SIA Worker Health Project
Since the late 1980’s, SIA and its member companies have participated in numerous research efforts to ensure the safety of the wafer fabrication environment and the health of this workforce. The current effort, conduct of a retrospective epidemiological study to assess cancer risks in fab workers is nearing completion, with results expected in the second half of 2010. SIA will report the findings to the media and other interested parties when the results are made public. We expect the publication of the results in a peer-reviewed scientific journal later in 2010. The history and status of this research project are presented immediately below, followed by a history of earlier SIA Worker Health Projects.
History and Status of the Retrospective Epidemiological Study
After the results of a feasibility study, conducted by Johns Hopkins University researchers, concluded that an epidemiology study was feasible, the SIA Board of Directors, at the March 2004 meeting, decided to fund a retrospective cohort epidemiology study to determine if wafer fabrication workers in the semiconductor industry have experienced higher rates of cancer than non-fabrication workers. The independent Scientific Advisory Board (SAB) to the SIA Worker Health Projects, formed in March 2003, has remained involved, as advisors, in all aspects of the retrospective cohort epidemiology study, including the selection of researchers and the design and conduct of the study. A Project Management Committee (PMC), consisting of occupational health and EHS representatives from the participating member companies and SIA and the Project Manager, Chuck Axten, Ph.D., has provided internal guidance to the study. Key activities in the planning and conduct of the study have been:
- The SIA PMC prepared and posted a Request for Proposal (RFP) for the epidemiology study on the SIA Website. Additionally, the RFP was advertised in the EpiMonitor and posted on the Duke University Web Server.
- After review of proposals and interviews of investigators by the PMC and the SAB, SIA announced, on August 2, 2005, that it had signed a contract with Vanderbilt University to conduct a retrospective epidemiological study to determine if there is an increased cancer risk among wafer fabrication workers compared to other semiconductor industry workers and the general population. (See Press Release)
- The Key Vanderbilt researchers are:
- Dr. Joseph McLaughlin- Principal Investigator, Epidemiology
- Dr. William Blot- Principal Investigator, Epidemiology
- Dr. John Boice- Project Manager
- Don Marano- Lead Investigator, Exposure Assessment
- Drs. McLaughlin, Blot, and Boice were formerly epidemiological researchers at the National Cancer Institute. Two earlier project managers, Dr. John Fryzek and Dr. Thomas Bender, left Vanderbilt and are no longer involved in the study.
- The multimillion dollar study will span nearly 30 years of activity.
- Vigorous efforts to identify workers at participating companies through review of employment and other records.
- The study will include review of over 100,000 worker records with follow-up for mortality of the cohort through December 31, 2007.
- The exposure assessment component has classified workers by fab or non-fab worker status and by subcategories of these groups.
- The study, which got underway in August 2005, is expected to be completed in the second half of 2010.
- The study findings, including papers on the epidemiology results and on the exposure assessment approach and findings, will be published in a peer-reviewed scientific journal.
History of the Research Projects and Activities that preceded the Retrospective Epidemiological Study
In 1999, in response to media articles and the desire of the SIA Board of Director to substantiate that cleanroom workers were not subject to excess cancer risk, the SIA under took an evaluation of existing data to identify if an assessment of risk could be made and whether or not sufficient data was available to perform a retrospective epidemiology study. To perform this evaluation, a Scientific Advisory Committee (SAC) consisting of seven experts in health and industrial hygiene was retained. NIOSH representatives agreed to serve an ex-officio role in this effort. The SAC concluded in late 2001 that there is no affirmative evidence of increased risk of cancer among U.S. semiconductor factory workers. The SAC also reported that insufficient data exists at the present time to conclude whether exposure to chemicals or other hazardous materials has or has not increased such a risk of cancer. (SAC Executive Summary). In 2002, acting on the SAC recommendations and those of the SIA committees supporting this effort, the SIA Board of Directors agreed to support and fund three initiatives as part of a new Worker Health Project:
- A retrospective cohort scoping initiative to evaluate if sufficient data existed to perform retrospective epidemiology;
- A health surveillance initiative to judge if it is feasible to identify a common language for classifying worker information to a common format and to perform a survey of health surveillance activities at non-semiconductor companies;
- A primary prevention initiative to identify ways to provide better chemical and better process information prior to introducing new chemicals into the semiconductor manufacturing workplace.
The status of these projects is as follows:
- A Project Manager, Chuck Axten, Ph.D., was contracted to manage the three initiatives.
- An RFP for retrospective scoping initiative was developed and broadly distributed.
- Johns Hopkins University was selected to perform the Retrospective Scoping Study.
- Dr. Jean Matanoski- lead investigator for epidemiology
- Dr. Peter Lees- lead investigator for exposure assessment
- A Scientific Advisory Board (SAB) consisting of an independent group of prominent scientists in the fields of medicine, industrial hygiene, epidemiology and toxicology was created to provide objective scientific and medical advice to the SIA Worker Health Project Project Management Committee (PMC) for all three initiatives. The SAB is made up of the following scientists:
- Dr. Nurtan Esmen- University of Illinois, Chicago, Industrial Hygiene
- Dr. Grace LeMasters- University of Cincinnati, Epidemiology
- Dr. Gary Marsh- University of Pittsburgh, Epidemiologist
- Dr. David Eaton- University of Washington, Toxicologist
- Dr. Marc Schenker- University of California at Davis, Occupational Medicine
- Dr. Bob Spear- University of California at Berkeley, Industrial Hygiene
- Prior to Dr. Eaton, Dr. Jack Moore served as the toxicologist on the SAB, until his retirement in 2004.
- Reports for the two other initiatives were submitted during the first quarter of 2004
- Health Surveillance Initiative - lead investigator, Dr. Don Lassiter
- Primary Prevention Initiative
- New Chemical Introduction - lead investigative team, Weston Solutions
- Opportunities for further reducing potential exposures during equipment maintenance - lead investigative team, EORM
- Results from the Retrospective Scoping Study were reported to the Project Management Committee, the SAB, and subsequently to the SIA Board of Directors in 2004.
- Retrospective epidemiology is feasible
- A meaningful retrospective cohort epidemiology study can be conducted
History of the Reproductive Outcomes Study
In 1989, in response to concerns raised about spontaneous abortion among female cleanroom workers, SIA undertook one of the largest reproductive epidemiology studies ever undertaken by an industry. To oversee the project, a Scientific Advisory Panel (SAP) was selected which consisted of world renowned health and industrial hygiene experts. A representative of NIOSH (the National Institute for Occupational Health and Safety) also participated as an ex-officio member of the SAP. The work, performed by investigators at the University of California, Davis and others, identified that women working in photolithography and potentially exposed to ethylene-based glycol ethers had a higher risk of miscarriage than women working in other areas of the cleanroom. As a result of this work, the SIA member companies and, eventually, most semiconductor manufacturers worldwide elected to voluntarily phase out ethylene-based glycol ethers from use in photolithography. The results of these studies, including multiple papers, were published in the American Journal of Industrial Medicine in 1995.
