Proposed Terms and Conditions for 

Bt Corn Registrations Set to Expire in Fall 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. # 29964-6 Optimum AcreMax RW Seed Blend of Herculex RW + Non-Bt

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

Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Syngenta 67979-1 Bt corn Event Bt11 with Cry1Ab 

(field corn – AgriSure CB) 

Feb-98 30-Sep-15 

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] 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] In light of recently published laboratory studies showing reduced growth in shredding caddis 

flies exposed to anti-lepidopteran Cry1A protein corn litter (Rosi-Marshall, et al. 2007), 

additional aquatic invertebrate data are required. A 7 to 14 day Daphnia magna study as per the 

885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, 

representing the functional group of a leaf shredder in headwater streams must be submitted by 

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 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 Cry1Ab protein in the target 

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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; 

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 

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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 

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 Dunkin, 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. 

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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. 

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 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 

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not complied with the program either do so in the future or lose their access to the Bt corn 

product. The registrant shall coordinate with other registrants in designing and implementing its 

compliance assurance program. 

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. 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. The options shall include 

withdrawal of the right to purchase Bt corn for an individual grower or for all growers in a 

specific region. An individual grower found to be significantly out of compliance two years in a 

row would be denied sales of the product the next year. Similarly, seed dealers who are not 

fulfilling their obligations to inform/educate growers of their IRM obligations will lose their 

opportunity to sell 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. 

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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. 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 noncompliance, and any follow-up actions taken. 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. This requirement may 

be phased in over the next three growing seasons, with 50% implementation in 2012 and full 

implementation for the 2013 growing season. 

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

risks for resistance: 

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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 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. 

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 Bt

corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt corn product. 

d. Insect Resistance Monitoring and Remedial Action Plan 

The Agency is imposing the following conditions for the Cry1Ab 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 fieldrelevant resistance be confirmed, an appropriate resistance management action plan will be 

implemented. 

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(1) Focused Population Sampling 

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

nubilalis (European corn borer; ECB), Diatraea grandiosella (Southwestern corn borer; S 

WCB), and Helicoverpa zea (corn earworm; CEW). Sampling for the target pests will be focused 

in areas identified as those with the highest risk of resistance development (e.g., where 

lepidopteran-active Bt hybrids are planted on a high proportion of the corn acres, and where the 

insect species are regarded as key pests of corn). Bioassay methods must be appropriate for the 

goal of detecting field-relevant shifts in population response to lepidopteran resistant Bt corn 

and/or changes in resistance allele frequency in response to the use 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

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 

8
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 

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 

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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: 

• EPA will receive notification within 30 days of resistance confirmation; 

• Affected customers and extension agents will be notified about confirmed resistance 

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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; 

 

3] Grower Education: substantive changes to education program completed the 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. 

 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 Bt11 field corn constitutes 

acceptance of these conditions. 

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Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Syngenta 65268-1 

Bt corn Event Bt11 with Cry1Ab ( 

sweet corn - Attribute--no refugia for 

sweet corn) 

Feb-98 30-Sep-15 

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] In light of recently published laboratory studies showing reduced growth in shredding caddis 

flies exposed to anti-lepidopteran Cry1A protein corn litter (Rosi-Marshall, et al. 2007), 

additional aquatic invertebrate data are required. A 7 to 14 day Daphnia magna study as per the 

885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, 

representing the functional group of a leaf shredder in headwater streams must be submitted by 

January 31, 2012. 

6] 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. 

7] 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 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; 

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

13
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 

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

insects; 

5] 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; 

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. 

14
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. 

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 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 (with the 

exception of home gardening or educational uses). 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 universities 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 

15
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 Bt corn 

product (with the exception of home gardening or educational uses). The registrant shall 

coordinate with other registrants in designing and implementing its compliance assurance 

program. 

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

growers who plant more than 20 acres of Bt corn: 

 

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. 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. The options shall include 

withdrawal of the right to purchase Bt corn for an individual grower or for all growers in a 

specific region. An individual grower found to be significantly out of compliance two years in a 

row would be denied sales of the product the next year. Similarly, seed dealers who are not 

fulfilling their obligations to inform/educate growers of their IRM obligations will lose their 

opportunity to sell Bt 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 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 methodology used, and the supporting data) to EPA by 

January 31 of each year. The registrant shall confer with EPA on changes to the design and 

content of the survey prior to its implementation. 

10] Annually, the registrant shall revise, and expand as necessary, its compliance assurance 

16
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 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, 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. 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 noncompliance, and any follow-up actions taken. 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. This requirement may 

be phased in over the next three growing seasons, with 50% implementation in 2012 and full 

implementation for the 2013 growing season. 

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

17
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 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. 

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 Bt

corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt corn product. 

d. Insect Resistance Monitoring and Remedial Action Plan 

The Agency is imposing the following conditions for the Cry1Ab 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 field18
relevant resistance be confirmed, an appropriate resistance management action plan will be 

implemented. 

(2) Focused Population Sampling 

The registrant 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. The 

registrant 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. 

The registrant 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 

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 

19
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: 

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, CEW, and FAW), the registrant will implement the actions described 

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

Suspected resistance

20
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 

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. 

21
• 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; 

• 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. 

22
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. 

 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 Bt11 sweet corn constitutes 

acceptance of these conditions.

23
Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Monsanto 524-489 Bt corn Event MON810 Cry1Ab 

(YieldGard) Dec-96 30-Sep-15 

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 Cry 

1Ab. 

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] In light of recently published laboratory studies showing reduced growth in shredding caddis 

flies exposed to anti-lepidopteran Cry1A protein corn litter (Rosi-Marshall, et al. 2007), 

additional aquatic invertebrate data are required. A 7 to 14 day Daphnia magna study as per the 

885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, 

representing the functional group of a leaf shredder in headwater streams must be submitted by 

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 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 Cry1Ab protein in the target 

24
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; 

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. 

25
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 

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 Dunkin, 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 

26
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. 

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). 

27
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 Bt corn 

product. The registrant shall coordinate with other registrants in designing and implementing its 

compliance assurance program. 

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. 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. The options shall include 

withdrawal of the right to purchase Bt corn for an individual grower or for all growers in a 

specific region. An individual grower found to be significantly out of compliance two years in a 

row would be denied sales of the product the next year. Similarly, seed dealers who are not 

fulfilling their obligations to inform/educate growers of their IRM obligations will lose their 

opportunity to sell 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 

28
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 

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. 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 noncompliance, and any follow-up actions taken. 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. This requirement may 

be phased in over the next three growing seasons, with 50% implementation in 2012 and full 

implementation for the 2013 growing season. 

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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 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. 

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 Bt

corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt corn product. 

d. Insect Resistance Monitoring and Remedial Action Plan 

The Agency is imposing the following conditions for the Cry1Ab 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; 

30
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 

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

31
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 

32
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: 

33
• 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; 

 

34
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. 

 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. 

35
Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Dow/Mycogen 68467-2 Bt corn Event TC1507 with plant 

optimized (PO) Cry1F (Herculex 1) May-01 30-Sep-15 

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

2] The subject registration will be limited to Bacillus thuringiensis corn Event TC1507 with PO 

Cry 1F. 

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] In light of recently published laboratory studies showing reduced growth in shredding caddis 

flies exposed to anti-lepidopteran Cry1A protein corn litter (Rosi-Marshall, et al. 2007), 

additional aquatic invertebrate data are required. A 7 to 14 day Daphnia magna study as per the 

885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, 

representing the functional group of a leaf shredder in headwater streams must be submitted by 

January 31, 2012. 

