for exposures to beryllium specified in the NOPR differed slightly employers are not sufficiently and, thus, may not be appropriately from those in DOE Notice 440.1, and independent. DOE does not agree with equipped for or aware of the need to suggested that DOE retain the NOPR this comment and has not adopted this protect themselves from potential language in the final rule in lieu of the recommendation. The vast majority of exposures. Warning signs also serve as language in the Interim CBDPP. DOE DOE’s safety and health training is a constant reminder to those who work notes that the warning signs and labels currently being conducted adequately in regulated areas that the potential for provisions of the NOPR were based on by responsible employers, and it is exposure to beryllium exists in the area the provisions of the Interim CBDPP, common outside of DOE for employers and that appropriate controls must be with minor modifications added to to provide safety and health training to used. clarify the intent of the requirements. their employees. Sections 850.38(b)(1) requires DOE has retained these clarifications in One commenter (Ex. 21) responsible employers to label with section 850.38 of the final rule. recommended that this section be appropriate hazard warnings all revised to include the adult education A third commenter (Ex. 9) was containers of beryllium, beryllium concerned that references to cancer and principles outlined in Appendix E of compounds, or beryllium-contaminated OSHA’s Hazard Communication cancer hazards in warning signs and clothing, equipment, waste, scrap, or labels may be misleading and deceptive, standard (29 CFR 1910.1200) because debris to ensure that individuals who these principles have been effective and, noting that the reference did not come in contact with the containers are represent the opinion of a qualified when applied to training workers. While aware of their contents and the need to DOE has not explicitly referenced this medical professional, recommended implement special handling advisory Appendix in the final rule, that DOE obtain a ‘‘qualified medical precautions. Because the effectiveness nothing in the rule prohibits its use. opinion’’ to resolve this issue. DOE of the warning labels in achieving these Although the Appendix appears to be a believes that the action of the objectives is greatly dependent upon the good example of the use of adult International Agency for Research on visibility, accuracy, and educational principles that an employer Cancer (IARC) and ACGIH in classifying understandability of the content of the could use to train workers on their beryllium as a human carcinogen labels, section 850.38(b)(2) further hazard communication program, it does provides sufficient basis for retaining specifies that labels bear the following not expressly identify or describe these the cancer warning on warning signs information: principles. Responsible employers and labels for beryllium-contaminated would have to infer the principles from DANGER materials. DOE further notes that NIOSH Appendix E and then apply those CONTAMINATED WITH BERYLLIUM has classified beryllium as a potential principles to their beryllium training DO NOT REMOVE DUST BY BLOWING occupational carcinogen since 1977. OR SHAKING program. In addition, DOE believes that Section 850.39—Recordkeeping and Use CANCER AND LUNG DISEASE an explicit reference to this Appendix in of Information the rule would be confusing because HAZARD this Appendix is not specifically Section 850.38(c) clarifies that the Section 850.39 (proposed as section applicable to beryllium training. warning signs and labels developed to 850.38) requires responsible employers comply with the CBDPP must also to establish and effectively manage Section 850.38—Warning Signs and comply with the OSHA Hazard records that relate to the CBDPP and to Labels Communication standard, 29 CFR periodically submit to the Office of Section 850.38 (proposed as section 1910.1200. DOE believes this Environment, Safety and Health a 850.37) requires responsible employers clarification is needed to avoid registry of beryllium-associated workers. to post warning signs and labels to duplication of effort. In addition, DOE Section 850.39(a) requires the ensure that the presence and dangers believes that ensuring that the content responsible employer to establish and associated with beryllium and and format of warning signs and labels maintain up-to-date and accurate beryllium-contaminated materials or comply with the Hazard records of all beryllium inventory areas are communicated to workers. Communication standard will result in information, hazard assessments, Section 850.38(a) requires the posting of a consistent, recognizable, and exposure measurements, exposure warning signs at all entranceways to comprehensive approach to alerting controls, and medical surveillance data. established regulated areas and that workers to beryllium’s potential to DOE believes that up-to-date and these signs bear the following warning: cause disease. accurate records are essential for DANGER One commenter (Ex. 20) asked if DOE effectively implementing the CBDPP, BERYLLIUM CAN CAUSE LUNG had given consideration to requiring assessing its adequacy, and studying the DAMAGE that warning signs and labels be relationship between workplace CANCER HAZARD provided in languages other than conditions and CBD. Some of these AUTHORIZED PERSONNEL ONLY English or the use of universal symbols records will be needed to implement the

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OSHA regulations at 29 CFR federal government to release generated as required by this rule. 1910.1200 (Hazard Communication) government records upon request, Protecting the confidentiality of these already require employers to keep except for information that is exempted records is required by the Americans records of beryllium inventory from disclosure to protect an overriding with Disabilities Act (42 U.S.C. information, and regulations at 29 CFR interest, such as privacy, national 12112(d)(4)), the Privacy Act (5 U.S.C. 1910.20 (Access to Employee Exposure security, and trade secrets and other 552a) and other applicable laws. In and Medical Records) already require confidential business information. The addition, DOE recognizes that many employers to keep records of beryllium FOIA exemption for information in beryllium-associated workers will hazard assessments, exposure personnel and medical files (5 U.S.C. participate in some of the voluntary measurements, and medical 552(b)(6)) is especially important for components of the CBDPP only if they surveillance data. DOE has not, DOE CBDPP-required records, because believe that their personal information however, included in section 850.39 many of these records contain medical will be kept confidential. references to these OSHA standards. information that is protected from Section 850.39(e)(1) explicitly DOE believes that this rule’s release by this FOIA provision and other requires responsible employers to requirements for maintaining and federal laws. ensure that all records that are transferring CBDPP-related records, One commenter (Ex. 21) transmitted to other parties do not while ensuring confidentiality of recommended that DOE address the contain names, social security numbers personal information, are stated in clear retention of records in this rule. DOE or any other variables, or combination of and concise wording specifically related has added to section 850.39(b) the variables, that could be used to identify to the CBDPP that is preferable to cross- requirement that Heads of DOE individuals. DOE recognizes that referenced OSHA standards. Departmental Elements ensure that the responsible employers must take these Furthermore, one commenter’s (Ex. 31) record series generated as required precautions to prevent the violation of primary concern was ensuring that under this rule are retained for at least confidentiality laws because personal workers have access to the information 75 years, which is consistent with information could be obtained from that relates to their personal exposure DOE’s policy on retaining medical transmitted records, or inferred from and medical status. DOE has addressed records. This requirement will ensure information other than personal this concern in section 850.24(g), by that required CBDPP records that relate identifiers in the records, unless these requiring responsible employers to to workplace conditions will be precautions are taken. notify affected workers of beryllium available in the future to correlate with One commenter (Ex. 4) stated that the monitoring results, and in section the beryllium-associated workers’ rule’s confidentiality requirements 850.34(d)(2), by requiring the SOMD to medical records. Heads of DOE could prevent industrial hygienists from provide to workers the results of Departmental elements will be able to obtaining the health outcome medical tests and procedures. ensure that they can comply with information that is necessary to perform DOE encourages responsible section 850.39(b) if the CBDPP-required the linkage of site workplace conditions employers to take advantage of existing records generated by DOE responsible and health outcomes required by section recordkeeping systems to minimize the employer contractors are identified in 850.39(d). DOE does not intend health burden of implementing section 850.39. the relevant contracts as DOE-owned outcome information that would Responsible employers also may find documents. Therefore, DOE expects that compromise confidentiality to be that records that are generated outside Heads of DOE Departmental elements provided to industrial hygienists. DOE the CBDPP may be useful in will direct their DOE contract officers to believes that the linkage required by implementing the CBDPP. Examples are stipulate DOE ownership of these section 850.39(d) could be performed records of beryllium training, personnel documents in those contracts. after personal identifiers are removed demographics, beryllium mission The same commenter recommended from the health outcome information, descriptions, and payroll records of that DOE address the transfer of records making it consistent with section projects that can be used to link workers to successive responsible employers. 850.39(e)(1). with potential beryllium exposure. DOE agrees that this information should Another commenter (Ex. 16) Section 850.39(b) requires Heads of be covered in the rule, and has added recommended that the final rule require DOE Departmental Elements to section 850.39(c) to require responsible the responsible employer to place designate all record series required to be employers to convey to DOE, or its beryllium medical records in the generated under this rule as federal designee, all record series generated custody of a medical director, as records and, therefore, subject to all under this rule if the responsible opposed to the proposed requirement applicable federal records management employer ceases to be involved in the that medical records be held by the and access laws. CBDPP (e.g., ceases to be a DOE responsible employer. DOE recognizes One commenter (Ex. 18), in contractor). that beryllium medical records may be commenting on the baseline inventory Section 850.39(d) requires that in the custody of physicians involved in provisions of the proposed rule, responsible employers create links CBD studies other than the SOMD. DOE recommended that DOE require full between data sets on workplace responds to this commenter’s (Ex. 16) public disclosure of health and safety conditions and health outcomes to serve concern in section 850.39(e)(2)(i) by documents related to past beryllium as a basis for understanding the requiring responsible employers to emissions and exposures. In the final beryllium health risk. This linkage of ensure that individual medical rule, DOE is requiring Heads of DOE data will assist DOE and responsible information generated by the CBDPP is Departmental Elements to designate the employers in identifying unsafe work either included as part of the worker’s CBDPP-required records as federal practices and understanding the site medical records and maintained by

