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Title: Regulations for Approving Imports of Designated Regulated Articles Ch
Date: 2021.06.29
Legislative: 1.Promulgated on July 21, 2021
Content: Article 1
These Regulations are established pursuant to Paragraph 4 of Article
15 of the Plant Protection and Quarantine Act (hereinafter referred
to as “the Act”).


Article 2
As used in this regulation, the term " designated regulated articles"
are established pursuant to Paragraph 1 of Article 15.
The designated regulated articles are only permitted to be imported
by government agencies (institutions), public enterprises, schools,
legal persons or organizations registered under relevant laws (
hereinafter referred to as “the importer”) and have to comply
with the purposes pursuant to Paragraph 2 of Article 15 of the Act
as following:
1.For purposes of experiments, research, education or exhibition;
2.Legal deposit of articles that are mentioned in Subparagraph 1
  and 2 of Paragraph 1 of Article 15 of the Act ;
3.Articles mentioned in Subparagraph 1 and 2 of Paragraph 1 of
  Article 15 of the Act for use in producing pest risk free products;
4.Insect pollinators mentioned in Subparagraph 1 of Paragraph 1
  of Article 15 of the Act, or biological control agents mentioned
  in Subparagraph 2 of Paragraph 1 of Article 15 of the Act that are
  used for field pollination or biological control, which have been
  assessed and approved by the central competent authority; and
5.Other specific purposes that are publicly notified by the central
  competent authority.


Article 3
To import designated regulated articles pursuant to Subparagraph
1, 2 or 5 of Paragraph 2 of the preceding article, importers shall
submit the application with the following documents or information
to the central competent authority for approval:
1.Name, quantity, source, basic information of the designated
  regulated articles to be imported;
2.Plan of experiments, research, education, exhibition, legal
  deposit or other specific purposes that are publicly notified
  by the central competent authority which must include: the purpose,
  how it is used, post-use treatment and duration for the intended
  use need to be included. If the use of designed regulated articles
  or other regulated articles  which are produced, propagated, or
  isolated from designed 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 quarantine facility and operating procedures to avoid the
  escape of designed regulated articles or their derivatives and
  pests shall be included;
4.The routes and means of transportation, both domestically and
  internationally, and packaging method;
5.The package and its contents during transportation;
6.Other relevant documents and information specified by the central
  competent authority.


Article 4
To import designated regulated articles pursuant to Subparagraph
3 of Paragraph 2 of Article 2, importers shall submit the application
with the following documents or information to the central competent
authority for approval:
1.Name, quantity, source, basic information of the designated
  regulated articles to be imported;
2.The process of producing articles that do not have the risk of
  spreading pests. The period of use and the purpose of the produced
  articles;
3.Post-entry quarantine management program of the duration of its
  use: the address, location of post-entry quarantine site and
  safety quarantine facility and operating procedures to avoid
  the escape of designed regulated articles or their derivatives
  and pest shall be included;
4.The routes and means of transportation, both domestically and
  internationally, and packaging method;
5.The packaging and its contents during transportation;
6.Other relevant documents and information specified by the central
  competent authority.


Article 5
To import designated regulated articles pursuant to subparagraph
4 of Paragraph 2 of Article 2, importers shall submit the application
with the following documents or information to the central competent
authority for approval:
1.The complete scientific name, product name, producer name and
  address, and export country of the designated regulated articles
  to be imported;
2.Plan of use: including the purpose, object, method, area and
  duration of usage period;
3.For those limited to use in facilities, post-entry quarantine
  management program of the duration of its use shall be attached.
  The address, or parcel number of post-entry quarantine site,
  location or geographic location map, plan metric map of post-entry
  quarantine site and safety quarantine facility and operating
  procedures to avoid the escape of designed regulated articles
  or their derivatives and pest shall be included;
4.The routes and means of transportation, both domestically and
  internationally, and packaging method;
5.The packaging and its contents during transportation;
6.Other relevant documents and information specified by the central
  competent authority.


Article 6
The relevant documents or information of pest risk assessment shall
be submitted by the importers to the central competent authority
for approval before importing. Only the pest risk assessment passed,
the regulated articles could be applied for importation pursuant
to preceding article.
1.Basic information: commodity name, scientific name of pollinating
  insect or biological control agents, name and address of foreign
  manufacturing plant, method and scope of use, management measures
  during use, etc.;
2.Biological information of pollinating insects or biological control
  agents: including life history, mobility, diapause or dormancy 
  characteristics, competitiveness, host range, hybridization
  characteristics, natural enemies or parasites, epidemic information;
3.The packaging and its contents during transportation;
4.Other relevant documents and information specified by the central
  competent authority.
When conducting the preceding risk assessment, the central competent
authority conduct may refer to International Standards for Phytosanitary
Measures, or other relevant international standards, and evaluate
the risk of invasion, and probability of introducing of pests and
risk management measures.
During the risk assessment, the central competent authority may
request the importers or the importers to contact the National
Plant Protection Organization (NPPO) of the export country to
provide supplementary documents, or send personnel to the export
country for verification and confirmation. The cost for verification
shall be borne by the importers according to the relevant laws or
regulations. 
If the central competent authority passes the pollinating insects
or biological control agents that can be used for field pollination
or biological control according to the risk assessment stipulated
in Paragraph 1, the plant quarantine authority shall publish it
on its website.


Article 7
If the required documents or information of Article 3 to preceding
article are incomplete, the central competent authority shall issue
a notice to request a supplement or correction within a specified
time period. If such a supplement or correction is not made or the
submitted content remains incomplete after the deadline, the application
will not be accepted.


