109-110年精進環境用藥管理及許可證登記專業支援計畫
2020-2021 Improvement and Assistant of Environmental Agents Regulations and Review of Environmental Agent Permit Application

本計畫工作主要為法規研擬修正、輔導訪查、多元宣導及許可申請文件資料初步檢核作業，分為四大面向執行內容：期透過調整環境用藥行政管理措施、修正法規、環境用藥許可證文件資料專業審查及專業諮詢服務，以達加速行政作業，精進環境用藥管理，簡政便民之計畫目標。法規研擬修正就環境用藥廣告管理，針對民眾於網路平臺違法廣告販售偽藥現況問題研擬短中長程規劃，用以強化廣告管理措施以有效減少違法廣告情形，短程訂定公告「網路平臺之強化環境用藥廣告管理措施」，協請網路平臺業者配合加強民眾刊登產品上架管理機制及加強環境用藥廣告巡檢作業；中長程規劃為修正環境用藥管理法及子法「環境用藥廣告管理辦法」，擬透過修正母法授權主管機關管理網路平臺業者，規範強化平臺業者應責之管理責任，以有效杜絕民眾透過網路平臺違法廣告偽藥情形。另針對環境用藥有效成分管理，完成汞及甲基汞納入環境用藥禁止含有成分之修正公告，與國內管理齊平並與國際接軌；針對國際關注成分陶斯松，提出分階段禁限用管制措施並與業者完成2場次意見座談會，擬定管制措施期程；另為達有效成分全面管理，完善環境用藥管理制度，研擬提出有效成分篩選原則，再評估制度及禁限用管理標準作業流程草案；研擬提出環境用藥免申請許可證篩選原則、免申請許可證成分清單(草案)及免申請環境用藥許可證之管理措施草案及建議，並針對上述議題及環境用藥管理範疇納入環境用藥管理法滾動修正。環境用藥之殺菌劑成分，完成國內外殺菌劑有效成分資料蒐集彙整，包括次氯酸及其鹽類、亞氯酸鈉、四級銨鹽類、二氧化氯、過氧化氫、戊二醛及L-乳酸，6類12個殺菌劑有效成分，並完成辦理2場次專家諮詢會及2場次意見蒐集座談會。輔導訪查，已辦理病媒防治業施藥人員訓練機構訪查作業11家，並協助修正「病媒防治業施藥人員訓練機構檢查評核要點」及研擬藥效檢測機構指定期間抽查作業要點，以更完善我國環境用藥各層面之管理。多元宣導，共計完成4場次環境用藥法規說明宣導活動，參與人數共計1,208人次；另透過廣播宣導短劇播放(491檔廣播宣導短劇播放，新增2則廣播宣導短劇錄製)、影音專訪(3則)、宣導動畫製作(5則)及雜誌廣告刊登(2則)之各種管道進行多元化宣導，宣導民眾正確的環境用藥使用觀念、環境用藥廣告相關法規宣導及教導民眾認識合法病媒防治業及查詢。環境用藥許可申請文件資料初步檢核作業方面，共計協助完成1,162件許可申請案之初步檢核作業及協助及辦理10場次許可審查專家諮詢會議，另配合許可審查辦理1場次製造廠現勘作業，並彙整申請案審查原則及專家委員意見更新至許可申請案審查指引中，並依據審查實務提出後續環境用藥許可證申請核發作業準則之法規的調修建議。

This project included regulations amended, inspection counseling, multiple advocacies, and preliminary review of permit applications. Four tasks included in this project were adjusting administrative measures for environmental agents, regulations amended, review of permit applications, and professional consulting service. The aim of the this project was to expedite administrative processing, improve environmental agents management, and provide convenience services. For regulations amended, short-, medium-, and long-term plan were developed to deal with illegal advertising and selling of counterfeit environmental agents on online platforms. The plans aimed to strengthen governance of the advertising and to reduce illegal advertising effectively. The short-term plan was to announce "Enhancing Management Measures for the Advertising of Environmental Agents on Online Platforms". Meanwhile, online platform operators were invited to strengthen the management and inspection of environmental agents products on their platform. The Environmental Agents Control Act and the Regulations Governing the Advertising of Environmental Agents were proposed to amend in the medium- and long-term plan. Through the amendment of the act, the competent authority was authorized to manage the online platform operators. It also requested the online platform operators to take responsibility for management of environmental agents and therefore to effectively prevent the public from illegally advertising counterfeit environmental agents on the online platform. Regarding active ingredients administration, prohibition of mercury and methylmercury in environmental agents was announced. Chlorpyrifos, which was a substance of international concern, was proposed to phase out in environmental agents, and two discussion forums for industry were completed to decide the measure. In addition to active ingredients, registration review process was provided to supervise active ingredients and to improve the administration of environmental agents. Environmental agents exempted from Act which included selection principle, active ingredients list, and permit regulation measure and suggestion are provided. The rolling program of amendment of the Environmental Agents Control Act involved the above issues and the scope of environmental agents management. For the ingredients of bactericides/fungicides, domestic and international information was collected, including hypochlorites, sodium hypochlorite, quaternary ammonium salts, chlorine dioxide, hydrogen peroxide, glutaraldehyde, and L-lactic acid. Two consulting meetings and two discussion forums were held. Regarding inspection counseling, inspections of 11 training agencies (institutions) for pest control operators were implemented. Meanwhile, the assessment criteria for training agencies (institutions) of pest control operators was amended. The assessment criteria for selective institutes of environmental agent efficacy (potency) for designated period was added to improve the administration of environmental agents. For multiple advocacies, four activities about environmental agent regulations were completed. A total of 1,208 people participated in these events. Multiple advocacies also included radio skit, audio/video interview, animation production, and magazine advertising. This project provided new content in 2 radio skits, 5 animations, 3 audio/video interviews, and 2 magazine advertisements. Moreover, radio skits were broadcast 491 times. It helped public to use environmental agent safely and to understand the legal pest control operators and inquiries. Regarding preliminary review of permit applications, this project assisted in 1,162 preliminary reviews of permit applications. Meanwhile, 10 consulting meetings about environmental agent permit review were held with experts. One on-site factory inspection was implemented with the permit review. Furthermore, the principles of permit applications review and suggestions from experts were updated to the guidelines for permit applications review. Some relevant amendments were proposed as well.