United States Office of Prevention,
Environmental Protection Pesticides
Agency and Toxic Substances
(7501P)
Pesticide
Fact Sheet
Name of Plant-Incorported Protectant(s):
Bacillus thuringiemis Cry 1 A.105 protein and the genetic material necessary (vector
PV-ZMIR245) for its production in corn event MON 89034
Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary (vector
PV-ZMIR245) for its production in corn event MON 89034
Bacillus thuringiensis Cry IF protein and the genetic material necessary (vector PHP8999) for its
production in corn event TCI507
Bacillus thuringiensis CrySBbl protein and the genetic material necessary (vector PV-ZMIR39)
for its production in com event MON 88017
Bacillus thuringiensis Cry34Abl protein and the genetic material necessary (vector PHP 17662)
for its production in corn event DAS-59122-7
Bacillus thuringiensis Cry35Abl protein and the genetic material necessary (vector PHP 17662)
for its production in corn event DAS-59122-7
OECD Unique Identifier: MON-89034-3x DAS- 01507-1 xMON-880iv-3x DAs-59i22-7)
Reason for Issuance: Registration
Date Issued: July 29,2009
I. Description of the Plant-Incorporated Protectant
• Pesticide Name: MON 89034 x TC1507 x MON 88017 x DAS-59122-7
• Date Registered: July 20, 2009
• Registration Numbers: 524-581 & 68467-7
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• Trade and Other Names: MON 89034 x TC1507 x MON 88017 x DAS-59122-7
Insect Protected, Herbicide-Tolerant Corn, Genuity™SmartStax™, SmartStax™
• OPP Chemical Codes: 006490, 006481, 006502, 006515, 006514
• Basic Manufacturers: Monsanto Company
800 North Lindbergh Blvd
St. Louis, MO 63167
Mycogen Seeds c/o Dow AgroSciences LLC
9330 Zionsville Road
Indianapolis, Indiana 46268-1054
• Type of Pesticide: Plant-Incorporated Protectant (PIP)
• Uses: Field Corn
• Target Pest(s): European corn borer (ECB)
Southwestern corn borer (SWCB)
Southern cornstalk borer (SCSB)
Corn earworm (CEW)
Fall armyworm (FAW)
Stalk borer
Lesser corn stalk borer
Sugarcane borer (SCB)
Western bean cutworm (WBC)
Black cutworm
Western com rootworm (WCRW)
Northern corn rootworm (NCRW)
Mexican corn rootworm (MCRW)
II. Summary
EPA has conditionally registered MON 89034 x TC1507 x MON 88017 x DAS-59122-7,
"SmartStax,", a new bioengineered corn seed product containing genes for two Bt PIPs active
against corn rootworm (CRW and three Bt PIPs to control different corn borer pests.. After
reviewing all pertinent data, the Agency has concluded that a lower CRW refuge of 5% is
scientifically justified for SmartStax corn and will further reduce the use of conventional
insecticides.
EPA has approved bioengineered "Bt corn" to control corn rootworm (CRW) since 2003. The
use of such Bt corn in the U.S. has reduced conventional insecticide use for CRW by more than
75%.
Bt corn products for CRW could lose their effectiveness due to the development of insect
resistance. To mitigate this risk, EPA currently requires the use of an external structured 20%
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refuge of non-Bt corn. Refuges produce Bt susceptible insects to dilute any resistance genes in
the pest population.
Monsanto and Dow have developed a new Bt corn product (SmartStax) with two Bt toxins
(Cry34Abl/Cry35Abl and CrySBbl) active against CRW. The use of multiple toxins against
the same pest is termed a "pyramid."
SmartStax also contains three Bt PIPs to control different corn borer pests. (Corn borers have
separate refuge requirements.)
EPA has previously approved a 5% refuge for corn borer pests where the corn earworm is not a
significant pest and a 20% combined refuge in cotton growing regions where the corn earworm
is a significant pest. The reduced CRW refuge could result in further reduction in conventional
insecticide use, increased crop yields for growers, and increased grower compliance with refuge
requirements.
EPA has approved a combined 5% refuge for corn rootworm and lepidopteran pests where the
corn earworm is not a significant pest and a 20% combined refuge in cotton growing regions
where the corn earworm is a significant pest.
III. Science Assessment
Product Characterization and Human Health Assessment
Current tolerance exemptions in 40 CFR Part 174 applicable to_MON 89034 x TCI507 x MON
88017 x DAS-59122-7.
§ 174.502 Bacillus thuringiensisCrylA.105 protein; exemption from the requirement of a
tolerance.
