Executive Summary

• The Registry includes 26 active reporting organizations with no changes during the 2018 reporting period.
• There were 9 changes in data coordinators in 2018. The Registry includes 37,805 workers among the active reporting sites.
• The majority of these workers are males over 50 years of age, representing 81%. The number of workers increased by 1,519 (from 36,286 workers in 2017 to 37,805 workers in 2018).

• Participants’ medical surveillance programs screened a total of 6,729 employees for beryllium sensitization in 2018, which included an increase of 1,007 new workers with beryllium sensitization test results reported to the Registry.
• The Registry has a total 523 beryllium-sensitized (BeS) workers and 148 workers diagnosed with chronic beryllium disease (CBD).
• The Registry reported 26 new beryllium sensitizations and 1 CBD case through 2018.
• The majority of BeS workers and CBD cases are associated with Y-12 and Hanford.
  • 28% of BeS workers are associated with employment at Y-12 and 22% of BeS workers are associated with Hanford.
  • 42% of CBD cases are associated with Y-12 and 23% of CBD cases are associated with Hanford.
• The majority of BeS workers and CBD cases are associated with work histories involving crafts and line operators.
  • Crafts work histories are associated with 105 (20%) BeS workers. Line operators account for an additional 88 (17%) BeS workers.
  • Crafts work histories are associated with 38 (26%) CBD cases. Line operators account for 23 (16%) CBD cases.

• The Registry received data for 2,924 air monitoring samples for 645 employees in 2018.
• Of the samples measured in 2018, approximately 92% had non-detectable results. Only 1.5% of the samples exceeded the 8-hour time weighted average (TWA) action level of 0.2 µg/m³. Idaho National Laboratory reported the largest number of samples exceeding the action level with 8%, followed by Sandia National Laboratories with 5%.
• The highest 8-hour TWA level measured during 2018 was 16.71 µg/m³ at Y-12 among engineering technicians. This was significantly lower than the highest reported measurement in 2017 which was 87 µg/m³ at Y-12 among machinists.

• Site medical programs screen a greater proportion of workers for beryllium sensitization than are monitored for exposure to airborne beryllium. This may be due to some extent from monitoring for the onset of BeS and CBD of workers no longer performing beryllium-related work; employees moving between sites/contractors; the discovery of legacy beryllium in poorly documented areas; and the use of swipe sampling results, not required for the Registry.
• 68% of workers identified as beryllium-sensitized do not have exposure monitoring results submitted to the Registry.
• 21% of CBD cases have exposure records dated earlier than their reported date of CBD diagnosis.
• Of those with exposure monitoring, 37% of workers only have exposure monitoring results after identification as beryllium-sensitized.

• The results of the BAWR data analyses indicate that the CBDPP has resulted in decreased exposure to beryllium which has helped to reduce the number of beryllium sensitizations and CBD cases over time.
• The yearly average for workers developing sensitization, whose first abnormal BeLPT results were between 2000 and 2009, was 34. This rate dropped to an average of 13 from 2010 to 2018.
  • For workers later diagnosed with CBD, the yearly averages dropped from 9 to less than 1 per year for the respective time frames. The CBDPP and the BAWR have been critical in reducing CBD among workers and remain valuable occupational health programs.
• The data in the BAWR have been used by both the DOE Office of Inspector General and by the reporting organizations to investigate the effectiveness of sites’ beryllium protection and prevention programs or follow-up to assure that recommendations from audits have been implemented. The BAWR has also provided special analyses for individual reporting organizations to help with quality assurance of their data and to prepare for internal or external audits. This cumulative data resource has proven to be more comprehensive and accurate than individual sites’ records, as well as designed to provide easy comparisons between the health and exposure information.

• Data from the BAWR were included in the Federal Register on June 7, 2016, in support of proposed amendments to 10 CFR 850. These proposed changes to the rule, reflecting DOE goals to achieve aggressive reduction and minimization of worker exposures to airborne beryllium, will further strengthen the current CBDPP, worker protection programs, and reporting of affected workers. As part of the justification for lowering DOE established personal exposure limits (PELs), BAWR data was analyzed to determine the effects of the current cutoff of 2.0 µg/m³, and played a critical role in lowering it to several levels between 1.0 and 0.33 µg/m³.
• Data from the BAWR were also used by DOE staff working on updates to the rule to monitor reporting organizations by geographic location and account for reporting organizations (and changes in numbers of employees), which had been combined when contracts were rebid and/or organization names had changed.

