Form APHIS 2000 APHIS 2000 Permit Application

FOR APHIS USE ONLY
State Notification Sent

State Review Received

Permit Issued
Yes

Date of Determination

Permit No.

No. of Permit Labels Issued

Supplemental Conditions Enclosed
Yes

Signature of BRS Official

APHIS FORM 2000
APR 2005

Date

Previous editions are obsolete.

No

Expiration Date

No

ENCLOSURES

ENCLOSED
("X")

IF PREVIOUSLY SUBMITTED,
LIST DATE & PERMIT NO.

a.
Names, addresses, and telephone numbers of the persons who developed
and/or supplied the regulated article.
b.
A description of the anticipated or actual expression of the altered genetic material in the
regulated article and how that expression differs from the expression in the non-modified
parental organism (e.g., morphological or structural characteristics, physiological activities
and processes, number of copies of inserted genetic material and the physical state of this
material inside the recipient organism (integrated or extrachromosomal), products and
secretions, growth characteristics).
c.
A detailed description of the molecular biology of the system (e.g., donor-recipient-vector)
which is or will be used to produce the regulated article.
d.
Country and locality where the donor organism, recipient organism, and vector or vector
agent were collected, developed, and produced.
e.
A detailed description of the purpose for the introduction of the regulated art icle including a
detailed description of the proposed experimental and/or production design.
f.
A detailed description of the processes, procedures, and safeguards which have been used
or will be used in the country of origin and in the United States to prevent contamination,
release, and dissemination in the production of the: donor organism; recipient organism;
vector or vector agent; constituent of each regulated article which is a product; and,
regulated article.
g.
A detailed description of the intended destination (including final and all intermediate
destinations), uses, and/or distribution of the regulated article (e.g., greenhouses,
laboratory, or growth chamber location; field trial location, pilot project location; production,
propagation, and manufacture location; proposed sale and distribution location).

h.

i.

A detailed description of the proposed procedures, processes, and safeguards wh ich will be
used to prevent escape and dissemination of the regulated article at each of th e intended
destinations.
A detailed description of the proposed method of final disposition of the regul ated article.

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a
valid OMB control number. The valid OMB control number for this information collection is 0579-0085. The time required to complete
this information collection is estimated to average 5 hours per response, including the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
APHIS FORM 2000 (Reverse)

INSTRUCTIONS - APHIS FORM 2000

This application form may be used to apply for a limited permit for interstate movement or importation; a permit
for release into the environment; or a courtesy permit.
Two copies of this application must be submitted to the U.S. Department of Agriculture, Animal and Plant Health
Inspection Service, BRS, Unit 147, 4700 River Road, Riverdale, MD 20737.
Each copy of the application must be signed by the "responsible person." The responsible person is the person
who has control and will maintain control over the introduction of the regulated article and ensure that all
conditions contained in the permit and regulations in 7 CFR Part 340 are complied with. A responsible person
must be a resident of the United States or designate an agent who is a resident of the United States.

Confidential Business Information
If there are portions of the application deemed to contain trade secret or confidential business information (CBI),
each page of the application containing such information should be marked "CBI Copy." In addition, those
portions of the application which are deemed "CBI" will be so designated. The second copy will have all such CBI
deleted and will be marked on each page of the application where CBI was deleted "CBI Deleted." If an
application does not contain CBI, the first page of both copies will be marked "No CBI."

