| Legislative： |
1.Promulgated on December 12, 1997
2.Amendment to all Articles promulgated on May 18, 2010
3.Amendment to all Articles promulgated on May 25, 2015
4.Amendment to all Articles promulgated on June 29, 2021
5.Amendment to Article 11-1 promulgated on August 26, 2024 |
| Content： |
Article 1
These Regulations are established pursuant to Paragraph 3 of Article
14 of the Plant Protection and Quarantine Act (hereinafter referred
to as “the Act”).
Article 2
To import prohibited plant regulated articles pursuant to Subparagraph
1 of Paragraph 1 of Article 14 (hereafter called “designed plant
regulated articles”) of the Act, importers shall submit the
application with the following documents or information to the
central competent authority for approval:
1.Name, quantity, source, basic information and pest status of
designed plant regulated articles to be imported;
2.Plan of experiments, research, teaching, legal deposit or
exhibition plan: the purpose, how it is to be used, post-use
treatment and duration for the intended use need to be included.
If the use of designed plant regulated articles or other regulated
articles which are produced, propagated, or isolated from designed
plant regulated articles (hereafter referred to as “derivatives”),
it must be clearly described in the plan;
3.Post-entry Quarantine management program of the duration of its
use: the address, location of post-entry quarantine site and
safety operating procedures to avoid the escape of designed
plant regulated articles or their derivatives and pests shall
be included;
4.The routes and means of transportation, both domestically and
internationally, and packing methods;
5.Other related documents and information specified by the central
competent authority.
If the requisite documents or information of the preceding paragraph
are incomplete, the central competent authority shall issue a
notice to request a supplementation or correction within a specified
time period. If such a supplement or correction is not made or
the submitted content remains incomplete within the deadline, the
application will not be accepted.
Article 3
If the plant quarantine authority deems necessary, it may dispatch
inspectors to perform on-site verification of the post-entry
quarantine site as stated in Subparagraph 3 of Paragraph 1 of the
preceding Article to confirm that the post-entry quarantine site
and post-entry quarantine management program can avoid the escape
of designed plant regulated articles or their derivatives and
pests.
If the plant quarantine authority performs an on-site verification
of the post-entry quarantine site and notifies that the improvement
shall be done within a specified time period but is not done, the
application of Paragraph 1 of the preceding Article will not be
approved.
Article 4
After being reviewed and approved by the central competent authority
and the import permit is issued, the application item of Article
2 shall be imported in accordance with the permit.
The import permit is valid within six months from the day issued.
If the approved plan of use, post-entry quarantine management
program, routes and means of transportation, both domestically
and internationally, and/or packing methods or related document
or information of Paragraph 1 are changed, the importer shall
submit application with the changed document or information to
the central competent authority for approval.
The approved duration of designed plant regulated articles or
their derivatives 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 central competent
authority to extend the duration thirty days prior to expiration
date; the extension period 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 approved exhibition plan.
To apply for an extension under the preceding paragraph, the
operation records 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 verification.
Article 5
The importer shall import the designed plant regulated articles
accompanied by the import permit, and apply for quarantine
inspections to the plant quarantine authority.
Article 6
Before sharing the designed plant regulated articles or their
derivatives to users during approved usage period, the user shall
submit the application with the following documents or information
to the central competent authority for approval:
1.Name and quantity of designed plant regulated articles or their
derivatives to be shared;
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. For
the use of designed plant regulated articles or their derivatives,
it must be clearly described in the plan;
3.The routes and means of domestic transportation and packing
methods;
4.Quarantine management program of the duration for having the
shared articles: the address, location, post-entry quarantine
site and safety operating procedures to avoid the escape of
designed plant regulated articles or their derivatives and pests
shall be included;
5.Supporting document showing the importer’s agreement to share
including the name and quantity of the designed plant regulated
articles or their derivatives and the number of import permit;
6.Other relevant documents and information specified by the central
competent authority.
For incomplete documents or information of the preceding paragraph
and the approval of post-entry quarantine site shall proceed
according to the Paragraph 2 of Article 2 and Article 3.
For the application stated in Paragraph 1, after being reviewed
and approved by the central competent authority and the sharing
permit is issued, the application item shall be shared in accordance
with the permit.
The sharing permits valid within six months from the day issued.
If the approved plan of use, post-entry quarantine management
program, routes and means of domestic transportation, and packing
methods or related documents or information of the permit of the
third Paragraph are changed, the user shall submit application
with the changed document or information to the central competent
authority for approval.