(a) Residues of Bacillus thuringiensis Cry 1 A. 105 protein in or on the food and feed
commodities of corn; corn, field, flour; corn, field, forage; corn, field, grain; corn, field,
grits; corn, field, meal; corn, field, refined oil; corn, field, stover; corn, sweet, forage; corn,
sweet, kernel plus cob with husk removed; corn, sweet, stover; corn, pop, grain and corn,
pop, stover are exempt from the requirement of a tolerance when the Bacillus thuringiensis
Cry 1 A. 105 protein is used as a plant-incorporated protectant in these food and feed corn
commodities.
§ 174.506 Bacillus thuringiensis Cry34Abl and CrySSAbl proteins in corn; exemption
from the requirement of a tolerance.
Residues of Bacillus thuringiensis Cry34Abl and Cry35Abl proteins in corn are exempted from
the requirement of a tolerance when used as plant-incorporated protectants in the food and feed
commodities of corn; corn, field; corn, sweet; and corn, pop.
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§ 174.507 Nucleic acids that are part of a plant-incorporated protectant; exemption from
the requirement of a tolerance.
Residues of nucleic acids that are part of a plant-incorporated protectant are exempt from the
requirement of a tolerance.
§ 174.518 Bacillus thuringiensis CrySBbl protein in corn; exemption from the
requirement of a tolerance.
Residues of Bacillus thuringiensis CrySBbl protein in corn are exempt from the requirement of a
tolerance when used as plant-incorporated protectants in the food and feed commodities of corn;
corn, field; corn, sweet; and corn, pop.
§ 174.519 Bacillus thuringiensis Cry2Ab2 protein in corn and cotton; exemption from the
requirement of a tolerance.
Residues of Bacillus thuringiensis Cry2Ab2 protein in or on corn or cotton are exempt from the
requirement of a tolerance when used as a plant-incorporated protectant in the food and feed
commodities of corn; corn, field; corn, sweet; corn, pop; and cotton seed, cotton oil, cotton meal,
cotton hay, cotton hulls, cotton forage, and cotton gin byproducts.
§ 174.520 Bacillus thuringiensis CrylF protein in corn; exemption from the requirement
of a tolerance.
Residues of Bacillus thuringiensis CrylF protein in corn are exempt from the requirement of a
tolerance when used as plant-incorporated protectants in the food and feed commodities of corn;
corn, field; corn, sweet; and corn, pop.
§ 174.523 CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS) synthase in all plants;
exemption from the requirement of a tolerance.
Residues of the CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS) synthase enzyme in all
plants are exempt from the requirement of a tolerance when used as plant-incorporated protectant
inert ingredients in all food commodities^
§ 174.522 Phosphinothricin Acetyltransferase (PAT); exemption from the requirement of
a tolerance.
Residues of the Phosphinothricin Acetyltransferase (PAT) enzyme are exempt from the
requirement of a tolerance when used as plant-incorporated protectant inert ingredients in all
food commodities.
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Southern Blot Analysis
Southern blot analysis confirmed in the combined trait corn product MON 89034 x TCI507 x
MON 88017 x DAS-59122-7 the presence of sequences identical to sequences derived from
MON 89034 and MON 88017.Hybridization patterns for the combined trait product were
identical to those of the parental lines with cry IF, cry34Abl, cry35Abl, and the pat gene probes
indicating that the TC1507 and DAS-59122-7 insertions were unaffected by combining with
MON 89034 and MON 88017 through conventional breeding.
Expression Levels
MON 89034 x TC1507 x MON 88017 x DAS-59122-7 is a combined trait corn that produces
lepidopteran-active and coleopteran-active Bacillus thuringiensis (Bf) proteins, as well as the 5-
enolpyruvylshikimate-3-phosphate synthase protein from Agrobacterium sp. strain CP4 (CP4
EPSPS) to confer tolerance to glyphosate herbicides and PAT to confer tolerance to glufosinate
herbicides. The levels of the lepidopteran-active CrylA.105, Cry2Ab2, CrySBbl proteins and
the CP4 EPSPS protein were determined in tissues from MON 89034 x TCI507 x MON 88017 x
DAS-59122-7 plants grown at five US field sites in 2006. The test also included a conventional
corn as a negative control and MON 89034 and MON 88017 corns as positive controls. Leaf,
root, and whole plant samples were collected over the growing season, as well as pollen and
grain samples at the appropriate times. The samples were extracted and analyzed using enzyme-
linked immunosorbent assays. The levels of the CrylA.105, Cry2Ab2, Cry3Bbl, and CP4
EPSPS proteins in MON 89034 x TC1507 x MON 88017 x DAS-59122-7 corn were comparable
to those in the appropriate MON 88017 or MON 89034 positive control.
