EPA 730-F-04-001
United States
Environmental Protection
Agency
Office of Prevention,
Pesticides
and Toxic Substances
(7501C)

S'1/,
PESTICIDE
A \
2K/	FAPT QHFFT
ll PRO**-0	¦¦¦ liar A A mbbI JLbI ¦¦¦
Name of chemical ( S) :	Bacillus thuringiensis Cry3Bbl Protein and the
Genetic Material Necessary for its Production (Vector
ZMIR13L) in Event MON 863 Corn
Bacillus thuringiensis Cryl Ab Delta-Endotoxin and
the Genetic Material Necessary for its Production in
Corn
Reason for Issuance:
Date Issued:
EPA Publication Number:
YieldGard® Plus Corn- Stacked PIP
Registration
December 2003
I. Description of the Plant-Incorporated Protectant (PIP)
•	Pesticide Names:
Bacillus thuringiensis Cry3Bbl Protein and the Genetic Material Necessary for its Production
(Vector ZMIR13L) in Event MON 863 Corn
Bacillus thuringiensis Cryl Ab Delta-Endotoxin and the Genetic Material Necessary for its
Production in Corn
•	EPA Registration Number: 524-545
•	Trade and Other Names: YieldGard® Plus Corn
•	OPP Chemical Codes: 006484 and 006430

-------
•	Bask Manufacturer: Monsanto Company
800 N. Lindbergh Blvd.
St. Louis, MO 63167
•	Type of Pesticide: Plant-Incorporated Protectant
•	Uses: Field Corn
•	Pests Controlled or Suppressed: European Corn Borer, Southwestern Corn Borer,
Southwestern Cornstalk Borer, Southern Cornstalk Borer, Sugarcane Cornstalk
Borer, Corn Earworm, Fall Armyworm, Stalk Borer, Western Corn Rootworm,
Northern Corn Rootworm, and Mexican Corn Rootworm
II,	Background
EPA has registered a stacked PIP product designed to provide control of two different kinds of
insects. A stacked PIP contains separate plant-incorporated protectant active ingredients which
target different kinds of pests. In the case of YieldGard® Plus corn, corn produces both the
Cryl Ab and Cry3Bbl proteins and controls leaf and stalk damage from insects such as the
European corn borer (a moth) and root damage from corn rootworms (a beetle).
YieldGard® Plus corn was produced by conventional breeding of single PIP trait corn lines
MON 810 (YieldGard® Corn Borer) and MON 863 (YieldGard® Rootworm), YieldGard® Plus
corn produces proteins derived from a soil bacterium known as Bacillus thuringiensis or Bt. For
many years, organic farmers have used Bt powders or sprays to control insects that attack plants.
Now scientists can place Bt derived genes into plants, so that the plants can produce proteins
thereby protecting the plant from the insect pests.
EPA evaluated data regarding the stacked product and has required non-target invertebrate field
studies and Cry protein field degradation studies, as was required for the single PEP trait products
from which YieldGard® Plus was bred. This is the first crop genetically engineered to target two
different insect groups.
The refuge requirements for YieldGard® Plus combine those requirements already in place for
the single PIP trait products MON 810 (YieldGard® Corn Borer and MON 863 (YieldGard®
Rootworm) that provide com borer and rootworm protection. The YieldGard® Plus refuges for
corn borer and rootworm can either be combined or separated.
III.	Science Assessment
Product characterization data demonstrated that YieldGard® Plus Corn, which resulted from the
conventional cross of MON 810 and MON 863, contains the crylAbl and crySBbl genes and
that there have been no major alterations or rearrangements in the conventional cross of these
2

