Terms and Conditions for 

Bt Corn Registrations

30 September 2010

Table of Contents

I. Cry 1Ab and Cry 1F BRAD Registered Products (pp.1-84)

a. Reg. # 67979-1 Bt Corn Event Bt11 with Cry 1Ab (Field Corn)

b. Reg. # 65268-1 Bt Corn Event Bt11 with Cry 1Ab (Sweet Corn)

c. Reg. # 524-489 Bt Corn Event MON 810 Cry1Ab

d. Reg. # 68467-2 Bt Corn Event TC1507 with PO Cry 1F

e. Reg. # 29964-3 Bt Corn Event TC1507 with PO Cry 1F

f. Reg. # 68467-4 Bt Corn Event DAS-06275-8 with MOCry1F

g. Reg. # 29964-7 1507 (POCry1F) x MON 810 (Cry1Ab)

II. Cry 3Bb1 BRAD Registered Products (pp.85-105)

a. Reg. # 524-528 Bt Corn Event MON 863 with Cry3Bb1

b. Reg. # 524-545 Bt Corn Stack Events MON 863 + MON 810 with Cry3Bb1 + 

Cry1Ab

c. Reg. # 524-551 Bt Corn Event MON 88017 with Cry3Bb1

d. Reg. # 524-552 Bt Corn Event MON 88017 + MON 810 with Cry 1Ab + Cry 

3Bb1

III. Cry 34Ab1/Cry35Ab1 BRAD Registered Products (pp.106-190)

a. Reg. # 68467-5 Bt Corn Event DAS-59122-7 with Cry34Ab1/Cry35Ab1

b. Reg. # 29964-4 Bt Corn Event DAS-59122-7 with Cry34Ab1/Cry35Ab1

c. Reg. # 68467-6 Bt Corn Event DAS-59122-7 + TC1507 with 

Cry34Ab1/Cry35Ab1 + PO Cry1F

d. Reg. # 29964-5 Bt Corn Event DAS-59122-7 + TC1507 with 

Cry34Ab1/Cry35Ab1 + PO Cry1F

e. Reg. # 29964-8 TC1507 (PO Cry1F) x DAS-59122 (PO Cry34Ab1/Cry35Ab1) x 

MON 810 (Cry 1Ab)

f. Reg. # 29964-9 DAS-59122 (Cry34Ab1/Cry35Ab1) x MON 810 (Cry1Ab)

IV. mCry3A BRAD Registered Products (pp.191-212)

a. Reg. # 67979-5 Bt Corn Event MIR 604 with modified Cry 3A

b. Reg. # 67979-8 Bt Corn Events MIR 604 + Bt11 with modified Cry3A + Cry1Ab

V. MON89034 BRAD Registered Products (pp.213-240)

a. Reg. # 524-575 Bt Corn Event MON 89034 with Cry 1A.105 + CryAb2

b. Reg. # 524-576 Bt Corn Events MON 89034 + 88017 with Cry1A.105 + Cry2Ab2 

+ Cry 3Bb1

VI. OAM BRAD Registered Products (pp.241-263)

a. Reg. # 29964-6 Optimum AcreMax 1 Seed Blend of Hercules Xtra + Herculex I

b. Reg. # 29964-10 Optimum AcreMax RW Seed Blend of Herculex RW + Non-Bt

corn
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I. Cry 1Ab and Cry 1F BRAD Registered Products

Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Syngenta 67979-1

Bt corn Event 

Bt11 with Cry1Ab 

(AgriSure CB/LL; 

field corn)

August 1996 Unconditional, Time-Limited

(converted 29 September 2010)

30 September 

2015

1] The subject registration will automatically expire on midnight September 30, 2015.

2] The subject registration will be limited to Bacillus thuringiensis corn Event Bt 11 with Cry 

1Ab for use in field corn.

3] This plant-incorporated protectant may be combined through conventional breeding with other 

registered plant-incorporated protectants that are similarly approved for use in combination, 

through conventional breeding, with other registered plant-incorporated protectants to produce 

inbred corn lines and hybrid corn varieties with combined pesticidal traits.

4] You must do the following Insect Resistance Management Program:

Insect Resistance Management:

The required IRM program for Bt corn must have the following elements:

1] Requirements relating to creation of a non-Bt corn and/or non-lepidopteran resistant Bt corn 

refuge in conjunction with the planting of any acreage of Bt corn;

2] Requirements for Syngenta Seeds, Inc. (Syngenta) to prepare and require Bt corn users to sign 

“grower agreements” that impose binding contractual obligations on the grower to comply with 

the refuge requirements;

3] Requirements regarding programs to educate growers about IRM requirements;

4] Requirements regarding programs to evaluate and promote growers’ compliance with IRM 

requirements;

5] Requirements regarding programs to evaluate whether there are statistically significant and 

biologically relevant changes in target insect susceptibility to Cry1Ab protein in the target 

insects; 

6] Requirements regarding a “remedial action plan” that contains measures Syngenta 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;

7] Submit 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 education program on or before January 31st each year. 
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a. Refuge Requirements 

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.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt

corn products, additional educational material and assistance are provided by Syngenta to help 

these growers meet the refuge requirements across their farming operations.

1] Corn-Belt Refuge Requirements 

Field corn grown outside cotton-growing areas (e.g., the Corn Belt), grower agreements (also 

known as stewardship agreements) will specify that growers must adhere to the refuge 

requirements as described in the grower guide/product use guide and/or in supplements to the 

grower guide/product use guide. 

· Specifically, growers must plant a structured refuge of at least 20% non-Bt corn and/or 

non-lepidopteran resistant Bt corn that may be treated with insecticides as needed to 

control lepidopteran stalk-boring and other pests.

 

· Refuge planting options include: separate fields, blocks within fields (e.g., along the 

edges or headlands), and strips across the field. 

· External refuges must be planted within 1⁄2 mile.

· When planting the refuge in strips across the field, refuges must be at least 4 rows wide. 

 

· Insecticide treatments for control of ECB, CEW, Southwestern corn borer (SWCB) and 

other lepidopteran target pests listed on the label, grower guides, or other educational 

material may be applied only if economic thresholds are reached for one or more of these 

target pests. Economic thresholds will be determined using methods recommended by 

local or regional professionals (e.g., Extension Service agents, crop consultants). 

Instructions to growers will specify that microbial Bt insecticides must not be applied to 

non-Bt corn and/or non-lepidopteran resistant Bt corn refuges. 

2] Cotton-Growing Area Refuge Requirements for Bt Corn 

For Bt field corn grown in cotton-growing areas, grower agreements (also known as stewardship 

agreements) will specify that growers must adhere to the refuge requirements as described in the 

grower guide/product use guide and/or in supplements to the grower guide/product use guide. 

· Specifically, growers in these areas must plant a structured refuge of at least 50% non-Bt

corn and/or non-lepidopteran resistant Bt corn that may be treated with insecticides as 

needed to control lepidopteran stalk-boring and other pests.

· Refuge planting options include: separate fields, blocks within fields (e.g., along the 
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edges or headlands), and strips across the field. 

· External refuges must be planted within 1⁄2 mile.

· When planting the refuge in strips across the field, refuges must be at least 4 rows wide. 

· Insecticide treatments for control of ECB, CEW, Southwestern corn borer (SWCB), and 

other lepidopteran target pests listed on the label, grower guides, or other educational 

material may be applied only if economic thresholds are reached for one or more of these 

target pests. Economic thresholds will be determined using methods recommended by 

local or regional professionals (e.g., Extension Service agents, crop consultants). 

Instructions to growers will specify that microbial Bt insecticides must not be applied to 

non-Bt corn and/or non-lepidopteran resistant Bt corn refuges.

· Cotton-growing areas include the following states: Alabama, Arkansas, Georgia, Florida, 

Louisiana, North Carolina, Mississippi, South Carolina, Oklahoma (only the counties of 

Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, 

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, Sussex) and Missouri (only the 

counties of Dunklin, New Madrid, Pemiscot, Scott, Stoddard). 

b. Grower Agreements

1] Persons purchasing the Bt corn 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] Syngenta must continue to integrate this amended registration into the current system used for 

its other Bt corn plant-incorporated-protectants, which is reasonably likely to assure that persons 

purchasing Bt11 Insect Protected Field Corn will affirm annually that they are contractually 

bound to comply with the requirements of the IRM program. 

4] Syngenta must continue to use its current grower agreement for Bt11 Insect Protected Field 

Corn. If Syngenta 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 (30) days prior to implementing a proposed change, Syngenta must submit to 

EPA the text of such changes to ensure that it is consistent with the terms and conditions of this 

amended registration.
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5] Syngenta must continue to integrate this amended registration into the current system used for 

its other Bt corn plant-incorporated-protectants, which is reasonably likely to assure that persons 

purchasing Bt11 Insect Protected Field Corn sign grower agreement(s). 

6] Syngenta shall maintain records of all Bt corn grower agreements for a period of three years 

from December 31 of the year in which the agreement was signed.

7] Syngenta shall provide EPA with a report showing the number of units of its Bt 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] Syngenta 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 Programs

1] Syngenta must continue to implement and enhance (as set forth in paragraph 17 of this 

section) a comprehensive, ongoing IRM education program designed to convey to Bt11 Insect 

Protected Field Corn users the importance of complying with the IRM program. The program 

shall include information encouraging Bt11 Insect Protected Field Corn users to pursue optional 

elements of the IRM program relating to refuge configuration and proximity to Bt11 Insect 

Protected Field 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 Bt11 Insect Protected Field 

Corn user separate from the grower technical guide. The communication shall inform the user of 

the current IRM requirements. Syngenta shall coordinate its education programs with 

educational efforts of other registrants and organizations, such as the National Corn Growers 

Association and state extension programs. 

2] Annually, Syngenta shall revise, and expand as necessary, its education program to take into 

account the information collected through the compliance survey required and from other 

sources. The changes shall address aspects of grower compliance that are not sufficiently high. 

3] Annually, each January 31st, Syngenta must provide EPA any substantive changes to its 

grower education activities as part of the overall IRM compliance assurance program report. 

Syngenta must either submit a separate report or contribute to the report from the industry 

working group (ABSTC). 

4] Syngenta must continue to implement and improve an ongoing IRM compliance assurance 

program designed to evaluate the extent to which growers purchasing Bt11 Insect Protected Field 

Corn 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 Syngenta corn PIP products. Syngenta shall coordinate with other Bt corn 
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registrants in improving its compliance assurance program and continue to integrate this 

amended registration into the current compliance assurance program used for its other Bt corn 

plant-incorporated protectants. Other required features of the program are described in 

paragraphs 5–22.

5] Syngenta must establish and publicize a “phased compliance approach,” i.e., a guidance 

document that indicates how it will address instances of non-compliance with the terms of the 

IRM program and general criteria for choosing among options for responding to any noncompliant growers after the first year of noncompliance. While recognizing that for reasons of 

difference in business practices there are needs for flexibility between different companies, 

Syngenta must use a consistent set of standards for responding to non-compliance. An 

individual grower found to be significantly out of compliance two years in a row would be 

denied access to Syngenta corn PIP products the next year. Additionally, seed dealers who are 

not fulfilling their obligations to inform/educate growers of their IRM obligations will lose their 

opportunity to sell Bt11 Insect Protected Field Corn.

6] The IRM compliance assurance program shall include an annual survey conducted by an 

independent third party of a statistically representative sample of growers of Bt corn borer 

protected products who plant the vast majority of all corn in the U.S. and in areas in which the 

selection intensity is greatest The survey shall consider only those growers who plant 200 or 

more acres of corn in the Corn-Belt and who plant 100 or more acres of corn in corn-cotton 

areas. 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.

i. A third party is classified as a party other than Syngenta, the grower, or anyone else 

with a direct interest in IRM compliance for Bt corn.

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] Syngenta shall provide a 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 31st of each year. Syngenta shall confer with other registrants and EPA on the design 

and content of the survey prior to its implementation.

10] Annually, Syngenta shall revise, and expand as necessary, its compliance assurance 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. 

Syngenta must confer with the Agency prior to adopting any changes.
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11] Syngenta shall conduct an annual on-farm assessment program. Syngenta shall train its 

representatives who make on-farm visits with growers of their Bt corn borer protected products 

to perform assessments of compliance with IRM requirements. There is no minimum corn 

acreage size for this program. Therefore, growers will be selected for this program from across 

all farm sizes. In the event that any of these visits result in the identification of a grower who is 

not in compliance with the IRM program, Syngenta shall take appropriate action, consistent with 

its "phased compliance approach," to promote compliance.

12] Syngenta 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, Syngenta shall take 

appropriate action, consistent with its “phased compliance approach.”

13] If a grower, who purchases Bt corn for planting, was specifically identified as not being in 

compliance during the previous year, Syngenta shall visit with the grower and evaluate whether 

that the grower is in compliance with the IRM program for the current year. 

14] Each registrant shall annually 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. Within one month of submitting this report to EPA, 

the registrant shall meet with EPA to discuss its findings. 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. The report must inform EPA of 

the number of growers deemed ineligible to purchase Bt corn seed on the basis of continued noncompliance with the insect resistance management refuge requirements. Syngenta may elect to 

coordinate information with other registrants and report collectively the results of their 

compliance assurance programs. 

15] Syngenta and the seed corn dealers for Syngenta 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. 

16] Syngenta shall revise and expand its existing Compliance Assurance Program to include the 

following elements. Syngenta must prepare and submit on or before January 31, 2011, a written 

description of its revised Compliance Assurance Program. Syngenta may coordinate with other 

registrants in designing and implementing its Compliance Assurance Program. 

17] Syngenta will enhance the refuge education program throughout the seed delivery channel: 

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the 

importance of correct refuge implementation and potential consequences of failure to 

plant the required refuge; 

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. The PIP 

product label accepted by EPA must include how this information will be conveyed 

to growers via text and graphics. This requirement may be phased in over the next 
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three growing seasons. Revised PIP product labels must be submitted by January 31, 

2011, 50% implementation on the Bt corn seed bags or bag tags must occur by the 

2012 growing season, and full implementation must occur by the 2013 growing 

season. 

18] Syngenta will focus the majority of on-farm assessments on regions with the greatest risks 

for resistance: 

i. Use Bt corn adoption, pest pressure information, and other available information to 

identify regions where the risk of resistance is greatest; 

ii. Focus approximately two-thirds of on-farm assessments on these regions, with the 

remaining assessments conducted across other regions where the product is used. 

19] Syngenta will use its available Bt sales records and other information to refine grower lists 

for on-farm assessments of their compliance with refuge requirements: 

i. Identify for potential on-farm assessment growers whose sales information indicates 

they have purchased the Bt corn product but may have purchased little or no refuge 

seed from Syngenta, licensee, or affiliated company. 

20] Syngenta will contract with third parties to perform on-farm assessments of compliance with 

refuge requirements: 

i. The third-party assessors will conduct all first-time on-farm assessments as well as 

second-year on-farm assessments of those growers found out of compliance in a firsttime assessment 

21] Syngenta will annually refine the on-farm assessment program for the Bt corn product to 

reflect the adoption rate and level of refuge compliance for the product. 

22] Syngenta will follow up with growers who have been found significantly out of compliance 

under the on-farm assessment program and are found to be back in compliance the following 

year: 

i. All growers found to be significantly out of compliance in a prior year will annually 

be sent additional refuge assistance information for a minimum of 2 years by 

Syngenta, a seed supplier, or a third-party assessor, after completing the assessment 

process.

ii. Syngenta will conduct follow-up checks on growers found to be significantly out of 

compliance within 3 years after they are found to be back in compliance. 

iii. A grower found with a second incident of significant non-compliance with refuge 

requirements for Bt11 Insect Protected Field Corn within a 5-year period will be 

denied access to Syngenta corn PIP products in the subsequent year.
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d. Insect Resistance Monitoring and Remedial Action Plan 

The Agency is imposing the following conditions for the Cry1Ab toxin expressed in this product: 

Syngenta will monitor for resistance to its lepidopteran-resistant Bt corn. The monitoring 

program shall consist of two approaches: (1) focused population sampling and laboratory testing; 

and (2) investigation of reports of less-than expected control of labeled insects. Should fieldrelevant resistance be confirmed, an appropriate resistance management action plan will be 

implemented.

(1) Focused Population Sampling

Syngenta 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 of Bt 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 of lepidopteran-resistant Bt corn. 

The Agency shall be consulted prior to the implementation of such modifications.

Syngenta 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 
9

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 survive the 

diagnostic concentration will be tested using methods that are representative of exposure to Bt

corn 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. If insects 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;

determining 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;

determining 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, Syngenta 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:

Syngenta will follow up on grower, extension specialist or consultant reports of unexpected 

levels of damage by the lepidopteran pests listed on the pesticide label. Syngenta will instruct its 

customers to contact them if such incidents occur. Syngenta 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), Syngenta will implement the actions described below, 

based on the following definitions of suspected resistance and confirmed resistance.

Suspected resistance
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EPA defines suspected resistance to mean field reports of unexpected levels of insect feeding 

damage for which:

the corn in question has been confirmed to be lepidopteran-active Bt corn;

the seed used had the proper percentage of corn expressing Bt protein;

the relevant plant tissues 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 confirm scientifically the presence of 

insects resistant to Bt corn in commercial production fields before responsive measures are 

undertaken.

If resistance is suspected, Syngenta will instruct growers to do the following:

Use alternative control measures in the Bt corn fields in the affected region to control the 

target pest during the immediate growing season.

Destroy Bt corn 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 over-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, Syngenta 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 corn 

hybrids under field conditions (ECB and SWCB only). 

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.
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In standardized laboratory bioassays, the LC50 exceeds the upper limit of the 95% 

confidence interval of the LC50 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 

Syngenta: 

EPA will receive notification within 30 days of resistance confirmation; 

Affected customers and extension agents will be notified about confirmed resistance 

within 30 days; 

Monitoring will be increased in the affected area and local target pest populations will be 

sampled annually to determine 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 corn hybrids in the affected area immediately until an effective 

local mitigation plan approved by EPA has been implemented; 

Syngenta will develop a case-specific resistance management action plan within 90 days 

according to the characteristics of the resistance event and local agronomic needs. 

Syngenta 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 

In subsequent growing seasons, maintain sales suspension and alternative resistance 

management strategies in the affected region(s) for the Bt corn hybrids that are affected 

by the resistant population until an EPA-approved local resistance management plan is in 

place to mitigate the resistance.
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A report on results of resistance monitoring and investigations of damage reports must be 

submitted to the Agency annually by August 31st each year for the duration of the conditional 

registration. 

e. Annual Reports

1] Annual Sales: reported and summed by state (county level data available by request), January 

31st each year; 

2] 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 31st 

each year;

3] Grower Education: substantive changes to education program completed the previous year, 

January 31st each year;

4] Compliance Assurance Plan: Compliance Assurance Program activities and results, January 

31st each year; 

5] Compliance: to include annual survey results and plans for the next year; full report January 

31st each year; 

6] Insect Resistance Monitoring Results: results of monitoring and investigations of damage 

reports, August 31st each year.
13

Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Syngenta 65268-1

Bt corn Event Bt11 

with Cry1Ab 

(Attribute; sweet 

corn, no refuge)

February 

1998

Conditional

(amended 29 September 2010)

30 September 

2015

1] The subject registration will automatically expire on midnight September 30, 2015.

2] The subject registration will be limited to Bacillus thuringiensis corn Event Bt 11 with Cry 

1Ab for use in sweet corn.

3] Submit/cite all data required for registration of your product under FIFRA § 3(c)(5) when the 

Agency requires registrants of similar products to submit such data.

4] This plant-incorporated protectant may be combined through conventional breeding with other 

registered plant-incorporated protectants that are similarly approved for use in combination, 

through conventional breeding, with other registered plant-incorporated protectants to produce 

inbred corn lines and hybrid corn varieties with combined pesticidal traits.

5] The Agency is requiring protein expression data in terms of dry weight, as the amount of 

protein present in the given tissue, specifically for Bt 11 sweet corn. Tissues for which 

expression data must be provided include: leaf, root, pollen, seed, and whole plant. In addition, 

data for each of these tissues should be provided for young plants in rapid growth, during 

flowering, and mature plants before harvest when that part of the plant is present. Data are due 

on or before January 31, 2012. 

6] You must commit to do the following Insect Resistance Management Program:

Insect Resistance Management:

The required IRM program for Bt corn must have the following elements:

1] Requirements (except for home garden use or educational use, i.e., marketed to home 

gardeners or educators for use on less than 20 acres) for Syngenta to prepare and require Bt corn 

users to sign “grower agreements” that impose binding contractual obligations on the grower to 

comply with the refuge requirements;

2] Requirements regarding programs to educate growers about IRM requirements;

3] Requirements regarding programs to evaluate and promote growers’ compliance with IRM 

requirements (except for home garden use or educational use, i.e., marketed to home gardeners 

or educators for use on less than 20 acres);

4] Requirements regarding programs to evaluate whether there are statistically significant and 
14

biologically relevant changes in target insect susceptibility to Cry1Ab protein in the target 

insects; 

5] Requirements regarding a “remedial action plan” that contains measures Syngenta 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;

6] Submit 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 education program on or before January 31st each year.

7] For home garden or educational use, submit annual reports on total number of estimated acres 

sold and the compliance assurance program including the education program on or before 

January 31st each year.

 

a. Sweet Corn Post-Harvest Requirements 

Sweet corn is harvested long before field corn. Therefore, if the sweet corn stalks remaining in 

the field and any insects remaining in the stalks are destroyed shortly after harvest, a refuge is 

not needed as a part of the IRM program for sweet corn. Growers must adhere to the following 

types of crop destruction requirements as described in the grower guide/product use guide and/or 

in supplements to the grower guide/product use guide, and in the case of home gardeners on the 

seed packet, in seed catalogues, and on websites offering Attribute® Insect Protected Sweet Corn 

Hybrids for sale to home gardeners.

1. Crop destruction must occur no later than 30 days following harvest, but preferably within 14 

days. 

2. The allowed crop destruction methods are: rotary mowing, discing, or plow- down or (for the 

home garden use) by chopping up the stalks using home garden tools such as a hoe. The crop 

destruction methods are intended to protect against development of insect resistance

b. Grower Agreements (except for home garden use or educational use, i.e., marketed to home 

gardeners or educators for use on less than 20 acres)

1] Persons purchasing the Bt corn 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] Syngenta must continue to integrate this amended registration into the current system used for 

its other Bt corn plant-incorporated protectants, which is reasonably likely to assure that persons 

purchasing Attribute® Insect Protected Sweet Corn will affirm annually that they are 

contractually bound to comply with the requirements of the IRM program.
15

4] Syngenta must continue to use its current grower agreement for Attribute® Insect Protected 

Sweet Corn. If Syngenta 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 (30) days prior to implementing a proposed change, Syngenta must submit 

to EPA the text of such changes to ensure that it is consistent with the terms and conditions of 

this amended registration. 

5] Syngenta must continue to integrate this amended registration into the current system used for 

its other Bt corn plant-incorporated protectants, which is reasonably likely to assure that persons 

purchasing Attribute® Insect Protected Sweet Corn sign grower agreement(s).

6] Syngenta shall maintain records of all Bt corn grower agreements for a period of three years 

from December 31 of the year in which the agreement was signed.

7] Syngenta shall provide EPA with a report showing the number of units of its Bt 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] Syngenta 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 Programs

1] Syngenta must continue to implement and enhance (as set forth in paragraph 17 of this 

section) a comprehensive, ongoing IRM education program designed to convey to Attribute® 

Insect Protected Sweet Corn users the importance of complying with the IRM program. The 

program shall include information encouraging Attribute® Insect Protected Sweet Corn users to 

pursue optional elements of the IRM program relating to refuge configuration and proximity to 

Attribute® Insect Protected Sweet 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 

Attribute® Insect Protected Sweet Corn user separate from the grower technical guide. The 

communication shall inform the user of the current IRM requirements. Syngenta shall 

coordinate its education programs with educational efforts of other registrants and organizations, 

such as the National Corn Growers Association and state extension programs. 

2] Annually, Syngenta shall revise, and expand as necessary, its education program to take into 

account the information collected through the compliance survey required and from other 

sources. The changes shall address aspects of grower compliance that are not sufficiently high. 

3] Annually, each January 31st, Syngenta must provide EPA any substantive changes to its 

grower education activities as part of the overall IRM compliance assurance program report. 
16

Syngenta must either submit a separate report or contribute to the report from the industry 

working group (ABSTC). 

4] Syngenta must design and implement an ongoing IRM compliance assurance program 

designed to evaluate the extent to which growers purchasing Attribute® Insect Protected Sweet 

Corn 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 Syngenta corn PIP products (with the exception of home gardening or educational 

uses). Syngenta shall coordinate with other Bt corn registrants in designing and implementing its 

compliance assurance program and continue to integrate this registration into the current 

compliance assurance program used for its other Bt corn plant-incorporated protectants. Other 

required features of the program are described in paragraphs 5–22.

The following IRM Education and IRM Compliance Monitoring Programs apply to all 

growers who plant more than 20 acres of Bt corn:

5] Syngenta must establish and publicize a “phased compliance approach,” i.e., a guidance 

document that indicates how it will address instances of non-compliance with the terms of the 

IRM program and general criteria for choosing among options for responding to any noncompliant growers after the first year of noncompliance. While recognizing that for reasons of 

difference in business practices there are needs for flexibility between different companies, 

Syngenta must use a consistent set of standards for responding to non-compliance. An 

individual grower found to be significantly out of compliance two years in a row would be 

denied access to Syngenta corn PIP products the next year. Additionally, seed dealers who are 

not fulfilling their obligations to inform/educate growers of their IRM obligations will lose their 

opportunity to sell Attribute® Insect Protected Sweet Corn.

6] The IRM compliance assurance program shall include an annual survey of all Bt sweet corn 

customers who purchase 5 or more bags of Bt11 sweet corn. The survey shall measure the degree 

of compliance with the IRM program, identify the response rate (e.g., the percent of Bt sweet 

corn acres covered by the responses), and consider the potential impact of non-response. An 

independent third party will participate in the design and implementation of the survey. Data and 

information derived from the annual survey will be audited by an independent third party.

i. A third party is classified as a party other than Syngenta, the grower, or anyone else 

with a direct interest in IRM compliance for Bt corn.

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] Syngenta shall provide a written summary of the results of the prior year’s survey (together 

with a description of the methodology used, and the supporting data) to EPA by January 31 of 

each year. Syngenta shall confer with EPA on changes to the design and content of the survey 

prior to its implementation.
17

10] Annually, Syngenta shall revise, and expand as necessary, its compliance assurance 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. 

Syngenta must confer with the Agency prior to adopting any changes.

11] Syngenta shall train its representatives who make on-farm visits with Bt corn 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, Syngenta 

shall take appropriate action, consistent with its "phased compliance approach," to promote 

compliance. 

12] Syngenta 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, Syngenta shall take 

appropriate action, consistent with its “phased compliance approach.”

13] If a grower, who purchases Bt corn for planting, was specifically identified as not being in 

compliance during the previous year, Syngenta shall visit with the grower and evaluate whether 

that the grower is in compliance with the IRM program for the current year. 

14] Each registrant shall annually 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. Within one month of submitting this report to EPA, 

the registrant will meet with EPA to discuss its findings. 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. The report must inform EPA of 

the number of growers deemed ineligible to purchase Bt corn seed on the basis of continued noncompliance with the insect resistance management refuge requirements. The registrants may 

elect to coordinate information and report collectively the results of their compliance assurance 

programs. 

15] Syngenta and the seed corn dealers for Syngenta 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. 

16] Syngenta shall revise and expand its existing Compliance Assurance Program to include the 

following elements. Syngenta must prepare and submit by January 31, 2011, a written 

description of its revised Compliance Assurance Program. Syngenta may coordinate with other 

registrants in designing and implementing its Compliance Assurance Program. 

Requirements 17-22 of this section shall not require any action by Syngenta until a total of 

20,000 acres in any county and/or a combined U.S. total of 250,000 acres per year have been 

planted of Attribute® Insect Protected Sweet Corn. 

17] Syngenta will enhance the refuge education program throughout the seed delivery channel: 
18

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of 

correct refuge implementation and potential consequences of failure to plant the required refuge; 

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. The PIP product label 

accepted by EPA must include how this information will be conveyed to growers via text and 

graphics. This requirement may be phased in over the next three growing seasons. Revised PIP 

product labels must be submitted by January 31, 2011, 50% implementation on the Bt corn seed 

bags or bag tags must occur by the 2012 growing season, and full implementation must occur by 

the 2013 growing season. 

18] Syngenta will focus the majority of on-farm assessments on regions with the greatest risks 

for resistance: 

i. Use Bt corn adoption, pest pressure information, and other available information to identify 

regions where the risk of resistance is greatest; 

ii. Focus approximately two-thirds of on-farm assessments on these regions, with the remaining 

assessments conducted across other regions where the product is used. 

19] Syngenta will use its available Bt sales records and other information to refine grower lists 

for on-farm assessments of their compliance with refuge requirements: 

i. Identify for potential on-farm assessment growers whose sales information indicates they have 

purchased the Bt corn product but may have purchased little or no refuge seed from Syngenta, 

licensee, or affiliated company. 

20] Syngenta will contract with third parties to perform on-farm assessments of compliance with 

refuge requirements: 

i. The third-party assessors will conduct all first-time on-farm assessments as well as second-year 

on-farm assessments of those growers found out of compliance in a first-time assessment 

21] Syngenta will annually refine the on-farm assessment program for the Bt corn product to 

reflect the adoption rate and level of refuge compliance for the product. 

22] Syngenta will follow up with growers who have been found significantly out of compliance 

under the on-farm assessment program and are found to be back in compliance the following 

year: 

i. All growers found to be significantly out of compliance in a prior year will annually 

be sent additional refuge assistance information for a minimum of 2 years by 

Syngenta, a seed supplier, or a third-party assessor, after completing the assessment 

process.
19

ii. Syngenta will conduct follow-up checks on growers found to be significantly out of 

compliance within 3 years after they are found to be back in compliance. 

iii. A grower found with a second incident of significant non-compliance with refuge 

requirements for Attribute® Insect Protected Sweet Corn within a 5-year period will 

be denied access to Syngenta corn PIP products in the subsequent year.

d. Insect Resistance Monitoring and Remedial Action Plan 

The Agency is imposing the following conditions for the Cry1Ab toxin expressed in this product: 

Syngenta will monitor for resistance to its lepidopteran-resistant Bt corn. The monitoring 

program shall consist of two approaches: (1) focused population sampling and laboratory testing; 

and (2) investigation of reports of less-than expected control of labeled insects. Should fieldrelevant resistance be confirmed, an appropriate resistance management action plan will be 

implemented.

(2) Focused Population Sampling

Syngenta will develop and ensure the implementation of a plan for resistance monitoring for 

Spodoprera frugiperda (fall armyworm or FAW) in counties in which CrylAb sweet corn 

acreage exceeds 5,000 acres and the pest is capable of overwintering in that county. Syngenta 

should consult with academic and USDA experts in developing the monitoring plan and will 

provide EPA with a copy of its proposed resistance monitoring plan for EPA’s approval prior to 

implementation. This proposed FAW monitoring plan must be submitted to EPA by January 31 

of the year following that in which Cry lAb sweet corn acreage exceeds the trigger specified in 

this requirement (i.e. greater than 5.000 acres in any county in which FAW overwinters). The 

proposed plan must be implemented the season following the acreage trigger being met. The 

proposed plan will remain in place until an EPA approved plan can be implemented.

Syngenta shall annually sample and bioassay populations of the key target pests Ostrinia 

nubilalis (European corn borer; ECB) 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 

of Bt 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 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 
20

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 of lepidopteran-resistant Bt corn. 

The Agency shall be consulted prior to the implementation of such modifications.

Syngenta 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 survive the 

diagnostic concentration will be tested using methods that are representative of exposure to Bt

corn 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. If insects 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;

determining 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;

determining 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, Syngenta will consult with the Agency to develop and implement a case-specific 

resistance management action plan.
21

(2) Investigation of Reports of Unexpected Levels of Damage by the Target Pests:

Syngenta will follow up on grower, extension specialist or consultant reports of unexpected 

levels of damage by the lepidopteran pests listed on the pesticide label. Syngenta will instruct its 

customers to contact them if such incidents occur. Syngenta 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, CEW, and FAW), Syngenta will implement the actions described 

below, based on the following definitions of suspected resistance and confirmed resistance.

Suspected resistance

EPA defines suspected resistance to mean field reports of unexpected levels of insect feeding 

damage for which:

the corn in question has been confirmed to be lepidopteran-active Bt corn;

the seed used had the proper percentage of corn expressing Bt protein;

the relevant plant tissues 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 confirm scientifically the presence of 

insects resistant to Bt corn in commercial production fields before responsive measures are 

undertaken.

If resistance is suspected, Syngenta will instruct growers to do the following:

Use alternative control measures in the Bt corn fields in the affected region to control the 

target pest during the immediate growing season.

Destroy Bt corn 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 over-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, Syngenta will collect samples of the insect population in the affected 

fields for laboratory rearing and testing. Such rearing and testing shall be conducted as 
22

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 corn 

hybrids under field conditions (ECB only). 

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 LC50 exceeds the upper limit of the 95% 

confidence interval of the LC50 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 

Syngenta: 

EPA will receive notification within 30 days of resistance confirmation; 

Affected customers and extension agents will be notified about confirmed resistance 

within 30 days; 

Monitoring will be increased in the affected area and local target pest populations will be 

sampled annually to determine 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 corn hybrids in the affected area immediately until an effective 

local mitigation plan approved by EPA has been implemented; 

Syngenta will develop a case-specific resistance management action plan within 90 days 

according to the characteristics of the resistance event and local agronomic needs. 
23

Syngenta 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 

In subsequent growing seasons, maintain sales suspension and alternative resistance 

management strategies in the affected region(s) for the Bt corn hybrids that are affected 

by the resistant population until an EPA-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 31st each year for the duration of the conditional 

registration.

e. Annual Reports

1] Annual Sales: reported and summed by state (county level data available by request), January 

31st each year; 

2] 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 31st 

each year;

3] Grower Education: substantive changes to education program completed the previous year, 

January 31st each year;

4] Compliance Assurance Plan: Compliance Assurance Program activities and results, January 

31st each year; 

5] Compliance: to include annual survey results and plans for the next year; full report January 

31st each year; 

6] Insect Resistance Monitoring Results: results of monitoring and investigations of damage 

reports, August 31st each year.
24

Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Monsanto 524-489 Bt corn Event MON 

810 Cry1Ab 

December 

1996

Unconditional, Time-Limited

(converted 29 September 2010)

30 September 

2015

1] The subject registration will automatically expire on midnight September 30, 2015.

2] The subject registration will be limited to Bacillus thuringiensis corn Event MON 810 

Cry1Ab.

3] This plant-incorporated protectant may be combined through conventional breeding with other 

registered plant-incorporated protectants that are similarly approved for use in combination, 

through conventional breeding, with other registered plant-incorporated protectants to produce 

inbred corn lines and hybrid corn varieties with combined pesticidal traits.

4] You must do the following Insect Resistance Management Program:

Insect Resistance Management:

The required IRM program for Bt corn must have the following elements:

1] Requirements relating to creation of a non-Bt corn and/or non-lepidopteran resistant Bt corn 

refuge in conjunction with the planting of any acreage of Bt corn;

2] Requirements for Monsanto Company (Monsanto) to prepare and require Bt corn users to sign 

“grower agreements” that impose binding contractual obligations on the grower to comply with 

the refuge requirements;

3] Requirements regarding programs to educate growers about IRM requirements;

4] Requirements regarding programs to evaluate and promote growers’ compliance with IRM 

requirements;

5] Requirements regarding programs to evaluate whether there are statistically significant and 

biologically relevant changes in target insect susceptibility to Cry1Ab protein in the target 

insects; 

6] Requirements regarding a “remedial action plan” that contains measures Monsanto 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;
25

7] Submit 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 education program on or before January 31st each year. 

a. Refuge Requirements 

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.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt

corn products, additional educational material and assistance are provided by Monsanto to help 

these growers meet the refuge requirements across their farming operations.

1] Corn-Belt Refuge Requirements 

Field corn grown outside cotton-growing areas (e.g., the Corn Belt), grower agreements (also 

known as stewardship agreements) will specify that growers must adhere to the refuge 

requirements as described in the grower guide/product use guide and/or in supplements to the 

grower guide/product use guide. 

· Specifically, growers must plant a structured refuge of at least 20% non-Bt corn and/or 

non-lepidopteran resistant Bt corn that may be treated with insecticides as needed to 

control lepidopteran stalk-boring and other pests.

 

· Refuge planting options include: separate fields, blocks within fields (e.g., along the 

edges or headlands), and strips across the field. 

· External refuges must be planted within 1⁄2 mile.

· When planting the refuge in strips across the field, refuges must be at least 4 rows wide. 

 

· Insecticide treatments for control of ECB, CEW, Southwestern corn borer (SWCB) and 

other lepidopteran target pests listed on the label, grower guides, or other educational 

material may be applied only if economic thresholds are reached for one or more of these 

target pests. Economic thresholds will be determined using methods recommended by 

local or regional professionals (e.g., Extension Service agents, crop consultants). 

Instructions to growers will specify that microbial Bt insecticides must not be applied to 

non-Bt corn and/or non-lepidopteran resistant Bt corn refuges. 

2] Cotton-Growing Area Refuge Requirements for Bt Corn 

For Bt field corn grown in cotton-growing areas, grower agreements (also known as stewardship 

agreements) will specify that growers must adhere to the refuge requirements as described in the 

grower guide/product use guide and/or in supplements to the grower guide/product use guide. 
26

· Specifically, growers in these areas must plant a structured refuge of at least 50% non-Bt

corn and/or non-lepidopteran resistant Bt corn that may be treated with insecticides as 

needed to control lepidopteran stalk-boring and other pests.

· Refuge planting options include: separate fields, blocks within fields (e.g., along the 

edges or headlands), and strips across the field. 

· External refuges must be planted within 1⁄2 mile.

· When planting the refuge in strips across the field, refuges must be at least 4 rows wide. 

· Insecticide treatments for control of ECB, CEW, Southwestern corn borer (SWCB), and 

other lepidopteran target pests listed on the label, grower guides, or other educational 

material may be applied only if economic thresholds are reached for one or more of these 

target pests. Economic thresholds will be determined using methods recommended by 

local or regional professionals (e.g., Extension Service agents, crop consultants). 

Instructions to growers will specify that microbial Bt insecticides must not be applied to 

non-Bt corn and/or non-lepidopteran resistant Bt corn refuges.

· Cotton-growing areas include the following states: Alabama, Arkansas, Georgia, Florida, 

Louisiana, North Carolina, Mississippi, South Carolina, Oklahoma (only the counties of 

Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, 

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, Sussex) and Missouri (only the 

counties of Dunklin, New Madrid, Pemiscot, Scott, Stoddard). 

b. Grower Agreements

1] Persons purchasing the Bt corn 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] Monsanto must continue to integrate this amended registration into the current system used for 

its other Bt corn plant-incorporated-protectants, which is reasonably likely to assure that persons 

purchasing MON 810 will affirm annually that they are contractually bound to comply with the 

requirements of the IRM program. 

4] Monsanto must continue to use its current grower agreement for MON 810. 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 
27

the legal enforceability of the provisions of the agreement relating to the IRM program, thirty 

(30) days prior to implementing a proposed change, Monsanto must submit to EPA the text of 

such changes to ensure that it is consistent with the terms and conditions of the amendment.

5] Monsanto must continue to integrate this amended registration into the current system used for 

its other Bt corn plant-incorporated-protectants, which is reasonably likely to assure that persons 

purchasing MON 810 sign grower agreement(s). 

6] Monsanto shall maintain records of all Bt corn grower agreements for a period of three years 

from December 31 of the year in which the agreement was signed.

7] Monsanto shall provide EPA with a report showing the number of units of its Bt 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] Monsanto 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 Programs

1] Monsanto must continue to implement and enhance (as set forth in paragraph 17 of this 

section) a comprehensive, ongoing IRM education program designed to convey to MON 810

users the importance of complying with the IRM program. The program shall include 

information encouraging MON 810 users to pursue optional elements of the IRM program 

relating to refuge configuration and proximity to MON 810 fields. The education program shall 

involve the use of multiple media (e.g., face-to-face meetings, mailing written materials, EPAreviewed 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 MON 810 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 organizations, such as the National 

Corn Growers Association and state extension programs. 

2] Annually, Monsanto shall revise, and expand as necessary, its education program to take into 

account the information collected through the compliance survey required and from other 

sources. The changes shall address aspects of grower compliance that are not sufficiently high. 

3] Annually, each January 31st, Monsanto must provide EPA any substantive changes to its 

grower education activities as part of the overall IRM compliance assurance program report. 

Monsanto must either submit a separate report or contribute to the report from the industry 

working group (ABSTC). 

4] Monsanto must continue to implement and improve an ongoing IRM compliance assurance 

program designed to evaluate the extent to which growers purchasing MON 810 are complying 
28

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 

Monsanto corn PIP products. Monsanto shall coordinate with other Bt corn registrants in 

improving its compliance assurance program and continue to integrate this amended registration 

into the current compliance assurance program used for its other Bt corn plant-incorporated 

protectants. Other required features of the program are described in paragraphs 5–22.

5] Monsanto must establish and publicize a “phased compliance approach,” i.e., a guidance 

document that indicates how it will address instances of non-compliance with the terms of the 

IRM program and general criteria for choosing among options for responding to any noncompliant growers after the first year of noncompliance. While recognizing that for reasons of 

difference in business practices there are needs for flexibility between different companies, 

Monsanto must use a consistent set of standards for responding to non-compliance. An 

individual grower found to be significantly out of compliance two years in a row would be 

denied access to Monsanto corn PIP products the next year. Additionally, seed dealers who are 

not fulfilling their obligations to inform/educate growers of their IRM obligations will lose their 

opportunity to sell MON 810.

6] The IRM compliance assurance program shall include an annual survey conducted by an 

independent third party of a statistically representative sample of growers of Bt corn borer 

protected products who plant the vast majority of all corn in the U.S. and in areas in which the 

selection intensity is greatest The survey shall consider only those growers who plant 200 or 

more acres of corn in the Corn-Belt and who plant 100 or more acres of corn in corn-cotton 

areas. 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.

i. A third party is classified as a party other than Monsanto, the grower, or anyone else 

with a direct interest in IRM compliance for Bt corn.

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] Monsanto shall provide a 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 31st of each year. Monsanto shall confer with other registrants and EPA on the design 

and content of the survey prior to its implementation.

10] Annually, Monsanto shall revise, and expand as necessary, its compliance assurance program 

to take into account the information collected through the compliance survey and from other 
29

sources. The changes shall address aspects of grower compliance that are not sufficiently high. 

The registrants must confer with the Agency prior to adopting any changes.

11] Monsanto shall conduct an annual on-farm assessment program. Monsanto shall train its 

representatives who make on-farm visits with growers of their Bt corn borer protected products 

to perform assessments of compliance with IRM requirements. There is no minimum corn 

acreage size for this program. Therefore, growers will be selected for this program from across 

all farm sizes. In the event that any of these visits result in the identification of a grower who is 

not in compliance with the IRM program, Monsanto shall take appropriate action, consistent 

with its "phased compliance approach," to promote compliance.

12] Monsanto 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, Monsanto shall take 

appropriate action, consistent with its “phased compliance approach.”

13] If a grower, who purchases Bt corn for planting, was specifically identified as not being in 

compliance during the previous year, Monsanto shall visit with the grower and evaluate whether 

that the grower is in compliance with the IRM program for the current year. 

14] Each registrant shall annually 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. Within one month of submitting this report to EPA, 

the registrant shall meet with EPA to discuss its findings. 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. The report must inform EPA of 

the number of growers deemed ineligible to purchase Bt corn seed on the basis of continued noncompliance with the insect resistance management refuge requirements. Monsanto may elect to 

coordinate information with other registrants and report collectively the results of their 

compliance assurance programs. 

15] Monsanto and the seed corn dealers for Monsanto 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. 

16] Monsanto shall revise and expand its existing Compliance Assurance Program to include the 

following elements. Monsanto must prepare and submit on or before January 31, 2011, a written 

description of its revised Compliance Assurance Program. Monsanto may coordinate with other 

registrants in designing and implementing its Compliance Assurance Program. 

17] Monsanto will enhance the refuge education program throughout the seed delivery channel: 

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the 

importance of correct refuge implementation and potential consequences of failure to 

plant the required refuge; 
30

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. The PIP 

product label accepted by EPA must include how this information will be conveyed 

to growers via text and graphics. This requirement may be phased in over the next 

three growing seasons. Revised PIP product labels must be submitted by January 31, 

2011, 50% implementation on the Bt corn seed bags or bag tags must occur by the 

2012 growing season, and full implementation must occur by the 2013 growing 

season. 

18] Monsanto will focus the majority of on-farm assessments on regions with the greatest risks 

for resistance: 

i. Use Bt corn adoption, pest pressure information, and other available information to identify 

regions where the risk of resistance is greatest; 

ii. Focus approximately two-thirds of on-farm assessments on these regions, with the remaining 

assessments conducted across other regions where the product is used. 