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Should the agency receive requirement that responsible employers allow current contractors easily to link a request for these records, it will use ensure that individual medical their data to the predecessor contractors’ every argument legally and reasonably information generated by the CBDPP is data on the same subject. DOE agrees available to it, including the authority maintained separately from other that successive contractor’s use of the granted under the FOIA and the Privacy records. A commenter (Ex. 19) same record retrieval identifiers would Act and the agency’s regulations recommended that the rule require make exposure-health outcome and implementing those statutes, to protect responsible employers to use only one epidemiology studies easier to conduct. the privacy of individuals in the records data system, maintained by the SOMD, Therefore, DOE encourages successor generated by the CBDPP. DOE’s policy to facilitate the analysis of the data and contractors to use the same record expressed in 10 CFR 1004.3(e)(ii), to to increase workers’ confidence in the retrieval identifiers as the predecessor maximize public disclosure of records confidentiality of SOMD-maintained contractor. DOE has not, however, made that pertain to concerns about the records. DOE retained this requirement, this a requirement in the final rule environment, public health or safety, or however, because the separation of because it would be inconsistent with employee grievances, has never been medical and other records is good file DOE’s commitment to a performance- applied to jeopardize the privacy management. Further, the Americans based rule to mandate this practice. interests of individuals in their medical with Disabilities Act (42 U.S.C. DOE’s goal in developing this rule is to records and will not be applied to 12112(d)(4)(C)) requires such separation allow the responsible employer jeopardize privacy interests in records for privately-owned medical maximum flexibility by specifying in generated by the CBDPP. information. DOE recognizes that the final rule only those record system Section 850.39(h) includes ‘‘exposure analysis of the data may be somewhat characteristics and practices that DOE measurements’’ in the registry as more difficult with separately believes are essential for achieving recommended by a commenter (Ex. 14). maintained medical records, but successful CBDPPs. DOE had inadvertently omitted separation of these records is required Section 850.39(g) requires the exposure measurements in the proposed responsible employer to transmit all registry provision. Also, section by law. There also are practical reasons records required by this rule, in a format 850.39(h) includes beryllium-associated to require the separation of these that protects the confidentiality of workers as recommended by a records. Personnel officials would individuals, to the DOE Assistant commenter (Ex. 28), rather than the require authorization from medical Secretary for Environment, Safety and narrower category of beryllium workers directors before accessing personnel Health on request. DOE replaced as proposed. DOE accepts this records that were stored with medical ‘‘Headquarters’’ in the proposed rule recommended change because it records. At the same time, the medical with ‘‘Assistant Secretary for recognizes that some DOE workers who directors would need a system to ensure Environment, Safety and Health’’ in the currently do not perform tasks involving that no confidential medical final rule to clarify that DOE’s Office of beryllium are nonetheless at risk of information was mixed in with the Environment, Safety and Health is the contracting CBD (based on past personnel records that personnel DOE organization that is responsible for potential exposure to beryllium) and officials accessed. Employers eliminate conducting occupational health studies must be included to complete the these administrative burdens by that involve DOE workers. registry. maintaining separate medical and Section 850.39(h) requires the DOE proposed including beryllium- personnel records. responsible employer semi-annually to associated workers’ names and social Section 850.39(f) requires the transmit to the DOE Office of security numbers in the data that would responsible employer to maintain all Epidemiologic Studies, Office of be included in the beryllium registry. records required by this part in current Environment, Safety and Health, an Several commenters (Exs. 16, 23, 28) and accessible electronic form to permit electronic registry of beryllium- argued that including the names and ready retrieval of data in a format that associated workers. The transmitted social security numbers of the maintains confidentiality. This registry must protect confidentiality and beryllium-associated workers in the requirement is necessary to facilitate include (but is not limited to) the registry would compromise their timely, efficient, and cost-effective following information for each worker privacy. DOE has responded to these transfer and analysis of CBDPP-related in the registry: a unique identifier, date commenters’ concerns by replacing the data. DOE has added the phrase ‘‘in of birth, gender, site, job history, proposed ‘‘names’’ and ‘‘social security current and accessible’’ to this section medical screening test results, exposure numbers’’ with ‘‘unique identifier.’’ The because DOE’s experience indicates that measurements, and results of referrals term ‘‘unique identifier’’ is defined in the ability to use information held in for specialized medical evaluations. section 850.3(a) to mean the part of a electronic records is severely hampered DOE’s collection of this information paired set of labels, used in records that if the electronic systems are out-of-date conforms to DOE Record System 88, contain confidential information, that or the records are difficult to obtain. ’’Epidemiologic and Other Studies, does not identify individuals except by Similarly, DOE has added the phrase Surveys, and Surveillance,’’ established using the matching label. Only the ‘‘that maintains confidentiality’’ to this as required by the Privacy Act. The SOMD will have the key to match the section because DOE’s experience Office of Epidemiologic Surveillance is unique identifier to the individual. This indicates that transferring information responsible for administrative and approach allows health and safety while maintaining confidentiality policy decisions related to the beryllium professionals and researchers to access cannot practically be accomplished registry and provides technical support the registry data and allows the SOMD using systems that must be modified, to the SOMD. to inform individuals of relevant study converted, or replaced before the The medical records generated by the results, while maintaining transfer can occur. CBDPP will be kept in appropriate confidentiality at all times.

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The beryllium registry will serve as a Two commenters (Exs. 19, 23) LIST OF COMMENTERSÐContinued repository for information on beryllium- recommended that the rule require that associated workers. DOE will use the a university or a university with input Exhibit Company/Organization registry to determine the exposure from an oversight board, or other No. profile and disease status of beryllium- suitably qualified organizations design 14 Gary Foster associated workers, and provide the epidemiological analysis of the 15 Darrell Lawson feedback to the responsible employer on CBDPP-generated data. Although 16 University of California, Laboratory the effectiveness of the CBDPP. The responsible employers and DOE’s Office Administration registry will give DOE the ability to of Environment, Safety and Health may 17 Hanford Environmental Health Foun- combine data from different facilities use universities or other suitably dation and perform analyses that are qualified organizations to design these 18 Serious Texans Against Nuclear impossible to perform with the small analyses, DOE thinks it would be Dumping (STAND), Incorporated amount of data that is available from inappropriate to specify the use of such 19 American College of Occupational each individual facility. The combined organizations in the rule. This and Environmental Medicine data may help DOE identify risk factors recommendation is not adopted. 20 Occupational Safety and Health Ad- for CBD and evaluate the predictive ministration (OSHA) Section 850.40—Performance Feedback value of medical tests such as the Be- 21 University of Cincinnati Medical Center LPT. Also, researchers may use the The final rule requirements for 22 Paper, Allied Industrial Chemical & registry to conduct further performance feedback in section 850.40 are essentially the same as those Energy Workers Union (PACE) epidemiological studies to better 23 Kaiser-Hill Company, Rocky Flats understand the cause and development proposed. Section 850.40(a) requires Environmental Technology Site of CBD and better identify those at risk. that responsible employers conduct 24 Lockheed Martin Energy Systems, One commenter (Ex. 26) periodic analysis and assessment of Incorporated, (Y±12 Facility) recommended that DOE delete the monitoring results, hazards identified, 25 Lockheed Martin Energy Research beryllium registry from the final rule medical surveillance results, attainment Corporation (Oak Ridge Labora- because the commenter believes that: (1) of exposure reduction and minimization tory) DOE has not adequately described the goals, and occurrence reporting data. 26 Brush Wellman, Incorporated research for which it will be used, and DOE believes that the analysis of these 27 James Turner data is important for the continuous 28 National Jewish Medical and Re- (2) implementing the registry will be search Center costly. This commenter suggested, as an improvement of the program. To ensure that all workers have the 29 National Institute for Occupational alternative, that DOE retain the Safety and Health (NIOSH) beryllium registry, but include in the information needed to safely perform their assigned tasks, section 850.40(b) 30 Consortium for Risk Evaluation with rule the specific research protocol that Stakeholder Participation would be used. DOE does not agree with requires that results of performance (CRESP) the commenter. DOE is confident that assessments conducted in accordance 31 International Chemical Workers the registry as provided in the final rule with this rule be provided to line Union Council of the United Food will support the studies needed to better managers, planners, worker protection and Commercial Workers Inter- understand the relationship between staff, workers, medical staff, and others. national Union (ICWUC/UFCW) workplace conditions and CBD. This 32 Concerned Citizens for Nuclear LIST OF COMMENTERS Safety (CCNS) knowledge should provide the basis for 33 Stanford Linear Accelerator Center improved worker protections. DOE also Exhibit (SLAC) thinks that the expense of the registry is No. Company/Organization 34 Fermi National Accelerator Labora- well justified by these benefits. DOE tory (Fermi Lab) also disagrees with the recommended 1 Atomic Weapons Establishment 35 United Steelworkers, Local 8031 alternative of including the research (AWE) 36 U.S. House of Representatives, Van protocols in this rule. Stipulating 2 Oak Ridge Institute for Science and Hilleary research protocols in regulations that Education (ORISE) 37 National Institute for Occupational 3 U.S. Department of Navy, Navy En- could only be changed through notice- Safety and Health (NIOSH) vironmental Health Center 38 Atomic Weapons Establishment and-comment rulemaking could stifle 4 Fluor Daniel Hanford, Incorporated research activities. (AWE) 5 Burlin McKinney 38 Commodore Advance Science, In- One commenter (Ex. 19) expressed the 6 Idaho National Engineering and En- corporated vironmental Laboratory (INEEL), concern that DOE’s Office of 40 Hanford Environmental Health Foun- Operated by Lockheed Martin Environment, Safety, and Health use of dation the beryllium registry could overshadow 7 Freddy D. Marler Jr. 8 Alfred Glenn Bell 41 Oak Ridge National Laboratory important site-specific studies. DOE 9 Lockheed Martin Idaho Tech- 42 Argonne National Laboratory believes that studies at both the site and nologies Company, INEEL 43 Fluor Daniel Hanford, Incorporated national level are important for 10 A Concerned American Citizen 44 University of Cincinnati Medical understanding the relationship between 11 Robert A. Gadon, CIH Center workplace conditions and CBD. DOE 12 Daniel R. Roberts, Danny Bush, 45 Gary Foster has included section 850.39(d), which Willie James Brooks, C.E. Tilley, 46 Pantex Plant requires responsible employers to link Robert Lang Freels, Edna & Er- 47 Kaiser-Hill, Rocky Flats Environ- mental Technology Site data on workplace conditions and nest Hugart, Victoria L. O'Sheel, 48 Paper, Allied Industrial Chemical & health outcomes, in part to facilitate the Kenneth L. Moore, Cheryll A. Dyer, James M. Harvey, J. R. Mil- Energy Workers Union (PACE) site level studies. The beryllium registry ler, Luis Revilla, Connie Willis, 49 Consortium for Risk Evaluation with established by section 850.39(h) will be Bruce Lawson, Lynn & Linda Cox, Stakeholder Participation used by the Office of Epidemiologic Roy & Debra Jones (CRESP) Surveillance to support national level 13 American Industrial Hygiene Asso- 50 Brush Wellman, Incorporated studies. ciation (AIHA) 51 University of Cincinnati

