SIA Worker Health Project

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1 SIA Wrker Health Prject Since the late 1980 s, SIA and its member cmpanies have participated in numerus research effrts t ensure the safety f the wafer fabricatin envirnment and the health f this wrkfrce. An exhaustive, five-year epidemilgical study cnducted by researchers frm Vanderbilt University cvering mre than 100,000 semicnductr industry wrkers fund n assciatin between verall cancer mrtality and wrking in wafer fabricatin cleanrms. The $7.5 millin study was cnducted by a team f researchers frm the Vanderbilt University Department f Medicine and the Vanderbilt- Ingram Cancer Center. The study was made pssible by research grant frm SIA. The study findings are detailed in tw peer-reviewed articles published in the Jurnal f Occupatinal and Envirnmental Medicine. An abstract can be reviewed at _in.5.aspx. In additin, a number f frequently asked questins appear at the end f this summary. The histry and status f this research prject are detailed belw, fllwed by a histry f earlier SIA Wrker Health Prjects. Histry and Status f the Retrspective Epidemilgical Study After the results f a feasibility study, cnducted by Jhns Hpkins University researchers, cncluded that an epidemilgy study was feasible, the SIA Bard f Directrs, at the March 2004 meeting, decided t fund a retrspective chrt epidemilgy study t determine if wafer fabricatin wrkers in the semicnductr industry have experienced higher rates f cancer than nn-fabricatin wrkers. The independent Scientific Advisry Bard (SAB) t the SIA Wrker Health Prjects, frmed in March 2003, has remained invlved, as advisrs, in all aspects f the retrspective chrt epidemilgy study, including the selectin f researchers and the design and cnduct f the study. A Prject Management Cmmittee (PMC), cnsisting f ccupatinal health and EHS representatives frm the participating member cmpanies and SIA and the Prject Manager, Chuck Axten, Ph.D., prvided internal guidance t the study. Key activities in the planning and cnduct f the study have been: The SIA PMC prepared and psted a Request fr Prpsal (RFP) fr the epidemilgy study n the SIA Website. Additinally, the RFP was advertised in the EpiMnitr and psted n the Duke University Web Server. After review f prpsals and interviews f investigatrs by the PMC and the SAB, SIA annunced, n August 2, 2005, that it had signed a cntract with Vanderbilt University t cnduct a retrspective epidemilgical study t determine if there is an increased cancer risk amng wafer fabricatin wrkers cmpared t ther semicnductr industry wrkers and the general ppulatin. (See Press Release) The Key Vanderbilt researchers are: Dr. Jseph McLaughlin- Principal Investigatr, Epidemilgy Dr. William Blt- Principal Investigatr, Epidemilgy Dr. Jhn Bice- Prject Manager

2 Dn Maran- Lead Investigatr, Expsure Assessment Drs. McLaughlin, Blt, and Bice were frmerly epidemilgical researchers at the Natinal Cancer Institute. The multimillin dllar study spanned nearly 30 years f activity. The study included review f ver 100,000 wrker recrds with fllw-up fr mrtality f the chrt thrugh December 31, The expsure assessment cmpnent classified wrkers by fab r nn-fab wrker status and by subcategries f these grups. The study, which gt underway in August 2005, was cmpleted in mid-2010 and underwent an exhaustive peer review prcess prir t be being accepted fr publicatin in the highly respected Jurnal f Occupatinal and Envirnmental Medicine. Histry f the Research Prjects and Activities that preceded the Retrspective Epidemilgical Study In 1999, the SIA under tk an evaluatin f existing data t identify if an assessment f risk culd be made and whether r nt sufficient data was available t perfrm a retrspective epidemilgy study. T perfrm this evaluatin, a Scientific Advisry Cmmittee (SAC) cnsisting f seven experts in health and industrial hygiene was retained. NIOSH representatives agreed t serve an ex-ffici rle in this effrt. The SAC cncluded in late 2001 that there is n affirmative evidence f increased risk f cancer amng U.S. semicnductr factry wrkers. The SAC als reprted that insufficient data exists at the present time t cnclude whether expsure t chemicals r ther hazardus materials has r has nt increased such a risk f cancer. (SAC Executive Summary). In 2002, acting n the SAC recmmendatins and thse f the SIA cmmittees supprting this effrt, the SIA Bard f Directrs agreed t supprt and fund three initiatives as part f a new Wrker Health Prject: A retrspective chrt scping initiative t evaluate if sufficient data existed t perfrm retrspective epidemilgy; A health surveillance initiative t judge if it is feasible t identify a cmmn language fr classifying wrker infrmatin t a cmmn frmat and t perfrm a survey f health surveillance activities at nn-semicnductr cmpanies; A primary preventin initiative t identify ways t prvide better chemical and better prcess infrmatin prir t intrducing new chemicals int the semicnductr manufacturing wrkplace. The status f these prjects is as fllws: A Prject Manager, Chuck Axten, Ph.D., was cntracted t manage the three initiatives.