19] Monsanto will use its available Bt sales records and other information to refine grower lists 

for on-farm assessments of their compliance with refuge requirements: 

i. Identify for potential on-farm assessment growers whose sales information indicates they have 

purchased the Bt corn product but may have purchased little or no refuge seed from Monsanto, 

licensee, or affiliated company. 

20] Monsanto will contract with third parties to perform on-farm assessments of compliance with 

refuge requirements: 

i. The third-party assessors will conduct all first-time on-farm assessments as well as second-year 

on-farm assessments of those growers found out of compliance in a first-time assessment 

21] Monsanto will annually refine the on-farm assessment program for the Bt corn product to 

reflect the adoption rate and level of refuge compliance for the product. 

22] Monsanto will follow up with growers who have been found significantly out of compliance 

under the on-farm assessment program and are found to be back in compliance the following 

year: 

i. All growers found to be significantly out of compliance in a prior year will annually 

be sent additional refuge assistance information for a minimum of 2 years by 

Monsanto, a seed supplier, or a third-party assessor, after completing the assessment 

process.

ii. Monsanto will conduct follow-up checks on growers found to be significantly out of 

compliance within 3 years after they are found to be back in compliance. 

iii. A grower found with a second incident of significant non-compliance with refuge 

requirements for MON 810 within a 5-year period will be denied access to Monsanto 

corn PIP products in the subsequent year.
31

d. Insect Resistance Monitoring and Remedial Action Plan 

The Agency is imposing the following conditions for the Cry1Ab toxin expressed in this product: 

Monsanto will monitor for resistance to its lepidopteran-resistant Bt corn. The monitoring 

program shall consist of two approaches: (1) focused population sampling and laboratory testing; 

and (2) investigation of reports of less-than expected control of labeled insects. Should fieldrelevant resistance be confirmed, an appropriate resistance management action plan will be 

implemented.

(3) Focused Population Sampling

Monsanto 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; CE W). 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 of Bt 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 of lepidopteran-resistant Bt corn. 

The Agency shall be consulted prior to the implementation of such modifications.

Monsanto 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 
32

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 survive the 

diagnostic concentration will be tested using methods that are representative of exposure to Bt

corn 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. If insects 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;

determining 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;

determining 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, Monsanto 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:

Monsanto will follow up on grower, extension specialist or consultant reports of unexpected 

levels of damage by the lepidopteran pests listed on the pesticide label. Monsanto will instruct its 

customers to contact them if such incidents occur. Monsanto 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), Monsanto will implement the actions described below, 

based on the following definitions of suspected resistance and confirmed resistance.

Suspected resistance

EPA defines suspected resistance to mean field reports of unexpected levels of insect feeding 

damage for which:
33

the corn in question has been confirmed to be lepidopteran-active Bt corn;

the seed used had the proper percentage of corn expressing Bt protein;

the relevant plant tissues 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 confirm scientifically the presence of 

insects resistant to Bt corn in commercial production fields before responsive measures are 

undertaken.

If resistance is suspected, Monsanto will instruct growers to do the following:

Use alternative control measures in the Bt corn fields in the affected region to control the 

target pest during the immediate growing season.

Destroy Bt corn 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 over-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, Monsanto 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 corn 

hybrids under field conditions (ECB and SWCB only). 

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 LC50 exceeds the upper limit of the 95% 
34

confidence interval of the LC50 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 

Monsanto: 

EPA will receive notification within 30 days of resistance confirmation; 

Affected customers and extension agents will be notified about confirmed resistance 

within 30 days; 

Monitoring will be increased in the affected area and local target pest populations will be 

sampled annually to determine 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 corn hybrids in the affected area immediately until an effective 

local mitigation plan approved by EPA has been implemented; 

Monsanto will develop a case-specific resistance management action plan within 90 days 

according to the characteristics of the resistance event and local agronomic needs. 

Monsanto 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 

In subsequent growing seasons, maintain sales suspension and alternative resistance 

management strategies in the affected region(s) for the Bt corn hybrids that are affected 

by the resistant population until an EPA-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 31st each year for the duration of the conditional 

registration. 
35

e. Annual Reports

1] Annual Sales: reported and summed by state (county level data available by request), January 

31st each year; 

2] 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 31st 

each year;

3] Grower Education: substantive changes to education program completed the previous year, 

January 31st each year;

4] Compliance Assurance Plan: Compliance Assurance Program activities and results, January 

31st each year; 

5] Compliance: to include annual survey results and plans for the next year; full report January 

31st each year; 

6] Insect Resistance Monitoring Results: results of monitoring and investigations of damage 

reports, August 31st each year.
36

1] The subject registration will automatically expire on midnight September 30, 2015.

2] The subject registration will be limited to Bacillus thuringiensis Cry1F protein and the 

genetic material (plasmid insert PHI8999A) necessary for its production in corn event DASØ15Ø7-1 in field corn.

3] This plant-incorporated protectant may be combined through conventional breeding with other 

registered plant-incorporated protectants that are similarly approved for use in combination, 

through conventional breeding, with other registered plant-incorporated protectants to produce 

inbred corn lines and hybrid corn varieties with combined pesticidal traits.

4] You must do the following Insect Resistance Management Program:

Insect Resistance Management:

The IRM terms and conditions for this product are as follows.

The required IRM program for Bt corn must have the following elements:

1] Requirements relating to creation of a non-Bt corn and/or non-lepidopteran resistant Bt corn 

refuge in conjunction with the planting of any acreage of Bt corn;

2] Requirements for the registrants to prepare and require Bt corn users to sign “grower 

agreements” that impose binding contractual obligations on the grower to comply with the refuge 

requirements;

3] Requirements regarding programs to educate growers about IRM requirements;

4] Requirements regarding programs to evaluate and promote growers’ compliance with IRM 

requirements;

5] Requirements regarding programs to evaluate whether there are statistically significant and 

biologically relevant changes in target insect susceptibility to Cry1F protein in the target insects; 

6] Requirements regarding a “remedial action plan” that contains measures the registrants 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;

Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Dow/Mycogen 68467-2

Bt corn Event 

TC1507 with plant 

optimized (PO) 

Cry1F (Herculex 1)

May 2001 Unconditional, Time-Limited

(converted 29 September 2010)

30 September 

2015
37

7] Submit 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 education program on or before January 31st each year. 

a. Refuge Requirements 

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.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt

corn products, additional educational material and assistance are provided by the registrant to 

help these growers meet the refuge requirements across their farming operations.

1] Corn-Belt Refuge Requirements 

Field corn grown outside cotton-growing areas (e.g., the Corn Belt), grower agreements (also 

known as stewardship agreements) will specify that growers must adhere to the refuge 

requirements as described in the grower guide/product use guide and/or in supplements to the 

grower guide/product use guide. 

· Specifically, growers must plant a structured refuge of at least 20% non-Bt corn and/or 

non-lepidopteran resistant Bt corn that may be treated with insecticides as needed to 

control lepidopteran stalk-boring and other pests.

 

· Refuge planting options include: separate fields, blocks within fields (e.g., along the 

edges or headlands), and strips across the field. 

· External refuges must be planted within 1⁄2 mile.

· When planting the refuge in strips across the field, refuges must be at least 4 rows wide. 

 

· Insecticide treatments for control of ECB, CEW, Southwestern corn borer (SWCB) and 

other lepidopteran target pests listed on the label, grower guides, or other educational 

material may be applied only if economic thresholds are reached for one or more of these 

target pests. Economic thresholds will be determined using methods recommended by 

local or regional professionals (e.g., Extension Service agents, crop consultants). 

Instructions to growers will specify that microbial Bt insecticides must not be applied to 

non-Bt corn and/or non-lepidopteran resistant Bt corn refuges. 

2] Cotton-Growing Area Refuge Requirements for Bt Corn 

For Bt field corn grown in cotton-growing areas, grower agreements (also known as stewardship 

agreements) will specify that growers must adhere to the refuge requirements as described in the 

grower guide/product use guide and/or in supplements to the grower guide/product use guide. 

· Specifically, growers in these areas must plant a structured refuge of at least 50% non-Bt
38

corn and/or non-lepidopteran resistant Bt corn that may be treated with insecticides as 

needed to control lepidopteran stalk-boring and other pests.

· Refuge planting options include: separate fields, blocks within fields (e.g., along the 

edges or headlands), and strips across the field. 

· External refuges must be planted within 1⁄2 mile.

· When planting the refuge in strips across the field, refuges must be at least 4 rows wide. 

· Insecticide treatments for control of ECB, CEW, Southwestern corn borer (SWCB), and 

other lepidopteran target pests listed on the label, grower guides, or other educational 

material may be applied only if economic thresholds are reached for one or more of these 

target pests. Economic thresholds will be determined using methods recommended by 

local or regional professionals (e.g., Extension Service agents, crop consultants). 

Instructions to growers will specify that microbial Bt insecticides must not be applied to 

non-Bt corn and/or non-lepidopteran resistant Bt corn refuges.

· Cotton-growing areas include the following states: Alabama, Arkansas, Georgia, Florida,

Louisiana, North Carolina, Mississippi, South Carolina, Oklahoma (only the counties of 

Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, 

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, Sussex) and Missouri (only the 

counties of Dunklin, New Madrid, Pemiscot, Scott, Stoddard). 

b. Grower Agreements

1] Persons purchasing the Bt corn 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 maintain a system that 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. 

4] The registrant must continue to use their current grower agreement. If the registrant 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.
39

5] The registrant must maintain a system that is reasonably likely to assure that persons 

purchasing the Bt corn sign grower agreement(s). 

6] The registrant shall maintain records of all Bt corn grower agreements for a period of three 

years from December 31 of the year in which the agreement was signed.

7] The registrant shall provide EPA with a report showing the number of units of its Bt 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 

confidential business information, including names, personal information, and grower license 

number, will be protected.

c. IRM Education and IRM Compliance Monitoring Programs

1] The registrant must maintain a comprehensive, ongoing IRM education program designed to 

convey to Bt corn users the importance of complying with the IRM program. The program shall 

include information encouraging Bt corn users to pursue optional elements of the IRM program 

relating to refuge configuration and proximity to Bt 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 Bt corn user separate from the grower technical guide. The communication shall inform the 

user of the current IRM requirements. The registrant 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 and from other 

sources. The changes shall address aspects of grower compliance that are not sufficiently high. 

3] Annually, each January 31st, the registrant must provide EPA any substantive changes to its 

grower education activities as part of the overall IRM compliance assurance program report. 

The registrant must either submit a separate report or contribute to the report from the industry 

working group (ABSTC). 

4] The registrant must maintain an ongoing IRM compliance assurance program designed to 

evaluate the extent to which growers purchasing its 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 registrant’s Bt

corn products. The registrant shall coordinate with other Bt corn registrants in improving its 

compliance assurance program and continue to integrate this registration into the current 
40

compliance assurance program used for its other Bt corn plant-incorporated protectants. Other 

required features of the program are described in paragraphs 5–22.

5] The registrant must maintain 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 

non-compliant growers after the first year of noncompliance. While recognizing that for reasons 

of difference in business practices there are needs for flexibility between different companies, all 

Bt corn registrants must use a consistent set of standards for responding to non-compliance. An 

individual grower found to be significantly out of compliance two years in a row would be 

denied access to the registrant’s Bt corn products 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 Bt corn.

6] The IRM compliance assurance program shall include an annual survey conducted by an 

independent third party of a statistically representative sample of growers of Bt corn borer 

protected products who plant the vast majority of all corn in the U.S. and in areas in which the 

selection intensity is greatest The survey shall consider only those growers who plant 200 or 

more acres of corn in the Corn-Belt and who plant 100 or more acres of corn in corn-cotton 

areas. 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.

i. A third party is classified as a party other than the registrant, the grower, or anyone else with a 

direct interest in IRM compliance for Bt corn.

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 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 31st of each year. The registrant shall confer with other registrants and 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 and from 

other sources. The changes shall address aspects of grower compliance that are not sufficiently 

high. The registrants must confer with the Agency prior to adopting any changes.

11] The registrant shall conduct an annual on-farm assessment program. The registrant shall train 

its representatives who make on-farm visits with growers of their Bt corn borer protected 
41

products to perform assessments of compliance with IRM requirements. There is no minimum 

corn acreage size for this program. Therefore, growers will be selected for this program from 

across all farm sizes. 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 

shall take appropriate action, consistent with its “phased compliance approach.”

13] If a grower, who purchases Bt 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] Each registrant shall annually 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. Within one month of submitting this report to EPA, 

the registrant shall meet with EPA to discuss its findings. 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. The report must inform EPA of 

the number of growers deemed ineligible to purchase Bt corn seed on the basis of continued noncompliance with the insect resistance management refuge requirements. The registrants may 

elect to coordinate information and report collectively the results of their compliance assurance 

programs. 

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. 

16] The registrant shall revise and expand its existing Compliance Assurance Program to include 

the following elements. The registrant must prepare and submit by January 31, 2011, a written 

description of its revised Compliance Assurance Program. The registrant may coordinate with 

other registrants in designing and implementing its Compliance Assurance Program. 

17] The registrant will enhance the refuge education program throughout the seed delivery 

channel: 

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of 

correct refuge implementation and potential consequences of failure to plant the required refuge; 

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. The PIP product label 

accepted by EPA must include how this information will be conveyed to growers via text and 

graphics. This requirement may be phased in over the next three growing seasons. Revised PIP 

product labels must be submitted by January 31, 2011, 50% implementation on the Bt corn seed 
42

bags or bag tags must occur by the 2012 growing season, and full implementation must occur by 

the 2013 growing season.

18] The registrant will focus the majority of on-farm assessments on regions with the greatest 

risks for resistance: 

i. Use Bt corn adoption, pest pressure information, and other available information to identify 

regions where the risk of resistance is greatest; 

ii. Focus approximately two-thirds of on-farm assessments on these regions, with the remaining 

assessments conducted across other regions where the product is used. 

19] The registrant will use its available Bt sales records and other information to refine grower 

lists for on-farm assessments of their compliance with refuge requirements: 

i. Identify for potential on-farm assessment growers whose sales information indicates they have 

purchased the Bt corn product but may have purchased little or no refuge seed from the 

registrant, licensee, or affiliated company. 

20] The registrant will contract with third parties to perform on-farm assessments of compliance 

with refuge requirements: 

i. The third-party assessors will conduct all first-time on-farm assessments as well as second-year 

on-farm assessments of those growers found out of compliance in a first-time assessment 

21] The registrant will annually refine the on-farm assessment program for the Bt corn product 

to reflect the adoption rate and level of refuge compliance for the product. 

22] The registrant will follow up with growers who have been found significantly out of 

compliance under the on-farm assessment program and are found to be back in compliance the 

following year: 

i. All growers found to be significantly out of compliance in a prior year will annually be sent 

additional refuge assistance information for a minimum of two years by the registrant, seed 

supplier, or third party assessor, after completing the assessment process; 

ii. The registrant will conduct follow-up checks on growers found to be significantly out of 

compliance within three years after they are found to be back in compliance; 

iii. A grower found with a second incident of significant non-compliance with refuge 

requirements for the Bt corn product within a five-year period will be denied access to the 

registrant’s Bt corn products the next year.

d. Insect Resistance Monitoring and Remedial Action Plan 

The Agency is imposing the following conditions for the Cry 1F toxin expressed in this product: 
43

The registrant will monitor for resistance to its lepidopteran-resistant Bt corn. The monitoring 

program shall consist of two approaches: (1) focused population sampling and laboratory testing; 

and (2) investigation of reports of less-than expected control of labeled insects. Should fieldrelevant resistance be confirmed, an appropriate resistance management action plan will be 

implemented.

(4) 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; CE W). 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 of Bt 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 of lepidopteran-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.
44

2. If the unusual response is reproducible and heritable, progeny of insects that survive the 

diagnostic concentration will be tested using methods that are representative of exposure to Bt

corn 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. If insects 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;

determining 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;

determining 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

EPA defines suspected resistance to mean field reports of unexpected levels of insect feeding 

damage for which:

the corn in question has been confirmed to be lepidopteran-active Bt corn;

the seed used had the proper percentage of corn expressing Bt protein;
45

the relevant plant tissues 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 confirm scientifically the presence of 

insects resistant to Bt corn 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 corn fields in the affected region to control the 

target pest during the immediate growing season.

Destroy Bt corn 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 over-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 corn 

hybrids under field conditions (ECB and SWCB only). 

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 LC50 exceeds the upper limit of the 95% 

confidence interval of the LC50 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
46

When field resistance is confirmed (as defined above), the following steps will be taken by the 

registrant: 

EPA will receive notification within 30 days of resistance confirmation; 

Affected customers and extension agents will be notified about confirmed resistance 

within 30 days; 

Monitoring will be increased in the affected area and local target pest populations will be 

sampled annually to determine 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 corn hybrids in the affected area immediately until an effective 

local mitigation plan approved by EPA has been implemented; 

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 

In subsequent growing seasons, maintain sales suspension and alternative resistance 

management strategies in the affected region(s) for the Bt corn hybrids that are affected 

by the resistant population until an EPA-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 31st each year for the duration of the conditional 

registration. 

e. Annual Reports

1] Annual Sales: reported and summed by state (county level data available by request), January 

31st each year; 
47

2] 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 31st 

each year;

3] Grower Education: substantive changes to education program completed the previous year, 

January 31st each year;

4] Compliance Assurance Plan: Compliance Assurance Program activities and results, January 

31st each year; 

5] Compliance: to include annual survey results and plans for the next year; full report January 

31st each year; 

6] Insect Resistance Monitoring Results: results of monitoring and investigations of damage 

reports, August 31st each year.
48

1] The subject registration will automatically expire on midnight September 30, 2015.

2] The subject registration will be limited to : Bacillus thuringiensis Cry1F protein and the 

genetic material (plasmid insert PHI8999A) necessary for its production in corn event DASØ15Ø7-1 in field corn.

3] This plant-incorporated protectant may be combined through conventional breeding with other 

registered plant-incorporated protectants that are similarly approved for use in combination, 

through conventional breeding, with other registered plant-incorporated protectants to produce 

inbred corn lines and hybrid corn varieties with combined pesticidal traits.

4] You must do the following Insect Resistance Management Program:

Insect Resistance Management:

The IRM terms and conditions for this product are as follows.

The required IRM program for Bt corn must have the following elements:

1] Requirements relating to creation of a non-Bt corn and/or non-lepidopteran resistant Bt corn 

refuge in conjunction with the planting of any acreage of Bt corn;

2] Requirements for the registrants to prepare and require Bt corn users to sign “grower 

agreements” that impose binding contractual obligations on the grower to comply with the refuge 

requirements;

3] Requirements regarding programs to educate growers about IRM requirements;

4] Requirements regarding programs to evaluate and promote growers’ compliance with IRM 

requirements;

5] Requirements regarding programs to evaluate whether there are statistically significant and 

biologically relevant changes in target insect susceptibility to Cry1F protein in the target insects; 

6] Requirements regarding a “remedial action plan” that contains measures the registrants 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;

Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Pioneer/Dupont 29964-3

Bt corn Event 

TC1507 with 

plant optimized 

(PO) Cry1F 

(Herculex 1)

May 2001 Unconditional, Time-Limited

(converted 29 September 2010)

30 September 

2015
49

7] Submit 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 education program on or before January 31st each year. 

a. Refuge Requirements 

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.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt

corn products, additional educational material and assistance are provided by the registrant to 

help these growers meet the refuge requirements across their farming operations.

1] Corn-Belt Refuge Requirements 

Field corn grown outside cotton-growing areas (e.g., the Corn Belt), grower agreements (also 

known as stewardship agreements) will specify that growers must adhere to the refuge 

requirements as described in the grower guide/product use guide and/or in supplements to the 

grower guide/product use guide. 

· Specifically, growers must plant a structured refuge of at least 20% non-Bt corn and/or 

non-lepidopteran resistant Bt corn that may be treated with insecticides as needed to 

control lepidopteran stalk-boring and other pests.

 

· Refuge planting options include: separate fields, blocks within fields (e.g., along the 

edges or headlands), and strips across the field. 

· External refuges must be planted within 1⁄2 mile.

· When planting the refuge in strips across the field, refuges must be at least 4 rows wide. 

 

· Insecticide treatments for control of ECB, CEW, Southwestern corn borer (SWCB) and 

other lepidopteran target pests listed on the label, grower guides, or other educational 

material may be applied only if economic thresholds are reached for one or more of these 

target pests. Economic thresholds will be determined using methods recommended by 

local or regional professionals (e.g., Extension Service agents, crop consultants). 

Instructions to growers will specify that microbial Bt insecticides must not be applied to 

non-Bt corn and/or non-lepidopteran resistant Bt corn refuges. 

2] Cotton-Growing Area Refuge Requirements for Bt Corn 

For Bt field corn grown in cotton-growing areas, grower agreements (also known as stewardship 

agreements) will specify that growers must adhere to the refuge requirements as described in the 

grower guide/product use guide and/or in supplements to the grower guide/product use guide. 

· Specifically, growers in these areas must plant a structured refuge of at least 50% non-Bt

corn and/or non-lepidopteran resistant Bt corn that may be treated with insecticides as 
50

needed to control lepidopteran stalk-boring and other pests.

· Refuge planting options include: separate fields, blocks within fields (e.g., along the 

edges or headlands), and strips across the field. 

· External refuges must be planted within 1⁄2 mile.

· When planting the refuge in strips across the field, refuges must be at least 4 rows wide. 

· Insecticide treatments for control of ECB, CEW, Southwestern corn borer (SWCB), and 

other lepidopteran target pests listed on the label, grower guides, or other educational 

material may be applied only if economic thresholds are reached for one or more of these 

target pests. Economic thresholds will be determined using methods recommended by 

local or regional professionals (e.g., Extension Service agents, crop consultants). 

Instructions to growers will specify that microbial Bt insecticides must not be applied to 

non-Bt corn and/or non-lepidopteran resistant Bt corn refuges.

· Cotton-growing areas include the following states: Alabama, Arkansas, Georgia, Florida, 

Louisiana, North Carolina, Mississippi, South Carolina, Oklahoma (only the counties of 

Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, 

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, Sussex) and Missouri (only the 

counties of Dunklin, New Madrid, Pemiscot, Scott, Stoddard). 

b. Grower Agreements

1] Persons purchasing the Bt corn 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 maintain a system that 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. 

4] The registrant must continue to use their current grower agreement. If the registrant 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.
51

5] The registrant must maintain a system that is reasonably likely to assure that persons 

purchasing the Bt corn sign grower agreement(s). 

6] The registrant shall maintain records of all Bt corn grower agreements for a period of three 

years from December 31 of the year in which the agreement was signed.

7] The registrant shall provide EPA with a report showing the number of units of its Bt 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 

confidential business information, including names, personal information, and grower license 

number, will be protected.

c. IRM Education and IRM Compliance Monitoring Programs

1] The registrant must maintain a comprehensive, ongoing IRM education program designed to 

convey to Bt corn users the importance of complying with the IRM program. The program shall 

include information encouraging Bt corn users to pursue optional elements of the IRM program 

relating to refuge configuration and proximity to Bt 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 Bt corn user separate from the grower technical guide. The communication shall inform the 

user of the current IRM requirements. The registrant 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 and from other 

sources. The changes shall address aspects of grower compliance that are not sufficiently high. 

3] Annually, each January 31st, the registrant must provide EPA any substantive changes to its 

grower education activities as part of the overall IRM compliance assurance program report. 

The registrant must either submit a separate report or contribute to the report from the industry 

working group (ABSTC). 

4] The registrant must maintain an ongoing IRM compliance assurance program designed to 

evaluate the extent to which growers purchasing its 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 registrant’s Bt

corn products. The registrant shall coordinate with other Bt corn registrants in improving its 

compliance assurance program and continue to integrate this registration into the current 

compliance assurance program used for its other Bt corn plant-incorporated protectants. Other 

required features of the program are described in paragraphs 5–22.
52

5] The registrant must maintain 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 

non-compliant growers after the first year of noncompliance. While recognizing that for reasons 

of difference in business practices there are needs for flexibility between different companies, all 

Bt corn registrants must use a consistent set of standards for responding to non-compliance. An 

individual grower found to be significantly out of compliance two years in a row would be 

denied access to the registrant’s Bt corn products 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 Bt corn.

6] The IRM compliance assurance program shall include an annual survey conducted by an 

independent third party of a statistically representative sample of growers of Bt corn borer 

protected products who plant the vast majority of all corn in the U.S. and in areas in which the 

selection intensity is greatest The survey shall consider only those growers who plant 200 or 

more acres of corn in the Corn-Belt and who plant 100 or more acres of corn in corn-cotton 

areas. 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.

i. A third party is classified as a party other than the registrant, the grower, or anyone else with a 

direct interest in IRM compliance for Bt corn.

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 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 31st of each year. The registrant shall confer with other registrants and 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 and from 

other sources. The changes shall address aspects of grower compliance that are not sufficiently 

high. The registrants must confer with the Agency prior to adopting any changes.

11] The registrant shall conduct an annual on-farm assessment program. The registrant shall train 

its representatives who make on-farm visits with growers of their Bt corn borer protected 

products to perform assessments of compliance with IRM requirements. There is no minimum 

corn acreage size for this program. Therefore, growers will be selected for this program from 

across all farm sizes. In the event that any of these visits result in the identification of a grower 
53

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 

shall take appropriate action, consistent with its “phased compliance approach.”

13] If a grower, who purchases Bt 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] Each registrant shall annually 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. Within one month of submitting this report to EPA, 

the registrant shall meet with EPA to discuss its findings. 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. The report must inform EPA of 

the number of growers deemed ineligible to purchase Bt corn seed on the basis of continued noncompliance with the insect resistance management refuge requirements. The registrants may 

elect to coordinate information and report collectively the results of their compliance assurance 

programs. 

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. 

16] The registrant shall revise and expand its existing Compliance Assurance Program to include 

the following elements. The registrant must prepare and submit by January 31, 2011, a written 

description of its revised Compliance Assurance Program. The registrant may coordinate with 

other registrants in designing and implementing its Compliance Assurance Program. 

17] The registrant will enhance the refuge education program throughout the seed delivery 

channel: 

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of 

correct refuge implementation and potential consequences of failure to plant the required refuge; 

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. The PIP product label 

accepted by EPA must include how this information will be conveyed to growers via text and 

graphics. This requirement may be phased in over the next three growing seasons. Revised PIP 

product labels must be submitted by January 31, 2011, 50% implementation on the Bt corn seed 

bags or bag tags must occur by the 2012 growing season, and full implementation must occur by 

the 2013 growing season. 
54

18] The registrant will focus the majority of on-farm assessments on regions with the greatest 

risks for resistance: 

i. Use Bt corn adoption, pest pressure information, and other available information to identify 

regions where the risk of resistance is greatest; 

ii. Focus approximately two-thirds of on-farm assessments on these regions, with the remaining 

assessments conducted across other regions where the product is used. 

19] The registrant will use its available Bt sales records and other information to refine grower 

lists for on-farm assessments of their compliance with refuge requirements: 

i. Identify for potential on-farm assessment growers whose sales information indicates they have 

purchased the Bt corn product but may have purchased little or no refuge seed from the 

registrant, licensee, or affiliated company. 

20] The registrant will contract with third parties to perform on-farm assessments of compliance 

with refuge requirements: 

i. The third-party assessors will conduct all first-time on-farm assessments as well as second-year 

on-farm assessments of those growers found out of compliance in a first-time assessment 

21] The registrant will annually refine the on-farm assessment program for the Bt corn product

to reflect the adoption rate and level of refuge compliance for the product. 

22] The registrant will follow up with growers who have been found significantly out of 

compliance under the on-farm assessment program and are found to be back in compliance the 

following year: 

i. All growers found to be significantly out of compliance in a prior year will annually be sent 

additional refuge assistance information for a minimum of two years by the registrant, seed 

supplier, or third party assessor, after completing the assessment process; 

ii. The registrant will conduct follow-up checks on growers found to be significantly out of 

compliance within three years after they are found to be back in compliance; 

iii. A grower found with a second incident of significant non-compliance with refuge 

requirements for the Bt corn product within a five-year period will be denied access to the 

registrant’s Bt corn products the next year.

d. Insect Resistance Monitoring and Remedial Action Plan 

The Agency is imposing the following conditions for the Cry1F toxin expressed in this product: 

The registrant will monitor for resistance to its lepidopteran-resistant Bt corn. The monitoring 

program shall consist of two approaches: (1) focused population sampling and laboratory testing; 

and (2) investigation of reports of less-than expected control of labeled insects. Should field-
55

relevant resistance be confirmed, an appropriate resistance management action plan will be 

implemented.

(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; CE W). 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 of Bt 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 of lepidopteran-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 survive the 

diagnostic concentration will be tested using methods that are representative of exposure to Bt
56

corn 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. If insects 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;

determining 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;

determining 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

EPA defines suspected resistance to mean field reports of unexpected levels of insect feeding 

damage for which:

the corn in question has been confirmed to be lepidopteran-active Bt corn;

the seed used had the proper percentage of corn expressing Bt protein;

the relevant plant tissues 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 
57

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 confirm scientifically the presence of 

insects resistant to Bt corn 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 corn fields in the affected region to control the 

target pest during the immediate growing season.

Destroy Bt corn 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 over-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 corn 

hybrids under field conditions (ECB and SWCB only). 

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 LC50 exceeds the upper limit of the 95% 

confidence interval of the LC50 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: 
58

EPA will receive notification within 30 days of resistance confirmation; 

Affected customers and extension agents will be notified about confirmed resistance 

within 30 days; 

Monitoring will be increased in the affected area and local target pest populations will be 

sampled annually to determine 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 corn hybrids in the affected area immediately until an effective 

local mitigation plan approved by EPA has been implemented; 

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 

In subsequent growing seasons, maintain sales suspension and alternative resistance 

management strategies in the affected region(s) for the Bt corn hybrids that are affected 

by the resistant population until an EPA-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 31st each year for the duration of the conditional 

registration. 

e. Annual Reports

1] Annual Sales: reported and summed by state (county level data available by request), January 

31st each year; 

2] 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 31st 

each year;
59

3] Grower Education: substantive changes to education program completed the previous year, 

January 31st each year;

4] Compliance Assurance Plan: Compliance Assurance Program activities and results, January 

31st each year; 

5] Compliance: to include annual survey results and plans for the next year; full report January 

31st each year; 

6] Insect Resistance Monitoring Results: results of monitoring and investigations of damage 

reports, August 31st each year.
60

1] The subject registration will automatically expire on midnight September 30, 2015.

2] The subject registration will be limited to : Bacillus thuringiensis var. aizawai strain PS811 

Cry1F protein and the genetic material necessary for its production (plasmid insert PHP12537) in 

corn event DAS-Ø6275-8 in field corn.

3] This plant-incorporated protectant may be combined through conventional breeding with other 

registered plant-incorporated protectants that are similarly approved for use in combination, 

through conventional breeding, with other registered plant-incorporated protectants to produce 

inbred corn lines and hybrid corn varieties with combined pesticidal traits.

4] You must do the following Insect Resistance Management Program:

The following registration requirements and conditions shall not require any action by Mycogen 

Seeds c/o Dow AgroSciences LLC unless and until Mycogen Seeds c/o Dow AgroSciences LLC 

commercializes moCry1F corn in the United States. The term “commercialization” shall mean 

the sale of moCry1F corn seed to one or more growers for the purposes of growing a commercial 

grain corn crop in the United States.

Insect Resistance Management:

The required IRM program for Bt corn must have the following elements:

1] Requirements relating to creation of a non-Bt corn and/or non-lepidopteran resistant Bt corn 

refuge in conjunction with the planting of any acreage of Bt corn;

2] Requirements for the registrants to prepare and require Bt corn users to sign “grower 

agreements” that impose binding contractual obligations on the grower to comply with the refuge 

requirements;

3] Requirements regarding programs to educate growers about IRM requirements;

4] Requirements regarding programs to evaluate and promote growers’ compliance with IRM 

requirements;

5] Requirements regarding programs to evaluate whether there are statistically significant and 

biologically relevant changes in target insect susceptibility to Cry1F protein in the target insects; 

6] Requirements regarding a “remedial action plan” that contains measures the registrants 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;

Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Dow 

Agrosciences 68467-4

Bt Cry1F Event 

DAS-06274-8 corn 27 May 2005 Unconditional, Time-Limited(converted 29 September 2010)

30 September 

2015
61

7] Submit 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 education program on or before January 31st each year. 

a. Refuge Requirements 

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.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt

corn products, additional educational material and assistance are provided by the registrant to 

help these growers meet the refuge requirements across their farming operations.

1] Corn-Belt Refuge Requirements 

Field corn grown outside cotton-growing areas (e.g., the Corn Belt), grower agreements (also 

known as stewardship agreements) will specify that growers must adhere to the refuge 

requirements as described in the grower guide/product use guide and/or in supplements to the 

grower guide/product use guide. 

· Specifically, growers must plant a structured refuge of at least 20% non-Bt corn and/or 

non-lepidopteran resistant Bt corn that may be treated with insecticides as needed to 

control lepidopteran stalk-boring and other pests.

 

· Refuge planting options include: separate fields, blocks within fields (e.g., along the 

edges or headlands), and strips across the field. 

· External refuges must be planted within 1⁄2 mile.

· When planting the refuge in strips across the field, refuges must be at least 4 rows wide. 

 

· Insecticide treatments for control of ECB, CEW, Southwestern corn borer (SWCB) and 

other lepidopteran target pests listed on the label, grower guides, or other educational 

material may be applied only if economic thresholds are reached for one or more of these 

target pests. Economic thresholds will be determined using methods recommended by 

local or regional professionals (e.g., Extension Service agents, crop consultants). 

Instructions to growers will specify that microbial Bt insecticides must not be applied to 

non-Bt corn and/or non-lepidopteran resistant Bt corn refuges. 

2] Cotton-Growing Area Refuge Requirements for Bt Corn 

For Bt field corn grown in cotton-growing areas, grower agreements (also known as stewardship 

agreements) will specify that growers must adhere to the refuge requirements as described in the 

grower guide/product use guide and/or in supplements to the grower guide/product use guide. 
62

· Specifically, growers in these areas must plant a structured refuge of at least 50% non-Bt

corn and/or non-lepidopteran resistant Bt corn that may be treated with insecticides as 

needed to control lepidopteran stalk-boring and other pests.

· Refuge planting options include: separate fields, blocks within fields (e.g., along the 

edges or headlands), and strips across the field. 

· External refuges must be planted within 1⁄2 mile.

· When planting the refuge in strips across the field, refuges must be at least 4 rows wide. 

· Insecticide treatments for control of ECB, CEW, Southwestern corn borer (SWCB), and 

other lepidopteran target pests listed on the label, grower guides, or other educational 

material may be applied only if economic thresholds are reached for one or more of these 

target pests. Economic thresholds will be determined using methods recommended by 

local or regional professionals (e.g., Extension Service agents, crop consultants). 

Instructions to growers will specify that microbial Bt insecticides must not be applied to 

non-Bt corn and/or non-lepidopteran resistant Bt corn refuges.

· Cotton-growing areas include the following states: Alabama, Arkansas, Georgia, Florida,

Louisiana, North Carolina, Mississippi, South Carolina, Oklahoma (only the counties of 

Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, 

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, Sussex) and Missouri (only the 

counties of Dunklin, New Madrid, Pemiscot, Scott, Stoddard). 

b. Grower Agreements

1] Persons purchasing the Bt corn 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 maintain a system that 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. 

4] The registrant must continue to use their current grower agreement. If the registrant 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 
63

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 maintain a system that is reasonably likely to assure that persons 

purchasing the Bt corn sign grower agreement(s). 

6] The registrant shall maintain records of all Bt corn grower agreements for a period of three 

years from December 31 of the year in which the agreement was signed.

7] The registrant shall provide EPA with a report showing the number of units of its Bt 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 

confidential business information, including names, personal information, and grower license 

number, will be protected.

c. IRM Education and IRM Compliance Monitoring Programs

1] The registrant must maintain a comprehensive, ongoing IRM education program designed to 

convey to Bt corn users the importance of complying with the IRM program. The program shall 

include information encouraging Bt corn users to pursue optional elements of the IRM program 

relating to refuge configuration and proximity to Bt 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 Bt corn user separate from the grower technical guide. The communication shall inform the 

user of the current IRM requirements. The registrant 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 and from other 

sources. The changes shall address aspects of grower compliance that are not sufficiently high. 

3] Annually, each January 31st, the registrant must provide EPA any substantive changes to its 

grower education activities as part of the overall IRM compliance assurance program report. 

The registrant must either submit a separate report or contribute to the report from the industry 

working group (ABSTC). 

4] The registrant must maintain an ongoing IRM compliance assurance program designed to 

evaluate the extent to which growers purchasing its 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 the registrant’s Bt

corn products. The registrant shall coordinate with other Bt corn registrants in improving its 
64

compliance assurance program and continue to integrate this registration into the current 

compliance assurance program used for its other Bt corn plant-incorporated protectants. Other 

required features of the program are described in paragraphs 5–22.

5] The registrant must maintain 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 

non-compliant growers after the first year of noncompliance. While recognizing that for reasons 

of difference in business practices there are needs for flexibility between different companies, all 

Bt corn registrants must use a consistent set of standards for responding to non-compliance. An 

individual grower found to be significantly out of compliance two years in a row would be 

denied access to the registrant’s Bt corn products 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 Bt corn.

6] The IRM compliance assurance program shall include an annual survey conducted by an 

independent third party of a statistically representative sample of growers of Bt corn borer 

protected products who plant the vast majority of all corn in the U.S. and in areas in which the 

selection intensity is greatest The survey shall consider only those growers who plant 200 or 

more acres of corn in the Corn-Belt and who plant 100 or more acres of corn in corn-cotton 

areas. 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.

i. A third party is classified as a party other than the registrant, the grower, or anyone else with a 

direct interest in IRM compliance for Bt corn.

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 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 31st of each year. The registrant shall confer with other registrants and 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 and from 

other sources. The changes shall address aspects of grower compliance that are not sufficiently 

high. The registrants must confer with the Agency prior to adopting any changes.
65

11] The registrant shall conduct an annual on-farm assessment program. The registrant shall train 

its representatives who make on-farm visits with growers of their Bt corn borer protected 

products to perform assessments of compliance with IRM requirements. There is no minimum 

corn acreage size for this program. Therefore, growers will be selected for this program from 

across all farm sizes. 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 

shall take appropriate action, consistent with its “phased compliance approach.”

13] If a grower, who purchases Bt 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] Each registrant shall annually 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. Within one month of submitting this report to EPA, 

the registrant shall meet with EPA to discuss its findings. 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. The report must inform EPA of 

the number of growers deemed ineligible to purchase Bt corn seed on the basis of continued noncompliance with the insect resistance management refuge requirements. The registrants may 

elect to coordinate information and report collectively the results of their compliance assurance 

programs. 

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. 

16] The registrant shall revise and expand its existing Compliance Assurance Program to include 

the following elements. The registrant must prepare and submit by January 31, 2011, a written 

description of its revised Compliance Assurance Program. The registrant may coordinate with 

other registrants in designing and implementing its Compliance Assurance Program. 

17] The registrant will enhance the refuge education program throughout the seed delivery 

channel: 

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of 

correct refuge implementation and potential consequences of failure to plant the required refuge; 

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. The PIP product label 

accepted by EPA must include how this information will be conveyed to growers via text and 

graphics. This requirement may be phased in over the next three growing seasons. Revised PIP 
66

product labels must be submitted by January 31, 2011, 50% implementation on the Bt corn seed 

bags or bag tags must occur by the 2012 growing season, and full implementation must occur by 

the 2013 growing season. 

18] The registrant will focus the majority of on-farm assessments on regions with the greatest 

risks for resistance: 

i. Use Bt corn adoption, pest pressure information, and other available information to identify 

regions where the risk of resistance is greatest; 

ii. Focus approximately two-thirds of on-farm assessments on these regions, with the remaining 

assessments conducted across other regions where the product is used. 

19] The registrant will use its available Bt sales records and other information to refine grower 

lists for on-farm assessments of their compliance with refuge requirements: 

i. Identify for potential on-farm assessment growers whose sales information indicates they have 

purchased the Bt corn product but may have purchased little or no refuge seed from the 

registrant, licensee, or affiliated company. 

20] The registrant will contract with third parties to perform on-farm assessments of compliance 

with refuge requirements: 

i. The third-party assessors will conduct all first-time on-farm assessments as well as second-year 

on-farm assessments of those growers found out of compliance in a first-time assessment 

21] The registrant will annually refine the on-farm assessment program for the Bt corn product 

to reflect the adoption rate and level of refuge compliance for the product. 

22] The registrant will follow up with growers who have been found significantly out of 

compliance under the on-farm assessment program and are found to be back in compliance the 

following year: 

i. All growers found to be significantly out of compliance in a prior year will annually be sent 

additional refuge assistance information for a minimum of two years by the registrant, seed 

supplier, or third party assessor, after completing the assessment process; 

ii. The registrant will conduct follow-up checks on growers found to be significantly out of 

compliance within three years after they are found to be back in compliance; 

iii. A grower found with a second incident of significant non-compliance with refuge 

requirements for the Bt corn product within a five-year period will be denied access to the 

registrant’s Bt corn products the next year.

d. Insect Resistance Monitoring and Remedial Action Plan 

The Agency is imposing the following conditions for the Cry1F toxin Expressed in this product: 
67

The registrant will monitor for resistance to its lepidopteran-resistant Bt corn. The monitoring 

program shall consist of two approaches: (1) focused population sampling and laboratory testing; 

and (2) investigation of reports of less-than expected control of labeled insects. Should fieldrelevant resistance be confirmed, an appropriate resistance management action plan will be 

implemented.

(2) 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; CE W). 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 of Bt 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 of lepidopteran-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.
68

2. If the unusual response is reproducible and heritable, progeny of insects that survive the 

diagnostic concentration will be tested using methods that are representative of exposure to Bt

corn 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. If insects 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;

determining 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;

determining 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

EPA defines suspected resistance to mean field reports of unexpected levels of insect feeding 

damage for which:

the corn in question has been confirmed to be lepidopteran-active Bt corn;

the seed used had the proper percentage of corn expressing Bt protein;

the relevant plant tissues are expressing the expected level of Bt protein; and
69

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 confirm scientifically the presence of 

insects resistant to Bt corn 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 corn fields in the affected region to control the 

target pest during the immediate growing season.

Destroy Bt corn 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 over-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 corn 

hybrids under field conditions (ECB and SWCB only). 

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 LC50 exceeds the upper limit of the 95% 

confidence interval of the LC50 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
70

When field resistance is confirmed (as defined above), the following steps will be taken by the 

registrant: 

EPA will receive notification within 30 days of resistance confirmation; 

Affected customers and extension agents will be notified about confirmed resistance 

within 30 days; 

Monitoring will be increased in the affected area and local target pest populations will be 

sampled annually to determine 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 corn hybrids in the affected area immediately until an effective 

local mitigation plan approved by EPA has been implemented; 

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 

In subsequent growing seasons, maintain sales suspension and alternative resistance 

management strategies in the affected region(s) for the Bt corn hybrids that are affected 

by the resistant population until an EPA-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 31st each year for the duration of the conditional 

registration. 

e. Annual Reports

1] Annual Sales: reported and summed by state (county level data available by request), January 

31st each year; 
71

2] 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 31st 

each year;

3] Grower Education: substantive changes to education program completed the previous year, 

January 31st each year;

4] Compliance Assurance Plan: Compliance Assurance Program activities and results, January 

31st each year; 

5] Compliance: to include annual survey results and plans for the next year; full report January 

31st each year; 

6] Insect Resistance Monitoring Results: results of monitoring and investigations of damage 

reports, August 31st each year.
72

Pioneer Hi-Bred International Corn PIP Products

Three Pioneer Hi-Bred International corn PIP products (1507 X MON810, EPA Reg No. 29964-

7; 1507 X 59122 X MON810, EPA Reg. No 29964-8; and 59122 X MON810, EPA Reg. No. 

29964-9) were registered February 24, 2010 with an expiration date of October 31, 2010. As part 

of the Agency’s public participation initiative, the Agency provided for a concurrent public 

comment period which closed March 28, 2010. During this comment period, the Agency 

received several comments on these products. These comments and comments pertinent to these 

registrations submitted as part of the 2010 Bt Corn Reassessment comment period will be 

addressed separately, by the October 31, 2010 expiration date. 

Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Pioneer/Dupont 29964-7

1507 (PO Cry1F) x 

MON 810 

(Cry1Ab)

24 February 

2010 Conditional 31 October 2010
73

II. Cry 3Bb1 BRAD Registered Products

Monsanto did not request an extension to their Corn Event MON 863 registration (EPA Reg. No. 

524-528); therefore, this registration expired on its own terms on September 30, 2010. The 

Agency considers the expiration of a conditional, time-limited registration to be a cancellation 

under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). A 

cancellation order, effective September 30, 2010, and appropriate provisions for disposition of 

existing stocks published in the Federal Register on August 25, 2010 (75 FR 52329) 

Registrant Registration # Active Ingredient Original 

Registration Date Status

Monsanto 524-528

Bt Corn Event MON863 

with Cry3Bb1 

(YieldGard® Rootworm)

24 February 2003 Cancelled

(Expired on 30 September 2010)
74

Monsanto did not request an extension to their MON 863 x MON 810 registration (EPA Reg. 