6] You must commit to 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; 

36
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; 

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 

37
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 

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 Dunkin, 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. 

38
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. 

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). 

39
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 Bt corn 

product. The registrant shall coordinate with other registrants in designing and implementing its 

compliance assurance program. 

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. 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. The options shall include 

withdrawal of the right to purchase Bt corn for an individual grower or for all growers in a 

specific region. An individual grower found to be significantly out of compliance two years in a 

row would be denied sales of the product the next year. Similarly, seed dealers who are not 

fulfilling their obligations to inform/educate growers of their IRM obligations will lose their 

opportunity to sell 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 

40
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 

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. 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 noncompliance, and any follow-up actions taken. 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. This requirement may 

be phased in over the next three growing seasons, with 50% implementation in 2012 and full 

implementation for the 2013 growing season. 

41
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 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. 

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 Bt

corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt corn product. 

d. Insect Resistance Monitoring and Remedial Action Plan 

The Agency is imposing the following conditions for the Cry 1F 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; 

42
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. 

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

43
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 

44
• 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 

45
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; 

2] Grower Agreement: number of units of Bt corn seeds shipped or sold and not returned, and the 

46
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. 

 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 Cry1F corn constitutes 

acceptance of these conditions. 

47
Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Pioneer/Dupont 29964-3 Bt corn Event TC1507 with POCry1F 

(Herculex 1) May-01 30-Sep-15 

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

2] The subject registration will be limited to Bacillus thuringiensis corn Event TC1507 with PO 

Cry 1F. 

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] In light of recently published laboratory studies showing reduced growth in shredding caddis 

flies exposed to anti-lepidopteran Cry1A protein corn litter (Rosi-Marshall, et al. 2007), 

additional aquatic invertebrate data are required. A 7 to 14 day Daphnia magna study as per the 

885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, 

representing the functional group of a leaf shredder in headwater streams must be submitted by 

January 31, 2012. 

6] You must commit to 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; 

48
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; 

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). 

49
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 

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 Dunkin, 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. 

50
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. 

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. 

51
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 Bt corn 

product. The registrant shall coordinate with other registrants in designing and implementing its 

compliance assurance program. 

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. 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. The options shall include 

withdrawal of the right to purchase Bt corn for an individual grower or for all growers in a 

specific region. An individual grower found to be significantly out of compliance two years in a 

row would be denied sales of the product the next year. Similarly, seed dealers who are not 

fulfilling their obligations to inform/educate growers of their IRM obligations will lose their 

opportunity to sell 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. 

52
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 

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. 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 noncompliance, and any follow-up actions taken. 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. This requirement may 

be phased in over the next three growing seasons, with 50% implementation in 2012 and full 

53
implementation for 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 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. 

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 Bt

corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt corn product. 

d. Insect Resistance Monitoring and Remedial Action Plan 

The Agency is imposing the following conditions for the Cry1F toxin expressed in this product: 

54
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; 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. 

55
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 

56
• 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 

57
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; 

2] Grower Agreement: number of units of Bt corn seeds shipped or sold and not returned, and the 

58
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. 

 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 Cry1F corn constitutes 

acceptance of these conditions. 

59
Registration 

#

Date 

Registered

Date 

Expired Registrant Active Ingredients

Dow 

Agrosciences 68467-4 

Bt corn Event DAS-06275-8 with 

MOCry1F (Mycogen Brand Bt Cry1F 

Event DAS-06274-8 corn) 

27-May-05 30-Sep-15 

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

2] The subject registration will be limited to Bacillus thuringiensis corn Event DAS-06275-8 

with MO Cry 1F. 

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] In light of recently published laboratory studies showing reduced growth in shredding caddis 

flies exposed to anti-lepidopteran Cry1A protein corn litter (Rosi-Marshall, et al. 2007), 

additional aquatic invertebrate data are required. A 7 to 14 day Daphnia magna study as per the 

885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, 

representing the functional group of a leaf shredder in headwater streams must be submitted by 

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 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 Cry1Ab protein in the target 

60
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; 

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 

61
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 

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 Dunkin, 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. 

62
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. 

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 

63
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 Bt corn 

product. The registrant shall coordinate with other registrants in designing and implementing its 

compliance assurance program. 

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. 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. The options shall include 

withdrawal of the right to purchase Bt corn for an individual grower or for all growers in a 

specific region. An individual grower found to be significantly out of compliance two years in a 

row would be denied sales of the product the next year. Similarly, seed dealers who are not 

fulfilling their obligations to inform/educate growers of their IRM obligations will lose their 

opportunity to sell 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 

64
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 

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. 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 noncompliance, and any follow-up actions taken. 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. This requirement may 

be phased in over the next three growing seasons, with 50% implementation in 2012 and full 

implementation for the 2013 growing season. 

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

65
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 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. 

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 Bt

corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt corn product. 

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 field66
relevant 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. 

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

67
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 

68
• 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 

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

69
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; 

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 

70
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. 

 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. 

71
Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Pioneer/Dupont 29964-7 1507 (PO Cry1F) x MON 

810 (Cry1Ab) 

February 24, 

2010 

31-Oct-22 

1. The subject registration will automatically expire on midnight October 31, 2022 

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

genetic material (PHI8999) necessary for its production in corn event TC 1507 (OECD 

Unique Identifier DAS-Ø15Ø7-1) x Bacillus thuringiensis Cry1Ab protein and the 

genetic material (PV-ZMBK07) necessary for it production in corn event MON 810 

(OECD Unique Identifier MON-ØØ81Ø-6) for use in field corn. 

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

the Agency requires all registrants of similar products to submit such data. 

4. The data submitted by Pioneer are sufficient to support registration for the combination 

PIP corn product 1507xMON810, provided that the registrant submits/cites any data 

required to support the PIP registrations of the individual parental events TC1507 (DASØ15Ø7-1) and MON810 (MON-ØØ81Ø-6) in corn, within the time frames required by 

the terms and conditions of EPA Registration Numbers 29964-3 and 524-489. 

5. In light of recently published laboratory studies showing reduced growth in shredding 

caddis flies exposed to anti-lepidopteran Cry1A protein corn litter (Rosi-Marshall, et al. 

2007), additional aquatic invertebrate data are required. A 7 to 14 day Daphnia magna

study as per the 885 series OPPTS Guidelines or a dietary study of the effects on an 

aquatic invertebrate, representing the functional group of a leaf shredder in headwater 

streams must be submitted by January 31, 2012. 

6. 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 1507xMON810 corn will annually affirm that they are contractually 

bound to comply with the requirements of the insect resistance management (IRM) 

program, has been submitted and is currently being reviewed. 

 

7. The insect resistance management terms and conditions for 1507xMON810 corn are as 

follows. 

 The required IRM program for 1507xMON810 corn must have 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 Bt corn; 

72
• Requirements for Pioneer 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; 

• 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 Cry1Ab 

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 compliance assurance 

program, including the educational program on or before January 31st each year, 

beginning in 2011. 

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 for Bt corn. Bt 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 of the Bt fields. 

73
• 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 

edges or headlands), and strips across the field. 

 

• External refuges must be planted within 1⁄2 mile of the Bt fields. 

• 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 Dunkin, New Madrid, Pemiscot, Scott, Stoddard). 

74
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. Pioneer must maintain a system which is reasonably likely to assure that persons 

purchasing the Bt corn product will affirm annually that they are contractually bound to 

comply with the requirements of the IRM program. 

