crop-chem-docs/corpus/epa_ppls/524-545.md

# MON 863 X MON 810

- EPA Reg No: **524-545**
- Registrant: BAYER CROPSCIENCE, LLC
- Signal word: Caution
- Active ingredients: Bacillus thuringiensis Cry3B1 protein and the genetic material necessary for its production (Vector ZMIR 13L) in corn (0.016%); Bacillus thuringiensis Cry1Ab protein and the genetic material (PV-ZMBK07) necessary for its production in corn event MON-00810-6; % dry weight (0.005%)
- Label accepted: 2009-03-19
- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00545-20090319.pdf

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UNITED C:rES ENVIR9NMEN.TAL PROTECTION AC _ JCY 
Ms. Margaret Wideman 
Regulatory Affairs Manager 
Monsanto Company 
800 North Lindbergh Blvd 
St. Louis, MO 63167 
Dear Ms. Wideman: 
MAR 1 S20m 
Subject: Your September 4, 2008 Amendment Request to Amend the Insect Resistance 
Management Terms and Conditions for MON 863 x MON 810 
EPA Registration No. 524-545 
The amendment referred to above, submitted in connection with registration under 
section 3 (c)(7)(A)of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, are 
acceptable subject to the following comments. 
Insect Resistance Management: 
The listed IRM terms and conditions are being modified as follows. 
1) Under 8a. Refuge Requirements, the following statement is added "These refuge 
requirements do not apply to seed propagation of inbred and hybrid corn seed corn up to a total 
of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active 
ingredient per registrant per year." 
,2) Under 8d. Insect Resistance Monitoring and 8e. Remedial Action Plans, the CrylAb-related 
portions (European corn beirer, Southwestern corn borer, and corn earworm; MON 810; 524-489) 
are removed and replaced by 8f. below. Further the 8d and 8e headings are modified to read as 
8d. Cry3Bbl Insect Resistance Monitoring and 8e. Cry3Bbl Remedial Action Plans. 
8f. Cryl Ab Insect Resistance Monitoring 
The Agency is imposing the following cOnditions for this product: 
The'registrant will monitor for resistance to its lepidopteran-resistant Bt com. The monitoring 
program shall consist of two approaches: (1) focused population sampling and l~boratory testing; 
and (2).investigation of reports ofless-than expected control oflabeled insects. Should field­
relevant resistance be confimied, an appropriate resistance management action plan will be 
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EPA Form 1320-1 A '(1/90) , Printed on Recycled Paper OFFICIAL FILE COpy 
.. U,S, Government Printing Omce: 2005 ~ (mac)

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(1) Focused Population Sampling 
The registrant shall annually sample and bioassay populations of the key target pests Ostrinia 
nubilalis (European corn borer; ECB), Diatraea grandiosella (Southwestern corn borer; S 
WCB), and Helicoverpa zea (corn earworm; CEW). Sampling for the target pests will be focused 
in areas identified as those with the highest risk of resistance development (e.g., where 
lepidopteran-active Bt hybrids are planted on a high proportion of the corn acres, and where the 
insect species are regarded as key pests of corn). Bioassay methods must be appropriate for the 
goal of detecting field-relevant shifts in population response to lepidopteran resistant Bt corn 
and/or changes in resistance allele frequency in response to the use ofBt corn and, as far as 
possible, should be consistent across sampling years to enable comparisons with historical data. 
The number of populations to be collected shall reflect the regional importance of the insect 
species as a pest, and specific collection regions will be identified for each pest. For ECB, a 
minimum of 12 populations across the sampling region will be targeted for collection at each 
annual sampling. For SWCB, the target will be a minimum of six populations. For CEW, the 
target will be a minimum of 10 populations. Pest populations should be collected from multiple 
corn'-growing states reflective of different geographies and agronomic conditions. To obtain 
sufficient sensitivity to detect resistance alleles before they become common enough to cause 
measurable field damage, each population collection shall attempt to target 400 insect genomes 
(egg masses, larvae, mated females, and/or mixed-sex adults), but a successful population 
collection will contain a minimum of 100 genomes. It is recognized that it may not be possible to 
collect the target number of insect populations or genomes due to factors such as natural 
fluctuations in pest density, environmental conditions, and area-wide pest suppression. 
The sampling program and geographic range of collections may be modified as appropriate 
based on changes in pest importance and for the adoption levels oflepidopteran-resistant Bt 
corn. The Agency shall be consulted prior to the implementation of such modifications. 
