Document ID: EPA-HQ-OPP-2006-0689-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-01-24T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

     WASHINGTON, D.C. 20460

OFFICE OF PREVENTION,                                                   
                                                       PESTICIDES  AND 
TOXIC

                                      SUBSTANCES

					FEB 23 2006

MEMORANDUM

SUBJECT:	Review of materials submitted by Syngenta in support of
extension of Section G Experimental Use Permit (EUP No: 67979-EUP-4) for
Event MIR604 corn, which contains the active ingredient mCry3A.
Submission dated December 12, 2005 and revised January 20, 2006,
February 9, 2006, and February 23, 2006.

TO:			Michael Mendelsohn

			Senior Regulatory Action Leader

			Microbial Pesticides Branch, Biopesticides and 

Pollution Prevention Division (7511C)

FROM:		Tessa Milofsky, M.S. Agronomist				signed

			Microbial Pesticides Branch, Biopesticides and	

Pollution Prevention Division (7511C)

Conclusion 

The requested EUP program and corresponding acreage are ACCEPTABLE. It
is recommended that the registrant’s full request of 6,894 EUP acres
should be granted.

Comments

The participant/collaborator information is sufficient provided that
collaborator names and contact information are submitted prior to
experiment initiation.

Background

Syngenta has submitted materials in support of their request to extend
the duration of their Event MIR604 Experimental Use Permit (67979-EUP-4)
to cover the period mid-March 2006 through February 2007. Event MIR604
field corn, which contains the active ingredient mCry3A Bacillus
thuringiensis delta endotoxin, is said to protect field corn against
western corn rootworm (Diabrotica virgifera virgifera), northern corn
rootworm (D. longicornis barveri), southern corn rootworm (D.
undecimpunctata howardi), and Mexican corn rootworm (D. virgifera zea).
Planting proposed under the EUP will take place in 29 states and Puerto
Rico, and will not exceed 6,894 total acres.

Program Overview

Participant/Collaborator Information

The names, telephone numbers, and mailing addresses of participants who
will supervise experimental work covered under this EUP are listed under
each protocol. Information on cooperators was not included, yet the
registrant states that this listing will be provided prior to planting
or initiation of the research trials. 

BPPD Review

Participant information provided in the submission is sufficient. Names
and contact information of collaborators must be submitted prior to
experiment initiation.

Field Trial Containment

In Syngenta’s revised February 9, 2006 EUP program submission, they
state that corn produced in Breeding and Observation, Efficacy
Evaluation, Inbred and Hybrid Production, and Regulatory trials will
comply with USDA-APHIS Performance Standards for regulated corn trials. 
However, if MIR604 corn is deregulated by USDA-APHIS during the EUP
program, Syngenta has stated that for acreage covered under Agronomic
Observation field trials, they may choose to terminate compliance with
USDA’s containment requirements for regulated corn. In particular,
Syngenta states that corn harvested from Agronomic Observation field
trials may be sold or distributed for use as food or feed. Note: Under
USDA-APHIS Performance Standards for regulated corn trials, corn may not
be used for food or feed. 

BPPD Review

Containment procedures described in the submission are adequate.

Acreage Calculation

Under this PIP EUP program submission, the registrant has requested a
total of 6,898 EUP acres, of which 3,665 acres are transgenic. A
breakdown of acreage by protocol and by PIP is provided below (Table 1).
Detailed tables that show acreage breakdowns by state and location are
provided in the Appendix.

Table 1. MIR604 and Bt11 EUP acreage requests by protocol for 2006-2007.

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.

BPPD Review

Syngenta’s approach to PIP EUP calculation appears to comply with
EPA’s guidelines for PIP EUP acreage calculation (below) and is
therefore acceptable.

Total PIP 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. It is recommended that total EUP acreage should be
broken down into PIP acres and non-PIP acres, since this delineation
will assist the registrant in their efforts to justify the requested EUP
acreage. For the purposes of PIP EUP acreage calculation, PIP plants are
defined as plants containing a 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 perimeter) 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.

Seed and Active Ingredient Quantities

MIR604 and Bt11 corn seed required for the proposed acreage was
calculated (by the reviewer) to be approximately 50,420 lbs; the
corresponding quantity of A.I. present in that seed was calculated to be
20.6 grams (based on 0.9 µg mCry3A/g fresh weight seed).

BPPD Review

MIR604 and Bt11 seed and A.I. calculations are acceptable.

Trial Protocols

Protocol descriptions provided in the Section G submission provide
information on the test sites (acres per state), objective, experimental
design, plot treatments, genotypes, estimated planting and harvest
schedules for each trial, and containment procedures (shipping, pollen
flow, and post-harvest). Protocol objectives are provided below. 