4. Pioneer must use an approved grower agreement and must submit to EPA, within 90 days 

from the date of registration, a copy of that agreement and any specific stewardship 

documents referenced in the grower agreement. If 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, then thirty 

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 

registration. 

5. Pioneer must implement an approved system equivalent to what is already approved for 

previously registered Pioneer Bt corn products, which is reasonably likely to assure that 

persons purchasing 1507xMON810 corn sign grower agreement(s). A description of the 

system must be submitted to EPA within 90 days from the date of registration. 

6. Pioneer shall maintain records of all 1507xMON810 corn grower agreements for a period 

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

7. Beginning on January 31, 2011, and annually thereafter, Pioneer 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. Note: 

The first report shall contain the specified information from the time frame starting with 

the date of registration and extending through the 2010 growing season. 

8. 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 

1. Pioneer must maintain a comprehensive, ongoing IRM education program designed to 

75
convey to Bt corn users the importance of complying with the IRM program for all Bt

corn products contain the Cry1F and Cry1Ab proteins. 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, Pioneer shall revise, and expand as necessary, its education program to account 

for the information collected through the compliance survey required under paragraph 6 

and from other sources. The registrant shall identify deficiencies in grower compliance 

and revise the education program to address those deficiencies. 

3. 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, Agricultural Biotechnology Stewardship Technical Committee (ABSTC). 

4. Pioneer must maintain an approved IRM compliance assurance program (CAP) 

equivalent to what is already approved for previously registered Pioneer Bt corn products, 

which is reasonably designed to evaluate the extent to which growers purchasing 1507x 

MON810 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 the Bt corn product. Pioneer shall coordinate 

with other Bt corn registrants in designing and implementing its compliance assurance 

program and integrate this registration into the current compliance assurance program 

used for their other Bt corn PIPs. Other required features of the program are described in 

paragraphs 5 - 15 below. 

5. Pioneer must maintain a “phased compliance approach” guidance document that indicates 

how they 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. It must be equivalent to what is already approved for previously registered 

Pioneer Bt corn products and it must be reasonable designed to assure that persons 

purchasing 1507x MON810 corn comply with the IRM program. 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 noncompliance. The options shall include withdrawal of the right to purchase 

1507xMON810 corn for an individual grower or for all growers in a specific region. An 

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

76
6. Pioneer must maintain an IRM compliance assurance program (CAP) that 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. It must be 

equivalent to what is already approved for previously registered Pioneer Bt corn products. 

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 

(required by paragraphs 6 through 8) and from other sources. The registrant shall 

identify deficiencies in grower compliance and revise the education program to address 

those deficiencies. 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 who is not in compliance with the IRM program, the registrant 

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

77
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. 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 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. This requirement 

may be phased in over the next three growing seasons, with 50% implementation in 2012 

and full implementation for 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 

78
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 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. 

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 secondyear 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 

Bt corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt corn 

product. 

d) Insect Resistance Monitoring 

The Agency is imposing the following conditions for the Cry1F and Cry1Ab toxins expressed in 

1507xMON810 corn: 

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 field79
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; 

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 

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 areawide 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 31st 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 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. 

80
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; and 

• 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 casespecific 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 proteins; 

• the relevant plant tissues are expressing the expected level of Bt proteins; and 

81
• 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 

82
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, the registrant will 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; 

• The registrant 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 

• In subsequent growing seasons, the registrant 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. 

e) Annual Reporting Requirements 

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 1507xMON810 corn seed shipped or 

83
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. 

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 the product constitutes 

acceptance of these conditions. 

 

84
II. Cry 3Bb1 BRAD Registered Products

Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Monsanto 524-528 Bt Corn Event MON863 with Cry3Bb1 

(YieldGard RW) Feb-03 30-Sep-10 

 

Monsanto has indicated that they are not intending to submit a request for a registration 

extension for Bt Corn Event MON863 with Cry3Bb1. Failure to receive a request prior to the 

expiration date, September 30, 2010, will result in a cancellation of the currently registered 

product(s) (EPA Registration # 524-528). 

85
Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Monsanto 524-545 

Bt corn Stack Event MON 863 + MON 

810 with Cry 3Bb1 + Cry1Ab 

(YieldGard Plus) 

31-Oct-03 30-Sep-10 

Monsanto has indicated that they are not intending to submit a request for a registration 

extension for Bt Corn Event MON863 with Cry3Bb1. Failure to receive a request prior to the 

expiration date, September 30, 2010, will result in a cancellation of the currently registered 

product(s) (EPA Registration # 524-545). 

86
Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Monsanto 524-551 Bt corn Event MON 88017 with 

Cry3Bb1 (YieldGard VT RW) 13-Dec-05 30-Sep-15 

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

2] The subject registration will be limited to Bacillus thuringiensis Cry3Bb1 protein and the 

genetic material necessary for its production (vector PV-ZMIR39) in MON 88017 corn (OECD 

Unique Identifier: MON-88Ø17-3) for use in field 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] In light of recently published laboratory studies showing reduced growth in shredding caddis 

flies exposed to anti-lepidopteran Cry1A protein corn litter (Rosi-Marshall, et al. 2007), 

additional aquatic invertebrate data are required. A 7 to 14 day Daphnia magna study as per the 

885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, 

representing the functional group of a leaf shredder in headwater streams must be submitted by 

January 31, 2012. 

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 the registrant 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-Cry3Bb1 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 rootworm are present unless the Cry3Bb1 field is treated in a 

similar manner. 

87
3. Refuge planting options include: refuge acres should be planted as blocks adjacent to 

MON 88017 corn fields or as in-field strips. 

4. External refuges must be planted adjacent to Cry3Bb1 MON 88017 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 Cry3Bb1 field is treated in a 

similar manner. 

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 continue to implement a system (equivalent to what is already approved 

for MON 810, EPA Reg. No. 524-489) 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] If Monsanto wishes to change any part of the grower agreement or any specific stewardship 

documents referenced in the grower agreement that would affect either the content of the 

IRM program or the legal enforceability of the provisions of the agreement relating to the 

IRM program, thirty days prior to implementing a proposed change, the registrant must 

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

conditions of the amendment. 

5] The registrant must continue to implement a system (equivalent to what is already approved 

for MON 810, EPA Reg. No. 524-489) that is reasonably likely to assure that persons 

purchasing the Bt corn sign grower agreement(s), and must provide within 90 days from the 

date of the registration a written description of that system. 

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

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

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

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] 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 

88
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 maintain and implement a comprehensive, ongoing IRM education program 

designed to convey to Bt MON 88017 corn users the importance of complying with the IRM 

program. The program shall include information encouraging Bt MON 88017 corn users to 

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

to Bt 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 Bt 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 other organizations, such as the National 

Corn Growers Association and state extension programs. 

2] Annually, the registrant shall revise, and expand as necessary, its education program to take 

into account the information collected through the compliance survey required under 

paragraph 6] and from other sources. The changes shall address aspects of grower 

compliance that are not sufficiently high. 

3] Annually, the registrant must provide a report to EPA summarizing the activities carried out 

under the education program for the prior year. Annually thereafter, the registrant must 

provide EPA 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] The registrant must design and implement an ongoing IRM compliance assurance program 

designed to evaluate the extent to which growers purchasing its MON 88017 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 MON 88017 Bt corn product. The registrant shall coordinate with other Bt

corn registrants in designing and implementing its compliance assurance program and 

integrate the Cry3Bb1 CAP with the CAP already approved for MON810, EPA Registration 

Number 524-489. The registrant must prepare and submit within 90 days of the date of 

registration a written description of their compliance assurance program including a 

summary of the program implemented in the 2003 growing season. Other required features of 

the program are described in paragraphs 5 - 22 below. 