The registrant will report to the Agency before August 31 each year the results of 
the population sampling and bioassay monitoring program. 
Any incidence of unusually low sensitivity to the Bt protein in bioassays shall be investigated as 
soon as possible to understand any field relevance of such a finding. Such investigations shall . 
proceed in a stepwise manner until the field relevance can be either confirmed or refuted, and 
results of these shall be reported to the Agency annually before August 31. The investigative 
steps will include: 
1. Re-test progeny of the collected population to determine whether the unusual 
bioassay response is reproducible and heritable. If it is not reproducible and 
heritable, no further action is required. 
2. If the unusual response is reproducible and heritable, progeny of insects that 
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survive the diagnostic concentration will be tested using methods that are 
representative of exposure to Bt com hybrids under field conditions. If progeny 
do not survive to adulthood, any suspected resistance is not field relevant and no 
further action is required. 
3. Ifinsects survive steps 1 and 2, resistance is confirmed, and further steps will be 
taken to evaluate the resistance. These steps may include: 
• determining the nature of the resistance (i.e., recessive or dominant, and the level 
of functional dominance); 
• estimating the resistance-allele frequency in the original population; 
• detennining whether the resistance-allele frequency is increasing by analyzing 
field collections in subsequent years sampled from .the same site where the 
resistance allele(s) was originally collected; 
• detennining the geographic distribution of the resistance allele by analyzing field 
collections in subsequent years from sites surrounding the site where the 
resistance allele(s) was originally collected. 
Should field-relevant resistance be confirmed, and the resistance appears to be 
increasing or spreading, the registrant will consult with the Agency to develop 
and implement a case-specific resistance management action plan. 
(2) Investigation of Reports of Unexpected Levels of Damage by the Target 
Pests: 
The registrant will follow up on grower; extension specialist or consultant reports 
of unexpected levels of damage by the lepidopteran pests listed on the pesticide 
label. The registrant will instruct its customers to contact them if such incidents 
occur. The registrant will investigate all legitimate reports submitted to the 
company or the company's representatives. 
If reports of unexpected levels of damage lead to the suspicion of resistance in 
any of the key target pests (ECB, SWCB, and CEW), the registrant will 
implement the actions described below, based on the following definitions of 
suspected resistance and confirmed resistance. 
Suspected resistance 
EP A defines suspected resistance to mean field reports of unexpected levels of 
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insect feeding damage for which: 
• the com in question has been confinned to be lepidopteran-active Bt com; 
• the seed used had the proper percentage of com expressing Bt protein; 
• the relevant planttissues are expressing the expected level of Bt protein; and 
• it has been ruled out that species not susceptible to the protein could be 
responsible for the damage, that no climatic or cultural reasons could be 
. responsible for the damage, and that that there could be no other reasonable 
causes for the damage. 
The Agency does not interpret suspected resistance to mean grower reports of 
possible control failures or suspicious results from annual insect monitoring 
assays, nor does the Agency intend that extensive field studies and testing be 
undertaken to confinn scientifically the presence of insects resistant to Bt com in 
commercial production fields before responsive measures are undertaken. 
If resistance is suspected, the registrant will instruct growers to do the following: 
• Use alternative control measures in the Bt com fields in the affected region to 
control the target pest during the immediate growing season. 
• Destroy Bt com crop residues in the affected region within one month after 
harvest with a technique appropriate for local production practices to minimize 
the possibility of resistant insects ov~r-wintering and contributing to the next 
season's target pest population. 
Additionally, if possible, and prior to the application of alternative control 
measures or destruction of crop residue, the registrant will collect samples of the 
insect population in the affected fields for laboratory rearing and testing. Such rearing and testing 
shall be conducted as expeditiously as practical. 
Confirmed resistance 
EPA defines confirmed resistance to mean, in the case of field reports of unexpected levels of 
damage from the key target pests, that all the following criteria are met: 
• There is >30% insect survival and commensurate insect feeding in a bioassay, initiated 
with neonate larvae, that uses methods that are representative of exposure to Bt com 
hybrids under field conditions (ECB and SWCB oniy). 
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• In standardized laboratory bioassays using diagnostic concentrations of the Bt protein 
suited to the target pest in question, the pest exhibits resistance that has a genetic basis 
and the level of survivorship indicates that there may be a resistance allele frequency of:::: 
0.1 in the sampled population. . 
