DOE Issues Proposed Rule on Chronic Beryllium Disease Prevention Program
Chronic Beryllium Disease Prevention Program
A Proposed Rule by the
Publication Date:
Agency:
Dates: The comment period for this proposed rule will end on
Comments Close:
Entry Type: Proposed Rule
Action: Notice of proposed rulemaking and public hearings.
Document Citation: 81 FR 36703
Page: 36703 -36759 (57 pages)
CFR: 10 CFR 850
Agency/Docket Number: Docket No. AU-RM-11-CBDPP
RIN: 1992-AA39
Document Number: 2016-12547
Shorter URL: https://federalregister.gov/a/2016-12547
ACTION
Notice Of Proposed Rulemaking And Public Hearings.
SUMMARY
UNIFIED AGENDA
Chronic Beryllium Disease Prevention Program
1 action from
NPRM
DATES:
The comment period for this proposed rule will end on
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Requests to speak at any of the hearings should be made by
ADDRESSES:
You may submit comments, identified by docket number AU-RM-11-CBDPP, and/or Regulation Identification Number (RIN) 1992-AA39 in one of four ways (please choose only one of the ways listed):
1. Federal e-Rulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
2. Email: [email protected]. Include docket number AU-RM-11-CBDPP and/or RIN 1992-AA39 in the subject line of the email. Please include the full body of your comments in the text of the message or as an attachment. If you have additional information such as studies or journal articles and cannot attach them to your electronic submission, please send them on a CD or USB flash drive to the address below. The additional material must clearly identify your electronic comments by name, date, subject, and docket number AU-RM-11-CBDPP.
3. Mail: Address written comments to
4. Hand Delivery/Courier:
For detailed instructions on submitting comments and additional information on the rulemaking process, see Section VI of this document (Public Participation).
Docket: The docket, which includes
The public hearings for this rulemaking will be held at the following addresses:
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FOR FURTHER INFORMATION CONTACT:
For information concerning the hearings, requests to speak at the hearings, submittal of written comments, or to obtain copies of materials referenced in this document, contact
SUPPLEMENTARY INFORMATION:
I. Introduction
A. Chemical Identification and Use
B. Health Effects
C. Beryllium Exposure at DOE Facilities
D. Value of Early Detection
II. Legal Authority and Relationship to Other Programs
III. Issues on Which DOE Requests Information and Seeks Comment
B. Beryllium Restricted Areas
C. Medical Screening for Individuals Conditionally Hired for Beryllium Work
IV. Section-by-Section Analysis
A. Subpart A--General Provisions
B. Subpart B--Administrative Requirements
C. Subpart C--Specific Program Requirements
D. Appendix A--Beryllium Worker Chronic Beryllium Disease Prevention Program Consent Form (Mandatory)
E. Appendix B to Part 850-- Beryllium-Associated Worker Chronic Beryllium Disease Prevention Program Consent Form (Mandatory)
V. Procedural Requirements
A. Review Under Executive Orders 12866 and 13563
B. Review Under the Regulatory Flexibility Act
C. Review Under the Paperwork Reduction Act
D. Review Under the National Environmental Policy Act
E. Review Under Executive Order 12988
F. Review Under Executive Order 13132
G. Review Under Executive Order 13175
H. Review Under the Unfunded Mandates Reform Act of 1995
I. Review Under Executive Order 13211
J. Review Under the
K. Review Under the
VI. Public Participation
A. Attendance at the Public Hearing
B. Conduct of the Public Hearing
C. Submission of Comments
I. Introduction
The
The inhalation and exposure to the skin of beryllium particles may cause beryllium sensitization (BeS) and chronic beryllium disease (CBD). BeS is a condition in which a person's immune system becomes highly responsive (allergic) to the presence of beryllium in the body. CBD is a chronic, often debilitating, and sometimes fatal lung condition. There has long been scientific consensus that exposure to airborne beryllium is the only cause of CBD.'
The current worker protection permissible exposure limit (PEL) of 2 Izg/m3, measured as an 8-hour, time-weighted average (TWA), was adopted by the
On
Revise the definitions of beryllium, beryllium worker, and beryllium associated worker, and add new definitions for beryllium sensitization and chronic beryllium disease.
