U.S. DEPARTMENT OF AGRICULTURE

ANIMAL AND PLANT HEALTH INSPECTION SERVICE

BIOTECHNOLOGY REGULATORY SERVICE

APPLICATION FOR PERMIT OR

COURTESY PERMIT UNDER 7 CFR 340

(Genetically Engineered Organisms or Products)

INSTRUCTIONS: PLEASE TYPE OR PRINT CLEARLY. PERMITS

ARE NOT ISSUED TO P.O. BOXES. READ THE ENTIRE

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.

This application is authorized by the Plant Protection Act of 2000. The information will be used to determine eligibility to receive all types of

permits. No permit will be issued until this application has been approved.

FORM APPROVED

OMB NO. 0579-0085

1. NAME, ADDRESS, AND E-MAIL OF APPLICANT 2. PERMIT REQUESTED ("X" one)

Limited - Interstate Movement

Limited - Importation

Release into the Environment

Courtesy Permit

3. THIS REQUEST IS ("X" one)

New

Renewal

Supplemental

4. TELEPHONE NUMBER 5. MEANS OF MOVEMENT

Mail

Common Carrier

Baggage or Hand carried

By whom_________________________

6. GIVE THE FOLLOWING (If applicable) Scientific Name Common Name 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 16. DATE

FOR APHIS USE ONLY

State Notification Sent State Review Received Permit Issued

Yes No

Date of Determination Permit No. No. of Permit Labels Issued Supplemental Conditions Enclosed

Yes No

Signature of BRS Official Date Expiration Date

APHIS FORM 2000

APR 2005

Previous editions are obsolete.

FAX NO.

Area Code ( )
ENCLOSURES ENCLOSED

("X")

IF PREVIOUSLY SUBMITTED,

LIST DATE & PERMIT NO.

Names, addresses, and telephone numbers of the persons who developed 

and/or supplied the regulated article.

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).

a.

b.

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.

c.

Country and locality where the donor organism, recipient organism, and vector or vector

agent were collected, developed, and produced.

d.

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.

e.

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.

f.

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).

g.

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.

h.

A detailed description of the proposed method of final disposition of the regul ated article.

i.

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.

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."

Confidential Business Information

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).

Limited Permit for Interstate Movement or Importation

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.