Article 8
If the plant quarantine authority deems necessary, it may dispatch
inspectors to perform on-site verification of the post-entry
quarantine site stated in Subparagraph 3 of Article 3 and Subparagraph
3 of Article 4, and facilities stated in Subparagraph 3 of Article
5 to confirm the post-entry quarantine site, facilities and post-entry
quarantine control program can avoid the escape of designed plant
regulated articles or their derivatives and pests.
If the plant quarantine agency performs an on-site verification
of the post-entry quarantine site and notifies that the improvement
shall be done within a specific time period but is not done, the
application of Article 3 to 5 will not be approved.


Article 9
After being reviewed and approved by the central competent authority
and the import permit is issued, the application item of Article
3 to 5 shall be imported in accordance with the permit.
The import permits is valid within one year from the day issued.
If the approved plan of use, post-entry quarantine management
program, routes and means of transportation, both domestically
and internationally, packing methods, the packaging and its contents
during transportation or relevant documents or information of the
permit 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 designated regulated article or derivatives
is as follows:
1.The approved duration of the designated regulated article mentioned
  in Subparagraph 1 and 5 of Paragraph 2 of Article 2, shall not
  exceed five years. However, research use of Drosophila melanogaster
  (hereinafter called “Drosophila melanogaster”) shall be in
  accordance to the duration applied by the importer.
2.The approved duration of the designated regulated articles that
  are mentioned in the Subparagraph 2 of Paragraph 2 of Article
  2 shall not exceed thirty years.
3.The approved duration of the designated regulated article as
  stated in Subparagraphs 3 and 4 of Paragraph 2 of Article 2
  shall be in accordance with the duration applied by the importer.
The importer may apply for approval to the central competent
authority to extend the duration thirty days prior to expiration
date; the extension hall 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 10
The importers shall import the designed regulated articles accompanied
by the import permit and apply for quarantine inspections to plant
quarantine authority.


Article 11
Before sharing the designated regulated articles and their derivatives
deposited in accordance with the law in the Subparagraph 1 and 2
of Paragraph 2 of Article 2 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 regulated articles or their derivative
  to be shared;
2.Plan of use: including purpose, the way to use or related experiment,
  research, teaching, exhibition or legal deposit plan, post-use
  treatment and duration for the intended use. For the use of
  designed 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.The packing and its contents during transportation;
5.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 regulated articles or their derivatives and pests hall
  be included;
6.Supporting document showing the importer’s agreement to share
  including the name and quantity of the designed regulated articles
  and the number of import permit;
7.Other relevant documents and information specified by the central
  competent authority.
For incomplete documents or information of the preceding paragraph,
and the approval process of post-entry quarantine site shall proceed
according to Articles 7 and 8.
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 are valid within six months from the day issued.
If the approved plan of use, post-entry quarantine management plan,
routes and means of domestic transportation, packing methods, the
packaging and its contents during transportation or relevant
documents or information of the permit of Paragraph 3 are changed,
the user shall submit application with the changed document(s) or
information to the central competent authority for approval.
The approved duration of sharing designated regulated article or
their derivatives shall not exceed five years. The approved duration
of sharing Drosophila melanogaster shall be in accordance with
the duration applied by the importer.
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 12
For re-sharing the designed regulated articles or their derivatives
to other users during the duration period 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 5 and 7 of Paragraph 1 of preceding article,
supporting document showing the user’s agreement to share and the
sharing permit number to the central competent authority for approval
and shall proceed according to the process mentioned in Paragraphs
2 to 8 of the preceding article.


Article 13
During the approved usage period, the importer and user shall
comply with the safety control measures as shown in the attached
table after the designed regulated articles or their derivatives
are approved for import or sharing.


Article 14
During the use of designed regulated articles or their derivatives,
except for those mentioned in Subparagraph 4 of Paragraph 2 of
Article 2, the plant quarantine authority shall send personnel
to inspect the status of post-entry quarantine site, the usage
and whether any escape of designed regulated articles or their
derivatives and the occurrence of pests as follows:
1.Drosophila melanogaster and the designed regulated articles that
  are mentioned in Subparagraphs 2 and 5 of Paragraph 2 of Article
  2: checking at least once every year.
2.Those that are not used for the purpose of the preceding paragraph:
  checking at least once every six months.


Article 15
For use of designated regulated articles or their derivatives that
violates the safety control measures of Article 13 and correction
or improvement are not done after being noticed by the plant
quarantine authority within a specific time period, the designated
regulated articles and their derivatives shall be re-exported or
destroyed jointly with plant quarantine authority.
Upon the expiration date or the end of use of designated regulated
articles or their derivatives, except for those that are not
limited to be used in facilities mentioned in Subparagraph 4 of
Paragraph 2 of Article 2, they shall be handled in the following
manner:
1.Drosophila melanogaster and the designated regulated articles
  that are mentioned in Subparagraph 4 of Paragraph 2 of Article
  2: shall be destroyed by the importers and users.
2.Designated regulated articles other than the preceding paragraph:
  shall be re-exported or destroyed in jointly with the plant
  quarantine authority.
Except for the application for exhibition use, importer or user
may apply to the central competent authority to lift the re-exportation
or destruction and safety control measures of Article 13 thirty
days prior to the expiration date for the permitted use.
If the risk assessment conducted by central competent authority
indicates potential invasive or pest risk, the application pursuant
to the preceding paragraph will not be approved.


Article 16
After the designed regulated articles or their derivatives are
approved for importation or sharing, the reference numbers of the
import permit or sharing permit shall be included in the pertinent
reports or literary work of the importer or user and be kept for
more than one year. The provision(s) of the article do not apply
to the importation of Drosophila melanogaster and the designated
regulated articles in Subparagraph 4 of Paragraph 2 of Article 2.


Article 17
These regulations become effective on the date of promulgation.
Attachments:
Data Source: Laws and Regulations Retrieving System