Lower the action level to 0.05 lg/m3.
Allow the use portable laboratories.
Modify the release criteria of formerly beryllium-contaminated equipment or areas without labeling if they contain beryllium in inaccessible locations or embedded in hard-to-remove substances, provided certain levels are not exceeded.
Allow releasing beryllium-contaminated equipment, items or areas with removable beryllium above 0.2 lg/100 cm2 or that have beryllium in material on the surface at levels above the natural level in soil at the point of release.
Ensure beryllium-associated workers are notified yearly of their right to participate in the medical surveillance program.
Require mandatory medical and periodic evaluations for beryllium workers.
Require medical evaluations for beryllium and beryllium-associated workers showing signs and symptoms of beryllium sensitization or chronic beryllium disease when the SOMD determines an evaluation is warranted.
Require exit medical evaluations for beryllium workers and beryllium-associated workers who voluntarily participated in the medical surveillance program
Add medical restriction requirements for workers.
Require mandatory medical removal for workers based on the site occupational medicine director's written opinion.
Ensure beryllium workers are informed and understand that medical testing is mandatory.
Revise the training requirements for beryllium-associated workers.
Revised the wording on beryllium warning signs.
Require labels for equipment or items containing beryllium in inaccessible locations or embedded in hard-to-remove substances.
Revised the consent forms for beryllium and beryllium-associated workers.
The proposed rule is estimated to cost from
Reduced controls from currently regulated areas that will no longer be regulated under the proposed definition of beryllium.
Reduced surface sampling for areas that are below 0.05 lg/m3 (instead of the current requirement to conduct sampling wherever beryllium is present).
Reduced turnaround time for exposure monitoring results as a result of using a portable laboratory;
Relaxed requirements for transferring contaminated equipment to another area in which beryllium work is performed.
Reduced costs, avoided confusion, reduced liability, and avoided disputes with employees over
Reduced medical evaluation costs due to allowing the SOMD to determine what exams and tests are needed for each worker.
Reduced training requirements for beryllium-associated workers (who currently have the same training requirements as beryllium workers).
DOE expects its sites, contractors and workers to experience the following benefits from the proposed amendment:
Reduced medical costs.
Reduced mortality.
Increased quality of life.
Increased medical surveillance for workers at risk.
Increased work-life for beryllium workers.
Reduced confusion and dispute over legal liability for DOE and DOE contractors.
Reduced restrictions and costs for the release and transfer of equipment or areas with potential beryllium contamination.
Reduced control of areas where contamination is a result of naturally high levels of beryllium in the soil or surrounding environment.
Reduced turnaround time for sample analysis due to the use of portable laboratories.
Reduced medical costs for periodic evaluations due to the Site Occupational Medicine Director's ability to judge that certain medical tests may be unnecessary for some workers.
A. Chemical Identification and Use
Beryllium (atomic number 4) is a silver-gray metallic element with a density of 1.85 g/cm3 and a high stiffness. The second lightest of the metals, beryllium also has a high melting point (1,285 degreeC) and high heat absorption capacity.
Beryllium occurs naturally in the earth's surface in about 30 minerals found in rocks, coal and oil, soil, and volcanic dust. Smith et al. report that the concentration of beryllium in surface soils in
Beryllium was not widely used in industry until the 1940s and 1950s. Beryllium can be used as a pure metal, mixed with other metals to form alloys, processed to salts that dissolve in water, and processed to form oxides and ceramic materials. Beryllium is primarily used to stiffen copper into alloys as strong as steel, but which retain copper's corrosion resistance and electrical and thermal conductivity (ref. 2). Copper alloy strip, rod, and wire containing 0.15 to 2.0 percent beryllium is stamped or machined into complex shapes for electrical connectors, clips, springs and molds for plastics. Copper-beryllium alloys are cast and machined into non-sparking tooling, for applications where fire and explosion are a concern, and into bushings, for bearings in landing gear of commercial and military aircraft. Its corrosion resistance has led to its use as housing for undersea cables. High-strength, light weight beryllium-aluminum alloys and composites are used for structural components in aerospace and defense applications. Nickel-beryllium alloys have niche markets as electrical connectors, in jewelry, and in dental prosthetic. The thermal conductivity and transparency to microwaves of beryllium oxide ceramic has led to its use in electronics, microwave and communication equipment.