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

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

terms of the IRM program and general criteria for choosing among options for responding to 

any non-compliant growers. The options shall include withdrawal of the right to purchase 

MON 88017 Bt corn for an individual grower or for all growers in a specific region. An 

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

denied sales of the product the next year. Similarly, seed dealers who are not fulfilling their 

obligations to inform/educate growers of their IRM obligations will lose their opportunity to 

sell MON 88017 Bt corn. 

89
6] The IRM compliance assurance program shall include an annual survey of a statistically 

representative sample of Bt corn growers conducted by an independent third party. The 

survey shall measure the degree of compliance with the IRM program by growers in different 

regions of the country and consider the potential impact of non-response. The sample size 

and geographical resolution may be adjusted annually, based upon input from the 

independent marketing research firm and academic scientists, to allow analysis of 

compliance behavior within regions or between regions. The sample size must provide a 

reasonable sensitivity for comparing results across the U.S. The survey will include only 

growers planting at least 200 acres of corn in the Corn Belt or 100 acres of corn in 

corn/cotton growing regions. 

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 final written summary of the results of the prior year’s survey 

(together with a description of the regions, the methodology used, and the supporting data) to 

EPA by January 31 of each year. The registrant shall confer with EPA on the design and 

content of the survey prior to its implementation. 

10] Annually, the registrant shall revise, and expand as necessary, its compliance assurance 

program to take into account the information collected through the compliance survey 

required under paragraphs 6 through 8 and from other sources. The changes shall address 

aspects of grower compliance that are not sufficiently high. The registrant must confer with 

the Agency prior to adopting any changes to a previously approved CAP. 

11] The registrant shall train its representatives who make on-farm visits with MON 88017 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, the registrant shall take appropriate action, consistent with its “phased 

compliance approach,” to promote compliance. This on-farm assessment program has no 

minimum acreage threshold for growers. 

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 MON 88017 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] 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. 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. 

90
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. This requirement may 

be phased in over the next three growing seasons, with 50% implementation in 2012 and full 

implementation for 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 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. 

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: 

91
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 Bt

corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt corn product. 

9d. Insect Resistance Monitoring and Remedial Action Plan 

The Agency is imposing the following conditions for the Cry3Bb1 toxin expressed in this 

product: 

The registrants 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. 

1. 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. 

2. The registrant must work to develop a diagnostic assay for corn rootworm resistance 

monitoring to detect potentially resistant individuals. As part of this effort, the registrant 

must investigate the feasibility of using the Sublethal Seedling AssayI

 as a diagnostic 

assay. A report on this requirement must be submitted to the Agency 6 months from the 

date of the amended registration. 

 

3. The registrant 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 Cry3Bb1. A report on this requirement must be 

submitted to the Agency 6 months from the date of the amended registration. 

4. The registrant must follow-up on grower, extension specialist or consultant reports of 

unexpected damage or control failures for corn rootworm. 

5. The registrant must provide EPA with an annual resistance monitoring report by 

August 31st of each year, reporting on populations collected the previous year. 

 I

 Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and 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) 

92
e. Remedial Action Plans 

Once a remedial action plan is approved for MON 863, it also must be used for corn 

rootworm suspected and confirmed resistance in MON 88017. If corn rootworm 

resistance is confirmed, all acres (MON 88017 and refuges) must be treated with 

insecticides targeted at CRW adults as well as larvae. 

 The annual reporting requirements are as follows: 

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, April 30th each year. 

93
Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Monsanto 524-552 

Bt corn Event MON 88017 + MON 810 

with Cry1Ab + Cry3Bb1 (YieldGard VT 

Plus) 

13-Dec-05 30-Sep-15 

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 MON 88017 corn 

(OECD Unique Identifier: MON-88Ø17-3)] x Cry1Ab [Bacillus thuringiensis Cry1Ab protein 

and the genetic material (PV-ZMBK07) necessary for it production in corn event MON 810 

(OECD Unique Identifier: MON-ØØ81Ø-6)] for use in field 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] 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 timeframes 

required by the terms and conditions of EPA Registration Numbers 524-551 and 524-489, 

respectively. 

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 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 following refuge requirements as described in the grower guide/product use guide 

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

Corn Belt / Non-Cotton Growing Region Refuge Requirements

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For corn grown in the US Corn Belt two options for deployment of the refuge are available to 

growers. 

The first option is planting a common refuge for both corn borers and corn rootworms. The 

common refuge must be planted with corn hybrids that do not contain Bt technologies for the 

control of corn rootworms or corn borers. The refuge area must represent at least 20% of the 

grower’s corn acres (i.e. sum of [MON 88017 x MON 810] acres and refuge acres). It may be 

planted as a block adjacent to the [MON 88017 x MON 810] field, perimeter strips, or in-field 

strips. If perimeter strips are implemented, the strips must be at least 4 consecutive rows wide. If 

strips within the [MON 88017 x MON 810] field are implemented, then at least 4 consecutive 

rows should be planted. 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; 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. 

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 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 may be treated with a soil-applied or seed-applied insecticide for corn 

rootworm larval control or a non-Bt foliar-applied insecticide for corn borer control if pest 

pressure reaches an economic threshold for damage. The corn rootworm refuge must be planted 

with a non-Bt/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 88017 x MON 810] acres and corn rootworm refuge acres) and may be 

planted as an adjacent block, perimeter strips, or in-field strips. 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 88017 x MON 810] field must be treated in a similar manner. Growers who fail to 

comply with the IRM requirements risk losing access to the product. 

Cotton Growing Area Refuge Requirements

For [MON 88017 x MON 810] corn grown in cotton-growing areas the common refuge and 

separate refuge options are also available, however, the refuge area is larger. Cotton-growing 

areas include the following states: Alabama, Arkansas, Florida, Georgia, Louisiana, North 

Carolina, Mississippi, South Carolina, Oklahoma (only the counties of Beckham, Caddo, 

Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, and Washita), Tennessee 

(only the counties of Carroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, 

Hardin, Haywood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), 

Texas (except the counties of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, Moore, 

Ochiltree, Roberts, and Sherman) Virginia (only the counties of Dinwiddie, Franklin City, 

Greensville, Isle of Wight, Northampton, Southampton, Suffolk City, Surrey, and Sussex), and 

Missouri (only the counties of Dunkin, New Madrid, Pemiscot, Scott, and Stoddard). 

95
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 50% of the 

grower’s corn acres (i.e. sum of [MON 88017 x MON 810] acres and refuge acres). It may be 

planted as a block adjacent to the [MON 88017 x MON 810] field, perimeter strips, or in-field 

strips. If perimeter strips are implemented, the strips must be at least 4 consecutive rows wide. If 

strips within the [MON 88017 x MON 810] field are implemented, then at least 4 consecutive 

rows should be planted. 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; 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. 

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 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 may be treated with a soil-applied or seed-applied insecticide for corn 

rootworm larval control or a non-Bt foliar-applied insecticide for corn borer control if pest 

pressure reaches an economic threshold for damage. The corn rootworm refuge must be planted 

with a non-Bt 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 88017 x MON 810] acres and corn rootworm refuge acres) and be 

planted as an adjacent block, perimeter strips, or in-field strips. 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 88017 x MON 810] field must be treated in a similar manner. Growers who fail to 

comply with the IRM requirements risk losing access to the product. 

b. Grower Agreements 

1] Persons purchasing the Bt 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 develop a system (equivalent to what is already approved for MON 810, 

EPA Reg. No. 524-489) 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. The proposed system will be submitted to EPA within 90 days from the 

date of registration. 