• Staff from ORISE and the BAWR have provided input to the revised algorithm, based on blood BeLPT results, for determining beryllium sensitization. The new algorithm will lead to, in many cases, earlier identification of affected workers.
• To determine the differences between algorithms, the current and the proposed algorithm were modeled for comparison. ORISE Beryllium Laboratory staff later provided expert testimony at the public hearings for revisions to 10 CFR 850 regarding the importance of adding an additional 3 borderlines criteria to the methodology, and the BAWR and Beryllium Laboratory provided supporting data.

• Results from BAWR analyses to study the effects of lowering DOE established personal exposure limits (PELs) were shared by DOE with the Occupational Safety and Health Administration (OSHA). The BAWR is the only source for these cumulative data for DOE-affiliated sites.
• Raw exposure data from the BAWR were requested and used by OSHA in evaluating lowering their permissible exposure limit (PEL) to 0.2 µg/m³. ORISE staff created and provided a de-identified file for OSHA with a limited number of fields to protect employees’ identities.

• As subject matter experts with regard to beryllium, worker health, and interpretation of BeLPT results, ORISE staff played a major role in assisting DOE in revising the Beryllium Lymphocyte Proliferation Testing (BeLPT) Technical Specification, DOE-SPEC-1142-2019. This specification had not been updated since 2001.
• ORISE staff with decades of experience with the BAWR, provided substantial input in guiding updates to the BAWR Technical Standard, which had not been updated since 2007. The DOE-STD-1187-2019 Technical Standard was completed in late 2019.
• Studies using BAWR data have provided a better understanding of impacts on worker health. Studies that combined data from the BAWR with data from the former DOE Illness and Injury Surveillance Program (IISP) include:
  • Illness Absences Among Beryllium Sensitized Workers (American Journal of Public Health, Janice Watkins, et. al., September 2014).
  • Y-12 American Recovery and Reinvestment Act (ARRA), workers hired after January 1, 2009, analyses of exposures and health data for the cohort (Paul Wambach, White Paper, July 2011).
• ORISE, in cooperation with DOE and National Jewish Health, continue to evaluate studies regarding beryllium test results, latency from first beryllium sensitization to disease onset, and evidence of a dose-response relationship between beryllium exposure and disease outcomes. The data in the BAWR are of interest with regard to discovering more about how these are correlated. Some examples include:
  • Clinical and laboratory factors contributing to uninterpretable beryllium lymphocyte proliferation tests (BeLPT) (American Journal of Industrial Medicine, Derek Smith, et. al., March 2018).
  • Exposure and genetics increase risk of beryllium sensitization and chronic beryllium disease in the nuclear weapons industry (Occupational and Environmental Medicine, Michael Van Dyke, et. al., November 2011).

• Because of the regular and required electronic reporting of data to the BAWR, the BAWR has been used as justification by the reporting organizations for streamlining their processes by developing new systems, infrastructure, and/or procuring new software. Over time, data have improved dramatically, as evidenced by decreasing error rates in the data condition reports. There is a continued effort made by BAWR and DOE staff to improve data quality, notably securing complete employee rosters and work history data.
• DOE and ORISE staff have worked together to help assure that once 10 CFR 850 is updated and published, the BAWR’s Technical Standard is specifically cited as containing the guidance and elements required to satisfy mandatory reporting. DOE and ORISE staff worked together to help assure the BAWR’s Technical Standard is specifically cited as the guidance and elements required to satisfy mandatory reporting in current updates to 10 CFR 850. This effort will ensure sites do a better job of complete and accurate reporting and correction of errors. As a result, the BAWR will be an even more robust resource to better understand the relationship between beryllium exposure and disease outcomes, in order to protect worker health.

The Registry does not contain PII (personally identifiable information) on workers. Each reporting organization is free to choose its own encryption algorithm to assign a unique identifier for a given worker. While this approach ensures the protection of the individual’s privacy, it restricts the Registry’s ability to determine when a given worker moves from one reporting organization to another.