No. 524-545); therefore, this registration expired on its own terms on September 30, 2010. The 

Agency considers the expiration of a conditional, time-limited registration to be a cancellation 

under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). A 

cancellation order, effective September 30, 2010, and appropriate provisions for disposition of 

existing stocks published in the Federal Register on August 25, 2010 (75 FR 52329). 

Registrant Registration # Active Ingredient Original 

Registration Date Status

Monsanto 524-545

Bt Corn Stack Event 

MON 863 + MON 819 

with Cry3Bb1 + Cry1Ab 

(YieldGard® Plus)

31 October 2003 Cancelled

(Expired on 30 September 2010)
75

Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Monsanto 524-551

Bt Corn Event MON 

88017 with Cry3Bb1 

(YieldGard VT 

Rootworm/RR2®)

13 December 

2005

Conditional

(amended 29 September 2010)

30 September 

2015

1] The subject registration will automatically expire on midnight September 30, 2015.

2] The subject registration will be limited to Cry3Bb1 [Bacillus thuringiensis Cry3Bb1 protein 

and the genetic material necessary for its production (vector PV-ZMIR39) in event MON 88017 

corn (OECD Unique Identifier: MON-88Ø17-3)] for use in field and sweet corn. Further, MON 

88017 sweet corn must only be used for breeding and testing purposes to produce 

MON 89034 x MON 88017 sweet corn seed.

3] Submit/cite all data required for registration of your product under FIFRA section 3(c)(5) 

when the Environmental Protection Agency (EPA) requires registrants of similar products to 

submit such data.

4] This plant-incorporated protectant (PIP) may be combined through conventional breeding 

with other registered plant-incorporated protectants that are similarly approved for use in 

combination, through conventional breeding, with other registered plant-incorporated protectants 

to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits.

5] You must commit to do the following Insect Resistance Management (IRM) Program, 

consisting of the following elements:

Requirements relating to creation of a non-(corn rootworm-protected PIP) corn refuge in 

conjunction with the planting of any acreage of commercial MON 88017 corn.

Requirements for Monsanto Company (Monsanto) to prepare and require MON 88017 

users to sign grower agreements that impose binding contractual obligations on growers 

to comply with the refuge requirements.

Requirements for Monsanto to develop, implement, and report to EPA on programs to 

educate growers about IRM requirements.

Requirements for Monsanto to develop, implement, and report to EPA on programs to 

evaluate and promote growers’ compliance with IRM requirements.

Requirements for Monsanto to develop, implement, and report to EPA on monitoring 

programs to evaluate whether there are statistically significant and biologically relevant 

changes in susceptibility to Cry3Bb1 protein in the target insects.
76

Requirements for Monsanto to develop, and if triggered, to implement a remedial action 

plan that would contain measures Monsanto would take in the event that any fieldrelevant insect resistance was detected, as well as to report on activity under the plan to 

EPA.

Requirements for Monsanto, on or before January 31st of each year, to submit reports on 

units sold by state (units sold by county level will made available to EPA upon request), 

IRM grower agreement results, and the compliance assurance program, including the 

education program.

Requirements for Monsanto, on or before August 31st of each year, to submit reports on 

resistance monitoring.

a. Refuge Requirements for MON 88017 

These refuge requirements do not apply to seed increase/propagation of inbred and hybrid seed 

corn up to a total of 20,000 acres per county and up to a combined United States (U.S.) total of 

250,000 acres per plant-incorporated protectant (PIP) active ingredient per registrant per year. 

Furthermore, these refuge requirements do not apply to MON 88017 sweet corn, used only for 

breeding and testing purposes to produce MON 89034 x MON 88017 sweet corn seed.

When on-farm assessments identify non-compliance with refuge requirements for one or more 

Bacillus thuringiensis (Bt) corn products, additional educational material and assistance will be 

provided by Monsanto to help these growers meet the refuge requirements across their farming 

operations.

Grower agreements (also known as stewardship agreements) will specify that growers must 

adhere to the refuge requirements as described in the grower guide/product use guide and/or in 

supplements to the grower guide/product use guide.

Specifically, growers must plant a structured refuge of at least 20% non-corn rootwormprotected corn that may be treated with insecticides as needed to control corn rootworm 

larvae. Growers will not be permitted to apply corn rootworm-labeled insecticides to the 

refuge for control of insect pests while adult corn rootworm are present unless the MON 

88017 field is treated in a similar manner.

Refuge planting options include the following: adjacent blocks, perimeter strips, or infield strips.

If blocks are implemented, they must be planted adjacent (e.g., across the road) to the 

MON 88017 field.

If perimeter or in-field strips are implemented, the strips must be at least four (4) 

consecutive rows wide.

Insecticide treatments for control of corn rootworm larvae may be applied. Instructions 

to growers will specify that insecticides labeled for control of corn rootworm adults 
77

cannot be applied while adults are present in the refuge unless the MON 88017 field is 

treated in a similar manner.

If the refuge is planted in a field that is in a crop rotation system, then MON 88017 must 

also be planted in a field that is in a crop rotation system.

If the refuge is planted on continuous corn, then the MON 88017 field may be planted on 

either continuous corn or in a field that is in a crop rotation system.

b. Post-Harvest Requirements for MON 88017 Sweet Corn

Sweet corn is harvested long before field corn. Therefore, if the sweet corn stalks remaining in 

the field and any insects remaining in the stalks are destroyed shortly after harvest, a refuge is 

not needed as part of the IRM program for sweet corn. For MON 88017 sweet corn, which is 

planted only for breeding and testing purposes to produce MON 89034 x MON 88017 sweet 

corn seed, the following crop destruction practices must be implemented:

Crop destruction must occur no later than thirty (30) days following harvest.

The allowed crop destruction methods are rotary mowing, discing, or plow down. These 

methods should destroy any surviving resistant insects.

c. Grower Agreements for MON 88017

1] Persons purchasing MON 88017 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 must continue to integrate this amended registration into the current system used 

for its other Bt corn plant-incorporated protectants, which is reasonably likely to assure that 

persons purchasing MON 88017 will affirm annually that they are contractually bound to comply 

with the requirements of the IRM program.

4] Monsanto must continue to use its current grower agreement for MON 88017. 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 

(30) days prior to implementing a proposed change, Monsanto must submit to EPA the text of 

such changes to ensure that it is consistent with the terms and conditions of this amended 

registration. 

5] Monsanto must continue to integrate this amended registration into the current system used 

for its other Bt corn plant-incorporated protectants, which is reasonably likely to assure that 
78

persons purchasing MON 88017 sign grower agreement(s).

6] Monsanto shall maintain records of all MON 88017 grower agreements for a period of three 

(3) years from December 31st of the year in which the agreement was signed.

7] Annually, Monsanto shall provide EPA with a report showing the number of units of MON 

88017 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 12-

month period covering the prior August through July.

8] Monsanto 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 

numbers of the growers, will be protected.

d. IRM Education and Compliance Monitoring Programs for MON 88017 

1] Monsanto must continue to implement and enhance (as set forth in paragraph 17 of this 

section) a comprehensive, ongoing IRM education program designed to convey to MON 88017 

users the importance of complying with the IRM program. The program shall include 

information encouraging MON 88017 users to pursue optional elements of the IRM program 

relating to refuge configuration and proximity to MON 88017 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 MON 88017 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 organizations, 

such as the National Corn Growers Association and state extension programs. 

2] Annually, Monsanto shall revise, and expand as necessary, its education program to take into 

account the information collected through the compliance survey, required under paragraph 6–8 

of this section, and from other sources. The changes shall address aspects of grower compliance 

that are not sufficiently high.

3] Annually, Monsanto must provide EPA any substantive changes to its grower education 

activities as part of the overall IRM compliance assurance program report. Monsanto must either 

submit a separate report or contribute to the report from the industry working group, Agricultural 

Biotechnology Stewardship Technical Committee (ABSTC). The required features of the 

compliance assurance program are described in paragraphs 4–22 of this section.

4] Monsanto must continue to implement and improve an ongoing IRM compliance assurance 

program designed to evaluate the extent to which growers purchasing MON 88017 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 Monsanto’s Bt corn products. Monsanto shall coordinate with other Bt corn registrants 

in improving its compliance assurance program and continue to integrate this amended 
79

registration into the current compliance assurance program used for its other Bt corn plantincorporated protectants. Other required features of the program are described in paragraphs 5–

22 of this section.

5] Monsanto must maintain and publicize a phased compliance approach (i.e., a guidance 

document that indicates how it will address instances of non-compliance with the terms of the 

IRM program and general criteria for choosing among options for responding to any noncompliant growers after the first year of non-compliance). While recognizing that for reasons of 

difference in business practices there are needs for flexibility between different companies, 

Monsanto must use a consistent set of standards for responding to non-compliance. An 

individual grower found to be significantly out of compliance two (2) years in a row would be 

denied access to Monsanto’s Bt corn products 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 Bt corn.

6] The IRM compliance assurance program shall include an annual survey, conducted by an 

independent third party, of a statistically representative sample of growers of MON 88017 who 

plant the vast majority of all corn in the United States and in areas in which the selection 

intensity is greatest. The survey shall consider only those growers who plant 200 or more acres 

of corn in the Corn Belt and who plant 100 or more acres of corn in corn-cotton areas. 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 independent marketing 

research firms 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 United States. 

i. A third party is classified as a party other than Monsanto, the grower, or anyone 

else with a direct interest in IRM compliance for Bt corn.

7] The survey shall be designed to provide an understanding of any difficulties growers 

encounter in implementing IRM requirements. An analysis of 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] Monsanto shall provide 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 on or before January 31st of each year. Monsanto shall confer with other registrants and 

EPA on the design and content of the survey prior to its implementation.

10] Annually, Monsanto shall revise, and expand as necessary, its compliance assurance 

program to take into account the information collected through the compliance survey, required 

under paragraphs 6–8 of this section, and from other sources. The changes shall address aspects 

of grower compliance that are not sufficiently high. Monsanto must confer with EPA prior to 

adopting any changes.
80

11] Monsanto shall conduct an annual on-farm assessment program. Monsanto shall train its 

representatives who make on-farm visits with MON 88017 growers to perform assessments of 

compliance with IRM requirements. There is no minimum corn acreage size for this program. 

Therefore, growers will be selected for this program from across all farm sizes. In the event that 

any of these visits result in the identification of a grower who is not in compliance with the IRM 

program, Monsanto shall take appropriate action, consistent with its phased compliance 

approach, to promote compliance.

12] Monsanto shall carry out a program for investigating legitimate tips and complaints that 

MON 88017 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, 

Monsanto shall take appropriate action, consistent with its phased compliance approach.

13] If a grower, who purchases MON 88017 for planting, was specifically identified as not 

being in compliance during the previous year, Monsanto shall visit with the grower and evaluate 

whether the grower is in compliance with the IRM program for the current year.

14] Annually, Monsanto shall provide a report to EPA summarizing the activities carried out 

under its compliance assurance program for the prior year and the plans for the compliance 

assurance program during the current year. Within one (1) month of submitting this report to

EPA, Monsanto shall meet with EPA to discuss its findings. 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. The report must inform EPA of 

the number of growers deemed ineligible to purchase Bt corn seed on the basis of continued noncompliance with the insect resistance management refuge requirements. Monsanto may elect to 

coordinate information with other registrants and report collectively the results of compliance 

assurance programs.

15] Monsanto and the seed corn dealers for Monsanto 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 numbers of the growers, will be protected.

16] Monsanto shall revise and expand its existing compliance assurance program to include the 

following elements. Monsanto must prepare and submit, on or before January 31, 2011, a 

written description of its revised compliance assurance program. Monsanto may coordinate with 

other registrants in designing and implementing its compliance assurance program.

17] Monsanto will enhance the refuge education program throughout the seed delivery channel: 

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the 

importance of correct refuge implementation and potential consequences of failure to 

plant the required refuge. 

ii. Include the refuge size requirement on all MON 88017 seed bags or bag tags. The 

MON 88017 label accepted by EPA must include how this information will be 

conveyed to growers via text and graphics. This requirement may be phased in over 
81

the next three (3) growing seasons. Revised MON 88017 labels must be submitted by 

January 31, 2011, 50% implementation on the MON 88017 seed bags or bag tags 

must occur by the 2012 growing season, and full implementation must occur by the 

2013 growing season.

18] Monsanto will focus the majority of on-farm assessments on regions with the greatest risk 

for resistance:

i. Use Bt corn adoption, pest pressure information, and other available information to 

identify regions where the risk of resistance is greatest.

ii. Focus approximately two-thirds of on-farm assessments on these regions, with the 

remaining assessments conducted across other regions where MON 88017 is used.

19] Monsanto will use its available MON 88017 sales records and other information to refine 

grower lists for on-farm assessments of their compliance with refuge requirements:

i. Identify for potential on-farm assessment growers whose sales information indicates 

they have purchased MON 88017 but may have purchased little or no refuge seed 

from Monsanto, licensees, or affiliated companies.

20] Monsanto will contract with third parties to perform on-farm assessments of compliance 

with refuge requirements:

i. The third-party assessors will conduct all first-time on-farm assessments, as well as 

second-year on-farm assessments, of those growers found out of compliance in a 

first-time assessment.

21] Annually, Monsanto will refine the on-farm assessment program for MON 88017 to reflect 

the adoption rate and level of refuge compliance for MON 88017.

22] Monsanto will follow up with growers who have been found significantly out of compliance 

under the on-farm assessment program and are found to be back in compliance the following 

year: 

i. All growers found to be significantly out of compliance in a prior year will annually 

be sent additional refuge assistance information for a minimum of two (2) years by 

Monsanto, a seed supplier, or a third-party assessor, after completing the assessment 

process.

ii. Monsanto will conduct follow-up checks on growers found to be significantly out of 

compliance within three (3) years after they are found to be back in compliance. 

iii. A grower found with a second incident of significant non-compliance with refuge 

requirements for MON 88017 within a 5-year period will be denied access to 

Monsanto’s Bt corn products the next year.

e. Insect Resistance Monitoring and Remedial Action Plan for MON 88017 
82

EPA is imposing the following conditions for the Cry3Bb1 toxin expressed in MON 88017:

1] Monsanto must monitor for Cry3Bb1 resistance and/or trends in increased tolerance for corn 

rootworm. Sampling should be focused in those areas in which there is the highest risk of 

resistance development.

2] The resistance monitoring plan must include the following: baseline sensitivity data, 

sampling (number of locations, samples per locations), sampling methodology and life stage 

sampled, bioassay methodology, standardization procedures (including quality assurance/quality 

control provisions), detection technique and sensitivity, statistical analysis of the probability of 

detecting resistance, and a revised description of rootworm damage guidelines.

3] Monsanto must develop a functional diagnostic assay for corn rootworm resistance 

monitoring to detect potentially resistant individuals and incorporate this assay into the annual 

resistance monitoring program by the 2011 season, with reporting in 2012. As part of this effort, 

Monsanto must investigate the feasibility of using the Sublethal Seedling Assay1as a diagnostic 

assay. A report of Monsanto’s progress towards this requirement must be submitted to EPA 

within six (6) months from the date of this amended registration.

4] Monsanto must develop a proactive resistance monitoring program for northern corn 

rootworm (Diabrotica barberi) by the 2012 season, with reporting in 2013. This program should 

include a proposal for annual sampling and testing of northern corn rootworm susceptibility to 

Cry3Bb1. As part of the effort, Monsanto may need to investigate novel techniques for rearing 

and conducting bioassays with northern corn rootworm. A report on Monsanto’s progress 

towards this requirement must be submitted within one (1) year from the date of this amended 

registration.

5] Monsanto must submit revised corn rootworm damage guidelines (to characterize unexpected 

pest damage) that take into consideration the comments and recommendations from EPA’s June 

30, 2010 review of the rootworm resistance monitoring program for Cry3Bb1 within six (6) 

months from the date of this amended registration.

6] Monsanto must follow-up on grower, extension specialist, or consultant reports of unexpected 

damage or control failures for corn rootworm.

7] Monsanto must provide EPA with a resistance monitoring report on or before August 31st of 

each year, reporting on populations collected the previous year.

8] The current remedial action plan approved for Cry3Bb1 must be used for corn rootworm 

suspected and confirmed resistance in MON 88017. If corn rootworm resistance is confirmed, 

all acres of MON 88017 and refuges must be treated with insecticides targeted at corn rootworm 

adults and larvae.

 

1 Nowatzki T, Lefko SA, Binning RR, Thompson SD, Spencer TA, Siegfried BD. 2008. Validation of a novel 

resistance monitoring technique for corn rootworm (Coleoptera: Chrysomelidae) and event DAS-59122-7 maize. J. 

Appl. Entomol. 132:177–188.
83

f. Annual Reporting Requirements for MON 88017

1] Annual Sales: reported and summed by state (county level data available by request), on or 

before January 31st of each year.

2] Grower Agreement Results: number of units of MON 88017 seeds sold or shipped and not 

returned, and the number of such units that were sold to persons who have signed grower 

agreements, on or before January 31st of each year.

3] Grower Education: substantive changes to the education program completed during the 

previous year, on or before January 31st of each year.

4) Compliance Assurance Program: compliance assurance program activities and results for the 

previous year and plans for the compliance assurance program during the current year, on or 

before January 31st of each year.

5) Compliance Assurance Program Survey Results: survey results for the previous year and 

plans for the current year, on or before January 31st of each year.

6) Insect Resistance Monitoring Results: results of monitoring and investigations of damage 

reports, on or before August 31st of each year.
84

1] The subject registration will automatically expire on midnight September 30, 2015.

2] The subject registration will be limited to Cry3Bb1 [Bacillus thuringiensis Cry3Bb1 protein 

and the genetic material necessary for its production (vector PV-ZMIR39) in event MON 88017 

corn (OECD Unique Identifier: MON-88Ø17-3)] x Cry1Ab [Bacillus thuringiensis Cry1Ab 

protein and the genetic material necessary for its production (vector PV-ZMCT01) in event 

MON 810 corn (OECD Unique Identifier: MON-ØØ81Ø-6)] for use in field corn.

3] Submit/cite all data required for registration of your product under FIFRA section 3(c)(5) 

when the Environmental Protection Agency (EPA) requires registrants of similar products to 

submit such data.

4] Submit/cite all data, determined by the Agency to be acceptable and required to support the 

individual plant-incorporated protectants in MON 88017 and MON 810, within the time frames 

required by the terms and conditions of EPA Registration Numbers 524-551 and 524-489, 

respectively.

5] This plant-incorporated protectant may be combined through conventional breeding with 

other registered plant-incorporated protectants that are similarly approved for use in 

combination, through conventional breeding, with other registered plant-incorporated protectants 

to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits.

6] You must commit to do the following Insect Resistance Management (IRM) Program, 

consisting of the following elements:

Requirements relating to creation of a refuge for the Cry3Bb1 and Cry1Ab components 

that meets the requirements of the individual traits. The refuge for both traits may be 

combined by planting non-Bacillus thuringiensis (Bt) corn as the refuge, or the refuge for 

each trait may be planted separately. In the latter case, corn rootworm-resistant Bt corn 

may be planted in the lepidopteran refuge for the Cry1Ab component, and lepidopteranresistant Bt corn may be planted in the corn rootworm refuge for the Cry3Bb1 

component.

Requirements for Monsanto Company (Monsanto) to prepare and require MON 88017 x 

MON 810 users to sign grower agreements that impose binding contractual obligations 

on growers to comply with the refuge requirements.

Requirements for Monsanto to develop, implement, and report to EPA on programs to 

educate growers about IRM requirements.

Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Monsanto 524-552

Bt Corn Event MON 88017 + 

MON 810 with Cry3Bb1 + 

Cry1Ab (YieldGard VT 

Triple®)

13 December 

2005

Conditional

(amended 29 September 

2010)

30 September 

2015
85

Requirements for Monsanto to develop, implement, and report to EPA on programs to 

evaluate and promote growers’ compliance with IRM requirements.

Requirements for Monsanto to develop, implement, and report to EPA on monitoring 

programs to evaluate whether there are statistically significant and biologically relevant 

changes in susceptibility to the Cry3Bb1 and Cry1Ab proteins in the target insects.

Requirements for Monsanto to develop, and if triggered, to implement a remedial action 

plan that would contain measures Monsanto would take in the event that any fieldrelevant insect resistance was detected, as well as to report on activity under the plan to 

EPA.

Requirements for Monsanto, on or before January 31st of each year, to submit reports on 

units sold by state (units sold by county level will made available to the Agency upon 

request), IRM grower agreement results, and the compliance assurance program, 

including the education program.

Requirements for Monsanto, on or before August 31st of each year, to submit reports on 

resistance monitoring.

a. Refuge Requirements for MON 88017 x MON 810

These refuge requirements do not apply to seed increase/propagation of inbred and hybrid seed 

corn up to a total of 20,000 acres per county and up to a combined United States (U.S.) total of 

250,000 acres per plant-incorporated protectant (PIP) active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt

corn products, additional educational material and assistance are provided by Monsanto to help 

these growers meet the refuge requirements across their farming operations.

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 Area Refuge Requirements

For MON 88017 x MON 810 grown in non-cotton-growing areas 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 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 borers or corn rootworms. The refuge area must represent at least 20% of the 

grower’s corn acres (i.e., sum of M ON 88017 x MON 810 acres and refuge acres). It must be 

planted as a block within or adjacent (e.g., across the road) to the MON 88017 x MON 810 

field, 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 common refuge 
86

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 MON 88017 x MON 810 field 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 or crop 

consultants).

The second option is planting separate refuge areas for corn borers and corn rootworms. The

corn borer refuge must be planted with corn that is not a lepidopteran-protected Bt hybrid, must 

represent at least 20% of the grower’s corn acres (i.e. sum of MON 88017 x MON 810 acres and 

corn borer refuge acres), and must be planted within 1⁄2 mile of the MON 88017 x MON 810 

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. Economic thresholds will be determined 

using method recommended by local or regional professionals (e.g., Extension Service agents or 

crop consultants). The corn rootworm refuge must be planted with corn that is not a corn 

rootworm-protected Bt hybrid, must represent at least 20% of the grower’s corn acres (i.e., sum 

of[MON 88017 x MON 810 acres and corn rootworm refuge acres), and must be planted as a 

block within or adjacent to the MON 88017 x MON 810 field, 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 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 if pest pressure reaches an 

economic threshold for damage; however, if rootworm adults are present at the time of foliar 

applications, then the MON 88017 x MON 810 field 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 or crop consultants). 

Growers who fail to comply with the IRM requirements risk losing access to Monsanto corn PIP 

products.

Corn/Cotton-Growing Area (Cotton-Growing Area) Refuge Requirements

For MON 88017 x MON 810 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 Dunklin, New Madrid, Pemiscot, Scott, and Stoddard).

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 
87

control of corn borers or corn rootworms. The refuge area must represent at least 50% of the 

grower’s corn acres (i.e., sum of MON 88017 x MON 810 acres and refuge acres). It must be 

planted as a block within or adjacent (e.g., across the road) to the MON 88017 x MON 810 field, 

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 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 MON 88017 x MON 810 field 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 or crop 

consultants).

The second option is planting separate refuge areas for corn borers and corn rootworms. The 

corn borer refuge must be planted with corn that is not a lepidopteran-protected Bt hybrid, must 

represent at least 50% of the grower’s corn acres (i.e., sum of MON 88017 x MON 810 acres and 

corn borer refuge acres), and must be planted within 1⁄2 mile of the MON 88017 x MON 810 

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. Economic thresholds will be determined 

using methods recommended by local or regional professionals (e.g., Extension Service agents or 

crop consultants). The corn rootworm refuge must be planted with corn that is not a corn 

rootworm-protected Bt hybrid, must represent at least 20% of the grower’s corn acres (i.e., sum 

of MON 88017 x MON 810 acres and corn rootworm refuge acres), and must be planted as a 

block within or adjacent to the MON 88017 x MON 810 field, 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 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 if pest pressure reaches an 

economic threshold for damage; however, if rootworm adults are present at the time of foliar 

applications, then the MON 88017 x MON 810 field 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 or crop consultants). 

Growers who fail to comply with the IRM requirements risk losing access to Monsanto corn PIP 

products.

b. Grower Agreements for MON 88017 x MON 810

1] Persons purchasing MON 88017 x MON 810 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.
88

3] Monsanto must continue to integrate this amended registration into the current system used 

for its other Bt corn plant-incorporated protectants, which is reasonably likely to assure that 

persons purchasing MON 88017 x MON 810 will affirm annually that they are contractually 

bound to comply with the requirements of the IRM program. 

4] Monsanto must continue to use its current grower agreement for MON 88017 x MON 810. 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 (30) days prior to implementing a proposed change, Monsanto must submit to 

EPA the text of such changes to ensure that it is consistent with the terms and conditions of this 

amended registration.

5] Monsanto must continue to integrate this amended registration into the current system used 

for its other Bt corn plant-incorporated protectants, which is reasonably likely to assure that 

persons purchasing MON 88017 x MON 810 sign grower agreement(s).

6] Monsanto shall maintain records of all MON 88017 x MON 810 grower agreements for a 

period of three (3) years from December 31st of the year in which the agreement was signed.

7] Annually, Monsanto shall provide EPA with a report showing the number of units of MON 

88017 x MON 810 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 12-month period covering the prior August through July. 

8] Monsanto 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 

numbers of the growers, will be protected.

c. IRM Education and Compliance Monitoring Programs for MON 88017 x MON 810

1] Monsanto must continue to implement and enhance (as set forth in paragraph 17 of this 

section) a comprehensive, ongoing IRM education program designed to convey to MON 88017 x 

MON 810 users the importance of complying with the IRM program. The program shall include 

information encouraging MON 88017 x MON 810 users to pursue optional elements of the IRM 

program relating to refuge configuration and proximity to MON 88017 x MON 810 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 MON 88017 x MON 810 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 organizations, such as the National Corn Growers Association and state extension programs.

2] Annually, Monsanto shall revise, and expand as necessary, its education program to take into 

account the information collected through the compliance survey, required under paragraph 6–8 
89

of this section, and from other sources. The changes shall address aspects of grower compliance 

that are not sufficiently high. 

3] Annually, Monsanto must provide EPA any substantive changes to its grower education 

activities as part of the overall IRM compliance assurance program report. Monsanto must either 

submit a separate report or contribute to the report from the industry working group, Agricultural 

Biotechnology Stewardship Technical Committee (ABSTC). The required features of the 

compliance assurance program are described in paragraphs 4–22 of this section. 

4] Monsanto must continue to implement and improve an ongoing IRM compliance assurance 

program designed to evaluate the extent to which growers purchasing MON 88017 x MON 810 

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 Monsanto’s Bt corn products. Monsanto shall coordinate with other Bt corn 

registrants in improving its compliance assurance program and continue to integrate this 

registration into the current compliance assurance program used for its other Bt corn plantincorporated protectants. Other required features of the program are described in paragraphs 5–

22 of this section.

5] Monsanto must maintain and publicize a phased compliance approach (i.e., a guidance 

document that indicates how it will address instances of non-compliance with the terms of the 

IRM program and general criteria for choosing among options for responding to any noncompliant growers after the first year of non-compliance). While recognizing that for reasons of 

difference in business practices there are needs for flexibility between different companies, 

Monsanto must use a consistent set of standards for responding to non-compliance. An 

individual grower found to be significantly out of compliance two (2) years in a row would be 

denied access to Monsanto’s Bt corn products 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 Bt corn.

6] The IRM compliance assurance program shall include an annual survey, conducted by an 

independent third party, of a statistically representative sample of growers of MON 88017 x 

MON 810 who plant the vast majority of all corn in the United States and in areas in which the 

selection intensity is greatest. The survey shall consider only those growers who plant 200 or 

more acres of corn in the Corn Belt and who plant 100 or more acres or corn in corn-cotton 

areas. 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 independent 

marketing research firms 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 United States. 

i. A third party is classified as a party other than Monsanto, the grower, or anyone 

else with a direct interest in IRM compliance for Bt corn.

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.
90

8] The survey shall be designed to obtain grower feedback on the usefulness of specific 

educational tools and initiatives.

9] Monsanto shall provide 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, on or before January 31st of each year. Monsanto shall confer with other registrants and 

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 6–8 of this section, and from other sources. The changes shall address aspects 

of grower compliance that are not sufficiently high. Monsanto must confer with EPA prior to 

adopting any changes.

11] Monsanto shall conduct an annual on-farm assessment program. Monsanto shall train its 

representatives who make on-farm visits with MON 88017 x MON 810 growers to perform 

assessments of compliance with IRM requirements. There is no minimum corn acreage size for 

this program. Therefore, growers will be selected for this program from across all farm sizes. In 

the event that any of these visits result in the identification of a grower who is not in compliance 

with the IRM program, Monsanto shall take appropriate action, consistent with its phased 

compliance approach, to promote compliance. 

12] Monsanto shall carry out a program for investigating legitimate tips and complaints that 

MON 88017 x MON 810 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, Monsanto shall take appropriate action, consistent with its phased compliance 

approach.

13] If a grower, who purchases MON 88017 x MON 810 for planting, was specifically 

identified as not being in compliance during the previous year, Monsanto shall visit with the 

grower and evaluate whether the grower is in compliance with the IRM program for the current 

year. 

14] Annually, Monsanto shall provide a report to EPA summarizing the activities carried out 

under its compliance assurance program for the prior year and the plans for the compliance 

assurance program during the current year. Within one (1) month of submitting this report to 

EPA, Monsanto shall meet with EPA to discuss its findings. 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. The report must inform EPA of 

the number of growers deemed ineligible to purchase Bt corn seed on the basis of continued noncompliance with the insect resistance management refuge requirements. Monsanto may elect to 

coordinate information with other registrants and report collectively the results of compliance 

assurance programs.

15] Monsanto and the seed corn dealers for Monsanto must allow a review of the compliance 

records by EPA or by a State pesticide regulatory agency if the State agency can demonstrate 
91

that confidential business information, including the names, personal information, and grower 

license numbers of the growers, will be protected. 

16] Monsanto shall revise and expand its existing compliance assurance program to include the 

following elements. Monsanto must prepare and submit, on or before January 31, 2011, a 

written description of its revised compliance assurance program. Monsanto may coordinate with 

other registrants in designing and implementing its compliance assurance program.

17] Monsanto will enhance the refuge education program throughout the seed delivery channel:

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the 

importance of correct refuge implementation and potential consequences of failure to 

plant the required refuge.

ii. Include the refuge size requirement on all MON 88017 x MON 810 seed bags or bag 

tags. The MON 88017 x MON 810 label accepted by EPA must include how this 

information will be conveyed to growers via text and graphics. This requirement may be 

phased in over the next three (3) growing seasons. Revised MON 88017 x MON 810 

labels must be submitted by January 31, 2011, 50% implementation on the MON 88017 x 

MON 810 bags or bag tags must occur by the 2012 growing season, and full 

implementation must occur by the 2013 growing season. 

18] Monsanto will focus the majority of on-farm assessments on regions with the greatest risk 

for resistance: 

i. Use Bt corn adoption, pest pressure information, and other available information to 

identify regions where the risk of resistance is greatest.

ii. Focus approximately two-thirds of on-farm assessments on these regions, with the 

remaining assessments conducted across other regions where MON 88017 x MON 810 is 

used. 

19] Monsanto will use its available MON 88017 x MON 810 sales records and other 

information to refine grower lists for on-farm assessments of their compliance with refuge 

requirements: 

i. Identify for potential on-farm assessment growers whose sales information indicates they 

have purchased MON 88017 x MON 810 but may have purchased little or no refuge seed 

from Monsanto, licensees, or affiliated companies. 

20] Monsanto will contract with third parties to perform on-farm assessments of compliance 

with refuge requirements: 

i. The third-party assessors will conduct all first-time on-farm assessments, as well as 

second-year on-farm assessments of those growers found out of compliance in a firsttime assessment. 

21] Annually, Monsanto will refine the on-farm assessment program for MON 88017 x MON 
92

810 to reflect the adoption rate and level of refuge compliance for MON 88017 x MON 810. 

22] Monsanto will follow up with growers who have been found significantly out of compliance 

under the on-farm assessment program and are found to be back in compliance the following 

year: 

i. All growers found to be significantly out of compliance in a prior year will annually be 

sent additional refuge assistance information for a minimum of 2 years by Monsanto, a 

seed supplier, or a third-party assessor, after completing the assessment process.

ii. Monsanto will conduct follow-up checks on growers found to be significantly out of 

compliance within 3 years after they are found to be back in compliance.

iii. A grower found with a second incident of significant non-compliance with refuge 

requirements for MON 88017 x MON 810 within a 5-year period will be denied access to 

Monsanto’s Bt corn products the next year.

d. Insect Resistance Monitoring and Remedial Action Plans for MON 88017 x MON 810

1] EPA is imposing the following conditions for the Cry3Bb1 toxin expressed in MON 88017 x 

MON 810:

i. Monsanto must monitor for Cry3Bb1 resistance and/or trends in increased tolerance for 

corn rootworm. Sampling should be focused in those areas in which there is the highest 

risk of resistance development. 

ii. The resistance monitoring plan must include the following: baseline sensitivity data, 

sampling (number of locations, samples per locations), sampling methodology and life 

stage sampled, bioassay methodology, standardization procedures (including quality 

assurance/quality control provisions), detection technique and sensitivity, the statistical 

analysis of the probability of detecting resistance, and a revised description of 

rootworm damage guidelines.

iii. Monsanto must develop a functional diagnostic assay for corn rootworm resistance 

monitoring to detect potentially resistant individuals and incorporate this assay into the 

annual resistance monitoring program by the 2011 season, with reporting in 2012. As 

part of this effort, Monsanto must investigate the feasibility of using the Sublethal 

Seedling Assay1as a diagnostic assay. A report of Monsanto’s progress towards this 

requirement must be submitted to EPA within six (6) months from the date of this 

amended registration.

iv. Monsanto must develop a proactive resistance monitoring program for northern corn 

rootworm (Diabrotica barberi) by the 2012 season, with reporting in 2013. This 

program should include a proposal for annual sampling and testing of northern corn 

rootworm susceptibility to Cry3Bb1. As part of the effort, Monsanto may need to 

investigate novel techniques for rearing and conducting bioassays with northern corn 

 

1

Nowatzki T, Lefko SA, Binning RR, Thompson SD, Spencer TA, Siegfried BD. 2008. Validation of a 

novel resistance monitoring technique for corn rootworm (Coleoptera: Chrysomelidae) and event DAS-59122-7 

maize. J. Appl. Entomol. 132:177–188.
93

rootworm. A report on Monsanto’s progress towards this requirement must be 

submitted within one (1) year from the date of this amended registration.

v. Monsanto must submit revised corn rootworm damage guidelines (to characterize 

unexpected pest damage) that take into consideration the comments and 

recommendations from EPA’s June 30, 2010 review of the rootworm resistance 

monitoring program for Cry3Bb1 within six (6) months from the date of this amended 

registration. 

vi. Monsanto must follow-up on grower, extension specialist, or consultant reports of 

unexpected damage or control failures for corn rootworm.

vii. Monsanto must provide EPA with a resistance monitoring report on or before August 

31st of each year, reporting on populations collected the previous year.

viii. The current remedial action plan approved for Cry3Bb1 must be used for corn 

rootworm suspected and confirmed resistance in MON 88017 x MON 810. If corn 

rootworm resistance is confirmed, all acres of MON 88017 x MON 810 and refuges 

must be treated with insecticides targeted at CRW adults and larvae.

2] EPA is imposing the following conditions for the Cry1Ab toxin expressed in MON 88017 x 

MON 810: 

Monsanto will monitor for resistance to Cry1Ab expressed in MON 88017 x MON 810. The 

monitoring program shall consist of two approaches: (1) focused population sampling and 

laboratory testing; and (2) investigation of reports of less-than expected control of labeled 

insects. Should field-relevant resistance be confirmed, an appropriate resistance management 

action plan will be implemented.

Focused Population Sampling

Monsanto shall annually sample and bioassay populations of the key target pests: Ostrinia 

nubilalis (European corn borer; ECB), Diatraea grandiosella (southwestern corn borer; SWCB), 

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 MON 88017 x MON 810 and/or 

changes in resistance allele frequency in response to the use of MON 88017 x MON 810 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 twelve (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 (6) populations. For 

CEW, the target will be a minimum of ten (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 
94

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 of MON 88017 x MON 810. 

EPA shall be consulted prior to the implementation of such modifications.

Monsanto will report to EPA, on or before August 31st of each year, the results of the population 

sampling and bioassay monitoring program. 

Any incidence of unusually low sensitivity to the Cry1Ab 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 EPA annually on or before August 

31st. The investigative steps will include the following:

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 survive the 

diagnostic concentration will be tested using methods that are representative of exposure to 

MON 88017 x MON 810 under field conditions. If progeny do not survive to adulthood, any 

suspected resistance is not field relevant and no further action is required.

3. If insects survive steps 1 and 2, resistance is confirmed, and further steps will be taken to 

evaluate the resistance. These steps may include the following:

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;

determining 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;

determining 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, Monsanto will consult with EPA to develop and implement a case-specific resistance 

management action plan.
95

Investigation of Reports of Unexpected Levels of Damage by the Target Pests

Monsanto will follow up on grower, extension specialist, or consultant reports of unexpected 

levels of damage by the lepidopteran pests listed on the pesticide label. Monsanto will instruct 

its customers to contact them if such incidents occur. Monsanto 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), Monsanto will implement the actions described below, 

based on the following definitions of suspected resistance and confirmed resistance.

Suspected Resistance

EPA defines suspected resistance to mean field reports of unexpected levels of insect-feeding 

damage for which:

the corn in question has been confirmed to be lepidopteran-active Bt corn;

the seed used had the proper percentage of corn expressing Bt protein;

the relevant plant tissues 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.

EPA does not interpret suspected resistance to mean grower reports of possible control failures 

or suspicious results from annual insect monitoring assays, nor does EPA intend that extensive 

field studies and testing be undertaken to confirm scientifically the presence of insects resistant 

to MON 88017 x MON 810 in commercial production fields before responsive measures are 

undertaken.

If resistance is suspected, Monsanto will instruct growers to do the following:

Use alternative control measures in MON 88017 x MON 810 fields in the affected region 

to control the target pest during the immediate growing season.

Destroy MON 88017 x MON 810 crop residues in the affected region within one (1) 

month after harvest with a technique appropriate for local production practices to 

minimize the possibility of resistant insects over-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 residues, Monsanto 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. 
96

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 corn 

hybrids under field conditions (ECB and SWCB only). 

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 LC50 exceeds the upper limit of the 95% 

confidence interval of the LC50 for susceptible populations surveyed both in the original 

baselines developed for this pest species and in previous years of field monitoring.

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 

Monsanto: 

EPA will receive notification within 30 days of resistance confirmation; 

Affected customers and extension agents will be notified about confirmed resistance 

within 30 days; 

Monitoring will be increased in the affected area and local target pest populations will be 

sampled annually to determine 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 corn hybrids in the affected area immediately until an effective 

local mitigation plan, approved by EPA, has been implemented; 

Monsanto will develop a case-specific resistance management action plan within 90 days 

according to the characteristics of the resistance event and local agronomic needs. 
97

Monsanto 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 

In subsequent growing seasons, maintain sales suspension and alternative resistance 

management strategies in the affected region(s) for the Bt corn hybrids that are affected 

by the resistant population until an EPA-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 EPA, on or before August 31st each year, for the duration of the registration.

e. Annual Reporting Requirements for MON 88017 x MON 810

1] Annual Sales: reported and summed by state (county level data available by request), on or 

before January 31st of each year.

2] Grower Agreement Results: number of units of MON 88017 x MON 810 seeds sold or 

shipped and not returned, and the number of such units that were sold to persons who have 

signed grower agreements, on or before January 31st of each year.

3] Grower Education: substantive changes to the education program completed during the 

previous year, on or before January 31st of each year.

4] Compliance Assurance Program: compliance assurance program activities and results for the 

previous year and plans for the compliance assurance program during the current year, on or 

before January 31st of each year.

5] Compliance Assurance Program Survey Results: survey results for the previous year and 

plans for the current year, on or before January 31st of each year.

6] Insect Resistance Monitoring Results: results of monitoring and investigations of damage 

reports, on or before August 31st of each year.
98

III. Cry 34Ab1/Cry35Ab1 BRAD Registered Products

Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Mycogen 

Seeds c/o 

Dow 

AgroSciences

68467-5

Bt Corn Event 

DAS-59122-7 with 

Cry 34/35Ab1 

(Herculex® RW Insect 

Protection)

31 August 

2005

Conditional

(amended 29 September 2010)

30 

September 

2015

1] The subject registration will automatically expire on midnight September 30, 2015.

2] The subject registration will be limited to Cry34Ab1 and Cry35Ab1 [Bacillus thuringiensis

Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their production 

(PHP17662 T-DNA) in event DAS-59122-7 corn (OECD Unique Identifier: DAS-59122-7)] for 

use in field corn. 

3] Submit/cite all data required for registration of your product under FIFRA section 3(c)(5) 

when the Environmental Protection Agency (EPA) requires registrants of similar products to 

submit such data.

4] This plant-incorporated protectant (PIP) may be combined through conventional breeding 

with other registered plant-incorporated protectants that are similarly approved for use in 

combination, through conventional breeding, with other registered plant-incorporated protectants 

to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits.

5] Should you wish to amend the refuge treatment option to allow independent treatment of the 

refuge for pests other than corn rootworms, data would be required regarding the impact of 

independent treatment of the refuge for other pests (not corn rootworm, e.g., corn borers, spider 

mites) on corn rootworm resistance management.

 

6] You must commit to do the following Insect Resistance Management (IRM) Program, 

consisting of the following elements:

Requirements relating to creation of a non-(corn rootworm-protected PIP) corn refuge in 

conjunction with the planting of any acreage of commercial Herculex® RW Insect 

Protection corn.

Requirements for Mycogen Seeds c/o Dow AgroSciences LLC (DAS) to prepare and 

require Herculex® RW Insect Protection corn users to sign grower agreements that 

impose binding contractual obligations on growers to comply with the refuge 

requirements.

Requirements for DAS to develop, implement, and report to EPA on programs to educate 

growers about IRM requirements.
99

Requirements for DAS to develop, implement, and report to EPA on programs to 

evaluate and promote growers’ compliance with IRM requirements.

Requirements for DAS to develop, implement, and report to EPA on monitoring 

programs to evaluate whether there are statistically significant and biologically relevant 

changes in susceptibility to the Cry34Ab1 and Cry35Ab1 proteins in the target insects. 

Requirements for DAS to develop, and if triggered, to implement a remedial action plan 

that would contain measures DAS 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.

Requirements for DAS, on or before January 31st of each year, to submit reports on units 

sold by state (units sold by county level will be made available to EPA upon request), 

IRM grower agreements results, and the compliance assurance program, including the 

education program.

Requirements for DAS, on or before August 31st of each year, to submit reports on 

resistance monitoring.

a. Refuge Requirements for Herculex® RW Insect Protection Corn

These refuge requirements do not apply to seed increase/propagation of inbred and hybrid seed 

corn up to a total of 20,000 acres per county and up to a combined United States (U.S.) total of 

250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more 

Bacillus thuringiensis (Bt) corn products, additional educational material and assistance are 

provided by DAS to help these growers meet the refuge requirements across their farming 

operations.

Grower agreements (also known as stewardship agreements) will specify that growers must 

adhere to the refuge requirements as described in the grower guide/product use guide and/or in 

supplements to the grower guide/product use guide. 

1) Refuge size. The use of Herculex® RW Insect Protection corn from event DAS-59122-7 

requires an accompanying 20% refuge.

2) Refuge location. The rootworm refuge is required to be planted within or adjacent (e.g., 

across the road) to the Herculex® RW Insect Protection corn field. 

3) Refuge management options. The rootworm refuge may be managed in such a way that there 

is little or no yield loss to rootworms, but must be managed in a way that it is sufficiently 

productive of susceptible rootworm adults. 

The in-field refuge options must be planted as a single block or as a series of strips 

measuring at least four (4) consecutive crop rows wide.
100

Seed mixtures of Herculex® RW Insect Protection and refuge corn are not permitted. 

If the refuge is planted on rotated ground, then Herculex® RW Insect Protection corn 

must also be planted on rotated ground. 

If the refuge is planted in continuous corn, the Herculex® RW Insect Protection corn 

field may be planted on either continuous or rotated land (option encouraged where 

western corn rootworm rotation-resistant biotype may be present). 

Application of soil insecticide is permitted in the refuge. 

Seed treatment is permitted in the refuge, either at a rate for rootworm protection or at a 

rate for controlling secondary soil pests. 

If aerial insecticides are applied to the refuge for control of corn rootworm adults, the 

same treatment must also be applied in the same time frame to Herculex® RW Insect 

Protection corn. 

Pests other than adult corn rootworms may only be treated with corn rootworm-labeled 

insecticides on the refuge acres without treating the Herculex® RW Insect Protection 

corn acres if treatment occurs when adult corn rootworms are not present. Pests on the 

Herculex® RW Insect Protection corn acres may be treated as needed without having to 

treat the refuge. 

The rootworm refuge may be planted to any corn hybrid that does not express plantincorporated protectants for rootworm control (e.g., lepidopteran-protected Bt corn, 

herbicide-tolerant corn, or conventional corn).