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LIST OF COMMENTERSÐContinued the compliance profiles. The profiles are of life; (4) increased medical designed to reflect the full opportunity surveillance for workers at risk; (5) Exhibit Company/Organization cost of compliance. For example, the increased work-life for beryllium No. compliance profile for performing a Be- workers; (6) increased productivity; (7) LPT test includes not only the test itself, reduced legal costs for DOE and DOE 52 Building & Construction Trades De- but also the labor time for the worker contractors; and (8) a reduction in the partment, AFL±CIO and physician to conduct the test, externality associated with beryllium shipping the sample to a lab, and exposure through a transfer of the V. Procedural Requirements analyzing and interpreting the results of medical costs from workers to DOE A. Review Under Executive Order 12866 the test. The cost data was obtained contractors. Because sufficient This rulemaking has been determined from a variety of sources, including information on the dose-response to be a significant regulatory action CBDPP plans submitted under DOE relationship for beryllium is not under Executive Order 12866, Notice 440.1, a 1999 Environment, available within the scientific Safety and Health (EH) Cost Survey, community, DOE could not relate ‘‘Regulatory Planning and Review,’’ 58 contact with DOE facilities subject to reduced levels of exposure to a specific FR 51735 (October 4, 1993). the CBDPP rule, trade publications, the reduction in CBD and beryllium Accordingly, today’s action was subject U.S. Office of Personnel Management sensitization. Nevertheless, DOE to review under the executive order by (OPM) (e.g., for wage rates), and estimates that the monetary benefits the Office of Information and Regulatory previous economic analyses of other from reduced lifetime medical costs Affairs (OIRA). The assessment of the regulations (e.g., regulatory impact could range from $10,100 to $16,093 for potential costs and benefits of the analyses of OSHA health standards). each avoided case of beryllium proposed rule, which was made This cost data was then applied to the sensitization or CBD. available to the public when the NOPR compliance profiles to determine the DOE also assessed the potential was published in the Federal Register, costs associated with each profile, economic impacts of the rule on the was updated to reflect changes made in providing an estimate of the incremental provision of public goods that contain the final rule. cost for each requirement. beryllium and the impact on the market Before conducting the assessment, DOE-wide cost estimates for each for beryllium. DOE assessed each of DOE profiled the sites and activities that requirement were generated by these potential impacts and determined will be affected by the CBDPP rule and multiplying the number of units affected neither will impose a significant estimated the number of workers that by each requirement by the incremental economic impact. DOE determined that will be affected by the rule. DOE cost for each requirement. Costs the potential reduction in the provision estimates that 1,634 workers may be estimated in this step were then of beryllium-containing public goods exposed or potentially exposed to annualized using a discount rate. will be minimal and, consequently, the airborne concentrations of beryllium in Discount rates are used to translate costs reduction in demand for beryllium will the DOE complex. Furthermore, DOE (and benefits) that are incurred in future also be small. estimates that 1,236 of these workers years into a present value. Following DOE’s assessment of the potential (75.6 percent) are potentially exposed OMB Guidance (1992), DOE chose a 7 costs and benefits of the final has been above the action level or the PEL percent discount rate. In the analysis, placed in the rulemaking file (Docket prescribed in the CBDPP rule. DOE uses the 7 percent discount rate for Number EH–RM–98–BRYLM). DOE also DOE began the cost estimation by three purposes: (1) To annualize the has placed in the rulemaking file a reviewing the rule to determine which costs of equipment or other program document that identifies the substantive requirements of the rule will impose elements that have a lifetime of more changes between the draft final rule costs on affected entities. DOE then than one year, (2) to translate the costs submitted to the OIRA for review and determined the controls (e.g., incurred in future years into a present the final rule published today, including implementation of procedures, purchase value, and (3) to calculate the identification of the changes suggested of equipment) necessary for affected annualized cost of initial requirements or recommended by OIRA. These entities to be in compliance with each of DOE N 440.1 and the CBDPP rule. documents may be reviewed and copied requirement. DOE’s assessment refers to DOE estimated the total compliance at the DOE of Information Reading these determinations as compliance costs of the CBDPP, including the costs Room, Room 1E–190, 1000 profiles. Since the goal of the of the interim CBDPP under DOE Notice Independence Avenue, SW, compliance cost estimation is to 440.1 and the costs of this final rule. Washington, DC 20585, between the determine the incremental costs of DOE estimates an $8.54 million hours of 8:30 a.m. and 4:00 p.m., compliance (OMB Guidance, 1996), the annualized cost on DOE contractors Monday through Friday, except Federal compliance profiles were compared to between July 1997 and December 1999 holidays. the procedures and controls that are (compliance with DOE Notice 440.1) currently in place at DOE facilities and a $31.55 million annualized cost on B. Review Under the Regulatory affected by the rule (i.e., the baseline). DOE contractors between December Flexibility Act Procedures and controls required by the 1999 (the assumed effective date of the The Regulatory Flexibility Act, 5 CBDPP rule that are not currently in final rule) and December 2009. This U.S.C. 601–612, requires that an agency place at DOE facilities were considered includes an initial (i.e., startup) cost of prepare a regulatory flexibility analysis new to the facilities, and thus would $9.02 million incurred in July 1997 and and publish it at the time of publication impose incremental costs on the another initial cost of $2.22 million of general notice of proposed affected entities. The compliance incurred in December 1999. rulemaking for the rule. This profiles were then adjusted to reflect DOE also assessed the potential requirement does not apply if the only the required incremental controls. benefits of the CBDPP for DOE, DOE agency certifies that the rule will not, if The next step in DOE’s assessment contractors, and workers. DOE assessed promulgated, have a significant was to estimate the costs for each the following benefits of the CBDPP economic impact on a substantial compliance profile. DOE collected data rule: (1) Reduced medical costs; (2) number of small entities (5 U.S.C. on the cost of each element contained in reduced mortality; (3) increased quality 605(b)).

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Today’s action establishes DOE’s 1969 (42 U.S.C. 4321 et seq.), the the review required by section 3(a), regulations for a CBDPP to reduce the Council on Environmental Quality section 3(b) of Executive Order 12988 number of DOE Federal and contractor regulations for implementing NEPA (40 specifically requires that Executive workers exposed to beryllium, minimize CFR parts 1500–1508), and DOE’s NEPA agencies make every reasonable effort to the levels of and potential for exposure implementing procedures (10 CFR Part ensure that the regulation: (1) Clearly to beryllium, and establish medical 1021). DOE has completed an specifies the preemptive effect, if any; surveillance requirements to ensure Environmental Assessment, and on the (2) clearly specifies any effect on early detection of disease. The basis of that assessment has determined existing federal law or regulation; (3) contractors who manage and operate that an environmental impact statement provides a clear legal standard for DOE facilities are principally is not required and issued a Finding of affected conduct while promoting responsible for implementing the No Significant Impact (FONSI) for this simplification and burden reduction; (4) CBDPP. DOE has considered whether rule. In the Notice of Proposed specifies the retroactive effect, if any; (5) these contractors are ‘‘small Rulemaking, the Department announced adequately defines key terms; and (6) businesses,’’ as that term is defined by the availability of the draft addresses other important issues the Regulatory Flexibility Act (5 U.S.C. Environmental Assessment and affecting clarity and general 601(3)). The Regulatory Flexibility Act’s requested comments on the Assessment. draftsmanship under any guidelines definition incorporates the definition of DOE did not receive any comments on issued by the Attorney General. Section ‘‘small business concern’’ in the Small the draft Environmental Assessment. 3(c) of Executive Order 12988 requires Business Act, which the Small Business The Environmental Assessment updates Executive agencies to review regulations Administration (SBA) has developed the draft Environmental Assessment in light of applicable standards in through size standards in 13 CFR part (DOE/EA 1249) to reflect changes in the section 3(a) and section 3(b) to 121. Small businesses are business final rule made in response to public determine whether they are met or it is concerns which, together with their comments on the rule. The unreasonable to meet one or more of affiliates, have no more than 500 to 1500 Environmental Assessment and FONSI them. DOE has completed the required employees, varying by SIC category, and are available for inspection at the DOE review and determined that this final annual receipts of between $0.5 million Freedom of Information Reading Room, rule meets the relevant standards of to $25 million, again varying by SIC 1E–190, 1000 Independence Avenue Executive Order 12988. category. The DOE contractors subject to SW, Washington, DC 20585, between G. Review Under the Unfunded the CBDPP requirements exceed the the hours of 9 a.m. and 4 p.m., Monday Mandates Reform Act of 1995 SBA’s size standards for small through Friday, except Federal holidays. businesses. In addition, DOE contractors Title II of the Unfunded Mandates E. Review Under Executive Order 13132 are reimbursed through their contracts Reform Act of 1995 (Pub. L. 104–4) with DOE for the costs of complying Executive Order 13132 (64 FR 43255, requires each federal agency, to the with DOE health and safety program August 4, 1999), imposes certain extent permitted by law, to prepare a requirements. They will not, therefore, requirements on agencies formulating written assessment of the effects of any be adversely impacted by the and implementing policies or Federal mandate in an agency rule that requirements in the rule. For these regulations that preempt State law or may result in the expenditure by State, reasons, DOE certifies that the final rule that have federalism implications. local, and tribal governments, in the will not have a significant economic Agencies are required to examine the aggregate, or by the private sector, of impact on a substantial number of small constitutional and statutory authority $100 million in any one year. It also entities. supporting any action that would limit requires a federal agency to develop an the policymaking discretion of the effective process to permit timely input C. Review Under the Paperwork States and carefully assess the necessity by elected officers of State, local, and Reduction Act for such actions. DOE has examined tribal governments on a proposed DOE submitted the proposed today’s rule and has determined that it ‘‘significant Federal intergovernmental collections of information in this rule to does not preempt State law and does not mandate,’’ and requires an agency plan the Office of Management and Budget have a substantial direct effect on the for giving notice and an opportunity for for review under section 3507(d) of the States, on the relationship between the timely input to potentially affected Paperwork Reduction Act of 1995 (42 national government and the States, or small governments before establishing U.S.C. 3507(d)). The information that on the distribution of power and any requirements that might DOE contractors are required to responsibilities among the various significantly or uniquely affect small produce, maintain and report is levels of government. No further action governments. The final rule published necessary to permit the Department to is required by Executive Order 13132. today applies only to activities manage and oversee the health and conducted by or for DOE, and its F. Review Under Executive Order 12988 safety programs that control worker implementation will not result in an exposure to beryllium. The Office of Section 3 of Executive Order 12988, expenditure of $100 million in any year Management and Budget has not yet ‘‘Civil Justice Reform,’’ 61 FR 4729 by State, local or tribal governments or approved the collections of information (February 7, 1996), instructs each the private sector. Therefore, the in this rule. An agency may not conduct agency to adhere to certain requirements requirements of Title II Unfunded or sponsor, and a person is not required in promulgating new regulations. Mandates Reform Act of 1995 do not to respond to a collection of information Executive agencies are required by apply. unless it displays a currently valid OMB section 3(a) to adhere to the following H. Review Under Small Business control number (5 CFR 1320.5(b)). general requirements: (1) Eliminate drafting errors and ambiguity; (2) write Regulatory Enforcement Fairness Act of D. Review Under the National regulations to minimize litigation; and 1996 Environmental Policy Act (3) provide a clear legal standard for As required by 5 U.S.C. 801, DOE will DOE has reviewed the promulgation affected conduct rather than a general report to Congress promulgation of this of 10 CFR Part 850 under the National standard and promote simplification rule prior to its effective date. The Environmental Policy Act (NEPA) of and burden reduction. With regard to report will state that it has been

