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Ann-Marie B. Dake John P. Knezovich William E. Nebo Lawrence Livermore National Laboratory, P. O. Box 808, Livermore, CA

Official Use Only. Genetic Effects of Benzene Exposure in Human Sperm: A Study of Chinese Factory Workers Department of Energy Human Subjects Working Group Meeting November 13 , 2009. Ann-Marie B. Dake John P. Knezovich William E. Nebo

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Ann-Marie B. Dake John P. Knezovich William E. Nebo Lawrence Livermore National Laboratory, P. O. Box 808, Livermore, CA

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  1. Official Use Only Genetic Effects of Benzene Exposure in Human Sperm: A Study of Chinese Factory WorkersDepartment of Energy Human Subjects Working Group MeetingNovember 13 , 2009 Ann-Marie B. Dake John P. Knezovich William E. Nebo Lawrence Livermore National Laboratory, P. O. Box 808, Livermore, CA 94551 This work performed under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under Contract DE-AC52-07NA27344

  2. Background • Benzene, a widely-used industrial chemical, is also a human leukemogen and a known human carcinogen • Studies have reported decreased testicular weight, testicular atrophy, and testes degeneration due to benzene exposure • PIs indicated that a recent study showed sperm from benzene-exposed factory workers were found to have significantly higher levels of abnormal numbers of chromosomes • Study was a collaboration with UC Berkeley, LLNL, Chinese Centers for Disease Control and Prevention in Beijing, and Tianjin Occupational Disease Hospital

  3. Study Objectives • Determine the effects of moderate-to-high occupational exposure to benzene on chromosomal defects in sperm and semen quality • Examine the associations between chromosomally defective sperm and chromosomally defective lymphocytes within the same group of benzene-exposed workers

  4. Experimental Design • Controls: ~50 workers involved in meat processing • Experimental: ~40 workers at 3 factories involved in making shoes and packaging materials • Heavy use of glues containing high levels of benzene • One-time collection of urine, blood, and semen samples

  5. Disposition of Samples and Questionnaire • Air badge monitors analyzed at CDC in Beijing • Urine, blood, and semen samples sent to LLNL • Urine sent to University of North Carolina for measuring benzene levels and benzene-related compounds • Blood samples sent to UC Berkeley for FISH analyses • Semen samples analyzed at LLNL • Questionnaire analyzed at UC Berkeley

  6. Informed Consent • UC Berkeley prepared the consent form • Several changes to the consent form were requested, mostly in the realm of revising the language (“too scientific”) for the layperson • Compensation of 60 Yuan (~$10 USD) to subjects

  7. Issues Raised at Board Meeting • Recruitment • Concerns about exploitation of population, and possible coercion from the government • Compensation • Payment given to participants was approximately one month’s salary for a factory worker • Privacy • Men lined up to give samples • Third party control • Chinese government approval was required to ship samples back to the U.S.

  8. Lessons Learned • Problems Encountered • Debriefing √ Many issues were discovered after the study was performed • Communication • Coercion • Safety standards in a foreign country • Privacy • Lack of control by U.S. PIs over protocol implementation by collaborators

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