環保專案成果報告查詢系統

專案計畫編號
經費年度	109
計畫經費	6,730 千元
預算科目	化學物質評估與管理-毒性及關注化學物質管理
專案開始日期	2020/05/04
專案結束日期	2020/12/20
專案主持人	許心蘭
主辦單位	毒物及化學物質局
承辦人	潘郁采
執行單位	財團法人工業技術研究院
專案分類	化學物質管理
中文關鍵字	毒化物、快篩技術、檢測量能
英文關鍵字	toxic chemical substance, screening method, analytical capability
協同主持人	鄭景智
共同主持人
計畫聯絡人	許心蘭
計畫聯絡電話	03-5732683#
計畫聯絡信箱	hlhsu@itri.org.tw

中文摘要	隨著毒性及關注化學物質管理法中列管的化學物質種類增加，為及早因應檢測量能不足的困境，本計畫旨在健全國內毒性及關注化學物質之檢測量能，包括檢測方法與標準品取得途徑之完備、國外化學物質分析運作系統之借鏡、評估國內化學物質水生生物毒性試驗方法等。此外，經由運作事業體訪視與採樣檢測，瞭解33項化學物質的運作型態與實際樣品的檢測實作，並研擬未知物採樣與檢測指導作業手冊，以及提出毒化物類別環境檢測方法認證申請。最後，研析本計畫執行之效益與規劃未來四年的執行方向。在檢測方法方面，針對國內尚無標準檢測方法的51項毒性化學物質以及20項研擬中的關注化學物質，參考「列管毒性化學物質及其運作管理事項」第14條可採用之國內外檢測方法來源，皆能盤點出可運用或參考的檢測方法，其中部分檢測方法屬家族式檢測，非單一化合物的檢測。由於國內毒管法依各項單一化合物管制，家族式檢測方法無法界定為何項化合物，在行政執法支援上略嫌不足。因應之道除了檢測技術開發之外，應同時評估調整毒管法管制方法，參考國外依毒化物毒理特性選用單一化合物管制或家族式管制，合理投入檢測資源。至於國內標準品取得困難的化學物質，向運作事業體廠家索取少量化學物質作為標準品乃一可行途徑，惟須具備濃度證明文件方可滿足標準品具量測追溯性的要件。在研析國外化學物質分析運作部分，歐盟、美國與日韓等國均採用優良實驗室操作(Good Labortory Practice, GLP)規範，要求化學物質檢測機構須符合一系列的實驗室運作與管理規範，以提升檢測數據品質與有效性，但不限定使用的檢測方法。此作法給予檢測機構有較大的彈性，尤其化學物質項目眾多且形態多樣化，這樣的彈性非常重要；對於執法機關而言，也較容易取得業界支援又同時保有數據品質。至於環境檢測分析，因為有限的管制項目與明確的環境基質，大多需取得對應標準方法的認證許可。相較於國內的作法，無論是執行環境基質樣品或毒性與關注化學物質的分析，環境檢驗測定機構皆需有對應方法的認證許可才能出具正式報告。所幸，近年來環保署公告的NIEA T101與NIEA T102等兩方法為現有體制賦予GLP彈性認證的精神，未來可望藉由認證此兩方法拓展化學物質檢測量能。水生生物毒性試驗方法評估係以水蚤及鯉魚評估高揮發性化學物質的急毒性，並參考OECD建議的試驗方法以氣密容器進行毒性試驗並減少頂空氣體，試驗結果顯示密閉容器相較於開放系統較不會高估LC50或EC50。此外，建議未來可以參考OECD建議的試驗方法，以不動率(Immobility)來定義半影響濃度(50%, Effective Concentration, EC50)。為瞭解國內33項化學物質運作型態，共訪視了30家運作事業體，採集203個樣品進行實驗室檢驗，相關檢測方法皆於本年度提出認證申請。部分樣品檢測結果顯示與業者提供的物質資料表濃度資訊不一致，且業者普遍無法進一步提出較具數據品質的濃度證明文件，建議未來持續評估是否要求工廠自主檢驗含有毒性或關注化學物質的成品或半成品以作為備查。經歸納綜整前述執行經驗，並納入專家諮詢會的建議，本計畫完成編撰「未知物採樣與檢測指導作業手冊」，並舉辦一場訓練課，邀集各縣（市）地方環保機關進行技術擴散。經由執行本計畫，可望達成多項效益，包括提升化學物質使用安全性、帶動快篩設備的需求與市場、毒化物檢測市場等。化學物質檢測量能的建置經過本計畫的進展也向前邁了一大步，未來仍需繼續努力的方向包括檢測方法持續建置、快篩技術持續精進、邊境查驗採樣與快篩等，此外，相關法規也有需要檢視與討論之處，包括法規管制方式以及實驗室採樣檢測毒化物相關的規定。
中文關鍵字	毒化物、快篩技術、檢測量能