The levels of the coleopteran-active Bacillus thuringiensis (Bf) proteins Cry34Abl, Cry35Abl,
and Cry IF, and the PAT protein were determined in tissues from MON 89034 x TCI 507 x MON
88017 x DAS-59122-7 plants grown at five US field sites in 2006. The test also included a
conventional corn as a negative control and TC1507 and DAS-59122-7 parental event corn as
positive controls. Leaf, root, and whole plant samples were collected over the growing season, as
well as pollen and grain samples at the appropriate times. The samples were extracted and
analyzed using enzyme-linked immunosorbent assays (ELISA). The results indicate that the
levels of Cry34Abl, Cry35Abl, and Cry IF in MON 89034 x TCI 507 x MON 88017 x DAS-
59122-7 were comparable to the levels produced in the appropriate TC1507 or DAS-59122-7
control corn. The level of PAT in MON 89034 x TC1507 x MON 88017 x DAS-59122-7 was
higher in the combined trait products compared to TC1507 and DAS-59122-7, likely due to the
presence of multiple copies of the pat gene in the stacks (one from each of the DAS parent lines).
Environmental Assessment
At present, the Agency has not identified any significant adverse effects of the CrylA.105,
Cry2Ab2, Cry IF, CrySBbl, or Cry34Abl/35Abl proteins on the abundance of non-target
organisms in any field population, whether expressed individually or as MON 89034 x TCI507 x
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MON 88017 x DAS-59122-7 combined PIP corn product. The potential for synergistic effects
has been evaluated and the data that were reviewed for the individual parental events can be
bridged to support the Sec. 3 registration of MON 89034 x TCI 507 x MON 88017 x DAS-
59122-7 combined PIP corn product.
It is unlikely that direct or indirect harmful effects to non-target organisms, including federally-
listed threatened or endangered species, would result from the insecticidal proteins Cry 1 A. 105,
Cry2Ab2, Cry IF, CrySBbl, or Cry34/35Ab as a result of the proposed Sec. 3 registration. The
Agency anticipates that for full commercial cultivation, no hazard will result to the environment.
Event MON 89034 produces the CrylA.105 and Cry2Ab2 Bt proteins, and Event TC1507
produces CrylF. These proteins are intended to control or suppress several lepidopteran pests of
corn, including European corn borer (ECB, Ostrinia nubilalis\ corn earworm (CEW,
Helicoverpa zed), fall army worm (FAW, Spodopterafrugiperdd), and black cutworm (BCW,
Agrotis ipsilori). MON 88017 produces the CrySBbl protein, and Event DAS-59122-7 produces
the Cry34Abl and Cry35Abl proteins. These two events provide additional control for
coleopteran pests, particularly corn rootworm pests (Diabrotica spp.).
It has been determined that each individual event has protein expression levels that are
comparable to the MON 89034 x TC1507 x MON 88017 x DAS-59122-7 corn hybrid (Kough,
2009). Therefore, the margins of exposure that were previously determined for the insecticidal
proteins in the individual events are applicable for the risk assessment of these proteins in the
stacked hybrid. Additionally, no synergistic or antagonistic effects were observed in several
combinations of the individual events in MON 89034 x TC1507 x MON 88017 x DAS-59122-7,
as well as the MON 89034 x TC1507 x MON 88017 x DAS-59122-7 hybrid itself. As a result,
the Agency concludes that there is no indication of synergistic effects or increased levels of
protein expressed in the combined PIP product, so the environmental risk assessment for the
single PIP lines are applicable to the assessment of MON 89034 x TCI 507 x MON 88017 x
DAS-59122-7.
As a result, the environmental risk assessment of the individual events, as well as an additional
study submitted on the toxicity of MON 89034 x TC1507 x MON 88017 x DAS-59122-7 to a
non-target insect, the Agency concludes that there will be no unreasonable adverse effects to the
environment, including endangered species, by MON 89034 x TCI507 x MON 88017 x DAS-
59122-7 combined trait corn.
Insect Resistance Management
1) Overall, Monsanto/Dow have provided sufficient scientific justification to support a reduced
corn rootworm (CRW) refuge of 5% for SmartStax Bt corn. Data reviewed by BPPD include
studies on dose for CRW, cross resistance between the CrySBbl and Cry34Abl/35Abl toxins,
and simulation modeling to predict potential resistance evolution. However, BPPD notes that
there is still uncertainty regarding the true CRW dose expressed by SmartStax (and its single trait
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components) and worst case simulation modeling (as described in the conclusions below).
Therefore, additional data have been required to be generated (as described below) to verify and
further buttress the current data supporting lower refuge. BPPD intends to conduct a post-
registration assessment of the lower refuge within several years of approval once any new data
have been submitted and reviewed.
2) Monsanto has previously provided data to support a 5% refuge for lepidopteran target pests of
SmartStax corn.
