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英譯法規內容

Title Regulations of import risk assessment for regulated articles with capability of propagation Ch
Date 2020.04.20
Legislative 1.Promulgated on April 20, 2020
Content

Article 1
These Regulations are established pursuant to Paragraph 4 of
Article 14 of the Plant Protection and Quarantine Act (hereinafter
called “the Act”).


Article 2
The term “regulated articles with capability of propagation”
under Paragraph 4 of Article 14 of the Act includes fresh plants
or plant products. However, it does not include vegetables
without fruits and their underground portion and fruiting body of
edible fungi.


Article 3
To apply for importation of regulated articles with the capability
of propagation from a country or district without import record
(hereinafter called “the first time imported regulated articles”),
the exporting country, importer or agent shall complete the
application and submit the following documents or information for
pest risk assessment to the plant quarantine authority for approval:
1.The scientific name (including the name of genus and species)
  or cultivar name of the first time imported regulated articles.
2.Production areas, growth properties, propagation methods, climatic
  conditions for growing regulated articles, yield,harvest season,
  the post-harvest process, and pest list, pest control measures,
  and list of chemicals used in the exporting countries for the
  first time imported regulated articles.
3.If the exporting country is in the immediate vicinity of the
  infested areas of a quarantine pest, as defined under Subparagraphs
  1 and 2 of Paragraph 1 of Article 14 of the Act, but the pest
  status is unclear, the plant quarantine authority of the exporting
  country shall provide the survey data and monitoring data of
  the pest.
4.After being reviewed and deemed necessary by the plant quarantine
  authority, it shall submit the documents or information of
  Subparagraphs 1 and 2 provided by plant quarantine authority of
  the exporting country or other required relevant documents and
  information specified by the plant quarantine authority.
If the required documents of the preceding paragraph are incomplete,
the plant quarantine 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 4
When applying for importation of the first time imported regulated
articles in accordance with proceeding Article and the articles
belongs to Subparagraph 1 of Paragraph 1 of Article 14 of the Act,
the exporting country, importer or agent shall contact the plant
quarantine authority of the exporting country to provide the
documents and information mentioned in Paragraph 1 of proceeding
Article and as follows:
1.Application for recognition as a pest free area or a pest free
  production site.
2.Phytosanitary treatment measures, standard and experiment reports.
3.Systems approach management measures.
The content of the application for recognition as a pest free area
or a pest free production site in the preceding paragraph are as
follows:
1.Description of the pest free area
2.Biology of the pest
3.Systems or data used to establish the pest free area
4.Quarantine measures used to maintain the status of the pest
  free area
5.Follow-up verification of the pest free area


Article 5
When conducting risk assessment for the first time imported
regulated articles, the plant quarantine authority may refer to
international standards such as the International Standards for
Phytosanitary Measures, etc., and evaluate the risk of invasion,
and probability of introducing of pests and its management measures.


Article 6
If the risk assessment results of the preceding article indicate
invasive or pest risk and lack of appropriate risk management
measures, the application pursuant to the preceding will not be
approved.
If the first time imported regulated article is approved for import
after the pest risk assessment, the plant quarantine authority
shall publish on its website.


Article 7
The plant quarantine authority may restart pest risk assessment
depending on the quarantine risk if any of the following situation
applies for the approved first time imported regulated articles:
1.Interception of any pest that does not occur in the territory
  from the importing regulated articles or their packing material
  that may present a possible threat to the agricultural production
  safety or ecological environment.
2.Interception of regulated pests from imported regulated articles
  or their packing material.
3.A new transmission pathway of plant pests with phytosanitary
  risk has been found.
4.Plant pests that present phytosanitary risk and have already
  caused economical or environmental impact in other countries or
  regions, and the plant quarantine authority has not yet taken
  any relevant quarantine control measures.
5.The plants or plant products have not been imported in the last
  five years.


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.


Article 9
The importer shall comply with the following safety control measures
after the special import articles is approved for import:
1.The approved special import 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; the importer shall provide transportation
  vehicles or bear the expenses for the transportation.
2.It shall not be opened and used before being checked by the 
  inspector dispatched by the plant quarantine authority of the
  location being 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 plant quarantine
  authority and maintenance of the post-entry quarantine site to
  avoid the escape of special import articles or their derivatives
  from the post-entry quarantine site in accordance with post-entry
  quarantine management program.
4.During the duration period of intended use, special import 
  articles or their derivatives shall be subject to supervision
  of their use by the plant quarantine authority. Evasion, hindering
  or denial of such supervision by importer is prohibited. While
  in use, importer shall take appropriate control measures and
  notify the plant quarantine authority immediately in case any
  pest is found. The costs associated with such measures shall be
  borne by importer.
5.Operation records shall be made during the duration period of
  the use of special import articles or their derivatives except
  for the purpose of exhibition. If the duration is less than one
  year, importer shall submit operation records to the plant
  quarantine authority within thirty days after end of use of
  special import articles or the expiration date. If the duration
  is more than one year, importer shall provide the operation
  records of the last year to the plant quarantine authority before
  March 31 each year.
6.Containers, tools, package materials, cultivation medium, plants
  or plant products and other articles used by or in contact with
  special import articles or their derivatives shall subject to
  proper treatment or be destroyed after the usage.
7.When re-exporting special import articles or their derivatives,
  importer shall conduct it jointly with the plant quarantine
  authority and use a sealed or the package which avoids the escape
  of the pest in package during transport.


Article 10
During the use of special import articles or their derivatives,
the plant quarantine authority shall send personnel to inspect
the status of post-entry quarantine site, plant growth and the
occurrence of pests as follows:
1.For experiment, research, teaching or exhibition purpose: at
  least once every three months
2.For legal deposit purpose or other designed purpose by applying
  from the plant quarantine authority: at least once per year


Article 11
Upon the expiration date, end of use of special import articles
or their derivatives, or violation of the safety measures of
Article 9 and correction or improvement not done after being
noticed by the plant quarantine authority within a time limit,
special import articles and their derivatives shall be re-exportedor
destroyed jointly with plant quarantine authority.
If pest risk assessment for special import articles and their
derivatives is finalized and the importation is permitted, re-export
or destruction of special import articles and their derivatives
is not necessary; safety measures of Article 9 are also lifted.


Article 12
The Regulations become effective on the date of promulgation.