生物科技產業被列為二十一世紀重點發展的產業項目，然而生技產業從業人員則可能暴露於一般較少見之生物危害問題，亦鮮少有相關研究報告或調查。為瞭解生物科技產業界對生物危害之認知程度，藉由本研究探討教育訓練方式是否能有效提升生物科技從業人員對生物危害的危害認知與管理。

依據經濟部工業局登記的生物科技產業，且具有微生物實驗室的公司為主要研究對象，依其員工人數分為100人以上、30人以上未滿100人、未滿30人作分層取樣。首先收集國外所訂立相關生物危害的資料，並參考國內目前已公告的相關生物危害規範，彙整成一套適合生物科技公司推動生物危害的管理系統，發函邀請生物科技產業的從業人員接受生物危害管理教育訓練，未接受教育訓練之公司作為對照組，並設計問卷作為評估廠商自評及專家訪視成績之依據。廠商自評方面，在訓練前後皆由同一位人員作答；專家訪視部分主要針對接受教育訓練的公司且包含至少兩位專家前往，以三個月的時間作為評估執行生物危害管理的成效，比較訓練前後廠商自評分數結果及專家訪視結果。

共有31家公司納入研究對象，10家公司接受生物危害教育訓練，另挑選10家員工人數規模相當的公司作為對照組。接受教育訓練前實驗組的平均分數為56.5(標準差6.1)，對照組的平均分數為44.8(標準差6.6)，實驗組與對照組於接受教育訓練前對於生物危害管理並沒有顯著的差異（p=0.34）。在教育訓練後實驗組的平均分數為80.2(標準差2.2)，對照組的平均分數為60.0(標準差3.5)，研究顯示實驗組在接受訓練後，在生物危害認知知識與生物危害管理皆有明顯提升(p=0.0009，p=0.02)，然而對照組在三個月後，在生物危害管理有顯著提升(p=0.04)，在生物危害認知知識方面的得分沒有明顯進步。另外以專家訪視結果來檢定實驗組於訓練後自評結果的可靠性，發現自評與專家訪視結果有較高的相關性(R2=0.583，p=0.01)，然而專家訪視的分數仍顯著低於自評結果(p=0.007)，表示自評仍可能高估對於生物危害認知程度與生物危害管理執行狀況。

生物危害的訓練可以增加危害的知識，因此對於生物科技產業列入生物危害教育訓練實有其必要性。雖然自評結果與專家訪視結果具相關性，但自評結果仍有高估趨勢，因此藉由定期專家探訪將有助於提升生物科技產業執行生物危害管理之成效。

Biotechnology is one of the rapidly developing industries in the 21st century. The workers of biotechnology industry may be exposed to biohazardous environment. The objective of this investigation is to determine the effectiveness of education and training on the workers’ recognition of biological safety and health.

Our candidates industries for this study are the registered biotechnology industries in Industrial Development Bureau of Ministry of Economic Affairs. The industries were stratified into 3 groups according to the number of employees, namely, above 100, 30 to 99, and below 30. Phone interview using structured questionnaire was conducted to evaluate knowledge, attitude and practice on biological safety and health. After initial evaluation, representatives of these companies were invited to receive education and training. The training program was composed of such documents from Council of Agriculture and National Science Council. Those who received biological safety and health training course were experiment group. Those who did not receive training were comparison group. After 3 months of training, a similar questionnaire was used to re-evaluate the companies. The questionnaire contained 15 questions, which were scored from 0 to 100 totally. In addition, industrial hygiene inspection was also conducted as a comparison with questionnaire.

Total of 31 companies with biological laboratory were selected as our study subjects. The industrial hygienists of 10 companies received the training program. Another 10 companies with similar size of employees were selected as comparison. The average score was 56.5 (SE of 6.1) in trained group and 44.8 (SE of 6.6) in comparison group before giving training. There is no statistical difference (p=0.34) between these two groups. Three months after training, the scores were 80.2 (SE of 2.2) and 60.0 (SE of 3.5), in trained and comparison groups, respectively. There was significant improvement in biohazard recognition(p=0.0009) and management(p=0.02) for trained groups. Therefore the untrained groups had improvement on biological safety and health management(p=0.04) but not in biohazard recognition. While comparing the scores between expert inspection and self-evaluation, these 2 scores were highly correlated (R2=0.583, p=0.01). However, the results of expert inspection were also significantly lower than self-evaluated (p=0.007).

It is concluded that biological safety and health training program is useful for improving safety and health knowledge, attitude, and practice in biotechnology industry. Although self-evaluation gives information on worker’s safety and health practice, its effect may be over-estimated. Therefore, regular inspection by experts is a better way to improve biological safety and health management.