Beryllium metal has been produced for various industrial uses, especially in the aerospace and defense industries. Both structural and instrument grade materials are manufactured, including windshield frames and other structures in high-speed aircraft and space vehicles, aircraft and space shuttles brakes, X-ray windows, neutron moderators or reflectors in nuclear reactors, and nuclear weapons components. Beryllium salts (e.g., sulfate or fluoride) and beryllium hydroxide are intermediates in production processes and small quantities are sold for use as laboratory reagents. Copper-beryllium is a common substrate for gold plated electrical connectors and may be encountered during precious metal recovery. Other beryllium materials include soluble beryllium salts and oxides. Beryllium soluble salts such as beryllium fluoride, chloride and sulfate, are used in nuclear reactors, in glass manufacturer, and as catalysts for certain chemical reactions. Beryllium oxide is used to make ceramics for electronics, and other electrical equipment. Beneficial properties of beryllium oxide include hardness, strength, excellent heat conductivity, and good electrical insulation.
Beryllium is also found as a trace metal in materials such as aluminum ore, abrasive blasting grit, and coal fly ash. Abrasive blasting grits such as coal slag and copper slag contain varying concentrations of beryllium, usually less than 0.1% by weight. The burning of bituminous and sub-bituminous coal for power generation causes the naturally occurring beryllium in coal to accumulate in the coal fly ash byproduct. Scrap and waste metal for smelting and refining may also contain beryllium (ref. 3).
Occupational exposure to beryllium can occur from inhalation of dusts, fumes, and mists. Beryllium dusts are created during operations where beryllium is cut, machined, crushed, ground, or otherwise mechanically sheared. Mists can also form during operations that use machining fluids. Beryllium fumes can form while welding with or on beryllium components, and from hot processes such as those found in metal foundries.
Occupational exposure to beryllium can also occur from skin, eye, and mucous membrane contact with beryllium particulates or solutions.
B. Health Effects
Beryllium exposure is associated with a wide range of health effects such as acute beryllium disease, immune system response and sensitization (BeS), CBD, lung cancer, and other possible systemic effects. The National Toxicology Program, the
1. Beryllium Sensitization (BeS)
BeS is an immune system response triggered by beryllium exposure (ref. 7). BeS can occur quickly or many years after exposure to beryllium, potentially progressing into disease (ref. 8). Only a subset of workers exposed to beryllium ever become sensitized. Reported prevalence of BeS ranges from less than 1% up to 19% (refs. 6, 7). BeS alone does not cause physical symptoms. However, individuals showing evidence of BeS may develop subclinical and clinical CBD, including disabling forms.
Sensitization to beryllium can result from both inhalation and skin exposure (refs. 5, 6, 7). The 2008
As mentioned earlier, individuals sensitized to beryllium are asymptomatic and are not physically impaired. Once sensitization has occurred, it is medically prudent to prevent additional exposure to beryllium. Physicians generally recommend removing the sensitized individual from future beryllium exposure to reduce the risk of progression, based on experience with other immunologically mediated diseases and evidence that exposure is a risk factor for developing CBD. No published research studies are available, however, examining whether the general practice of recommending removal is a benefit. Moreover, the
The Beryllium-Induced Lymphocyte Proliferation Test (BeLPT) is used as a diagnostic tool, as well as for medical surveillance and screening for BeS. Currently, it is the most commonly available diagnostic tool for identifying BeS.
2. Chronic Beryllium Disease (CBD)
CBD is an immune-mediated, granulomatous lung disease caused by exposure to airborne beryllium particulate (ref. 8). Granulomas are abnormal tissues that form due to a proliferation of immune system cells known as lymphocytes. In the lung, accumulations of granulomas can interfere with gas exchange between the blood and the lungs. The immune response to beryllium in the lung includes inflammation, which, if it persists, forms scar tissue (fibrosis), resulting in permanent lung damage. This beryllium-induced proliferative and granulomatous response is specific to CBD. CBD pathology is similar to sarcoidosis, a more common disease. Sarcoidosis, however, usually resolves during its normal course, whereas clinically evident CBD generally does not resolve but may reach a steady state condition and may worsen over time.
