微生物產業生物危害調查

Investigation of Biohazards in Microbial Industry

由於現代生物科技快速發展，利用微生物於生產製程並經由生物程序來生產製造產品，或是改良微生物及其相關產品的產業日益蓬勃，這類產業統稱為「微生物產業」。因為某些特定微生物已被證實或懷疑和人類一些特定的不良健康效應有關聯，微生物產業工作人員因使用操作微生物，所造成的微生物暴露狀況及其可能引發的生物危害問題必須加以正視。在本研究中，我們對國內現今微生物產業在研究實驗和生產製造所可能造成的微生物暴露狀況，以郵寄問卷和電話訪問方式，調查廠商所使用的微生物的菌種名稱、生產製程使用微生物的情形、並對含微生物的原料和產品資料進行收集。此外，並針對 30 家廠商實施現場訪視評估，實地了解其作業人員可能的微生物暴露的可能性，及現有的暴露控制預防措施。結果發現：國內的微生物產業大體上可分為傳統食品釀造及新興的生物科技。新興的微生物產業依其產品適用對象，可大致上分為：菌體肥料或生物肥料、動物飼料添加物、農業或環保生物製劑、生技製藥、檢驗試劑、人體和動物疫苗和保健或健康食品等七大類。傳統食品釀造使用食用菌或是對人體無害的菌種，且未涉及基因改造的問題。新興的生物科技產業確有基因改造微生物的使用，但尚未使用於疫苗的製造。微生物產業作業人員的微生物暴露狀況，未來應加以重視並實施監測的產業項目包括：疫苗製造和檢驗試劑製造；並針對涉及醱酵製程，進一步評估作業環境中非致病性微生物種類與濃度，以評估用於醱酵製程的微生物是否有引發作業員工過敏反應的健康風險。

Because of the rapid development of modern biotechnology, the industry involving the application of microorganisms and bioprocesses to the manufacturing processes or the modification of microorganisms and the usage of these modified microorganisms in making products has grown tremendously. This type of industry is generally called “microbial industry”. Since some specific microorganisms have been confirmed or suspected to be associated with some adverse health effects, it is necessary to focus on the issues of biohazards relevant to workers’ exposure to microorganisms from the handling and manipulation of microorganisms. In this study, we searched for the literatures of adverse effects induced by exposure to microorganisms in microbial industry and the basic information of manufacturers of microbial products. We designed questionnaires to collect the information of process-used microorganisms and microorganism-containing products and the routes and frequency of exposure to microorganisms in these manufacturing processes. We also conducted telephone interviews and field investigations to gather more detailed information. Thirty manufactures were chosen for field investigations. From the results of this study, we found that in general microbial industry might be classified into traditional food fermentation and recently-developed biotechnology. According to the characteristics of product-applied subjects, the recently-developed biotechnology can be classified into seven categories: microorganismcontaining fertilizers, animal feed additives, environmental or agricultural biological agents, biotechnical medicines, diagnostic test kits, human and animal vaccines, and healthy food products. The traditional food fermentation used the microorganisms which are not hazardous to human beings and not genetically modified. The recently-developed biotechnology industry used genetically modified microorganisms in the manufacturing processes, but not in the vaccine preparation. Monitoring workers’ exposures to microorganisms in microbial industry especially for vaccine preparation and diagnostic kit production should be conducted in further studies. In addition, for the manufacturing processes with fermentation, the characterization of the species and concentration of non-pathogenic microorganisms is necessary to assess the risk of allergy among workers.