Breeding and Observation

Objectives: 1) Introgress the mcry3A gene into elite parent inbred corn
lines for the purposes of determining gene stability, inheritance
pattern, and efficacy in different elite genetic backgrounds that may
also include Event Bt11; and 2) Make up hybrid test-crosses for future
evaluation.

Efficacy Evaluation

Objective: To assess the efficacy of up to 100 Event MIR604 and/or
stacked MIR604 X Bt11 lines towards corn insect pests, including
northern, western, southern and Mexican corn rootworms and/or insects
specifically controlled by Bt11 corn.

Agronomic Observation

Objectives: 1) Assess Event MIR604 and/or stacked MIR604 X Bt11 lines
and inbred lines in small plots (packet plots) for a variety of
agronomic traits pertinent to corn production, including germinability,
early-season vigor, days to pollen shed, and yield; and 2) Assess Event
MIR604 hybrids in strip plots under a wide range of field conditions for
numerous traits pertinent to corn production. 

Inbred and Hybrid Production

Objectives: 1) Produce up to 60 hybrid crosses with Event MIR604, Bt11
and MIR604 X Bt11 and up to 20 inbred corn lines for future evaluations.
 Assess parameters including stand, uniformity, plant population,
frequency of off-types, overall growth rating, and flowering
synchronicity; and 2) Increase seed of MIR604, Bt11 or stacked MIR604 X
Bt11 inbreds for use in hybrid production, feeding and safety studies.

Regulatory Field Trials

Objective: Obtain regulatory-quality data for the development and
support of the assessment of Event MIR604 corn and/or stacked MIR604 X
Bt11 corn which will include but not be limited to insect resistance
management field trials and large-scale, non-target insect field trials.

BPPD Review

Acreage requests for each protocol are acceptable.

Appendix

Table A1.  Proposed Experimental Use Program for MIR604 Field Corn
Plantings from March 2006 through February 2007

ST	Tot.

	Breeding & Obs.	Efficacy Evaluation.	Agronomic Observation
Inbred/Hybrid Prod.	Regulatory Studies	Max. No.

	MIR

604

Ac.	Tot.

Oth.

Ac.	Tot.

No.

Loc	MIR

604

Ac.	Oth.

Ac.	No.

Loc.	MIR

604

Ac.	Oth.

Ac.	No.

Loc.	MIR

604

Ac.	Oth.

Ac.	No.

Loc.	MIR

604

Ac.	Oth.

Ac.	No.

Loc.	MIR604

Ac.	Oth.

Ac.	No.

Loc.	MIR604

Plants

AR	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	0

CA	1	20	1	 	 	 	1	20	1	0	0	0	 	 	 	 	 	 	30,000

CO	11	35	6	0	0	0	2	10	2	9	25	4	 	 	 	 	 	 	330,000

FL	5	5	3	 	 	 	5	5	3	0	0	0	 	 	 	 	 	 	150,000

HI	176	12	62	36	12	12	0	0	0	0	0	0	140	0	50	 	 	 	5,280,000

IA	997	306	126	17	11	12	7	45	35	166	230	47	800	0	30	7	20	2	29,910,000

ID	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	0

IL	162	348	95	17	11	15	14	90	40	123	227	38	0	0	0	10	20	2	4,920,000

IN	42	74	30	0	0	0	2	10	17	40	64	13	0	0	0	 	 	 	1,260,000

KS	17	25	13	0	0	0	2	10	7	15	15	6	 	 	 	 	 	 	510,000

KY	2	10	1	0	0	0	0	0	0	2	10	1	 	 	 	 	 	 	60,000

LA	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	0

MD	10	20	2	 	 	 	0	0	0	0	0	0	 	 	 	10	20	2	300,000

MI	4	4	1	0	0	0	0	0	0	4	4	1	0	0	0	 	 	 	120,000

MN	132	246	60	17	11	8	7	45	21	98	170	29	0	0	0	10	20	2	3,960,000

MO	12	45	19	0	0	0	2	10	11	9	25	4	0	0	0	1	10	4	360,000

MS	3	17	4	 	 	 	3	17	4	0	0	0	 	 	 	 	 	 	90,000

NC	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	0

NM	7	15	6	 	 	 	2	10	3	0	0	0	 	 	 	5	5	3	210,000

NE	148	139	63	0	0	0	2	10	25	95	119	26	50	0	10	1	10	2	4,500,000

ND	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	0

NY	10	18	5	 	 	 	2	10	3	8	8	2	 	 	 	 	 	 	300,000

OH	12	28	17	0	0	0	2	10	14	10	18	3	0	0	0	 	 	 	360,000

PA	4	4	1	 	 	 	0	0	0	4	4	1	 	 	 	 	 	 	120,000

PR	150	18	24	30	18	12	0	0	0	0	0	0	120	0	12	 	 	 	1,230,000

SD	34	59	18	0	0	0	2	10	8	31	39	9	 	 	 	1	10	1	1,020,000

TN	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	0

TX	2	10	3	0	0	0	2	10	3	0	0	0	 	 	 	 	 	 	60,000

VA	2	10	3	 	 	 	2	10	3	0	0	0	 	 	 	 	 	 	60,000

WI	9	41	25	0	0	0	2	10	13	7	31	12	0	0	0	 	 	 	270,000

Tot.	1954	1509	588	117	63	59	61	342	213	621	989	196	1110	0	102	45	115	18
58,620,000