Frequently reported symptoms of CBD include one or more of the following: dyspnea (shortness of breath) on exertion, cough, fever, night sweats, chest pain, and, less frequently, arthralgias (neuralgic pain in joints), fatigue, weight loss, and appetite loss. On physical examination, a physician may find signs of CBD, such as rales (changes in lung sounds), cyanosis (lack of oxygen), digital clubbing (thickening or widening of the ends of the fingers or toes), or lymphadenopathy (enlarged lymph nodes). A radiograph (X-ray) of the lungs may show many small scars. Patients may also have abnormal breathing and pulmonary function test results. Examination of the lung tissue under the microscope may show granulomas, which are signs of damage due to the body's reaction to beryllium. In advanced cases, there may be manifestations of right-sided heart failure, including cor pulmonale (enlarged right ventricle of the heart caused by blockage in the lungs).
Individuals with CBD may experience mild to severe forms of disease. In severe cases, the affected individuals may be permanently and totally disabled. Mortality of the sensitized individuals directly attributable to CBD and its complications is estimated to be 30% (ref. 12). This estimate is based upon historical data reflecting both the higher levels of exposure that occurred in the workplace prior to regulation of workplace exposure to beryllium in the late 1940s and a tracking of the medical history of subjects of CBD over several decades.
The BeLPT is used as a diagnostic tool for patients who present with possible CBD, as well as for medical surveillance and screening for BeS. For individuals with abnormal blood BeLPT screening results, a positive BeLPT conducted on cells washed from a segment of the lung of an individual can help confirm the presence of CBD. In the absence of granulomata or other clinical evidence of CBD, individuals with a positive BeLPT are classified as sensitized to beryllium.
Stange et al. provided estimates of the sensitivity and specificity of the BeLPT for BeS by evaluating paired results from different testing laboratories. The authors examined 20,275 BeLPT results from medical evaluations of 7,820 current and former DOE workers over a 10-year period. The program led to the diagnosis of 117 cases of CBD and the confirmation of 184 cases of BeS without disease for a combined prevalence of 3.85% (301/7,820) (ref. 13). With borderline BeLPT results included, the sensitivity of the test was estimated to be 68.3% and the specificity was estimated to be 96.9%. In this same population, the percentage of beryllium sensitized individuals found to have CBD by clinical evaluation (positive predictive value) ranged from 71% for 24 sensitized beryllium machinists to 9% for 11 sensitized scientists, with an overall average of 35% for 235 subjects found sensitized by this study (ref. 14).
As noted above, BeS precedes the development of CBD, but the true risk and rate of disease progression is not known based on available study data (refs. 6, 7, 15). Data suggests that CBD can occur at relatively low exposure levels and, in some cases, after relatively brief durations of exposure (ref. 14). However, CBD can take months to years after initial beryllium exposure before signs and symptoms appear (ref. 15).
The clinical course--the latency period, rate of progression, and severity--of CBD is highly variable. A 2008
The observed variability in the clinical progression of CBD is possibly due to variation in exposure amount, route and type, and genetic and other host susceptibility factors. The factors that affect progression are not understood well enough to allow physicians to provide patients with specific advice on their likely prognosis. Currently, there is no medical therapy to prevent possible progression of BeS to CBD. Diagnostic evaluations are required to determine whether a BeS individual has progressed to CBD. Workers are counseled to seek medical attention if they develop new or worsening respiratory symptoms.
A number of studies suggest that the rate of progression from BeS to CBD may be related to the level of exposure and the form of beryllium (ref. 16). Newman et al. evaluated a group of patients with BeS but no CBD at two-year intervals (ref. 15). Of the 55 patients, 17 (31%) progressed to CBD within an average of 3.8 years. In this group, machinists had a higher risk of progression to CBD. The group of 55 patients was a subset of patients described in a subsequent publication by Mroz et al., which examined 171 beryllium exposed workers with CBD and 229 with BeS to look at risk factors for, and progression of, surveillance-identified CBD over a 20 year period (ref. 16). In addition to being machinists, those diagnosed with CBD, as opposed to BeS only, were more likely to have been exposed in the ceramics industry and less likely to have only bystander exposures, suggesting that the form and dose of beryllium may contribute to development of CBD. It was reported that 8.8% of all workers initially identified as having BeS only developed CBD over the course of the study. The study noted that physiologic changes can occur from within one month of first exposure to beyond 30 years from first exposure. However, the authors note that clinical follow-up was incomplete for this larger cohort.