• In standardized laboratory bioassays, the LCso exceeds the upper limit of the 95% 
confidence interval of the LCso for susceptible populations surveyed both in the original 
baselines developed for this pest species and in previous years of field monitoring. 
(3) Response to Confirmed Resistance in a Key Target Pest as the Cause of Unexpected 
Levels of Damage in the Field 
When field resistance is confirmed (as defined above), the following steps will be taken by the 
registrant: 
• EPA will receive notificatioJ;l within 30 days of resistance confinnation; 
• Affected customers and extension agents will be notified about confinned resistance 
within 30 days; 
• Monitoring will be increased in the affected area and local target pest populations will be 
sampled annually to detennine the extent and impact of resistance; 
• If appropriate (depending on the resistant pest species, the extent of resistance, the timing 
of resistance, and the nature of resistance, and the availability of suitable alternative 
control measures), alternative control measures will be employed to reduce or control 
target pest populations in the affected area. Alternative control measures may include 
advising customers and extension agents in the affected area to incorporate crop residues 
into the soil following harvest to minimize the possibility of over-wintering insects, 
and/or applications of chemical insecticides; 
• Unless otherwise agreed with EPA, stop sale and distribution of the relevant 
lepidopteran-active Bt com hybrids in the affected area immediately until an effective 
local mitigation plan approved by EPA has been implemerited; 
• The registrant will develop a case-specific resistance management action plan within 90 
days according to the characteristics of the resistance event and . local agronomic needs. 
The registrant will consult with appropriate stakeholders in the development of the action 
plan, and the details of such a plan shall be approved by EPA prior to implementation; 
• Notify affected parties (e.g. growers, consultants, extension agents, seed distributors, 
university cooperators and state/federal authorities as appropriate) in the region of the 
resistance situation and approved action plan; and 
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• In subsequent growing seasons, maintain sales suspension and alternative r€?sistance 
management strategies in the affected region(s) for the Bt com hybrids that are affected 
by the resistant population until an EP A -approved local resistance management plan is in 
place to mitigate the resistance. 
A report on results of resistance monitoring and investigations of damage reports. must be 
submitted to the Agency annually by August 31 st each year for the duration of the conditional 
registration. . 
If these conditions are not complied with, the registration will be subject to cancellation 
in accordance with FIFRA section 6(e). Your release for shipment of Cry lAb com constitutes 
acceptance of these conditions. 
A stamped copy of the FIFRA label is enclosed for your records. 
Sincerely, 
cf!:!du~ef 
Microbial Pesticides Branch 
Biopesticides and Pollution 
Prevention Division (7511P) 
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MON 863 x MON 810 
Rootworm-and Corn Borer-Protected Corn Seed 
(OECD Unique Identifier: MON-00863-5 x MON-00810-6) 
This product is effective in controlling com leaf, stalk and ear damage caused by corn borers 
and root feeding damage caused by com rootworm larvae. 
Active Ingredient: 
Bacillus thuringiensis Cry3Bbl protein and the genetic material necessary for its production 
(Vector ZMIR13L) in MON 863 com (OECD Unique Identifier: MON-00863-5) ............ . 
... .... .... ..................... ........ ........................ ............................ .. 0.003 - 0.0160/0 
Bacillus thuringiensis CrylAb delta-endotoxin and the genetic material necessary for its 
production (Vector PV-ZMCTOl) in event MON 810 .com (OECD Unique Identifier: 
MON-00810-6): ........................................................................ 0.002 - 0.005% 
Other Ingredients: 
Substance produced by a marker gene and the genetic material necessary for its production 
(Vector ZMIR13L) in event MON 863 com (OECD Unique Identifier: MON-00863-5) 
......................................................................................... 0.00005 - 0.0001 % 
Percentage (wt/wt) on a dry weight basis for whole plant (forage). 
CAUTION 
KEEP OUT OF REACH OF CHILDREN 
NET CONTENTS ___ _ 
EPA Registration No. 524-545 
EPA Establishment No. 524-MO-002 
Monsanto Company 
800 North Lindbergh Blvd. 
St. Louis, MO 63198 
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. DIRECTIONS FOR USE 
It is a violation of Federal law to use this product in any manner inconsistent with this 
labeling~ The following information regarding commercial production must be included in 
the MON 863 x MON 810 Technology Use Guide (IRM Guide). 
MON 863 x MON 810 protects com crops from leaf, stalk, and ear damage caused by com 
borers and root damage caused by com rootworm larvae. In order to minimize the risk of 
these pests developing resistance to MON 863 x MON 810 com, an insect resistance 
management plan must be implemented which includes planting of a structured refuge. 