-------
two events (lines) for these two gene inserts. The data generated for the CrylAb and Cry3Bbl
proteins individually support the food safety determination for the stacked trait corn since the
mode of action for these proteins does not suggest an enhanced activity in combination for
mammalian species. This lack of synergism is also suggested by the absence of enhanced
responses in sensitive target species tested with the combination of CrylAb and Cry3Bbl
proteins. Studies were conducted and submitted to test the hypothesis that the CrylAb and
Cry3Bbl proteins do not interact when combined in YieldGard® Plus Corn. It was concluded
from leaf disk, whole plant and in vitro studies with purified Bt protein that there are no
interactive effects on susceptible insect pests when the CrylAb and Cry3Bbl proteins are
combined in YieldGard® Plus Corn. Since combining these proteins in YieldGard® Plus Corn
does not change the level of susceptibility of susceptible pests compared to single trait MON 810
and MON 863 corn, it can be concluded that there will not be a difference for non-target insects
not susceptible to the CrylAb or Cry3Bbl proteins.
IV. Terms and Conditions of the Registration
EPA Registration Number 524-545
Monsanto is required to do the following as terms and conditions of the registration.
1)	The subject registration will automatically expire on midnight May 1, 2004. The registration
must expire on this date because this is the date of expiration of the tolerance exemption under
40 CFR 180.1214. We note that Monsanto has submitted a petition to amend the tolerance
exemption in order to remove the expiration date. Based on the Agency's review of the data
submitted and cited in support of this application, and provided that the Agency finalizes a rule
which amends 40 CFR 180.1214 so that its expiration date is removed; the Agency anticipates at
this time that an expiration date of February 24, 2006 would be appropriate.
2)	The subject registration will be limited to the use of a) Bacillus thuringiensis Cry3Bbl Protein
and the Genetic Material Necessary for its Production (Vector ZMIR13L) in MON 863 com and
b) Bacillus thuringiensis Cry 1AM Protein and the Genetic Material Necessary for its Production
in corn in YieldGard® Plus field corn produced via the conventional breeding of MON 810 and
MON 863 corn.
3)	Monsanto must submit/cite all data required for registration of their product under FIFRA §
3(c)(5) when the Agency requires registrants of similar products to submit such data.
4)	Monsanto must submit production information for this product to the Office of Pesticide
Programs for the fiscal year in which this product is conditionally registered, in accordance with
FIFRA § 29. The fiscal year begins October 1 and ends September 30. Production information
will be submitted to the Agency no later than December 15, following the end of the preceding
fiscal year.
5)	Monsanto must submit all data required to support the individual plant-incorporated
3

-------
protectants in YieldGard® Com Borer (MON 810) and YieldGard® Rootworm (MON 863)
corn, EPA Registration Nos. 524-489 & 524-528.
6)	Monsanto must submit small and large-scale field studies conducted with YieldGard® Plus
Com with appropriate end points and statistical power to verify there are no adverse ecological
effects to non-target invertebrate populations. Monsanto must submit annual reports each year of
this registration every April 30th, beginning in 2005, provided the registration expiration date is
extended.
7)	Monsanto must submit field degradation studies evaluating accumulation and persistence of
CrylAb and Cry3Bbl from YieldGard® Plus Com in several different soils in various strata.
Representative fields must have been planted with YieldGard® Plus Com for at least three
consecutive years and include both conventional tillage and no-till samples and be harvested
under typical agronomic conditions. Sampling must begin after three consecutive years of
YieldGard® Plus Com planting and continue until the limit of detection is reached. Studies
should include soils with high levels of a variety of clays. Both ELISA and insect bioassays need
to be conducted and compared to determine if CrylAb and Cry3Bbl are accumulating or
persisting in soil samples. A protocol is due within 120 days of the date of registration. Planting
of YieldGard® Plus Com for the study must begin in 2004, with sampling beginning after the
2006 growing season. Provided, the registration and tolerance exemption are amended to extend
the expiration dates, a final report is due November 15, 2007.
8)	Monsanto must do the following Insect Resistance Management Program:
The required IRM program for YieldGard Plus® Bt com has the following elements:
1]	Requirements relating to creation of either common or seperate refuges for Cry3Bbl and
CrylAb in conjunction with the planting of any acreage of commercial YieldGard Plus® Bt com;
2]	Requirements for the registrant to prepare and require YieldGard Plus® Bt com users to sign
"grower agreements" which impose binding contractual obligations on the grower to comply
with the refuge requirements;
3]	Requirements for the registrant to develop, implement, and report to EPA on programs to
educate growers about IRM requirements;
4]	Requirements for the registrant to develop, implement, and report to EPA on programs to
evaluate and promote growers' compliance with IRM requirements (the YieldGard Plus®
Compliance Assurance Program (CAP) must integrate with the Cryl and Cry3Bb 1 CAPs);
5]	Requirements for the registrant to develop, implement, and report to EPA on monitoring
programs to evaluate whether there are statistically significant and biologically relevant changes
in target insect susceptibility to Cry3Bb 1 or CrylAb proteins in the target insects;
4