Table A2.  Proposed Experimental Use Program for Stacked MIR604 X Bt11
Field Corn Plantings from March 2006 through February 2007

	Total Acres

Breeding & Obs’n	Efficacy Evaluation	Agronomic Observ’n	Inbred &
Hybrid Production	Regulatory Studies	Max. No.

ST	MIR

604+

Bt11	MIR

604	Bt

11	

Oth.	Tot

Loc.	MIR

604+Bt11Ac.	Oth

Ac.	No.Loc	MIR

604+ Bt11

Ac.	Oth. Ac.	No Loc	MIR

604+Bt11Ac.	Oth. Ac.	No.Loc	604+Bt11

Ac.	MIR

604

Ac.	

Bt11

Ac.	Oth. Ac.	No.Loc	604+Bt11

Ac.	Oth

Ac.	No.

Loc	MIR604 +/or, 

Bt11

Plants

AR	0	0	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	 	 	0

CA	1	0	0	20	1	 	 	 	1	20	1	0	0	0	 	 	 	 	 	 	 	 	30,000

CO	9	0	0	25	4	0	0	0	0	0	0	9	25	4	 	 	 	 	 	 	 	 	270,000

FL	5	0	0	5	3	 	 	 	5	5	3	0	0	0	 	 	 	 	 	 	 	 	150,000

HI	163	10	10	15	52	33	15	12	0	0	0	0	0	0	130	10	10	0	40	 	 	 
5,490,000

IA	195	300	600	308	126	15	13	12	7	45	35	166	230	47	0	300	600	0	30	7	20	2
32,850,000

ID	0	0	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	 	 	0

IL	162	0	0	350	95	15	13	15	14	90	40	123	227	38	0	 	 	0	0	10	20	2
4,860,000

IN	42	0	0	74	30	0	0	0	2	10	17	40	64	13	0	 	 	0	0	 	 	 	1,260,000

KS	15	0	0	15	6	0	0	0	0	0	0	15	15	6	 	 	 	 	 	 	 	 	450,000

KY	2	0	0	10	1	0	0	0	0	0	0	2	10	1	 	 	 	 	 	 	 	 	60,000

LA	0	0	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	 	 	0

MD	10	0	0	20	2	 	 	 	0	0	0	0	0	0	 	 	 	 	 	10	20	2	300,000

MI	4	0	0	4	1	0	0	0	0	0	0	4	4	1	0	 	 	0	0	 	 	 	120,000

MN	130	0	0	248	60	15	13	8	7	45	21	98	170	29	0	 	 	0	0	10	20	2
3,900,000

MO	12	0	0	45	19	0	0	0	2	10	11	9	25	4	0	 	 	0	0	1	10	4	360,000

MS	3	0	0	17	4	 	 	 	3	17	4	0	0	0	 	 	 	 	 	 	 	 	90,000

NC	0	0	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	 	 	0

NM	5	0	0	5	3	 	 	 	0	0	0	0	0	0	 	 	 	 	 	5	5	3	150,000

NE	98	20	20	139	63	0	0	0	2	10	25	95	119	26	0	20	20	0	10	1	10	2	4,140,000

ND	0	0	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	 	 	0

NY	10	0	0	18	5	 	 	 	2	10	3	8	8	2	 	 	 	 	 	 	 	 	300,000

OH	10	0	0	18	3	0	0	0	0	0	0	10	18	3	0	 	 	0	0	 	 	 	300,000

PA	4	0	0	4	1	 	 	 	0	0	0	4	4	1	 	 	 	 	 	 	 	 	120,000

PR	44	16	40	20	24	28	20	12	0	0	0	0	0	0	16	16	40	0	12	 	 	 	3,000,000

SD	32	0	0	49	10	0	0	0	0	0	0	31	39	9	 	 	 	 	 	1	10	1	960,000

TN	0	0	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	 	 	0

TX	0	0	0	0	0	0	0	0	0	0	0	0	0	0	 	 	 	 	 	 	 	 	0

VA	0	0	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	 	 	0

WI	9	0	0	41	25	0	0	0	2	10	13	7	31	12	0	 	 	0	0	 	 	 	270,000

			 

 PAGE   

Page   PAGE  1  of   NUMPAGES  6