3 An RFP fr retrspective scping initiative was develped and bradly distributed. Jhns Hpkins University was selected t perfrm the Retrspective Scping Study. Dr. Jean Matanski- lead investigatr fr epidemilgy Dr. Peter Lees- lead investigatr fr expsure assessment A Scientific Advisry Bard (SAB) cnsisting f an independent grup f prminent scientists in the fields f medicine, industrial hygiene, epidemilgy and txiclgy was created t prvide bjective scientific and medical advice t the SIA Wrker Health Prject Prject Management Cmmittee (PMC) fr all three initiatives. The SAB is made up f the fllwing scientists: Dr. Nurtan Esmen- University f Illinis, Chicag, Industrial Hygiene Dr. Grace LeMasters- University f Cincinnati, Epidemilgy Dr. Gary Marsh- University f Pittsburgh, Epidemilgist Dr. David Eatn- University f Washingtn, Txiclgist Dr. Marc Schenker- University f Califrnia at Davis, Occupatinal Medicine Dr. Bb Spear- University f Califrnia at Berkeley, Industrial Hygiene Prir t Dr. Eatn, Dr. Jack Mre served as the txiclgist n the SAB, until his retirement in Reprts fr the tw ther initiatives were submitted during the first quarter f 2004 Health Surveillance Initiative - lead investigatr, Dr. Dn Lassiter Primary Preventin Initiative New Chemical Intrductin - lead investigative team, Westn Slutins Opprtunities fr further reducing ptential expsures during equipment maintenance - lead investigative team, EORM Results frm the Retrspective Scping Study were reprted t the Prject Management Cmmittee, the SAB, and subsequently t the SIA Bard f Directrs in Retrspective epidemilgy is feasible A meaningful retrspective chrt epidemilgy study can be cnducted Histry f the Reprductive Outcmes Study In 1989, in respnse t cncerns raised abut spntaneus abrtin amng female cleanrm wrkers, SIA undertk ne f the largest reprductive epidemilgy studies ever undertaken by an industry. T versee the prject, a Scientific Advisry Panel (SAP) was selected which cnsisted f wrld renwned health and industrial hygiene experts. A representative f NIOSH (the Natinal Institute fr Occupatinal Health and Safety) als participated as an ex-ffici member f the SAP. The wrk, perfrmed by investigatrs at the University f Califrnia, Davis and thers, identified that wmen

4 wrking in phtlithgraphy and ptentially expsed t ethylene-based glycl ethers had a higher risk f miscarriage than wmen wrking in ther areas f the cleanrm. As a result f this wrk, the SIA member cmpanies and, eventually, mst semicnductr manufacturers wrldwide elected t vluntarily phase ut ethylenebased glycl ethers frm use in phtlithgraphy. The results f these studies, including multiple papers, were published in the American Jurnal f Industrial Medicine in Frequently Asked Questins Q. What was the purpse f this study and why did the industry spnsr it? A. The purpse f the study was t determine if there is an increased risk f cancer amng wafer fabricatin wrkers cmpared t ther semicnductr industry wrkers and the general ppulatin. The leaders f SIA senir fficials frm member cmpanies recgnized that the semicnductr manufacturing prcess necessarily requires use f ptentially hazardus chemicals and materials. These leaders als nted that there have been a number f media articles that raised questins as t whether there has been sufficient scientific analysis t determine whether wrking in semicnductr manufacturing increases cancer risk t industry wrkers. SIA and its member cmpanies have participated in r spnsred a number f research effrts ver the past three decades t ensure the safety and health f the industry wrkfrce. In 2004 the SIA bard decided t fund a retrspective epidemilgy 1 study t determine whether semicnductr manufacturing wrkers face a higher risk f cancer when cmpared t nn-manufacturing wrkers and the general ppulatin. Q. Wh cnducted this study and hw were the researchers selected? A. The study was cnducted by a team f researchers frm Vanderbilt University and the Vanderbilt-Ingram Cancer Center. 1 Fr a brief summary f what an epidemilgy study is, please see the ntes at the end f this dcument.