-------
6]	Requirements for the registrant to develop, and if triggered, to implement a "remedial action
plan" which would contain measures the registrants would take in the event that any insect
resistance was detected as well as to report on activity under the plan to EPA;
7]	Submit annual reports on sales(by state and county), IRM grower agreements results,
compliance, and educational program on or before January 31st each year beginning in 2005.
a. Refuge Requirements
Grower agreements (also known as stewardship agreements) will specify that growers must
adhere to the following refuge requirements as described in the grower guide/product use guide
and/or in supplements to the grower guide/product use guide.
Corn Belt / Non-Cotton Growing Region Refuge Requirements
For corn grown in the US Corn Belt two options for deployment of the refuge are available to
growers.
The first option is planting a common refuge for both corn borers and corn rootworms. The
common refuge must be planted with corn hybrids that do not contain Bt technologies for the
control of corn rootworms or corn borers. Hie refuge area must represent at least 20% of the
grower's corn acres (i.e. sum of YieldGard Plus acres and refuge acres). It can be planted as a
block adjacent to the YieldGard Plus field, perimeter strips, or in-field strips. If perimeter strips
are implemented, the strips must be at least 6, and preferably 12 consecutive rows wide. If strips
within the YieldGard Plus field are implemented, then at least 6, and preferably 12 consecutive
rows should be planted. The common refuge can be treated with a soil-applied or seed-applied
insecticide to control rootworm larvae and other soil pests. The refuge can also be treated with a
non-Bt foliar insecticide for control of late season pests if pest pressure reaches an economic
threshold for damage; however, if rootworm adults are present at the time of foliar applications
then the YieldGard Plus field must be treated in a similar manner.
The second option is planting separate refuge areas for com borers and com rootworms. The
corn borer refuge must be planted with a non-Bt/lepidoteran-protected hybrid, must represent at
least 20% of the grower's corn acres (i.e. sum of YieldGard Plus acres and corn borer refuge
acres), and must be planted within 54 mile of the YieldGard Plus field. The corn borer refuge can
be treated with a soil-applied or seed-applied insecticide for corn rootworm larval control, or a
non-Bt foliar-applied insecticide for corn borer control if pest pressure reaches an economic
threshold for damage. The corn rootworm refuge must be planted with a non-Bt/eorn rootworm-
protected hybrid, but can be planted with Bt com hybrids that control corn borers. The corn
rootworm refuge must represent at least 20% of the grower's com acres (i.e. sum of YieldGard
Plus acres and corn rootworm refuge acres) and can be planted as an adjacent block, perimeter
strips, or in-field strips. The corn rootworm refuge can be treated with a soil-applied or seed-
applied insecticide to control rootworm larvae and other soil pests. The refuge can also be
treated with a non-Bt foliar insecticide for control of late season pests; however, if rootworm
5