4] The registrant must use grower agreements and submit to EPA within 90 days from the date of 

registration a copy of that agreement and any specific stewardship documents referenced in the 

grower agreement. If Monsanto wishes to change any part of the grower agreement or any 

specific stewardship documents referenced in the grower agreement that would affect either the 

content of the IRM program or the legal enforceability of the provisions of the agreement 

96
relating to the IRM program, thirty days prior to implementing a proposed change, the registrant 

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

conditions of the amendment. 

5] The registrant must establish a system (equivalent to what is already approved for MON 810, 

EPA Reg. No. 524-489) that is reasonably likely to assure that persons purchasing the Bt corn 

sign grower agreement(s), and must provide within 90 days from the date of the registration a 

written description of that system. 

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

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

7] Annually, the registrant shall provide EPA with a report showing the number of units of its 

[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 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] Monsanto must design and implement a comprehensive, ongoing IRM education program 

designed to convey to [MON 88017 x MON 810] corn users the importance of complying 

with the IRM program. The program shall include information encouraging [MON 88017 x 

MON 810] corn users to pursue optional elements of the IRM program relating to refuge 

configuration and proximity to [MON 88017 x MON 810] 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 88017 x MON 810] corn user separate from 

the grower technical guide. The communication shall inform the user of the current IRM 

requirements. Monsanto shall coordinate its education programs with educational efforts of 

other registrants and other organizations, such as the National Corn Growers Association and 

state extension programs. 

2] Annually, the registrant shall revise, and expand as necessary, its education program to take 

into account the information collected through the compliance survey required under 

paragraph 6] and from other sources. The changes shall address aspects of grower 

compliance that are not sufficiently high. 

3] Annually, the registrant must provide EPA 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] The registrant must design and implement an ongoing IRM compliance assurance program 

designed to evaluate the extent to which growers purchasing its [MON 88017 x MON 810] 

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 [MON 88017 x MON 810] Bt corn product. The 

registrant shall coordinate with other Bt corn registrants in designing and implementing its 

compliance assurance program and integrate the Cry3Bb1 CAP with the CAP already 

97
approved for MON810, EPA Registration Number 524-489. The registrant must prepare and 

submit within 90 days of the date of registration a written description of their compliance 

assurance program including a summary of the program implemented in the 2003 growing 

season. Other required features of the program are described in paragraphs 5 - 22 below. 

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

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

terms of the IRM program and general criteria for choosing among options for responding to 

any non-compliant growers. The options shall include withdrawal of the right to purchase 

[MON 88017 x MON 810] corn for an individual grower or for all growers in a specific 

region. An individual grower found to be significantly out of compliance two years in a row 

would be denied sales of the product the next year. Similarly, seed dealers who are not 

fulfilling their obligations to inform/educate growers of their IRM obligations will lose their 

opportunity to sell [MON 88017 x MON 810] corn. 

6] The IRM compliance assurance program shall include an annual survey of a statistically 

representative sample of Bt corn growers conducted by an independent third party. The 

survey shall measure the degree of compliance with the IRM program by growers in different 

regions of the country and consider the potential impact of non-response. The sample size 

and geographical resolution may be adjusted annually, based upon input from the 

independent marketing research firm and academic scientists, to allow analysis of 

compliance behavior within regions or between regions. The sample size must provide a 

reasonable sensitivity for comparing results across the U.S. The survey will include only 

growers planting at least 200 acres of corn in the Corn Belt or 100 acres of corn in 

corn/cotton growing regions. 

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 final written summary of the results of the prior year’s survey 

(together with a description of the regions, the methodology used, and the supporting data) to 

EPA by January 31 of each year. The registrant shall confer with EPA on the design and 

content of the survey prior to its implementation. 

10] Annually, the registrant shall revise, and expand as necessary, its compliance assurance 

program to take into account the information collected through the compliance survey 

required under paragraphs 6 through 8 and from other sources. The changes shall address 

aspects of grower compliance that are not sufficiently high. The registrant must confer with 

the Agency prior to adopting any changes to a previously approved CAP. 

11] The registrant shall train its representatives who make on-farm visits with [MON 88017 x 

MON 810] 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, the registrant shall take appropriate action, consistent 

with its “phased compliance approach,” to promote compliance. This on-farm assessment 

program will have no minimum acreage threshold for growers. 

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 

98
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 [MON 88017 x MON 810] 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] 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. The report will include information regarding 

grower interactions (including, but not limited to, on-farm visits, verified tips and complaints, 

grower meetings and letters), the extent of non-compliance, corrective measures to address 

the non-compliance, and any follow-up actions taken. 

15] The registrant and the seed corn dealers for the registrant must allow a review of the 

compliance records by EPA or by a State pesticide regulatory agency if the State agency can 

demonstrate that confidential business information, including the names, personal 

information, and grower license number of the growers will be protected. 

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. This requirement 

may be phased in over the next three growing seasons, with 50% implementation in 2012 and 

full implementation for 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 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. 

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 secondyear 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. 

99
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 Bt

corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt corn 

product. 

d. Cry 3Bb1 Insect Resistance Monitoring 

 

The Agency is imposing the following conditions for this product: 

1] Monitoring must be carried out under the same protocols used for the products MON 810 524-

528. The registrants 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: 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] The registrant must work to develop a diagnostic assay for corn rootworm resistance 

monitoring to detect potentially resistant individuals. As part of this effort, the registrant 

must investigate the feasibility of using the Sublethal Seedling AssayII as a diagnostic assay. 

A report on this requirement must be submitted to the Agency 6 months from the date of the 

amended registration. 

 

4] The registrant 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 Cry3Bb1. A report on this requirement must be submitted to the 

Agency 6 months from the date of the amended registration. 

5] The registrant must follow-up on grower, extension specialist or consultant reports of 

unexpected damage or control failures for corn rootworm. 

6] The registrant must provide EPA with an annual resistance monitoring report by August 31st, 

reporting on populations collected the previous year. 

 II Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and 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) 

100
e. Cry3Bb1 Remedial Action Plans 

Once a remedial action plan is approved for MON 863, it also must be used for corn rootworm 

suspected and confirmed resistance in. [MON 88017 x MON 810]. If corn rootworm resistance 

is confirmed, all acres ([MON 88017 x MON 810] and refuges) must be treated with insecticides 

targeted at CRW adults as well as larvae. 

f. Cry1Ab Insect Resistance Monitoring 

The Agency is imposing the following conditions for 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 fieldrelevant resistance be confirmed, an appropriate resistance management action plan will be 

implemented. 

(3) 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. 

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. 

101
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: 

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. 

102
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 

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: 

103
• 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; 

• 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 

104
• 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. 

 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. 

 

105
III. Cry 34Ab1/Cry35Ab1 BRAD Registered Products 

Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Dow AgroSciences 68467-5 

Bt corn Event DAS-59122-7 

with Cry 34Ab1/Cry35Ab1 

(Herculex RW) 

31-Aug-05 30-Sep-15 

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

2] The subject registration will be limited to Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 

proteins and the genetic material necessary for their production (plasmid insert 

PHP17662) in Event DAS-59122-7 corn (OECD Unique Identifier: DAS-59122-7) use in 

field 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] In light of recently published laboratory studies showing reduced growth in shredding 

caddis flies exposed to anti-lepidopteran Cry1A protein corn litter (Rosi-Marshall, et al. 

