Document ID: EPA-HQ-OPP-2006-0689-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-01-24T05:00Z

SEQ CHAPTER \h \r 1 	

								

				

							MAR 02 2006

						

								

							

Dr. Demetra Vlachos

Senior Manager, Regulatory Affairs 

Syngenta Seeds, Inc.

P.O. Box 12257

Research Triangle Park, NC 27709-2257

Dear Dr. Vlachos:

Subject:  Your 8/15/2005 Application, Revised Section G Dated 2/9/2006,
and 2/22/2006 Section G Revisions; Modified Cry3A Corn 

 	EPA Experimental Use Permit No. 67979-EUP-4

Effective Dates: Plantings Through February 28, 2007 and Associated
Field Operations Through October 15, 2007   Quantity Authorized: 50,420
lbs MIR604 and Bt11 Corn Seed; 20.6 grams Cry3A & Cry1Ab Protein in
Seeds Shipped

4-5). Shipment and/or use under this Permit is subject to the
provisions of 40 CFR Part 172. Tolerance exemptions currently under 40
CFR 180.1173 and being extended under 40 CFR Part 174.456 apply to the
plant-incorporated protectants in corn to be tested under this permit. 

	Prior to shipment and/or use of the subject corn, you must consult with
the pesticide regulatory officials and, if applicable, the biotechnology
regulatory officials of the State(s) in which your experimental program
will be conducted, and obtain a State permit or license if such is
required.  (Note Hawaii’s reporting requirement for genetically
modified organisms under section 321-11.6 of the Hawaii revised
statutes.) Issuance of this Federal permit does not negate the need for
permission from individual States.  Prior to initiating this
experimental program in any State, you are to notify the lead Agency of
the State(s) in which your experimental program will be conducted of the
specific testing program (when, where, how much, etc.).   Failure to do
so may result in revocation or modification of this EUP. You must comply
with all requirements of the USDA/APHIS as they apply to the proposed
testing. 

	You must provide notice to the State pesticide regulatory Agency at
least 72 hours before you begin to apply the experimental use product.  
You must also provide a copy of this authorization letter, approved
label, and February 9, 2006 experimental program section G, and February
22, 2006 section G Revisions to all cooperators, participants, and users
prior to the initial pesticide application made in accordance with this
EUP. The Agency is also notifying the relevant EPA Region(s), by sending
them copies of this EUP. 

	 Based upon the submitted experimental program, the subject corn seed
may be shipped for use under this permit to the following State(s) and
be planted on the following acreage, provided that the agronomically
justified acreage as listed below is not exceeded and that  States agree
to the trials and all other requirements of the USDA/APHIS have been met
as they apply to the testing. 

	

MIR604

Acres	

MIR

604 xBt11

Acres	Bt11

Acres	Other

Acres

CA	1	1	0	40

CO	11	9	0	60

FL	5	5	0	10

HI	186	163	10	27

IA	1297	195	600	614

IL	162	162	0	698

IN	42	42	0	148

KS	17	15	0	40

KY	2	2	0	20

MD	10	10	0	40

MI	4	4	0	8

MN	134	130	0	494

MO	12	12	0	90

MS	3	3	0	34

NM	7	5	0	20

NE	168	98	20	278

NY	10	10	0	36

OH	12	10	0	46

PA	4	4	0	8

PR	166	44	40	38

SD	34	32	0	108

TX	2	0	0	10

VA	2	0	0	10

WI	9	9	0	82

Tot.	2300	965	670	2959

                              

Protocol Type	EUP Acreage*

	PIP Acreage

	Non-PIP Acreage	Total EUP Acreage

	MIR604	MIR604 x Bt11	Bt11

Breeding and observation	117	106	0	137	360

Efficacy evaluation	61	47	0	614	722

Agronomic observation	621	621	0	1,978	3,220

Inbred and hybrid production	1,456	146	670	0	2,272

Regulatory field trials (e.g. IRM and non-target insect field trials,
etc.)	45	45	0	230	320

Total	2300	965	670	2,959	6,894

* EUP acreage is the sum of the acreage found within the perimeter of
all associated experimental blocks. This includes PIP plants plants,
non-PIP plants, and border rows included within the blocks.

Conditions under which the EUP is being issued are as follows.

	1. The total amount of corn seed to be used will not exceed the
quantity authorized by the EUP and its planting acres.

	2. The permittee must immediately notify the Environmental Protection
Agency of any findings from the experimental uses that have a bearing on
safety (i.e., reporting to the Agency of any adverse effects from the
use of, or exposure to, the pesticide is required).  The permittee will
also keep records of production, distribution and performance, and, on
request, make the records available to any authorized officer or
employee of the Environmental Protection Agency.

	3. You must provide a final report within 180 days of the expiration of
the permit.  The final report must include all of the items set forth in
40 CFR § 172.8(b). 

	4. Per 40 CFR §172.4(b)(v), you must provide the name and street
address of all cooperators as soon as available and prior to planting. 

	5. The labeling submitted in connection with your application is
acceptable and must be used for all shipments of MIR604 modified Cry3A
seed, Bt11 Cry1Ab seed, and MIR604 x Bt11 seed subsequent to receiving
this approval and be in possession of the user under this EUP.  

	6. This experimental use permit is not a limited seed increase
registration under § 3 of FIFRA and plantings solely for commercial
seed increase are prohibited

                                                   

					Sincerely,

					

				

					

					James Jones, Director

					Office of Pesticide Programs

Enclosure  

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