Regulations of import risk assessment for regulated articles with capability of propagation Article 8

If governmental agencies (institutions), public enterprises, schools, corporations or organizations registered under relevant laws pursuant submit application for the first time imported regulated articles in accordance with Article 3 and not prohibitedarticles of Subparagraph 1 of Paragraph 1 of Article 14 of the Actfor the purpose of experiment, research, teaching, legal deposit, exhibition or other designated purpose promulgated by the plant quarantine authority, the following documents or information may be provided for special import application to the plant quarantine authority before the risk assessment is finalized.(hereafter called “special import articles”)1.Scientific name, quantity, source, basic information of the special import articles to be imported;2.Plan of use: including purpose, the way to use or related experiment, research, teaching, legal deposit or exhibition plan, post-use treatment and duration for the intended use. If the use of special import articles or other regulated article produces, propagates, or isolates from special import articles (hereafter refer as derivatives), it must be clearly described in the plan;3.Post-entry quarantine management program: the address, the location, safety quarantine measures and operating procedures to avoid the escape of special import articles and their derivatives of the post-entry quarantine site shall be included;4.The routes and means of transportation, both domestically and internationally, and packing methods;5.Other relevant documents and information required by the plant quarantine authority.If the plant quarantine authority deems necessary, it may dispatch inspectors to perform on-site verification of the post-entry quarantine site as de-noted in Subparagraph 3 of the preceding Paragraph to confirm the post-entry quarantine site and post-entryquarantine management program can avoid the escape of special import articles and their derivatives.If the plant quarantine authority reviews the application documents or information, performs on-site verification of the post-entry quarantine site and notifies the correction or improvement shall be done within a specified time period but not done, the application will not be approved.After being reviewed and approved by the plant quarantine authority and the import permit is issued, the application item of Paragraph 1 shall be imported in accordance with the permit. The import permitis valid within six months from the day issued. For importer who is incapable of completing the importation in the specified duration, the importer may apply for extension once ten days prior to the expiration of the period. The extension shall not exceed six months.If the approved plan of use, post-entry quarantine management program, routes and means of transportation, both domestically and internationally, and packing methods or related document or information of preceding Paragraph is changed, the importer shall submit application with the changed document or information to the plant quarantine authority for approval.The approved duration of special import articles shall not exceed five years. The approved duration of the intended use for legal deposit shall not exceed thirty years.The importer may apply for approval to the plant quarantine authority to extend the duration thirty days prior to expiration date; every extension shall not exceed five years. Application for extending the duration of exhibitive use may be done three days prior to the expiration date; the extension shall not be longer than the exhibition plan.To apply for an extension under the preceding paragraph, the operation records and the reports of usage, reason of extension, and follow-up safety quarantine management program shall be submitted. The plant quarantine authority may, if it deems necessary,dispatch inspectors to conduct an on-site inspection.
中文原文 具繁殖力之檢疫物輸入風險評估作業辦法第8條
政府機關(構)、公營事業機構、學校、法人或依法設立登記之團體,依第三條申請首次輸入之檢疫物非屬本法第十四條第一項第一款公告禁止輸入之檢疫物,為供實驗、研究、教學、依法寄存、展覽或符合其他經植物檢疫機關公告之特定目的,於未完成風險評估前得檢附下列文件、資料,向植物檢疫機關申請專案核准輸入首次輸入之檢疫物(以下簡稱專案首次輸入之檢疫物):
一、專案首次輸入之檢疫物學名、數量、來源及基本資料。
二、使用計畫:其內容應包括使用目的、使用方式或實驗、研究、教學、依法寄存或展覽之計畫、使用後之處理方式及使用期限。
有使用專案首次輸入之檢疫物本體或其所生產、繁殖或分離之其他檢疫物(以下簡稱衍生物)者,應於計畫中敘明。
三、使用期間之隔離管制計畫:其內容應包括隔離處所之地址、位置及避免專案首次輸入之檢疫物或其衍生物及有害生物逸散之安全隔離設施、方法。
四、國內、國外之運輸路線、方式及包裝方法。
五、其他經植物檢疫機關指定之相關文件、資料。
前項第三款隔離管制計畫之隔離處所,植物檢疫機關認有必要時,得派員實地查核確認其隔離處所及其隔離管制計畫可避免專案首次輸入之檢疫物或其衍生物及有害生物逸散。
審查申請文件、資料或實地查核經植物檢疫機關限期命其補正或改善而未補正或改善者,不予核准。
第一項申請,經植物檢疫機關審查核准發給輸入許可者,始得依核准內容辦理輸入。
輸入許可自核發之日起算六個月內有效;未能於期限內輸入者,輸入人得於原輸入許可期限屆滿十日前,向植物檢疫機關申請展延一次,並以六個月為限。
前項核准內容之使用計畫、輸入後使用期間之隔離管制計畫與國內、國外之運輸路線、方式及包裝方法等文件、資料擬變更時,輸入人應填具申請書,並檢附變更文件、資料,向植物檢疫機關申請核准。
專案首次輸入之檢疫物或其衍生物核准使用期限,最長以五年為限;但供依法寄存用途者,最長以三十年為限。
輸入人得於核准使用期限屆滿三十日前,向植物檢疫機關申請核准延長使用,每次展延以五年為限。
但供展覽用途者,得於核准使用期限屆滿三日前申請展延,其展延期限不得超過核准展覽計畫之使用期間。
申請前項展延時,應檢附使用紀錄、使用情形報告、展延使用之原因及後續安全隔離管制計畫資料。
植物檢疫機關認有必要時,得派員實地查核。

English translation for reference only; the Chinese text prevails. Not legal advice.