VerDate 29-OCT-99 10:58 Dec 07, 1999 Jkt 190000 PO 00000 Frm 00050 Fmt 4701 Sfmt 4700 E:\FR\FM\A08DE0.248 pfrm04 PsN: 08DER3 Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 / Rules and Regulations 68903 determined that the rule is not a ‘‘major Epidemiologic and Immunologic Evidence Test and the Beryllium Levels in Working rule’’ as defined by 5 U.S.C. 804(2). for Continuing Risk from Exposure to Low Environment.’’ Industrial Health, Volume Level Beryllium Fume.’’ American Review 35(3):374–9 (Jul 1997). Appendix A to the Preamble References of Respiratory Disease, Volume 32. Threshold Limit Value for Chemical 135(1):201–208 (1987). Substances and Physical Agents and 1. ‘‘Beryllium Disease: Reducing the Risks.’’ 16. Kreiss K, Mroz MM, Zhen B et al. Biological Exposure Indices, Notice of National Jewish Medical and Research ‘‘Epidemiology of Beryllium Sensitization Intended Change (1999). Center Website (http:// and Disease in Nuclear Workers.’’ 33. U.S. Environmental Protection Agency: www.nationaljewish.org/beryllium/). 1999. American Review of Respiratory Disease, Integrated Risk Information System, 2. Green DM et al. ‘‘Agency for Toxic Volume 148:985–991 (1993). Substance File—Beryllium and Substances and Disease Registry (ASTDR) 17. Kreiss K et al. ‘‘Beryllium Disease Compounds, CASRN 7440–41; U.S. Case Studies in Environmental Medicine, Screening in the Ceramics Industry.’’ Environmental Protection Agency, No.19.’’ U.S. Department of Health and Journal of Occupational Medicine, Volume Washington, DC (1998). Human Services. 1992. 35:267–274 (1993). 34. Epstein WL. ‘‘Cutaneous Effects of 3. Hardy HL, Tabershaw IR. ‘‘Delayed 18. Health Assessment Document for Beryllium.’’ In: Beryllium Biomedical and Chemical Pneumonitis Occurring in Beryllium [Publication No. EPA/600/8–84/ Environmental Aspects. Rossman MD, Workers Exposed to Beryllium 026F] U.S. Environmental Protection Preuss OP, and Powers MB, eds. Baltimore: Compounds.’’ Journal of Industrial Hygiene Agency. (1987). Williams and Wilkins, 1991. Toxicology, Volume 28:197 (1946). 19. Stange AW et al. ‘‘Possible Health Risks 35. Sanderson WT et. al. ‘‘Beryllium 4. Powers MB. ‘‘History of Beryllium.’’ In from Low Level Exposure to Beryllium.’’ Contamination Inside Vehicles of Machine Beryllium Biomedical and Environmental Toxicology, Volume 111:213–224 (1996). Shop Workers.’’ Applied Occupational Aspects. Rossman MD, Preuss OP, and 20. Barnard AE, et al. ‘‘Retrospective Environmental Hygiene, Volume 14:223– Powers MB, eds. Baltimore: Williams and 230 (1999). Wilkins, 1991. Beryllium Exposure Assessment at the 5. Eisenbud M et al. ‘‘Non-occupational Rocky Flats Environmental Technology Appendix B to the Preamble— Berylliosis.’’ Journal of Industrial Hygiene Site.’’ American Industrial Hygiene Questions and Answers Concerning the Association Journal, Volume 57:804–808 Toxicology, Volume 31:282–294 (1949). Beryllium-Induced Lymphocyte 6. Eisenbud M, Lisson J. ‘‘Epidemiologic (1996). 21. Kreiss K et al. ‘‘Machining Risk of Proliferation Test (Be-LPT), Medical Aspects of Beryllium-Induced Records, and the Department of Energy Nonmalignant Lung Disease: A 30–Year Beryllium Disease and Sensitization with µ 3 (DOE) Beryllium Registry Update.’’ Journal of Occupational Median Exposures Below 2 g/m ,’’ Medicine, Volume 25:196–202 (1983). American Journal of Industrial Medicine, What Is the Be-LPT Blood Test? 7. Sterner JH, Eisenbud M. ‘‘Epidemiology of Volume 30:16–25 (1996). Beryllium Intoxication.’’ Archives of 22. Kreiss K, Mroz M, Zhen B, Wiedemann In the Be-LPTs, disease-fighting blood Industrial Hygiene and Occupational H, Barna B. Risks of beryllium disease cells that are normally found in the Medicine, Volume 4:123–157 (1951). related to work processes at a metal, alloy, body, called lymphocytes, are examined 8. Newman LS, Kreiss K. ‘‘Nonoccupational and oxide production plant. Occupational in the laboratory and separated from Beryllium Disease Masquerading as and Environmental Medicine, Volume your blood. Beryllium and other test Sarcoidosis: Identification by Blood 54:605–612 (1997). agents are then added to small groups of Lymphocyte Proliferative Response to 23. Cohen BS. ‘‘Air Sampling.’’ In: Beryllium Biomedical and Environmental Aspects. these lymphocytes. If these lymphocytes Beryllium.’’ American Review of react to the beryllium in a specific way, Respiratory Disease, Volume 145:1212– Rossman MD, Preuss OP, and Powers MB, 1214 (1992). eds. Baltimore: Williams and Wilkins, the test results are ‘‘positive.’’ If they do 9. Tepper LB. ‘‘Introduction.’’ In: Beryllium 1991. not react to beryllium, the test is Biomedical and Environmental Aspects. 24. Finch GL. ‘‘In Vitro Dissolution ‘‘negative.’’ Rossman MD, Preuss OP, and Powers MB, Characteristics of Beryllium Oxide and Experts believe that the Be-LPT shows eds. Baltimore: Williams and Wilkins, Beryllium Metal Aerosols.’’ Journal of positive results in individuals who have 1991. Aerosols Science, Volume 19:333–342 become sensitive or allergic to 10. Sprince NL, Kazemi H. ‘‘Beryllium (1988). beryllium. It is unclear what this 2∂ 2∂ Disease.’’ In: Environmental and 25. Newman LS. ‘‘To Be or Not to Be : sensitivity means. Studies have shown Occupational Medicine, 2nd ed. Room W, Immunogenetics and Occupational Exposure.’’ Science, Volume 262:197–198 it to be an early sign of chronic ed. Boston: Little, Brown, 1992. beryllium disease (CBD) in many 11. Newman LS et al. ‘‘Pathologic and (8 October 1993). Immunologic Alterations in Early Stages of 26. Haley PJ. ‘‘Mechanisms of Granulomatous individuals. In others, sensitivity might Beryllium Disease. Reexamination of Lung Disease from Inhaled Beryllium: The simply mean that the person was Disease Definition and Natural History.’’ Role of Antigenicity in Granuloma exposed to beryllium and that his or her American Review of Respiratory Disease, Formation.’’ Toxicologic Pathology, body has reacted. It might mean that an Volume 139:1479–11486, (1989). Volume 19:514–525 (1991). individual is more likely than others to 12. Kreiss K, Newman LS, Mroz MM, 27. Finch GL. ‘‘Clearance, Translocation, and get CBD. You are being offered the Be- Campbell, PA. ‘‘Screening Blood Test Excretion of Beryllium Following LPT because doctors believe it is useful Inhalation of Beryllium Oxide by Beagle Identifies Subclinical Beryllium Disease.’’ in detecting cases of CBD early or cases Journal of Occupational Medicine, Volume Dogs.’’ Fundamentals of Applied 31:603–608 (1989). Toxicology, Volume 15:231–241 (1990). that might otherwise be missed or 13. Rossman MD, Kern JA, Elias JA et al. 28. Richeldi L et al. ‘‘HLA-DPB1 Glutamate diagnosed as another type of lung ‘‘Proliferative Response of Bronchoalveolar 69: A Genetic Marker of Beryllium problem. Once CBD is identified, Lymphocytes to Beryllium: A Test For Disease.’’ Science, Volume 262:242–244 (8 doctors can determine the treatment that Chronic Beryllium Disease.’’ Annals of October 1993). is needed to minimize the lung damage Internal Medicine, Volume 108:687–693 29. Eisenbud M. ‘‘The Standard for Control that CBD causes. (1988). of Chronic Beryllium Disease.’’ Applied As in any other medical test, the Be- 14. Saltini C, Winestock K, Kirby M et al. Occupational Environmental Hygiene, LPT sometimes fails or provides unclear ‘‘Maintenance of Alveolitis in Patients with Volume 13(1):25–31 (January 1998). results. The laboratory calls these Chronic Beryllium Disease by Beryllium 30. Pappas GP et al. ‘‘Early Pulmonary Specific Helper T-Cells.’’ New England Physiologic Abnormalities in Beryllium results ‘‘uninterpretable.’’ Even when Journal of Medicine, Volume 320:103–1109 Disease.’’ American Review of Respiratory the test appears successful, it may (1989). Disease, Volume 148:661–666 (1993). appear positive when a person is not 15. Cullen MR et al. ‘‘Chronic Beryllium 31. Yoshida T et. al. ‘‘A Study on the sensitive or allergic to beryllium. This is Disease in a Metal Refinery. Clinical Beryllium Lymphocyte Transformation called a ‘‘false positive’’ result. It is also

VerDate 29-OCT-99 10:58 Dec 07, 1999 Jkt 190000 PO 00000 Frm 00051 Fmt 4701 Sfmt 4700 E:\FR\FM\A08DE0.249 pfrm04 PsN: 08DER3 68904 Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 / Rules and Regulations possible that the test will show requested when the extra tests are given. results in your medical records will be ‘‘negative’’ results when a person is You can always refuse additional tests, kept in specially secured files under the actually ‘‘sensitized’’ to beryllium. This if you so choose. Your employer will supervision of physicians and nurses in is a ‘‘false negative’’ result. If you have pay for all tests. the clinic, separate from other personnel a ‘‘uninterpretable’’ blood Be-LPT records. Your test results will be When Will I Receive the Results of My result, you will be asked to provide medically confidential data and will not Be-LPT Blood Test? another blood sample so the test can be be released to anyone other than those repeated. If you have ‘‘positive’’ results, It could take 2 to 4 weeks for you to listed in the following, unless you you will be offered further medical tests receive a letter informing you of your provide written permission. The to confirm or rule out CBD. Remember test results. The test itself usually takes following groups will have direct access that you may refuse further tests at this 8 days to perform. The testing laboratory to this information: point or at any point during your reports results to the physician who 1. Clinic staff members; medical evaluations. examined you and he or she will notify 2. Medical specialists who will It is important for you to know that you. provide or arrange for additional if the physical examination or the medical treatment or tests, if necessary; Could a Positive Be-LPT Blood Test results from other tests you are receiving 3. U.S. Department of Energy suggest that you have CBD, you may be Affect My Job Assignment? Beryllium Registry staff; and offered further medical tests. These Yes. If you have a positive Be-LPT or 4. The Centers for Disease Control and medical tests may be offered even if have been diagnosed with CBD, your Prevention and the National Institute for your Be-LPT is ‘‘negative.’’ employer may inform you that the Occupational Safety and Health officials Some individuals with confirmed SOMD has recommended that you be may require direct access to records that ‘‘positive’’ Be-LPTs but no other signs of temporarily or permanently removed identify you by name for health studies. CBD have developed the disease. The from working with beryllium. You will If information about you is used in likelihood of this happening will only be given information and counseling to reports or a published health study, be known after large groups of help you decide whether to accept your identity will be disguised. You will potentially exposed individuals have medical removal. If you agree to medical not be identified in any published had their blood tested, have had further removal, every effort will be made to report or presentation. medical tests, and are studied for many offer you another job that you are What Laws Protect Me if I Consent To years. qualified (or can be trained for in a short Participate in the Blood Be-LPT Testing period) to perform and where the Do I Have To Have the Be-LPT Done? Program? beryllium exposures will be as low as No. Your participation in the medical possible, but in no case above the action State medical and nursing licensing surveillance program is strictly level. boards enforce codes of ethics that voluntary. You may refuse any of the If you are temporarily removed, you require doctors and nurses to keep tests offered to you, including the Be- will maintain your total normal medical information confidential. The LPT. If you change your mind, you are earnings, seniority, and other benefits Privacy Act prevents unauthorized free to participate in the program at any until you are placed in another job for access to your DOE records without time. Talking with your family, your 1 year, whichever comes first. If you are your permission. The information in doctor, or other people you trust may permanently removed, you will records kept by your employer must be help you decide. The physicians in the maintain your total normal earnings, handled in accordance with the clinic that provide the tests can also seniority, and other benefits until you Americans with Disabilities Act and the help answer any questions that you are placed in another job or for 2 years, Privacy Act of 1974. The consent form might have. whichever comes first. If you become you sign also provides additional protection. What Will Happen if I Decide To Have physically unable to continue working, the Be-LPT Blood Test? you may be eligible for workers’ Can My Privacy and the Confidentiality compensation and other benefits. A small amount of your blood will be of My Medical Records Be Guaranteed? drawn from a vein in your arm and sent Will I Lose Any Pay or Any Other No. Access to or release of records to a laboratory. There is little physical Benefits by Having the Examination could be required under court order, or risk in drawing blood. Slight pain and During Normal Working Hours? DOE directive, but it is unlikely. It bruising may occur in a few individuals. No. Your examination will be would also be available as the Freedom Rarely, the needle puncture will become scheduled during normal work hours. of Information Act or Privacy Act infected. Other routine medical You will not be required to take leave provide, such as to Congress, to an evaluation tests may be offered when to have the examination, nor will you individual upon a showing of you have the Be-LPTs including a lose pay or any other benefits. compelling circumstances affecting the physical examination, a chest X-ray, and health and safety of an individual, etc. breathing tests that help find signs of What Will Happen to the Records of the If you apply for another job or for CBD, if they exist. Medical Examination Results? insurance, you may be requested to Other diseases may resemble CBD. The results of your Be-LPT and other release the records to a future employer Different medical tests can help a screening tests will be made available to or an insurance company. If, for medical physician decide if a person has CBD or you and, with your consent, to your reasons, it is recommended that you another disease. If the examining physician. The information also will transfer to an area where you will not physician suspects that you have CBD, become part of your medical record, contact beryllium, and you elect to do he or she will recommend additional which the clinic keeps. so, the personnel department and your medical tests to help confirm a The results of tests and examinations supervisor will be notified. They will diagnosis. Separate information in your medical record will be available not be told the specific results of your regarding these additional medical tests to the physicians and nurses in this tests but, because of the restrictions, will be given to you if they are clinic, and possibly to scientists they may assume that your Be-LPT recommended. Your consent will be conducting health studies. The test results were positive.