中文摘要

隨著毒性及關注化學物質管理法中列管的化學物質種類增加，為及早因應檢測量能不足的困境，本計畫旨在健全國內毒性及關注化學物質之檢測量能，包括檢測方法與標準品取得途徑之完備、國外化學物質分析運作系統之借鏡、評估國內化學物質水生生物毒性試驗方法等。此外，經由運作事業體訪視與採樣檢測，瞭解33項化學物質的運作型態與實際樣品的檢測實作，並研擬未知物採樣與檢測指導作業手冊，以及提出毒化物類別環境檢測方法認證申請。最後，研析本計畫執行之效益與規劃未來四年的執行方向。在檢測方法方面，針對國內尚無標準檢測方法的51項毒性化學物質以及20項研擬中的關注化學物質，參考「列管毒性化學物質及其運作管理事項」第14條可採用之國內外檢測方法來源，皆能盤點出可運用或參考的檢測方法，其中部分檢測方法屬家族式檢測，非單一化合物的檢測。由於國內毒管法依各項單一化合物管制，家族式檢測方法無法界定為何項化合物，在行政執法支援上略嫌不足。因應之道除了檢測技術開發之外，應同時評估調整毒管法管制方法，參考國外依毒化物毒理特性選用單一化合物管制或家族式管制，合理投入檢測資源。至於國內標準品取得困難的化學物質，向運作事業體廠家索取少量化學物質作為標準品乃一可行途徑，惟須具備濃度證明文件方可滿足標準品具量測追溯性的要件。在研析國外化學物質分析運作部分，歐盟、美國與日韓等國均採用優良實驗室操作(Good Labortory Practice, GLP)規範，要求化學物質檢測機構須符合一系列的實驗室運作與管理規範，以提升檢測數據品質與有效性，但不限定使用的檢測方法。此作法給予檢測機構有較大的彈性，尤其化學物質項目眾多且形態多樣化，這樣的彈性非常重要；對於執法機關而言，也較容易取得業界支援又同時保有數據品質。至於環境檢測分析，因為有限的管制項目與明確的環境基質，大多需取得對應標準方法的認證許可。相較於國內的作法，無論是執行環境基質樣品或毒性與關注化學物質的分析，環境檢驗測定機構皆需有對應方法的認證許可才能出具正式報告。所幸，近年來環保署公告的NIEA T101與NIEA T102等兩方法為現有體制賦予GLP彈性認證的精神，未來可望藉由認證此兩方法拓展化學物質檢測量能。水生生物毒性試驗方法評估係以水蚤及鯉魚評估高揮發性化學物質的急毒性，並參考OECD建議的試驗方法以氣密容器進行毒性試驗並減少頂空氣體，試驗結果顯示密閉容器相較於開放系統較不會高估LC50或EC50。此外，建議未來可以參考OECD建議的試驗方法，以不動率(Immobility)來定義半影響濃度(50%, Effective Concentration, EC50)。為瞭解國內33項化學物質運作型態，共訪視了30家運作事業體，採集203個樣品進行實驗室檢驗，相關檢測方法皆於本年度提出認證申請。部分樣品檢測結果顯示與業者提供的物質資料表濃度資訊不一致，且業者普遍無法進一步提出較具數據品質的濃度證明文件，建議未來持續評估是否要求工廠自主檢驗含有毒性或關注化學物質的成品或半成品以作為備查。經歸納綜整前述執行經驗，並納入專家諮詢會的建議，本計畫完成編撰「未知物採樣與檢測指導作業手冊」，並舉辦一場訓練課，邀集各縣（市）地方環保機關進行技術擴散。經由執行本計畫，可望達成多項效益，包括提升化學物質使用安全性、帶動快篩設備的需求與市場、毒化物檢測市場等。化學物質檢測量能的建置經過本計畫的進展也向前邁了一大步，未來仍需繼續努力的方向包括檢測方法持續建置、快篩技術持續精進、邊境查驗採樣與快篩等，此外，相關法規也有需要檢視與討論之處，包括法規管制方式以及實驗室採樣檢測毒化物相關的規定。