The refuge and Herculex® RW Insect Protection corn should be sown on the same date, 

or with the shortest window possible between planting dates, to ensure that corn root 

development is similar among varieties.

Growers are encouraged to plant the rootworm refuge in the same location each year, as it 

allows the rootworm population to remain high and the durability of the trait is extended. 

This option may be preferable to growers who wish to only think of their refuge design 

once and for growers who grow continuous corn; however, for those growers who need 

to employ crop rotation, a fixed refuge would be impractical.

b. Grower Agreements for Herculex® RW Insect Protection Corn

1] Persons purchasing Herculex® RW Insect Protection 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 
101

program.

3] DAS must continue to integrate this amended registration into the current system used for its 

other Bt corn plant-incorporated protectants, which is reasonably likely to assure that persons 

purchasing Herculex® RW Insect Protection corn will affirm annually that they are contractually 

bound to comply with the requirements of the IRM program.

4] DAS must continue to use its current grower agreement for Herculex® RW Insect Protection 

corn. If DAS 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 (30) days prior to implementing a proposed change, DAS must submit to EPA 

the text of such changes to ensure that it is consistent with the terms and conditions of this 

amended registration.

5] DAS must continue to integrate this amended registration into the current system used for its 

other Bt corn plant-incorporated protectants, which is reasonably likely to assure that persons 

purchasing Herculex® RW Insect Protection corn sign grower agreement(s).

6] DAS shall maintain records of all Herculex® RW Insect Protection corn grower agreements 

for a period of three (3) years from December 31st of the year in which the agreement was 

signed.

7] Annually, DAS shall provide EPA with a report showing the number of units of Herculex® 

RW Insect Protection 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 12-month period covering the prior August through July.

8] DAS 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 numbers of the 

growers, will be protected.

c. IRM Education and Compliance Monitoring Programs for Herculex® RW Insect 

Protection Corn

1] DAS must continue to implement and enhance (as set forth in paragraph 17 of this section) a 

comprehensive, ongoing IRM education program designed to convey to Herculex® RW Insect 

Protection corn users the importance of complying with the IRM program. The program shall 

include information encouraging Herculex® RW Insect Protection corn users to pursue optional 

elements of the IRM program relating to refuge configuration and proximity to Herculex® RW 

Insect Protection 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 Herculex® RW 

Insect Protection corn user separate from the grower technical guide. The communication shall 

inform the user of the current IRM requirements. DAS shall coordinate its education programs 
102

with educational efforts of other registrants and organizations, such as the National Corn 

Growers Association and state extension programs.

2] Annually, DAS shall revise, and expand as necessary, its education program to take into 

account the information collected through the compliance survey, required under paragraph 6–8 

of this section, and from other sources. The changes shall address aspects of grower compliance 

that are not sufficiently high.

3] Annually, DAS must provide EPA any substantive changes to its grower education activities 

as part of the overall IRM compliance assurance program report. DAS must either submit a 

separate report or contribute to the report from the industry working group, Agricultural 

Biotechnology Stewardship Technical Committee (ABSTC). The required features of the 

compliance assurance program are described in paragraphs 4–22 of this section.

4] DAS must continue to implement and improve an ongoing IRM compliance assurance 

program designed to evaluate the extent to which growers purchasing Herculex® RW Insect 

Protection corn 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 DAS’ Bt corn products. DAS shall coordinate with other Bt

corn registrants in improving its compliance assurance program and continue to integrate this 

amended registration into the current compliance assurance program used for its other Bt corn 

plant-incorporated protectants. Other required features of the program are described in 

paragraphs 5–22 of this section.

5] DAS must maintain and publicize a phased compliance approach (i.e., a guidance document 

that indicates how it will address instances of non-compliance with the terms of the IRM 

program and general criteria for choosing among options for responding to any non-compliant 

growers after the first year of non-compliance). While recognizing that for reasons of difference 

in business practices there are needs for flexibility between different companies, DAS must use a 

consistent set of standards for responding to non-compliance. An individual grower found to be 

significantly out of compliance two (2) years in a row would be denied access to DAS’ Bt corn 

products 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 Bt corn.

6] The IRM compliance assurance program shall include an annual survey, conducted by an 

independent third party, of a statistically representative sample of growers of Herculex® RW 

Insect Protection corn who plant the vast majority of all corn in the United States and in areas in 

which the selection intensity is greatest. The survey shall consider only those growers who plant 

200 or more acres of corn in the Corn Belt and who plant 100 or more acres of corn in corncotton areas. 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 

independent marketing research firms 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 United States. 

i. A third party is classified as a party other than DAS, the grower, or anyone 

else with a direct interest in IRM compliance for Bt corn.
103

7] The survey shall be designed to provide an understanding of any difficulties growers 

encounter in implementing IRM requirements. An analysis of 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] DAS shall provide 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 on or 

before January 31st of each year. DAS shall confer with other registrants and EPA on the design 

and content of the survey prior to its implementation.

10] Annually, DAS shall revise, and expand as necessary, its compliance assurance program to

take into account the information collected through the compliance survey, required under 

paragraphs 6–8 of this section, and from other sources. The changes shall address aspects of 

grower compliance that are not sufficiently high. DAS must confer with EPA prior to adopting 

any changes.

11] DAS shall conduct an annual on-farm assessment program. DAS shall train its 

representatives who make on-farm visits with Herculex® RW Insect Protection corn growers to 

perform assessments of compliance with IRM requirements. There is no minimum corn acreage 

size for this program. Therefore, growers will be selected for this program from across all farm 

sizes. In the event that any of these visits result in the identification of a grower who is not in 

compliance with the IRM program, DAS shall take appropriate action, consistent with its phased 

compliance approach, to promote compliance.

12] DAS shall carry out a program for investigating legitimate tips and complaints that 

Herculex® RW Insect Protection corn 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, DAS shall take appropriate action, consistent with its phased compliance 

approach.

13] If a grower, who purchases Herculex® RW Insect Protection corn for planting, was 

specifically identified as not being in compliance during the previous year, DAS shall visit with 

the grower and evaluate whether the grower is in compliance with the IRM program for the 

current year.

14] Annually, DAS shall provide a report to EPA summarizing the activities carried out under 

its compliance assurance program for the prior year and the plans for the compliance assurance 

program during the current year. Within one (1) month of submitting this report to EPA, DAS 

shall meet with EPA to discuss its findings. 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. The report must inform EPA of the number of 

growers deemed ineligible to purchase Bt corn seed on the basis of continued non-compliance 

with the insect resistance management refuge requirements. DAS may elect to coordinate 

information with other registrants and report collectively the results of compliance assurance 
104

programs.

15] DAS and the seed corn dealers for DAS 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 

numbers of the growers, will be protected.

16] DAS shall revise and expand its existing compliance assurance program to include the 

following elements. DAS must prepare and submit, on or before January 31, 2011, a written 

description of its revised compliance assurance program. DAS may coordinate with other 

registrants in designing and implementing its compliance assurance program.

17] DAS will enhance the refuge education program throughout the seed delivery channel: 

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the 

importance of correct refuge implementation and potential consequences of failure to 

plant the required refuge. 

ii. Include the refuge size requirement on all Herculex® RW Insect Protection corn seed 

bags or bag tags. The Herculex® RW Insect Protection corn label accepted by EPA 

must include how this information will be conveyed to growers via text and graphics. 

This requirement may be phased in over the next three (3) growing seasons. Revised 

Herculex® RW Insect Protection corn labels must be submitted by January 31, 2011, 

50% implementation on the Herculex® RW Insect Protection corn bags or bag tags 

must occur by the 2012 growing season, and full implementation must occur by the 

2013 growing season.

18] DAS will focus the majority of on-farm assessments on regions with the greatest risk for 

resistance:

i. Use Bt corn adoption, pest pressure information, and other available information to 

identify regions where the risk of resistance is greatest.

ii. Focus approximately two-thirds of on-farm assessments on these regions, with the 

remaining assessments conducted across other regions where Herculex® RW Insect 

Protection corn is used.

19] DAS will use its available Herculex® RW Insect Protection corn sales records and other 

information to refine grower lists for on-farm assessments of their compliance with refuge 

requirements:

i. Identify for potential on-farm assessment growers whose sales information indicates 

they have purchased Herculex® RW Insect Protection corn but may have purchased 

little or no refuge seed from DAS, licensees, or affiliated companies.

20] DAS will contract with third parties to perform on-farm assessments of compliance with 

refuge requirements:
105

i. The third-party assessors will conduct all first-time on-farm assessments, as well as 

second-year on-farm assessments, of those growers found out of compliance in a 

first-time assessment.

21] Annually, DAS will refine the on-farm assessment program for Herculex® RW Insect 

Protection corn to reflect the adoption rate and level of refuge compliance for Herculex® RW 

Insect Protection corn.

22] DAS will follow up with growers who have been found significantly out of compliance 

under the on-farm assessment program and are found to be back in compliance the following 

year: 

i. All growers found to be significantly out of compliance in a prior year will annually 

be sent additional refuge assistance information for a minimum of 2 years by DAS, a 

seed supplier, or a third-party assessor, after completing the assessment process.

ii. DAS will conduct follow-up checks on growers found to be significantly out of 

compliance within three (3) years after they are found to be back in compliance. 

iii. A grower found with a second incident of significant non-compliance with refuge 

requirements for Herculex® RW Insect Protection corn within a 5-year period will be 

denied access to DAS’ Bt corn products the next year.

d. Insect Resistance Monitoring and Remedial Action Plan for Herculex® RW Insect 

Protection Corn

EPA is imposing the following conditions for the Cry34Ab1 and Cry35Ab1 toxins expressed in 

Herculex® RW Insect Protection corn:

1] DAS must monitor for Cry34/35Ab1 resistance and/or trends in increased tolerance for corn 

rootworm. Sampling should be focused in those areas in which there is the highest risk of 

resistance development.

2] The resistance monitoring plan must include the following: baseline sensitivity data, 

sampling (number of locations, samples per locations), sampling methodology and life stage 

sampled, bioassay methodology, standardization procedures (including quality assurance/quality 

control provisions), detection technique and sensitivity, statistical analysis of the probability of 

detecting resistance, and a revised description of rootworm damage guidelines.

3] DAS must develop a functional diagnostic assay for corn rootworm resistance monitoring to 

detect potentially resistant individuals and incorporate this assay into the annual resistance 

monitoring program by the 2011 season, with reporting in 2012. As part of this effort, DAS 

must investigate the feasibility of using the Sublethal Seedling AssayIas a diagnostic assay. A 

 

I Nowatzki T, Lefko SA, Binning RR, Thompson SD, Spencer TA, Siegfried BD. 2008. Validation of a novel 

resistance monitoring technique for corn rootworm (Coleoptera: Chrysomelidae) and event DAS-59122-7 maize. J. 

Appl. Entomol. 132:177–188.
106

report of DAS’ progress towards this requirement must be submitted to EPA within six (6) 

months from the date of this amended registration.

4] DAS must develop a proactive resistance monitoring program for northern corn rootworm 

(Diabrotica barberi) by the 2012 season, with reporting in 2013. This program should include a 

proposal for annual sampling and testing of northern corn rootworm susceptibility to 

Cry34/35Ab1. As part of the effort, DAS may need to investigate novel techniques for rearing 

and conducting bioassays with northern corn rootworm. A report on DAS’ progress towards this 

requirement must be submitted within one (1) year from the date of this amended registration.

5] DAS must submit revised corn rootworm damage guidelines (to characterize unexpected pest 

damage) that take into consideration the comments and recommendations from EPA’s June 30, 

2010 review of the rootworm resistance monitoring program for Cry34/35Ab1 within six (6) 

months from the date of this amended registration.

6] DAS must follow-up on grower, extension specialist, or consultant reports of unexpected 

damage or control failures for corn rootworm.

7] DAS must provide EPA with a resistance monitoring report on or before August 31st of each 

year, reporting on populations collected the previous year.

8] The remedial action plan is designed as a tiered approach for mitigating Diabrotica virgifera 

virgifera (western corn rootworm; WCRW), Diabrotica barberi (northern corn rootworm; 

NCRW), and Diabrotica virgifera zeae (Mexican corn rootworm; MCRW) resistance 

development to the Cry34Ab1 and Cry35Ab1 proteins. The following program summary 

describes, in order of events, the steps that must be taken to implement a remedial action plan if 

resistance to the target pests is confirmed. 

Definition of Suspected Resistance

Resistance will be suspected if investigations of unexpected damage reports show the following:

i. implicated corn plant roots were expressing the Cry34Ab1 and Cry35Ab1 proteins at 

the expected levels;

ii. the seed used was not mixed with non-Cry34/35Ab1 seed;

iii. alternative causes of damage or lodging, such as nontarget pest insect species,

weather, physical damage, larval movement from alternate hosts, planting errors, and 

other reasonable causes for the observations, have been ruled out; and

iv. the level of damage exceeds guidelines for expected damage.

If resistance is suspected, DAS will instruct affected growers to use alternate pest control 

measures, such as adulticide treatment, crop rotation the following year, or use of soil or seed 

insecticides the following year. These measures are intended to reduce the possibility of 

potentially resistant insects contributing to the following year’s pest population.
107

Confirmation of Resistance

Resistance will be confirmed if all of the following criteria are met by progeny from the target 

pest species sampled from the area of suspected resistance:

i. the proportion of larvae that can feed and survive on Herculex® RW Insect Protection 

corn roots from neonate to adult is significantly higher than the baseline proportion 

(currently being established);

ii. the LC50 of the test population exceeds the upper limit of the 95% confidence interval 

for the LC50 of a standard unselected population, and/or survival in the diagnostic 

assay is significantly greater than that of a standard unselected population, as 

established by the ongoing baseline monitoring program;

iii. the ability to survive is heritable;

iv. Herculex® RW Insect Protection corn plant assays determine that damage caused by 

surviving insects would exceed economic thresholds; and

v. if subsequent collections in the affected field area demonstrate similar bioassay 

results.

Response to Confirmed Resistance

When resistance is confirmed, the following steps will be taken: 

i. EPA will receive notification within 30 days of confirming resistance;

ii. affected customers and extension agents will be notified about confirmed resistance;

iii. affected customers and extension agents will be encouraged to employ alternative 

corn rootworm control measures;

iv. sale and distribution of Herculex® RW Insect Protection corn in the affected area will 

cease immediately; and

v. a long-term resistance management action plan will be devised according to the 

characteristics of the resistance event and local agronomic needs. 

e. Annual Reporting Requirements for Herculex® RW Insect Protection Corn

1] Annual Sales: reported and summed by state (county level data available by request), on or 

before January 31st of each year.

2] Grower Agreement Results: number of units of Herculex® RW Insect Protection corn seeds 

sold or shipped and not returned, and the number of such units that were sold to persons who 

have signed grower agreements, on or before January 31st of each year.
108

3] Grower Education: substantive changes to the education program completed during the 

previous year, on or before January 31st of each year.

4] Compliance Assurance Program: compliance assurance program activities and results for the 

previous year and plans for the compliance assurance program during the current year, on or 

before January 31st of each year.

5] Compliance Assurance Program Survey Results: survey results for the previous year and 

plans for the current year, on or before January 31st of each year.

6] Insect Resistance Monitoring Results: results of monitoring and investigations of damage 

reports, on or before August 31st of each year.
109

Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Pioneer HiBred 

International, 

Incorporated

29964-4

Bt Corn Event 

DAS-59122-7 

with Cry34/35Ab1

(Herculex® 

Rootworm Insect 

Protection)

31 August 

2005

Conditional

(amended 29 September 2010)

30 September 

2015

1] The subject registration will automatically expire on midnight September 30, 2015.

2] The subject registration will be limited to Cry34Ab1 and Cry35Ab1 [Bacillus thuringiensis

Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their production 

(PHP17662 T-DNA) in event DAS-59122-7 corn (OECD Unique Identifier: DAS-59122-7)] for 

use in field corn. 

3] Submit/cite all data required for registration of your product under FIFRA section 3(c)(5) 

when the Environmental Protection Agency (EPA) requires registrants of similar products to 

submit such data.

4] This plant-incorporated protectant (PIP) may be combined through conventional breeding 

with other registered plant-incorporated protectants that are similarly approved for use in 

combination, through conventional breeding, with other registered plant-incorporated protectants 

to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits.

5] Should you wish to amend the refuge treatment option to allow independent treatment of the 

refuge for pests other than corn rootworms, data would be required regarding the impact of 

independent treatment of the refuge for other pests (not corn rootworm, e.g., corn borers, spider 

mites) on corn rootworm resistance management. 

6] You must commit to do the following Insect Resistance Management (IRM) Program, 

consisting of the following elements:

Requirements relating to creation of a non-(corn rootworm-protected PIP) corn refuge in 

conjunction with the planting of any acreage of commercial Herculex® Rootworm Insect 

Protection corn.

Requirements for Pioneer Hi-Bred International, Incorporated (Pioneer) to prepare and 

require Herculex® Rootworm Insect Protection corn users to sign grower agreements that 

impose binding contractual obligations on growers to comply with the refuge 

requirements.

Requirements for Pioneer to develop, implement, and report to EPA on programs to 

educate growers about IRM requirements.

Requirements for Pioneer to develop, implement, and report to EPA on programs to 
110

evaluate and promote growers’ compliance with IRM requirements.

Requirements for Pioneer to develop, implement, and report to EPA on monitoring 

programs to evaluate whether there are statistically significant and biologically relevant 

changes in susceptibility to the Cry34Ab1 and Cry35Ab1 proteins in the target insects. 

Requirements for Pioneer to develop, and if triggered, to implement a remedial action 

plan that would contain measures Pioneer 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.

Requirements for Pioneer, on or before January 31st of each year, to submit reports on 

units sold by state (units sold by county level will be made available to EPA upon 

request), IRM grower agreements results, and the compliance assurance program, 

including the education program. 

Requirements for Pioneer, on or before August 31st of each year, to submit reports on 

resistance monitoring.

a. Refuge Requirements for Herculex® Rootworm Insect Protection Corn

These refuge requirements do not apply to seed increase/propagation of inbred and hybrid seed 

corn up to a total of 20,000 acres per county and up to a combined United States (U.S.) total of 

250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more 

Bacillus thuringiensis (Bt) corn products, additional educational material and assistance will be 

provided by Pioneer to help these growers meet the refuge requirements across their farming 

operations.

Grower agreements (also known as stewardship agreements) will specify that growers must 

adhere to the refuge requirements as described in the grower guide/product use guide and/or in 

supplements to the grower guide/product use guide.

1] Refuge size. The use of Herculex® Rootworm Insect Protection corn from event DAS 59122-

7 requires an accompanying 20% refuge.

2] Refuge location. The rootworm refuge is required to be planted within or adjacent (e.g., 

across the road) to the Herculex® Rootworm Insect Protection corn field. 

3] Refuge management options. The rootworm refuge may be managed in such a way that there 

is little or no yield loss to rootworms, but must be managed in a way that it is sufficiently 

productive of susceptible rootworm adults. 

The in-field refuge options must be planted as a single block or as a series of strips 

measuring at least four (4) consecutive crop rows wide.
111

Seed mixtures of Herculex® Rootworm Insect Protection and refuge corn are not 

permitted. 

If the refuge is planted on rotated ground, then Herculex® Rootworm Insect Protection 

corn must also be planted on rotated ground. 

If the refuge is planted in continuous corn, the Herculex® Rootworm Insect Protection 

corn field may be planted on either continuous or rotated land (option encouraged where 

western corn rootworm rotation-resistant biotype may be present). 

Application of soil insecticide is permitted in the refuge. 

Seed treatment is permitted in the refuge, either at a rate for rootworm protection or at a 

rate for controlling secondary soil pests. 

If aerial insecticides are applied to the refuge for control of corn rootworm adults, the 

same treatment must also be applied in the same time frame to Herculex® Rootworm 

Insect Protection corn. 

Pests other than adult corn rootworms can only be treated with corn rootworm-labeled 

insecticides on the refuge acres without treating the Herculex® Rootworm Insect 

Protection corn acres if treatment occurs when adult corn rootworms are not present. 

Pests on the Herculex® Rootworm Insect Protection corn acres can be treated as needed 

without having to treat the refuge. 

The rootworm refuge can be planted to any corn hybrid that does not express plantincorporated protectants for rootworm control (e.g., lepidopteran-protected Bt corn, 

herbicide-tolerant corn, or conventional corn).

The refuge and Herculex® Rootworm Insect Protection 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.

Growers are encouraged to plant the rootworm refuge in the same location each year, as it 

allows the rootworm population to remain high and the durability of the trait is extended. 

This option may be preferable to growers who wish to only think of their refuge design 

once and for growers who grow continuous corn; however, for those growers who need 

to employ crop rotation, a fixed refuge would be impractical.

b. Grower Agreements for Herculex® Rootworm Insect Protection Corn

1] Persons purchasing Herculex® Rootworm Insect Protection 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 
112

agreement, a grower must be contractually bound to comply with the requirements of the IRM 

program.

3] Pioneer must continue to integrate this amended registration into the current system used for 

its other Bt corn plant-incorporated protectants, which is reasonably likely to assure that persons 

purchasing Herculex® Rootworm Insect Protection corn will affirm annually that they are 

contractually bound to comply with the requirements of the IRM program.

4] Pioneer must continue to use its current grower agreement for Herculex® Rootworm Insect 

Protection corn. If Pioneer 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 (30) days prior to implementing a proposed change, Pioneer must submit to 

EPA the text of such changes to ensure that it is consistent with the terms and conditions of this 

amended registration. 

5] Pioneer must continue to integrate this amended registration into the current system used for 

its other Bt corn plant-incorporated protectants, which is reasonably likely to assure that persons 

purchasing Herculex® Rootworm Insect Protection corn sign grower agreement(s).

6] Pioneer shall maintain records of all Herculex® Rootworm Insect Protection corn grower 

agreements for a period of 3 years from December 31st of the year in which the agreement was 

signed.

7] Annually, Pioneer shall provide EPA with a report showing the number of units of 

Herculex® Rootworm Insect Protection 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 12-month period covering the prior August through July.

8] Pioneer 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 numbers of the 

growers, will be protected.

c. IRM Education and Compliance Monitoring Programs for Herculex® Rootworm Insect 

Protection Corn

1] Pioneer must continue to implement and enhance (as set forth in paragraph 17 of this section) 

a comprehensive, ongoing IRM education program designed to convey to Herculex® Rootworm 

Insect Protection corn users the importance of complying with the IRM program. The program 

shall include information encouraging Herculex® Rootworm Insect Protection corn users to 

pursue optional elements of the IRM program relating to refuge configuration and proximity to 

Herculex® Rootworm Insect Protection 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 

Herculex® Rootworm Insect Protection corn user separate from the grower technical guide. The 
113

communication shall inform the user of the current IRM requirements. Pioneer shall coordinate 

its education programs with educational efforts of other registrants and organizations, such as the 

National Corn Growers Association and state extension programs.

2] Annually, Pioneer shall revise, and expand as necessary, its education program to take into 

account the information collected through the compliance survey, required under paragraph 6–8 

of this section, and from other sources. The changes shall address aspects of grower compliance 

that are not sufficiently high.

3] Annually, Pioneer must provide EPA any substantive changes to its grower education 

activities as part of the overall IRM compliance assurance program report. Pioneer must either 

submit a separate report or contribute to the report from the industry working group, Agricultural 

Biotechnology Stewardship Technical Committee (ABSTC). The required features of the 

compliance assurance program are described in paragraphs 4–22 of this section.

4] Pioneer must continue to implement and improve an ongoing IRM compliance assurance 

program designed to evaluate the extent to which growers purchasing Herculex® Rootworm 

Insect Protection corn 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 Pioneer’s Bt corn products. Pioneer shall coordinate with 

other Bt corn registrants in improving its compliance assurance program and continue to 

integrate this amended registration into the current compliance assurance program used for its 

other Bt corn plant-incorporated protectants. Other required features of the program are 

described in paragraphs 5–22 of this section.

5] Pioneer must maintain and publicize a phased compliance approach (i.e., a guidance 

document that indicates how it will address instances of non-compliance with the terms of the 

IRM program and general criteria for choosing among options for responding to any noncompliant growers after the first year of non-compliance). While recognizing that for reasons of 

difference in business practices there are needs for flexibility between different companies, 

Pioneer must use a consistent set of standards for responding to non-compliance. An individual 

grower found to be significantly out of compliance two (2) years in a row would be denied 

access to Pioneer’s Bt corn products 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 Bt corn.

6] The IRM compliance assurance program shall include an annual survey, conducted by an 

independent third party, of a statistically representative sample of growers of Herculex® 

Rootworm Insect Protection corn who plant the vast majority of all corn in the United States and 

in areas in which the selection intensity is greatest. The survey shall consider only those growers 

who plant 200 or more acres of corn in the Corn Belt and who plant 100 or more acres of corn in 

corn-cotton areas. 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 

independent marketing research firms 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 United States. 
114

i. A third party is classified as a party other than Pioneer, the grower, or anyone 

else with a direct interest in IRM compliance for Bt corn.

7] The survey shall be designed to provide an understanding of any difficulties growers 

encounter in implementing IRM requirements. An analysis of 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] Pioneer shall provide 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 on or before January 31st of each year. Pioneer shall confer with other registrants and EPA 

on the design and content of the survey prior to its implementation.

10] Annually, Pioneer shall revise, and expand as necessary, its compliance assurance program 

to take into account the information collected through the compliance survey, required under 

paragraphs 6–8 of this section, and from other sources. The changes shall address aspects of 

grower compliance that are not sufficiently high. Pioneer must confer with EPA prior to 

adopting any changes.

11] Pioneer shall conduct an annual on-farm assessment program. Pioneer shall train its 

representatives who make on-farm visits with Herculex® Rootworm Insect Protection corn 

growers to perform assessments of compliance with IRM requirements. There is no minimum 

corn acreage size for this program. Therefore, growers will be selected for this program from 

across all farm sizes. In the event that any of these visits result in the identification of a grower 

who is not in compliance with the IRM program, Pioneer shall take appropriate action, consistent 

with its phased compliance approach, to promote compliance.

12] Pioneer shall carry out a program for investigating legitimate tips and complaints that 

Herculex® Rootworm Insect Protection corn 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, Pioneer shall take appropriate action, consistent with its 

phased compliance approach.

13] If a grower, who purchases Herculex® Rootworm Insect Protection corn for planting, was 

specifically identified as not being in compliance during the previous year, Pioneer shall visit 

with the grower and evaluate whether the grower is in compliance with the IRM program for the 

current year.

14] Annually, Pioneer shall provide a report to EPA summarizing the activities carried out under 

its compliance assurance program for the prior year and the plans for the compliance assurance 

program during the current year. Within one (1) month of submitting this report to EPA, Pioneer 

shall meet with EPA to discuss its findings. 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. The report must inform EPA of the number of 

growers deemed ineligible to purchase Bt corn seed on the basis of continued non-compliance 
115

with the insect resistance management refuge requirements. Pioneer may elect to coordinate 

information with other registrants and report collectively the results of compliance assurance 

programs.

15] Pioneer and the seed corn dealers for Pioneer 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 

numbers of the growers, will be protected.

16] Pioneer shall revise and expand its existing compliance assurance program to include the 

following elements. Pioneer must prepare and submit, on or before January 31, 2011, a written 

description of its revised compliance assurance program. Pioneer may coordinate with other 

registrants in designing and implementing its compliance assurance program.

17] Pioneer will enhance the refuge education program throughout the seed delivery channel: 

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the 

importance of correct refuge implementation and potential consequences of failure to 

plant the required refuge. 

ii. Include the refuge size requirement on all Herculex® Rootworm Insect Protection 

corn seed bags or bag tags. The Herculex® Rootworm Insect Protection corn label 

accepted by EPA must include how this information will be conveyed to growers via 

text and graphics. This requirement may be phased in over the next three (3) growing 

seasons. Revised Herculex® Rootworm Insect Protection corn labels must be 

submitted by January 31, 2011, 50% implementation on the Herculex® Rootworm 

Insect Protection corn seed bags or bag tags must occur by the 2012 growing season,

and full implementation must occur by the 2013 growing season.

18] Pioneer will focus the majority of on-farm assessments on regions with the greatest risk for 

resistance:

i. Use Bt corn adoption, pest pressure information, and other available information to 

identify regions where the risk of resistance is greatest.

ii. Focus approximately two-thirds of on-farm assessments on these regions, with the 

remaining assessments conducted across other regions where Herculex® Rootworm 

Insect Protection corn is used.

19] Pioneer will use its available Herculex® Rootworm Insect Protection corn sales records and 

other information to refine grower lists for on-farm assessments of their compliance with refuge 

requirements:

i. Identify for potential on-farm assessment growers whose sales information indicates 

they have purchased Herculex® Rootworm Insect Protection corn but may have 

purchased little or no refuge seed from Pioneer, licensees, or affiliated companies.

20] Pioneer will contract with third parties to perform on-farm assessments of compliance with 
116

refuge requirements:

i. The third-party assessors will conduct all first-time on-farm assessments, as well as 

second-year on-farm assessments, of those growers found out of compliance in a 

first-time assessment.

21] Annually, Pioneer will refine the on-farm assessment program for Herculex® Rootworm 

Insect Protection corn to reflect the adoption rate and level of refuge compliance for Herculex® 

Rootworm Insect Protection corn.

22] Pioneer will follow up with growers who have been found significantly out of compliance 

under the on-farm assessment program and are found to be back in compliance the following 

year: 

i. All growers found to be significantly out of compliance in a prior year will annually 

be sent additional refuge assistance information for a minimum of 2 years by Pioneer, 

a seed supplier, or a third-party assessor, after completing the assessment process.

ii. Pioneer will conduct follow-up checks on growers found to be significantly out of 

compliance within three (3) years after they are found to be back in compliance. 

iii. A grower found with a second incident of significant non-compliance with refuge 

requirements for Herculex® Rootworm Insect Protection corn within a 5-year period 

will be denied access to Pioneer’s Bt corn products the next year.

d. Insect Resistance Monitoring and Remedial Action Plan for Herculex® Rootworm 

Insect Protection Corn

EPA is imposing the following conditions for the Cry34Ab1 and Cry35Ab1 toxins expressed in 

Herculex® Rootworm Insect Protection corn:

1] Pioneer must monitor for Cry34/35Ab1 resistance and/or trends in increased tolerance for 

corn rootworm. Sampling should be focused in those areas in which there is the highest risk of 

resistance development.

2] The resistance monitoring plan must include the following: baseline sensitivity data, sampling 

(number of locations, samples per locations), sampling methodology and life stage sampled, 

bioassay methodology, standardization procedures (including QA/QC provisions), detection 

technique and sensitivity, statistical analysis of the probability of detecting resistance, and a 

revised description of rootworm damage guidelines.

3] Pioneer must develop a functional diagnostic assay for corn rootworm resistance monitoring 

to detect potentially resistant individuals and incorporate this assay into the annual resistance 

monitoring program by the 2011 season, with reporting in 2012. As part of this effort, Pioneer 

must investigate the feasibility of using the Sublethal Seedling AssayII as a diagnostic assay. A 

 

II Nowatzki T, Lefko SA, Binning RR, Thompson SD, Spencer TA, Siegfried BD. 2008. Validation of a novel 

resistance monitoring technique for corn rootworm (Coleoptera: Chrysomelidae) and event DAS-59122-7 maize. J. 
117

report of Pioneer’s progress towards this requirement must be submitted to EPA within six (6) 

months from the date of this amended registration.

4] Pioneer must develop a proactive resistance monitoring program for northern corn rootworm 

(Diabrotica barberi) by the 2012 season, with reporting in 2013. This program should include a 

proposal for annual sampling and testing of northern corn rootworm susceptibility to 

Cry34/35Ab1. As part of the effort, Pioneer may need to investigate novel techniques for rearing 

and conducting bioassays with northern corn rootworm. A report on Pioneer’s progress towards 

this requirement must be submitted within one (1) year from the date of this amended 

registration.

5] Pioneer must submit revised corn rootworm damage guidelines (to characterize unexpected 

pest damage) that take into consideration the comments and recommendations from EPA’s June 

30, 2010 review of the rootworm resistance monitoring program for Cry34/35Ab1 within six (6) 

months from the date of this amended registration.

6] Pioneer must follow-up on grower, extension specialist, or consultant reports of unexpected 

damage or control failures for corn rootworm.

7] Pioneer must provide EPA with a resistance monitoring report on or before August 31st of 

each year, reporting on populations collected the previous year.

8] The remedial action plan is designed as a tiered approach for mitigating Diabrotica virgifera 

virgifera (western corn rootworm; WCRW), Diabrotica barberi (northern corn rootworm; 

NCRW), and Diabrotica virgifera zeae (Mexican corn rootworm; MCRW) resistance 

development to the Cry34Ab1 and Cry35Ab1 proteins. The following program summary 

describes, in order of events, the steps that must be taken to implement a remedial action plan if 

resistance to the target pests is confirmed. 

Definition of Suspected Resistance

If resistance is “suspected”, the registrants will instruct affected growers to use alternate pest 

control measures such as adulticide treatment, crop rotation the following year, or use of soil or 

seed insecticides the following year. These measures are intended to reduce the possibility of 

potentially resistant insects contributing to the following year’s pest population.

Resistance will be suspected if investigations of unexpected damage reports show the following:

i. implicated corn plant roots were expressing the Cry34Ab1 and Cry35Ab1 proteins at 

the expected levels;

ii. the seed used was not mixed with non-Cry34/35Ab1 seed;

iii. alternative causes of damage or lodging, such as nontarget pest insect species, 

weather, physical damage, larval movement from alternate hosts, planting errors, and 

other reasonable causes for the observations, have been ruled out; and

 

Appl. Entomol. 132:177–188.
118

iv. the level of damage exceeds guidelines for expected damage.

If resistance is suspected, Pioneer will instruct affected growers to use alternate pest control 

measures, such as adulticide treatment, crop rotation the following year, or use of soil or seed 

insecticides the following year. These measures are intended to reduce the possibility of 

potentially resistant insects contributing to the following year’s pest population.

Confirmation of Resistance

Resistance will be confirmed if all of the following criteria are met by progeny from the target 

pest species sampled from the area of suspected resistance:

i. the proportion of larvae that can feed and survive on Herculex® Rootworm Insect 

Protection corn roots from neonate to adult is significantly higher than the baseline 

proportion (currently being established);

ii. the LC50 of the test population exceeds the upper limit of the 95% confidence interval 

for the LC50 of a standard unselected population, and/or survival in the diagnostic 

assay is significantly greater than that of a standard unselected population, as 

established by the ongoing baseline monitoring program;

iii. the ability to survive is heritable;

iv. Herculex® Rootworm Insect Protection corn plant assays determine that damage 

caused by surviving insects would exceed economic thresholds; and

v. if subsequent collections in the affected field area demonstrate similar bioassay 

results.

Response to Confirmed Resistance

When resistance is confirmed, the following steps will be taken: 

i. EPA will receive notification within 30 days of confirming resistance;

ii. affected customers and extension agents will be notified about confirmed resistance;

iii. affected customers and extension agents will be encouraged to employ alternative 

corn rootworm control measures;

iv. sale and distribution of Herculex® Rootworm Insect Protection corn in the affected 

area will cease immediately; and

v. a long-term resistance management action plan will be devised according to the 

characteristics of the resistance event and local agronomic needs. 

e. Annual Reporting Requirements for Herculex® Rootworm Insect Protection Corn
119

1] Annual Sales: reported and summed by state (county level data available by request), on or 

before January 31st of each year.

2] Grower Agreement Results: number of units of Herculex® Rootworm Insect Protection corn

seeds sold or shipped and not returned, and the number of such units that were sold to persons 

who have signed grower agreements, on or before January 31st of each year.

3] Grower Education: substantive changes to the education program completed during the 

previous year, on or before January 31st of each year.

4] Compliance Assurance Program: compliance assurance program activities and results for the 

previous year and plans for the compliance assurance program during the current year, on or 

before January 31st of each year.

5] Compliance Assurance Program Survey Results: survey results for the previous year and 

plans for the current year, on or before January 31st of each year.

6] Insect Resistance Monitoring Results: results of monitoring and investigations of damage 

reports, on or before August 31st of each year.
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Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Mycogen Seeds 

c/o Dow 

AgroSciences

68467-6

Bt Corn Events DAS59122-7 + TC1507 with 

Cry34Ab1/Cry35Ab1 + 

PO Cry1F (Herculex® 

XTRA Insect 

Protection)

27 October 

2005

Conditional

(amended 29 September 2010)

30 

September 

2015

1] The subject registration will automatically expire on midnight September 30, 2015.

2] The subject registration will be limited to Cry1F [Bacillus thuringiensis Cry1F protein and 

the genetic material necessary for its production (plasmid insert PHI8999A) in event TC1507 

corn (OECD Unique Identifier: DAS-Ø15Ø7-1)] x Cry34Ab1 and Cry35Ab1 [Bacillus 

thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their 

production (PHP17662 T-DNA) in event DAS-59122-7 corn (OECD Unique Identifier: DAS59122-7)] for use in field corn. 

3] Submit/cite all data required for registration of your product under FIFRA section 3(c)(5) 

when the Environmental Protection Agency (EPA) requires registrants of similar products to 

submit such data.

4] Submit/cite all data, determined by EPA to be acceptable and required to support the 

individual plant-incorporated protectants in Herculex® I Insect Protection and Herculex® RW 

Insect Protection, within the time frames required by the terms and conditions of EPA 

Registration Numbers 68467-2 and 68467-5, respectively.

5] This plant-incorporated protectant (PIP) may be combined through conventional breeding 

with other registered plant-incorporated protectants that are similarly approved for use in 

combination, through conventional breeding, with other registered plant-incorporated protectants 

to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits.

6] You must commit to do the following Insect Resistance Management (IRM) Program, 

consisting of the following elements:

Requirements relating to creation of a refuge for the Cry1F and Cry34/35Ab1 

components that meets the requirements of the individual traits. The refuge for both 

traits may be combined by planting non-Bacillus thuringiensis (Bt) corn as the refuge, or 

the refuge for each trait may be planted separately. In the latter case, corn rootwormresistant Bt corn may be planted in the lepidopteran refuge for the Cry1F component, and 

lepidopteran-resistant Bt corn may be planted in the corn rootworm refuge for the 

Cry34/35Ab1 component.

Requirements for Mycogen Seeds c/o Dow AgroSciences LLC (DAS) to prepare and 

require Herculex® XTRA Insect Protection corn users to sign grower agreements that 

impose binding contractual obligations on growers to comply with the refuge 

requirements.
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Requirements for DAS to develop, implement, and report to EPA on programs to educate 

growers about IRM requirements.

Requirements for DAS to develop, implement, and report to EPA on programs to 

evaluate and promote growers’ compliance with IRM requirements.

Requirements for DAS to develop, implement, and report to EPA on monitoring 

programs to evaluate whether there are statistically significant and biologically relevant 

changes in susceptibility to the Cry1F and Cry34/35Ab1 proteins in the target insects.

Requirements for DAS to develop, and if triggered, to implement a remedial action plan 

that would contain measures DAS 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.

Requirements for DAS, on or before January 31st of each year, to submit reports on units 

sold by state (units sold by county level will made available to EPA upon request), IRM 

grower agreement results, and the compliance assurance program, including the 

education program.

Requirements for DAS, on or before August 31st of each year, to submit reports on 

resistance monitoring.

a. Refuge Requirements for Herculex® XTRA Insect Protection Corn

These refuge requirements do not apply to seed increase/propagation of inbred and hybrid seed 

corn up to a total of 20,000 acres per county and up to a combined United States (U.S.) total of 

250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt

corn products, additional educational material and assistance are provided by the registrant to 

help these growers meet the refuge requirements across their farming operations.

Grower agreements (also known as stewardship agreements) will specify that growers must 

adhere to the refuge requirements as described in the grower guide/product use guide and/or in 

supplements to the grower guide/product use guide.

The use of Herculex® XTRA Insect Protection corn requires accompanying refuge corn for both 

the Cry1F and Cry34/35Ab1 components that meets the requirements of the individual traits, as 

described below. The refuge for both traits may be combined by planting non-Bt corn as the 

refuge (see the “Combined Refuge Option” section), or the refuge for each trait may be planted 

separately (see the “Lepidopteran Refuge for the Cry1F Component” and “Corn Rootworm 

Refuge for the Cry34/35Ab1 Component” sections). 

For the separate refuges, corn rootworm-resistant Bt corn (e.g., Herculex® RW Insect 

Protection) may be planted in the lepidopteran refuge for the Cry1F component and 

lepidopteran-resistant Bt corn (e.g., Herculex® I Insect Protection) may be planted in the corn 
122

rootworm refuge for the Cry34/35Ab1 component. Depending on cropping practices, pest 

problems, and pest management options employed on any given farm, growers may need to 

choose different refuge arrangements for different fields. Two refuge blocks (one for rootworm, 

one for Lepidoptera) can be planted within one field, or strips can be used for either refuge. 

Alternatively, a block of Herculex® RW Insect Protection corn can serve as an in-field 

lepidopteran refuge for one field planted to Herculex® XTRA Insect Protection corn and an 

external lepidopteran refuge for separate fields planted to Herculex® XTRA Insect Protection 

corn, while the rootworm refuge is planted as Herculex® I Insect Protection corn in an external 

adjacent field. In all options, size and management of each individual refuge must be followed 

as described in the “Lepidopteran Refuge for the Cry1F Component” and “Corn Rootworm 

Refuge for the Cry34/35Ab1 Component” sections.

Other refuge designs and combinations are permissible as long as, in all cases, the size and 

management of each refuge are described in the “Lepidopteran Refuge for the Cry1F 

Component,” “Corn Rootworm Refuge for the Cry34/35Ab1 Component,” or “Combined 

Refuge Option” sections.

Lepidopteran Refuge for the Cry1F Component

1] Refuge size, Corn-growing areas (Corn Belt and other non-corn/cotton-growing areas). The 

use of Herculex® XTRA Insect Protection corn requires an accompanying 20% refuge 

consisting of non-Bt corn or corn that is not a lepidopteran-protected Bt hybrid. 

2] *Refuge size, Corn/cotton-growing areas. The use Herculex® XTRA Insect Protection corn 

requires an accompanying 50% refuge consisting of non-Bt corn or corn that is not a 

lepidopteran-protected Bt hybrid.

3] Refuge location.

The lepidopteran refuge can be planted in a separate field not more than 1⁄2 mile from the 

Herculex® XTRA Insect Protection corn field.

The lepidopteran refuge can be planted within the Herculex® XTRA Insect Protection 

corn field as blocks (e.g., along the edges or headlands).

The lepidopteran refuge can be planted within the Herculex® XTRA Insect Protection 

corn field as strips across the field at least four (4) consecutive rows wide.

4] Refuge management. 

Insecticide treatment for European corn borer (ECB), corn earworm (CEW), southwestern corn 

borer (SWCB), and other lepidopteran pests listed on the label, grower guides, or other 

educational material may be applied only if economic thresholds are reached for one (1) or more 

of these target pests. Economic thresholds will be determined using methods recommended by 

local or regional professionals (e.g., Extension Service agents or crop consultants). Instructions 

to growers will specify that microbial Bt insecticides must not be applied to refuges consisting of 

non-Bt corn or corn that is not a lepidopteran-protected Bt hybrid. 
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*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 Dunklin, New Madrid, Pemiscot, Scott, 

and Stoddard).

Corn Rootworm Refuge for the Cry34/35Ab1 Component

1] Refuge size. The use of Herculex® XTRA Insect Protection corn requires an accompanying 

20% refuge consisting of non-Bt corn or corn that is not a rootworm-protected Bt hybrid.

2] Refuge location. The rootworm refuge is required to be planted within or adjacent (e.g., 

across the road) to the Herculex® XTRA Insect Protection corn field.

3] Refuge management options. The rootworm refuge can be managed in such a way that there 

is little or no yield loss to rootworms, but must be managed in a way that it is sufficiently 

productive of susceptible rootworm adults.

The in-field rootworm refuge options must be planted as a single block or as a series of 

strips measuring at least four (4) consecutive crop rows wide.

Seed mixtures of Herculex® XTRA Insect Protection and rootworm refuge corn are not 

permitted.

If the rootworm refuge is planted on rotated ground, then Herculex® XTRA Insect 

Protection corn must also be planted on rotated ground.

If the rootworm refuge is planted in continuous corn, the Herculex® XTRA Insect 

Protection corn field may be planted on either continuous or rotated land (option 

encouraged where western corn rootworm rotation-resistant biotype may be present).

Application of soil insecticide is permitted in the rootworm refuge.

Seed treatment is permitted in the rootworm refuge, either at a rate for rootworm 

protection or at a rate for controlling secondary soil pests.

If aerial insecticides are applied to the rootworm refuge for control of corn rootworm 

adults, the same treatment must also be applied in the same time frame to Herculex® 

XTRA Insect Protection corn.
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Pests other than adult corn rootworms can be treated on the rootworm refuge acres 

without treating the Herculex® XTRA Insect Protection corn acres only if treatment 

occurs when adult corn rootworms are not present or if pesticide without activity against 

adult corn rootworms is used. Pests on the Herculex® XTRA Insect Protection corn 

acres can be treated as needed without having to treat the rootworm refuge.