Rosenman et al. studied 577 former workers from a beryllium processing plant whose first exposure, on average, began in the 1960s (ref. 17). This study involved testing subjects more than 20 years after their last exposure to beryllium. The authors identified 7.6% to have definite or probable CBD and another 7.0% with BeS at the time of the study. Those with BeS had a shorter duration of exposure to airborne beryllium, began work later, worked with beryllium longer ago, had lower measures of cumulative and peak exposure to airborne beryllium, and had lower non-soluble beryllium exposures than those with CBD, again suggesting that exposure variables may affect progression from BeS to CBD.
Two other studies have also reported that individuals with positive blood BeLPTs were less likely to have CBD at the time of their initial evaluation if they had jobs and worked in industries with low airborne beryllium exposures. Welch et al. report a total of 75,000 construction workers potentially available for screening, of which 4,458 were initially screened. Of those, 3,842 completed beryllium testing (BeLPT) (ref. 18). The authors reported that 53 (1.4%) of those tested had two or more abnormal BeLPT results. Of the 33 workers who were clinically evaluated, 5 (15%) were diagnosed with CBD. Arjomandi et al. reported similar results among current and former workers at
Studies have shown that some people who are diagnosed with CBD have never been occupationally exposed to beryllium. For example, under the direction of Dr.
In addition, CBD has been reported among family members of beryllium workers who were presumably exposed to contaminated work clothing during the 1940s and 1950s (refs. 22, 23). The virtual disappearance of CBD caused by air pollution or household exposure has been attributed to more stringent control of air emissions and improved work practices, such as mandatory work clothing exchange. However, in 1989, a woman previously diagnosed with sarcoidosis was diagnosed with CBD. The woman had no occupational exposure to beryllium, but her husband was a beryllium production worker. This was the first new case of non-occupational CBD reported in 30 years (ref. 24).
C. Beryllium Exposure at DOE Facilities
The Department's medical screening programs discovered cases of CBD among workers who were first exposed after 1970, when DOE facilities were expected to maintain workers' exposure to beryllium below the OSHA PEL. As of
The final rule, issued in 1999, established a Beryllium-Associated Worker Registry (the Beryllium Registry) to gather beryllium task, exposure, and health data for use in identifying trends that inform DOE in how best to continuously improve the Department's CBDPP. In 2002, employers began submitting data to the Beryllium Registry. As of
Table 1 shows the BeS and CBD rates at DOE sites. Genetic factors have been reported to be a risk factor in determining who will progress from BeS to CBD (ref. 25). This makes a few percent of exposed individuals more sensitive to exposure to beryllium (ref. 26). DOE assumes that the proportion of workers with a genetic predisposition to contract BeS and CBD is essentially the same among the different sites and, therefore, differences in the prevalence of sensitization and disease among the sites are due to differences in exposure levels.
Table 1--Prevalence of Sensitization (BeS) and Chronic Beryllium Disease (CBD) by DOE Site Through 2013
Site..... Employees with BeLPT results..... Sensitized employees (no CBD)..... CBD Employees
DOE
East Tennessee Technology Plant..... 399..... 6..... 1.5%..... 4..... 1.0%
Hanford Site..... 7,480..... 91..... 1.2%..... 34..... 0.5%
Kansas City Plant..... 1,208..... 41..... 3.4%..... 14..... 1.2%
LLNL-Clean Harbors Environmental Services..... 13..... 0..... 0%..... 0..... 0%
National Strategic Protective Security Services..... 10..... 0..... 0%..... 0..... 0%
Nevada National Security Site..... 1,028..... 23..... 2.2%..... 4..... 0.4%
Savannah River Site..... 713..... 15..... 2.1%..... 6..... 0.8%
Stanford Linear Accelerator Center..... 47..... 0..... 0%..... 1..... 2.1%
Totals..... 21,453..... 407..... 1.9%..... 146..... 0.7%
Note: "Sensitized" indicates the number of individuals found sensitized from two or more peripheral blood BeLPTs or from a bronchoalveolar lavage BeLPT, and does not include individuals who have been diagnosed as having CBD.