中文關鍵字

毒化物、快篩技術、檢測量能

類型	檔名	檔案大小	說明	最新版公開日期
期末報告	毒物及關注化學物質檢測量能盤點與採樣檢測支援計畫_成果報告.pdf	3MB		2021/1/31 上午 12:00:00

摘要	There is a growing need for chemical analysis of toxic chemical substances in order to support the administrative actions under the amended Toxic and Concerned Chemical Substances Control Act. This project aims to develop the needed analytical capabilities via the tasks including completing the analytical method database and the acquirement of the standard materials, learning from the international operations of the laboratory management for chemical substances, assessment of the aquatic toxicity, sampling and analysis of chemical substances from factories, and submission for accreditation of 33 chemical substances. Besides, benefits from this project were analyzed and the follow-up tasks in the near future were also proposed. To complete the analytical method database, relevant methods for the 51 toxic substances, which lack domestic standand methods, and 20 candidates of the concerned chemical substances can be found from the sources listed in Article 14 of the “Management and Operation of Toxic Chemical Substances and Regulations”. However, some of the methods analyze the toxic groups of concern instead of the individual compound, whereas the concentration of the individual compound shall be on demand based on our regulation in Taiwan. Although analytical methods for the individual compound may be studied, it was suggested to consider adopting group regulations for those whose toxicity concerns are only associated with the particular groups. As for the standard materials not available in the regular commodity channel, obtaining from the users is a doable way as long as the certificate of analysis can be provided. As for the operation system of the laboratories in countires such as those of European Uion, the U.S., Korean and Japen, laboratories compliance with Good Labortory Practice (GLP) are qualified for chemical substance analysis. GLP is a quality system of management controls without limitations on the analytical methods used. For laboratories, this way of operation provides the needed flexibility in order to analyze hundreds of chemical substances that may come in different ways. On the contrary, for the environmental sample analysis, laboratories must obtain the accreditation of the analytical method specific to the target compounds in the matrix of the samples. While there are two different operation systems in these foreign countries, there is only one syetem in Taiwan, which is similar to that aforementioned for the environmental sample analysis. Fortunately, the NIEA T101 and NIEA T102 methods specific for chemical substances announced in recent years by Taiwan EPA provide the flexibility similar to that of GLP and thus are very helpful for the development of the analytical capability of chemical substances. Assessment of aquatic toxicity was conducted using daphnia and carp to evaluate the acute toxicity of volitle organic chemicals. Evaluation was performed in a close system with little headspace based on the test method recommended by OECD. Results showed that over-estimation of LC50 or EC50 can be minimized in close systems compared to open systems. Besides, it was recommended that EC50 be defined based on immobility instead of death. In order to understand how the chemical substances are handled in the industries, 33 compounds were chosen as targets in this work and 30 factories handling at least one of the targets were visited. A total of 203 samples containing more or less the targets were sampled from the factories and analyzed by 2 laboratories, which completed the submission of accreditation application by the end of this project. Some of the analysis results were not consistent with the claimed concentrations on safety data sheets (SDS) provided by the factories, and frequently a certificate of analysis with data quality quarenteed was not available. It was suggested that chemical handlers should have certificates of analysis as a legal proof of the concentration especially when the toxic chemical substances are contained. With the experience of taking samples of various toxic chemical sunstances from industries, we incorporated the advices from several experts and completed a draft of Handbook of Sampling, Screening and Analysis for Chemicals. We also managed a training course and shared these experiences with the local enforcement officers. Benefits of this project include enhancing the safety of chemical substances and promoting the needs and market of screening and analysis of chemical substances, not to mention a significant progress in the development of the domestic analytical capability. In the future, efforts to improve are still needed and a 4-year blueprint was presented in this work with focuses on the directions including both regulations and technical enhancement.
英文關鍵字	toxic chemical substance, screening method, analytical capability