3) Given that SmartStax will likely have different refuge requirements for Lepidoptera and CRW
than other registered Bt corn products, BPPD has required that Monsanto/Dow submit a revised
compliance plan. This strategy should be specific for SmartStax and the new refuge
requirements. Compliance is an area of ongoing concern — recent data have shown that refuge
compliance for Bt corn has fallen in recent years.
4) Existing programs for resistance monitoring and remedial action that were established for
MON 89034 (CrylA.105 and Cry2Ab2), MON 88017 (CrySBbl), and Herculex Xtra (CrylF
and Cry34Abl/35Abl) should be applicable to SmartStax corn. In light of lower required
structured Bt corn structured refuge for SmartStax, BPPD has required that the CRW resistance
monitoring program be expanded (i.e. with additional sampling and collection sites or improved
monitoring techniques). Also, a revised definition of "resistance" may be needed for the CRW
monitoring and remedial action plans based on recent research and selection experiments (Lefko
et al. 2008; Meihls et al. 2008).
Conclusions Regarding Dose, Resistance Allele Frequency, and Modeling Data
5) BPPD agrees with Monsanto/Dow that the methodology used to calculate dose for SmartStax
(developed in Storer et al. 2006 and used in Hucakaba and Storer 2008) is a reasonable approach
to addressing dose for CRW. There is some conflicting evidence about the effect of density
dependent mortality on dose calculations; BPPD agrees with Monsanto/Dow's use of the data
from the Huckaba and Storer (2008) study that was not adjusted for density dependent effects.
These more conservative dose estimates (96.17 - 99.96% for CrySBbl, 94.20 - 99.18% for
Cry34/35, and 98.22 - 99.97% for CrySBbl + Cry34/35 pyramid) were used in a revised model
simulation.
6) Although Monsanto/Dow have used the best available dose estimates for CRW, BPPD
believes that there is still uncertainty on dose in both the methodology and interpretation of
available studies. This is largely due to the biology of CRW — assessing larval response and
behavior in a subterranean environment is difficult and confounding factors such as density-
dependent (or independent) mortality must be considered. Storer et al. (2006) is probably the
best current approach to evaluating dose, but BPPD notes that limited data have been developed
using this technique (e.g. only one year with six locations of data were developed for CrySBbl).
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Other Diabrotica spp. may also need to be investigated: data previously submitted for northern
corn rootworm revealed mortality as low as 92.8% on Cry34/35 .
7) To address the uncertainty regarding CRW dose and buttress the dose assumptions used in the
models, BPPD has required that Monsanto/Dow provide additional dose data (using the methods
of Storer et al. 2006) for CrySBbl and Cry34Abl/35Abl. Further dose studies could also be
conducted with varying egg infestation levels (above and below egg levels expected to trigger
density-dependent mortality) to tease out any egg density effects. New techniques to assess
CRW dose may need to be pursued as well, if Monsanto/Dow or academic researchers can
develop such approaches.
8) Monsanto/Dow conducted modeling simulations to investigate the effect of initial resistance
allele frequency (RAF). The results from these simulations with a pyramid showed that the
initial RAF was insensitive in the model — the final RAF did not increase significantly from the
initial frequency after 10 generations of selection (regardless of the starting value).
Nevertheless, BPPD is still concerned that resistance alleles for CRW-targeted Bt traits may be
relatively common in the field based on published CRW selection studies (Lefko et al. 2008;
Meihls et al. 2008). Monsanto/Dow's default assumption of an initial RAF of 0.001. This may
be suitable for other pests (e.g. Lepidoptera), but BPPD must consider the possibility that actual
RAF for CRW is higher (perhaps close to 0.01). To further investigate this issue, BPPD
recommends resistance selection experiments to further characterize putative resistance alleles
and frequency of occurrence in CRW populations.
9) As with Monsanto/Dow's previous modeling, revised simulation modeling conducted with the
lower dose estimates (described in #5 above) showed that resistance did not evolve to a pyramid
with a 5% refuge, while single trait PIPs with a 20% refuge developed resistance in < 10
generations. An initial resistance allele frequency of 0.001 was used in the model; as discussed
in #8 above, BPPD is concerned that resistance alleles may be more common among CRW in
natural populations. However, BPPD notes that all modeling reviewed to date, including models
submitted by Monsanto/Dow and published by independent researchers (Roush 1998; Zhao et al.
2003; Gould et al. 2006; Onstad 2009 - draft), strongly suggest that pyramided PIPs are superior
to the current single trait CRW products and can justify a lower refuge for the SmartStax
pyramid.
10) BPPD has required that new model simulations be conducted to incorporate new data (i.e.
from studies conducted under #7 and 8 above) or using possible "worst case" parameters.