2007), additional aquatic invertebrate data are required. A 7 to 14 day Daphnia magna

study as per the 885 series OPPTS Guidelines or a dietary study of the effects on an 

aquatic invertebrate, representing the functional group of a leaf shredder in headwater 

streams must be submitted by January 31, 2012. 

6] The following insect resistance management data are recommended. 

Additional research on corn rootworm pest biology and ecology, genetics and 

mechanisms of resistance, functional dominance, fitness costs, cross-resistance potential, 

dose (including the role of density-dependence), and mode of action are recommended to 

evaluate the sustainability of the insect resistance management durability plan and 

confirm the assumptions made in the simulation models. Research reports should be 

provided to the Agency once the research is completed and at least nine months prior to 

the expiration of this registration. 

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. 

106
7) You must commit to do the following Insect Resistance Management Program which has 

the following elements: 

a) Requirements relating to creation of a non-(corn rootworm-protected PIP) corn 

refuge in conjunction with the planting of any acreage of commercial Cry34/35Ab1 

Bt corn; 

b) Requirements for the registrants to prepare and require Cry34/35Ab1 Bt corn users to 

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

grower to comply with the refuge requirements; 

c) Requirements for the registrants to develop, implement, and report to EPA on 

programs to educate growers about IRM requirements; 

d) Requirements for the registrants to develop, implement, and report to EPA on 

programs to evaluate and promote growers’ compliance with IRM requirements 

(the Cry34/35Ab1 Compliance Assurance Program (CAP) must integrate with the 

Cry1 Caps); 

e) Requirements for the registrants to develop, implement, and report to EPA on 

monitoring programs to evaluate whether there are statistically significant and 

biologically relevant changes in target insect susceptibility to Cry34/35Ab1 proteins 

in the target insects; 

f) Requirements for the registrants to develop, and if triggered, to implement a 

“remedial action plan” that would contain measures the registrants would take in 

the event that any insect resistance was detected as well as to report on activity 

under the plan to EPA; 

g) 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, compliance 

assurance program including the education program, and resistance monitoring on 

or before January 31st each year. 

 

7a. Refuge Requirements 

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. 

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. 

107
1. Refuge size. The use of Cry34/35 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 Cry34/35 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 may be planted as a single block or as a series of strips measuring at least 

four (4) crop rows wide. 

• Seed mixtures of Cry34/35 and refuge corn are not permitted. 

• If the refuge is planted on rotated ground, then Cry34/35 corn must also be 

planted on rotated ground. 

• If the refuge is planted in continuous corn, the Cry34/35 field may be planted on 

either continuous or rotated land (option encouraged where WCRW rotationresistant biotype may be present). 

• Application of soil insecticide is permitted in the refuge. 

• Seed treatment is permitted in the refuge, either for rootworm protection or for 

controlling secondary soil pests. 

• If aerial insecticides are applied to the refuge for control of CRW adults, the 

same treatment must also be applied in the same time-frame to Cry34/35 corn. 

Pests other than adult corn rootworms may only be treated with CRW-labeled 

insecticide on the refuge acres without treating the Cry34/35 acres if treatment 

occurs when adult corn rootworms are not present. Pests on the Cry34/35 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 

PIPs for rootworm control (e.g. lepidopteran-protected Bt corn, herbicidetolerant corn, or conventional corn). 

• The refuge and Cry34/35 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. It is recognized, however, that for those growers who need to employ 

crop rotation, a fixed refuge would be impractical. 

108
 7b. 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 develop a system (equivalent to what is already approved for 

Cry1F Bt corn) 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] 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. 

 

5] The registrant must establish a system (equivalent to what is already approved for 

Cry1F Bt Corn) 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 31st of the year in which the agreement was signed. 

7] Annually, the registrant shall provide EPA with a report showing the number of units 

of its Cry34/35Ab1 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.

7c. IRM Education and IRM Compliance Monitoring Programs

1] The registrants must implement a comprehensive, ongoing IRM education program 

designed to convey to Bt Cry34/35Ab1 corn users the importance of complying 

with the IRM program. The program shall include information encouraging Bt

Cry34/35Ab1 corn users to pursue optional elements of the IRM program relating 

to refuge configuration and proximity to Bt Cry34/35Ab1 corn fields. The 

109
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. The program shall involve at least one written 

communication annually to each Bt Cry34/35Ab1 corn user separate from the 

grower technical guide. The communication shall inform the user of the current 

IRM requirements. The registrants shall coordinate their 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 account for 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, the registrant must provide EPA 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] The registrant must design and implement an ongoing IRM compliance assurance 

program designed to evaluate the extent to which growers purchasing its 

Cry34/35Ab1 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 Cry34/35Ab1 

Bt corn product. The registrant shall coordinate with other Bt corn registrants in 

designing and implementing its compliance assurance program and integrate the 

Cry34/35Ab1 CAP with the Cry1 Caps. Other required features of the program are 

described in paragraphs 5 - 22 below. 

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

guidance document that indicates how the registrant will address instances of noncompliance with the terms of the IRM program and general criteria for choosing 

among options for responding to any non-compliant growers. The options shall 

include withdrawal of the right to purchase Cry34/35Ab1 Bt corn for an individual 

grower or for all growers in a specific region. An individual grower found to be 

significantly out of compliance two years in a row would be denied sales of the 

product the next year. Similarly, seed dealers who are not fulfilling their 

obligations to inform/educate growers of their IRM obligations will lose their 

opportunity to sell Cry34/35Ab1 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 

Cry34/35Ab1 Bt corn growers 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 

110
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 31 of each year. The registrant shall confer 

with EPA on the design and content of the survey prior to its implementation. 

10] Annually, the registrant shall revise, and expand as necessary, its compliance 

assurance program to take into account the information collected through the 

compliance survey required under paragraphs 6 through 8 and from other sources. 

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

high. The registrant must confer with the Agency prior to adopting any significant 

changes. 

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

shall train its representatives who make on-farm visits with Cry34/35Ab1 Bt 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, 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 Cry34/35Ab1 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. 

111
14] Annually, The registrants shall provide a report to EPA summarizing the activities 

carried out under their compliance assurance program for the prior year including 

changes to the grower education program, 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, third-party grower 

survey, on-farm visitation program, verified tips and complaints, education 

programs (e.g., grower meetings and letters), the extent of non-compliance, 

corrective measures to address the non-compliance (phased-compliance program), 

and any follow-up actions taken. 

15] The registrant and the seed corn dealers for the registrant must allow a review of 

the compliance records by EPA or by a State pesticide regulatory agency if the 

State agency can demonstrate that confidential business information, including the 

names, personal information, and grower license number of the growers will be 

protected. 

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. This 

requirement may be phased in over the next three growing seasons, with 50% 

implementation in 2012 and full implementation for 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 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. 

112
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 Bt corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt corn 

product. 

7d. Insect Resistance Monitoring and Remedial Action Plan 

The Agency is imposing the following conditions for the Cry34Ab/35Ab toxin expressed in this 

product: 

The registrants must monitor for Cry34Ab1/35Ab1 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. 

1. 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. 

2. The registrant must work to develop a diagnostic assay for corn rootworm resistance 

monitoring to detect potentially resistant individuals. As part of this effort, the 

113
registrant must investigate the feasibility of using the Sublethal Seedling AssayIII

 as a 

diagnostic assay. A report on this requirement must be submitted to the Agency 6 

months from the date of the amended registration. 

 

3. The registrant 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 Cry3Bb1. A report on this requirement must be 

submitted to the Agency 6 months from the date of the amended registration. 