Reporting of air monitoring samples have declined each year. Due to beryllium sensitization (BeS) and chronic beryllium disease (CBD) observed in workers without exposure monitoring data, reporting organizations may need to review and update exposure sampling plans. In contrast, health monitoring for BeS appears to be robust, although additional medical follow-up of CBD cases would be useful.

Morbidity and mortality data are not reported by sites to the BAWR. However, the Registry does capture health outcome information on workers’ development of beryllium sensitization (BeS) or chronic beryllium disease (CBD). The clinical criteria and incidence rules for the case definition of beryllium sensitizations is one of the following:

• Individual must have 2 abnormal blood tests, or
• 1 abnormal and 2 borderline blood tests, or
• An abnormal bronchoalveolar lavage BeLPT, or
• Clinical evaluation with a diagnosis of beryllium sensitization.
  
  The current diagnostic algorithm used in the identification of cases is limited because of the time lapse between meeting any one of the above criteria to a time when the worker may already be experiencing health effects. When 10 CFR 850 is updated and published, revisions to the current algorithm for determining beryllium sensitization will result in earlier dates of BeS for many workers, providing more timely identification and subsequent medical follow-up or appropriate work restrictions.
• Cause of death is not available to the Registry, which prevents further analyses focused on estimation of mortality risk from particular causes.

Reporting organizations are not required to submit data on the total number of workers for each reporting year. Additionally, it is difficult to ensure that each reporting organization has submitted a complete roster of employees with potential beryllium exposure due to current or past work locations or activities. The number of workers tested using the beryllium lymphocyte proliferation test (BeLPT), therefore, is the denominator in many of the analyses and calculated rates of beryllium sensitization or CBD.

The Registry cannot always confirm the date of first hire because some organizations define the date of first hire as the date of first hire by the current (sub)contractor, and this date overwrites the previous date of first hire by a former contractor. Resetting this date negatively impacts BAWR analyses to examine latency from possible exposure to development of sensitization to disease onset.

Although most workers represented in the figures and tables are unique cases, there is potential duplication of workers and counts. This issue can arise when a worker moves from one reporting organization to another and is assigned a new identifier based on a different encryption algorithm. Although the number of workers in this category is believed to be small, given the absence of personally identified information on individuals, we cannot be absolutely certain that the total numbers of individuals shown in figures and tables represent unique individuals. We have used this approach to err on the site of protecting the workers’ privacy.

Significant delays in reporting impact BAWR analyses and conclusions drawn from them. Such delays also impact the ability to identify problems and defer refinement of protocols.

Timely and complete reporting of exposure monitoring data is necessary to characterize beryllium-related work at a site and analyze employees’ actual exposure levels and time weighted averages. Timely and complete reporting of BeS and CBD cases (and their related work history) is critical to identifying problems, assessing the effectiveness of CBD Prevention Programs, and refining protocols.

In recent years, reporting organizations observed sensitizations among security guards, administrative personnel, and field engineers. These workers had no expected exposure, are not covered in sites’ industrial hygiene sampling plans, and did not use personal protective equipment. These cases highlight the importance of proactive hazard assessments and sampling approaches. Timely reporting of data is critical to earlier identification of potential work areas or sources of beryllium exposure, particularly locations or work activities not anticipated to be significant sources of beryllium exposure.

There are reasons contributing to delayed reporting of data:

• Turnover in data coordinators often results in the need for additional training and subsequent delays in data submissions. Therefore, significant data coordinator turnover can impact the timely acquisition of data and subsequent reporting of results.
• Exposure monitoring data are often submitted late, particularly when the delay is due to a data quality assurance issue. This results in a delay in data submissions to the Registry during a calendar year. For example, of the 3,104 exposure samples submitted to the Registry during CY2018, 2,924 had dates monitoring conducted in 2018 and the other 180 had earlier dates (some from several years earlier and most with high actual exposure levels and/or time weighted averages). With decreasing numbers of exposure samples being submitted in recent years, the relative impact of these late-reported records to the BAWR analyses can be significant.

There have been delays in reporting of BeS and CBD cases, most often for those cases where workers did not hold beryllium-related jobs. Therefore, several years elapsed before beryllium was identified as a factor. As a result, workers were enrolled in medical surveillance programs, or were referred to a pulmonary laboratory, for further testing and evaluation.