5 The research team includes natinally knwn scientists with expertise in cancer, epidemilgy, txiclgy, and related disciplines. The research team was selected thrugh a cmpetitive prcess invlving a detailed request fr prpsals. The qualificatins, experience, and credentials f thse wh submitted prpsals were reviewed by an independent Science Advisry Bard (SAB). Requisite qualificatins included demnstratin f their ability t cnduct a study f this type, cmplexity and magnitude; the availability f a sufficient number f qualified staff; their experience in cnducting similar studies; the time frame fr cnducting the study; and cst. The SIA bard f directrs made the final decisin t award a research grant t the Vanderbilt University research team. Q. Hw much did the study cst and wh paid fr it? A. The SIA grant t the Vanderbilt University research team amunted t $7.5 millin. The funds were prvided by SIA member cmpanies. There were substantial additinal csts assciated with cllecting data and infrmatin requested by the researchers and prviding access t manufacturing facilities and ther lgistical supprt essential t cnducting the study. These csts were brne by member cmpanies and were significant but have nt been itemized. Q. What was dne t ensure the independence f the researchers? A. The research team designed the study, analyzed and interpreted the data, and wrte the peer-reviewed articles that summarized the study findings. An independent Science Advisry Bard, whse members included experts in epidemilgy, medicine, txiclgy, and related disciplines, prvided technical assistance.

6 Ultimately, the credibility f any epidemilgy study and its cnclusins depend n the quality f the study and the integrity, credentials, and reputatin f the researchers. The research team at Vanderbilt University is natinally recgnized fr its capability, integrity, and experience. Q. What were the basic findings f the study? A. The researchers cncluded that: Wrk in the US semicnductr industry, including semicnductr wafer fabricatin in cleanrms, was nt assciated with increased cancer mrtality verall r mrtality frm any specific frm f cancer. 2 The researchers als fund n evidence f increased mrtality frm all causes r frm all cancers when cmparing emplyees wrking in cleanrms t nn-fabricatin wrkers. Q. Hw many wrkers were in the study ppulatin? A. The study chrt 3 cnsisted f mre than 100,000 wrkers emplyed at tw U.S. semicnductr cmpanies between 1968 and Mre than 14,000 f the emplyees in the study ppulatin began emplyment in the semicnductr industry befre The study ppulatin included wrkers invlved in wafer fabricatin as well as nn-fab jbs, and hurly and nn-hurly wrkers. Q. Hw many cmpanies participated in the study? A. All SIA member cmpanies cntributed t funding the study. By agreement, the identity f the cmpanies that prvided data t the researchers was nt reprted in the study. 2 T review the cmplete articles n the summary as published in the Jurnal f Occupatinal and Envirnmental Medicine fllw this link: 3 Please see the ntes at the end f this dcument fr a definitin f this term, which is used t describe the specific ppulatin invlved in an epidemilgical study.

7 The agreement between SIA and the researchers als prtects the privacy f the individuals that made up the study ppulatin. Ultimately, the availability f requisite data led the researchers t recmmend that the study ppulatin be drawn frm tw cmpanies that they cnsidered t be representative f the wrkfrce f the industry. Q. Why were wrkers frm nly tw cmpanies selected fr the study ppulatin? A. This was a very cmplex study. It cvered a perid f mre than 40 years. Researchers needed cmplete wrk histries n mre than 100,000 wrkers and sufficient data t create a chemical expsure assessment mdel. Mre than 60 different chemicals, 37,000 department and 8,600 jb cdes were invlved in develping the expsure assessment mdel. Ultimately, the availability f the requisite data led the researchers t draw the study ppulatin frm tw cmpanies. The study invlved site visits t 10 cities in five states with wafer fabricatin facilities. Of the ttal study ppulatin f mre than 100,000 wrkers, mre than 14,000 wrkers began emplyment prir t Q. Why did the study fcus n cancer mrtality (i.e., deaths attributed t cancer) rather than cancer incidence? A. The limited availability f reliable data n cancer incidence precluded ding such a study. Q. Hw did the researchers learn abut the causes f death f frmer emplyees? Aren t medical recrds cnfidential? A. Deaths and causes f death were derived frm publicly available dcuments r databases, nt frm participating cmpanies. The primary surces fr infrmatin abut deaths were the Natinal Death Index (NDI), Scial Security mrtality recrds, and, when needed, death certificates. The NDI, which has recrds f nearly all deaths and causes f death, was established specifically t facilitate studies by medical researchers. The NDI is nt accessible t cmpanies r the