The approved duration of the sharing designed plant regulated
articles or their derivatives shall not exceed five years.
The user may apply for approval to the central competent authority
to extend the duration thirty days prior to expiration date; the
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
approved exhibition plan.
To apply for an extension under the preceding paragraph, the
operation records 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 verification.
Article 7
For re-sharing the designed plant regulated articles or their
derivatives to other users during the duration of sharing, unless
other laws or regulations have other requirements, the other users
shall submit the application with the documents or information in
accordance with Subparagraphs 1 to 4 and 6 of Paragraph 1 of the
preceding article, supporting document showing the user’s agreement
to share and the copy of sharing permit to the central competent
authority for approval and shall proceed according to the process
mentioned in Paragraph 2 to 8 of the preceding Article.
Article 8
During the approved duration of intended use, the importer or user
shall comply with the following safety control measures after the
designed plant regulated articles or their derivatives are approved
for import or sharing:
1.The approved designed plant regulated articles or their derivatives
shall be sealed by the plant quarantine authority and then escorted
by the plant quarantine authority or transported domestically
by the importer or user; the importer or user shall provide
transportation vehicles or bear the expenses for the transportation.
2.It shall not be opened and used unless being checked by the
inspector dispatched by the plant quarantine authority of the
location while it is transported to the post-entry quarantine
site.
3.It shall be utilized according to the intended purposes in the
post-entry quarantine site as approved by the central competent
authority and maintenance of the post-entry quarantine site to
avoid the escape of designed plant regulated articles or their
derivatives and pests in accordance with post-entry quarantine
management plan.
4.During the duration of the use, designed plant regulated articles
or their derivatives and post-entry quarantine site shall be
subject to supervision by the plant quarantine authority. Evasion,
hindering or denial of such supervision by the importer or user
is prohibited. During the duration, the importer or user shall
take appropriate control measures and notify the plant quarantine
authority immediately in case escape of designed plant regulated
articles or their derivatives or any pest is found. The costs
associated with such measures shall be borne by importer or user.
5.Records of operations shall be made during the use of designed
plant regulated articles or their derivatives except for the
purpose of exhibition. The description for importation, destruction,
sharing or usage needs to be included in the records of operations.
If the duration is less than one year, importer or user shall
submit records of operations to the plant quarantine authority
within thirty days after end of use of designed plant regulated
articles or the expiration date. If the duration is more than
one year, importer or user shall provide the operation records
of the last year to the plant quarantine authority before March
31 of each year and must be kept for three years.
6.Containers, tools, package materials, cultivation media, plants
or plant products and other articles used by or in contact with
designed plant regulated articles or their derivatives have any
risk for escape of designed plant regulated articles or their
derivatives or pest shall be subject to proper treatment or be
destroyed after the usage.
7.When re-exporting designed plant regulated articles or their
derivatives, it shall be jointly conducted with the plant
quarantine authority and use a sealed or the package which
prevents the escape of the pest in the package during transport.
Article 9
During the use of designed plant regulated articles or their
derivatives, the plant quarantine authority shall send personnel
to inspect the usage of designed plant regulated articles or their
derivatives and the status of post-entry quarantine site, and
whether any escape or occurrence of pests as follows:
1.For experiment, research, teaching or exhibition purpose: checking
at least once every three months.
2.For legal deposit purpose or other designed purpose by applying
from the central competent authority: checking at least once per
year.
Article 10
Upon the expiration date or the end of use of designed plant
regulated articles or their derivatives, or violation of the
safety control measures of Article 8 and correction or improvement
not done after being noticed by the plant quarantine authority
within a specified time period, the designed plant regulated
articles or their derivatives shall be re-exported or destroyed
jointly with the plant quarantine authority.
Except for the application for exhibition use, importer or users
may apply to the central competent authority to lift the re-exportation
or destruction and safety measures of Article 8 thirty days prior
to the expiration date for the permitted use.
If the risk assessment conducted by the central competent authority
indicates potential invasive or pest risk, the application pursuant
to the preceding paragraph will not be approved.
Article 11
After the designed plant regulated articles or their derivatives
are approved for import or sharing, the reference numbers of the
import or sharing permit shall be included in the pertinent reports
or literary work of importer or user and be kept for more than
one year.
Article 11-1
The central competent authority may authorize the plant quarantine
authority to handle the matters stipulated in Article 2, Article 4,
Article 6, Article 7 and Article 10.
Article 12
These regulations become effective on the date of promulgation. |