The rootworm refuge can be planted to any corn hybrid that does not express plantincorporated protectants for rootworm control (e.g., lepidopteran-protected Bt corn, 

herbicide-tolerant corn, or conventional corn).

The rootworm refuge and Herculex® XTRA Insect Protection 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.

Growers are encouraged to plant the rootworm refuge in the same location each year, as it 

allows the rootworm population to remain high and the durability of the trait is extended. 

This option may be preferable to growers who wish to only think of their refuge design 

once and for growers who grow continuous corn; however, for those growers who need 

to employ crop rotation, a fixed refuge would be impractical.

Combined Refuge Option

For the combined refuge option (i.e. the lepidopteran refuge combined with the rootworm refuge 

by planting non-Bt corn), the refuge must be planted and managed such that it is consistent with 

the requirements of the two individual traits, Cry1F and Cry34/35Ab1.

1] Refuge size. The use of Herculex® XTRA Insect Protection corn requires an accompanying 

20% refuge in corn-growing areas and 50% refuge in cotton-growing areas consisting of non-Bt

corn. For the latter, see the list of states labeled with “*” in the “Lepidopteran Refuge for the 

Cry1F Component” section. 

2] Refuge location. The combined refuge is required to be planted within or adjacent (e.g., 

across the road) to the Herculex® XTRA Insect Protection corn field.

3] Refuge management options.

The in-field combined refuge options must be planted as a single block or as a series of 

strips measuring at least four (4) consecutive crop rows wide.

Seed mixtures of Herculex® XTRA Insect Protection and combined refuge corn are not 

permitted.

If the combined refuge is planted on rotated ground, then Herculex® XTRA Insect 

Protection corn must also be planted on rotated ground.
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If the combined refuge is planted in continuous corn, the Herculex® XTRA Insect 

Protection corn field may be planted on either continuous or rotated land (option 

encouraged where western corn rootworm rotation-resistant biotype may be present).

Application of soil insecticide for corn rootworm control is permitted in the combined 

refuge.

Seed treatment is permitted in the combined refuge, either at a rate for rootworm 

protection or at a rate for controlling secondary soil pests.

If aerial insecticides are applied to the combined refuge for control of corn rootworm 

adults, the same treatment must also be applied in the same time frame to Herculex® 

XTRA Insect Protection corn.

Insecticide treatments in the combined refuge for control of ECB, CEW, SWCB, and 

other lepidopteran pests listed on the label, grower guides, or other educational material 

may be applied only if economic thresholds are reached for one (1) or more of these 

target pests. Economic thresholds will be determined using methods recommended by 

local or regional professionals (e.g., Extension Service agents or crop consultants). These 

pests can be treated with corn rootworm-labeled insecticide on the combined refuge acres 

without treating the Herculex® XTRA Insect Protection corn acres only if treatment 

occurs when adult corn rootworms are not present. Instructions to growers will specify 

that microbial Bt insecticides must not be applied to the combined refuges. 

Pests other than adult corn rootworms can be treated with corn rootworm-labeled 

insecticide on the combined refuge acres without treating the Herculex® XTRA Insect 

Protection corn acres only if treatment occurs when adult corn rootworms are not present. 

Pests on the Herculex® XTRA Insect Protection corn acres can be treated as needed 

without having to treat the combined refuge.

The combined refuge can be planted to any corn hybrid that does not express plantincorporated protectants for lepidopteran or rootworm control (i.e., herbicide-tolerant 

corn or conventional corn).

The combined refuge and Herculex® XTRA Insect Protection 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.

b. Grower Agreements for Herculex® XTRA Insect Protection Corn

1] Persons purchasing Herculex® XTRA Insect Protection 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 
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agreement, a grower must be contractually bound to comply with the requirements of the IRM 

program.

3] DAS must continue to integrate this amended registration into the current system used for its 

other Bt corn plant-incorporated protectants, which is reasonably likely to assure that persons 

purchasing Herculex® XTRA Insect Protection corn will affirm annually that they are 

contractually bound to comply with the requirements of the IRM program.

4] DAS must continue to use its current grower agreement for Herculex® XTRA Insect 

Protection corn. If DAS 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 (30) days prior to implementing a proposed change, DAS must submit to 

EPA the text of such changes to ensure that it is consistent with the terms and conditions of this 

amended registration. 

5] DAS must continue to integrate this amended registration into the current system used for its 

other Bt corn plant-incorporated protectants, which is reasonably likely to assure that persons 

purchasing Herculex® XTRA Insect Protection corn sign grower agreement(s). 

6] DAS shall maintain records of all Herculex® XTRA Insect Protection corn grower 

agreements for a period of 3 years from December 31st of the year in which the agreement was 

signed.

7] Annually, DAS shall provide EPA with a report showing the number of units of Herculex® 

XTRA Insect Protection 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 12-month period covering the prior August through July.

8] DAS 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 numbers of the 

growers, will be protected.

c. IRM Education and Compliance Monitoring Programs for Herculex® XTRA Insect 

Protection Corn

1] DAS must continue to implement and enhance (as set forth in paragraph 17 of this section) a 

comprehensive, ongoing IRM education program designed to convey to Herculex® XTRA 

Insect Protection corn users the importance of complying with the IRM program. The program 

shall include information encouraging Herculex® XTRA Insect Protection corn users to pursue 

optional elements of the IRM program relating to refuge configuration and proximity to 

Herculex® XTRA Insect Protection 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 
127

Herculex® XTRA Insect Protection corn user separate from the grower technical guide. The 

communication shall inform the user of the current IRM requirements. DAS shall coordinate its 

education programs with educational efforts of other registrants and organizations, such as the 

National Corn Growers Association and state extension programs.

2] Annually, DAS shall revise, and expand as necessary, its education program to take into 

account the information collected through the compliance survey, required under paragraph 6–8 

of this section, and from other sources. The changes shall address aspects of grower compliance 

that are not sufficiently high.

3] Annually, DAS must provide EPA any substantive changes to its grower education activities 

as part of the overall IRM compliance assurance program report. DAS must either submit a 

separate report or contribute to the report from the industry working group, Agricultural 

Biotechnology Stewardship Technical Committee (ABSTC). The required features of the 

compliance assurance program are described in paragraphs 4–22 of this section.

4] DAS must continue to implement and improve an ongoing IRM compliance assurance 

program designed to evaluate the extent to which growers purchasing Herculex® XTRA Insect 

Protection corn 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 DAS’ Bt corn products. DAS shall coordinate with other Bt

corn registrants in improving its compliance assurance program and continue to integrate this 

amended registration into the current compliance assurance program used for its other Bt corn 

plant-incorporated protectants. Other required features of the program are described in 

paragraphs 5–22 of this section.

5] DAS must maintain and publicize a phased compliance approach (i.e., a guidance document 

that indicates how it will address instances of non-compliance with the terms of the IRM 

program and general criteria for choosing among options for responding to any non-compliant 

growers after the first year of non-compliance). While recognizing that for reasons of difference 

in business practices there are needs for flexibility between different companies, DAS must use a 

consistent set of standards for responding to non-compliance. An individual grower found to be 

significantly out of compliance two (2) years in a row would be denied access to DAS’ Bt corn 

products 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 Bt corn.

6] The IRM compliance assurance program shall include an annual survey, conducted by an 

independent third party, of a statistically representative sample of growers of Herculex® XTRA 

Insect Protection corn who plant the vast majority of all corn in the United States and in areas in 

which the selection intensity is greatest. The survey shall consider only those growers who plant 

200 or more acres of corn in the Corn Belt and who plant 100 or more acres of corn in corncotton areas. 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 

independent marketing research firms 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 United States. 
128

i. A third party is classified as a party other than DAS, the grower, or anyone 

else with a direct interest in IRM compliance for Bt corn.

7] The survey shall be designed to provide an understanding of any difficulties growers 

encounter in implementing IRM requirements. An analysis of 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] DAS shall provide 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 on or 

before January 31st of each year. DAS shall confer with other registrants and EPA on the design 

and content of the survey prior to its implementation.

10] Annually, DAS shall revise, and expand as necessary, its compliance assurance program to 

take into account the information collected through the compliance survey, required under 

paragraphs 6–8 of this section, and from other sources. The changes shall address aspects of 

grower compliance that are not sufficiently high. DAS must confer with EPA prior to adopting 

any changes.

11] DAS shall conduct an annual on-farm assessment program. DAS shall train its 

representatives who make on-farm visits with Herculex® XTRA Insect Protection corn growers 

to perform assessments of compliance with IRM requirements. There is no minimum corn 

acreage size for this program. Therefore, growers will be selected for this program from across 

all farm sizes. In the event that any of these visits result in the identification of a grower who is 

not in compliance with the IRM program, DAS shall take appropriate action, consistent with its 

phased compliance approach, to promote compliance.

12] DAS shall carry out a program for investigating legitimate tips and complaints that 

Herculex® XTRA Insect Protection corn 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, DAS shall take appropriate action, consistent with its phased compliance 

approach.

13] If a grower, who purchases Herculex® XTRA Insect Protection corn for planting, was 

specifically identified as not being in compliance during the previous year, DAS shall visit with 

the grower and evaluate whether the grower is in compliance with the IRM program for the 

current year.

14] Annually, DAS shall provide a report to EPA summarizing the activities carried out under 

its compliance assurance program for the prior year and the plans for the compliance assurance 

program during the current year. Within one (1) month of submitting this report to EPA, DAS 

shall meet with EPA to discuss its findings. 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. The report must inform EPA of the number of 
129

growers deemed ineligible to purchase Bt corn seed on the basis of continued non-compliance 

with the insect resistance management refuge requirements. DAS may elect to coordinate 

information with other registrants and report collectively the results of compliance assurance 

programs.

15] DAS and the seed corn dealers for DAS 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 

numbers of the growers, will be protected.

16) DAS shall revise and expand its existing compliance assurance program to include the 

following elements. DAS must prepare and submit, on or before January 31, 2011, a written 

description of its revised compliance assurance program. DAS may coordinate with other 

registrants in designing and implementing its compliance assurance program.

17) DAS will enhance the refuge education program throughout the seed delivery channel: 

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the 

importance of correct refuge implementation and potential consequences of failure to 

plant the required refuge. 

ii. Include the refuge size requirement on all Herculex® XTRA Insect Protection corn 

seed bags or bag tags. The Herculex® XTRA Insect Protection corn label accepted by 

EPA must include how this information will be conveyed to growers via text and 

graphics. This requirement may be phased in over the next three (3) growing seasons. 

Revised Herculex® XTRA Insect Protection corn labels must be submitted by January 

31, 2011, 50% implementation on the Herculex® XTRA Insect Protection corn bags 

or bag tags must occur by the 2012 growing season, and full implementation must 

occur by the 2013 growing season.

18) DAS will focus the majority of on-farm assessments on regions with the greatest risk for 

resistance:

i. Use Bt corn adoption, pest pressure information, and other available information to 

identify regions where the risk of resistance is greatest.

ii. Focus approximately two-thirds of on-farm assessments on these regions, with the 

remaining assessments conducted across other regions where Herculex® XTRA 

Insect Protection corn is used.

19] DAS will use its available Herculex® XTRA Insect Protection corn sales records and other 

information to refine grower lists for on-farm assessments of their compliance with refuge 

requirements:

i. Identify for potential on-farm assessment growers whose sales information indicates 

they have purchased Herculex® XTRA Insect Protection corn but may have 

purchased little or no refuge seed from DAS, licensees, or affiliated companies.
130

20] DAS will contract with third parties to perform on-farm assessments of compliance with 

refuge requirements:

i. The third-party assessors will conduct all first-time on-farm assessments, as well as 

second-year on-farm assessments, of those growers found out of compliance in a 

first-time assessment.

21] Annually, DAS will refine the on-farm assessment program for Herculex® XTRA Insect 

Protection corn to reflect the adoption rate and level of refuge compliance for Herculex® XTRA 

Insect Protection corn.

22] DAS will follow up with growers who have been found significantly out of compliance 

under the on-farm assessment program and are found to be back in compliance the following 

year: 

i. All growers found to be significantly out of compliance in a prior year will annually 

be sent additional refuge assistance information for a minimum of two (2) years by 

DAS, a seed supplier, or a third-party assessor, after completing the assessment 

process.

ii. DAS will conduct follow-up checks on growers found to be significantly out of 

compliance within three (3) years after they are found to be back in compliance. 

iii. A grower found with a second incident of significant non-compliance with refuge 

requirements for Herculex® XTRA Insect Protection corn within a 5-year period will 

be denied access to DAS’ Bt corn products the next year.

d. Insect Resistance Monitoring and Remedial Action Plan for Herculex® XTRA Insect 

Protection Corn

1] EPA is imposing the following conditions for the Cry1F toxin expressed in Herculex® 

XTRA Insect Protection corn: 

DAS will monitor for resistance to Cry1F expressed in Herculex® XTRA Insect Protection corn. 

The monitoring program shall consist of two approaches: (1) focused population sampling and 

laboratory testing; and (2) investigation of reports of less-than expected control of labeled 

insects. Should field-relevant resistance be confirmed, an appropriate resistance management 

action plan will be implemented.

Focused Population Sampling

DAS shall annually sample and bioassay populations of the key target pests: Ostrinia nubilalis 

(European corn borer; ECB), Diatraea grandiosella (southwestern corn borer; SWCB), 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 lepidopteranactive 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 Herculex® XTRA Insect Protection corn
131

and/or changes in resistance allele frequency in response to the use of Herculex® XTRA Insect 

Protection 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 twelve (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 (6) populations. For 

CEW, the target will be a minimum of ten (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 of Herculex® XTRA Insect 

Protection corn. EPA shall be consulted prior to the implementation of such modifications.

DAS will report to EPA, on or before August 31st of each year, the results of the population 

sampling and bioassay monitoring program. 

Any incidence of unusually low sensitivity to the Cry1F 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 EPA annually on or before August 

31st. The investigative steps will include the following:

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 survive the 

diagnostic concentration will be tested using methods that are representative of exposure to 

Herculex® XTRA Insect Protection corn under field conditions. If progeny do not survive to 

adulthood, any suspected resistance is not field relevant and no further action is required.

3. If insects survive steps 1 and 2, resistance is confirmed, and further steps will be taken to 

evaluate the resistance. These steps may include the following:

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;
132

determining 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;

determining 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, DAS will consult with EPA to develop and implement a case-specific resistance 

management action plan.

Investigation of Reports of Unexpected Levels of Damage by the Target Pests

DAS will follow up on grower, extension specialist, or consultant reports of unexpected levels of 

damage by the lepidopteran pests listed on the pesticide label. DAS will instruct its customers to 

contact them if such incidents occur. DAS 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), DAS will implement the actions described below, based 

on the following definitions of suspected resistance and confirmed resistance.

Suspected Resistance

EPA defines suspected resistance to mean field reports of unexpected levels of insect-feeding 

damage for which:

the corn in question has been confirmed to be lepidopteran-active Bt corn;

the seed used had the proper percentage of corn expressing Bt protein;

the relevant plant tissues 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.

EPA does not interpret suspected resistance to mean grower reports of possible control failures 

or suspicious results from annual insect monitoring assays, nor does EPA intend that extensive 

field studies and testing be undertaken to confirm scientifically the presence of insects resistant 

to Herculex® XTRA Insect Protection corn in commercial production fields before responsive 

measures are undertaken.

If resistance is suspected, DAS will instruct growers to do the following:
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Use alternative control measures in Herculex® XTRA Insect Protection corn fields in the 

affected region to control the target pest during the immediate growing season.

Destroy Herculex® XTRA Insect Protection corn crop residues in the affected region 

within one (1) month after harvest with a technique appropriate for local production 

practices to minimize the possibility of resistant insects over-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 residues, DAS 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 corn 

hybrids under field conditions (ECB and SWCB only). 

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 LC50 exceeds the upper limit of the 95% 

confidence interval of the LC50 for susceptible populations surveyed both in the original 

baselines developed for this pest species and in previous years of field monitoring.

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 DAS: 

EPA will receive notification within 30 days of resistance confirmation; 

Affected customers and extension agents will be notified about confirmed resistance 

within 30 days; 

Monitoring will be increased in the affected area and local target pest populations will be 

sampled annually to determine 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 
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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 corn hybrids in the affected area immediately until an effective 

local mitigation plan, approved by EPA, has been implemented; 

DAS will develop a case-specific resistance management action plan within 90 days 

according to the characteristics of the resistance event and local agronomic needs. DAS 

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 

In subsequent growing seasons, maintain sales suspension and alternative resistance 

management strategies in the affected region(s) for the Bt corn hybrids that are affected 

by the resistant population until an EPA-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 EPA, on or before August 31st of each year, for the duration of the registration.

2) EPA is imposing the following conditions for the Cry34Ab1 and Cry35Ab1 toxins expressed 

in Herculex® XTRA Insect Protection corn:

i. DAS must monitor for Cry34/35Ab1 resistance and/or trends in increased tolerance 

for corn rootworm. Sampling should be focused in those areas in which there is the 

highest risk of resistance development.

ii. The resistance monitoring plan must include the following: baseline sensitivity data, 

sampling (number of locations, samples per locations), sampling methodology and 

life stage sampled, bioassay methodology, standardization procedures (including 

quality assurance/quality control provisions), detection technique and sensitivity, 

statistical analysis of the probability of detecting resistance, and a revised description 

of rootworm damage guidelines.

iii. DAS must develop a functional diagnostic assay for corn rootworm resistance 

monitoring to detect potentially resistant individuals and incorporate this assay into 

the annual resistance monitoring program by the 2011 season, with reporting in 2012. 

As part of this effort, DAS must investigate the feasibility of using the Sublethal 

Seedling AssayIII as a diagnostic assay. A report of DAS’ progress towards this 

 

III Nowatzki T, Lefko SA, Binning RR, Thompson SD, Spencer TA, Siegfried BD. 2008. Validation of a novel 

resistance monitoring technique for corn rootworm (Coleoptera: Chrysomelidae) and event DAS-59122-7 maize. J. 
135

requirement must be submitted to EPA within six (6) months from the date of this 

amended registration.

iv. DAS must develop a proactive resistance monitoring program for northern corn 

rootworm (Diabrotica barberi) by the 2012 season, with reporting in 2013. This 

program should include a proposal for annual sampling and testing of northern corn 

rootworm susceptibility to Cry34/35Ab1. As part of the effort, DAS may need to 

investigate novel techniques for rearing and conducting bioassays with northern corn 

rootworm. A report on DAS’ progress towards this requirement must be submitted 

within one (1) year from the date of this amended registration.

v. DAS must submit revised corn rootworm damage guidelines (to characterize 

unexpected pest damage) that take into consideration the comments and 

recommendations from EPA’s June 30, 2010 review of the rootworm resistance 

monitoring program for Cry34/35Ab1 within six (6) months from the date of this 

amended registration.

vi. DAS must follow-up on grower, extension specialist, or consultant reports of 

unexpected damage or control failures for corn rootworm.

vii. DAS must provide EPA with a resistance monitoring report on or before August 31st

of each year, reporting on populations collected the previous year.

viii. The remedial action plan is designed as a tiered approach for mitigating Diabrotica 

virgifera virgifera (western corn rootworm; WCRW), Diabrotica barberi (northern 

corn rootworm; NCRW), and Diabrotica virgifera zeae (Mexican corn rootworm; 

MCRW) resistance development to the Cry34Ab1 and Cry35Ab1 proteins. The 

following program summary describes, in order of events, the steps that must be 

taken to implement a remedial action plan if resistance to the target pests is

confirmed. 

Definition of Suspected Resistance

Resistance will be suspected if investigations of unexpected damage reports show the 

following:

i. implicated corn plant roots were expressing the Cry34Ab1 and Cry35Ab1 proteins at 

the expected levels;

ii. the seed used was not mixed with non-Cry34/35Ab1 seed;

iii. alternative causes of damage or lodging, such as nontarget pest insect species, 

weather, physical damage, larval movement from alternate hosts, planting errors, and 

other reasonable causes for the observations, have been ruled out; and

iv. the level of damage exceeds guidelines for expected damage.

 

Appl. Entomol. 132:177–188.
136

If resistance is suspected, DAS will instruct affected growers to use alternate pest control 

measures, such as adulticide treatment, crop rotation the following year, or use of soil or 

seed insecticides the following year. These measures are intended to reduce the 

possibility of potentially resistant insects contributing to the following year’s pest 

population.

Confirmation of Resistance

Resistance will be confirmed if all of the following criteria are met by progeny from the 

target pest species sampled from the area of suspected resistance:

i. the proportion of larvae that can feed and survive on Herculex® XTRA Insect 

Protection corn roots from neonate to adult is significantly higher than the baseline 

proportion (currently being established);

ii. the LC50 of the test population exceeds the upper limit of the 95% confidence interval 

for the LC50 of a standard unselected population, and/or survival in the diagnostic 

assay is significantly greater than that of a standard unselected population, as 

established by the ongoing baseline monitoring program;

iii. the ability to survive is heritable;

iv. Herculex® XTRA Insect Protection corn plant assays determine that damage caused 

by surviving insects would exceed economic thresholds; and

v. if subsequent collections in the affected field area demonstrate similar bioassay 

results.

Response to Confirmed Resistance

When resistance is confirmed, the following steps will be taken: 

i. EPA will receive notification within 30 days of confirming resistance;

ii. affected customers and extension agents will be notified about confirmed resistance;

iii. affected customers and extension agents will be encouraged to employ alternative 

corn rootworm control measures;

iv. sale and distribution of Herculex® XTRA Insect Protection corn in the affected area 

will cease immediately; and

v. a long-term resistance management action plan will be devised according to the 

characteristics of the resistance event and local agronomic needs. 

e. Annual Reporting Requirements for Herculex® XTRA Insect Protection Corn
137

1) Annual Sales: reported and summed by state (county level data available by request), on or 

before January 31st of each year.

2) Grower Agreement Results: number of units of Herculex® XTRA Insect Protection corn

seeds sold or shipped and not returned, and the number of such units that were sold to persons 

who have signed grower agreements, on or before January 31st of each year.

3) Grower Education: substantive changes to the education program completed during the 

previous year, on or before January 31st of each year.

4) Compliance Assurance Program: compliance assurance program activities and results for the 

previous year and plans for the compliance assurance program during the current year, on or 

before January 31st of each year.

5) Compliance Assurance Program Survey Results: survey results for the previous year and 

plans for the current year, on or before January 31st of each year.

6) Insect Resistance Monitoring Results: results of monitoring and investigations of damage 

reports, on or before August 31st of each year.
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Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Pioneer HiBred 

International, 

Incorporated

29964-5

Bt Corn Events 

DAS-59122-7 + 

TC1507 with 

Cry34Ab1/Cry35Ab1 

+ PO Cry1F 

(Herculex XTRA® 

Insect Protection)

27 October 

2005

Conditional

(amended 29 September 2010)

30 

September 

2015

1] The subject registration will automatically expire on midnight September 30, 2015.

2] The subject registration will be limited to Cry1F [Bacillus thuringiensis Cry1F protein and 

the genetic material necessary for its production (plasmid insert PHP8999A) in event TC1507 

corn (OECD Unique Identifier: DAS-Ø15Ø7-1)] x Cry34Ab1 and Cry35Ab1 [Bacillus 

thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their 

production (PHP17662 T-DNA) in event DAS-59122-7 corn (OECD Unique Identifier: DAS59122-7)] for use in field corn.

3] Submit/cite all data required for registration of your product under FIFRA section 3(c)(5) 

when the Environmental Protection Agency (EPA) requires registrants of similar products to 

submit such data.

4] Submit/cite all data, determined by EPA to be acceptable and required to support the 

individual plant-incorporated protectants in Herculex® I Insect Protection and Herculex® 

Rootworm Insect Protection, within the time frames required by the terms and conditions of EPA 

Registration Numbers 29964-3 and 29964-4, respectively.

5] This plant-incorporated protectant (PIP) may be combined through conventional breeding 

with other registered plant-incorporated protectants that are similarly approved for use in 

combination, through conventional breeding, with other registered plant-incorporated protectants 

to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits.

6] You must commit to do the following Insect Resistance Management (IRM) Program, 

consisting of the following elements:

Requirements relating to creation of a refuge for the Cry1F and Cry34/35Ab1 

components that meets the requirements of the individual traits. The refuge for both 

traits may be combined by planting non-Bacillus thuringiensis (Bt) corn as the refuge, or 

the refuge for each trait may be planted separately. In the latter case, corn rootwormresistant Bt corn may be planted in the lepidopteran refuge for the Cry1F component, and 

lepidopteran-resistant Bt corn may be planted in the corn rootworm refuge for the 

Cry34/35Ab1 component.

Requirements for Pioneer Hi-Bred International, Incorporated (Pioneer) to prepare and 

require Herculex® XTRA Insect Protection corn users to sign grower agreements that 

impose binding contractual obligations on growers to comply with the refuge 
139

requirements.

Requirements for Pioneer to develop, implement, and report to EPA on programs to 

educate growers about IRM requirements.

Requirements for Pioneer to develop, implement, and report to EPA on programs to 

evaluate and promote growers’ compliance with IRM requirements.

Requirements for Pioneer to develop, implement, and report to EPA on monitoring 

programs to evaluate whether there are statistically significant and biologically relevant 

changes in susceptibility to the Cry1F and Cry34/35Ab1 proteins in the target insects.

Requirements for Pioneer to develop, and if triggered, to implement a remedial action 

plan that would contain measures Pioneer 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.

Requirements for Pioneer, on or before January 31st of each year, to submit reports on 

units sold by state (units sold by county level will made available to EPA upon request), 

IRM grower agreement results, and the compliance assurance program, including the 

education program.

Requirements for DAS, on or before August 31st of each year, to submit reports on 

resistance monitoring.

a. Refuge Requirements for Herculex® XTRA Insect Protection Corn

These refuge requirements do not apply to seed increase/propagation of inbred and hybrid seed 

corn up to a total of 20,000 acres per county and up to a combined United States (U.S.) total of 

250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt 

corn products, additional educational material and assistance will be provided by Pioneer to help 

these growers meet the refuge requirements across their farming operations.

Grower agreements (also known as stewardship agreements) will specify that growers must 

adhere to the refuge requirements as described in the grower guide/product use guide and/or in 

supplements to the grower guide/product use guide.

The use of Herculex® XTRA Insect Protection corn requires accompanying refuge corn for both 

the Cry1F and Cry34/35Ab1 components that meets the requirements of the individual traits, as 

described below. The refuge for both traits may be combined by planting non-Bt corn as the 

refuge (see the “Combined Refuge Option” section), or the refuge for each trait may be planted 

separately (see the “Lepidopteran Refuge for the Cry1F Component” and “Corn Rootworm 

Refuge for the Cry34/35Ab1 Component” sections).

For the separate refuges, corn rootworm-resistant Bt corn (e.g., Herculex® Rootworm Insect 

Protection) may be planted in the lepidopteran refuge for the Cry1F component, and 
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lepidopteran-resistant Bt corn (e.g., Herculex® I Insect Protection) may be planted in the corn 

rootworm refuge for the Cry34/35Ab1 component. Depending on cropping practices, pest 

problems, and pest management options employed on any given farm, growers may need to 

choose different refuge arrangements for different fields. Two refuge blocks (one for rootworm, 

one for Lepidoptera) can be planted within one field, or strips can be used for either refuge. 

Alternatively, a block of Herculex® Rootworm Insect Protection corn can serve as an in-field 

lepidopteran refuge for one field planted to Herculex® XTRA Insect Protection corn and an 

external lepidopteran refuge for separate fields planted to Herculex® XTRA Insect Protection 

corn, while the rootworm refuge is planted as Herculex® I Insect Protection corn in an external 

adjacent field. In all options, size and management of each individual refuge must be followed 

as described in the “Lepidopteran Refuge for the Cry1F Component” and “Corn Rootworm 

Refuge for the Cry34/35Ab1 Component” sections.

Other refuge designs and combinations are permissible as long as, in all cases, the size and 

management of each refuge are described in the “Lepidopteran Refuge for the Cry1F 

Component,” “Corn Rootworm Refuge for the Cry34/35Ab1 Component,” or “Combined 

Refuge Option” sections.

Lepidopteran Refuge for the Cry1F Component

1] Refuge size, Corn-growing areas (Corn Belt and other non-corn/cotton-growing areas). The 

use of Herculex® XTRA Insect Protection corn requires an accompanying 20% refuge 

consisting of non-Bt corn or corn that is not a lepidopteran-protected Bt hybrid. 

2] *Refuge size, Corn/cotton-growing areas. The use of Herculex® XTRA Insect Protection 

corn requires an accompanying 50% refuge consisting of non-Bt corn or corn that is not a 

lepidopteran-protected Bt hybrid. 

 

3] Refuge location.

The lepidopteran refuge can be planted in a separate field not more than 1⁄2 mile from the 

Herculex® XTRA Insect Protection corn field.

The lepidopteran refuge can be planted within the Herculex® XTRA Insect Protection 

corn field as blocks (e.g., along the edges or headlands).

The lepidopteran refuge can be planted within the Herculex® XTRA Insect Protection 

corn field as strips across the field at least four (4) consecutive rows wide.

4] Refuge management.

Insecticide treatment for European corn borer (ECB), corn earworm (CEW), southwestern corn 

borer (SWCB), and other lepidopteran pests listed on the label, grower guides, or other 

educational material may be applied only if economic thresholds are reached for 1 or more of 

these target pests. Economic thresholds will be determined using methods recommended by 

local or regional professionals (e.g., Extension Service agents or crop consultants). Instructions 
141

to growers will specify that microbial Bt insecticides must not be applied to refuges consisting of 

non-Bt corn or corn that is not a lepidopteran-protected Bt hybrid. 

*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 Dunklin, New Madrid, Pemiscot, Scott, 

and Stoddard).

Corn Rootworm Refuge for the Cry34/35Ab1 Component

1] Refuge size. The use of Herculex® XTRA Insect Protection corn requires an accompanying 

20% refuge consisting of non-Bt corn or corn that is not a rootworm-protected Bt hybrid.

2] Refuge location. The rootworm refuge is required to be planted within or adjacent (e.g., 

across the road) to the Herculex® XTRA Insect Protection corn field.

3] Refuge management options. The rootworm refuge can be managed in such a way that there 

is little or no yield loss to rootworms, but must be managed in a way that it is sufficiently 

productive of susceptible rootworm adults. 

The in-field rootworm refuge options must be planted as a single block or as a series of 

strips measuring at least four (4) consecutive crop rows wide.

Seed mixtures of Herculex® XTRA Insect Protection and rootworm refuge corn are not 

permitted.

If the rootworm refuge is planted on rotated ground, then Herculex® XTRA Insect 

Protection corn must also be planted on rotated ground.

If the rootworm refuge is planted in continuous corn, the Herculex® XTRA Insect 

Protection corn field may be planted on either continuous or rotated land (option 

encouraged where western corn rootworm rotation-resistant biotype may be present).

Application of soil insecticide is permitted in the rootworm refuge.

Seed treatment is permitted in the rootworm refuge, either at a rate for rootworm 

protection or at a rate for controlling secondary soil pests.
142

If aerial insecticides are applied to the rootworm refuge for control of corn rootworm 

adults, the same treatment must also be applied in the same time frame to Herculex® 

XTRA Insect Protection corn.

Pests other than adult corn rootworms can be treated on the rootworm refuge acres 

without treating the Herculex® XTRA Insect Protection corn acres only if treatment 

occurs when adult corn rootworms are not present or if pesticide without activity against 

adult corn rootworms is used. Pests on the Herculex® XTRA Insect Protection corn 

acres can be treated as needed without having to treat the rootworm refuge.

The rootworm refuge can be planted to any corn hybrid that does not express plantincorporated protectants for rootworm control (e.g., lepidopteran-protected Bt corn, 

herbicide-tolerant corn, or conventional corn).

The rootworm refuge and Herculex® XTRA Insect Protection 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.

Growers are encouraged to plant the rootworm refuge in the same location each year, as it 

allows the rootworm population to remain high and the durability of the trait is extended. 

This option may be preferable to growers who wish to only think of their refuge design 

once and for growers who grow continuous corn; however, for those growers who need 

to employ crop rotation, a fixed refuge would be impractical.

Combined Refuge Option

For the combined refuge option (i.e., the lepidopteran refuge combined with the rootworm refuge 

by planting non-Bt corn), the refuge must be planted and managed such that it is consistent with 

the requirements of the individual traits, Cry1F and Cry34/35Ab1.

1] Refuge size. The use of Herculex® XTRA Insect Protection corn requires an accompanying 

20% refuge in corn-growing areas and 50% refuge in cotton-growing areas consisting of non-Bt

corn. For the latter, see the list of states labeled with “*” in the “Lepidopteran Refuge for the 

Cry1F Component” section. 

2] Refuge location. The combined refuge is required to be planted within or adjacent (e.g., 

across the road) to the Herculex® XTRA Insect Protection corn field.

3] Refuge management options.

The in-field combined refuge options must be planted as a single block or as a series of 

strips measuring at least four (4) consecutive crop rows wide.

Seed mixtures of Herculex® XTRA Insect Protection and combined refuge corn are not 

permitted.
143

If the combined refuge is planted on rotated ground, then Herculex® XTRA Insect 

Protection corn must also be planted on rotated ground.

If the combined refuge is planted in continuous corn, the Herculex® XTRA Insect 

Protection corn field may be planted on either continuous or rotated land (option 

encouraged where western corn rootworm rotation-resistant biotype may be present).

Application of soil insecticide for corn rootworm control is permitted in the combined 

refuge.

Seed treatment is permitted in the combined refuge, either at a rate for rootworm 

protection or at a rate for controlling secondary soil pests.

If aerial insecticides are applied to the combined refuge for control of corn rootworm 

adults, the same treatment must also be applied in the same time frame to Herculex® 

XTRA Insect Protection corn.

Insecticide treatments in the combined refuge for control of ECB, CEW, SWCB, and 

other lepidopteran pests listed on the label, grower guides, or other educational material 

may be applied only if economic thresholds are reached for one (1) or more of these 

target pests. Economic thresholds will be determined using methods recommended by 

local or regional professionals (e.g., Extension Service agents or crop consultants). These 

pests can be treated with corn rootworm-labeled insecticide on the combined refuge acres 

without treating the Herculex® XTRA Insect Protection corn acres only if treatment 

occurs when adult corn rootworms are not present. Instructions to growers will specify 

that microbial Bt insecticides must not be applied to the combined refuges. 

Pests other than adult corn rootworms can be treated with corn rootworm-labeled 

insecticide on the combined refuge acres without treating the Herculex® XTRA Insect 

Protection corn acres only if treatment occurs when adult corn rootworms are not present. 

Pests on the Herculex® XTRA Insect Protection corn acres can be treated as needed 

without having to treat the combined refuge.

The combined refuge can be planted to any corn hybrid that does not express plantincorporated protectants for lepidopteran or rootworm control (i.e., herbicide-tolerant 

corn or conventional corn).

The combined refuge and Herculex® XTRA Insect Protection 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.

b. Grower Agreements for Herculex® XTRA Insect Protection Corn

1] Persons purchasing Herculex® XTRA Insect Protection corn must sign a grower agreement. 

The term grower agreement refers to any grower purchase contract, license agreement, or similar 

legal document.
144

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] Pioneer must continue to integrate this amended registration into the current system used for 

its other Bt corn plant-incorporated protectants, which is reasonably likely to assure that persons 

purchasing Herculex® XTRA Insect Protection corn will affirm annually that they are 

contractually bound to comply with the requirements of the IRM program.

4] Pioneer must continue to use its current grower agreement for Herculex® XTRA Insect 

Protection corn. If Pioneer 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 (30) days prior to implementing a proposed change, Pioneer must submit to 

EPA the text of such changes to ensure that it is consistent with the terms and conditions of this 

amended registration. 

5] Pioneer must continue to integrate this amended registration into the current system used for 

its other Bt corn plant-incorporated protectants, which is reasonably likely to assure that persons 

purchasing Herculex® XTRA Insect Protection corn sign grower agreement(s).

6] Pioneer shall maintain records of all Herculex® XTRA Insect Protection corn grower 

agreements for a period of three (3) years from December 31st of the year in which the agreement 

was signed.

7] Annually, Pioneer shall provide EPA with a report showing the number of units of 

Herculex® XTRA Insect Protection 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 12-month period covering the prior August through July.

8] Pioneer 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 numbers of the 

growers, will be protected.

c. IRM Education and Compliance Monitoring Programs for Herculex® XTRA Insect 

Protection Corn

1] Pioneer must continue to implement and enhance (as set forth in paragraph 17 of this section) 

a comprehensive, ongoing IRM education program designed to convey to Herculex® XTRA 

Insect Protection corn users the importance of complying with the IRM program. The program 

shall include information encouraging Herculex® XTRA Insect Protection corn users to pursue 

optional elements of the IRM program relating to refuge configuration and proximity to 

Herculex® XTRA Insect Protection 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 
145

records. The program shall involve at least one written communication annually to each 

Herculex® XTRA Insect Protection corn user separate from the grower technical guide. The 

communication shall inform the user of the current IRM requirements. Pioneer shall coordinate 

its education programs with educational efforts of other registrants and organizations, such as the 

National Corn Growers Association and state extension programs. 

2] Annually, Pioneer shall revise, and expand as necessary, its education program to take into 

account the information collected through the compliance survey, required under paragraph 6–8 

of this section, and from other sources. The changes shall address aspects of grower compliance 

that are not sufficiently high.

3] Annually, Pioneer must provide EPA any substantive changes to its grower education 

activities as part of the overall IRM compliance assurance program report. Pioneer must either 

submit a separate report or contribute to the report from the industry working group, Agricultural 

Biotechnology Stewardship Technical Committee (ABSTC). The required features of the 

compliance assurance program are described in paragraphs 4–22 of this section.

4] Pioneer must continue to implement and improve an ongoing IRM compliance assurance 

program designed to evaluate the extent to which growers purchasing Herculex® XTRA Insect 

Protection corn 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 Pioneer’s Bt corn products. Pioneer shall coordinate with 

other Bt corn registrants in improving its compliance assurance program and continue to 

integrate this amended registration into the current compliance assurance program used for its 

other Bt corn plant-incorporated protectants. Other required features of the program are 

described in paragraphs 5–22 of this section.

5] Pioneer must maintain and publicize a phased compliance approach (i.e., a guidance 

document that indicates how it will address instances of non-compliance with the terms of the 

IRM program and general criteria for choosing among options for responding to any noncompliant growers after the first year of non-compliance). While recognizing that for reasons of 

difference in business practices there are needs for flexibility between different companies, 

Pioneer must use a consistent set of standards for responding to non-compliance. An individual 

grower found to be significantly out of compliance two (2) years in a row would be denied 

access to Pioneer’s Bt corn products 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 Bt corn.

6) The IRM compliance assurance program shall include an annual survey, conducted by an 

independent third party, of a statistically representative sample of growers of Herculex® XTRA 

Insect Protection corn who plant the vast majority of all corn in the United States and in areas in 

which the selection intensity is greatest. The survey shall consider only those growers who plant 

200 or more acres of corn in the Corn Belt and who plant 100 or more acres of corn in corncotton areas. 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 

independent marketing research firms and academic scientists, to allow analysis of compliance 

behavior within regions or between regions. The sample size must provide a reasonable 
146

sensitivity for comparing results across the United States. 

i. A third party is classified as a party other than the registrant, the grower, or 

anyone else with a direct interest in IRM compliance for Bt corn.

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] Pioneer shall provide 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 on or before January 31st of each year. Pioneer shall confer with other registrants and EPA 

on the design and content of the survey prior to its implementation.

10] Annually, Pioneer shall revise, and expand as necessary, its compliance assurance program 

to take into account the information collected through the compliance survey, required under 

paragraphs 6–8 of this section, and from other sources. The changes shall address aspects of 

grower compliance that are not sufficiently high. Pioneer must confer with EPA prior to 

adopting any changes.

11] Pioneer shall conduct an annual on-farm assessment program. Pioneer shall train its 

representatives who make on-farm visits with Herculex® XTRA Insect Protection corn growers 

to perform assessments of compliance with IRM requirements. There is no minimum corn 

acreage size for this program. Therefore, growers will be selected for this program from across 

all farm sizes. In the event that any of these visits result in the identification of a grower who is 

not in compliance with the IRM program, Pioneer shall take appropriate action, consistent with 

its phased compliance approach, to promote compliance. 

12] Pioneer shall carry out a program for investigating legitimate tips and complaints that 

Herculex® XTRA Insect Protection corn 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, Pioneer shall take appropriate action, consistent with its phased compliance 

approach.

13] If a grower, who purchases Herculex® XTRA Insect Protection corn for planting, was 

specifically identified as not being in compliance during the previous year, Pioneer shall visit 

with the grower and evaluate whether that the grower is in compliance with the IRM program for 

the current year. 

14] Annually, Pioneer shall provide a report to EPA summarizing the activities carried out under 

its compliance assurance program for the prior year and the plans for the compliance assurance 

program during the current year. Within one (1) month of submitting this report to EPA, Pioneer 

shall meet with EPA to discuss its findings. The report will include information regarding 

grower interactions (including, but not limited to, on-farm visits, verified tips and complaints, 
147

grower meetings and letters), the extent of non-compliance, corrective measures to address the 

non-compliance, and any follow-up actions taken. The report must inform EPA of the number of 

growers deemed ineligible to purchase Bt corn seed on the basis of continued non-compliance 

with the insect resistance management refuge requirements. Pioneer may elect to coordinate 

information with other registrants and report collectively the results of compliance assurance 

programs.

15] Pioneer and the seed corn dealers for Pioneer 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 

numbers of the growers, will be protected. 

16] Pioneer shall revise and expand its existing compliance assurance program to include the 

following elements. Pioneer must prepare and submit, on or before January 31, 2011, a written 

description of its revised compliance assurance program. Pioneer may coordinate with other 

registrants in designing and implementing its compliance assurance program. 

17] Pioneer will enhance the refuge education program throughout the seed delivery channel: 

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the 

importance of correct refuge implementation and potential consequences of 

failure to plant the required refuge. 

ii. Include the refuge size requirement on all Herculex® XTRA Insect Protection

corn seed bags or bag tags. The Herculex® XTRA Insect Protection corn label 

accepted by EPA must include how this information will be conveyed to growers 

via text and graphics. This requirement may be phased in over the next three (3) 

growing seasons. Revised Herculex® XTRA Insect Protection corn labels must 

be submitted by January 31, 2011, 50% implementation on the Herculex® XTRA 

Insect Protection corn seed bags or bag tags must occur by the 2012 growing 

season, and full implementation must occur by the 2013 growing season.

18] Pioneer will focus the majority of on-farm assessments on regions with the greatest risk for 

resistance: 

i. Use Bt corn adoption, pest pressure information, and other available information 

to identify regions where the risk of resistance is greatest.

ii. Focus approximately two-thirds of on-farm assessments on these regions, with the 

remaining assessments conducted across other regions where Herculex® XTRA 

Insect Protection corn is used. 

19] Pioneer will use its available Herculex® XTRA Insect Protection corn sales records and 

other information to refine grower lists for on-farm assessments of their compliance with refuge 

requirements: 

i. Identify for potential on-farm assessment growers whose sales information 
148

indicates they have purchased Herculex® XTRA Insect Protection corn but may 

have purchased little or no refuge seed from the registrant, licensees, or affiliated 

companies. 

20] Pioneer will contract with third parties to perform on-farm assessments of compliance with 

refuge requirements: 

i. The third-party assessors will conduct all first-time on-farm assessments, as well 

as second-year on-farm assessments, of those growers found out of compliance in 

a first-time assessment. 

21] Annually, Pioneer will refine the on-farm assessment program for Herculex® XTRA Insect 

Protection corn to reflect the adoption rate and level of refuge compliance for Herculex® XTRA 

Insect Protection corn. 

22] Pioneer will follow up with growers who have been found significantly out of compliance 

under the on-farm assessment program and are found to be back in compliance the following 

year: 

i. All growers found to be significantly out of compliance in a prior year will 

annually be sent additional refuge assistance information for a minimum of two 

(2) years by Pioneer, a seed supplier, or a third party assessor, after completing 

the assessment process.

ii. Pioneer will conduct follow-up checks on growers found to be significantly out of 

compliance within three (3) years after they are found to be back in compliance. 

iii. A grower found with a second incident of significant non-compliance with refuge 

requirements for Herculex® XTRA Insect Protection corn within a 5-year period 

will be denied access to Pioneer’s Bt corn products the next year. 

d. Insect Resistance Monitoring and Remedial Action Plan for Herculex® XTRA Insect 

Protection Corn

1] EPA is imposing the following conditions for the Cry1F toxin expressed in Herculex® 

XTRA Insect Protection corn:

Pioneer will monitor for resistance to Cry1F expressed in Herculex® XTRA Insect Protection 

corn. The monitoring program shall consist of two approaches: (1) focused population sampling 

and laboratory testing; and (2) investigation of reports of less-than expected control of labeled 

insects. Should field-relevant resistance be confirmed, an appropriate resistance management 

action plan will be implemented.

Focused Population Sampling

Pioneer shall annually sample and bioassay populations of the key target pests: Ostrinia nubilalis 

(European corn borer; ECB), Diatraea grandiosella (southwestern corn borer; SWCB), and 
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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 lepidopteranactive 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 Herculex® XTRA Insect Protection corn

and/or changes in resistance allele frequency in response to the use of Herculex® XTRA Insect 

Protection 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 twelve (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 (6) populations. For 

CEW, the target will be a minimum of ten (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 of Herculex® XTRA Insect 

Protection corn. EPA shall be consulted prior to the implementation of such modifications.

