Document ID: EPA-HQ-OPP-2006-0689-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-01-24T05:00Z

SEQ CHAPTER \h \r 1 	

								

JUN 29 2005						

						

							

								

							

Dr. Natalia N. Bogdanova

Regulatory Affairs Manager

Monsanto Company

800 North Lindbergh Blvd.

St. Louis, MO 63167

Dear Dr. Bogdanova:

Subject:  Your Application to Test MON 89034 x MON 88017 Combined
Insecticidal Trait Stacked Corn Along with MON 89034 and MON 88017 Corn.

 	EPA Experimental Use Permit No. 524-EUP-97 

Effective Dates: Plantings Through June 30, 2008 and Associated
Activities Such as Collection of Field Data; Harvesting & Processing of
Seed After Last Planting; Etc.    Quantity Authorized: 165,700 lb seed
(0.47 lbs Cry1A.105 Protein, 0.41 Cry2Ab2 Protein, and 1.49 Cry3Bb1
Protein in Seeds Shipped)  

	On the basis of the information furnished by the applicant and the
annexed program, this experimental use permit (EUP) under § 5 of the
Federal Insecticide, Fungicide, and Rodenticide Act is hereby issued to
test MON 89034 (Cry1A.105 & Cry2Ab2) x MON 88017 (Cry3Bb1) combined
insecticidal trait stacked corn along with MON 89034 and MON 88017 corn;
Bacillus thuringiensis Cry1A.105 protein and the genetic material
necessary for it production (vector PV-ZMIR245) in Event MON 89034 corn,
Cry2Ab2 protein and the genetic material necessary for it production
(vector PV-ZMIR245) in Event MON 89034 corn, and Bacillus thuringiensis
Cry3Bb1 protein and the genetic material necessary for its production
(vector ZMIR39) in Event MON 88017 corn. Shipment and/or use under this
Permit is subject to the provisions of 40 CFR Part 172. Tolerance
exemptions currently under 40 CFR Part 180.1214 and being issued under
40 CFR Parts 174.518 and 174.519 apply to these 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 and stamped
labels, as well as the non-confidential portion of the Administrative
Material and Section G dated November 15, 2005 to all cooperators,
participants, and users prior to the initial pesticide application made
in accordance with the EUP. The Agency is also notifying the relevant
EPA Region(s), by sending them copies of this EUP. 

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) and must include the following items.

A state-by-state breakdown of locations per protocol. 

A listing of experiments conducted within each protocol.

	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 seed  subsequent to
receiving this approval and be  in possession of the user under this
EUP. A stamped copy is enclosed for your records.

	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.

	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 test plots are not
located within ¼ mile of the habitats of endangered/threatened
lepidoptera or coleoptera species as listed by the U.S. Fish and
Wildlife Service, that the protocol specific acreage is not exceeded,
that the States agree to the trials, and all requirements of the
USDA/APHIS have been met as they apply to the testing. Note that non-PIP
plants refers to all corn plants included in the experiment, and in
internal and external border areas, which do not contain the Bt proteins
produced in Events MON 89034, MON 89034 

x MON 88017, or MON 88017.

Table 1.  Tabulation of approved acreage for each state and territory
for

MON 89034, MON 89034 x MON 88017, and MON 88017 for 2006 - 2007.

	MON 89034 	MON 89034 x MON 88017 	MON 88017	

NON-PIP PLANTS	TOTAL PIP

AL	7	0	0	4	7

AR	7	0	0	4	7

CA	118	55	15	19	188

CO	12	10	4	3	26

FL	13	0	0	8	13

GA	8	0	0	6	8

HI	347	95	22	76	464

IA	197	112	64	72	373

ID	6	0	1	6	7

IL	142	102	64	57	308

IN	40	22	57	22	119

KS	16	10	3	7	29

KY	5	0	0	4	5

LA	5	0	0	4	5

MD	3	0	0	2	3

MI	75	100	50	26	225

MN	9	2	1	4	12

MO	20	8	3	6	31

MS	11	0	0	6	11

NC	7	0	0	6	7

NE	57	24	58	31	139

OH	18	0	0	6	18

OR	3	0	0	2	3

PA	12	0	0	8	12

PR	67	15	7	31	89

SD	9	5	3	6	17

TN	14	0	0	6	14

TX	14	0	0	8	14

WA	107	55	10	19	172

WI	7	2	1	2	10

Total	1356	617	363	

461	2336

Table 2.  Tabulation of approved acreage for each state and territory
for

MON 89034, MON 89034 × MON 88017, and MON 88017 for 2007 – 2008.