-------
adults are present at the time of foliar applications then the YieldGard Plus field must be treated
in a similar manner. Growers who fail to comply with the IRM requirements risk losing access
to the product.
Cotton Growing Area Refuge Requirements
For YieldGard Plus corn grown in cotton-growing areas the common refuge and separate refuge
options are also available, however, the refuge area is larger. Cotton-growing areas include the
following states: Alabama, Arkansas, Florida, Georgia, Louisiana, North Carolina, Mississippi,
South Carolina, Oklahoma (only the counties of Beckham, Caddo, Comanche, Custer, Greer,
Harmon, Jackson, Kay, Kiowa, Tillman, and Washita), Tennessee (only the counties of Carroll,
Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Haywood, Lake, Lauderdale,
Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), Texas (except the counties of Carson,
Dallam, Hansford, Hartley, Hutchinson, Lipscomb, Moore, Ochiltree, Roberts, and Sherman)
Virginia (only the counties of Dinwiddie, Franklin City, Greensville, Isle of Wight, Northampton,
Southampton, Suffolk City, Surrey, and Sussex), and Missouri (only the counties of Dunkin, New
Madrid, Pemiscot, Scott, and Stoddard).
The first option is planting a common refuge for both corn borers and com rootworms. The common
refuge must be planted with com hybrids that do not contain Bt technologies for the control of com
rootworms or corn borers. The refuge area must represent at least 50% of the grower's com acres
(i.e. sum of YieldGard Plus acres and refuge acres). It can be planted as a block adjacent to the
YieldGard Plus field, perimeter strips, or in-field strips. If perimeter strips are implemented, the
strips must be at least 6, and preferably 12 consecutive rows wide. If strips within the YieldGard
Plus field are implemented, then at least 6, and preferably 12 consecutive rows should be planted.
The common refuge can be treated with a soil-applied or seed-applied insecticide to control
rootworm larvae and other soil pests. The refuge can also be treated with a non-Bt foliar insecticide
for control of late season pests if pest pressure reaches an economic threshold for damage; however,
if rootworm adults are present at the time of foliar applications then the YieldGard Plus field must
be treated in a similar manner.
The second option is planting separate refuge areas for com borers and com rootworms. The com
borer refuge must be planted with a non-Bt/lepidopteran-protected hybrid, must represent at least
50% of the grower's com acres (i.e. sum of YieldGard Plus acres and com borer refuge acres), and
must be planted within Vi mile of the YieldGard Plus field. The com borer refuge can be treated with
a soil-applied or seed-applied insecticide for com rootworm larval control, or a non-Bt foliar-applied
insecticide for com borer control if pest pressure reaches an economic threshold for damage. The
com rootworm refuge must be planted with a non-Bt corn/rootworm-protected hybrid, but can be
planted with Bt com hybrids that control com borers. The com rootworm refuge must represent at
least 20% of the grower's com acres (i.e. sum of YieldGard Plus acres and com rootworm refuge
acres) and be planted as an adjacent block, perimeter strips, or in-field strips. The com rootworm
refuge can be treated with a soil-applied or seed-applied insecticide to control rootworm larvae and
other soil pests. The refuge can also be treated with a non-Bt foliar insecticide for control of late
season pests; however, if rootworm adults are present at the time of foliar applications then the
6

-------
YieldGard Plus field must be treated in a similar manner. Growers who fail to comply with the IRM
requirements risk losing access to the product.
b. Grower Agreements
1]	Persons purchasing the Bt com product must sign a grower agreement. The term "grower
agreement" refers to any grower purchase contract, license agreement, or similar legal document.
2]	The grower agreement and/or specific stewardship documents referenced in the grower
agreement must clearly set forth the terms of the current IRM program. By signing the grower
agreement, a grower must be contractually bound to comply with the requirements of the IRM
program.
3]	The registrant must develop a system (equivalent to what is already approved for MON 810,
EPA Reg. No. 524-489) which is reasonably likely to assure that persons purchasing the Bt corn
product will affirm annually that they are contractually bound to comply with the requirements of
the IRM program. The proposed system will be submitted to EPA within 90 days from the date
of registration.
4]	The registrant must use grower agreements and submit to EPA within 90 days from the date of
registration a copy of that agreement and any specific stewardship documents referenced in the
grower agreement. If Monsanto wishes to change any part of the grower agreement or any
specific stewardship documents referenced in the grower agreement that would affect either the
content of the IRM program or the legal enforceability of the provisions of the agreement relating
to the IRM program, thirty days prior to implementing a proposed change, the registrant must
submit to EPA the text of such changes to ensure that it is consistent with the terms and
conditions of the amendment.
5]	The registrant must establish a system (equivalent to what is already approved for MON 810,
EPA Reg. No. 524-489) which is reasonably likely to assure that persons purchasing the Bt corn
sign grower agreement(s), and must provide within 90 days from the date of the registration a
written description of that system.
6]	The registrant shall maintain records of all Bt corn grower agreements for a period of three
years from December 31st of the year in which the agreement was signed.
7]	Beginning on January 31, 2005 and annually thereafter, the registrant shall provide EPA with a
report showing the number of units of its YieldGard Plus® corn seeds sold or shipped and not
returned, and the number of such units that were sold to persons who have signed grower
agreements. The report shall cover the time frame of the twelve-month period covering the prior
August through July.
8]	The registrant must allow a review of the grower agreements and grower agreement records by
EPA or by a State pesticide regulatory agency if the State agency can demonstrate that
7