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What Is the DOE Beryllium Registry? PART 850ÐCHRONIC BERYLLIUM (3) Any current DOE employee, DOE DISEASE PREVENTION PROGRAM contractor employee, or other worker at Your health and the health of all a DOE facility who is or was exposed or workers is a major concern to DOE. Subpart AÐGeneral Provisions potentially exposed to beryllium at a There is a need to learn more about Sec. DOE facility. chronic beryllium disease and what 850.1 Scope. (b) This part does not apply to: causes some individuals to react more 850.2 Applicability. (1) Beryllium articles; and strongly than others do. A DOE 850.3 Definitions. (2) DOE laboratory operations that beryllium registry has been established 850.4 Enforcement. meet the definition of laboratory use of 850.5 Dispute resolution. to collect and maintain information on hazardous chemicals in 29 CFR workers who are exposed to beryllium. Subpart BÐAdministrative Requirements 1910.1450, Occupational Exposure to This registry is a tool that will be used 850.10 Development and approval of the Hazardous Chemical in Laboratories. CBDPP. in health studies to better understand § 850.3 Definitions. the nature of the disease. With it we can 850.11 General CBDPP requirements. 850.12 Implementation. (a) As used in this part: measure the burden of health effects 850.13 Compliance. Action level means the level of related to beryllium exposure. The Subpart CÐSpecific Program Requirements airborne concentration of beryllium registry will also be used to evaluate the established pursuant to section 850.23 effectiveness of exposure control 850.20 Baseline beryllium inventory. of this part that, if met or exceeded, programs. 850.21 Hazard assessment. 850.22 Permissible exposure limit. requires the implementation of worker In addition to information about your 850.23 Action level. protection provisions specified in that beryllium-related exposures, the results 850.24 Exposure monitoring. section. of beryllium sensitization testing and/or 850.25 Exposure reduction and Authorized person means any person CBD status collected by your employer minimization. required by work duties to be in a will be added to the registry. Your 850.26 Regulated areas. regulated area. 850.27 Hygiene facilities and practices. employer must treat this information as Beryllium means elemental beryllium 850.28 Respiratory protection. and any insoluble beryllium compound confidential medical information and 850.29 Protective clothing and equipment. can only use or disclose this or alloy containing 0.1 percent 850.30 Housekeeping. beryllium or greater that may be information in conformance with the 850.31 Release criteria. released as an airborne particulate. Privacy Act of 1974, the Americans with 850.32 Waste disposal. 850.33 Beryllium emergencies. Beryllium activity means an activity Disabilities Act, and other applicable taken for, or by, DOE at a DOE facility laws. Your employer will establish a 850.34 Medical surveillance. 850.35 Medical removal. that can expose workers to airborne unique identifier for you that will be 850.36 Medical consent. beryllium, including but not limited to included in the registry instead of your 850.37 Training and counseling. design, construction, operation, personal identifying information (such 850.38 Warning signs and labels. maintenance, or decommissioning, and as your name and social security 850.39 Recordkeeping and use of which may involve one DOE facility or number). The unique identifier will be information. operation or a combination of facilities 850.40 Performance feedback. used to inform your employer of any and operations. study results that you and your Appendix A to Part 850—Chronic Beryllium Beryllium article means a employer’s Site Occupational Medical Disease Prevention Program Informed manufactured item that is formed to a Director (SOMD) should know about. Consent Form. specific shape or design during The SOMD will know to whom the Authority: 42 U.S.C. 2201(i)(3), (p); 29 manufacture, that has end-use functions unique identifier refers and will notify U.S.C. 668; E.O. 12196, 3 CFR 1981 comp., that depend in whole or in part on its you of these results. At no time will p. 145 as amended. shape or design during end use, and that does not release beryllium or otherwise your name or other personal identifying Subpart AÐGeneral Provisions information be included in any report. result in exposure to airborne The confidentiality of personal § 850.1 Scope. concentrations of beryllium under normal conditions of use. information in DOE records is protected This part establishes a chronic under the Privacy Act of 1974. Beryllium-associated worker means a beryllium disease prevention program current worker who is or was exposed List of Subjects in 10 CFR Part 850 (CBDPP) that supplements and is or potentially exposed to airborne integrated into existing worker concentrations of beryllium at a DOE Beryllium, Chronic beryllium disease, protection programs that are established facility, including: Hazardous substances, Lung diseases, for Department of Energy (DOE) (1) A beryllium worker; Occupational safety and health, employees and DOE contractor (2) A current worker whose work Reporting and recordkeeping employees. history shows that the worker may have requirements. § 850.2 Applicability. been exposed to airborne concentrations of beryllium at a DOE facility; Issued in Washington, D.C., on November (a) This part applies to: 24, 1999. (3) A current worker who exhibits (1) DOE offices responsible for signs or symptoms of beryllium Bill Richardson, operations or activities that involve exposure; and Secretary of Energy. present or past exposure, or the (4) A current worker who is receiving For the reason set forth in the potential for exposure, to beryllium at medical removal protection benefits. preamble, Title 10, Chapter III of the DOE facilities; Beryllium emergency means any Code of Federal Regulations is amended (2) DOE contractors with operations occurrence such as, but not limited to, by adding a new part 850 as set forth or activities that involve present or past equipment failure, container rupture, or below. exposure, or the potential for exposure, failure of control equipment or to beryllium at DOE facilities; and operations that results in an unexpected

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(1) The Beryllium worker means a current Site Occupational Medical Director responsible employer at a DOE facility worker who is regularly employed in a (SOMD) means the physician must ensure that a CBDPP is prepared DOE beryllium activity. responsible for the overall direction and for the facility and submitted to the Breathing zone is defined as a operation of the site occupational appropriate Head of DOE Field Element hemisphere forward of the shoulders, medicine program. before beginning beryllium activities, centered on the mouth and nose, with Unique identifier means the part of a but no later than April 6, 2000 of this a radius of 6 to 9 inches. paired set of labels, used in records that part. DOE means the U.S. Department of contain confidential information, that (2) If the CBDPP has separate sections Energy. does not identify individuals except by addressing the activities of multiple DOE contractor means any entity using the matching label. contractors at the facility, the Head of under contract with DOE (or its Worker means a person who performs DOE Field Element will designate a subcontractor) that has responsibility for work for or on behalf of DOE, including single DOE contractor to review and performing beryllium activities at DOE a DOE employee, an independent approve the sections prepared by other facilities. contractor, a DOE contractor or contractors, so that a single consolidated DOE facility means any facility subcontractor employee, or any other CBDPP for the facility is submitted to operated by or for DOE. person who performs work at a DOE the Head of DOE Field Element for Head of DOE Field Element means an facility. review and approval. individual who is the manager or head Worker exposure means the exposure (b) DOE review and approval. The of the DOE operations office or field of a worker to airborne beryllium that appropriate Head of DOE Field Element office, or any official to whom the Head would occur if the worker were not must review and approve the CBDPP. of DOE Field Element delegates his or using respiratory protective equipment. (1) The initial CBDPP and any her functions under this part. (b) Terms undefined in this part that updates are deemed approved 90 days High-efficiency particulate air (HEPA) are defined in the Atomic Energy Act of after submission if they are not filter means a filter capable of trapping 1954 shall have the same meaning as specifically approved or rejected by and retaining at least 99.97 percent of under that Act. DOE earlier. 0.3 micrometer monodispersed (2) The responsible employer must particles. § 850.4 Enforcement. furnish a copy of the approved CBDPP, Immune response refers to the series DOE may take appropriate steps upon request, to the DOE Assistant of cellular events by which the immune under its contracts with DOE Secretary for Environment, Safety and system reacts to challenge by an antigen. contractors to ensure compliance with Health or designee, DOE program Medical removal protection benefits this part. These steps include, but are offices, and affected workers or their means the employment rights not limited to, contract termination or designated representatives. established by section 850.35 of this reduction in fee. (c) Update. The responsible employer part for beryllium-associated workers must submit an update of the CBDPP to § 850.5 Dispute resolution. who voluntarily accept temporary or the appropriate Head of DOE Field permanent medical removal from (a) Subject to paragraphs (b) and (c) of Element for review and approval beryllium areas following a this section, any worker who is whenever a significant change or recommendation by the Site adversely affected by an action taken, or significant addition to the CBDPP is Occupational Medicine Director. failure to act, under this part may made or a change in contractors occurs. Operational area means an area where petition the Office of Hearings and The Head of DOE Field Element must workers are routinely in the presence of Appeals for relief in accordance with 10 review the CBDPP at least annually and, beryllium as part of their work activity. CFR part 1003, Subpart G. if necessary, require the responsible Regulated area means an area (b) The Office of Hearings and employer to update the CBDPP. demarcated by the responsible employer Appeals may not accept a petition from (d) Labor Organizations. If a in which the airborne concentration of a worker unless the worker requested responsible employer employs or beryllium exceeds, or can reasonably be the responsible employer to correct the supervises beryllium-associated workers expected to exceed, the action level. violation, and the responsible employer who are represented for collective Removable contamination means refused or failed to take corrective bargaining by a labor organization, the beryllium contamination that can be action within a reasonable time. responsible employer must: removed from surfaces by (c) If the dispute relates to a term or (1) Give the labor organization timely nondestructive means, such as casual condition of employment that is covered notice of the development and contact, wiping, brushing or washing. by a grievance-arbitration provision in a implementation of the CBDPP and any Responsible employer means: collective bargaining agreement, the updates thereto; and (1) For DOE contractor employees, the worker must exhaust all applicable (2) Upon timely request, bargain DOE contractor office that is directly grievance-arbitration procedures before concerning implementation of this part, responsible for the safety and health of filing a petition for relief with the Office consistent with the Federal labor laws. DOE contractor employees while of Hearings and Appeals. A worker is performing a beryllium activity or other deemed to have exhausted all applicable § 850.11 General CBDPP requirements. activity at a DOE facility; or grievance-arbitration procedures if 150 (a) The CBDPP must specify the (2) For DOE employees, the DOE days have passed since the filing of a existing and planned operational tasks office that is directly responsible for the grievance and a final decision on it has that are within the scope of the CBDPP. safety and health of DOE Federal not been issued. The CBDPP must augment and, to the