Although Monsanto/Dow's new model simulations have been more conservative than previous
runs, BPPD remains concerned that "worst case" scenarios for SmartStax have not yet been fully
investigated. CRW-protected corn is highly adopted in some areas with heavy infestations so
that intense selection pressure for resistance can be expected. In light of this, and the large
proposed reduction in minimum refuge (from 20% to 5%; a 75% total reduction), BPPD believes
that worst case analyses are warranted to help determine the potential for resistance. In
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particular, model parameters for dose and initial resistance allele frequency could be adjusted to
include more conservative estimates (e.g. dose ranges < 94% and RAF > 0.001).
Gould, F., M. B. Cohen, J. S. Bentur, G. C. Kennedy, and J. Van Duyn. 2006. Impact of small
fitness costs on pest adaptation to crop varieties with multiple toxins: a heuristic model. J. Econ.
Entomol. 99: 2091-2099.
Lefko, S.A. et al., 2008. Characterizing laboratory colonies of western corn rootworm
(Coleoptera: Chrysomelidae) selected for survival on maize containing event DAS 59122-7. J.
Appl. Entomol. 132: 189-204.
Meihls, L., M. Hidgon, B. Siegfried, N. Miller, T. Sappington, M. Ellersieck, T. Spencer, and B.
Hibbard, 2008. Increased survival of western corn rootworm on transgenic corn within three
generations of on-plant greenhouse selection. Proc. Nat. Acad. Sci. 105 (49): 19177-19182.
Onstad, D., 2009 (draft). Modeling Evolution ofDiabrotica virgifera virgifera (Coleoptera:
Chrysomelidae) to Transgenic Corn with Two Insecticidal Traits. J. Econ Entomol. Draft - to be
submitted in 2009.
Roush, R.T., 1998. Two toxin strategies for management of insecticidal transgenic crops:
pyramiding succeed where pesticide mixtures have not? Phil. Trans. R. Soc. Lond. 353:1777-
1786.
Zhao, J., J. Cao, Y. Li, H. Collins, R. Roush, E. Earle, and A. Shelton, 2003. Transgenic plants
expressing two Bacillus thuringiensis toxins delay insect resistance evolution. Nature
Biotechnology. 21: 1493-1497.
IV. Terms and Conditions of the Registration
1) The subject registration will automatically expire on midnight November 30, 2011.
2) The subject registration will be limited to MON 89034 x TCI507 x MON 88017 x DAS-
59122-7 in field corn.
3) Submit the following data in the time frames listed:
OPPTS Guideline/
Study Type
Required Data
Due Date
Insect Resistance
Management
To address the uncertainty regarding CRW dose and
buttress the dose assumptions used in the models, provide
additional dose data (using the methods of Storer et al.
2006) for CrySBbl and Cry34Abl/35Abl. Further dose
studies could also be conducted with varying egg infestation
Report Due
11/30/2010
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OPPTS Guideline/
Study Type
Required Data
Due Date
levels (above and below egg levels expected to trigger
density-dependent mortality) to tease out any egg density
effects. New techniques to assess CRW dose may need to
be pursued as well, if Monsanto/Dow or academic
researchers can develop such approaches.
Insect Resistance
Management
Monsanto/Dow conducted modeling simulations to
investigate the effect of initial resistance allele frequency
(RAF). The results from these simulations with a pyramid
showed that the initial RAF was insensitive in the model —
the final RAF did not increase significantly from the initial
frequency after 10 generations of selection (regardless of
the starting value). Nevertheless, BPPD is still concerned
that resistance alleles for CRW-targeted Bt traits may be
relatively common in the field based on published CRW
selection studies (Lefko et al. 2008; Meihls et al. 2008).
Monsanto/Dow's modeling has assumed an initial RAF of
0.001. This may be suitable for other pests (e.g.
lepidoptera), but BPPD must consider the possibility that
actual RAF for CRW is higher (perhaps close to 0.01). To
further investigate this issue, resistance selection
experiments must be conducted to further characterize the
potential for resistance alleles and frequency of occurrence
in CRW populations.
Annually
First Report
Due 11/30/2010
Insect Resistance
Management
New model simulations must be conducted to incorporate
new data (i.e. from studies conducted under items above) or
using possible "worst case" parameters. Although
Monsanto/Dow's new model simulations have been more
conservative than previous runs, BPPD remains concerned
that "worst case" scenarios for SmartStax have not yet been
fully investigated. CRW-protected corn is highly adopted
in some areas with heavy infestations so that intense
selection pressure for resistance can be expected. In light of
this, and the large proposed reduction in refuge (from 20%
to 5%; a 75% total reduction), BPPD believes that worst
case analyses are warranted to help determine the potential
for resistance. In particular, model parameters for dose and
initial resistance allele frequency could be adjusted to
include more conservative estimates (e.g. dose ranges <
94% and RAF > 0.001).