D. Value of Early Detection
Early detection of a disease is of value if it leads to reduced exposure, earlier treatment and a better prognosis for the tested individual. Screening for CBD with the BeLPT of peripheral blood can provide less invasive, earlier detection than is possible with other tests. In some cases, this has led to diagnosis and early treatment of CBD to reduce lung damage that may not have been possible if the CBD remained undiagnosed by other tests. In addition, there is increasing evidence that removal from exposure or reduction in exposure can lower the likelihood of progression from BeS to CBD and disability.
Pappas and Newman compared the lung functions of patients with CBD who had been identified through abnormal chest X-rays or clinical symptoms to those of patients with CBD who had been identified through positive BeLPTs of peripheral blood (ref. 27). Twelve of 21 BeLPT-positive patients were subsequently found to have lung abnormalities, including reduced exercise tolerance. Fourteen of the 15 patients identified through chest X-rays or clinical symptoms had abnormal lung function, and their abnormalities were more severe than those identified through a positive BeLPT. The authors concluded that screening with the BeLPT of peripheral blood was useful because it permitted detection of CBD earlier in the disease process, when individuals are likely asymptomatic.
Early treatment of CBD may prevent progression of disease to permanent lung damage and disability. Although not providing definitive proof, studies have concluded that the long-standing standard of care for CBD has been shown to reduce the progression of disease in some patients. Marchand-
Corticosteroid treatment in patients suffering from serious chronic beryllium disease improved symptoms, pulmonary function tests and radiology by acting on inflammatory granulomas. The control of inflammatory granulomatosis limited the fibrotic evolution as long as doses were monitored under the control of clinical examination, serum angiotensin-converting enzyme and high resolution computed tomography scanning. However, corticosteroids seemed insufficient to stop this poor evolution for some patients.
Though a small study, the observed effectiveness of corticosteroids in suppressing the growth of granulomas and limiting progressive fibrosis in the majority of patients in the study suggests that proactive treatment may prevent the progression of disease to permanent lung damage and disability. BeS identified via BeLPT screening provides the earliest indication that working conditions and work practices are affecting the health of exposed workers. This allows for an earlier opportunity to initiate corrective actions and possibly to prevent cases of CBD.
II. Legal Authority and Relationship to Other Programs
This proposed rule continues to establish minimum requirements for the protection of beryllium and beryllium-associated workers, and is being promulgated pursuant to
III. Issues on Which DOE Requests Information and Seeks Comment
A. Request for Information
The Department is considering additional requirements in other areas covered by the NOPR. It is especially interested in comments supported by technical evidence, rationale, and cost whenever possible, regarding the following areas:
1. Surface action level. It appears that not all individuals who become sensitized progress to disease, but individuals with CBD are sensitized, which suggests that sensitization must occur before disease can occur. Preventing sensitization should, therefore, prevent disease.
DOE has found no studies that have determined a threshold of beryllium surface contamination that results in skin contact that, in turn, results in beryllium sensitization although a number of epidemiology studies and reviews of studies suggest that skin contact causes sensitization. DOE, therefore, is relying upon operational experience, rather than a demonstrated relationship between surface levels and health effects, in considering to propose a surface action level which would require employers to implement specified provisions of the rule.
DOE is considering adding in the final rule a surface action level of 1.5 lg/100 cm2 as a preventive approach to control the beryllium health risk. This level is based on the assumption that surface contamination is a potential source of exposure through re-entrainment from energetic tasks. The Department requests that interested parties submit comments regarding the validity of a 1.5 lg/100 cm2 surface action level. If an alternate level is suggested, provide the rationale and associated cost implications for choosing the alternate surface action level.