Pioneer will report to EPA, on or before August 31st of each year, the results of the population 

sampling and bioassay monitoring program. 

Any incidence of unusually low sensitivity to the Cry1F 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 EPA annually on or before August 

31st. The investigative steps will include the following:

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 survive the 

diagnostic concentration will be tested using methods that are representative of exposure to 

Herculex® XTRA Insect Protection corn under field conditions. If progeny do not survive to 

adulthood, any suspected resistance is not field relevant and no further action is required.

3. If insects survive steps 1 and 2, resistance is confirmed, and further steps will be taken to 

evaluate the resistance. These steps may include the following:
150

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;

determining 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;

determining 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, Pioneer will consult with EPA to develop and implement a case-specific resistance 

management action plan.

Investigation of Reports of Unexpected Levels of Damage by the Target Pests

Pioneer will follow up on grower, extension specialist, or consultant reports of unexpected levels 

of damage by the lepidopteran pests listed on the pesticide label. Pioneer will instruct its 

customers to contact them if such incidents occur. Pioneer 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), Pioneer will implement the actions described below, 

based on the following definitions of suspected resistance and confirmed resistance.

Suspected Resistance

EPA defines suspected resistance to mean field reports of unexpected levels of insect-feeding 

damage for which:

the corn in question has been confirmed to be lepidopteran-active Bt corn;

the seed used had the proper percentage of corn expressing Bt protein;

the relevant plant tissues 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.

EPA does not interpret suspected resistance to mean grower reports of possible control failures 

or suspicious results from annual insect monitoring assays, nor does EPA intend that extensive 

field studies and testing be undertaken to confirm scientifically the presence of insects resistant 
151

to Herculex® XTRA Insect Protection corn in commercial production fields before responsive 

measures are undertaken.

If resistance is suspected, Pioneer will instruct growers to do the following:

Use alternative control measures in Herculex® XTRA Insect Protection corn fields in the 

affected region to control the target pest during the immediate growing season.

Destroy Herculex® XTRA Insect Protection corn crop residues in the affected region 

within one (1) month after harvest with a technique appropriate for local production 

practices to minimize the possibility of resistant insects over-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 residues, Pioneer 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 corn 

hybrids under field conditions (ECB and SWCB only). 

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 LC50 exceeds the upper limit of the 95% 

confidence interval of the LC50 for susceptible populations surveyed both in the original 

baselines developed for this pest species and in previous years of field monitoring.

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 

Pioneer: 

EPA will receive notification within 30 days of resistance confirmation; 

Affected customers and extension agents will be notified about confirmed resistance 

within 30 days; 
152

Monitoring will be increased in the affected area and local target pest populations will be 

sampled annually to determine 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 corn hybrids in the affected area immediately until an effective 

local mitigation plan, approved by EPA, has been implemented; 

Pioneer will develop a case-specific resistance management action plan within 90 days 

according to the characteristics of the resistance event and local agronomic needs. 

Pioneer 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 

In subsequent growing seasons, maintain sales suspension and alternative resistance 

management strategies in the affected region(s) for the Bt corn hybrids that are affected 

by the resistant population until an EPA-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 EPA, on or before August 31st of each year, for the duration of the registration.

2] EPA is imposing the following conditions for the Cry34Ab1 and Cry35Ab1 toxins expressed 

in Herculex® XTRA Insect Protection corn:

i. Pioneer must monitor for Cry34/35Ab1 resistance and/or trends in increased 

tolerance for corn rootworm. Sampling should be focused in those areas in which 

there is the highest risk of resistance development.

ii. The resistance monitoring plan must include the following: baseline sensitivity data, 

sampling (number of locations, samples per locations), sampling methodology and 

life stage sampled, bioassay methodology, standardization procedures (including 

quality assurance/quality control provisions), detection technique and sensitivity, 

statistical analysis of the probability of detecting resistance, and a revised 

description of rootworm damage guidelines.
153

iii. Pioneer must develop a functional diagnostic assay for corn rootworm resistance 

monitoring to detect potentially resistant individuals and incorporate this assay into 

the annual resistance monitoring program by the 2011 season, with reporting in 

2012. As part of this effort, Pioneer must investigate the feasibility of using the 

Sublethal Seedling Assay1as a diagnostic assay. A report of Pioneer’s progress 

towards this requirement must be submitted to EPA within six (6) months from the 

date of this amended registration.

iv. Pioneer must develop a proactive resistance monitoring program for northern corn 

rootworm (Diabrotica barberi) by the 2012 season, with reporting in 2013. This 

program should include a proposal for annual sampling and testing of northern corn 

rootworm susceptibility to Cry34/35Ab1. As part of the effort, Pioneer may need to 

investigate novel techniques for rearing and conducting bioassays with northern 

corn rootworm. A report on Pioneer’s progress towards this requirement must be 

submitted within one (1) year from the date of this amended registration.

v. Pioneer must submit revised corn rootworm damage guidelines (to characterize 

unexpected pest damage) that take into consideration the comments and 

recommendations from EPA’s June 30, 2010 review of the rootworm resistance 

monitoring program for Cry34/35Ab1 within six (6) months from the date of this 

amended registration.

vi. Pioneer must follow-up on grower, extension specialist, or consultant reports of 

unexpected damage or control failures for corn rootworm.

vii. Pioneer must provide EPA with a resistance monitoring report on or before August 

31st of each year, reporting on populations collected the previous year.

viii. The remedial action plan is designed as a tiered approach for mitigating Diabrotica 

virgifera virgifera (western corn rootworm; WCRW), Diabrotica barberi (northern

corn rootworm; NCRW), and Diabrotica virgifera zeae (Mexican corn rootworm; 

MCRW) resistance development to the Cry34Ab1 and Cry35Ab1 proteins. The 

following program summary describes, in order of events, the steps that must be 

taken to implement a remedial action plan if resistance to the target pests is 

confirmed. 

Definition of Suspected Resistance

Resistance will be suspected if investigations of unexpected damage reports show the 

following:

i. implicated corn plant roots were expressing the Cry34Ab1 and Cry35Ab1 proteins at 

the expected levels;

 

1 Nowatzki T, Lefko SA, Binning RR, Thompson SD, Spencer TA, Siegfried BD. 2008. Validation of a novel 

resistance monitoring technique for corn rootworm (Coleoptera: Chrysomelidae) and event DAS-59122-7 maize. J. 

Appl. Entomol. 132:177–188.
154

ii. the seed used was not mixed with non-Cry34/35Ab1 seed;

iii. alternative causes of damage or lodging, such as nontarget pest insect species, 

weather, physical damage, larval movement from alternate hosts, planting errors, and 

other reasonable causes for the observations, have been ruled out; and

iv. the level of damage exceeds guidelines for expected damage.

If resistance is suspected, Pioneer will instruct affected growers to use alternate pest 

control measures, such as adulticide treatment, crop rotation the following year, or use of 

soil or seed insecticides the following year. These measures are intended to reduce the 

possibility of potentially resistant insects contributing to the following year’s pest 

population.

Confirmation of Resistance

Resistance will be confirmed if all of the following criteria are met by progeny from the 

target pest species sampled from the area of suspected resistance:

i. the proportion of larvae that can feed and survive on Herculex® XTRA Insect 

Protection corn roots from neonate to adult is significantly higher than the baseline 

proportion (currently being established);

ii. the LC50 of the test population exceeds the upper limit of the 95% confidence interval 

for the LC50 of a standard unselected population, and/or survival in the diagnostic 

assay is significantly greater than that of a standard unselected population, as 

established by the ongoing baseline monitoring program;

iii. the ability to survive is heritable;

iv. Herculex® XTRA Insect Protection corn plant assays determine that damage caused 

by surviving insects would exceed economic thresholds; and

v. if subsequent collections in the affected field area demonstrate similar bioassay 

results.

Response to Confirmed Resistance

When resistance is confirmed, the following steps will be taken: 

i. EPA will receive notification within 30 days of confirming resistance;

ii. affected customers and extension agents will be notified about confirmed resistance;

iii. affected customers and extension agents will be encouraged to employ alternative 

corn rootworm control measures;
155

iv. sale and distribution of Herculex® XTRA Insect Protection corn in the affected area 

will cease immediately; and

v. a long-term resistance management action plan will be devised according to the 

characteristics of the resistance event and local agronomic needs. 

e. Annual Reporting Requirements for Herculex® XTRA Insect Protection Corn

1) Annual Sales: reported and summed by state (county level data available by request), on or 

before January 31st of each year.

2) Grower Agreement Results: number of units of Herculex® XTRA Insect Protection corn

seeds sold or shipped and not returned, and the number of such units that were sold to persons 

who have signed grower agreements, on or before January 31st of each year.

3) Grower Education: substantive changes to the education program completed during the 

previous year, on or before January 31st of each year.

4) Compliance Assurance Program: compliance assurance program activities and results for the 

previous year and plans for the compliance assurance program during the current year, on or 

before January 31st of each year.

5) Compliance Assurance Program Survey Results: survey results for the previous year and 

plans for the current year, on or before January 31st of each year.

6) Insect Resistance Monitoring Results: results of monitoring and investigations of damage 

reports, on or before August 31st of each year.
156

Pioneer Hi-Bred International Corn PIP Products

Three Pioneer Hi-Bred International corn PIP products (1507 X MON810, EPA Reg No. 29964-

7; 1507 X 59122 X MON810, EPA Reg. No 29964-8; and 59122 X MON810, EPA Reg. No. 

29964-9) were registered February 24, 2010 with an expiration date of October 31, 2010. As part 

of the Agency’s public participation initiative, the Agency provided for a concurrent public 

comment period which closed March 28, 2010. During this comment period, the Agency 

received several comments on these products. These comments and comments pertinent to these 

registrations submitted as part of the 2010 Bt Corn Reassessment comment period will be 

addressed separately, by the October 31, 2010 expiration date. 

Registrant Registration # Active Ingredient Original 

Registration Date Status Expiration Date

Pioneer/Dupont 29964-8

TC1507 (PO Cry1F) x 

DAS-59122 

(Cry34Ab1/Cry35Ab1) 

x MON810 (Cry1Ab)

24 February 2010 Conditional 31 October 

2010
157

Pioneer Hi-Bred International Corn PIP Products

Three Pioneer Hi-Bred International corn PIP products (1507 X MON810, EPA Reg No. 29964-

7; 1507 X 59122 X MON810, EPA Reg. No 29964-8; and 59122 X MON810, EPA Reg. No. 

29964-9) were registered February 24, 2010 with an expiration date of October 31, 2010. As part 

of the Agency’s public participation initiative, the Agency provided for a concurrent public 

comment period which closed March 28, 2010. During this comment period, the Agency 

received several comments on these products. These comments and comments pertinent to these 

registrations submitted as part of the 2010 Bt Corn Reassessment comment period will be 

addressed separately, by the October 31, 2010 expiration date. 

Registrant Registration # Active Ingredient Original 

Registration Date Status Expiration Date

Pioneer/Dupont 29964-9

DAS-59122

(PO 

Cry34Ab1/Cry35Ab1) 

x MON810 (Cry1Ab)

24 February 2010 Conditional 31 October 

2010
158

IV. mCry3A BRAD Registered Products

1] The subject registration will automatically expire on midnight September 30, 2015.

2] The subject registration will be limited to Agrisure® RW (MIR604) Rootworm-Protected

(MIR604) Corn with modified Cry3A protein and the genetic material necessary for its 

production (via elements of vector pZM26) in corn SYN-IR6Ø4-5.

3] Submit/cite all data required for registration of your product under FIFRA § 3(c)(5) when the 

Agency requires registrants of similar products to submit such data.

4] Three (3) year full-scale field or semi-field studies for evaluation of mCry3A Event MIR604 

corn exposure on non-target invertebrates must be conducted. Full-scale field experiments 

must be appropriately designed to provide a measure of ecological impacts (larger fields, 

more replicates, more samples per plot based on recommendations of the August, 2002 SAP 

and subsequent relevant research on appropriate study design). A protocol is due within 90 

days of the date of registration. A final report is due January 31, 2011. 

Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Syngenta 67979-5

Bt Corn Event MIR 

604 with modified 

Cry3A (Agrisure RW)

3 October 2006 Conditional

(amended 29 September 2010)

30 September 

2015
159

5] The subject plant-incorporated protectant may be combined through conventional breeding 

with other registered plant-incorporated protectants that are similarly approved for use in 

combination, through conventional breeding, with other plant-incorporated protectants to 

produce inbred corn lines and hybrid corn varieties with combined pesticidal traits.

6] You must commit to do the following Insect Resistance Management Program:

a. Refuge Requirements. 

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.

When on-farm assessments identify non-compliance with refuge requirements for one or 

more Bt corn products, additional educational material and assistance are provided by 

Syngenta to help these growers meet the refuge requirements across their farming 

operations.

1) Grower agreements (also known as stewardship agreements) will specify that growers 

must adhere to the refuge requirements as described in the grower guide/product use 

guide and/or in supplements to the grower guide/product use guide. 

2) Specifically, growers must plant a structured refuge of at least 20% non-corn 

rootworm protected Bt corn that may be treated with insecticides as needed to control 

corn rootworm larvae. Growers will not be permitted to apply CRW labeled 

insecticides to the refuge for control of insect pests while adult corn rootworms are 

present unless the Agrisure® RW (MIR604) Rootworm-Protected Corn field is 

treated in a similar manner. 

3) Refuge planting options include: refuge acres should be planted as blocks adjacent to 

Agrisure® RW (MIR604) Rootworm-Protected Corn Rootworm-Protected Corn 

fields, perimeter strips, or as in-field strips. 

4) External refuges must be planted adjacent to (e.g., across the road from) Agrisure® 

RW (MIR604) Rootworm-Protected Corn fields. 

5) When planting the refuge in strips across the field, refuges must be at least 4 

consecutive rows wide. 

6) Insecticide treatments for control of corn rootworm larvae may be applied. 

Instructions to growers will specify that insecticides labeled for control of corn 

rootworm adults cannot be applied while adults are present in the refuge unless the 

Agrisure® RW (MIR604) Rootworm-Protected Corn field is treated in a similar 

manner. 

7) If the refuge is planted in a field that is in a crop rotation system, then Agrisure® RW 

(MIR604) Rootworm-Protected Corn must also be planted in a field that is in a crop 
160

rotation system. 

8) If the refuge is planted on continuous corn, then the Agrisure® RW (MIR604) 

Rootworm-Protected Corn field may be planted on either continuous or in a field that 

is in a crop rotation system.

b. Grower Agreements

1) Persons purchasing the Bt corn 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) Syngenta must continue to integrate this amended registration into the current system 

used for its other Bt corn plant-incorporated protectants, which is reasonably likely to 

assure that persons purchasing Agrisure® RW (MIR604) Rootworm-Protected Corn 

product will affirm annually that they are contractually bound to comply with the 

requirements of the IRM program.

4) Syngenta must continue to use its current grower agreement for Agrisure® RW 

(MIR604) Rootworm-Protected Corn product. If Syngenta 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 (30) days prior to implementing a proposed change, Syngenta must submit to 

EPA the text of such changes to ensure that it is consistent with the terms and 

conditions of this amended registration.

5) Syngenta must continue to integrate this amended registration into the current system 

used for its other Bt corn plant-incorporated protectants, which is reasonably likely to 

assure that persons purchasing Agrisure® RW (MIR604) Rootworm-Protected Corn 

product sign grower agreement(s).

6) Syngenta 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) Annually Syngenta shall provide EPA with a report showing the number of units of 

its Bt Agrisure® RW (MIR604) Rootworm-Protected 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) Annually Syngenta shall submit annual reports on units sold by State (units sold by 

county level will be made available to the Agency upon request), IRM grower 
161

agreement results, and the compliance assurance program, including the education 

program on or before January 31st each year.

9) Syngenta 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 Programs 

1) Syngenta must continue to implement and enhance (as set forth in paragraph 17 of 

this section) a comprehensive, ongoing IRM education program designed to convey 

to Agrisure® RW (MIR604) Rootworm-Protected Corn product users the importance 

of complying with the IRM program. The program shall include information 

encouraging Agrisure® RW (MIR604) Rootworm-Protected Corn product users to

pursue optional elements of the IRM program relating to refuge configuration and 

proximity to Agrisure® RW (MIR604) Rootworm-Protected Corn product 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 Agrisure® RW (MIR604) Rootworm-Protected Corn product user separate from 

the grower technical guide. The communication shall inform the user of the current 

IRM requirements. Syngenta shall coordinate its education programs with 

educational efforts of other registrants and organizations, such as the National Corn 

Growers Association and state extension programs. 

2) Annually, Syngenta 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) Annually, Syngenta must provide a report to EPA summarizing the activities carried 

out under the education program for the prior year and any substantive changes to its 

grower education activities as part of the overall IRM Compliance Assurance 

Program (CAP) report. The required features of the Compliance Assurance Program 

are described in paragraphs 4 to 22 below.

4) Syngenta must continue to implement and improve an ongoing IRM Compliance 

Assurance Program designed to evaluate the extent to which growers purchasing 

Agrisure® RW (MIR604) Rootworm-Protected 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 Syngenta corn PIP products. Syngenta shall coordinate with other Bt

corn registrants in improving its Compliance Assurance Program and continue to 

integrate this amended registration into the current Compliance Assurance Program 

used for its other Bt corn plant-incorporated protectants. Other required features of 
162

the program are described in paragraphs 5–22.

5) Syngenta must maintain and publicize a “phased compliance approach,” i.e., a 

guidance document that indicates how it will address instances of non-compliance 

with the terms of the IRM program and general criteria for choosing among options 

for responding to any non-compliant growers after the first year of noncompliance. 

While recognizing that for reasons of difference in business practices there are needs 

for flexibility between different companies, all Bt corn registrants must use a 

consistent set of standards for responding to non-compliance. An individual grower 

found to be significantly out of compliance 2 years in a row would be denied access 

to the registrant’s Bt corn products the next year. Additionally, seed dealers who are 

not fulfilling their obligations to inform/educate growers of their IRM obligations will 

lose their opportunity to sell Bt corn.

6) The IRM Compliance Assurance Program shall include an annual survey conducted 

by an independent third party of a statistically representative sample of growers of Bt

corn products who plant the vast majority of all corn in the U.S. and in areas in which 

the selection intensity is greatest. The survey shall consider only those growers who 

plant 200 or more acres of corn in the Corn-Belt and who plant 100 or more acres of 

corn in corn-cotton areas. 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.

(a) A third party is classified as a party other than Syngenta, the grower, or anyone 

else with a direct interest in IRM compliance for Bt corn.

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) Syngenta shall provide 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. 

10) Annually, Syngenta 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. Syngenta must 

confer with the Agency prior to adopting any changes to a previously approved CAP. 
163

11) Syngenta shall conduct an annual on-farm assessment program. Syngenta shall train 

its representatives who make on-farm visits with growers of their Bt corn products to 

perform assessments of compliance with IRM requirements. There is no minimum 

corn acreage size for this program. Therefore, growers will be selected for this 

program from across all farm sizes. In the event that any of these visits result in the 

identification of a grower who is not in compliance with the IRM program, Syngenta 

shall take appropriate action, consistent with its "phased compliance approach," to 

promote compliance.

12) Syngenta 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, Syngenta shall take appropriate action, consistent with its "phased 

compliance approach." 

13) If a grower, who purchases Agrisure® RW (MIR604) Rootworm-Protected Bt corn 

for planting, was specifically identified as not being in compliance during the 

previous year, Syngenta shall visit with the grower and evaluate whether that the 

grower is in compliance with the IRM program for the current year.

14) Each registrant shall annually 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, onfarm visits, verified tips and complaints, grower meetings and letters), the extent of 

non-compliance, corrective measures to address the non-compliance, and any followup actions taken. The report must inform EPA of the number of growers deemed 

ineligible to purchase Bt corn seed on the basis of continued non-compliance with the 

insect resistance management refuge requirements. The registrants may elect to 

coordinate information and report collectively the results of their compliance 

assurance programs. Within one month of submitting this report to EPA, the 

registrant shall meet with EPA to discuss its findings.

15) Syngenta and the seed corn dealers for Syngenta 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. 

16) Syngenta shall revise and expand its existing Compliance Assurance Program to 

include the following elements. Syngenta must prepare and submit by January 31, 

2011, a written description of its revised Compliance Assurance Program. Syngenta 

may coordinate with other registrants in designing and implementing its Compliance 

Assurance Program. 

17) Syngenta will enhance the refuge education program throughout the seed delivery 

channel to: 
164

(a) Ensure sales representatives, licensees, seed dealers, and growers recognize the 

importance of correct refuge implementation and potential consequences of 

failure to plant the required refuge; 

(b) Include the refuge size requirement on all Bt corn seed bags or bag tags. The PIP 

product label accepted by EPA must include how this information will be 

conveyed to growers via text and graphics. This requirement may be phased in 

over the next three growing seasons. Revised PIP product labels must be 

submitted by January 31, 2011; 50% implementation on the Bt corn seed bags or 

bag tags must occur by the 2012 growing season; and full implementation must 

occur by the 2013 growing season. 

18) Syngenta will focus the majority of on-farm assessments on regions with the greatest 

risks for resistance and will: 

(a) Use Bt corn adoption, pest pressure information, and other available information 

to identify regions where the risk of resistance is greatest; 

(b) Focus approximately two-thirds of on-farm assessments on these regions, with the 

remaining assessments conducted across other regions where the product is used. 

19) Syngenta will use its available Bt sales records and other information to refine grower 

lists for on-farm assessments of grower compliance with refuge requirements: 

(a) Identify for potential on-farm assessment growers whose sales information 

indicates they have purchased the Bt corn product but may have purchased little 

or no refuge seed from Syngenta, licensee, or affiliated company. 

20) Syngenta will contract with third parties to perform on-farm assessments of 

compliance with refuge requirements: 

(a) The third-party assessors will conduct all first-time on-farm assessments as well 

as second-year on-farm assessments of those growers found out of compliance in 

a first-time assessment. 

21) Syngenta will annually refine the on-farm assessment program for the Bt corn product 

to reflect the adoption rate and level of refuge compliance for the product. 

22) Syngenta will follow up with growers who have been found significantly out of 

compliance under the on-farm assessment program and are found to be back in 

compliance the following year:

(a) All growers found to be significantly out of compliance in a prior year will 

annually be sent additional refuge assistance information for a minimum of 2 

years by Syngenta, a seed supplier, or a third-party assessor, after completing the 

assessment process.

(b) Syngenta will conduct follow-up checks on growers found to be significantly out 
165

of compliance within 3 years after they are found to be back in compliance. 

(c) A grower found with a second incident of significant non-compliance with refuge 

requirements for Agrisure® RW (MIR604) Rootworm-Protected Corn product

within a 5-year period will be denied access to and/or sales of the registrant’s Bt 

corn products the next year.

d. Insect Resistance Monitoring and Remedial Action Plan

The Agency is imposing the following conditions for the mCry3A toxin expressed in this 

product: 

1) Syngenta must monitor for mCry3A resistance and/or trends in increased tolerance 

for corn rootworm. Sampling should be focused in those areas in which there is the 

highest risk of resistance development. 

2) The resistance monitoring plan must include: baseline sensitivity data, sampling 

(number of locations, samples per locations), sampling methodology and life-stage 

sampled, bioassay methodology, standardization procedures (including QA/QC 

provisions), detection technique and sensitivity, the statistical analysis of the 

probability of detecting resistance, and an interim description of rootworm damage 

guidelines. 

3) Syngenta must develop a functional diagnostic assay for corn rootworm resistance 

monitoring to detect potentially resistant individuals and incorporate this assay into 

the annual resistance monitoring program by the 2011 season with reporting in 2012. 

As part of this effort, Syngenta must investigate the feasibility of using the Sublethal 

Seedling Assay (Nowatzki et al. 2008)IV as a diagnostic assay. A report on 

Syngenta’s progress towards this requirement must be submitted to EPA within six 

(6) months from the date of this amended registration.

3) Syngenta must develop a proactive resistance monitoring program for northern corn 

rootworm (Diabrotica barberi) by the 2012 season with reporting in 2013. This 

program should include a proposal for annual sampling and testing of northern corn 

rootworm susceptibility to mCry3A toxin. As part of the effort, Syngenta may need 

to investigate novel techniques for rearing and conducting bioassays with northern 

corn rootworm. A report on Syngenta’s progress towards this requirement must be 

submitted within one year (12 months) from the date of this amended registration.

4) Syngenta must submit revised corn rootworm damage guidelines (to characterize 

unexpected pest damage). The revised guidelines must take into consideration the 

comments and recommendations from EPA’s June 30, 2010, review of the rootworm 

resistance monitoring program for mCry3A. A report on this requirement must be 

 

IV Reference: Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, B.D. 

Siegfried, 2008. Validation of a novel resistance monitoring technique for corn rootworm 

(Coleoptera: Chrysomelidae) and event DAS-59122-7 maize. J. Appl. Entomol. 132: 177-

188.
166

submitted to the Agency within six (6) months from the date of the amended 

registration.

5) Syngenta must follow-up on grower, extension specialist or consultant reports of 

unexpected damage or control failures for corn rootworm. 

6) Syngenta must provide EPA with an annual resistance monitoring report by August 

31st of each year, reporting on populations collected the previous year.

e. Remedial Action Plans 

The following program summary describes, in order of events, the steps that must be 

taken to implement a remedial action plan if resistance to target pests is confirmed (this 

general process has been implemented for CRW Bt corn products). 

1) Definition of Suspected Resistance: Resistance will be suspected if investigations 

of unexpected damage reports show that:

(a) implicated maize plant roots were expressing the mCry3A protein at the expected 

level;

(b) alternative causes of damage or lodging, such as non-target pest insect species, 

weather, physical damage, larval movement from alternate hosts, planting errors, 

and other reasonable causes for the observations, have been ruled out;

(c) the level of damage exceeds guidelines for expected damage.

2) If resistance is “suspected”, Syngenta will instruct affected growers to use alternate 

pest control measures such as adulticide treatment, crop rotation the following year, 

or use of soil or seed insecticides the following year. These measures are intended to

reduce the possibility of potentially resistant insects contributing to the following 

year’s pest population.

3) Confirmation of Resistance: Resistance will be confirmed if all of the following 

criteria are met by progeny from the target pest species sampled from the area of 

“suspected resistance:”

(a) the proportion of larvae that can feed and survive on mCry3A roots from neonate 

to adult is significantly higher than the baseline proportion (currently being 

established);

(b) the LC50 of the test population exceeds the upper limit of the 95% confidence 

interval for the LC50 of a standard unselected population and/or survival in the 

diagnostic assay is significantly greater than that of a standard unselected 

population, as established by the ongoing baseline monitoring program;

(c) the ability to survive is heritable;
167

(d) mCry3A plant assays determine that damage caused by surviving insects would 

exceed economic thresholds;

(e) the identified frequency of field resistance could lead to widespread product 

failure if subsequent collections in the affected field area(s) demonstrated similar 

bioassay results.

4) Response to Confirmed Resistance: When resistance is “confirmed”, the following 

steps will be taken:

(a) EPA will receive notification within 30 days of resistance confirmation;

(b) affected customers and extension agents will be notified about confirmed 

resistance;

(c) affected customers and extension agents will be encouraged to employ alternative 

CRW control measures;

(d) sale and distribution of mCry3A maize in the affected area will cease 

immediately;

(e) a long-term resistance management action plan will be devised according to the 

characteristics of the resistance event and local agronomic needs. The details of 

such a plan should be approved by EPA and all appropriate stakeholders.

f. Annual Reporting Requirements 

1) Annual Sales: reported and summed by state (county level data available by request), 

January 31st each year; 

2) 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 31st each year;

3) Grower Education: substantive changes to education program completed previous 

year, January 31st each year;

4) Compliance Assurance Plan: Compliance Assurance Program activities and results, 

January 31st each year; 

5) Compliance: to include annual survey results and plans for the next year; full report 

January 31st each year; 

6) Insect Resistance Monitoring Results: results of monitoring and investigations of 

damage reports, August 31st each year.
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1] The subject registration will automatically expire on midnight September 30, 2015.

2] The subject registration will be limited to mCry3A (MIR604) corn with modified Cry3A 

protein and the genetic material necessary for its production (via elements of vector pZM26) 

in corn SYN-IR6Ø4-5. and Bacillus thuringiensis Cry1Ab delta-endotoxin protein (Bt11) and 

the genetic material necessary for its product (via elements of vector pZ01502 in corn (SYNBTØ11-1)

3] Submit/cite all data required for registration of your product under FIFRA § 3(c)(5) when the 

Agency requires registrants of similar products to submit such data.

4] The subject plant-incorporated protectant may be combined through conventional breeding 

with other registered plant-incorporated protectants that are similarly approved for use in 

combination, through conventional breeding, with other plant-incorporated protectants to 

produce inbred corn lines and hybrid corn varieties with combined pesticidal traits.

5] Three (3) year full-scale field or semi-field studies for evaluation of mCry3A Event MIR604 

corn exposure on non-target invertebrates must be conducted. Full-scale field experiments 

must be appropriately designed to provide a measure of ecological impacts (larger fields, 

more replicates, more samples per plot based on recommendations of the August, 2002 SAP 

and subsequent relevant research on appropriate study design). A protocol is due within 90 

days of the date of registration. A final report is due January 31, 2011.

6] Submit/cite all data, determined by the Agency to be acceptable, required to support the 

individual plant-incorporated protectants in Event MIR 604 with modified Cry3A (Agrisure 

RW) corn and Bacillus thuringiensis corn Event Bt11 with Cry 1Ab for use in field corn 

within the timeframes required by the terms and conditions of EPA Registration Numbers 

67979-5 and 67979-1.

7] You must commit to do the following Insect Resistance Management Program:

a. Refuge Requirements 

These refuge requirements do not apply to seed increase/propagation of inbred and hybrid seed 

corn up to a total of 20,000 acres per county and up to a combined United States (U.S.) total of 

250,000 acres per plant-incorporated protectant (PIP) active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt

corn products, additional educational material and assistance will be provided by Syngenta to 

help these growers meet the refuge requirements across their farming operations.

Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Syngenta 67979-8

Bt Corn Event MIR 

604 + Bt11 with 

modified Cry3A + 

Cry1Ab (Agrisure 

CB/RW)

24 January 

2007

Conditional

(amended 29 September 2010)

30 September 

2015
169

Grower agreements (also known as stewardship agreements) will specify that growers must 

adhere to the 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 Area Refuge Requirements 

For Bt11 x MIR604 Field Corn (expressing Cry1Ab and mCry3A proteins) grown in non-cottongrowing areas 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 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 borers or corn rootworms. The refuge area must represent at least 20% of the 

grower’s corn acres (i.e., sum of Bt11 x MIR604 acres and refuge acres). It must be planted as a 

block within or adjacent (e.g., across the road) to the Bt11 x MIR604 field, 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 common refuge can be treated with a soilapplied 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 Bt11 x MIR604 field 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 or crop consultants). 

The second option is planting separate refuge areas for corn borers and corn rootworms. The 

corn borer refuge must be planted with corn that is not a lepidopteran-protected Bt hybrid, must 

represent at least 20% of the grower’s corn acres (i.e., sum of Bt11 x MIR604 acres and corn 

borer refuge acres), and must be planted within 1⁄2 mile of the Bt11 x MIR604 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. Economic thresholds will be determined using 

methods recommended by local or regional professionals (e.g., Extension Service agents or crop 

consultants). The corn rootworm refuge must be planted with corn that is not a corn rootwormprotected Bt hybrid, must represent at least 20% of the grower’s corn acres (i.e., sum of Bt11 x 

MIR604 acres and corn rootworm refuge acres), and must be planted as a block within or 

adjacent (e.g., across the road) to the Bt11 x MIR604 field, 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 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 if pest pressure reaches an 

economic threshold for damage; however, if rootworm adults are present at the time of foliar 

applications, then the Bt11 x MIR604 field 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 or crop consultants).

Growers who fail to comply with the IRM requirements risk losing access to Syngenta corn PIP 

products. 
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Corn/Cotton-Growing Area (Cotton-Growing Area) Refuge Requirements

For Bt11 x MIR604 grown in cotton-growing areas of the United States, 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 Dunklin, New Madrid, Pemiscot, Scott, and Stoddard).

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 borers or corn rootworms. The refuge area must represent at least 50% of the 

grower’s corn acres (i.e., sum of Bt11 x MIR604 acres and refuge acres). It must be planted as a 

block within or adjacent (e.g., across the road) to the Bt11 x MIR604 field, 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 common refuge can be treated with a soilapplied 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 Bt11 x MIR604 field 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 or crop consultants). 

The second option is planting separate refuge areas for corn borers and corn rootworms. The 

corn borer refuge must be planted with corn that is not a lepidopteran-protected Bt hybrid, must 

represent at least 50% of the grower’s corn acres (i.e., sum of Bt11 x MIR604 acres and corn 

borer refuge acres), and must be planted within 1⁄2 mile of the Bt11 x MIR604 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. Economic thresholds will be determined using 

methods recommended by local or regional professionals (e.g., Extension Service agents or crop 

consultants). The corn rootworm refuge must be planted with corn that is not a corn rootwormprotected Bt hybrid, must represent at least 20% of the grower’s corn acres (i.e., sum of Bt11 x 

MIR604 acres and corn rootworm refuge acres), and must be planted as a block within or 

adjacent (e.g., across the road) to the Bt11 x MIR604 field, 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 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 if pest pressure reaches an 

economic threshold for damage; however, if rootworm adults are present at the time of foliar 

applications, then the Bt11 x MIR604 field must be treated in a similar manner. Economic 
171

thresholds will be determined using methods recommended by local or regional professionals 

(e.g., Extension Service agents or crop consultants).

Growers who fail to comply with the IRM requirements risk losing access to Syngenta corn PIP 

products. 

b. Grower Agreements

1) Persons purchasing the Bt corn 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) Syngenta must continue to integrate this amended registration into the current system 

used for its other Bt corn plant-incorporated protectants, which is reasonably likely to 

assure that persons purchasing Bt11 x MIR604 corn product will affirm annually that 

they are contractually bound to comply with the requirements of the IRM program.

4) Syngenta must continue to use its current grower agreement for Bt11 x MIR604 corn 

product. If Syngenta 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 (30) days prior to implementing a 

proposed change, Syngenta must submit to EPA the text of such changes to ensure 

that it is consistent with the terms and conditions of this amended registration. 

5) Syngenta must continue to integrate this amended registration into the current system 

used for its other Bt corn plant-incorporated protectants, which is reasonably likely to 

assure that persons purchasing Bt11 x MIR604 corn product sign grower 

agreement(s).

6) Syngenta 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) Annually, Syngenta shall provide EPA with a report showing the number of units of 

its Bt11 x MIR604 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) Annually, Syngenta shall submit annual reports on units sold by State (units sold by 

county level will be made available to the Agency upon request), IRM grower 

agreement results, and the compliance assurance program, including the education 

program on or before January 31st each year.
172

9) Syngenta 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 Programs 

1) Syngenta must continue to implement and enhance (as set forth in paragraph 17 of 

this section) a comprehensive, ongoing IRM education program designed to convey 

to Bt11 x MIR604 corn product users the importance of complying with the IRM 

program. The program shall include information encouraging Bt11 x MIR604 corn 

product users to pursue optional elements of the IRM program relating to refuge 

configuration and proximity to Bt11 x MIR604 corn product 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 Bt11 x 

MIR604 corn product user separate from the grower technical guide. The 

communication shall inform the user of the current IRM requirements. Syngenta 

shall coordinate its education programs with educational efforts of other registrants 

and organizations, such as the National Corn Growers Association and state extension 

programs.

2) Annually, Syngenta 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) Annually, Syngenta must provide a report to EPA summarizing the activities carried 

out under the education program for the prior year and any substantive changes to its 

grower education activities as part of the overall IRM compliance assurance program 

report. The required features of the compliance assurance program are described in 

paragraphs 4-22 below.

4) Syngenta must continue to implement and improve an ongoing IRM Compliance 

Assurance Program (CAP) designed to evaluate the extent to which growers 

purchasing Bt11 x MIR604 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 Syngenta 

corn PIP products. Syngenta shall coordinate with other Bt corn registrants in 

improving its Compliance Assurance Program and continue to integrate this amended 

registration into the current Compliance Assurance Program used for its other Bt corn 

plant-incorporated protectants. Other required features of the program are described 

in paragraphs 5–22.

5) Syngenta must maintain and publicize a “phased compliance approach,” i.e., a 
173

guidance document that indicates how it will address instances of non-compliance 

with the terms of the IRM program and general criteria for choosing among options 

for responding to any non-compliant growers after the first year of noncompliance. 

While recognizing that for reasons of difference in business practices there are needs 

for flexibility between different companies, all Bt corn registrants must use a 

consistent set of standards for responding to non-compliance. An individual grower 

found to be significantly out of compliance 2 years in a row would be denied access 

to the registrant’s Bt corn products the next year. Additionally, seed dealers who are 

not fulfilling their obligations to inform/educate growers of their IRM obligations will 

lose their opportunity to sell Bt corn.

6) The IRM compliance assurance program shall include an annual survey conducted by 

an independent third party of a statistically representative sample of growers of Bt

corn products who plant the vast majority of all corn in the U.S. and in areas in which 

the selection intensity is greatest. The survey shall consider only those growers who 

plant 200 or more acres of corn in the Corn-Belt and who plant 100 or more acres of 

corn in corn-cotton areas. 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.

a. A third party is classified as a party other than Syngenta, the grower, or 

anyone else with a direct interest in IRM compliance for Bt corn.

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) Syngenta shall provide 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. Syngenta shall confer with other 

Bt corn registrants and EPA on the design and content of the survey prior to its 

implementation.

10) Annually, Syngenta 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. Syngenta must 

confer with the Agency prior to adopting any changes to a previously approved CAP.

11) Syngenta shall conduct an annual on-farm assessment program. Syngenta shall train 
174

its representatives who make on-farm visits with growers of their Bt corn products to 

perform assessments of compliance with IRM requirements. There is no minimum 

corn acreage size for this program. Therefore, growers will be selected for this 

program from across all farm sizes. In the event that any of these visits result in the 

identification of a grower who is not in compliance with the IRM program, Syngenta 

shall take appropriate action, consistent with its "phased compliance approach," to 

promote compliance.

12) Syngenta 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, Syngenta shall take appropriate action, consistent with its "phased 

compliance approach." 

13) If a grower who purchases Bt11 x MIR604 corn for planting was specifically 

identified as not being in compliance during the previous year, Syngenta shall visit 

with the grower and evaluate whether that the grower is in compliance with the IRM 

program for the current year.

14) Each registrant shall annually 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, onfarm visits, verified tips and complaints, grower meetings and letters), the extent of 

non-compliance, corrective measures to address the non-compliance, and any followup actions taken. The report must inform EPA of the number of growers deemed 

ineligible to purchase Bt corn seed on the basis of continued non-compliance with the 

insect resistance management refuge requirements. The registrants may elect to 

coordinate information and report collectively the results of their compliance 

assurance programs. Within one month of submitting this report to EPA, the 

registrant shall meet with EPA to discuss its findings.

15) Syngenta and the seed corn dealers for Syngenta 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.

16) Syngenta shall revise and expand its existing Compliance Assurance Program to 

include the following elements. Syngenta must prepare and submit by January 31, 

2011, a written description of its revised Compliance Assurance Program. Syngenta 

may coordinate with other registrants in designing and implementing its Compliance 

Assurance Program.

17) Syngenta will enhance the refuge education program throughout the seed delivery 

channel to:

a. Ensure sales representatives, licensees, seed dealers, and growers recognize 

the importance of correct refuge implementation and potential consequences 
175

of failure to plant the required refuge;

b. Include the refuge size requirement on all Bt corn seed bags or bag tags. The 

PIP product label accepted by EPA must include how this information will be 

conveyed to growers via text and graphics. This requirement may be phased in 

over the next three growing seasons. Revised PIP product labels must be 

submitted by January 31, 2011; 50% implementation on the Bt corn seed bags 

or bag tags must occur by the 2012 growing season; and full implementation 

must occur by the 2013 growing season.

18) Syngenta will focus the majority of on-farm assessments on regions with the greatest 

risks for resistance and will:

a. Use Bt corn adoption, pest pressure information, and other available 

information to identify regions where the risk of resistance is greatest; 

b. Focus approximately two-thirds of on-farm assessments on these regions, with 

the remaining assessments conducted across other regions where the product 

is used. 

19) Syngenta will use its available Bt sales records and other information to refine grower 

lists for on-farm assessments of their compliance with refuge requirements: 

a. Identify for potential on-farm assessment growers whose sales information 

indicates they have purchased the Bt corn product but may have purchased 

little or no refuge seed from Syngenta, licensee, or affiliated company. 

20) Syngenta will contract with third parties to perform on-farm assessments of 

compliance with refuge requirements: 

a. The third-party assessors will conduct all first-time on-farm assessments as 

well as second-year on-farm assessments of those growers found out of 

compliance in a first-time assessment.

21) Syngenta will annually refine the on-farm assessment program for the Bt corn product 

to reflect the adoption rate and level of refuge compliance for the product.

22) Syngenta will follow up with growers who have been found significantly out of 

compliance under the on-farm assessment program and are found to be back in 

compliance the following year:

a. All growers found to be significantly out of compliance in a prior year will 

annually be sent additional refuge assistance information for a minimum of 2 

years by Syngenta, a seed supplier, or a third-party assessor, after completing 

the assessment process.

b. Syngenta will conduct follow-up checks on growers found to be significantly 

out of compliance within 3 years after they are found to be back in 
176

compliance.

c. A grower found with a second incident of significant non-compliance with 

refuge requirements for Bt11 x MIR604 corn product within a 5-year period 

will be denied access to and/or sales of the registrant’s Bt corn products the 

next year.

d. Insect Resistance Monitoring and Remedial Action Plan (mCry3A – Corn 

Rootworm)

The Agency is imposing the following conditions for the mCry3A toxin expressed in this 

product: 

1) Syngenta must monitor for mCry3A resistance and/or trends in increased tolerance 

for corn rootworm. Sampling should be focused in those areas in which there is the 

highest risk of resistance development. 

2) The resistance monitoring plan must include: baseline sensitivity data, sampling 

(number of locations, samples per locations), sampling methodology and life-stage 

sampled, bioassay methodology, standardization procedures (including QA/QC 

provisions), detection technique and sensitivity, the statistical analysis of the 

probability of detecting resistance, and an interim description of rootworm damage 

guidelines.

3) Syngenta must develop a functional diagnostic assay for corn rootworm resistance 

monitoring to detect potentially resistant individuals and incorporate this assay into 

the annual resistance monitoring program by the 2011 season with reporting in 2012. 

As part of this effort, Syngenta must investigate the feasibility of using the Sublethal 

Seedling Assay (Nowatzki et al. 2008)Vas a diagnostic assay. A report on 

Syngenta’s progress towards this requirement must be submitted to EPA within six 

(6) months from the date of this amended registration.

7) Syngenta must develop a proactive resistance monitoring program for northern corn 

rootworm (Diabrotica barberi) by the 2012 season with reporting in 2013. This 

program should include a proposal for annual sampling and testing of northern corn 

rootworm susceptibility to mCry3A toxin. As part of the effort, Syngenta may need 

to investigate novel techniques for rearing and conducting bioassays with northern 

corn rootworm. A report on Syngenta’s progress towards this requirement must be 

submitted within one year (12 months) from the date of this amended registration.

8) Syngenta must submit revised corn rootworm damage guidelines (to characterize 

unexpected pest damage). The revised guidelines must take into consideration the 

 

V

Reference: Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, B.D. 

Siegfried, 2008. Validation of a novel resistance monitoring technique for corn rootworm 

(Coleoptera: Chrysomelidae) and event DAS-59122-7 maize. J. Appl. Entomol. 132: 177-

188.
177

comments and recommendations from EPA’s June 30, 2010, review of the rootworm 

resistance monitoring program for mCry3A. A report on this requirement must be 

submitted to the Agency within six (6) months from the date of the amended 

registration.

9) Syngenta must follow-up on grower, extension specialist or consultant reports of 

unexpected damage or control failures for corn rootworm. 

10) Syngenta must provide EPA with an annual resistance monitoring report by August 

31st of each year, reporting on populations collected the previous year.

e. Remedial Action Plans

The following program summary describes, in order of events, the steps that must be 

taken to implement a remedial action plan if resistance to target pests is confirmed (this 

general process has been implemented for other lepidopteron and CRW Bt corn 

products). 

1) Definition of Suspected Resistance: Resistance will be suspected if investigations of 

unexpected damage reports show that:

a. implicated maize plant roots were expressing the mCry3A protein at the expected 

level;

b. alternative causes of damage or lodging, such as non-target pest insect species, 

weather, physical damage, larval movement from alternate hosts, planting errors, 

and other reasonable causes for the observations, have been ruled out;

c. the level of damage exceeds guidelines for expected damage.

2) If resistance is “suspected”, Syngenta will instruct affected growers to use alternate 

pest control measures such as adulticide treatment, crop rotation the following year, 

or use of soil or seed insecticides the following year. These measures are intended to 

reduce the possibility of potentially resistant insects contributing to the following 

year’s pest population.