-------
confidential business information, including names, personal information, and grower license
number, will be protected.
c. IRM Education and IRM Compliance Monitoring Programs
1 ] Monsanto must design and implement a comprehensive, ongoing IRM education program
designed to convey to YieldGard Plus corn users the importance of complying with the IRM
program. The program shall include information encouraging YieldGard Plus corn users to
pursue optional elements of the IRM program relating to refuge configuration and proximity to
YieldGard Plus corn fields. The education program shall involve the use of multiple media, e.g.
face-to-face meetings, mailing written materials, EPA reviewed language on IRM requirements
on the bag or bag tag, and electronic communications such as by Internet, radio, or television
commercials. Copies of the materials will be provided to EPA for its records. The program shall
involve at least one written communication annually to each YieldGard Plus corn user separate
from the grower technical guide. The communication shall inform the user of the current IRM
requirements. Monsanto shall coordinate its education programs with educational efforts of
other registrants and other organizations, such as the National Corn Grower Association and state
extension programs.
2]	Annually, the registrant shall revise, and expand as necessary, its education program to take
into account the information collected through the compliance survey required under paragraph
6] and from other sources. The changes shall address aspects of grower compliance that are not
sufficiently high.
3]	Beginning January 31,2005 and annually thereafter, the registrants must provide a report to
EPA summarizing the activities carried out under the education program for the prior year and
the plans for their education program during the current year. The registrant must either submit a
separate report or contribute to the report from the industry working group (ABSTC).
4]	The registrant must design and implement an ongoing IRM compliance assurance program
designed to evaluate the extent to which growers purchasing its YieldGard® Plus Bt corn product
are complying with the IRM program and that takes such actions as are reasonably needed to
assure that growers who have not complied with the program either do so in the future or lose
their access to the YieldGard® Plus Bt com product. Monsanto shall ensure that the YieldGard®
Plus compliance assurance program (CAP) will be consistent with and integrated with the CAPs
for MON 863 and MON 810, EPA Registration Nos. 524-489 and 524-528. The registrant must
prepare and submit within 90 days of the date of registration a written description of their
compliance assurance program including a summary of the program to be implemented in the
2004 growing season. Other required features of the program are described in paragraphs 5] -
15] below.
5]	The registrant must establish and publicize a "phased compliance approach," i.e., a guidance
document that indicates how the registrant will address instances of non-compliance with the
terms of the IRM program and general criteria for choosing among options for responding to any
8

-------
non-compliant growers. The options shall include withdrawal of the right to purchase YieldGard
Plus corn for an individual grower or for all growers in a specific region. An individual grower
found to be significantly out of compliance two years in a row would be denied sales of the
product the next year. Similarly, seed dealers who are not fulfilling their obligations to
inform/educate growers of their IRM obligations will lose their opportunity to sell YieldGard
Plus com.
6]	The IRM compliance assurance program shall include an annual survey of a statistically
representative sample of Bt com growers conducted by an independent third party. The survey
shall measure the degree of compliance with the IRM program by growers in different regions of
the country and consider the potential impact of non-response. The sample size and geographical
resolution may be adjusted annually, based upon input from the independent marketing research
firm and academic scientists, to allow analysis of compliance behavior within regions or between
regions. The sample size must provide a reasonable sensitivity for comparing results across the
U.S.
7]	The survey shall be designed to provide an understanding of any difficulties growers
encounter in implementing IRM requirements. An analysis of the survey results must include the
reasons, extent, and potential biological significance of any implementation deviations.
8]	The survey shall be designed to obtain grower feedback on the usefulness of specific
educational tools and initiatives.
9]	The registrant shall provide a preliminary summary of their findings by November 15 and a
final written summary of the results of the prior year's survey (together with a description of the
regions, the methodology used, and the supporting data) to EPA by January 31 of each year. The
registrant shall confer with EPA on the design and content of the survey prior to its
implementation.
10]	Annually, the registrant shall revise, and expand as necessary, its compliance assurance
program to take into account the information collected through the compliance survey required
under paragraphs 6] through 8] and from other sources. The changes shall address aspects of
grower compliance that are not sufficiently high. The registrant must confer with the Agency
prior to adopting any changes.
11]	The registrant shall train its representatives who make on-farm visits with YieldGard Plus
com growers to perform assessments of compliance with IRM requirements. In the event that
any of these visits result in the identification of a grower who is not in compliance with the IRM
program, the registrant shall take appropriate action, consistent with its "phased compliance
approach," to promote compliance.
12]	The registrant shall carry out a program for investigating legitimate "tips and complaints"
that its growers are not in compliance with the IRM program. Whenever an investigation results
in the identification of a grower who is not in compliance with the IRM program, the registrant
9