2. Beryllium restricted areas. Currently, part 850 provides for "regulated areas", which are areas demarcated by the employer in which the airborne concentration of beryllium is at or above, or can reasonably be expected to be at or above, the action level. However, part 850 contains no provision for demarcating areas designating specified surface levels of beryllium. The Department is considering requiring in the final rule the establishment of beryllium restricted areas where the surface levels of beryllium are at or above a surface action level of 1.5 lg/100 cm2, restricting access to authorized persons, and requiring employers to demarcate and control restricted areas from the rest of the workplace in a manner that alerts workers to the boundaries of such areas. The Department requests that interested parties provide information on the feasibility and effect of requiring such restricted areas.
3. Medical screening for individuals conditionally hired for beryllium work. When part 850 was issued in
DOE believes the early detection, made possible with medical evaluations is essential for ensuring that individuals who have been adversely affected by beryllium are not placed in a job where they will be exposed to beryllium at or above the action level. In addition, given that under this NOPR, current beryllium workers with BeS and CBD will be subject to medical removal, and current beryllium workers with another medical condition for which exposure to beryllium at or above the action level would be contraindicated will be subject to medical restriction, the Department does not believe it is reasonable to place newly hired individuals with such conditions into jobs where the airborne concentration of beryllium is at or above the action level if they too would be subject to removal or restriction once hired. Under Section 161 of the AEA, the Department has broad authority to prescribe such regulations as it deems necessary to govern any activity authorized by the AEA, including standards for the protection of health and minimization of danger to life. Accordingly, DOE is considering including a requirement for mandatory medical screening of individuals conditionally hired for beryllium work to determine if such individuals have a medical condition for which exposure to beryllium at or above the action level is contraindicated. An "individual conditionally hired for beryllium work" would be an individual who has been offered a job as a beryllium worker (either a new hire or a current worker being transferred into a new job as a beryllium worker), but such offer would be subject to the outcome of a medical evaluation. DOE would require as part of these provisions that the employer inform applicants that any job offer would be conditional pending outcome of a medical evaluation, thus, candidates would have the option of not accepting the conditional offer.
In those cases where the medical screening indicates the individual conditionally hired for beryllium work has CBD, BeS, or another medical condition for which exposure to airborne concentrations of beryllium at or above the action level would be contraindicated, and the employer determines that no reasonable accommodation is available to enable the conditionally hired individual to work in an area where the airborne concentration of beryllium is at or above the action level, the employer would not be permitted to retain the individual as a beryllium worker. Such conditionally hired individuals would not be eligible for medical removal benefits under 10 CFR 850.36. Currently, under 10 CFR part 851, appendix A section 8(g)(2)(i), the occupational medical provider may require "[a]t the time of employment entrance or transfer to a job with new functions and hazards, a medical placement evaluation of the individual's general health and physical and psychological capacity to perform work" to "establish a baseline record of physical condition and assure fitness for duty." Therefore, the Department is considering including in section850.34(b)(1)(iii) a provision that would require employers to use the medical evaluation provided to conditionally hired individuals as the baseline medical evaluation for newly hired beryllium workers.
For consistency in the examinations provided to conditionally hired individuals, the Department is considering adding a provision requiring the identification of the elements of such examinations. In such cases, the Department is considering adding in section850.34(c) the following:
Employers would be required to provide individuals conditionally hired for beryllium work the required medical evaluations and procedures at no cost, and at a time and place that is reasonable and convenient for the conditionally hired individual.
Employers would be required to inform applicants for jobs where exposure to airborne concentration of beryllium is at or above the action level, that:
The job involves a beryllium activity at or above the action level, includes a medical qualification, and requires a medical evaluation;
Any job offer would be conditional pending the outcome of the medical evaluation;
The employer would not be permitted to retain the individual as a beryllium worker if the Site Occupational Medical Director (SOMD) diagnosis indicates the individual has CBD, BeS, or another medical condition for which exposure to beryllium at or above the action level would be contraindicated, and the employer determines that no reasonable accommodation is available to enable the conditionally hired individual to work in a beryllium activity; and
Once conditionally hired, no work or training may be performed prior to the worker being cleared by the SOMD for beryllium work.
Employers would be prohibited from asking or requiring a conditionally hired individual to have a medical evaluation performed before making the conditional job offer.
Employers would be required to ensure both the SOMD and the conditionally hired individual complete the consent form included in an appendix, before any medical evaluations of the conditionally hired individual are performed.
