EPA-97-J101-02-204

097

4,000 千元

2008/08/20

2008/12/31

鄧淑霞

環管處

黃明輝

環資國際有限公司

廢棄物管理

許可證, 審查作業, 毒性化學物質, 環境用藥

Permit, Review, Toxic, Environmental Agents Control

林葆音

(02)6630-8000轉220

emma@eri.com.tw

本計畫順利完成環境用藥及毒性化學物質許可審查安全管理評析工作，包括製造、輸入許可證及樣品申請案審查作業、辦理美、日及世界農糧組織等國際間環境用藥許可管理法規之調查評析、完成製作環境用藥有效成分原體中文毒理資料，以利用藥安全管理。 制定審查檢核原則，並建置環境用藥及毒性化學物質審查輔助系統，使作業標準程序化，增進審查效能。 環境用藥許可技術審查作業，共審查申請件數200件，證明文件及資料1,423份，於執行期間其平均審查日數與計畫規定審查期限相比，共縮短35%之審查日數；毒化物許可技術審查作業，共審查申請件數101件，證明文件及資料842份，執行期間其平均審查日數與計畫規定審查期限比較，共縮短32.1%之審查日數，有效縮減審查時程，提升行政效率。 為降低許可證申請案退補件，針對環保局、業者辦理共3場次說明會，有效降低許可證申請再行補件申請作業，增進行政效率，達到簡政便民。 完成30種環境用藥有效成分原體中文毒理資料，並建置該毒理資料庫，有助於環境用藥管理。 完成美、日及世界農糧組織國際間環境用藥許可管理法規之調查評析，並建置該資訊平台，以利環保署掌握國際間管理制度。

許可證, 審查作業, 毒性化學物質, 環境用藥

EPA-97-J101-02-204.pdf

27MB

[期末報告]公開完整版

2009/2/1 上午 12:00:00

The task of this project was to carry out the permit reviewing of environmental agents and toxic chemical substances. The completed tasks were permit reviewing on manufacturing and import, as well as sample production. Also, the comparison of regulatory management among the U.S., Japan, and Food and Agriculture Organization of the United Nations (FAO) and Taiwan were studied. The ingredients and toxicity information of environmental agents and toxic chemical substances were complied. All the aforementioned tasks were completed to enhance the safety management. The review mechanism along with Environmental Agents & Toxic Chemical Substance Auxiliary Permit Reviewing System, EATCSAPRS) were established. The review time was shortened and standardized operation made management efficiency higher. For the environmental agent permit reviewing, 200 applications were reviewed, and the applicants submitted 1,423 descriptive documents. 35 percent of the actual reviewing time was shorten when compared with expected reviewing time. For the toxic chemical substance permit reviewing, 101 applications were reviewed, and the applicants submitted 842 descriptive documents. There were 32.1 percent of the actual reviewing time shorten when compared with expected reviewing time. Such achievement effectively raised management efficiency. To reduce the possibility of application rejection or resubmission due to incorrect application content, we held 3 training sessions to local EPB and enterprises. These training sessions effectively lowered the chances of application resubmission and increased the management efficiency by delivering precise instruction on how to make correct application. The ingredients and toxicity information of environmental agents and toxic chemical substances database was established. The establishment of this information database enabled the EPA to better manage the environmental agents and toxic chemical substances. The environmental agents and toxic chemical substances permitting regulation on the U.S., Japan, and FAO were carried out and an information platform was established. Such comparison enabled the EPA to understand better the current international management.

Permit, Review, Toxic, Environmental Agents Control