8 general public a researcher must have a legitimate reasn t access NDI data and must frmally apply. Using identifiers such as name, scial security number, and date f birth, researchers can in mst cases determine the health utcmes fr individuals, even years after they may have left participating cmpanies. Q. Will the industry spnsr a fllw- up study? A. The researchers nted that the study ppulatin had a relatively lw average age and an assciated relatively lw number f deaths amng the study ppulatin. They cncluded that regular mrtality updates f the study ppulatin are warranted. The industry will cntinue t supprt activities that will ensure the safest pssible wrk envirnment fr emplyees. If there is a reasn in the future t cnsider anther study r a fllw-n study, the SIA bard will make a decisin based n the best infrmatin available t it at that time. Q. Describe sme f the nging activities f the semicnductr industry t address wrker health and safety issues. A. The semicnductr industry is wrking n a wrldwide basis t supprt a number f initiatives n envirnmental, health, and safety issues. SIA and member cmpanies have taken a leadership rle in these effrts that include: Cntinuusly seeking chemicals that present the fewest risks t its wrkfrce and managing any ptential risks thrugh effective engineering cntrls; Re-designing prcesses t use smaller amunts f chemicals and t use chemicals that are less hazardus t human health and the envirnment wherever pssible. Develping new tls and equipment t islate emplyees frm expsure t chemicals that culd ptentially pse health risks; Develping engineering cntrls t eliminate expsures (exhausts, interlcks, islatin f materials); Installing cntinuus mnitring devices where necessary and apprpriate; Retaining highly skilled prfessinals t design, implement, and manage cmprehensive safety and industrial hygiene prgrams and prcedures; Making chemical infrmatin mre readily accessible t wrkers;

9 Implementing engineering r administrative cntrls that eliminate any expsures and minimize the need fr persnal prtective equipment. Many f these activities entail significant investment in capital equipment, research and develpment, and human resurces. Wrking thrugh the Wrld Semicnductr Cuncil, SIA and its cunterparts in Eurpe, Japan, Krea, China, and Chinese Taipei share infrmatin n best practices and crdinate effrts t achieve cntinuus imprvement in EHS prgrams. Q. Have there been ther studies f cancer in the semicnductr industry? A. There have been tw ther recent epidemilgy studies f emplyees in the semicnductr industry. The University f Alabama-Birmingham cnducted a cancer mrtality and cancer incidence study f IBM emplyees at tw large semicnductr facilities. The Health and Safety Executive (HSE) in the United Kingdm cnducted a cancer mrtality and incidence study f a Natinal Semicnductr wafer fabricatin facility in Sctland and updated the study in The findings f these studies were reassuring in nt finding evidence f an increased cancer risk assciated with wrking in wafer fabricatin. Bth studies prduced results that were cnsistent with the findings f the Vanderbilt study. When, as in this situatin, the findings f several epidemilgic studies f different ppulatins are cnsistent with ne anther, it strengthens the cnfidence in the cnclusins f the studies. Ntes 1) Epidemilgy is the branch f medicine that deals with the causes, distributin, and cntrl f diseases in ppulatins. Epidemilgic studies attempt t identify, measure, cunt, and cntrl causes f untimely deaths. Such studies are based n cmparisns f different grups f peple. These studies prvide infrmatin abut the ccurrence f disease in a ppulatin r its subgrups ver time. Data surces include death certificates, special disease registries, surveys, and ppulatin censuses. 2) The Jurnal f Occupatinal and Envirnmental Medicine is the fficial publicatin f the American Cllege f Occupatinal and Envirnmental Medicine. The publicatin carries peer-reviewed, in-depth research articles and technical reprts t keep ccupatinal and envirnmental medicine specialists up t date n new develpments in the preventin, diagnsis, and rehabilitatin f envirnmentally induced cnditins and wrk-related injuries and illnesses. 3) The term study chrt refers t a well-defined grup f subjects r patients wh have had a cmmn experience r expsure and are then fllwed up fr the incidence f diseases.

10 Semicnductr Industry Assciatin

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