摘要

There is a growing need for chemical analysis of toxic chemical substances in order to support the administrative actions under the amended Toxic and Concerned Chemical Substances Control Act. This project aims to develop the needed analytical capabilities via the tasks including completing the analytical method database and the acquirement of the standard materials, learning from the international operations of the laboratory management for chemical substances, assessment of the aquatic toxicity, sampling and analysis of chemical substances from factories, and submission for accreditation of 33 chemical substances. Besides, benefits from this project were analyzed and the follow-up tasks in the near future were also proposed. To complete the analytical method database, relevant methods for the 51 toxic substances, which lack domestic standand methods, and 20 candidates of the concerned chemical substances can be found from the sources listed in Article 14 of the “Management and Operation of Toxic Chemical Substances and Regulations”. However, some of the methods analyze the toxic groups of concern instead of the individual compound, whereas the concentration of the individual compound shall be on demand based on our regulation in Taiwan. Although analytical methods for the individual compound may be studied, it was suggested to consider adopting group regulations for those whose toxicity concerns are only associated with the particular groups. As for the standard materials not available in the regular commodity channel, obtaining from the users is a doable way as long as the certificate of analysis can be provided. As for the operation system of the laboratories in countires such as those of European Uion, the U.S., Korean and Japen, laboratories compliance with Good Labortory Practice (GLP) are qualified for chemical substance analysis. GLP is a quality system of management controls without limitations on the analytical methods used. For laboratories, this way of operation provides the needed flexibility in order to analyze hundreds of chemical substances that may come in different ways. On the contrary, for the environmental sample analysis, laboratories must obtain the accreditation of the analytical method specific to the target compounds in the matrix of the samples. While there are two different operation systems in these foreign countries, there is only one syetem in Taiwan, which is similar to that aforementioned for the environmental sample analysis. Fortunately, the NIEA T101 and NIEA T102 methods specific for chemical substances announced in recent years by Taiwan EPA provide the flexibility similar to that of GLP and thus are very helpful for the development of the analytical capability of chemical substances. Assessment of aquatic toxicity was conducted using daphnia and carp to evaluate the acute toxicity of volitle organic chemicals. Evaluation was performed in a close system with little headspace based on the test method recommended by OECD. Results showed that over-estimation of LC50 or EC50 can be minimized in close systems compared to open systems. Besides, it was recommended that EC50 be defined based on immobility instead of death. In order to understand how the chemical substances are handled in the industries, 33 compounds were chosen as targets in this work and 30 factories handling at least one of the targets were visited. A total of 203 samples containing more or less the targets were sampled from the factories and analyzed by 2 laboratories, which completed the submission of accreditation application by the end of this project. Some of the analysis results were not consistent with the claimed concentrations on safety data sheets (SDS) provided by the factories, and frequently a certificate of analysis with data quality quarenteed was not available. It was suggested that chemical handlers should have certificates of analysis as a legal proof of the concentration especially when the toxic chemical substances are contained. With the experience of taking samples of various toxic chemical sunstances from industries, we incorporated the advices from several experts and completed a draft of Handbook of Sampling, Screening and Analysis for Chemicals. We also managed a training course and shared these experiences with the local enforcement officers. Benefits of this project include enhancing the safety of chemical substances and promoting the needs and market of screening and analysis of chemical substances, not to mention a significant progress in the development of the domestic analytical capability. In the future, efforts to improve are still needed and a 4-year blueprint was presented in this work with focuses on the directions including both regulations and technical enhancement.

英文關鍵字

toxic chemical substance, screening method, analytical capability