Annually
First Report
Due 11/30/2010
10
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4) Submit or cite all data required to support the Herculex Xtra and the MON 89034 x MON
88017 stacked plant-incorporated protectant products within the timeframes required by the
terms and conditions of EPA Registration Numbers 68467-6 and 524-576.
5) Do the following Insect Resistance Management Program for MON 89034 x TCI507 x MON
88017 xDAS-59122-7.
The required IRM program for MON 89034 x TC1507 x MON 88017 x DAS-59122-7 corn must
have the following elements:
Requirements relating to creation of a non-Bt corn refuge in conjunction with the planting of any
acreage of MON 89034 x TC1507 x MON 88017 x DAS-59122-7corn;
Requirements for Monsanto/Dow to prepare and require MON 89034 x TCI507 x MON 88017 x
DAS-59122-7 corn users to sign "grower agreements," which impose binding contractual
obligations on the grower to comply with the refuge requirements;
Requirements regarding programs to educate growers about IRM requirements;
Requirements regarding programs to evaluate and promote growers' compliance with IRM
requirements;
Requirements regarding programs to evaluate whether there are statistically significant and
biologically relevant changes in target insect susceptibility to CrylA.105, Cry2Ab2, CrySBbl,
Cry IF and Cry34Abl/Cry35Abl proteins in the target insects;
Requirements regarding a "remedial action plan," which contains measures Monsanto/Dow
would take in the event that any field-relevant insect resistance was detected as well as to report
on activity under the plan to EPA;
Annual reports on units sold by state (units sold by county level will be made available to the
Agency upon request), IRM grower agreements results, and the compliance assurance program
including the educational program on or before January 31 st each year, beginning in 2011.
a) Refuge Requirements for MON 89034 x TC1507 x MON 88017 x DAS-59122-7
These refuge requirements do not apply to seed propagation of inbred and hybrid corn seed 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. 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.
A common refuge must be planted for both corn borers and corn rootworms. The refuge must be
planted with corn hybrids that do not contain Bt technologies for the control of corn rootworms
or corn borers. The refuge and MON 89034 x TC1507 x MON 88017 x DAS-59122-7 corn
should be sown on the same day, or with the shortest window possible between planting dates to
ensure that corn root development is similar among varieties. If the refuge is planted on rotated
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ground, then the MON 89034 x TC1507 x MON88017 x DAS-59122-7 corn must also be
planted on rotated ground. If the combined refuge is planted on continuous corn, the MON
89034 x TC1507 x MON88017 x DAS-59122-7field may be planted on either continuous or
rotated land (option encouraged where WCRW rotation resistant biotype may be present).
Refuge options are based on the planting of MON 89034 x TCI 507 x MON 88017 x DAS-
59122-7 in cotton or non-cotton growing regions and the insect pressure present in those
locations. The refuge sizes for these regions are either 20% in cotton growing regions (i.e. 20
acres of non-Bt corn for every 80 acres MON 89034 x TC1507 x MON 88017 x DAS-59122-7
planted) or 5% in non-cotton growing regions (5 acres of non-Bt corn for every 95 acres of MON
89034 x TC1507 x MON 88017 x DAS-59122-7 planted). If corn rootworms are significant
within a region, the structured refuge must be planted as an in-field or adjacent refuge using corn
hybrids that do not contain Bt technologies for the control of corn borers or corn rootworms. It
can be planted as a block within or adjacent (e.g., across the road) to the MON 89034 x TC1507
x MON 88017 x DAS-59122-7, perimeter strips (i.e., strips around the field), or in-field strips. If
perimeter or in-field strips are implemented, the strips must be at least 4 consecutive rows wide.
The refuge can be protected from lepidopteran damage by use of non-Bt insecticides if the
population of one or more target lepidopteran pests of MON 89034 x TCI 507 x MON 88017 x
DAS-59122-7 in the refuge exceeds economic thresholds. In addition, the refuge can be
protected from CRW damage by an appropriate seed treatment or soil insecticide; however,
insecticides labeled for adult CRW control must be avoided in the refuge during the period of
CRW adult emergence. If insecticides are applied to the refuge for control of CRW adults, the
same treatment must also be applied in the same timeframe to MON 89034 x TCI507 x MON
88017 x DAS-59122-7. Economic thresholds will be determined using methods recommended
by local or regional professionals (e.g., Extension Service agents, crop consultants). If corn
rootworms are not significant within a region, the structured refuge may be planted as an in-field
or adjacent refuge or as a separate block that is within 1/2 mile of the MON 89034 x TC1507 x
MON 88017 x DAS-59122-7 field. The structured refuge must be planted with corn hybrids that
do not contain Bt technologies for the control of corn borers or corn rootworms. Economic
thresholds will be determined using methods recommended by local or regional professionals
(e.g., Extension Service agents, crop consultants).