-------
shall take appropriate action, consistent with its "phased compliance approach."
13]	If a grower, who purchases YieldGard Plus corn for planting, was specifically identified as
not being in compliance during the previous year, the registrant shall visit with the grower and
evaluate whether that the grower is in compliance with the IRM program for the current year.
14]	Beginning January 31, 2005 and annually thereafter, Monsanto shall provide a report to EPA
summarizing the activities carried out under their compliance assurance program for the prior
year and the plans for the compliance assurance program during the current year. The report will
include information regarding grower interactions (including, but not limited to, on-farm visits,
verified tips and complaints, grower meetings and letters), the extent of non-compliance,
corrective measures to address the non-compliance, and any follow-up actions taken.
15]	The registrant and the seed corn dealers for the registrant must allow a review of the
compliance records by EPA or by a State pesticide regulatory agency if the State agency can
demonstrate that confidential business information, including the names, personal information,
and grower license number of the growers will be protected,
d. Insect Resistance Monitoring
The Agency is imposing the following conditions for this product:
1)	The registrant will monitor for resistance and/or trends in increased tolerance for com
rootworm, European corn borer, Southwestern corn borer, and com earworm. Sampling should
be focused in those areas in which there is the highest risk of resistance development. Monitoring
must be carried out under the same protocols used for the individual trait products MON 810 and
MON 863, EPA Registration Nos. 524-489 and 524-528.
2)	The registrant shall provide to EPA a description of its resistance monitoring plan by January
31, 2005. The description shall include: sampling (number of locations and samples per
locations), sampling methodology, bioassay methodology, standardization procedures, detection
technique and sensitivity, and the statistical analysis of the probability of detecting resistance.
3)	The registrant must follow up on grower, extension specialist or consultant reports of less
than expected results or control failures for all pests listed on the label and/or grower guide. The
registrant will instruct its customers (growers and seed distributors) to contact them (e.g., via a
toll-free customer service number) if incidents of unexpected levels of damage occurs from these
target pests. The registrant will investigate all damage reports submitted to the company or the
company's representatives. See Remedial Action Plans section below.
4)	A report on results of resistance monitoring and investigations of damage reports must be
submitted to the Agency annually by April 30th each year for the duration of the conditional
registration, beginning in 2005.
10

-------
e. Remedial Action Plans
A Remedial Action Plan covering both suspected and confirmed resistance for corn rootworm,
European corn borer, southwestern corn borer, and com earworm must be submitted by
1/31/2005. If resistance is confirmed, all acres (YieldGard Plus and refuges) should be treated
with insecticides targeted at CRW adults as well as larvae.
Annual Reports:
The registrant will provide an annual reports to EPA on its YieldGard Plus PIP expressed in corn
based on the following table.
Report
Description
Due Date
Annual Sales
Reported by county and state summed by
state
January 31st each year
beginning in 2005
Grower Agreement
Number of units of Bt corn seeds shipped or
sold and not returned, and the number of
such units that were sold to persons who have
signed grower agreements
January 31s1 each year
beginning in 2005
Grower Education
Education program completed previous year
and plan for next year
January 31st each year
beginning in 2005
Proposed
Compliance Plan
Written description of Compliance Assurance
Program
90 Days of the Date of
Registration
Compliance
Assurance Plan
Compliance Assurance Program Activities
and Results
January 31st each year
starting in 2005
Compliance
To include annual survey results and plans
for the next year
Preliminary survey
report November 15th
each year (beginning
2004) and full report
January 31"' each year
thereafter
11