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(c) With respect to a particular the permissible exposure limit (1) Include formal plans and measures established in 29 CFR 1910.1000, as for maintaining exposures to beryllium beryllium activity, the contractor in charge of the activity is responsible for measured in the worker’s breathing zone at or below the permissible exposure by personal monitoring, or a more level prescribed in § 850.22; complying with this part. If no contractor is responsible for a beryllium stringent TWA PEL that may be (2) Satisfy each requirement in activity, DOE must ensure promulgated by the Occupational Safety subpart C of this part; implementation of, and compliance and Health Administration as a health (3) Contain provisions for: with, this part. standard. (i) Minimizing the number of workers § 850.23 Action level. exposed and potentially exposed to Subpart CÐSpecific Program (a) The responsible employer must beryllium; Requirements include in its CBDPP an action level (ii) Minimizing the number of § 850.20 Baseline beryllium inventory. that is no greater than 0.2 µg/m3, opportunities for workers to be exposed (a) The responsible employer must calculated as an 8-hour TWA exposure, to beryllium; develop a baseline inventory of the as measured in the worker’s breathing (iii) Minimizing the disability and lost locations of beryllium operations and zone by personal monitoring. work time of workers due to chronic other locations of potential beryllium (b) If an airborne concentration of beryllium disease, beryllium contamination, and identify the workers beryllium is at or above the action level, sensitization and associated medical exposed or potentially exposed to the responsible employer must care; and beryllium at those locations. implement §§ 850.24(c) (periodic (iv) Setting specific exposure (b) In conducting the baseline monitoring), 850.25 (exposure reduction reduction and minimization goals that inventory, the responsible employer and minimization), 850.26 (regulated are appropriate for the beryllium must: areas), 850.27 (hygiene facilities and activities covered by the CBDPP to (1) Review current and historical practices), 850.28 (respiratory further reduce exposure below the records; protection), 850.29 (protective clothing permissible exposure limit prescribed in (2) Interview workers; and equipment), and 850.38 (warning § 850.22. (3) Document the characteristics and signs) of this part. locations of beryllium at the facility; § 850.12 Implementation. and § 850.24 Exposure monitoring. (a) The responsible employer must (4) Conduct air, surface, and bulk (a) General. The responsible employer manage and control beryllium sampling. must ensure that: (1) Exposure monitoring is managed exposures in all DOE beryllium (c) The responsible employer must by a qualified individual (e.g., a activities consistent with the approved ensure that: certified industrial hygienist); and CBDPP. (1) The baseline beryllium inventory is managed by a qualified individual (2) The individuals assigned to this (b) No person employed by DOE or a (e.g., a certified industrial hygienist); task have sufficient industrial hygiene DOE contractor may take or cause any and knowledge and experience to perform action inconsistent with the (2) The individuals assigned to this such activities properly. requirements of: task have sufficient knowledge and (b) Initial monitoring. The responsible (1) This part, experience to perform such activities employer must perform initial (2) An approved CBDPP, and properly. monitoring in areas that may have (3) Any other Federal statute or airborne beryllium, as shown by the regulation concerning the exposure of § 850.21 Hazard assessment. baseline inventory and hazard workers to beryllium at DOE facilities. (a) If the baseline inventory assessment. The responsible employer establishes the presence of beryllium, must apply statistically-based (c) No task involving potential the responsible employer must conduct monitoring strategies to obtain a exposure to airborne beryllium that is a beryllium hazard assessment that sufficient number of sample results to outside the scope of the existing CBDPP includes an analysis of existing adequately characterize exposures, may be initiated until an update of the conditions, exposure data, medical before reducing or terminating CBDPP is approved by the Head of DOE surveillance trends, and the exposure monitoring. Field Element, except in an unexpected potential of planned activities. The (1) The responsible employer must situation and, then, only upon approval exposure determinants, characteristics determine workers’ 8-hour TWA of the Head of DOE Field Element. and exposure potential of activities exposure levels by conducting personal (d) Nothing in this part precludes a must be prioritized so that the activities breathing zone sampling. responsible employer from taking any with the greatest risks of exposure are (2) Exposure monitoring results additional protective action that it evaluated first. obtained within the 12 months determines to be necessary to protect (b) The responsible employer must preceding the effective date of this part the health and safety of workers. ensure that: may be used to satisfy this requirement (e) Nothing in this part affects the (1) The hazard assessment is managed if the measurements were made as responsibilities of DOE officials under by a qualified individual (e.g., a provided in paragraph (b)(1) of this the Federal Employee Occupational certified industrial hygienist); and section. Safety and Health Program (29 CFR part (2) The individuals assigned to this (c) Periodic exposure monitoring. The 1960) and related DOE directives. task have sufficient knowledge and responsible employer must conduct

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This periodic exposure addition: from exiting areas that contain monitoring must be performed at least (1) Where exposure levels are at or beryllium with contamination on their every 3 months (quarterly). above the action level, establish a formal bodies or their personal clothing. (b) Change rooms or areas. The (d) Additional exposure monitoring. exposure reduction and minimization responsible employer must provide The responsible employer must perform program to reduce exposure levels to clean change rooms or areas for additional monitoring if operations, below the action level, if practicable. beryllium workers who work in maintenance or procedures change, or This program must be described in the regulated areas. when the responsible employer has any responsible employer’s CBDPP and (1) Separate facilities free of beryllium reason to suspect such a change has must include: must be provided for beryllium workers occurred. (i) Annual goals for exposure reduction and minimization; to change into, and store, personal (e) Accuracy of monitoring. The (ii) A rationale for and a strategy for clothing, and clean protective clothing responsible employer must use a meeting the goals; and equipment to prevent cross- method of monitoring and analysis that (iii) Actions that will be taken to contamination; has an accuracy of not less than plus or achieve the goals; and (2) The change rooms or areas that are minus 25 percent, with a confidence (iv) A means of tracking progress used to remove beryllium-contaminated level of 95 percent, for airborne towards meeting the goals or clothing and protective equipment must concentrations of beryllium at the action demonstrating that the goals have been be maintained under negative pressure level. met. or located so as to minimize dispersion (f) Analysis. The responsible (2) Where exposure levels are below of beryllium into clean areas; and employer must have all samples the action level, implement actions for (c) Showers and handwashing collected to satisfy the monitoring reducing and minimizing exposures, if facilities. (1) The responsible employer requirements of this part analyzed in a practicable. The responsible employer must provide handwashing and shower laboratory accredited for metals by the must include in the CBDPP a facilities for beryllium workers who American Industrial Hygiene description of the steps to be taken for work in regulated areas. Association (AIHA) or a laboratory that exposure reduction and minimization (2) The responsible employer must demonstrates quality assurance for and a rationale for those steps. assure that beryllium workers who work metals analysis that is equivalent to (c) The responsible employer must in regulated areas shower at the end of AIHA accreditation. implement exposure reduction and the work shift. minimization actions using the (d) Lunchroom facilities. (1) The (g) Notification of monitoring results. conventional hierarchy of industrial responsible employer must provide (1) The responsible employer must, hygiene controls (i.e., engineering lunchroom facilities that are readily within 10 working days after receipt of controls, administrative controls, and accessible to beryllium workers, and any monitoring results, notify the personal protective equipment in that ensure that tables for eating are free of affected workers of monitoring results in order). beryllium, and that no worker in a writing. This notification of monitoring lunchroom facility is exposed at any results must be: § 850.26 Regulated areas. time to beryllium at or above the action (i) Made personally to the affected (a) If airborne concentrations of level. worker; or beryllium in areas in DOE facilities are (2) The responsible employer must (ii) Posted in location(s) that is readily measured at or above the action level, assure that beryllium workers do not accessible to the affected worker, but in the responsible employer must establish enter lunchroom facilities with a manner that does not identify the regulated areas for those areas. protective work clothing or equipment individual to other workers. (b) The responsible employer must unless the surface beryllium has been demarcate regulated areas from the rest removed from clothing and equipment (2) If the monitoring results indicate of the workplace in a manner that by HEPA vacuuming or other method that a worker’s exposure is at or above adequately alerts workers to the that removes beryllium without the action level, the responsible boundaries of such areas. dispersing it. employer must include in the notice: (c) The responsible employer must (e) The change rooms or areas, shower (i) A statement that the action level limit access to regulated areas to and handwashing facilities, and has been met or exceeded; and authorized persons. lunchroom facilities must comply with (d) The responsible employer must (ii) A description of the corrective 29 CFR 1910.141, Sanitation. keep records of all individuals who action being taken by the responsible enter regulated areas. These records § 850.28 Respiratory protection. employer to reduce the worker’s must include the name, date, time in (a) The responsible employer must exposure to below the action level, if and time out, and work activity. establish a respiratory protection practicable. program that complies with the (3) If the monitoring results indicate § 850.27 Hygiene facilities and practices. respiratory protection program that worker exposure is at or above the (a) General. The responsible employer requirements of 29 CFR 1910.134, action level, the responsible employer must assure that in areas where workers Respiratory Protection. must also notify DOE and the SOMD of are exposed to beryllium at or above the (b) The responsible employer must these results within 10 working days action level, without regard to the use provide respirators to, and ensure that after receipt. of respirators: they are used by, all workers who:

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(1) Are exposed to an airborne full-body protective clothing and and change the filters as often as needed concentration of beryllium at or above footwear before they begin work in to maintain their capture efficiency. the action level, or regulated areas. (d) The responsible employer must (2) Are performing tasks for which (d) The responsible employer must ensure that the cleaning equipment that analyses indicate the potential for ensure that no worker removes is used to clean beryllium-contaminated exposures at or above the action level. beryllium-contaminated protective surfaces is labeled, controlled, and not (c) The responsible employer must clothing and equipment from areas that used for non-hazardous materials. include in the respiratory protection contain beryllium, except for workers § 850.31 Release criteria. program any beryllium-associated authorized to launder, clean, maintain, worker who requests to use a respirator or dispose of the clothing and (a) The responsible employer must for protection against airborne equipment. clean beryllium-contaminated beryllium, regardless of measured (e) The responsible employer must equipment and other items to the lowest exposure levels. prohibit the removal of beryllium from contamination level practicable, but not (d) The responsible employer must protective clothing and equipment by to exceed the levels established in select for use by workers: blowing, shaking, or other means that paragraphs (b) and (c) of this section, (1) Respirators approved by the may disperse beryllium into the air. and label the equipment or other items, National Institute for Occupational (f) The responsible employer must before releasing them to the general Safety and Health (NIOSH) if NIOSH- ensure that protective clothing and public or a DOE facility for non- approved respirators exist for a specific equipment is cleaned, laundered, beryllium use, or to another facility for DOE task; or repaired, or replaced as needed to work involving beryllium. (b) Before releasing beryllium- (2) Respirators that DOE has accepted maintain effectiveness. The responsible contaminated equipment or other items under the DOE Respiratory Protection employer must: to the general public or for use in a non- Acceptance Program if NIOSH-approved (1) Ensure that beryllium- beryllium area of a DOE facility, the respirators do not exist for specific DOE contaminated protective clothing and tasks. responsible employer must ensure that: equipment, when removed for (1) The removable contamination § 850.29 Protective clothing and laundering, cleaning, maintenance, or level of equipment or item surfaces does equipment. disposal, is placed in containers that not exceed the higher of 0.2 µg/100 cm 2 (a) The responsible employer must prevent the dispersion of beryllium dust or the concentration level of beryllium provide protective clothing and and that are labeled in accordance with in soil at the point or release, whichever equipment to beryllium workers and § 850.38 of this part; and is greater; ensure its appropriate use and (2) Inform organizations that launder (2) The equipment or item is labeled maintenance, where dispersible forms of or clean DOE beryllium-contaminated in accordance with § 850.38(b); and beryllium may contact worker’s skin, protective clothing or equipment that (3) The release is conditioned on the enter openings in workers’ skin, or exposure to beryllium is potentially recipient’s commitment to implement contact workers’ eyes, including where: harmful, and that clothing and controls that will prevent foreseeable (1) Exposure monitoring has equipment should be laundered or beryllium exposure, considering the established that airborne concentrations cleaned in a manner prescribed by the nature of the equipment or item and its of beryllium are at or above the action responsible employer to prevent the future use and the nature of the level; release of airborne beryllium. beryllium contamination. (2) Surface contamination levels § 850.30 Housekeeping. (c) Before releasing beryllium- measured or presumed prior to contaminated equipment or other items initiating work are above the level (a) Where beryllium is present in to another facility performing work with prescribed in § 850.30; operational areas of DOE facilities, the beryllium, the responsible employer (3) Surface contamination levels responsible employer must conduct must ensure that: results obtained to confirm routine surface sampling to determine (1) The removable contamination housekeeping efforts are above the level housekeeping conditions. Surfaces level of equipment or item surfaces does prescribed in § 850.30; and contaminated with beryllium dusts and not exceed 3 µg/100 cm 2; (4) Any beryllium-associated worker waste must not exceed a removable (2) The equipment or item is labeled µ 2 who requests the use of protective contamination level of 3 g/100 cm in accordance with § 850.38(b); and clothing and equipment for protection during non-operational periods. This (3) The equipment or item is enclosed against airborne beryllium, regardless of sampling would not include the interior or placed in sealed, impermeable bags measured exposure levels. of installed closed systems such as or containers to prevent the release of (b) The responsible employer must enclosures, glove boxes, chambers, or beryllium dust during handling and comply with 29 CFR 1910.132, Personal ventilation systems. transportation. Protective Equipment General (b) When cleaning floors and surfaces Requirements, when workers use in areas where beryllium is present at § 850.32 Waste disposal. personal protective clothing and DOE facilities, the responsible employer (a) The responsible employer must equipment. must clean beryllium-contaminated control the generation of beryllium- (c) The responsible employer must floors and surfaces using a wet method, containing waste, and beryllium- establish procedures for donning, vacuuming or other cleaning methods, contaminated equipment and other doffing, handling, and storing protective such as sticky tack cloths, that avoid the items that are disposed of as waste, clothing and equipment that: production of airborne dust. through the application of waste (1) Prevent beryllium workers from Compressed air or dry methods must minimization principles. exiting areas that contain beryllium not be used for such cleaning. (b) Beryllium-containing waste, and with contamination on their bodies or (c) The responsible employer must beryllium-contaminated equipment and their personal clothing; and equip the portable or mobile vacuum other items that are disposed of as (2) Include beryllium workers units that are used to clean beryllium- waste, must be disposed of in sealed, exchanging their personal clothing for contaminated areas with HEPA filters, impermeable bags, containers, or

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The medical protective and respiratory protective evaluation must include the § 850.33 Beryllium emergencies. equipment used by the worker in the requirements of paragraph (b)(2) of this (a) The responsible employer must past, present, or anticipated future use. section. comply with 29 CFR 1910.120(l) for (b) Medical evaluations and (c) Multiple physician review. The handling beryllium emergencies related procedures. The responsible employer responsible employer must establish a to decontamination and must provide, to beryllium-associated multiple physician review process for decommissioning operations. workers who voluntarily participate in beryllium-associated workers that (b) The responsible employer must the medical surveillance program, the allows for the review of initial medical comply with 29 CFR 1910.120(q) for medical evaluations and procedures findings, determinations, or handling beryllium emergencies related required by this section at no cost and recommendations from any medical to all other operations. at a time and place that is reasonable evaluation conducted pursuant to and convenient to the worker. paragraph (b) of this section. § 850.34 Medical surveillance. (1) Baseline medical evaluation. The (1) If the responsible employer selects (a) General. (1) The responsible responsible employer must provide a the initial physician to conduct any employer must establish and implement baseline medical evaluation to medical examination or consultation a medical surveillance program for beryllium-associated workers. This provided to a beryllium-associated beryllium-associated workers who evaluation must include: voluntarily participate in the program. (i) A detailed medical and work worker, the worker may designate a (2) The responsible employer must history with emphasis on past, present, second physician to: designate a Site Occupational Medical and anticipated future exposure to (i) Review any findings, Director (SOMD) who is responsible for beryllium; determinations, or recommendations of administering the medical surveillance (ii) A respiratory symptoms the initial physician; and program. questionnaire; (ii) Conduct such examinations, (3) The responsible employer must (iii) A physical examination with consultations and laboratory tests, as the ensure that the medical evaluations and special emphasis on the respiratory second physician deems necessary to procedures required by this section are system, skin and eyes; facilitate this review. performed by, or under the supervision (iv) A chest radiograph (posterior- (2) The responsible employer must of, a licensed physician who is familiar anterior, 14 x 17 inches) interpreted by promptly notify a beryllium-associated with the health effects of beryllium. a National Institute for Occupational worker in writing of the right to seek a (4) The responsible employer must Safety and Health (NIOSH) B-reader of second medical opinion after the initial establish, and maintain, a list of pneumoconiosis or a board-certified physician provided by the responsible beryllium-associated workers who may radiologist (unless a baseline chest employer conducts a medical be eligible for protective measures radiograph is already on file); examination or consultation. under this part. The list must be: (v) Spirometry consisting of forced (3) The responsible employer may (i) Based on the hazard assessment, vital capacity (FVC) and forced condition its participation in, and exposure records, and other information expiratory volume at 1 second (FEV1); payment for, multiple physician review regarding the identity of beryllium- (vi) A Be-LPT; and upon the beryllium-associated worker associated workers; and (vii) Any other tests deemed doing the following within fifteen (15) (ii) Adjusted at regular intervals based appropriate by the examining physician days after receipt of the notice, or on periodic evaluations of beryllium- for evaluating beryllium-related health receipt of the initial physician’s written associated workers performed under effects. opinion, whichever is later: paragraph (b)(2) of this section; (2) Periodic evaluation. (i) The (i) Informing the responsible responsible employer must provide to (5) The responsible employer must employer in writing that he or she beryllium workers a medical evaluation provide the SOMD with the information intends to seek a second medical annually, and to other beryllium- needed to operate and administer the opinion; and associated workers a medical evaluation medical surveillance program, including (ii) Initiating steps to make an every three years. The periodic medical the: appointment with a second physician. (i) List of beryllium-associated evaluation must include: (4) If the findings, determinations, or workers required by paragraph (a)(4) of (A) A detailed medical and work recommendations of the second this section; history with emphasis on past, present, (ii) Baseline inventory; and anticipated future exposure to physician differ from those of the initial (iii) Hazard assessment and exposure beryllium; physician, then the responsible monitoring data; (B) A respiratory symptoms employer and the beryllium-associated (iv) Identity and nature of activities or questionnaire; worker must make efforts to encourage operations on the site that are covered (C) A physical examination with and assist the two physicians to resolve under the CBDPP, related duties of emphasis on the respiratory system; any disagreement. beryllium-associated workers; and (D) A Be-LPT; and (5) If, despite the efforts of the (v) Type of personal protective (E) Any other medical evaluations responsible employer and the equipment used. deemed appropriate by the examining beryllium-associated worker, the two (6) The responsible employer must physician for evaluating beryllium- physicians are unable to resolve their provide the following information to the related health effects. disagreement, then the responsible SOMD and the examining physician: (ii) The responsible employer must employer and the worker, through their (i) A copy of this rule and its provide to beryllium-associated workers respective physicians, must designate a preamble; a chest radiograph every five years. third physician to:

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(i) Review any findings, SOMD must provide each beryllium- (i) In this section, ‘‘final medical determinations, or recommendations of associated worker with a written determination’’ means the outcome of the other two physicians; and medical opinion containing the results the multiple physician review process (ii) Conduct such examinations, of all medical tests or procedures, an or the alternate medical determination consultations, laboratory tests, and explanation of any abnormal findings, process provided for in paragraphs (c) consultations with the other two and any recommendation that the and (d) of § 850.34. physicians, as the third physician worker be referred for additional testing (ii) If a beryllium-associated worker is deems necessary to resolve the for evidence of CBD, within 10 working temporarily removed from beryllium disagreement among them. days after the SOMD’s receipt of the exposure pursuant to this section, the (6) The SOMD must act consistently results of the medical tests or responsible employer must transfer the with the findings, determinations, and procedures. worker to a comparable job for which recommendations of the third (2) The responsible employer must, the worker is qualified (or for which the physician, unless the SOMD and the within 30 days after a request by a worker can be trained in a short period) beryllium-associated worker reach an beryllium-associated worker, provide and where beryllium exposures are as agreement that is consistent with the the worker with the information the low as possible, but in no event at or recommendations of at least one of the responsible employer is required to above the action level. other two physicians. provide the examining physician under (iii) The responsible employer must (d) Alternate physician determination. paragraph (a)(6) of this section. maintain the beryllium-associated The responsible employer and the (g) Reporting. The responsible worker’s total normal earnings, beryllium-associated worker or the employer must report on the applicable seniority, and other worker rights and worker’s designated representative may OSHA reporting form beryllium benefits as if the worker had not been agree upon the use of any alternate form sensitization, CBD, or any other removed. of physician determination in lieu of the abnormal condition or disorder of (iv) If there is no such job available, multiple physician review process workers caused or aggravated by the responsible employer must provide provided by paragraph (c) of this occupational exposure to beryllium. to the beryllium-associated worker the section, so long as the alternative is (h) Data analysis. (1) The responsible medical removal protection benefits expeditious and at least as protective of employer must routinely and specified in paragraph (b)(2) of this the worker. systematically analyze medical, job, and section, until a job becomes available or (e) Written medical opinion and exposure data with the aim of for one year, whichever comes first. recommendation. (1) Within two weeks identifying individuals or groups of (2) Permanent medical removal. (i) of receipt of results, the SOMD must individuals potentially at risk for CBD The responsible employer must offer a provide to the responsible employer a and working conditions that are beryllium-associated worker permanent written, signed medical opinion for each contributing to that risk. medical removal from exposure to medical evaluation performed on each (2) The responsible employer must beryllium if the SOMD determines in a beryllium-associated worker. The use the results of these analyses to written medical opinion that the worker written opinion must take into account identify additional workers to whom the should be permanently removed from the findings, determinations and responsible employer must provide exposure to beryllium. recommendations of the other medical surveillance and to determine (ii) If a beryllium-associated worker is examining physicians who may have the need for additional exposure removed permanently from beryllium examined the beryllium-associated controls. exposure based on the SOMD’s worker. The SOMD’s opinion must recommendation pursuant to this § 850.35 Medical removal. contain: section, the responsible employer must (i) The diagnosis of the worker’s (a) Medical removal protection. The provide the worker the medical removal condition relevant to occupational responsible employer must offer a protection benefits specified in exposure to beryllium, and any other beryllium-associated worker medical paragraph (b) of this section. medical condition that would place the removal from exposure to beryllium if (3) Worker consultation before worker at increased risk of material the SOMD determines in a written temporary or permanent medical impairment to health from further medical opinion that it is medically removal. If the SOMD determines that a exposure to beryllium; appropriate to remove the worker from beryllium-associated worker should be (ii) Any recommendation for removal such exposure. The SOMD’s temporarily or permanently removed of the worker from DOE beryllium determination must be based on one or from exposure to beryllium, the SOMD activities, or limitation on the worker’s more positive Be-LPT results, chronic must: activities or duties or use of personal beryllium disease diagnosis, an (i) Advise the beryllium-associated protective equipment, such as a examining physician’s recommendation, worker of the determination that respirator; and or any other signs or symptoms that the medical removal is necessary to protect (iii) A statement that the SOMD or SOMD deems medically sufficient to the worker’s health; examining physician has clearly remove a worker. (ii) Provide the beryllium-associated explained to the worker the results of (1) Temporary removal pending final worker with a copy of this rule and its the medical evaluation, including all medical determination. The responsible preamble, and any other information the tests results and any medical condition employer must offer a beryllium- SOMD deems necessary on the risks of related to beryllium exposure that associated worker temporary medical continued exposure to beryllium and requires further evaluation or treatment. removal from exposure to beryllium on the benefits of removal; (2) The SOMD’s written medical each occasion that the SOMD (iii) Provide the beryllium-associated opinion must not reveal specific determines in a written medical opinion worker the opportunity to have any records, findings, and diagnoses that are that the worker should be temporarily questions concerning medical removal not related to medical conditions that removed from such exposure pending a answered; and may be affected by beryllium exposure. final medical determination of whether (iv) Obtain the beryllium-associated (f) Information provided to the the worker should be removed worker’s signature acknowledging that beryllium-associated worker. (1) The permanently. the worker has been advised to accept