This plant-incorporated protectant may be combined through conventional breeding with 
other registered plant-incorporatedprotectants that are similarly approved for use in 
combination, through conventional breeding, with other plant-incorporated protectants to 
produce inbred com lines and hybrid com varieties with combined pesticidal traits. 
INSECT RESISTANCE MANAGEMENT 
Corn Belt / Noncotton Growing Region Refuge Requirements 
For MON 863 x MON 810 com groWn in noncotton growing regions of the United States, 
two options for deployment of the refuge are available to growers. 
The first option is planting a common refuge for both com borers and com rootworms. The 
common refuge must be planted with com hybrids that do not contain Bacillus thuringiensis 
(B.t.) technologies for the control of com borers or com rootworms. The refuge area must 
represent at least 20% of the grower's com acres (i.e., sum ofMON 863 x MON 810 acres 
and refuge acres; refuge area must contain 20 acres of com for every 80 acres ofMON 863 x 
MON 810 com planted). It can be planted as a block within or adjacent (e.g., across the 
road) to the MON 863 x MON 810 field, perimeter strips (i.e. strips around the field), or in­
field strips. Ifperimeter or in-field strips are implemented, the strips must be at least 4 
consecutive rows wide. The common refuge' can be treated with an insecticide to control 
rootworm larvae and other soil pests. The refuge can also be treated with a non-B.t. 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 
MON 863 x MON 810 field (acres) must be treated in a similar manner. Economic 
thresholds will be determined using methods recommended by local or regional professionals 
(e.g., Extension Service agents, crop consultants, etc.). A schematic of one common refuge 
deployment option is shown below:

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Common Refuge 
MON863xMON 
810 Corn (80 ac) 
( 
[
Refuge: J Non-B.t. Corn 
(20 ac) 
The second option is planting separate refuge areas (e.g., two refuge areas, a double refuge, 
paired refuge areas) for com borers and com rootworms. The com borer refuge must be 
planted with com that is not a lepidoteran-protected B.t. hybrid, must represent at least 20% 
of the grower's com acres, and must be planted within Y2 mile of the MON 863 x MON 810 
field. The com borer refuge can be treated with an insecticide for com rootworm larval 
control, or a non-B.t. foliar-applied insecticide for com borer control if pest pressure reaches 
an economic threshold for damage. 
The com rootworm refuge must be planted with com that is not a com rootworm-protected 
B.t. hybrid, but can be planted with B.t. hybrids that control com borers. The com rootworm 
refuge must represent at least 20% of the grower's com acres (i.e., corn rootwoim refuge 
must contain 20 acres of corn for every 80 acres of MON 863 x MON 810 corn planted) and 
can be planted as a block within or adjacent to the MON 863 x MON 810 field, strips around 
the field; or in-field strips. The com rootworm refuge can be treated with an insecticide to 
control rootworm larvae and other soil pests. The refuge can also be treated with a non-B.t. 
foliar insecticide for control of late season pests; however, if corn rootworm adults are 
present at the time of foliar applications then the MON 863 x MON 810 field must be treated 
in a similar manner. A schematic of one separate refuge option with the com rootworm 
refuge planted as a block within the field and the corn borer refuge planted within a Y2 mile 
of the MON 863 x MON 810 field is shown below:

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Separate-Refuge Option 
{Two-Refuge Option, Double-Refuge Option, Paired-Refuge Option} 
MON 863 xMON 
810 Corn 
(80 ac) 
r 
Refuge: 
Corn borer 
protected corn 
(20 ac) ..... 