Region
Cotton growing where CEW is a
significant pest and WCRW, NCRW and
MCRW are not significant: AR, NC,
SC,GA, FL, TN (only the counties of
Carroll, Chester, Crockett, Dyer, Fayette,
Franklin, Gibson, Hardeman, Hardin,
Haywood, Lake, Lauderdale, Lincoln,
Refuge size
20% non-
Bt corn
In-field or
adjacent
refuge is
allowed
Yes
Refuge separated
by up to 1/2 mile is
allowed
Yes
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Region
Madison, Obion, Rutherford, Shelby, and
Tipton) AL, MS, LA, VA (only the
counties of Dinwiddie, Franklin City,
Greensville, Isle of Wight, Northampton,
Southampton, Suffolk City, Surrey, and
Sussex)
Cotton growing where CEW is a
significant pest and WCRW,
NCRW, and/or MCRW are significant:
TX (except the counties of Carson,
Dallam, Hansford, Hartley, Hutchinson,
Lipscomb, Moore, Ochiltree, Roberts, and
Sherman), OK (only the counties of
Beckham, Caddo, Comanche, Custer,
Greer, Harmon, Jackson, Kay, Kiowa,
Tillman, and Washita), MO (only the
counties of Dunkin, New Madrid,
Pemiscot, Scott, and Stoddard).
Cotton growing where CEW is not a
significant pest and WCRW, NCRW
and MCRW are not significant: NM,
AZ, CA, NV
Non-cotton growing where WCRW,
NCRW and MCRW are not significant
OR, WA, ID, MT, WY, UT, VA (except
the counties of Dinwiddie, Franklin City,
Greensville, Isle of Wight, Northampton,
Southampton, Suffolk City, Surrey, and
Sussex), WV, PA, MD, DE, CT, RI, NJ,
NY, ME, MA, NH, VT, HI, AK,
TN(except the counties of Carroll,
Chester, Crockett, Dyer, Fayette, Franklin,
Gibson, Hardeman, Hardin, Hay wood,
Lake, Lauderdale, Lincoln, Madison,
Obion, Rutherford, Shelby, and Tipton)
Non-cotton growing where WCRW,
NCRW and/or MCRW are significant:
KS, NE, SD, ND, MN, IA, MO (except
Refuge size
20% non-
Bt corn
5% non-Bt
corn
5% non-Bt
corn
5% non-Bt
corn
In-field or
adjacent
refuge is
allowed
Yes
Yes
Yes
Yes
Refuge separated
by up to 1/2 mile is
allowed
No
Yes
Yes
No
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Region
Refuge size
In-field or
adjacent
refuge is
allowed
Refuge separated
by up to 1/2 mile is
allowed
the counties of Dunkin, New Madrid,
Pemiscot, Scott, and Stoddard), IL, WI,
MI, IN, OH, KY, CO, OK (except the
counties of Beckham, Caddo, Comanche,
Custer, Greer, Harmon, Jackson, Kay,
Kiowa, Tillman, and Washita), TX (only
the counties of Carson, Dallam, Hansford,
Hartley, Hutchinson, Lipscomb, Moore,
Ochiltree, Roberts, and Sherman)
b) Grower Agreement for MON 89034x TC1507x MON 88017x DAS-59122-7 Corn
1) Persons purchasing MON 89034 x TC1507 x MON 88017 x DAS-59122-7 corn 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) Monsanto and Dow must implement a system (equivalent to what is already approved for
previously registered Monsanto and Dow Bt corn products), which is reasonably likely to assure
that persons purchasing MON 89034 x TC1507 x MON 88017 x DAS-59122-7 corn will affirm
annually that they are contractually bound to comply with the requirements of the IRM program.
A description of the system must be submitted to EPA within 90 days from the date of
registration.
4) Monsanto and Dow must use a grower agreement and must 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 and Dow wishe 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, 30 days prior to implementing a
proposed change, Monsanto and Dow must submit to EPA the text of such changes to ensure that
it is consistent with the terms and conditions of this registration.
5) Monsanto and Dow must implement a system (equivalent to what is already approved for
previously registered Monsanto and Dow Bt corn products), which is reasonably likely to assure
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that persons purchasing MON 89034 x TC1507 x MON 88017 x DAS-59122-7 corn sign grower
agreement(s). A description of the system must be submitted to EPA within 90 days from the
date of registration.
6) Monsanto and Dow shall maintain records of all MON 89034 x TC1507x MON 88017 x
DAS-59122-7 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, 2011 and annually thereafter, Monsanto and Dow shall provide
EPA with a report on the number of units of MON 89034 x TCI 507 x MON 88017 x DAS-
59122-7 corn seed 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 a twelve-
month period. Note: The first report shall contain the specified information from the time frame
starting with the date of registration and extending through the 2010 growing season.