Medical evaluations for conditionally hired individuals would be required to include:
A detailed medical and work history with emphasis on exposure or potential exposure to beryllium;
A respiratory symptoms questionnaire;
A physical examination, with special emphasis on the respiratory system, skin, and eyes;
A chest radiograph (posterior-anterior, 14 x 17 inches) or a standard digital chest radiographic image, interpreted by a NIOSH B-reader of pneumoconiosis or a board-certified radiologist;
Spirometry consisting of forced vital capacity (FVC) and forced expiratory volume at one second (FEV 1);
Two peripheral blood BeLPTs; and
Any other tests that would be deemed appropriate by the SOMD for evaluating beryllium-induced medical conditions.
The Department is considering adding a new section850.34(d)(3), which would provide the requirements for the medical opinion and determination for individuals conditionally hired for beryllium work. This proposed new section would require, with respect to a conditionally hired individual, that:
The SOMD's written opinion to the employer would:
Be delivered within 10 working days after the SOMD received the results of the medical evaluation performed pursuant to proposed section850.34(c)(5); and
Contain a determination of whether the conditionally hired individual is sensitized to beryllium, has CBD, or has another medical condition for which exposure to beryllium at or above the action level would be contraindicated.
The employer would not be permitted to retain the conditionally hired individual as a beryllium worker, if the SOMD determines that the individual conditionally hired for beryllium work has CBD, BeS, or another medical condition for which exposure to beryllium at or above the action level would be contraindicated, and the employer determines that no reasonable accommodation is available to enable the conditionally hired individual to work in a beryllium activity.
The Department is considering including in part 850 an appendix with a new mandatory form for conditionally hired individuals to ensure they receive consistent information on the medical testing required prior to working in a beryllium area. This proposed new form would be similar to the proposed mandatory form in appendix A and entitled: Conditionally Hired Individual Chronic Beryllium Disease Prevention Program Consent Form, and include sections for consent, medical evaluation consent, and the physician's review of the medical evaluation results. DOE is aware that the term "informed consent" has a different meaning when used in other contexts (e.g., human subject research). The Department, however, used this term in the original 10 CFR part 850 published in
The Department is requesting that interested parties provide their comments supported by technical evidence, rationale, and cost information whenever possible, on the feasibility and the effect of mandatory medical qualification for conditionally hired individuals for beryllium work. Alternatively, the Department is considering allowing conditionally hired individuals and current beryllium workers who are sensitized to beryllium but who do not have CBD to work in a beryllium job after signing an acknowledgment stating the worker has been informed of the risks of continued exposure to beryllium and has voluntarily elected to work in a beryllium job. The Department is also requesting that interested parties provide their comments supported by technical evidence, rationale, and cost information whenever possible, on the feasibility and the effect of allowing workers who are sensitized to beryllium to work in a beryllium job.
4. Mandatory medical evaluations and removals. DOE is proposing both mandatory medical evaluations and mandatory medical removal provisions under this proposed amendment based on its commitment to the health and safety of its workers and the understanding that early detection and removal from beryllium exposure is important to prevent harm to workers at risk for developing CBD. Based on these considerations, DOE believes that these provisions are responsible and prudent measures in protecting the health of DOE and contractor workers. DOE recognizes that its proposed lower action level may result in an increased number of activities or work areas that pose the potential for airborne concentrations of beryllium at or above the action level with a corresponding increased number of beryllium workers subject to mandatory medical evaluations and the potential for mandatory medical removals. DOE believes, however, that the additional protections (triggered by the action level) available to workers at a lower action level would result in reduced worker exposures and fewer workers developing BeS or CBD. Since medical removal would be triggered by a BeS or CBD diagnosis, this would result in fewer workers being subject to medical removal.
DOE received several comments concerning whether to continue to require a worker's consent for medical removal, or instead require mandatory medical removal in response to its
5. Site Occupational Medicine Director's written medical opinion. DOE is aware of the increased concerns about protection of confidential medical information that have arisen since
Editor's note: For the full-text of this document, click this link or copy it into your browser: https://www.federalregister.gov/articles/2016/06/07/2016-12547/chronic-beryllium-disease-prevention-program.
[FR Doc. 2016-12547 Filed 6-6-16;
BILLING CODE 6450-01-P
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