Form APHIS Form 2000 APHIS Form 2000 Application for Permit or Courtesy Permit Under 7 CFR 34

According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information
unless it displays a valid OMB control number. The valid OMB control numbers for this information collection are 0579-0085 and 0579-0471. The time required to
OMB APPROVED
complete this information collection is estimated to average between 1 and 10 hours per response, including the time for reviewing instructions, searching existing
0579-0085 and 0579-0471
data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
U.S. DEPARTMENT OF AGRICULTURE
INSTRUCTIONS: PLEASE TYPE OR PRINT CLEARLY. PERMITS
ANIMAL AND PLANT HEALTH INSPECTION SERVICE
ARE NOT ISSUED TO P.O. BOXES. READ THE ENTIRE
BIOTECHNOLOGY REGULATORY SERVICE

APPLICATION BEFORE COMPLETING. ENCLOSE THE
SUPPORTING MATERIALS LISTED ON PAGE 2. SEE PAGE 3 FOR
DETAILED INSTRUCTIONS. ATTACH ADDITIONAL SHEETS OF
PAPER IF MORE SPACE IS NEEDED.

APPLICATION FOR PERMIT OR
COURTESY PERMIT UNDER 7 CFR 340
(Genetically Engineered Organisms or Products)

1. NAME, ADDRESS, OF APPLICANT

2. PERMIT REQUESTED ("X" one)
Limited - Interstate Movement
Limited - Importation
Release into the Environment
Courtesy Permit

4. TELEPHONE NUMBER
Area Code (

5. MEANS OF MOVEMENT
Mail
Common Carrier

)

6. GIVE THE FOLLOWING (If applicable)

Scientific Name

Common Name

3. THIS REQUEST IS ("X" one)
New
Renewal
Supplemental

Baggage or Hand-carried
By whom_________________________
Trade Name

Other Designation

a. Donor Organism

b. Recipient Organism

c. Vector or Vector Agent

d. Regulated Organism or Product

e. If product, list names of constituents
7. QUANTITY OF REGULATED ARTICLE TO BE INTRODUCED AND PROPOSED
SCHEDULE AND NUMBER OF INTRODUCTIONS

8. DATE (or inclusive dates of period) OF IMPORTATION, INTERSTATE
MOVEMENT, OR RELEASE

9. COUNTRY OR POINT OF ORIGIN OF THE REGULATED ARTICLE

10. PORT OF ARRIVAL, DESTINATION OF MOVEMENT, OR SPECIFIC
LOCATION OF RELEASE

11. ANY BIOLOGICAL MATERIAL (e.g., culture medium, or host material) ACCOMPANYING THE REGULATED ARTICLE DURING MOVEMENT

12. APPLICANTS FOR A COURTESY PERMIT - STATE WHY YOU BELIEVE THE ORGANISM OR P RODUCT DOES NOT COME WITHIN THE DEFINITION OF A
REGULATED ARTICLE

13. SEE PAGE 2

WARNING: Any alteration, forgery, or unauthorized use of this document is subject to civil penalties of up to $250,000 (7 U.S.C. s7734(b)) or
punishable by a fine of not more than $10,000, or imprisonment of not more than 5 years, or both (18 U.S.C. s1001).
I hereby certify that the information in this application and all attachments is complete and accurate to the best of my knowledge and belief.
14. SIGNATURE OF RESPONSIBLE PERSON

15. PRINTED NAME AND TITLE

FOR APHIS USE ONLY
State Review Received

State Notification Sent

16. DATE

Permit Issued
Yes

Date of Determination

Permit No.

No. of Permit Labels Issued

Supplemental Conditions Enclosed
Yes

Signature of BRS Official

APHIS FORM 2000
FEBRUARY 2010

Date

Previous editions are obsolete.

No

Expiration Date

No

ENCLOSURES
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-recipientvector) 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 article
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.
A detailed description of the proposed procedures, processes, and safeguards which
will be used to prevent escape and dissemination of the regulated article at each of the
intended destinations.
i.
A detailed description of the proposed method of final disposition of the regulated article.

APHIS FORM 2000 (Reverse)

ENCLOSED
("X")

IF PREVIOUSLY SUBMITTED,
LIST DATE & PERMIT NO.

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.