4. The registrants must follow-up on grower, extension specialist or consultant reports 

of unexpected damage or control failures for corn rootworm. 

5. The registrants must provide EPA with an annual resistance monitoring report by 

January 31st of each year, reporting on populations collected the previous year. 

7e. Remedial Action Plans

 The remedial action plan is designed as a tiered approach for mitigating WCRW, NCRW, 

and MCRW resistance development to the Cry34/35Ab1 protein. 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. However, the levels of “expected” damage 

cannot be identified until baseline sensitivity is determined. EPA requires that the registrants 

establish the baseline sensitivity by January 31, 2008, so that expected levels of crop damage and 

target pest resistance can be established, and a remedial action plan initiated when needed. 

1. Definition of Suspected Resistance: Resistance will be suspected if investigations of 

unexpected damage reports show that: 

a. implicated corn plant roots were expressing Cry34/35Ab1 proteins at the expected levels; 

b. the seed used was not mixed with non-Cry34/35Ab1 seed 

c. 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; 

d. the level of damage exceeds guidelines for expected damage. 

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. 

2. 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”: 

 III Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and 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) 

114
a. the proportion of larvae that can feed and survive on Cry34/35Ab1 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; 

d. Cry34/35Ab1 plant assays determine that damage caused by surviving insects would 

exceed economic thresholds; 

e. if subsequent collections in the affected field area demonstrate similar bioassay results. 

3. Response to Confirmed Resistance: When resistance is “confirmed”, the following steps will 

be taken: EPA will receive notification within 30 days of confirming resistance; 

a. affected customers and extension agents will be notified about confirmed resistance; 

b. affected customers and extension agents will be encouraged to employ alternative CRW 

control measures; 

c. sale and distribution of Cry34/35Ab1 corn in the affected area will cease immediately; 

d. a long-term resistance management action plan will be devised according to the 

characteristics of the resistance event and local agronomic needs. 

8) Annual Reports:

The registrant must provide annual reports to EPA on its Cry34/35Ab1 PIP expressed in corn 

based on the following table. 

Report Description Due Date

Annual Sales Units sold by state (county information is 

available upon request by the Agency) 

January 31st each year 

beginning in 2007 

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 

beginning in 2007 

Grower Education (part of 

the Compliance Assurance 

Program Report, except for 

the 2006 growing season) 

Education program for the 2006 growing 

season. Subsequent changes to the grower 

education program must be included in the 

annual compliance assurance program report. 

January 31, 2007. Annual 

changes January 31st,each year 

beginning in 2008 as part of the 

Compliance Assurance Program 

Report 

Compliance Assurance 

Program 

Compliance Assurance Program Activities 

and Results: third-party grower survey, onfarm visitation program, phased-compliance 

report, tips and complaints, and grower 

education programs 

 January 31st each year starting 

in 2007 

Insect Resistance 

Monitoring 

Annual report of the insect resistance 

monitoring program. Results of monitoring 

and investigations of damage reports 

August 31st each year 

beginning in 2008 

115
 

Additional reports are due to EPA on its Cry34/35Ab1 PIP expressed in corn based on the 

following table as described in the following table: 

Report Description Due Date

Changes to Grower 

Agreement and/or 

IRM documents 

Current grower agreement(s) and any specific 

stewardship documents 

At least 30 days before 

any changes related to 

IRM are expected to be 

imposed. 

116
Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Pioneer/Dupont 29964-4 

Bt corn Event DAS-591227-

7 with Cry 34Ab1/Cry35Ab1 

(Herculex RW) 

31-Aug-05 30-Sep-15 

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

2] The subject registration will be limited to Bacillus thuringiensis Cry34Ab1 and 

Cry35Ab1 proteins and the genetic material necessary for their production (plasmid insert 

PHP17662) 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 § 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] In light of recently published laboratory studies showing reduced growth in shredding 

caddis flies exposed to anti-lepidopteran Cry1A protein corn litter (Rosi-Marshall, et al. 

2007), additional aquatic invertebrate data are required. A 7 to 14 day Daphnia magna

study as per the 885 series OPPTS Guidelines or a dietary study of the effects on an 

aquatic invertebrate, representing the functional group of a leaf shredder in headwater 

streams must be submitted by January 31, 2012. 

6] The following insect resistance management data are recommended. 

Additional research on corn rootworm pest biology and ecology, genetics and 

mechanisms of resistance, functional dominance, fitness costs, cross-resistance potential, 

dose (including the role of density-dependence), and mode of action are recommended to 

evaluate the sustainability of the insect resistance management durability plan and 

confirm the assumptions made in the simulation models. Research reports should be 

provided to the Agency once the research is completed and at least nine months prior to 

the expiration of this registration. 

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. 

7] You must commit to do the following Insect Resistance Management Program which has 

117
the following elements: 

a) Requirements relating to creation of a non-(corn rootworm-protected PIP) corn 

refuge in conjunction with the planting of any acreage of commercial Cry34/35Ab1 

Bt corn; 

b) Requirements for the registrants to prepare and require Cry34/35Ab1 Bt corn users to 

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

grower to comply with the refuge requirements; 

c) Requirements for the registrants to develop, implement, and report to EPA on 

programs to educate growers about IRM requirements; 

d) Requirements for the registrants to develop, implement, and report to EPA on 

programs to evaluate and promote growers’ compliance with IRM requirements 

(the Cry34/35Ab1 Compliance Assurance Program (CAP) must integrate with the 

Cry1 Caps); 

e) Requirements for the registrants to develop, implement, and report to EPA on 

monitoring programs to evaluate whether there are statistically significant and 

biologically relevant changes in target insect susceptibility to Cry34/35Ab1 proteins 

in the target insects; 

f) Requirements for the registrants to develop, and if triggered, to implement a 

“remedial action plan” that would contain measures the registrants would take in 

the event that any insect resistance was detected as well as to report on activity 

under the plan to EPA; 

g) 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, compliance 

assurance program including the education program, and resistance monitoring on 

or before January 31st each year. 

 

7a. Refuge Requirements 

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. 

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. 

118
1. Refuge size. The use of Cry34/35 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 Cry34/35 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 may be planted as a single block or as a series of strips measuring at least 

four (4) crop rows wide. 

• Seed mixtures of Cry34/35 and refuge corn are not permitted. 

• If the refuge is planted on rotated ground, then Cry34/35 corn must also be 

planted on rotated ground. 

• If the refuge is planted in continuous corn, the Cry34/35 field may be planted on 

either continuous or rotated land (option encouraged where WCRW rotationresistant biotype may be present). 

• Application of soil insecticide is permitted in the refuge. 

• Seed treatment is permitted in the refuge, either for rootworm protection or for 

controlling secondary soil pests. 

• If aerial insecticides are applied to the refuge for control of CRW adults, the 

same treatment must also be applied in the same time-frame to Cry34/35 corn. 

Pests other than adult corn rootworms can only be treated with CRW-labeled 

insecticide on the refuge acres without treating the Cry34/35 acres if treatment 

occurs when adult corn rootworms are not present. Pests on the Cry34/35 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 

PIPs for rootworm control (e.g. lepidopteran-protected Bt corn, herbicidetolerant corn, or conventional corn). 

• The refuge and Cry34/35 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. 

119
7b. 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 develop a system (equivalent to what is already approved for 

Cry1F Bt corn) 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] 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. 

 

5] The registrant must establish a system (equivalent to what is already approved for 

Cry1F Bt Corn) 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 31st of the year in which the agreement was signed. 