::SYz mile 
,.- J Refuge: 
Non-B.t. Corn 
'- (25 ac) 
Corn/Cotton Growing Area (Cotton Growing Area) Refuge Requirements 
For MON 863 x MON 810 com grown in cotton growing areas of the U.S. the common 
refuge and separate refuge options (e.g., two-refuge options, double-refuge options, paired­
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 com borers and com rootworms. The 
common refuge must be planted with com hybrids that do not contain B.t. technologies for 
the control of com rootworms or com borers. The refuge area must represent at least 50% of 
the grower's com acres (i.e., refuge must contain 50 acres ofnon-B.t. com for every 50 acres 
ofMON 863 x MON 810 com planted). It can be planted as a block within or adjacent to the 
MON 863 x MON 810 field, strips around the field, or in-field strips. Ifperimeter or in-field 
strips are implemented, the strips must be at least 4 consecutive rows wide. The common 
refuge can be treated with an insecticide to control rootworm larvae and other soil pests. The 
refuge can also be treated with a non-B. t. 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 thenthe MON 863 x MON 810 field must be treated 
in a similar manner. A schematic of one common refuge deployment option is shown below: 
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Common Refuge 
MON 863 x MOl' Refuge: 
810 Corn (50 ac) . Non-B.t. Corn 
(50 ac) 
The second option is planting separate refuge areas (e.g., two refuge areas, double refuge 
areas, paired refuge areas) for com borers and comrootworms. The com borer refuge must 
be planted with com that is not a lepidopteran-protected B.t. hybrid, must represent at least 
50% of the grower's com acres (i.e., must contain 50 acres of com for every 50 acres of 
lepidopteran-protected com planted), and must be planted within 12 mile of the MON 863 x 
MON 810 field. The com borer refuge can be treated with an insecticide for com rootworm 
larval control, or a non-B.t. foliar-applied insecticide for com borer control If pest pressure 
reaches an economic threshold for damage. Economic thresholds will be determined using 
methods recommended by local or regional professionals (e.g., Extension Service agents, 
crop consultants, etc.). 
The com rootworm refuge must be planted with com that is not a rootw6rm-protected B. t. 
hybrid, but can be planted with B.t. hybrids that control com borers. The com rootworm 
refuge must represent at least 20% of the grower's com acres (i.e., com rootworm refuge 
must contain 20 acres of com for every 80 acres of MON 863 x MON 810 com planted) and· 
be planted as a block within or adjacent to the MON 863 x MON 810 field, strips around the 
field, or in-field strips. The com rootworm refuge can be treated with an insecticide to 
control rootworm larvae and other soil pests. The refuge can also be treated with a non-B.t. 
foliar insecticide for control of late season pests; however, if rootworm adults are present at 
the time of foliar applications then the MON 863 x MON 810 field must be treated in a 
similar manner. Schematics for two separate-refuge options with the com rootworm refuge 
planted as a block within the MON 863 x MON 810 field and the com borer refuge planted 
as a block within a 12 mile of the MON 863 xMON 810 field are shown below: 
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Separate-Refuge Option 
{Two-Refuge Option, Double-Refuge Option; Paired-Refuge Option} 
MON863xMON 
810 Corn (80 ac) 
[ , Corn borer 
protected corn 
(20 ac) 
-
MON863xMON 
810 Corn (80 ac) 
..... 
[ Corn borer 
protected corn 
(20 ac) 
~Y2 mile 
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- or - . 
~Y2 mile 
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Non-B.t. Corn 
(100 ac) 
MON863 Corn 
(80 ac) 
[ Non-B.L corn' 
(20 ac) 
--'" 
Grower agreements will specify that growers must adhere to the refuge requirements that will 
be described in the Technology Use Guide (IRM Guide) for MON 863 x MON 810 com or 
other applicable product use documents. Growers who fail to comply with the IRM 
requirements risk losing access to the product. 
These refuge requirements do not apply to seed propagation of inbred and hybrid com seed 
up to total qf 20,000 acres per county and up to a combined U.S. total of 250,000 acres per 
PIP active ingredient per registrant per year.

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CORN INSECTS CONTROLLED OR SUPPRESSED 
Field com has been genetically transformed to produce the B.t. CrylAb and Cry3Bbl 
proteins for the control or suppression of the following lepidopteran and coleopteran insects, 
respectively: 
European com borer (Ostrinia nubilalis)· 
Southwestern com borer (Diatraea grandiosella) 
Southern cornstalk borer (Diatraea crambidoides) 
Sugarcane cornstalk borer (Diatraea saccharalis) 
Com earworm (Helicoverpa zea) 
Fall armyworm (SpodopteraJrugiperda) 
Stalk borer (Papaipema nebris) 
Western com rootworm (Diabrotica virgifera virgifera) 
Northern com rootworm (Diabrotica barberi) 
. Mexican com rootworm (Diabrotica virgifera zeae) 
MON 863 x MON 810 is a product of Monsanto's research program offering unique genetic 
characteristics for specific grower needs and may be protected by one or more of the 
following U.S. Patents: 5,023,179,5,110,732,5,352,605,5,424,412, 5,484,956, 5,859,347, 
5,593,874,6,063,597,6,174,724,6,331,665" 6,501,009, 7,064248 and 7,231,056.