8) Monsanto and Dow 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 confidential business information, including names, personal information, and grower
license number, will be protected.
c) IRM Education and IRM Compliance Monitoring Program for MON 89034 x TCI507x
MON 88017 x DAS-59122- 7Corn
1) Monsanto and Dow must design and implement a comprehensive, ongoing IRM education
program designed to convey to MON 89034 x TC1507 x MON 88017 x DAS-59122-7 corn
users the importance of complying with the IRM program. 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
their records. The program shall involve at least one written communication annually to each
MON 89034 x TC1507 x MON 88017 x DAS-59122-7 corn user separate from the grower
technical guide. The communication shall inform the user of the current IRM requirements.
Monsanto and Dow shall coordinate its education program with the educational efforts of other
registrants and other organizations, such as the National Corn Growers Association and state
extension programs.
2) Annually, Monsanto/Dow shall revise, and expand as necessary, its education program to
take into account the information collected through the compliance survey and from other
sources. The changes shall address aspects of grower compliance that are not sufficiently high.
3) Beginning January 31, 2011, Monsanto and Dow must provide a report to EPA summarizing
the activities it carried out under its education program for the prior year. Annually thereafter,
Monsanto and Dow must provide EPA any substantive changes to its grower education activities
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as part of the overall IRM compliance assurance program report. Monsanto/Dow must either
submit a separate report or contribute to the report from the industry working group, Agricultural
Biotechnology Stewardship Technical Committee (ABSTC).
4) Given that MON 89034 x TC1507 x MON 88017 x DAS-59122-7 will likely have different
refuge strategies for lepidoptera and CRW than other registered Bt corn products,
Monsanto/Dow must submit a revised compliance assurance program (CAP) within 90 days of
the date of registration. This revised CAP must be found acceptable by BPPD by April 1, 2010.
This strategy should be specific for MON 89034 x TC1507 x MON 88017 x DAS-59122-7 and
the new refuge requirements. Availability of non-Bt corn refuge seeds in desirable varieties
must be addressed. Compliance is an area of ongoing concern — recent data have shown that
refuge compliance for Bt corn has fallen in recent years.
d) Insect Resistance Monitoring and Remedial Action Plans for MON 89034 x TC1507x
MON 88017 x DAS-59122- 7 Corn
Existing programs for resistance monitoring and remedial action that were established for MON
89034 (CrylA.105 and Cry2Ab2), MON 88017 (Cry3Bbl), and Herculex Xtra (CrylF and
Cry34Abl/35Abl) should be applicable to MON 89034 x TC1507 x MON 88017 x DAS-59122-
7 corn. In light of potentially lower overall structured Bt corn structured refuge, the CRW
resistance monitoring program must be expanded (i.e. with additional sampling and collection
sites or improved monitoring techniques). Also, a revised definition of "resistance" may be
needed for the CRW monitoring and remedial action plans based on recent research and selection
experiments (Lefko et al. 2008; Meihls et al. 2008). Monsanto/Dow must submit a revised
resistance monitoring and remedial action plan within 90 days of the date of registration that
must be found acceptable to BPPD by April 1, 2010.
A report on results of resistance monitoring and investigations of damage reports must be
submitted to the Agency annually by August 31st each year, beginning in 2011, for the duration
of the conditional registration.
e) Annual Reporting Requirements for MON 89034 x TCI507x MON 88017x DAS-59122-7
Corn
1) Annual Sales: reported and summed by state (county level data available by request)
January 31st each year, beginning in 2011;
2) Grower Agreements: number of units of MON 89034 x TCI 507 x MON 88017 x DAS-
59122-7corn seed shipped or sold and not returned, and the number of such units that were sold
to persons who have signed grower agreements, January 31st each year, beginning in 2011;
3) Grower Education: substantive changes to education program completed previous
year, January 31st each year, beginning in 2011;
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4) Compliance Assurance Program: compliance assurance program activities and results for the
prior year and plans for the compliance assurance program for the current year,
January 31 st each year, beginning in 2011;
5) Compliance Survey Results: results of annual surveys for the prior year and survey
plans for the current year; full report January 31st each year, beginning in 2011;
6) Insect Resistance Monitoring Results: results of monitoring and investigations of
damage reports, August 31st each year, beginning in 2011.
V. Contact Person at EPA
Mike Mendelsohn
Senior Regulatory Specialist
Biopesticides and Pollution Prevention Division (751 IP)
Office of Pesticide Programs
Environmental Protection Agency
1200 Pennsylvania Avenue NW
Washington, D. C. 20460
Office location and telephone number:
8th Floor
One Potomac Yard
2777 S, Crystal Drive
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.
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