[1].財團法人生技中心：田蔚城，”生物技術的發展與應用：生物技術導論”第一版，1998年2月，頁1-18
[2].經濟部工業局，”1900~2000產業技術白皮書”，2000
[3].蘇遠志，”生物技術產業國內外市場發展趨勢”，2000
[4].經濟部工業局，”2002生技產業白皮書”初版，財團法人印刷工業技術研究中心，台北市，頁41，91年9月
[5].孫智麗，”建構知識經濟運作之創新系統-台灣生物技術產業發展現況與策略”，台灣經濟研究院，2001年12月
[6].行政院國家科學委員會，”加強生物技術產業推動方案”，生物產業，第六卷第三期，1995
[7].生技時代股份有限公司，”生技時代”，No.14，2002年12月，頁83
[8].Robins TG. Hugentobler MK. Kaminski M. Klitzman S., 1994, ”A joint labor-management hazard communication training program: a case study in worker health and safety training”, Occupational Medicine. 9:135-45
[9].Eckebrecht, T.，2000, “Occupational Standards for the Protection of Employees in Biotechnology”, Int. Arch. Occup. Environ. Health, 73: S4-S7.
[10].Frommer, W. et al. 1993; “Safe Biotechnology 5: Recommendations for safe work with animal and human cell cultures concerning potential human pathogens”, Appl Microbiol Biotechnol, 39:141 -147.
[11].Lelieveld, H.L., Bachmayer, H., Boon, B., Brunius, G., Burki, K., Chmiel, A., Collins, C.H., Crooy, P., Doblhoff-Dier, O., Economidis, I., et al., 1995; ”Safe biotechnology. Part 6. Safety assessment, in respect of human health, of microorganisms used in biotechnology. “, Working Party “Safety in Biotechnology" of the EuropeanFederation Biotechnology. Appl Microbiol Biotechnol, 43(3):389-393.
[12].Organization for Economic Cooperation and Development, 1992，”Recombinant DNA safety consideration”，OECD， Paris
[13].Lelieveld H.L., Boon B., Bennett A., Brunius G., Cantley M., Chmiel A., Collins C.H., Crooy P., Doblhoff-Dier O., Economidis I. et al., 1996; “Safe biotechnology. 7. Classification of microorganisms on the basis of hazard.” Working Party Safety in Biotechnology of the European Federation Biotechnology. “，Appl Microbiol Biotechnol，45:723-729.
[14].Belgian Biosafety Swever，”European Directives 90/679/EEC, 93/88/EEC, 95/30/CE, 97/59/CE and 97/65/CE”，Royal Decision，August
[15].European Union legislation，”Protection of Workers exposed to Biological Agents at work”，August 1999
[16].Population and Public Health Branch，”Laboratory Biosafety Guidelines”，2nd Edition，Canada，1996
[17].CDC/NIH，”Biosafety in Microbiological and Biomedical Laboratories”，4th edition，April 1999
[18].NIH，”NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) “，May 1999
[19].CDC，”The Laboratory Biosafety Guidelines”，3rd edition-Draft，September 2001
[20].Lee, S.B., Ryan, L.J. Jr. 1996; “Occupational health and safety in the biotechnology industry--a survey of practicing professionals. “，Amer Indust Hygi Assoc, 57:381-386.
[21]. World Health Organization，”Laboratory biosafety manual”，Geneva： WHO，April, 2003
[22].行政院農業委員會家畜衛生試驗所，”行政院農業委員會家畜衛生試驗所實驗室生物安全手冊”， 行政院農業委員會
[23].行政院國家科學委員會生物科學發展處，”基因重組實驗守則”91年1月再修，行政院國家科學委員會，生物科學發展處，91年1月
[24].UCSD EH&S Biosafety Team，”UCSD Biosafety Handbook”，San Diego，1996
[25].行政院衛生署，”公告部分感染性醫療廢棄物滅菌處理標準及相關規定”，九十年四月二十六日
[26].行政院環保署，”事業廢棄物貯存清除處理方法及設施標準”，行政院環保署，九十二年六月十八日
[27].行政院勞工委員會，”勞工安全衛生法”，行政院勞工委員會，九十一年六月十二日
[28].行政院勞工委員會，”危險物及有害物通識規則”，行政院勞工委員會，八十八年六月二十九日
[29].行政院勞工委員會，”勞工健康保護規則”，行政院勞工委員會，九十一年十一月二十日
[30].張靜文、洪其壁、陳振和、吳俊德、于台珊等，”微生物產業之生物性危害研究”，行政院勞工委員會勞工危害研究所，2002年2月
[31].陳秋蓉、郭育良、許昺奇等，”生物科技產業勞工健康危害調查評估研究－問卷訪視及危害監測模式建立”，行政院勞工委員會勞工危害研究所，2002年1月初版
[32].劉紹興、吳聰能、辜志弘、陳惠敏等，”生物性危害預防與控制先驅研究”，行政院勞工委員會勞工危害研究所，89年9月
[33].Lauwerys，RR/Hoet，Perrine，”Industrial Chemical Exposure： Guidelines for Biological Monitoring”，Boca Raton：Lewis Publishers，1993
[34].Liberman DF.，”Biohazards Management Handbook” 2nd edition，New York：Marcel Dekker，1995
[35].Mendelsohn ML.，Peeters JP.，Normandy MJ.，”Biomarkers and Occupational Health：Progress and Perspectives”，Washington, D.C.：Joseph Henry Press，1995
[36].Wald, Peter H.，Stave, Gregg M.，”Physical and Biological Hazards of the Workplace”，New York：Van Nostrand Reinhold，1994
[37].Saari J. Bedard S. Dufort V. Hryniewiecki J. Theriault G., 1994, ”Successful training strategies to implement a workplace hazardous materials information system. An evaluation study at 80 plants. ”, Occup. Med., 36:569-74
[38].Smith D. Hsu, PC., 2001, ”Occupational health and safety in Taiwan. ” Journal of Occupational Health and Safety-Austrial and New Zealand 17:1-3
[39].Grizzle WE. Fredenburgh J., 2001, ”Avoiding biohazards in medical, veterinary and research laboratories. ” Biotechnic & Histochemistry. 76(4):183-206
[40].Weeks B., 1998, “Research labs present unique health and safety issues. “, Healthcare Hazardous Materials Management. 11:1-5
[41].Weidner BL., 2000, “Testing as a measure of worker health and safety training: perspectives from a hazardous materials program.” , American Journal of Industrial Medicine. 37:221-8