-------
Insect Resistance
Monitoring
Description of the program including
sampling (number of locations and samples
per locations), sampling methodology,
bioassay methodology, standardization
procedures, detection technique and
sensitivity, and the statistical analysis of the
probability of detecting resistance.
January 31, 2005
Additional reports are due as described in the following table:
IRM Grower
Agreements
Proposed system to assure powers
sign grower agreements
90 Days of the Date of
Registration
IRM Affirmation
Plan
System to assure annual affirmation
by growers of their IRM obligations
90 Days of the Date of
Registration
Changes to Grower
Agreement and/or
IRM documents
Current grower agreement(s) and any
specific stewardship documents
At least 30 days before any
changes related to IRM are
expected to be imposed.
Insect Resistance
Monitoring Results
Results of monitoring and
investigations of damage reports
April 30th each year,
beginning 2005
V. Contact Person at EPA
Michael Mendelsohn
Senior Regulatory Specialist
Biopesticides and Pollution Prevention Division (7511C)
Office of Pesticide Programs
Environmental Protection Agency
1200 Pennsylvania Avenue NW
Washington, D. C. 20460
Office location and telephone number:
12

-------
9th Floor
Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
(703)308-8715
Email: mendelsohn.mike@epa.gov
DISCLAIMER: The information in this Pesticide Fact Sheet is a summary only and is not to be
used to satisfy data requirements for pesticide registration. Contact the Senior Regulatory
Specialist listed above for further information.
13

-------
REPORT DOCUMENTATION PAGE
Form Approved
OMB No. 0704-0188
Public res>cning Burden for thts ejection of mlo'matton !«, ?si'«r*aie<2 average 1 hed' oc response. 'needing the ttfn* tor revtew«ng instructions, searching earning data source*,
gathering and maintaining data reeded, and competing ana 'pvtewirg the collection of information. Send comments reqaro»ng this txjrden estimate or any other aspect of this
cr„. _ .. .~t~. 	 	j	reducing Durden *o Washington Heaaauanerv Services. Directorate for information Os*?»tions and Repots, U15 ieHeoon
( ?. and to tne Office Managemem and 8ufl 5^!. Pspe^worK Reduction Project (0?D«a-0 i8S).Waih!pgton, DC 205Q3.
[2, REPORT DATE 3. REPORT TYPE AND DATES COVERED
pecember 2003
4. TITLE AND SUBTITLE
EPA Pesticide Fact Sheet - Bacillus thuringiensis Cry3Bbl
Protein and the Genetic Material Necessary for its Produc-
tion fVector 7.MIR13U in Event. MOM 8..3 Corn
5. FUNDING NUMBERS
6. AUTHOR(S)
EPA, Office of Pesticide Programs,Biopesticides Pollution
& Prevention Division
7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES)
U.S. Environmental Protection Agency
Office of Pesticide Programs
Biopesticides Pollution & Prevention Division
401 M Street, S.W.
Washington, D.C. 20460
8, PERFORMING ORGANIZATION
REPORT NUMBER
EPA 730-F-04-001
8. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES)
Same as #7
10. SPONSORING/MONITORING
AGENCY REPORT NUMBER
11. SUPPLEMENTARY NOTES
12a. DISTRIBUTION/AVAILABILITY STATEMENT
12b. DISTRIBUTION CODE
Publicly Available

13. ABSTRACT (Maximum 200 words)
This document contains up-to-date chemical information, including a summary
of the Agency's regulatory position and rationale, on a specific pesticide or
group of pesticides. A Fact Sheet is issued after one of the following actions
has occurred.
1.	Issuance or reissuance of a registration standard,
2.	Issuance of each special review document,
3.	Registration of a significantly changed use pattern,
4.	Registration of a new chemical, or
5.	An immediate need for information to resolve controversial issues
relating to a specific chemical or use pattern.
14. SUBJECT TERMS

15, NUMBER OF PAGES
Pesticides: Regulation: Chemical Information Fact Sheet:
13
Use Patterns; Science Findings

16, PRICE CODE
17. SECURITY CLASSIFICATION 1 IS. SECURITY CLASSIFICATION
OF REPORT 1 OF THIS PAGf
UncU..«l.d | U.cU.ifcrf
19. SECURITY CLASSIFICATION
TT OE ABSTRACT ,
Unclassifled
20. LIMITATION OF ABSTRACT
%
NSN 7540-01 -280-5500
s*
inda'Ci "CT 298 (Rev 2-89)
ir, Z"39- !§

-------