NORA Manufacturing Sector Strategic Goals
927Z6RG - Long-Term Efficacy of a Preventive ProgramStart Date: 10/1/2006
End Date: 9/30/2010
Principal Investigator (PI)Name: Carrie Thomas
Funded By: NIOSH
Primary Goal Addressed5.0
Secondary Goal Addressed
Attributed to Manufacturing
This NORA project assesses the effectiveness of a comprehensive preventive program for preventing sensitization and chronic beryllium disease in beryllium workers. Working collaboratively with beryllium producer Brush Wellman Inc., we will survey current and former workers from three facilities who were hired after implementation of the program. Upon completion, we will determine the efficacy of the preventive model and/or ways to improve its design or implementation. As there is currently no proven program to prevent beryllium disease and there are at least 134,000 current US workers potentially exposed to beryllium, the results of this research will provide important information. This preventive program is also of interest to other manufacturing industries with exposure limits that are either not protective or nonexistent, as well as OSHA, which has started beryllium rulemaking.
There are currently no preventive programs that have demonstrated long-term effectiveness in preventing beryllium sensitization and chronic beryllium disease (CBD). Recent short-term evidence suggests that the comprehensive preventive program implemented by Brush Wellman Inc. (BWI) has successfully reduced incidence of beryllium sensitization among its current workers, but longer follow-up among a larger group of current and former workers is required. The objective of this project is to characterize the effectiveness of a comprehensive preventive program in preventing beryllium sensitization and CBD among beryllium-exposed workers. We will address this objective by testing the following hypotheses: 1) the comprehensive preventive program has significantly reduced development of beryllium sensitization among newly-hired workers over an eight-year period of follow-up; 2) workers hired after a sentinel improvement in the comprehensive preventive program are at reduced risk of sensitization compared to workers hired between the beginning of the program and before the "sentinel improvement;" 3) among workers hired after implementation of the comprehensive preventive program, risk of sensitization is associated with inheritance of known genetic characteristics, known higher-risk work processes, and indices of the effectiveness of the program; and 4) the comprehensive preventive program has significantly reduced development of CBD among workers hired after implementation of the program. Between June 2008 and April 2009, we will ask current and former BWI workers at three facilities who were hired after implementation of the comprehensive preventive program to provide blood samples for beryllium lymphocyte proliferation testing (BeLPT) and complete a medical/work history questionnaire. We will compare those results to survey results at each facility collected before the program's implementation. We will evaluate specific aspects of each facility's program, and evaluate work processes, genetic risk factors, and program effectiveness criteria for their relationship to disease. We are uniquely qualified to carry out this project, as we have collaborated on beryllium research with BWI since 1998. The project team is multidisciplinary, comprising epidemiologists, industrial hygienists, physicians and genetic researchers, and collaborates and communicates with researchers from other divisions. Products of this research will include peer-reviewed scientific publications; communications at worker, company, and public health meetings; and postings on the NIOSH beryllium web page. This project is part of a larger program of research in the NORA Manufacturing sector that includes physicochemical characterization of beryllium materials, characterization of dermal exposure, animal models for beryllium disease, and research to practice emphasis. The principal stakeholders are BWI, its employees and customers, other employers with beryllium-exposed workers including the Department of Energy, the Occupational Safety and Health Administration (which has started beryllium rule-making), other divisions and offices within NIOSH with interests in control banding, safety culture, and research-to-practice opportunities, and the research community.
We will assess the program's effectiveness by comparing levels of beryllium sensitization and chronic beryllium disease pre- and post-intervention, as we have cross-sectional survey data for each facility obtained just prior to implementation of the comprehensive preventive program. We will assess whether any significant changes in the implementation of the preventive program at each facility had a marked effect on sensitization incidence since the beginning of the program. We will determine if risk of sensitization at each facility is affected by genetic characteristics, known higher-risk work processes, and indices of the preventive program's effectiveness. We will also compare levels of CBD pre- and post-program. Discussions with stakeholders will allow us to determine how elements of this preventive program are being implemented in other workplaces. Discussions with OSHA will enable us to determine how they use these results in considering the current occupational exposure limit and how it may be improved.
This project addresses the scientific knowledge critical to the prevention of chronic beryllium disease (CBD), a chronic lung disease that occurs in workers who become sensitized to beryllium in metal fabrication, the nuclear industry, dental laboratory work, and electronics applications, among others. It is likely that at least one million United States (US) workers have ever been exposed to beryllium, and in some primary beryllium industry populations, cumulative prevalence of sensitization and CBD has been as high as 16 and 11%, respectively. The use of targeted engineering controls to reduce risk of sensitization and CBD has not been effective. There are currently no preventive programs that have been demonstrated to have long-term effectiveness in preventing beryllium sensitization and CBD among beryllium-exposed workers. A comprehensive preventive program has been developed by the largest US producer of beryllium and beryllium-containing products; preliminary evidence suggests that incidence of beryllium sensitization among newly-hired workers has been reduced. The evaluation of this program over a longer period of time and among a larger population will provide evidence for its efficacy and/or approaches to improving the program or its implementation. The results will be used to improve health and safety in the beryllium industry by informing Occupational Safety and Health Administration rulemaking, Department of Energy policies for beryllium-exposed workers in the nuclear industry, and manufacturing employers with similar challenges in preventing disease to toxic metals and sensitizers. The work in this project is targeted to the NORA Program Portfolio Manufacturing sector. It contributes to the NIOSH Cross-Sector programs in Respiratory Diseases, Communication and Information Dissemination, and Surveillance and Exposure Assessment, and may have relevance for Immune and Dermal Diseases.
– Strategic Goal 5 (09PPMNFSG5): Reduce the number of respiratory conditions and diseases due to exposures in the manufacturing sector.
– This project will contribute to the following intermediate and activity/output goals: (09PPRDRAOG2.4.1): evaluate the effectiveness of a comprehensive preventive program that includes reduction of skin exposures at a copper-beryllium alloy in reducing immunological sensitization to beryllium and chronic beryllium disease;
– (09PPRDRAOG2.4.2): evaluate the effectiveness of a comprehensive preventive program that includes reduction of skin exposures at a beryllium manufacturing facility in reducing immunological sensitization to beryllium and chronic beryllium disease.
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