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(i) The responsible employer, beryllium-associated worker is reduced a site where beryllium activities are subject to paragraph (a)(4)(ii) of this to the extent that the worker receives conducted. section, must not return a beryllium- compensation for earnings lost during (b) The training provided for workers associated worker who has been the period of removal either from a identified in paragraph (a)(1) of this permanently removed under this section publicly- or employer-funded section, must: to the worker’s former job status unless compensation program, or from (1) Be in accordance with 29 CFR the SOMD first determines in a written employment with another employer 1910.1200, Hazard Communication; medical opinion that continued medical made possible by virtue of the worker’s (2) Include the contents of the CBDPP; removal is no longer necessary to removal. and protect the worker’s health. (3) Include potential health risks to (5) For the purposes of this section, (ii) Not withstanding paragraph (a)(4) beryllium worker family members and the requirement that a responsible (i) of this section, if, in the SOMD’s others who may come in contact with employer provide medical removal opinion, continued exposure to beryllium on beryllium workers or protection benefits is not intended to beryllium will not pose an increased beryllium workers’ personal clothing or expand upon, restrict, or change any risk to the beryllium-associated worker’s other personal items as the result of a rights to a specific job classification or health, and medical removal is an beryllium control failure at a DOE position under the terms of an inappropriate remedy in the facility. circumstances, the SOMD must fully applicable collective bargaining (c) The training provided for workers discuss these matters with the worker agreement. identified in paragraph (a)(2) of this and then, in a written determination, (6) The responsible employer may section must consist of general may authorize the responsible employer condition the provision of medical awareness about beryllium hazards and to return the worker to his or her former removal protection benefits upon the controls. job status. Thereafter, the returned beryllium-associated worker’s (d) The responsible employer must beryllium-associated worker must participation in medical surveillance provide the training required by this continue to be provided with medical provided in accordance with § 850.34 of section before or at the time of initial surveillance under § 850.34 of this part. this part. assignment and at least every two years (b) Medical removal protection § 850.36 Medical consent. thereafter. benefits. (1) If a beryllium-associated (e) The employer must provide worker has been permanently removed (a) The responsible employer must retraining when the employer has from beryllium exposure pursuant to provide each beryllium-associated reason to believe that a beryllium paragraph (a)(2) of this section, the worker with a summary of the medical worker lacks the proficiency, responsible employer must provide the surveillance program established in knowledge, or understanding needed to beryllium-associated worker: § 850.34 at least one week before the work safely with beryllium, including at (i) The opportunity to transfer to first medical evaluation or procedure or least the following situations: another position which is available, or at any time requested by the worker. (1) To address any new beryllium later becomes available, for which the This summary must include: hazards resulting from a change to beryllium-associated worker is qualified (1) The type of data that will be operations, procedures, or beryllium (or for which the worker can be trained collected in the medical surveillance controls about which the beryllium in a short period) and where beryllium program; worker was not previously trained; and exposures are as low as possible, but in (2) How the data will be collected and (2) If a beryllium worker’s no event at or above the action level; or maintained; performance involving beryllium work (ii) If the beryllium-associated worker (3) The purpose for which the data indicates that the worker has not cannot be transferred to a comparable will be used; and retained the requisite proficiency. job where beryllium exposures are (f) The responsible employer must (4) A description of how confidential below the action level, a maximum of 2 develop and implement a counseling data will be protected. years of permanent medical removal program to assist beryllium-associated protection benefits (specified in (b) Responsible employers must also workers who are diagnosed by the paragraph (b)(2) of this section). provide each beryllium-associated SOMD to be sensitized to beryllium or (2) If required by this section to worker with information on the benefits to have CBD. This counseling program provide medical removal protection and risks of the medical tests and must include communicating with benefits, the responsible employer must examinations available to the worker at beryllium-associated workers maintain the removed worker’s total least one week prior to any such concerning: normal earnings, seniority and other examination or test, and an opportunity (1) The medical surveillance program worker rights and benefits, as though to have the worker’s questions provisions and procedures; the worker had not been removed. answered. (2) Medical treatment options; (3) If a removed beryllium-associated (c) The responsible employer must (3) Medical, psychological, and career worker files a claim for workers’ have the SOMD obtain a beryllium- counseling; compensation payments for a beryllium- associated worker’s signature on the (4) Medical benefits; related disability, then the responsible informed consent form found in (5) Administrative procedures and employer must continue to provide Appendix A to this part, before workers rights under applicable medical removal protection benefits performing medical evaluations or any Workers’ Compensation laws and pending disposition of the claim. The tests. regulations;

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(6) Work practice procedures limiting variables, or combination of variables, Appendix A to Part 850—Chronic beryllium-associated worker exposure to that could be used to identify particular Beryllium Disease Prevention Program beryllium; and individuals; and Informed Consent Form (7) The risk of continued beryllium (2) Individual medical information I, lllllll have carefully read and exposure after sensitization. generated by the CBDPP is: understand the attached information about § 850.38 Warning signs and labels. the Be-LPT and other medical tests. I have (i) Either included as part of the had the opportunity to ask any questions that (a) Warning signs. The responsible worker’s site medical records and I may have had concerning these tests. employer must post warning signs at maintained by the SOMD, or is I understand that this program is voluntary each access point to a regulated area maintained by another physician and I am free to withdraw at any time from with the following information: designated by the responsible employer; all or any part of the medical surveillance program. I understand that the tests are DANGER (ii) Maintained separately from other BERYLLIUM CAN CAUSE LUNG confidential, but not anonymous. I records; and understand that if the results of any test DAMAGE (iii) Used or disclosed by the suggest a health problem, the examining CANCER HAZARD physician will discuss the matter with me, AUTHORIZED PERSONNEL ONLY responsible employer only in whether or not the result is related to my (b) Warning labels. (1) The conformance with any applicable work with beryllium. I understand that my responsible employer must affix requirements imposed by the Americans employer will be notified of my diagnosis warning labels to all containers of with Disabilities Act, the Privacy Act of only if I have a beryllium sensitization or beryllium, beryllium compounds, or 1974, the Freedom of Information Act, chronic beryllium disease. My employer will beryllium-contaminated clothing, and any other applicable law. not receive the results or diagnoses of any equipment, waste, scrap, or debris. health conditions not related to beryllium (f) The responsible employer must exposure. (2) Warning labels must contain the maintain all records required by this I understand that, if the results of one or following information: part in current and accessible electronic more of these tests indicate that I have a DANGER systems, which include the ability health problem that is related to beryllium, CONTAMINATED WITH BERYLLIUM readily to retrieve data in a format that additional examinations will be recommended. If additional tests indicate I DO NOT REMOVE DUST BY BLOWING maintains confidentiality. OR SHAKING do have a beryllium sensitization or CBD, the CANCER AND LUNG DISEASE (g) The responsible employer must Site Occupational Medical Director may HAZARD transmit all records generated as recommend that I be removed from working required by this rule, in a format that with beryllium. If I agree to be removed, I (c) Warning signs and labels must be understand that I may be transferred to in accordance with 29 CFR 1910.1200, protects the confidentiality of another job for which I am qualified (or can Hazard Communication. individuals, to the DOE Assistant be trained for in a short period) and where Secretary for Environment, Safety and my beryllium exposures will be as low as § 850. 39 Recordkeeping and use of Health on request. possible, but in no case above the action information. (h) The responsible employer must level. I will maintain my total normal (a) The responsible employer must earnings, seniority, and other benefits for up establish and maintain accurate records semi-annually transmit to the DOE to two years if I agree to be permanently of all beryllium inventory information, Office of Epidemiologic Studies within removed. hazard assessments, exposure the Office of Environment, Safety and I understand that if I apply for another job measurements, exposure controls, and Health an electronic registry of or for insurance, I may be requested to medical surveillance. beryllium-associated workers that release my medical records to a future employer or an insurance company. (b) Heads of DOE Departmental protects confidentiality, and the registry must include, but is not limited to, a I understand that my employer will Elements must: maintain all medical information relative to (1) Designate all record series as unique identifier, date of birth, gender, the tests performed on me in segregated required under this rule as agency site, job history, medical screening test medical files separate from my personnel records and, therefore, subject to all results, exposure measurements, and files, treated as confidential medical records, applicable agency records management results of referrals for specialized and used or disclosed only as provided by and access laws; and medical evaluations. the Americans with Disability Act, the (2) Ensure that these record series are Privacy Act of 1974, or as required by a court retained for a minimum of seventy-five § 850.40 Performance feedback. order or under other law. years. I understand that the results of my medical (a) The responsible employer must tests for beryllium will be included in the (c) The responsible employer must conduct periodic analyses and Beryllium Registry maintained by DOE, and convey to DOE or its designee all record assessments of monitoring activities, that a unique identifier will be used to series required under this rule if the hazards, medical surveillance, exposure maintain the confidentiality of my medical employer ceases to be involved in the reduction and minimization, and information. Personal identifiers will not be CBDPP. occurrence reporting data. included in any reports generated from the (d) The responsible employer must DOE Beryllium Registry. I understand that link data on workplace conditions and (b) To ensure that information is the results of my tests and examinations may health outcomes in order to establish a available to maintain and improve all be published in reports or presented at basis for understanding the beryllium elements of the CBDPP continuously, meetings, but that I will not be identified. health risk. the responsible employer must give I consent to having the following medical evaluations: (e) The responsible employer must results of periodic analyses and ensure the confidentiality of all work- assessments to the line managers, / / Physical examination concentrating on planners, worker protection staff, my lungs and breathing related records generated under this rule / / Chest X-ray by ensuring that: workers, medical staff, and labor / / Spirometry (a breathing test) (1) All records that are transmitted to organizations representing beryllium- / / Blood test called the beryllium-induced other parties do not contain names, associated workers who request such lymphocyte proliferation test or Be-LPT social security numbers or any other information. / / Other test(s). Specify:

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