3) Confirmation of Resistance: Resistance will be confirmed if all of the following 

criteria are met by progeny from the target pest species sampled from the area of 

“suspected resistance:”

a. the proportion of larvae that can feed and survive on mCry3A roots from neonate 

to adult is significantly higher than the baseline proportion (currently being 

established);

b. the LC50 of the test population exceeds the upper limit of the 95% confidence 

interval for the LC50 of a standard unselected population and/or survival in the 

diagnostic assay is significantly greater than that of a standard unselected 

population, as established by the ongoing baseline monitoring program;
178

c. the ability to survive is heritable;

d. mCry3A plant assays determine that damage caused by surviving insects would 

exceed economic thresholds;

e. the identified frequency of field resistance could lead to widespread product 

failure if subsequent collections in the affected field area(s) demonstrated similar 

bioassay results.

4) Response to Confirmed Resistance: When resistance is “confirmed”, the following 

steps will be taken:

a. EPA will receive notification within 30 days of resistance confirmation;

b. affected customers and extension agents will be notified about confirmed 

resistance;

c. affected customers and extension agents will be encouraged to employ alternative 

CRW control measures;

d. sale and distribution of mCry3A maize in the affected area will cease 

immediately;

e. a long-term resistance management action plan will be devised according to the 

characteristics of the resistance event and local agronomic needs. The details of 

such a plan should be approved by EPA and all appropriate stakeholders.

f. Insect Resistance Monitoring (Cry1Ab – Corn Borer)

The Agency is imposing the following conditions for this product: 

Syngenta will monitor for resistance to its lepidopteran-resistant Bt corn. The monitoring 

program shall consist of two approaches: (1) focused population sampling and laboratory 

testing; and (2) investigation of reports of less-than expected control of labeled insects. 

Should field-relevant resistance be confirmed, an appropriate resistance management 

action plan will be implemented.

1) Focused Population Sampling

Syngenta 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 fieldrelevant shifts in population response to lepidopteran resistant Bt corn and/or changes 
179

in resistance allele frequency in response to the use of Bt 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 of 

lepidopteran-resistant Bt corn. The Agency shall be consulted prior to the 

implementation of such modifications.

Syngenta 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:

a. 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.

b. If the unusual response is reproducible and heritable, progeny of insects that 

survive the diagnostic concentration will be tested using methods that are 

representative of exposure to Bt corn hybrids under field conditions. If progeny do 

not survive to adulthood, any suspected resistance is not field relevant and no 

further action is required.

c. If insects survive steps 1 and 2, resistance is confirmed, and further steps will be 

taken to evaluate the resistance. These steps may include:

(a) determining the nature of the resistance (i.e., recessive or dominant, and the 

level of functional dominance);
180

(b) estimating the resistance-allele frequency in the original population;

(c) determining 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;

(d) determining 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, Syngenta 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:

Syngenta will follow up on grower, extension specialist or consultant reports of 

unexpected levels of damage by the lepidopteran pests listed on the pesticide label. 

Syngenta will instruct its customers to contact them if such incidents occur. Syngenta 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), Syngenta will implement the actions 

described below, based on the following definitions of suspected resistance and 

confirmed resistance.

Suspected resistance

EPA defines suspected resistance to mean field reports of unexpected levels of insect 

feeding damage for which:

(a) the corn in question has been confirmed to be lepidopteran-active Bt corn;

(b) the seed used had the proper percentage of corn expressing Bt protein;

(c) the relevant plant tissues are expressing the expected level of Bt protein; and

(d) 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 confirm 

scientifically the presence of insects resistant to Bt corn in commercial production fields 

before responsive measures are undertaken.
181

If resistance is suspected, Syngenta will instruct growers to do the following:

(a) Use alternative control measures in the Bt corn fields in the affected region to 

control the target pest during the immediate growing season.

(b) Destroy Bt corn 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 over-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, Syngenta 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: 

(a) 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 corn hybrids under field conditions (ECB and SWCB only). 

(b) 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.

(c) In standardized laboratory bioassays, the LC50 exceeds the upper limit of the 95% 

confidence interval of the LC50 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 Syngenta: 

(a) EPA will receive notification within 30 days of resistance confirmation; 

(b) Affected customers and extension agents will be notified about confirmed 

resistance within 30 days; 

(c) Monitoring will be increased in the affected area and local target pest populations 

will be sampled annually to determine the extent and impact of resistance; 
182

(d) 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; 

(e) Unless otherwise agreed with EPA, stop sale and distribution of the relevant 

lepidopteran-active Bt corn hybrids in the affected area immediately until an 

effective local mitigation plan approved by EPA has been implemented; 

(f) Syngenta will develop a case-specific resistance management action plan within 

90 days according to the characteristics of the resistance event and local 

agronomic needs. Syngenta 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; 

(g) Syngenta will 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 

(h) In subsequent growing seasons, Syngenta will maintain sales suspension and 

alternative resistance management strategies in the affected region(s) for the Bt

corn hybrids that are affected by the resistant population until an EPA-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 31st 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 Cry1Ab corn 

constitutes acceptance of these conditions.

g. Annual Reporting Requirements 

1) Annual Sales: reported and summed by state (county level data available by request), 

January 31st each year; 

2) 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 31st each year;

3) Grower Education: substantive changes to education program completed previous 

year, January 31st each year;
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4) Compliance Assurance Plan: Compliance Assurance Program activities and results, 

January 31st each year; 

5) Compliance: to include annual survey results and plans for the next year; full report 

January 31st each year; 

6) Insect Resistance Monitoring Results: results of monitoring and investigations of 

damage reports, August 31st each year.
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V. MON89034 BRAD Registered Products

Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Monsanto 524-575

Bt corn Event 

MON 89034 with 

Cry1A.105 + 

CryAb2

10 June 2008 Conditional

(amended 29 September 2010)

30 September 

2022

1) The subject registration will automatically expire on midnight September 30, 2022.

2) The subject registration will be limited to MON 89034 [Bacillus thuringiensis

Cry1A.105 and Cry2Ab2 proteins and the genetic material necessary for their 

production (vector PV-ZMIR245) in event MON 89034 corn (OECD Unique Identifier: 

MON-89034-3) for use in field or sweet corn. Further, MON 89034 sweet corn may 

only be sold directly to processors or through commercial dealers to large growers. 

MON 89034 sweet corn must not be sold to small roadside or home growers.

3) Submit/cite all data required for registration of your product under FIFRA § 3(c)(5) 

when the Environmental Protection Agency (EPA) requires registrants of similar 

products to submit such data.

4) This plant-incorporated protectant may be combined through conventional breeding 

with other registered plant-incorporated protectants that are similarly approved for use 

in combination, through conventional breeding, with other registered plant-incorporated 

protectants to produce inbred corn lines and hybrid corn varieties with combined 

pesticidal traits.

5) Submit the following data in the time frames listed:

OPPTS Guideline/ 

Study Type

Required Data Due Date

Insect Resistance 

Management –

Resistance 

Monitoring

Baseline susceptibility studies and/or a discriminating 

concentration assay are required for the Cry1A.105 

protein against Southwestern corn borer (SWCB), and 

for the Cry2Ab2 protein against SWCB. These data 

were submitted and are being evaluated.

Insect Resistance 

Management –

Resistance 

Monitoring

To support sweet corn uses, baseline susceptibility 

studies must be conducted on fall armyworm (FAW) 

populations collected from sweet corn growing areas. 

Monitoring studies will be conducted on FAW 

populations collected from sweet corn distribution areas 

in states in which Monsanto MON 89034 and/or MON 

89034 x MON 88017 sweet corn plantings exceed 5,000 

acres. The collected populations of FAW will be 

monitored for changes in susceptibility to the 

Cry1A.105 and Cry2Ab2 proteins.

4/1/2012*
185

*

Extensions were granted as listed in the above table.

6) You must commit to do the following Insect Resistance Management (IRM) Program, 

consisting of the following elements:

Requirements relating to creation of a non-Bt corn and/or non-lepidopteran resistant Bt 

corn refuge in conjunction with the planting of any acreage of MON 89034 field corn.

Requirements for Monsanto Company (Monsanto) to prepare and require MON 89034 

users to sign “grower agreements,” that impose binding contractual obligations on the 

grower to comply with the refuge requirements.

Requirements for Monsanto to develop, implement, and report to EPA on programs to 

educate growers about IRM requirements.

Requirements for Monsanto to develop, implement, and report to EPA on programs to 

evaluate and promote growers’ compliance with IRM requirements.

Requirements for Monsanto to develop, implement, and report to EPA on programs to 

evaluate whether there are statistically significant and biologically relevant changes in 

susceptibility to Cry1A.105 and Cry2Ab2 proteins in the target insects.

Requirements for Monsanto to develop, and if triggered, to implement a “remedial action 

plan,” that contains measures Monsanto 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; 

Requirements for Monsanto, on or before January 31st of each year, to submit reports on 

units sold by state (units sold by county level will be made available to the Agency upon 

request), IRM grower agreement results, and the compliance assurance program 

including the education program. 

Requirements for Monsanto, on or before August 31st of each year, to submit reports on resistance 

monitoring.

 a) Refuge Requirements for MON 89034 Field Corn

These refuge requirements do not apply to seed increase/propagation of inbred and hybrid 

seed corn up to a total of 20,000 acres per county and up to a combined United States (U.S.) total 

of 250,000 acres per plant-incorporated protectant (PIP) active ingredient per registrant per year. 

Furthermore, these refuge requirements do not apply to commercial hybrid sweet corn.

When on-farm assessments identify non-compliance with refuge requirements for one or 

more Bt corn products, additional educational material and assistance will be provided by 

Monsanto to help these growers meet the refuge requirements across their farming operations.
186

Grower agreements (also known as stewardship agreements) will specify that growers must 

adhere to the refuge requirements as described in the grower guide/product use guide and/or in 

supplements to the grower guide/product use guide.

 1) Corn-Belt Refuge Requirements

For MON 89034 field corn grown outside cotton-growing areas (e.g., the Corn Belt), grower 

agreements (also known as stewardship agreements) will specify that growers must adhere to the 

refuge requirements as described in the grower guide/product use guide and/or in supplements to 

the grower guide/product use guide.

Specifically, growers must plant a structured refuge of at least 5% non-Bt corn and/or 

non-lepidopteran resistant Bt corn that may be treated with insecticides, as detailed 

below, to control lepidopteran stalk-boring and other pests.

Refuge planting options include: separate fields, blocks within fields (e.g., along the 

edges or headlands), perimeter strips, and strips across the field.

External refuges must be planted within 1⁄2 mile.

When planting the refuge as strips across the field or as perimeter strips, refuges must be 

at least 4 consecutive rows wide.

Insecticide treatments for control of ECB, CEW, SWCB, and other lepidopteran target 

pests listed on the label, grower guides, or other educational material may be applied only 

if economic thresholds are reached for one or more of these target pests. Economic 

thresholds will be determined using methods recommended by local or regional 

professionals (e.g., Extension Service agents or crop consultants). Instructions to 

growers will specify that microbial Bt insecticides must not be applied to non-Bt corn 

and/or non-lepidopteran resistant Bt corn refuges. 

 2) Cotton-Growing Area Refuge Requirements

 For MON 89034 field corn grown in cotton-growing areas, grower agreements (also known 

as stewardship agreements) will specify that growers must adhere to the refuge requirements as 

described in the grower guide/product use guide and/or in supplements to the grower guide/ 

product use guide.

Specifically, growers in these areas must plant a structured refuge of at least 20% non-Bt

corn and/or non-lepidopteran resistant Bt corn that may be treated with insecticides, as 

detailed below, to control lepidopteran stalk-boring and other pests.

Refuge planting options include: separate fields, blocks within fields (e.g., along the 

edges or headlands), perimeter strips, and strips across the field.

External refuges must be planted within 1⁄2 mile.
187

When planting the refuge as strips across the field or as perimeter strips, refuges must be 

at least 4 consecutive rows wide.

Insecticide treatments for control of ECB, CEW, SWCB, and other lepidopteran target 

pests listed on the label, grower guides, or other educational material may be applied only 

if economic thresholds are reached for one or more of these target pests. Economic 

thresholds will be determined using methods recommended by local or regional 

professionals (e.g., Extension Service agents or crop consultants). Instructions to 

growers will specify that microbial Bt insecticides must not be applied to non-Bt corn 

and/or non-lepidopteran resistant Bt corn refuges. 

Cotton-growing areas include the following states: Alabama, Arkansas, Georgia, Florida, 

Louisiana, North Carolina, Mississippi, South Carolina, Oklahoma (only the counties of 

Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, 

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, Sussex), and Missouri (only the 

counties of Dunklin, New Madrid, Pemiscot, Scott, and Stoddard). 

 b) Post-Harvest Requirements for MON 89034 Sweet Corn

 Sweet corn is harvested long before field corn. Therefore, if the sweet corn stalks remaining 

in the field and any insects remaining in the stalks are destroyed shortly after harvest, a refuge is 

not needed as a part of the IRM program for sweet corn. Growers must adhere to the following 

types of crop destruction requirements as described in the grower guide/product use guide and/or 

in supplements to the grower guide/product use guide.

Crop destruction must occur no later than 30 days following harvest, but preferably 

within 14 days.

The allowed crop destruction methods are: rotary mowing, discing, or plow-down. Crop 

destruction methods should destroy any surviving resistant insects.

c) Grower Agreements for MON 89034 

1) Persons purchasing MON 89034 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 
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grower agreement, a grower must be contractually bound to comply with the 

requirements of the IRM program.

3) Monsanto must continue to integrate this amended registration into the current system 

used for its other Bt corn plant-incorporated protectants, which is reasonably likely to 

assure that persons purchasing MON 89034 corn will affirm annually that they are 

contractually bound to comply with the requirements of the IRM program. 

4) Monsanto must continue to use its current grower agreement for MON 89034 corn. 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 (30) days prior to implementing a proposed change, Monsanto must 

submit to EPA the text of such changes to ensure that it is consistent with the terms and 

conditions of this amended registration.

5) Monsanto must continue to integrate this amended registration into the current system 

used for its other Bt corn plant-incorporated protectants, which is reasonably likely to 

assure that persons purchasing MON 89034 corn sign grower agreement(s).

6) Monsanto shall maintain records of all MON 89034 grower agreements for a period of 

three years from December 31st of the year in which the agreement was signed.

7) Annually, Monsanto shall provide EPA with a report showing the number of units of 

MON 89034 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) Monsanto 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.

 d) IRM Education and Compliance Monitoring Programs for MON 89034

1) Monsanto must continue to implement and enhance (as set forth in paragraph 17 of this 

section) a comprehensive, ongoing IRM education program designed to convey to MON 

89034 corn users the importance of complying with the IRM program. The program 

shall include information encouraging MON 89034 corn users to pursue optional 

elements of the IRM program relating to refuge configuration and proximity to MON 

89034 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 

MON 89034 corn user separate from the grower technical guide. The communication 

shall inform the user of the current IRM requirements. Monsanto shall coordinate its 
189

education programs with educational efforts of other registrants and organizations, such 

as the National Corn Growers Association and state extension programs.

2) Annually, Monsanto shall revise, and expand as necessary, its education program to take 

into account the information collected through the compliance survey required under 

paragraphs 6a or 6b and from other sources. The changes shall address aspects of grower 

compliance that are not sufficiently high.

3) Annually Monsanto must provide EPA any substantive changes to its grower education 

activities as part of the overall IRM compliance assurance program report. Monsanto 

must either submit a separate report or contribute to the report from the industry working 

group, Agricultural Biotechnology Stewardship Technical Committee (ABSTC). The 

required features of the compliance assurance program are described in paragraphs 4–22 

of this section.

4) Monsanto must continue to implement and improve an ongoing IRM compliance 

assurance program designed to evaluate the extent to which growers purchasing MON 

89034 corn 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 Monsanto corn PIP products. Monsanto shall 

coordinate with other Bt corn registrants in improving its compliance assurance program 

and continue to integrate this amended registration into the current compliance assurance 

program used for its other Bt corn plant-incorporated protectants. Other required features 

of the program are described in paragraphs 5–22.

.

5) Monsanto must maintain and publicize a “phased compliance approach,” i.e., a guidance 

document that indicates how Monsanto will address instances of non-compliance with the 

terms of the IRM program and general criteria for choosing among options for 

responding to any non-compliant growers after the first year of noncompliance. While 

recognizing that for reasons of difference in business practices there are needs for 

flexibility between different companies, all Bt corn registrants must use a consistent set of 

standards for responding to non-compliance. An individual grower found to be 

significantly out of compliance two years in a row would be denied access to Monsanto’s 

Bt corn products 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 Bt corn

6a) MON 89034 Field Corn: The IRM compliance assurance program shall include an annual 

survey, conducted by an independent third party, of a statistically representative sample 

of growers of MON 89034 field corn who plant the vast majority of all corn in the United 

States and in areas in which the selection intensity is greatest. The survey shall consider 

only those growers who plant 200 or more acres of corn in the Corn-Belt and who plant 

100 or more acres of corn in corn-cotton areas. 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 
190

resolution may be adjusted annually, based upon input from independent marketing 

research firms 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 United States. 

i. A third party is classified as a party other than the registrant, the grower, or anyone 

else with a direct interest in IRM compliance for Bt corn.

6b) MON 89034 Sweet Corn: The IRM compliance assurance program shall include an 

annual survey of all MON 89034 sweet corn customers who purchase 5 or more bags of 

MON 89034 sweet corn. The survey shall measure the degree of compliance with the 

IRM program, identify the response rate (e.g., the percent of MON 89034 sweet corn 

acres covered by the responses), and consider the potential impact of non-response. An 

independent third party will participate in the design and implementation of the survey. 

Data and information derived from the annual survey will be audited by an independent 

third party.

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.

9a) MON 89034 Field Corn: Monsanto shall provide 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 on or before January 31st of each year. Monsanto 

shall confer with other registrants and EPA on the design and content of the survey prior 

to its implementation.

9b) MON 89034 Sweet Corn: Monsanto shall provide a written summary of the results of the 

prior year’s survey (together with a description of the methodology used and the 

supporting data) to EPA on or before January 31st of each year. Monsanto shall confer 

with EPA on changes to the design and content of the survey prior to its implementation.

10) Annually, Monsanto shall revise, and expand as necessary, its compliance assurance 

program to take into account the information collected through the compliance survey 

required under paragraphs 6a through 8 and from other sources. The changes shall 

address aspects of grower compliance that are not sufficiently high. Monsanto must 

confer with the Agency prior to adopting any changes.

11) Monsanto shall conduct an annual on-farm assessment program. Monsanto shall train its 

representatives who make on-farm visits with growers of MON 89034 to perform 

assessments of compliance with IRM requirements. There is no minimum corn acreage 

size for this program. Therefore, growers will be selected for this program from across 

all farm sizes. In the event that any of these visits result in the identification of a grower 

who is not in compliance with the IRM program, Monsanto shall take appropriate action, 
191

consistent with its “phased compliance approach,” to promote compliance. 

12) Monsanto 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, 

Monsanto shall take appropriate action, consistent with its “phased compliance 

approach.”

13) If a grower, who purchases MON 89034 for planting, was specifically identified as not 

being in compliance during the previous year, Monsanto shall visit with the grower and 

evaluate whether the grower is in compliance with the IRM program for the current year. 

14) Annually, 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. Within one month of submitting 

this report to EPA, Monsanto shall meet with EPA to discuss its findings. 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 noncompliance, corrective measures to address the non-compliance, and any follow-up 

actions taken. The report must inform EPA of the number of growers deemed ineligible 

to purchase Bt corn seed on the basis of continued non-compliance with the insect 

resistance management refuge requirements. Monsanto may elect to coordinate 

information with other registrants and report collectively the results of compliance 

assurance programs.

15) Monsanto and the seed corn dealers for Monsanto 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.

16) Monsanto shall revise and expand its existing Compliance Assurance Program to include 

the following elements. The registrant must prepare and submit by January 31, 2011, a 

written description of its revised Compliance Assurance Program. The registrant may 

coordinate with other registrants in designing and implementing its Compliance 

Assurance Program. 

17) The registrant will enhance the refuge education program throughout the seed delivery 

channel: 

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance 

of correct refuge implementation and potential consequences of failure to plant the 

required refuge; 

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. The PIP product 

label accepted by EPA must include how this information will be conveyed to growers 

via text and graphics. This requirement may be phased in over the next three growing 

seasons. Revised PIP product labels must be submitted by January 31, 2011, 50% 

implementation on the Bt corn seed bags or bag tags must occur by the 2012 growing 
192

season, and full implementation must occur by the 2013 growing season. 

18) Monsanto will focus the majority of on-farm assessments on regions with the greatest 

risks for resistance: 

i. Use Bt corn adoption, pest pressure information, and other available information to identify 

regions where the risk of resistance is greatest; 

ii. Focus approximately two-thirds of on-farm assessments on these regions, with the 

remaining assessments conducted across other regions where the product is used. 

19) Monsanto will use its available MON 89034 sales records and other information to refine 

grower lists for on-farm assessments of their compliance with refuge requirements: 

i. Identify for potential on-farm assessment growers whose sales information indicates they 

have purchased the MON 89034 corn product but may have purchased little or no refuge 

seed from the registrant, licensee, or affiliated company. 

20) Monsanto will contract with third parties to perform on-farm assessments of compliance 

with refuge requirements: 

i. The third-party assessors will conduct all first-time on-farm assessments as well as secondyear on-farm assessments of those growers found out of compliance in a first-time 

assessment 

21) Annually, Monsanto will refine the on-farm assessment program for the MON 89034 

corn product to reflect the adoption rate and level of refuge compliance for MON 89034 . 

22) Monsanto will follow up with growers who have been found significantly out of 

compliance under the on-farm assessment program and are found to be back in 

compliance the following year: 

i. All growers found to be significantly out of compliance in a prior year will annually be sent 

additional refuge assistance information for a minimum of two years by Monsanto, a seed 

supplier, or third party assessor, after completing the assessment process; 

ii. Monsanto will conduct follow-up checks on growers found to be significantly out of 

compliance within three years after they are found to be back in compliance; 

iii. A grower found with a second incident of significant non-compliance with refuge 

requirements for MON 89034 corn within a five-year period will be denied access to 

and/or sales of Monsanto’s Bt corn products the next year.

 

e) Insect Resistance Monitoring and Remedial Action Plan for MON 89034

1) The Agency is imposing the following conditions for the Cry1A.105 and Cry2Ab2 toxins 

expressed in MON 89034: 
193

i. Monsanto must monitor for resistance to Cry1A.105 and Cry2Ab2 expressed in MON 

89034. 

 

ii. The resistance monitoring program must include the following two approaches: (1) 

focused population sampling and laboratory testing and (2) investigation of reports of 

less-than expected control of labeled insects. Should field relevant resistance be 

confirmed, an appropriate resistance management action plan will be implemented.

(1) Focused Population Sampling

 Monsanto must develop and ensure the implementation of a plan for resistance monitoring 

for Spodoptera frugiperda (fall armyworm or FAW) in counties in which MON 89034 and/or 

MON 89034 x MON 88017 sweet corn acreage exceeds 5,000 acres and the pest is capable of 

overwintering in that county. Monsanto should consult with academic and United States 

Department of Agriculture (USDA) experts in developing the monitoring plan and will provide 

EPA with a copy of its proposed resistance monitoring plan for EPA’s approval prior to 

implementation. This proposed FAW monitoring plan must be submitted to EPA by January 31st

of the year following that in which MON 89034 and/or MON 89034 x MON 88017 sweet corn 

acreage exceeds the trigger specified in this requirement (i.e., greater than 5,000 acres in any 

county in which FAW overwinters). The proposed plan must be implemented the season 

following the acreage trigger being met. The proposed plan will remain in place until an EPA 

approved plan can be implemented.

 

 Annually, Monsanto shall sample and bioassay populations of the key target pests: Ostrinia 

nubilalis (European corn borer; ECB), Diatraea grandiosella (Southwestern corn borer; SWCB), 

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 MON 89034 and/or changes in 

resistance-allele frequency in response to the use of MON 89034 and, as far as possible, should 

be consistent across sampling years to enable comparisons with historical data. Each protein in 

MON 89034 must be tested separately, rather than a mixture of the two proteins, because 

resistance to one protein could be masked by the activity of the other. 

 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.
194

 The sampling program and geographic range of collections may be modified as appropriate 

based on changes in pest importance and for the adoption levels of MON 89034. The Agency 

shall be consulted prior to the implementation of such modifications.

 Monsanto will report to the Agency by August 31st of each year, the results of the population 

sampling and bioassay monitoring program. 

 Any incidence of unusually low sensitivity to the Cry1A.105 and Cry2Ab2 proteins 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

st

,. 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 survive the 

diagnostic concentration will be tested using methods that are representative of exposure 

to MON 89034 under field conditions. If progeny do not survive to adulthood, any 

suspected resistance is not field relevant and no further action is required.

3. If insects survive steps 1 and 2, resistance is confirmed, and further steps will be taken to 

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;

determining 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;

determining 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, Monsanto will consult with the Agency to develop and implement a case-specific 

resistance management action plan.
195

 (2) Investigation of Reports of Unexpected Levels of Damage by the Target Pests:

 Monsanto will follow up on grower, extension specialist or consultant reports of unexpected 

levels of damage by the lepidopteran pests listed on the pesticide label. Monsanto will instruct 

its customers to contact them if such incidents occur. Monsanto 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, CEW, and FAW), Monsanto will implement the actions described 

below, based on the following definitions of suspected resistance and confirmed resistance.

 Suspected resistance

 EPA defines suspected resistance to mean field reports of unexpected levels of insect feeding 

damage for which:

the corn in question has been confirmed to be lepidopteran-active Bt corn;

the seed used had the proper percentage of corn expressing Bt protein;

the relevant plant tissues 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 there could be no other reasonable causes for 

the damage.

 EPA 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 confirm scientifically the presence of 

insects resistant to MON 89034 in commercial production fields before responsive measures are 

undertaken.

 If resistance is suspected, Monsanto will instruct growers to do the following:

Use alternative control measures in MON 89034 fields in the affected region to 

control the target pest during the immediate growing season.

Destroy MON 89034 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 over-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, Monsanto will collect samples of the insect population in the 
196

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 corn hybrids under field conditions (ECB and SWCB only). 

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 LC50 exceeds the upper limit of the 95% 

confidence interval of the LC50 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 

Monsanto: 

EPA will receive notification within 30 days of resistance confirmation; 

Affected customers and extension agents will be notified about confirmed 

resistance within 30 days; 

Monitoring will be increased in the affected area and local target pest populations 

will be sampled annually to determine 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 corn hybrids in the affected area immediately until an 

effective local mitigation plan approved by EPA has been implemented;
197

Monsanto will develop a case-specific resistance management action plan within 90 

days according to the characteristics of the resistance event and local agronomic 

needs. Monsanto 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

In subsequent growing seasons, maintain sales suspension and alternative resistance 

management strategies in the affected region(s) for the Bt corn hybrids that are 

affected by the resistant population until an EPA-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 31st each year, beginning in 2010, for the duration 

of the conditional registration. 

f) Annual Reporting Requirements for MON 89034

1) Annual Sales: reported and summed by state (county level data available by request), on 

or before January 31st of each year.

2) Grower Agreement Results: number of units of MON 89034 seeds shipped or sold and 

not returned, and the number of such units that were sold to persons who have signed 

grower agreements, on or before January 31st of each year.

3) Grower Education: substantive changes to education program completed previous year, 

on or before January 31st of each year,.

4) Compliance Assurance Plan: Compliance Assurance Program activities and results, for 

the previous year and plans for the compliance assurance program during the current 

year, on or before January 31st of each year.

5) Compliance Assurance Plan Survey Results: to include annual survey results and plans 

for the next year; on or before January 31st of each year.

6) Insect Resistance Monitoring Results: results of monitoring and investigations of damage 

reports, on or before August 31st each year.
198

Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Monsanto 524-576

Bt corn Event 

MON 89034 + 

MON 88017 with 

Cry1A.105 + 

Cry2Ab2 + Cry 

3Bb1

10 June 2008 Conditional

(amended 29 September 2010)

30 September 

2015

1) The subject registration will automatically expire on midnight September 30, 2015.

2) The subject registration will be limited to MON 89034 x MON 88017 [Bacillus 

thuringiensis Cry1A.105 and Cry2Ab2 proteins and the genetic material necessary for 

their production (vector PV-ZMIR245) in event MON 89034 corn (OECD Unique 

Identifier: MON-89034-3) x Bacillus thuringiensis Cry3Bb1 protein and the genetic 

material necessary for its production (vector PV-ZMIR39) in event MON 88017 corn 

(OECD Unique Identifier: MON-88Ø17-3)] for use in field or sweet corn. Further, MON 

89034 x MON 88017 sweet corn may only be sold directly to processors or through 

commercial dealers to large growers. MON 89034 x MON 88017 sweet corn must not be 

sold to small roadside or home growers.

3) Submit/cite all data required for registration of your product under FIFRA § 3(c)(5) when 

the Environmental Protection Agency (EPA) requires registrants of similar products to 

submit such data.

4) This plant-incorporated protectant may be combined through conventional breeding with 

other registered plant-incorporated protectants that are similarly approved for use in 

combination, through conventional breeding, with other registered plant-incorporated 

protectants to produce inbred corn lines and hybrid corn varieties with combined 

pesticidal traits.

5) Submit the following data in the time frames listed:

OPPTS Guideline/ 

Study Type

Required Data Due Date

Insect Resistance 

Management –

Resistance 

Monitoring

Baseline susceptibility studies and/or a discriminating 

concentration assay are required for the Cry1A.105 

protein against Southwestern corn borer (SWCB), and 

for the Cry2Ab2 protein against SWCB. These data 

were submitted and are being evaluated.

Insect Resistance 

Management –

Resistance 

Monitoring

To support sweet corn uses, baseline susceptibility 

studies must be conducted on fall armyworm (FAW) 

populations collected from sweet corn growing areas. 

Monitoring studies will be conducted on FAW 

populations collected from sweet corn distribution areas 

4/1/2012
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in states in which Monsanto MON 89034 and/or MON 

89034 x MON 88017 sweet corn plantings exceed 5,000 

acres. The collected populations of FAW will be 

monitored for changes in susceptibility to the 

Cry1A.105 and Cry2Ab2 proteins.

*

Extensions were granted as listed in the above table.

6) You must commit to do the following Insect Resistance Management (IRM) Program, 

consisting of the following elements:

Requirements relating to creation of a refuge for the Cry3Bb1, Cry1A.105, and Cry2Ab2 

components that meets the requirements of the individual traits. The refuge for both traits 

may be combined by planting non-Bacillus thuringiensis (Bt) corn as the refuge, or the 

refuge for each trait may be planted separately. In the latter case, corn rootworm-resistant Bt

corn may be planted in the lepidopteran refuge for the Cry1A.105 and Cry2Ab2 components, 

and lepidopteran-resistant Bt corn may be planted in the corn rootworm refuge for the 

Cry3Bb1 component.

Requirements for Monsanto Company (Monsanto) to prepare and require MON 89034 x 

MON 88017 users to sign “grower agreements,” that impose binding contractual obligations 

on the grower to comply with the refuge requirements.

Requirements for Monsanto to develop, implement and report to EPA on programs to 

educate growers about IRM requirements.

Requirements for Monsanto to develop, implement and report to EPA on programs to 

evaluate and promote growers’ compliance with IRM requirements.

Requirements for Monsanto to develop, implement and report to EPA on programs to 

evaluate whether there are statistically significant and biologically relevant changes in target 

insect susceptibility to Cry1A.105, Cry2Ab2, and Cry3Bb1 proteins in the target insects.

Requirements for Monsanto to develop, and if triggered to implement a “remedial action 

plan,” that contains measures Monsanto 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. 

Requirements for Monsanto, on or before January 31st of each year, to submit annual reports 

on units sold by state (units sold by county level will be made available to the Agency upon 

request), IRM grower agreement results, and the compliance assurance program including 

the education program on or before January 31st each year. 

Requirements for Monsanto, on or before August 31st of each year, to submit reports on 

resistance monitoring.

a) Refuge Requirements for MON 89034 x MON 88017 Field Corn
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 These refuge requirements do not apply to seed increase/propagation of inbred and hybrid 

seed corn up to a total of 20,000 acres per county and up to a combined United States (U.S.) total 

of 250,000 acres per plant-incorporated protectant (PIP) active ingredient per registrant per year. 

Furthermore, these refuge requirements do not apply to commercial hybrid sweet corn.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt

corn products, additional educational material and assistance are provided by the registrant to 

help these growers meet the refuge requirements across their farming operations.

Grower agreements (also known as stewardship agreements) will specify that growers must 

adhere to the refuge requirements as described in the grower guide/product use guide and/or in 

supplements to the grower guide/product use guide.

 1) Corn-Belt Refuge Requirements

 For MON 89034 x MON 88017 field corn grown outside cotton-growing areas (e.g., the 

Corn Belt), grower agreements (also known as stewardship agreements) will specify that growers 

must adhere to the refuge requirements as described in the grower guide/product use guide 

and/or in supplements to the grower guide/product use guide. Two options for the 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. The refuge area must represent at least 20% of the 

grower’s corn acres (i.e. sum of MON 89034 x MON 88017 acres and refuge acres). It must be 

planted as a block adjacent to the MON 89034 x MON 88017 field, perimeter strips, or in-field 

strips. If perimeter or in-field strips are implemented, the strips must be at least 4 consecutive 

rows wide. The common refuge may be treated with a soil-applied or seed-applied insecticide to 

control rootworm larvae and other soil pests. The refuge may also be treated with a non-Bt foliar 

insecticide for control of late season pests if pest pressure reaches an economic threshold for 

damage (determined using methods recommended by local or regional professionals); however, 

if rootworm adults are present at the time of foliar applications, then the MON 89034 x MON 

88017 field must be treated in a similar manner.

 The second option is planting separate refuge areas for corn borers and corn rootworms. The 

corn borer refuge must be planted with a non-Bt/lepidopteran-protected hybrid, must represent at 

least 5% of the grower’s corn acres (i.e. sum of MON 89034 x MON 88017 acres and corn borer 

refuge acres), and must be planted within 1⁄2 mile of the MON 89034 x MON 88017 field. 

Refuge planting options include: separate fields, blocks within fields (e.g., along the edges or 

headlands), perimeter strips, or in-field strips. If perimeter or in-field strips are implemented, the 

strips must be at least 4 consecutive rows wide. The corn borer refuge may be treated with a 

soil-applied or seed-applied insecticide for corn rootworm larval control or a non-Bt foliarapplied insecticide for corn borer control if pest pressure reaches an economic threshold for 

damage (determined using methods recommended by local or regional professionals). The corn 

rootworm refuge must be planted with a non-Bt/corn rootworm-protected hybrid but may be 

planted with Bt corn hybrids that control corn borers. The corn rootworm refuge must represent 

at least 20% of the grower’s corn acres (i.e. sum of MON 89034 x MON 88017 acres and corn 

rootworm refuge acres) and must be planted as an adjacent block, perimeter strips, or in-field 
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strips. If perimeter or in-field strips are implemented, the strips must be at least 4 consecutive 

rows wide. The corn rootworm refuge may be treated with a soil-applied or seed- applied 

insecticide to control rootworm larvae and other soil pests. The refuge may 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 MON 89034 x MON 88017 field must be 

treated in a similar manner. 

 2) Cotton-Growing Area Refuge Requirements

 For MON 89034 x MON 88017 field corn grown in cotton-growing areas, grower 

agreements (also known as stewardship agreements) will specify that growers must adhere to the 

refuge requirements as described in the grower guide/product use guide and/or in supplements to 

the grower guide/product use guide.

 Cotton-growing areas include the following states: Alabama, Arkansas, Georgia, Florida, 

Louisiana, North Carolina, Mississippi, South Carolina, Oklahoma (only the counties of 

Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, 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, 

Sussex), and Missouri (only the counties of Dunklin, New Madrid, Pemiscot, Scott, and 

Stoddard).

 Two options for the 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. The refuge area must represent at least 20% of the 

grower’s corn acres (i.e. sum of MON 89034 x MON 88017 acres and refuge acres). It must be 

planted as a block adjacent to the MON 89034 x MON 88017 field, perimeter strips, or in-field 

strips. If perimeter or in-field strips are implemented, the strips must be at least 4 consecutive 

rows wide. The common refuge may be treated with a soil-applied or seed-applied insecticide to 

control rootworm larvae and other soil pests. The refuge may also be treated with a non-Bt foliar 

insecticide for control of late season pests if pest pressure reaches an economic threshold for 

damage (determined using methods recommended by local or regional professionals); however, 

if rootworm adults are present at the time of foliar applications, then the MON 89034 x MON 

88017 field must be treated in a similar manner.

 The second option is planting separate refuge areas for corn borers and corn rootworms. The 

corn borer refuge must be planted with a non-Bt/lepidopteran-protected hybrid, must represent at 

least 20% of the grower’s corn acres (i.e. sum of MON 89034 x MON 88017 acres and corn 

borer refuge acres), and must be planted within 1⁄2 mile of the MON 89034 x MON 88017 field. 

 Refuge planting options include: separate fields, blocks within fields (e.g., along the edges or 

headlands), perimeter strips, or in-field strips. If perimeter or in-field strips are implemented, the 

strips must be at least 4 consecutive rows wide. The corn borer refuge may be treated with a 
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soil- applied or seed-applied insecticide for corn rootworm larval control or a non-Bt foliarapplied insecticide for corn borer control if pest pressure reaches an economic threshold for 

damage (determined using methods recommended by local or regional professionals). The corn 

rootworm refuge must be planted with a non-Bt/corn rootworm-protected hybrid but may be 

planted with Bt corn hybrids that control corn borers. The corn rootworm refuge must represent 

at least 20% of the grower’s corn acres (i.e. sum of MON 89034 x MON 88017 acres and corn 

rootworm refuge acres) and must be planted as an adjacent block, perimeter strips, or in-field 

strips. If perimeter or in-field strips are implemented, the strips must be at least 4 consecutive 

rows wide. The corn rootworm refuge may be treated with a soil-applied or seed-applied 

insecticide to control rootworm larvae and other soil pests. The refuge may 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 MON 89034 x MON 88017 field must be 

treated in a similar manner. 
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 b) Post-Harvest Requirements for MON 89034 x MON 88017 Sweet Corn

 Sweet corn is harvested long before field corn. Therefore, if the sweet corn stalks remaining 

in the field and any insects remaining in the stalks are destroyed shortly after harvest, a refuge is 

not needed as a part of the IRM program for sweet corn. Growers must adhere to the following 

types of crop destruction requirements as described in the grower guide/product use guide and/or 

in supplements to the grower guide/product use guide.

Crop destruction must occur no later than 30 days following harvest, but 

preferably within 14 days.

The allowed crop destruction methods are: rotary mowing, discing, or plow down. 

Crop destruction methods should destroy any surviving resistant insects.

c) Grower Agreements for MON 89034 x MON 88017 

1) Persons purchasing MON 89034 x MON 88017 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 must continue to integrate this amended registration into the current system 

used for its other Bt corn plant-incorporated protectants, which is reasonably likely to 

assure that persons purchasing MON 89034 x MON 88017 corn will affirm annually that 

they are contractually bound to comply with the requirements of the IRM program.

4) Monsanto must continue to use its current grower agreement for MON 89034 x MON 

88017 corn. 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 (30) days prior to implementing a 

proposed change, Monsanto must submit to EPA the text of such changes to ensure that it 

is consistent with the terms and conditions of this amended registration. 

5) Monsanto must continue to integrate this amended registration into the current system 

used for its other Bt corn plant-incorporated protectants, which is reasonably likely to 

assure that persons purchasing MON 89034 x MON 88017 corn sign grower 

agreement(s).

6) Monsanto shall maintain records of all MON 89034 x MON 88017 grower agreements 

for a period of three years from December 31st of the year in which the agreement was 

signed.
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 7) Annually, Monsanto shall provide EPA with a report showing the number of units of 

MON 89034 x MON 88017 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) Monsanto 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.

 d) IRM Education and Compliance Monitoring Programs for MON 89034 x MON 

88017

1) Monsanto must continue to implement and enhance (as set forth in paragraph 17 of this 

section) a comprehensive, ongoing IRM education program designed to convey to MON 

89034 x MON 88017 corn users the importance of complying with the IRM program. 

The program shall include information encouraging MON 89034 x MON 88017 corn 

users to pursue optional elements of the IRM program relating to refuge configuration 

and proximity to MON 89034 x MON 88017 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 MON 89034 x MON 88017 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 organizations, such as the National Corn Growers 

Association and state extension programs.

2) Annually, Monsanto shall revise, and expand as necessary, its education program to take 

into account the information collected through the compliance survey required under 

paragraphs 6a -8 of this section and from other sources. The changes shall address 

aspects of grower compliance that are not sufficiently high.

3) Annually, Monsanto must provide EPA any substantive changes to its grower education 

activities as part of the overall IRM compliance assurance program report. Monsanto 

must either submit a separate report or contribute to the report from the industry working 

group, Agricultural Biotechnology Stewardship Technical Committee (ABSTC).

4) Monsanto must continue to implement and improve an ongoing IRM compliance 

assurance program designed to evaluate the extent to which growers purchasing [MON 

89034 x MON 88017 corn 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 Monsanto’s corn PIP products. 

Monsanto shall coordinate with other Bt corn registrants in improving its compliance 

assurance program and continue to integrate this amended registration into the current 
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compliance assurance program used for its other Bt corn plant-incorporated protectants. 

Other required features of the program are described in paragraphs 5–22.

5) Monsanto. must maintain 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 non-compliant growers after the first year of noncompliance. While 

recognizing that for reasons of difference in business practices there are needs for 

flexibility between different companies, all Bt corn registrants must use a consistent set of 

standards for responding to non-compliance. An individual grower found to be 

significantly out of compliance two years in a row would be denied access to 

Monsanto’s Bt corn products 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 Bt corn.

6a) MON 89034 x MON 88017 Field Corn: The IRM compliance assurance program shall 

include an annual survey, conducted by an independent third party, of a statistically 

representative sample of growers of MON 89034 x MON 88017 field corn who plant the 

vast majority of all corn in the United States and in areas in which the selection intensity 

is greatest. The survey shall consider only those growers who plant 200 or more acres of 

corn in the Corn-Belt and who plant 100 or more acres of corn in corn-cotton areas. 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 

independent marketing research firms 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 United States. 

i. A third party is classified as a party other than the registrant, the grower, or anyone else 

with a direct interest in IRM compliance for Bt corn.

6b) MON 89034 x MON 88017 Sweet Corn: The IRM compliance assurance program shall 

include an annual survey of all MON 89034 x MON 88017 sweet corn customers who 

purchase 5 or more bags of MON 89034 x MON 88017 sweet corn. The survey shall 

measure the degree of compliance with the IRM program, identify the response rate (e.g., 

the percent of MON 89034 x MON 88017 sweet corn acres covered by the responses), 

and consider the potential impact of non-response. An independent third party will 

participate in the design and implementation of the survey. Data and information derived 

from the annual survey will be audited by an independent third party.

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.
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9a) MON 89034 x MON 88017 Field Corn: Monsanto shall provide 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 on or before January 31st of each 

year, beginning in 2010. Monsanto shall confer with other registrants and EPA on the 

design and content of the survey prior to its implementation.

9b) MON 89034 x MON 88017 Sweet Corn: Monsanto shall provide a written summary of 

the results of the prior year’s survey (together with a description of the methodology 

used and the supporting data) to EPA on or before January 31st of each year, beginning 

in 2010. Monsanto shall confer with EPA on changes to the design and content of the 

survey prior to its implementation.

10) Annually, Monsanto shall revise, and expand as necessary, its compliance assurance 

program to take into account the information collected through the compliance survey 

required under paragraphs 6a through 8 and from other sources. The changes shall 

address aspects of grower compliance that are not sufficiently high. Monsanto must 

confer with the Agency prior to adopting any changes.

11) Monsanto shall conduct an annual on-farm assessment program. Monsanto shall train 

its representatives who make on-farm visits with growers of MON89034 x MON 88017 

to perform assessments of compliance with IRM requirements. There is no minimum 

corn acreage size for this program. Therefore, growers will be selected for this program 

from across all farm sizes. In the event that any of these visits result in the identification 

of a grower who is not in compliance with the IRM program, Monsanto shall take 

appropriate action, consistent with its “phased compliance approach,” to promote 

compliance. 

12) Monsanto 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, Monsanto shall take appropriate action, consistent with its “phased 

compliance approach.”

13) If a grower, who purchases MON 89034 x MON 88017 for planting, was specifically 

identified as not being in compliance during the previous year, Monsanto shall visit 

with the grower and evaluate whether the grower is in compliance with the IRM 

program for the current year.

14) Annually, 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. Within one month of submitting 

this report to EPA, Monsanto shall meet with EPA to discuss its findings. 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 followup actions taken. The report must inform EPA of the number of growers deemed 

ineligible to purchase Bt corn seed on the basis of continued non-compliance with the 
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insect resistance management refuge requirements Monsanto may elect to coordinate 

information with other registrants and report collectively the results of compliance 

assurance programs.