STATE	MON 89034 	MON 89034 x MON 88017 	MON 88017	

NON-PIP PLANTS	TOTAL PIP

AL	6	0	0	4	6

AR	6	0	0	4	6

CA	422	110	25	30	557

CO	12	10	4	4	26

FL	10	0	0	8	10

GA	8	0	0	6	8

HI	532	160	62	66	754

IA	531	232	239	82	1002

ID	6	0	1	6	7

IL	220	132	239	78	591

IN	122	92	232	28	446

KS	18	10	3	12	31

KY	5	0	0	4	5

LA	5	0	0	4	5

MD	3	0	0	2	3

MI	403	125	225	32	753

MN	10	2	1	5	13

MO	20	3	3	9	26

MS	9	0	0	7	9

NC	6	0	0	6	6

NE	140	97	233	31	470

OH	18	0	0	8	18

OR	2	0	0	2	2

PA	12	0	0	7	12

PR	57	20	7	31	84

SD	10	5	3	7	18

TN	15	0	0	8	15

TX	13	0	0	7	13

WA	912	110	20	30	1042

WI	8	2	1	3	11

Total	3541	1110	1298	

531	5859

Table 3. Total approved acreage for MON 89034, MON 89034 x MON 88017,
MON 88017 and non-Bt corn acreage by protocol for growing season
2006-2007.

PROTOCOL	MON 89034	MON 89034 x MON 88017	MON 88017	NON-PIP PLANTS	TOTAL
PIP

1- Breeding and Observation Nursery	319	117	25	91	552

2- Inbred Seed Increase Production	537	250	15	92	894

3- Line Per Se, Hybrid Yield and Herbicide Tolerance  Trials	215	182	285
123	805

4- Insect Efficacy Trials	211	58	28	92	389

5– Product Characterization and Performance Trials	8	0	0	3	11

6- Insect Resistance Management Trials	27	5	5	26	63

7- Benefit Trials	29	5	5	24	63

8- Seed Treatment Trials

	10	0	0	10	20

TOTAL	1356	617	363	461	2336

Table 4. Total approved acreage for MON 89034, MON 89034 x MON 88017,
MON 88017 and non-Bt corn acreage by protocol for growing season
2007-2008.

PROTOCOL	MON 89034	MON 89034 x MON 88017	MON 88017	NON-PIP PLANTS	TOTAL

1- Breeding and Observation Nursery	327	125	25	99	576

2- Inbred Seed Increase Production	2284	450	15	97	2846

3- Line Per Se, Hybrid Yield and Herbicide Tolerance  Trials	657	467
1220	178	2522

4- Insect Efficacy Trials	204	58	28	94	384

5– Product Characterization and Performance Trials	8	0	0	3	11

6- Insect Resistance Management Trials	26	5	5	26	62

7- Benefit Trials	25	5	5	24	59

8- Seed Treatment Trials

	10	0	0	10	20

TOTAL	3541	1110	1298	531	5859

We note that future EUP submissions should include the following
information.

Estimated state-by-state breakdown of locations per protocol. 

County testing locations.

Seed and active ingredient quantity presented separately for each
program year.

Non-PIP plants contained within EUP experiments.

Total EUP acreage is equivalent to the sum of the acreage contained
within each experiment covered under protocols listed in the EUP program
submission. If a single experiment is divided among multiple locations,
acreage at all locations must be summed to determine total acreage for
the experiment. Total EUP acreage should be broken down into PIP acres
and non-PIP acres. PIP plants are defined as plants containing a
plant-incorporated protectant (PIP) and all non-PIP plants that are
intentionally crossed with PIP plants. Non-PIP plants are defined as all
non-PIP containing plants included within the experiment, such as border
row (internal and external) and control plants, that are not intentional
recipients of pollen from PIP-containing plants. Buffer acreage (e.g.
660 feet for corn) is not included in PIP EUP acreage calculation.

						Sincerely,

						/s/

						James Jones, Director

						Office of Pesticide Programs

Enclosure