Limited Permit for Interstate Movement or Importation
The responsible person seeking a limited permit for interstate movement or importation must complete all items
on the application EXCEPT 12, 13(a), (b), (e), and (f).
a. Interstate Movement - The responsible person may apply for a single limited permit for the interstate
movement of multiple regulated articles in lieu of submitting an application for each individual interstate
movement. Each limited permit issued will be valid for 1 year from the date of issuance. If a permit is sought for
multiple interstate movements between contained facilities, the responsible person will specify in the permit
application all the regulated articles to be moved interstate; the origins and destinations of all proposed
shipments; a detailed description of all the destinations (contained facilities) where regulated articles will be
utilized; and a description of the containers that will be used to transport the regulated articles. A limited permit
for interstate movement of a regulated article will only be valid for the movement of those regulated articles
moving between those locations specified in the application. If a person seeks to move regulated articles other
than those specified in the application, or to locations other than those listed in the application, a supplemental
application will be submitted to BRS. No person will move a regulated article interstate unless the number of the
limited permit appears on the outside of the shipping container. The responsible person who ships a regulated
article interstate will keep records for 1 year to demonstrate that the regulated article arrived at its intended
destination.

b. Importation - The responsible person seeking a limited permit for the importation of a regulated article will
submit an application for a permit prior to the importation of EACH shipment of regulated articles. The
responsible person importing a regulated article will keep records for 1 year demonstrating that the regulated
article arrived at its intended destination.

Permit for Release into the Environment
The responsible person seeking a permit for release into the environment of a regulated article should complete
this form in its entirety by submitting data called for by items (1) - (16).

Courtesy Permit
The responsible person seeking a courtesy permit for the introduction (importation, interstate movement, or
release into the environment) of genetically engineered organisms not subject to regulation under Part 340 must
complete items (1) through (4), (6), (9), (12), (13(b)), and (14) through (16).

Standard Permit Conditions
For the Introduction of a
Regulated Article
(7 CFR 340.4(f))

Permit Conditions: A person who is issued a permit and his/her employees or agents shall
comply with the following conditions , and any supplemental conditions which shall be listed on the
permit, as deemed by the Deputy Administrator to be necessary to prevent the dissemination and
establishment of plant pests:
(1) The regulated article shall be maintained and disposed of (when necessary) in a manner so as
to prevent the dissemination and establishment of plant pests.
(2) All packing material, shipping containers, and any other material accompanying the regulated
article shall be treated or disposed of in such a manner so as to prevent the dissemination and
establishment of plant pests.
(3) The regulated article shall be kept separate from other organisms, except as specifically allowed
in the permit.
(4) The regulated article shall be maintained only in areas and premises specified in the permit.
(5) An inspector shall be allowed access, during regular business hours, to the place where the
regulated article is located and to any records relating to the introduction of a regulated article.
(6) The regulated article shall, when possible, be kept identified with a label showing the name of
the regulated article, and the date of importation.
(7) The regulated article shall be subject to the application of measures determined by the
Administrator to be necessary to prevent the accidental or unauthorized release of the regulated
article.
(8) The regulated article shall be subject to the application of remedial measures (including
disposal) determined by the Administrator to be necessary to prevent spread of plant pests.
(9) A person who has been issued a permit shall submit to APHIS a field test report within 6
months after the termination of the field test. A field test report shall include the APHIS reference
number, methods of observation, resulting data, and analysis regarding all deleterious effects on
plants, non-target organisms, or the environment.
(10) APHIS shall be notified within the time periods and manner specified below, in the event of the
following occurrences:
(i) Orally notified immediately upon discovery and notify in writing within 24 hours in the event
of any accidental or unauthorized release of the regulated article;
(ii) In writing as soon as possible but not later than within 5 working days if the regulated article
or associated host organism is found to have characteristics substantially different from those listed
in the application for a permit or suffers any unusual occurrence (excessive mortality or morbidity, or
unanticipated effect on non-target organisms);
(11) A permittee or his/her agent and any person who seeks to import a regulated article into the
United States shall:
(i) Import or offer the regulated article for entry only at a port of entry which is designated by an
asterisk in 7 CFR 319.37-14(b);
(ii) Notify APHIS promptly upon arrival of any regulated article at a port of entry, or its arrival by
such means as a manifest, customs entry document, commercial invoice, waybill, a broker's
document, or a notice form provided for such purpose; and
(iii) Mark and identify the regulated article in accordance with 7 CFR 340.7.