15) Monsanto and the seed corn dealers for Monsanto 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.

16) Monsanto shall revise and expand its existing Compliance Assurance Program to include 

the following elements. The registrant must prepare and submit by January 31, 2011, a 

written description of its revised Compliance Assurance Program. The registrant may 

coordinate with other registrants in designing and implementing its Compliance 

Assurance Program. 

17) The registrant will enhance the refuge education program throughout the seed delivery 

channel: 

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance 

of correct refuge implementation and potential consequences of failure to plant the 

required refuge; 

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. The PIP product 

label accepted by EPA must include how this information will be conveyed to growers 

via text and graphics. This requirement may be phased in over the next three growing 

seasons. Revised PIP product labels must be submitted by January 31, 2011, 50% 

implementation on the Bt corn seed bags or bag tags must occur by the 2012 growing 

season, and full implementation must occur by the 2013 growing season. 

18) Monsanto will focus the majority of on-farm assessments on regions with the greatest 

risks for resistance: 

i. Use Bt corn adoption, pest pressure information, and other available information to 

identify regions where the risk of resistance is greatest; 

ii. Focus approximately two-thirds of on-farm assessments on these regions, with the 

remaining assessments conducted across other regions where the product is used. 

19) Monsanto will use its available MON 89034 x MON 88017 sales records and other 

information to refine grower lists for on-farm assessments of their compliance with 

refuge requirements: 

i. Identify for potential on-farm assessment growers whose sales information indicates they 

have purchased the MON 89034 x MON 88017 corn product but may have purchased 

little or no refuge seed from the registrant, licensee, or affiliated company. 

20) The registrant will contract with third parties to perform on-farm assessments of 

compliance with refuge requirements: 
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i. The third-party assessors will conduct all first-time on-farm assessments as well as 

second-year on-farm assessments of those growers found out of compliance in a firsttime assessment 

21) The registrant will annually refine the on-farm assessment program for the Bt corn 

product to reflect the adoption rate and level of refuge compliance for the product. 

22) Monsanto will follow up with growers who have been found significantly out of 

compliance under the on-farm assessment program and are found to be back in 

compliance the following year: 

i. All growers found to be significantly out of compliance in a prior year will annually be 

sent additional refuge assistance information for a minimum of two years by Monsanto, a 

seed supplier, or third party assessor, after completing the assessment process; 

ii. Monsanto will conduct follow-up checks on growers found to be significantly out of 

compliance within three years after they are found to be back in compliance; 

iii. A grower found with a second incident of significant non-compliance with refuge 

requirements for MON 89034 x 88017 corn within a five-year period will be denied 

access to and/or sales of Monsanto’s Bt corn products the next year.

e) Insect Resistance Monitoring and Remedial Action Plans for MON 89034 x MON 

88017

1) The Agency is imposing the following conditions for the Cry1A.105 and Cry2Ab2 toxins 

expressed in MON 89034: 

i. Monsanto must monitor for resistance to Cry1A.105 and Cry2Ab2 expressed in MON 

89034. 

ii. The resistance monitoring program must include the following two approaches: (1) 

focused population sampling and laboratory testing and (2) investigation of reports of 

less-than expected control of labeled insects. Should field relevant resistance be 

confirmed, an appropriate resistance management action plan will be implemented.

(a) Focused Population Sampling

 Monsanto must develop and ensure the implementation of a plan for resistance monitoring 

for Spodoptera frugiperda (fall armyworm or FAW) in counties in which MON 89034 and/or 

MON 89034 x MON 88017 sweet corn acreage exceeds 5,000 acres and the pest is capable of 

overwintering in that county. Monsanto should consult with academic and United States 

Department of Agriculture (USDA) experts in developing the monitoring plan and will provide 

EPA with a copy of its proposed resistance monitoring plan for EPA’s approval prior to 

implementation. This proposed FAW monitoring plan must be submitted to EPA by January 31st

of the year following that in which MON 89034 and/or MON 89034 x MON 88017 sweet corn 

acreage exceeds the trigger specified in this requirement (i.e., greater than 5,000 acres in any 
209

county in which FAW overwinters). The proposed plan must be implemented the season 

following the acreage trigger being met. The proposed plan will remain in place until an EPA 

approved plan can be implemented.

 Annually, Monsanto shall sample and bioassay populations of the key target pests: Ostrinia 

nubilalis (European corn borer; ECB), Diatraea grandiosella (Southwestern corn borer; SWCB), 

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 MON 89034 x MON 88017 

and/or changes in resistance-allele frequency in response to the use of MON 89034 x MON 

88017 and, as far as possible, should be consistent across sampling years to enable comparisons 

with historical data. Each protein in MON 89034 must be tested separately, rather than a mixture 

of the two proteins, because resistance to one protein could be masked by the activity of the 

other. 

 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 of MON 89034 x MON 88017. 

The Agency shall be consulted prior to the implementation of such modifications.

 Monsanto will report to the Agency by August 31st of each year, beginning in 2010, the 

results of the population sampling and bioassay monitoring program. 

 Any incidence of unusually low sensitivity to the Cry1A.105 and Cry2Ab2 proteins in 

bioassay 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 31st. 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 survive the 
210

diagnostic concentration will be tested using methods that are representative of exposure 

to MON 89034 x MON 88017 under field conditions. If progeny do not survive to 

adulthood, any suspected resistance is not field relevant and no further action is required.

3. If insects survive steps 1 and 2, resistance is confirmed, and further steps will be taken to 

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;

determining 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;

determining 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, Monsanto will consult with the Agency to develop and implement a case-specific 

resistance management action plan.

 (b) Investigation of Reports of Unexpected Levels of Damage by the Target Pests:

 Monsanto will follow up on grower, extension specialist or consultant reports of unexpected 

levels of damage by the lepidopteran pests listed on the pesticide label. Monsanto will instruct 

its customers to contact them if such incidents occur. Monsanto 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, CEW, and FAW), Monsanto will implement the actions described 

below, based on the following definitions of suspected resistance and confirmed resistance.

 Suspected resistance

 EPA defines suspected resistance to mean field reports of unexpected levels of insect feeding 

damage for which:

the corn in question has been confirmed to be lepidopteran-active Bt corn;

the seed used had the proper percentage of corn expressing Bt protein;

the relevant plant tissues are expressing the expected level of Bt protein; and

it has been ruled out that species not susceptible to the protein could be 
211

responsible for the damage, that no climatic or cultural reasons could be 

responsible for the damage, and that there could be no other reasonable causes for 

the damage.

 EPA 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 confirm scientifically the presence of 

insects resistant to MON 89034 x MON 88017 in commercial production fields before 

responsive measures are undertaken.

 If resistance is suspected, Monsanto will instruct growers to do the following:

Use alternative control measures in MON 89034 x MON 88017 fields in the 

affected region to control the target pest during the immediate growing season.

Destroy MON 89034 x MON 88017 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 over-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, Monsanto 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 corn hybrids under field conditions (ECB and SWCB only) . 

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 LC50 exceeds the upper limit of the 95% 

confidence interval of the LC50 for susceptible populations surveyed both in the 

original baselines developed for this pest species and in previous years of field 

monitoring.

 (c) Response to Confirmed Resistance in a Key Target Pest as the Cause of Unexpected 

Levels of Damage in the Field
212

 When field resistance is confirmed (as defined above), the following steps will be taken by 

Monsanto: 

EPA will receive notification within 30 days of resistance confirmation; 

Affected customers and extension agents will be notified about confirmed 

resistance within 30 days; 

Monitoring will be increased in the affected area and local target pest populations 

will be sampled annually to determine 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 corn hybrids in the affected area immediately until an 

effective local mitigation plan approved by EPA has been implemented; 

Monsanto will develop a case-specific resistance management action plan within 

90 days according to the characteristics of the resistance event and local 

agronomic needs. Monsanto 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 

In subsequent growing seasons, maintain sales suspension and alternative 

resistance management strategies in the affected region(s) for the Bt corn hybrids 

that are affected by the resistant population until an EPA-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 31st each year, beginning in 2010, for the duration 

of the conditional registration. 

(2) The Agency is imposing the following conditions for the Cry3Bb1 toxin expressed in 

MON 88017:
213

i. Monsanto must monitor for Cry3Bb1 resistance and/or trends in increased tolerance 

for corn rootworm utilizing the current corn rootworm resistance monitoring plan for 

MON 89034 x MON 88017. Sampling should be focused in those areas in which 

there is the highest risk of resistance development.

ii. The resistance monitoring plan must include the following: baseline sensitivity data, 

sampling (number of locations, samples per locations), sampling methodology and 

life stage sampled, bioassay methodology, standardization procedures (including 

quality assurance/quality control provisions), detection technique and sensitivity, 

statistical analysis of the probability of detecting resistance, and a revised description 

of rootworm damage guidelines.

iii. Monsanto must develop a functional diagnostic assay for corn rootworm resistance 

monitoring to detect potentially resistant individuals and incorporate this assay into 

the annual resistance monitoring program by the 2011 season, with reporting in 

2012. As part of this effort, Monsanto must investigate the feasibility of using the 

Sublethal Seedling AssayVI as a diagnostic assay. A report of Monsanto’s progress 

towards this requirement must be submitted to EPA within six (6) months from the 

date of this amended registration.

iv. Monsanto must develop a proactive resistance monitoring program for northern corn 

rootworm (Diabrotica barberi) by the 2012 season, with reporting in 2013. This 

program should include a proposal for annual sampling and testing of northern corn 

rootworm susceptibility to Cry3Bb1. As part of the effort, Monsanto may need to 

investigate novel techniques for rearing and conducting bioassays with northern corn 

rootworm. A report on Monsanto’s progress towards this requirement must be 

submitted within one (1) year from the date of this amended registration.

v. Monsanto must submit revised corn rootworm damage guidelines (to characterize 

unexpected pest damage) that take into consideration the comments and 

recommendations from EPA’s June 30, 2010 review of the rootworm resistance 

monitoring program for Cry3Bb1 within six (6) months from the date of this 

amended registration.

vi. Monsanto must follow-up on grower, extension specialist, or consultant reports of 

unexpected damage or control failures for corn rootworm.

vii. Monsanto must provide EPA with a resistance monitoring report on or before 

August 31st of each year, reporting on populations collected the previous year.

viii. The current remedial action plan approved for Cry3Bb1 must be used for corn 

rootworm suspected and confirmed resistance in MON 88017 x MON 810. If corn 

rootworm resistance is confirmed, all acres of MON 88017 x MON 810 and refuges 

must be treated with insecticides targeted at corn rootworm adults and larvae.

 

VI Nowatzki T, Lefko SA, Binning RR, Thompson SD, Spencer TA, Siegfried BD. 2008. 

Validation of a novel resistance monitoring technique for corn rootworm (Coleoptera: 

Chrysomelidae) and event DAS-59122-7 maize. J. Appl. Entomol. 132:177–188.
214

f) Annual Reporting Requirements for Mon 89034 x MON 88017

1) Annual Sales: reported and summed by state (county level data available by request), on 

or before January 31st of each year.

2) Grower Agreement Results: number of units of MON 89034 x MON 88017 seeds 

shipped or sold and not returned, and the number of such units that were sold to persons 

who have signed grower agreements, on or before January 31st of each year.

3) Grower Education: substantive changes to education program completed previous year, 

on or before January 31st of each year. 

4) Compliance Assurance Plan: Compliance Assurance Program activities and results, for 

the previous year and plans for the compliance assurance program during the current 

year, on or before January 31st of each year. 

5) Compliance Survey Results: to include annual survey results and plans for the next year; 

full report on or before January 31st of each year. 

6) Insect Resistance Monitoring Results: results of monitoring and investigations of damage 

reports, on or before August 31st each year.
215

VI. OAM BRAD Registered Products

1] The subject registration will automatically expire on midnight September 30, 2012.

2] The subject registration will be limited to a seed mix of DAS-Ø15Ø7-1 (Cry1F) x DAS59122-7 (Cry34Ab1/Cry35Ab1) corn seed blended with not less than 10% DAS-Ø15Ø7-1 

(Cry1F) corn seed.

3] Submit/cite all data required for registration of your product under FIFRA § 3(c)(5) when the 

Agency requires registrants of similar products to submit such data.

4] This plant-incorporated protectant may be combined through conventional breeding with other 

registered plant-incorporated protectants that are similarly approved for use in combination, 

through conventional breeding, with other registered plant-incorporated protectants to produce 

inbred corn lines and hybrid corn varieties with combined pesticidal traits.

5] Submit the following data in the timeframes listed:

Study Type Required Data Due Date

Insect Resistance 

Management

Pioneer must provide the Agency with a copy of the 

grower agreement, associated stewardship documents, 

and written description of a system, which assures that 

growers will sign grower agreements and persons 

purchasing OAM1 corn will annually affirm that they are 

contractually bound to comply with requirements of the 

insect resistance management (IRM) program. (This 

information has been submitted and is being evaluated by 

the Agency.)

90 days from 

the date of 

registration

Insect Resistance 

Management

Pioneer must implement an enhanced resistance 

monitoring plan for OAM1. Pioneer must provide the 

Agency with a baseline (benchmark) study that shows 

the susceptibility of western corn rootworm populations 

(WCRW) in the Sublethal Seedling Assay prior to the 

large-scale introduction of OAM1. Although northern 

corn rootworm (NCRW) is difficult to rear, Pioneer must 

attempt to obtain benchmark susceptibility data using the 

Sublethal Seedling Assay for NCRW as well.

12/1/2010 for 

WCRW

12/1/11 for 

NCRW

Insect Resistance Pioneer must submit a detailed OAM1-specific resistance 12/1/2010

Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Pioneer/Dupont 29964-6

Optimum AcreMax 

1 (OAM 1) Seed 

Blend of Herculex 

Xtra + Herculex I

30 April 2010 Conditional

(amended 29 September 2010)

30 September 

2012
216

Management monitoring and remedial action plan, including an 

analysis to determine the expected field performance 

criteria for OAM1 products so that unexpected damage 

can be benchmarked. Pioneer will update the plan by 

12/1/2012, if needed, based on continued field evaluation 

of OAM1 performance.

6] Pioneer must implement the following Insect Resistance Management Program:

The required IRM program for OAM1 corn must have the following elements:

Requirements relating to creation of a lepidopteran refuge (consisting of corn that does not 

contain any Bt trait for lepidopteran control) in conjunction with the planting of any acreage of 

OAM1 corn;

Requirements for Pioneer to prepare and require OAM1 users to sign “grower agreements,” that 

impose binding contractual obligation 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 Cry1F and Cry34Ab1/Cry35Ab1 

proteins in the target insects;

Requirements regarding a “remedial action plan,” that contains measures Pioneer 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 31st of each year, beginning in 2011.

a) Refuge requirements for OAM1

Because the refuge for corn rootworm is blended in each bag or box of OAM1 seed, no 

additional corn rootworm refuge is required. A refuge must be planted for corn borers. The 

refuge must be planted with corn hybrids that do not contain Bt technologies for the control of 

corn borers. Refuge options are based on the planting of OAM1 in cotton or non-cotton growing 

regions and insect pressure present in those locations. The refuge sizes for these regions are 

either 50% in cotton-growing regions (i.e., 50 acres of corn that does not contain Bt technology 

for the control of corn borers for every 50 acres of OAM1) or 20% in non-cotton growing 

regions (i.e., 20 acres of corn that does not contain Bt technology for the control of corn borers 

for every 80 acres of OAM1). Refuge planting options include: separate fields, blocks within 

fields (e.g., along the edges or headlands), and strips across the field. Cotton-growing regions 
217

consist of the following states Alabama, Arkansas, Georgia, Florida, Louisiana, North Carolina, 

Mississippi, South Carolina, Oklahoma(only the counties of Beckham, Caddo, Comanche, 

Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, 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, Sussex) and Missouri (only the 

counties of Dunklin, New Madrid, Pemiscot, Scott and Stoddard.

External refuges must be planted within 1⁄2 mile. 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 of the target 

lepidopteran pests of OAM1 in the refuge exceeds economic thresholds. Economic thresholds 

will be determined using methods recommended by local or regional professionals (e.g., 

Extension Service agents, crop consultants).

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.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt

corn products, additional educational material and assistance are provided by the registrant to 

help these growers meet the refuge requirements across their farming operations.

b) Grower Agreement for OAM1 Corn

1. Persons purchasing OAM1 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. Pioneer must implement a system equivalent to what is already approved for 

previously registered Pioneer Bt corn products, which is reasonably likely to 

assure that persons purchasing OAM1 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. (This information has been submitted and is being evaluated by 

the Agency.)

4. Pioneer 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. (This information 

has been submitted and is being evaluated by the Agency.)If Pioneer wishes to 
218

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, 

Pioneer must submit to EPA the text of such changes to ensure it is consistent 

with the terms and conditions of this registration.

5. Pioneer shall maintain records of all OAM1 corn grower agreements for a period 

of three years from December 31st of the year in which the agreement was signed.

6. Beginning on January 31, 2011, and annually thereafter, Pioneer shall provide 

EPA with a report on the number of units of OAM1 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.

7. Pioneer 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 OAM1 Corn

1. Pioneer must design and implement a comprehensive, ongoing IRM education program 

designed to convey to OAM1 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 OAM1 corn user separate from the grower technical 

guide. The communication shall inform the user of the current IRM requirements and 

specifically the need to plant a lepidopteran refuge. Pioneer 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. Pioneer must design and immediately implement a “bag tag” that will be attached to all bags 

of OAM1 seed sold and delivered for the 2011 growing season and annually thereafter. The 

purpose of this bag tag is to remind growers that OAM1 products require a separate 20% 

lepidopteran refuge, and a 50% refuge requirement in cotton-growing areas. The PIP product 

label accepted by EPA must include how this information will be conveyed to growers via text 

and graphics. A revised PIP product label must be submitted by January 31, 2011. 

3. Pioneer must conduct targeted, on-farm compliance assessments for growers who purchase 

OAM1 seed to ensure growers are compliant with the requirement of a 20% refuge for 

lepidopteran pests. For the 2010 growing season, Pioneer must conduct at least 500 on-farm 

assessments or roughly half the number of assessments that Pioneer will contribute to the 2010 
219

Agricultural Biotechnology Stewardship Technical Committee (ABSTC) compliance assurance 

program assessment for corn borer and stacked products. Beginning in 2011 and annually 

thereafter, Pioneer will contract with an independent third party to conduct these compliance 

assessments and target twice the number of on-farm assessments for OAM1 as Pioneer conducts 

for corn borer and stacked products on an annual basis. The table below reflects the relative 

number of on-farm assessments for OAM1 based on Pioneer’s contribution to the ABSTC 

compliance assurance program report and is subject to change with time as appropriate. 

i. A third party is classified as a party other than the registrant, the grower, or anyone else with a 

direct interest in IRM compliance for Bt corn.

Number of on-farm assessments conducted by Pioneer

Products Year: 2010

Year: 2011, 

annually 

thereafter

Corn Borer and Stacked 

Products 1000 1000

OAM1 500 2000

Total 1500 3000

Pioneer must provide a report to EPA summarizing the OAM1 compliance assurance program 

activities and results for the prior year and plans for the OAM1 compliance assurance program 

for the current year, by January 31, 2011, and annually thereafter. Within one month of 

submitting this report to EPA, the registrant shall meet with EPA to discuss its findings. The 

report must inform EPA of the number of growers deemed ineligible to purchase Bt corn seed on 

the basis of continued non-compliance with the insect resistance management refuge 

requirements.

4. Annually, Pioneer 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.

5. Beginning January 31, 2011, Pioneer must provide a report to EPA summarizing the activities 

it carried out under its education program for the prior year. Annually thereafter, Pioneer must 

provide EPA any substantive changes to its grower education activities as part of the overall 

IRM compliance assurance program report. Pioneer must either submit a separate report or 

contribute to the report from the industry working group, ABSTC. 
220

6. The registrant shall revise and expand its Compliance Assurance Program to include the 

following elements. The registrant must prepare and submit by January 31, 2011, a written 

description of its revised Compliance Assurance Program. The registrant may coordinate with 

other registrants in designing and implementing its Compliance Assurance Program. 

7. The registrant will enhance the refuge education program throughout the seed delivery 

channel: 

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of 

correct refuge implementation and potential consequences of failure to plant the required refuge; 

ii. As stated in 6)c)2), Pioneer must design and immediately implement a “bag tag” that will be 

attached to all bags of OAM1 seed sold and delivered for the 2011 growing season and annually 

thereafter. The purpose of this bag tag is to remind growers that OAM1 products require a 

separate 20% lepidopteran refuge, and a 50% refuge requirement in cotton-growing areas. The 

PIP product label accepted by EPA must include how this information will be conveyed to 

growers via text and graphics. A revised PIP product label must be submitted by January 31, 

2011. 

8. The registrant will focus the majority of on-farm assessments on regions with the greatest risks 

for resistance: 

i. Use Bt corn adoption, pest pressure information, and other available information to identify 

regions where the risk of resistance is greatest; 

ii. Focus approximately two-thirds of on-farm assessments on these regions, with the remaining 

assessments conducted across other regions where the product is used. 

9. The registrant will use its available Bt sales records and other information to refine grower 

lists for on-farm assessments of their compliance with refuge requirement: 

i. Identify for potential on-farm assessment growers whose sales information indicates they have 

purchased the Bt corn product but may have purchased little or no refuge seed from the 

registrant, licensee, or affiliated company. 

10. The registrant will contract with third parties to perform on-farm assessments of compliance 

with refuge requirements: 

i. The third-party assessors will conduct all first-time on-farm assessments as well as second-year 

on-farm assessments of those growers found out of compliance in a first-time assessment 

11. The registrant will annually refine the on-farm assessment program for the Bt corn product 

to reflect the adoption rate and level of refuge compliance for the product. 

12. The registrant will follow up with growers who have been found significantly out of 

compliance under the on-farm assessment program and are found to be back in compliance the 

following year: 
221

i. All growers found to be significantly out of compliance in a prior year will annually be sent 

additional refuge assistance information for a minimum of two years by the registrant, seed 

supplier, or third party assessor, after completing the assessment process; 

ii. The registrant will conduct follow-up checks on growers found to be significantly out of 

compliance within three years after they are found to be back in compliance; 

iii. A grower found with a second incident of significant non-compliance with refuge 

requirements for the Bt corn product within a five-year period will be denied access to Pioneer 

Hi-Bred’s Bt corn products 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 

Bt corn.

d) Insect Resistance Monitoring and Remedial Action Plan for OAM1 Corn

The Agency is imposing the following conditions for this lepidopteran toxin: 

The registrant will monitor for resistance to its lepidopteran-resistant Bt corn. The monitoring 

program shall consist of two approaches: (1) focused population sampling and laboratory testing; 

and (2) investigation of reports of less-than expected control of labeled insects. Should fieldrelevant resistance be confirmed, an appropriate resistance management action plan will be 

implemented.

(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 of Bt 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. 
222

The sampling program and geographic range of collections may be modified as appropriate 

based on changes in pest importance and for the adoption levels of lepidopteran-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 survive the 

diagnostic concentration will be tested using methods that are representative of exposure to Bt

corn 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. If insects 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;

determining 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;

determining 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:
223

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

EPA defines suspected resistance to mean field reports of unexpected levels of insect feeding 

damage for which:

the corn in question has been confirmed to be lepidopteran-active Bt corn;

the seed used had the proper percentage of corn expressing Bt protein;

the relevant plant tissues 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 confirm scientifically the presence of 

insects resistant to Bt corn 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 corn fields in the affected region to control the 

target pest during the immediate growing season.

Destroy Bt corn 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 over-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
224

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 corn 

hybrids under field conditions (ECB and SWCB only). 

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 LC50 exceeds the upper limit of the 95% 

confidence interval of the LC50 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 notification within 30 days of resistance confirmation; 

Affected customers and extension agents will be notified about confirmed resistance 

within 30 days; 

Monitoring will be increased in the affected area and local target pest populations will be 

sampled annually to determine 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 corn hybrids in the affected area immediately until an effective 

local mitigation plan approved by EPA has been implemented; 

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; 
225

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 

In subsequent growing seasons, maintain sales suspension and alternative resistance 

management strategies in the affected region(s) for the Bt corn hybrids that are affected 

by the resistant population until an EPA-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 31st each year for the duration of the conditional 

registration. 

The Agency is imposing the following conditions for this corn rootworm toxin:

In addition to the existing two-pronged approach to insect resistance monitoring (monitoring 

insect populations using the diet bioassay and investigations of field reports) that are required for 

Cry34/35 for Herculex Rootworm Insect Protection (29964-4) and Herculex Xtra Insect 

Protection (29964-5), Pioneer must also conduct enhanced monitoring using the Sublethal 

Seedling Assay as a complement to the diet bioassay method. Pioneer must submit a detailed 

OAM1/OAMRW-specific resistance monitoring plan to the Agency by December 1, 2010.

With respect to the implementation of the Sublethal Seedling Assay:

1. Pioneer must monitor for resistance and or changes in target pest susceptibility that will 

lead to increased injury potential in western and northern corn rootworm feeding on the 

rootworm component of OAM1 products. Sampling must be focused in the four regions 

of highest risk of resistance development: Region – 1 (Illinois, Indiana); Region 2 (Iowa, 

Missouri), Region 3 (Nebraska and Kansas), and Region 4 (Minnesota, South Dakota and 

Wisconsin). 

2. Pioneer must provide the EPA its detailed western corn rootworm resistance monitoring 

plan for approval by December 1, 2010, and its northern corn rootworm resistance 

monitoring plan for approval by December 1, 2011. These plans will include baseline 

(benchmark) susceptibility data and an enhanced annual resistance monitoring plan. The 

reports will contain:

Sampling scheme: annual collection should target a range of 16-20 western 

and/or northern rootworm populations (4-5 per region), with a minimum 

number of 2,000 beetles collected per population.

Bioassay methodology (precision, detection level, etc.). Pioneer must 

bioassay a target of 3000 larvae on 59122 plants for each population.

A description of how monitoring results relate to and are predictive of changes 

in field efficacy, and change in injury potential to DAS-59122-7 constituting 

product failure and development of a remedial action plan.
226

3. Pioneer will provide the EPA with an annual OAM1 resistance monitoring report by 

August 31st of each year beginning with 2011 for western corn rootworm and 2012 for 

northern corn rootworm, reporting on populations collected the previous year. 

In addition to screening of wide-area corn rootworm populations as outlined above, for 

the second prong of resistance monitoring Pioneer must investigate grower, extension 

specialist or consultant reports of less-than-expected efficacy or field performance of 

OAM1 products.

e) Remedial Action Plan for Corn Rootworm and OAM1 Corn

The remedial action plan is designed as a tiered approach for mitigating western and northern 

corn rootworm resistance development specifically due to the commercialization of OAM1 corn. 

The following program summary describes, in order of events, the steps that must be taken to 

implement a remedial action plan if resistance to target pests is confirmed. 

Pioneer will complete a benchmark study of susceptibility of western corn rootworm using the 

Sublethal Seedling Assay and analyze field efficacy data to set a benchmark for expected levels 

of damage to finalize the OAM1 remedial action plan by December 1, 2010, so that decision 

points regarding crop damage and target pest resistance are established, and a remedial action 

plan can be initiated when needed. Although northern corn rootworm is difficult to rear in the 

laboratory, Pioneer will attempt to complete a benchmark study for susceptibility of northern 

corn rootworm using the Sublethal Seedling Assay.

1. Suspected Resistance from Population Monitoring

Definition of Suspected Resistance - Resistance will be suspected if investigations of target pest 

injury potential to OAM1 maize from the Sublethal Seedling Assay show that:

Injury potential of a target pest population obtained as part of the annual insect 

monitoring program has increased to a level representative of product failure in 

field conditions;

The seeds used in the investigation of this population’s injury potential contain 

Cry34/Cry35Ab1 at levels representative of (and in the same genetic background 

as) the benchmark study; and

The change in injury potential has been documented as a heritable characteristic 

of the target pest population and not a result of experimental error.

If resistance is "suspected", Pioneer will inform growers in the area of the potential benefit of 

augmenting CRW control such as adulticide treatment and/or crop rotation or use of soil or seedapplied insecticides at rates providing corn rootworm control the following year. These 

measures are intended to educate growers of the potential for change in efficacy, reduce the 

possibility of grower loss from change in efficacy and reduce potentially resistant insects 

contributing to the following year's pest population.

2. Confirmed Resistance from Population Monitoring
227

Definition of Confirmed Resistance - Resistance will be confirmed if all of the following criteria 

are met by progeny from a subsequent rootworm population collected from the area of 

"suspected resistance" the following year:

Injury potential of the subsequent field-collected rootworm population feeding on 

plants containing DAS-59122-7 remains at a level likely to produce repeated 

product failure in field conditions;

The change in injury potential has been documented as a heritable characteristic 

of the target pest population;

Greenhouse node-injury evaluation confirms product failure;

Subsequent populations collected from the area and assayed show that the results 

are repeatable; and

Continued monitoring of the area suggests that the change is spreading.

3. Suspected Resistance – Investigation of Field Reports

The registrant will follow up on grower, extension specialist or consultant reports of unexpected 

product performance due to corn rootworm species listed on the label. The registrants will 

instruct its customers to contact them if such incidents occur. The registrants will investigate all 

such reports submitted to the company or the company’s representatives. 

Confirm the corn in question is rootworm-active Bt corn;

Confirm the field in question contains the correct blend rate of refuge corn;

Confirm that species not susceptible to the protein are not responsible for the 

damage, that no climatic or cultural reasons could be responsible for the 

damage, and that all other reasonable causes based on historical experience for 

the observed root damage have been ruled out;

If not due to other reasons, the registrant will conduct a thorough investigation 

of the factors known to affect the manifestation of corn rootworm feeding 

damage. 

If the investigation fails to rule out target pest resistance as the cause, 

resistance is suspected. 

If resistance is "suspected", Pioneer will inform growers in the area of the potential benefit of 

augmenting CRW control such as adulticide treatment, crop rotation the following year or use of 

soil or seed insecticides the following year. These measures are intended to educate growers of 

the potential for change in efficacy, reduce the possibility of grower loss from change in efficacy 

and reduce potentially resistant insects contributing to the following year's pest population.

Pioneer will collect insects as soon as possible from the area for laboratory studies to test for 

resistance by comparing with benchmark susceptibility data. These studies will be performed 

following the same laboratory protocols as used for the benchmark determination and monitoring 

programs.

4. Confirmed Resistance – Investigation of Field Reports 
228

Injury potential of the field-collected rootworm population feeding on plants 

containing DAS-59122-7 remains at a level likely to produce repeated product 

failure in field conditions;

Subsequent populations collected from the area and assayed show that the results 

are repeatable;

The change in injury potential has been documented as a heritable characteristic 

of the target pest population;

Greenhouse node-injury evaluation confirms product failure; and

Continued monitoring of the area suggests that the change is spreading.

5. Remedial Action

When resistance is "confirmed", the following steps will be taken:

The EPA will receive notification within 30 days of confirmed resistance;

Affected customers and Extension specialists will be immediately notified about 

confirmed resistance;

Affected customers and Extension specialists will be strongly encouraged to 

implement alternative CRW control measures such as adulticide treatment, crop 

rotation the following year, or use of soil or seed insecticides the following year;

Within 60 days of notification, Pioneer and EPA will jointly determine the extent 

of the mitigation needed and determine whether sales should be stopped on an 

appropriate geographic (i.e., county or regional) basis; and

Pioneer will develop a case-specific resistance mitigation action plan within 90 

days according to the characteristics of the resistance event and local agronomic 

needs. Pioneer will consult with appropriate stakeholders in the development of 

the action plan, and the details of such a plan shall be approved by the EPA prior 

to implementation. The resistance management plan could include such measures 

layering additional technologies in future OAM1 products.

f) Remedial Action Plan for lepidopteran pests and OAM1 Corn 

When field resistance is confirmed (as previously defined), the following steps will be taken by 

the registrant:

• EPA will receive notification within 30 days of resistance confirmation;

• Affected customers and extension agents will be notified about confirmed resistance

within 30 days;

• Monitoring will be increased in the affected area and local target pest populations will be 

sampled annually to determine 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 
229

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 lepidopteranactive Bt corn hybrids in the affected area immediately until an effective local mitigation plan 

approved by EPA has been implemented;

• 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

• In subsequent growing seasons, maintain sales suspension and alternative resistance 

management strategies in the affected region(s) for the Bt corn hybrids that are affected by the 

resistant population until an EPA-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 31st each year for the duration of the conditional 

registration.

g) Refuge Assurance Program for OAM1 Corn

Pioneer must implement a Blended Seed Refuge Assurance Program designed to ensure OAM1 

products are formulated with the appropriate rate of refuge seeds. The program must include the 

following four elements:

1. Trait purity check on seed lots prior to blending;

2. ISO 9000 Standard Operating Procedures for the blending process;

3. Calibration of blending equipment; and

4. Records and data retention records for seed blend products.

Calibration records - Pioneer will retain documentation for a specified period of 

time on the equipment calibration including the procedure, when it was conducted 

and the results. 

Blend proportion records (weight and kernel based) - Pioneer will retain 

documentation for a specified period of time on the kernel per pound data of the 

components, the calculations to determine the proportions based on weight and 

the actual weights that are blended together to make up an OAM1 product by seed 

lot. 
230

All records must be maintained at the Pioneer blending facility and must be available for the 

EPA review upon request.

h) Annual Reporting Requirements for OAM1 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 OAM1 corn 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;

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 31st 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 for 

western corn rootworm and 2012 for northern corn rootworm.
231

1] The subject registration will automatically expire on midnight September 30, 2012.

2] The subject registration will be limited to a seed mix of DAS-59122-7 (Cry34Ab1/Cry35Ab1) 

corn seed blended with not less than 10% non-Bt corn seed.

3] Submit/cite all data required for registration of your product under FIFRA § 3(c)(5) when the 

Agency requires registrants of similar products to submit such data.

4] This plant-incorporated protectant may be combined through conventional breeding with other 

registered plant-incorporated protectants that are similarly approved for use in combination, 

through conventional breeding, with other registered plant-incorporated protectants to produce 

inbred corn lines and hybrid corn varieties with combined pesticidal traits.

Because OAMRW controls corn rootworm pests and contains an integrated corn rootworm 

refuge, no additional refuge is required. When a grower plants a bag of OAMRW, all refuge 

requirements are fully and automatically met for this product. Therefore, grower agreements 

(demonstrating persons purchasing OAMRW corn will annually affirm that they are 

contractually bound to comply with requirements of the insect resistance management (IRM) 

program) and other associated stewardship documents are neither necessary nor required.

Targeted on-farm compliance assessments are neither necessary nor required for OAMRW 

because the refuge is automatically implemented when planting this product.

OAMRW may be used as the Lepidopteran refuge for OAM1. In this case, on-farm assessments 

to ensure that the Lepidopteran refuge is planted and placed appropriately would be covered by 

OAM1 grower education, targeted on-farm assessments and stewardship documents.

5] Submit the following data in the timeframes listed:

Study Type Required Data Due Date

Insect Resistance 

Management

Pioneer must implement an enhanced resistance 

monitoring plan for OAMRW. Pioneer must provide the 

Agency with a baseline (benchmark) study that shows 

the susceptibility of western corn rootworm populations 

(WCRW) in the Sublethal Seedling Assay prior to the 

large-scale introduction of OAMRW. Although northern 

corn rootworm (NCRW) is difficult to rear, Pioneer must 

12/1/2010 for 

WCRW

12/1/11 for 

NCRW

Registrant Registration # Active Ingredient

Original 

Registration 

Date

Status Expiration 

Date

Pioneer/Dupont 29964-10

Optimum AcreMax 

RW (OAM RW) 

Seed Blend of 

Herculex RW + 

Non-Bt corn 

30 April 2010 Conditional

(amended 29 September 2010)

30 September 

2012
232

attempt to obtain benchmark susceptibility data for 

NCRW as well.

Insect Resistance 

Management

Pioneer must submit a detailed OAMRW-specific 

resistance monitoring and remedial action plan, including 

an analysis to determine the expected field performance 

criteria for OAMRW products so that unexpected 

damage can be benchmarked. Pioneer will update the 

plan by 12/1/2012, if needed, based on continued field 

evaluation of OAM1 performance.

12/1/2010

6] Pioneer must do the following Insect Resistance Management Program for OAMRW.

The required IRM program for OAMRW corn must have the following elements:

- Requirements regarding programs to evaluate whether there are statistically 

significant and biologically relevant changes in target insect susceptibility to 

Cry34Ab1/Cry35Ab1 proteins in the target insects;

- Requirements regarding a “remedial action plan,” that contains measures 

Pioneer 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) on or before January 31st of each year, beginning in 2011.

a) Insect Resistance Monitoring for OAMRW Corn

In addition to the existing two-pronged approach to insect resistance monitoring (monitoring 

insect populations using the diet bioassay and investigations of field reports) that are required for 

Cry34/35 for Herculex Rootworm (29964-4), Pioneer must also conduct enhanced monitoring 

using the Sublethal Seedling Assay as a complement to the diet bioassay method. Pioneer must 

submit a detailed OAM1/OAMRW-specific resistance monitoring plan to the Agency by 

December 1, 2010.

With respect to the implementation of the Sublethal Seedling Assay:

1. Pioneer must monitor for resistance and or changes in target pest susceptibility 

that will lead to increased injury potential in western and northern corn rootworm 

feeding on the rootworm component of OAMRW products. Sampling must be 

focused in the four regions of highest risk of resistance development: Region – 1 

(Illinois, Indiana); Region 2 (Iowa, Missouri), Region 3 (Nebraska and Kansas), 

and Region 4 (Minnesota, South Dakota and Wisconsin).

2. Pioneer must provide the EPA its detailed western corn rootworm resistance 

monitoring plan for approval by December 1, 2010, and its northern corn 

rootworm resistance monitoring plan for approval by December 1, 2011. These 
233

plans will include baseline (benchmark) susceptibility data and an enhanced 

annual resistance monitoring plan. The reports will contain:

Sampling scheme: annual collection should target a range of 16-20 western 

and/or northern rootworm populations (4-5 per region), with a minimum 

number of 2,000 beetles collected per population.

Bioassay methodology (precision, detection level, etc.). Pioneer must 

bioassay a target of 3000 larvae on 59122 plants for each population.

A description of how monitoring results relate to and are predictive of changes 

in field efficacy, and change in injury potential to DAS-59122-7 constituting 

product failure and development of a remedial action plan.

3. Pioneer will provide the EPA with an annual OAMRW resistance monitoring 

report by August 31st of each year beginning with 2011 for western corn 

rootworm and 2012 for northern corn rootworm, reporting on populations 

collected the previous year. 

In addition to screening of wide-area corn rootworm populations as outlined above, for the 

second prong of resistance monitoring Pioneer must investigate grower, extension specialist or 

consultant reports of less-than-expected efficacy or field performance of OAMRW products.

b) Remedial Action Plan for Corn Rootworm and OAMRW Corn

The remedial action plan is designed as a tiered approach for mitigating western and northern 

corn rootworm resistance development specifically due to the commercialization of OAMRW 

corn. The following program summary describes, in order of events, the steps that must be taken 

to implement a remedial action plan if resistance to target pests is confirmed. 

Pioneer will complete a benchmark study of susceptibility of western corn rootworm using the 

Sublethal Seedling Assay and analyze field efficacy data to set a benchmark for expected levels 

of damage to finalize the OAMRW remedial action plan by December 1, 2010, so that decision 

points regarding crop damage and target pest resistance are established, and a remedial action 

plan can be initiated when needed. Although northern corn rootworm is difficult to rear in the 

laboratory, Pioneer will attempt to complete a benchmark study for susceptibility of northern 

corn rootworm using the Sublethal Seedling Assay as well.

1. Suspected Resistance from Population Monitoring

Definition of Suspected Resistance - Resistance will be suspected if investigations of target pest 

injury potential to OAMRW maize from the Sublethal Seedling Assay show that:

Injury potential of a target pest population obtained as part of the annual insect 

monitoring program has increased to a level representative of product failure in 

field conditions;

The seeds used in the investigation of this population’s injury potential contain 
234

Cry34/Cry35Ab1 at levels representative of (and in the same genetic background 

as) the benchmark study; and

The change in injury potential has been documented as a heritable characteristic 

of the target pest population and not a result of experimental error.

If resistance is "suspected", Pioneer will inform growers in the area of the potential benefit of 

augmenting CRW control such as adulticide treatment and/or crop rotation or use of soil or seedapplied insecticides at rates providing corn rootworm control the following year. These 

measures are intended to educate growers of the potential for change in efficacy, reduce the 

possibility of grower loss from change in efficacy and reduce potentially resistant insects 

contributing to the following year's pest population.

2. Confirmed Resistance from Population Monitoring

Definition of Confirmed Resistance - Resistance will be confirmed if all of the following criteria 

are met by progeny from a subsequent rootworm population collected from the area of 

"suspected 

resistance" the following year:

Injury potential of the subsequent field-collected rootworm population feeding on 

plants containing DAS-59122-7 remains at a level likely to produce repeated 

product failure in field conditions;

The change in injury potential has been documented as a heritable characteristic 

of the target pest population;

Greenhouse node-injury evaluation confirms product failure;

Subsequent populations collected from the area and assayed show that the results 

are repeatable; and

Continued monitoring of the area suggests that the change is spreading.

3. Suspected Resistance – Investigation of Field Reports

The registrant will follow up on grower, extension specialist or consultant reports of unexpected 

product performance due to corn rootworm species listed on the label. The registrants will 

instruct its customers to contact them if such incidents occur. The registrants will investigate all 

such reports submitted to the company or the company’s representatives. 

Confirm the corn in question is rootworm-active Bt corn;

Confirm the field in question contains the correct blend rate of refuge corn;

Confirm that species not susceptible to the protein are not responsible for the 

damage, that no climatic or cultural reasons could be responsible for the 

damage, and that all other reasonable causes based on historical experience for 

the observed root damage have been ruled out;

If not due to other reasons, the registrant will conduct a thorough investigation 

of the factors known to affect the manifestation of corn rootworm feeding 

damage. 

If the investigation fails to rule out target pest resistance as the cause, 

resistance is suspected. 
235

If resistance is "suspected", Pioneer will inform growers in the area of the potential benefit of 

augmenting CRW control such as adulticide treatment, crop rotation the following year or use of 

soil or seed insecticides the following year. These measures are intended to educate growers of 

the potential for change in efficacy, reduce the possibility of grower loss from change in efficacy 

and reduce potentially resistant insects contributing to the following year's pest population.

Pioneer will collect insects as soon as possible from the area for laboratory studies to test for 

resistance by comparing with benchmark susceptibility data. These studies will be performed 

following the same laboratory protocols as used for the benchmark determination and monitoring 

programs.

4. Confirmed Resistance – Investigation of Field Reports 

Injury potential of the field-collected rootworm population feeding on plants 

containing DAS-59122-7 remains at a level likely to produce repeated product 

failure in field conditions;

Subsequent populations collected from the area and assayed show that the results 

are repeatable;

The change in injury potential has been documented as a heritable characteristic 

of the target pest population;

Greenhouse node-injury evaluation confirms product failure; and

Continued monitoring of the area suggests that the change is spreading.

5. Remedial Action

When resistance is "confirmed", the following steps will be taken:

The EPA will receive notification within 30 days of confirmed resistance;

Affected customers and Extension specialists will be immediately notified about 

confirmed resistance;

Affected customers and Extension specialists will be strongly encouraged to 

implement alternative CRW control measures such as adulticide treatment, crop 

rotation the following year, or use of soil or seed insecticides the following year;

Within 60 days of notification, Pioneer and EPA will jointly determine the extent 

of the mitigation needed and determine whether sales should be stopped on an 

appropriate geographic (i.e., county or regional) basis; and

Pioneer will develop a case-specific resistance mitigation action plan within 90 

days according to the characteristics of the resistance event and local agronomic 

needs. Pioneer will consult with appropriate stakeholders in the development of 

the action plan, and the details of such a plan shall be approved by the EPA prior 

to implementation. The resistance management plan could include such measures 

layering additional technologies in future OAMRW products.

c) Refuge Assurance Program for OAMRW Corn
236

Pioneer must implement a Blended Seed Refuge Assurance Program designed to ensure 

OAMRW products are formulated with the appropriate rate of refuge seeds. The program must 

include the following four elements:

1. Trait purity check on seed lots prior to blending;

2. ISO 9000 Standard Operating Procedures for the blending process;

3. Calibration of blending equipment; and

4. Records and data retention records for seed blend products.

Calibration records - Pioneer will retain documentation for a specified period of 

time on the equipment calibration including the procedure, when it was conducted 

and the results. 

Blend proportion records (weight and kernel based) - Pioneer will retain 

documentation for a specified period of time on the kernel per pound data of the 

components, the calculations to determine the proportions based on weight and 

the actual weights that are blended together to make up an OAMRW product by 

seed lot. 

All records must be maintained at the Pioneer blending facility and must be available for the 

EPA review upon request.

d) Annual Reporting Requirements for OAMRW Corn

1. Annual Sales: reported and summed by state (county level data available by 

request) January 31st each year, beginning in 2011;

2. Insect Resistance Monitoring Results: results of monitoring and investigations of 

damage reports, August 31st each year, beginning in 2011 for western corn 

rootworm and 2012 for northern corn rootworm.