7] Annually, the registrant shall provide EPA with a report showing the number of units 

of its Cry34/35Ab1 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.

7c. IRM Education and IRM Compliance Monitoring Programs

1] The registrants must implement a comprehensive, ongoing IRM education program 

designed to convey to Bt Cry34/35Ab1 corn users the importance of complying 

with the IRM program. The program shall include information encouraging Bt

Cry34/35Ab1 corn users to pursue optional elements of the IRM program relating 

to refuge configuration and proximity to Bt Cry34/35Ab1 corn fields. The 

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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 for the first year of commercialization (2006 growing season) by January 

31, 2007. The program shall involve at least one written communication annually 

to each Bt Cry34/35Ab1 corn user separate from the grower technical guide. The 

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

registrants shall coordinate their 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 account for 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, the registrant must provide EPA 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] The registrant must design and implement an ongoing IRM compliance assurance 

program designed to evaluate the extent to which growers purchasing its 

Cry34/35Ab1 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 Cry34/35Ab1 

Bt corn product. The registrant shall coordinate with other Bt corn registrants in 

designing and implementing its compliance assurance program and integrate the 

Cry34/35Ab1 CAP with the Cry1 Caps. Other required features of the program are 

described in paragraphs 5 - 22 below. 

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

guidance document that indicates how the registrant will address instances of noncompliance with the terms of the IRM program and general criteria for choosing 

among options for responding to any non-compliant growers. The options shall 

include withdrawal of the right to purchase Cry34/35Ab1 Bt corn for an individual 

grower or for all growers in a specific region. An individual grower found to be 

significantly out of compliance two years in a row would be denied sales of the 

product the next year. Similarly, seed dealers who are not fulfilling their 

obligations to inform/educate growers of their IRM obligations will lose their 

opportunity to sell Cry34/35Ab1 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 

Cry34/35Ab1 Bt corn growers 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 

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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 31 of each year. The registrant shall confer 

with EPA on the design and content of the survey prior to its implementation. 

10] Annually, the registrant shall revise, and expand as necessary, its compliance 

assurance program to take into account the information collected through the 

compliance survey required under paragraphs 6 through 8 and from other sources. 

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

high. The registrant must confer with the Agency prior to adopting any significant 

changes. 

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

shall train its representatives who make on-farm visits with Cry34/35Ab1 Bt 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, 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 Cry34/35Ab1 Bt corn for planting, was specifically 

identified as not being in compliance during the previous year, the registrant shall 

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visit with the grower and evaluate whether that the grower is in compliance with the 

IRM program for the current year. 

14] Annually, the registrants shall provide a report to EPA summarizing the activities 

carried out under their compliance assurance program for the prior year including 

changes to the grower education program, 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, third-party grower 

survey, on-farm visitation program, verified tips and complaints, education 

programs (e.g., grower meetings and letters), the extent of non-compliance, 

corrective measures to address the non-compliance (phased-compliance program), 

and any follow-up actions taken. 

15] The registrant and the seed corn dealers for the registrant must allow a review of 

the compliance records by EPA or by a State pesticide regulatory agency if the 

State agency can demonstrate that confidential business information, including the 

names, personal information, and grower license number of the growers will be 

protected. 

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. This 

requirement may be phased in over the next three growing seasons, with 50% 

implementation in 2012 and full implementation for 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 requirement: 

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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 Bt corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt corn 

product. 

9d. Insect Resistance Monitoring and Remedial Action Plan 

The Agency is imposing the following conditions for the Cry34Ab/35Ab toxin expressed in this 

product: 

The registrants must monitor for Cry34Ab1/35Ab1 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. 

1.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. 

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2. The registrant must work to develop a diagnostic assay for corn rootworm resistance 

monitoring to detect potentially resistant individuals. As part of this effort, the 

registrant must investigate the feasibility of using the Sublethal Seedling AssayIV as 

a diagnostic assay. A report on this requirement must be submitted to the Agency 6 

months from the date of the amended registration. 

 

3. The registrant 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 Cry3Bb1. A report on 

this requirement must be submitted to the Agency 6 months from the date of the 

amended registration. 

4. The registrants must follow-up on grower, extension specialist or consultant reports 

of unexpected damage or control failures for corn rootworm. 

5. The registrants must provide EPA with an annual resistance monitoring report by 

January 31st of each year, reporting on populations collected the previous year. 

7e. Remedial Action Plans

 The remedial action plan is designed as a tiered approach for mitigating WCRW, NCRW, 

and MCRW resistance development to the Cry34/35Ab1 protein. 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. However, the levels of “expected” damage 

cannot be identified until baseline sensitivity is determined. EPA requires that the registrants 

establish the baseline sensitivity by January 31, 2008, so that expected levels of crop damage and 

target pest resistance can be established, and a remedial action plan initiated when needed. 

1. Definition of Suspected Resistance: Resistance will be suspected if investigations of 

unexpected damage reports show that: 

e. implicated corn plant roots were expressing Cry34/35Ab1 proteins at the expected levels; 

f. the seed used was not mixed with non-Cry34/35Ab1 seed 

g. 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; 

h. the level of damage exceeds guidelines for expected damage. 

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. 

 IV Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and 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) 

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2. 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”: 

f. the proportion of larvae that can feed and survive on Cry34/35Ab1 roots from neonate to 

adult is significantly higher than the baseline proportion (currently being established); 

g. 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; 

h. the ability to survive is heritable; 

i. Cry34/35Ab1 plant assays determine that damage caused by surviving insects would 

exceed economic thresholds; 

j. if subsequent collections in the affected field area demonstrate similar bioassay results. 

3. Response to Confirmed Resistance: When resistance is “confirmed”, the following steps will 

be taken: EPA will receive notification within 30 days of confirming resistance; 

e. affected customers and extension agents will be notified about confirmed resistance; 

f. affected customers and extension agents will be encouraged to employ alternative CRW 

control measures; 

g. sale and distribution of Cry34/35Ab1 corn in the affected area will cease immediately; 

h. a long-term resistance management action plan will be devised according to the 

characteristics of the resistance event and local agronomic needs. 

8) Annual Reports:

The registrant must provide annual reports to EPA on its Cry34/35Ab1 PIP expressed in corn 

based on the following table. 

Report Description Due Date

Annual Sales Units sold by state (county information is available 

upon request by the Agency) 

January 31st each year 

beginning in 2007 

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 

beginning in 2007 

Grower Education (part 

of the Compliance 

Assurance Program 

Report, except for the 

2006 growing season) 

Education program for the 2006 growing season. 

Subsequent changes to the grower education program 

must be included in the annual compliance assurance 

program report. 

January 31, 2007. 

Annual changes January 

31st,each year beginning in 

2008 as part of the 

Compliance Assurance 

Program Report 

Compliance Assurance 

Program 

Compliance Assurance Program Activities and 

Results: third-party grower survey, on-farm visitation 

program, phased-compliance report, tips and 

complaints, and grower education programs 

 January 31st each year 

starting in 2007 

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Report Description Due Date

Insect Resistance 

Monitoring 

Annual report of the insect resistance monitoring 

program. Results of monitoring and investigations of 

damage reports 

August 31st each year 

beginning in 2008 

Additional reports are due to EPA on its Cry34/35Ab1 PIP expressed in corn based on the 

following table as described in the following table: 

Report Description Due Date

Changes to Grower 

Agreement and/or IRM 

documents 

Current grower agreement(s) and any specific 

stewardship documents 

At least 30 days before any changes 

related to IRM are expected to be 

imposed. 

Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Dow 

AgroSciences 68467-6 

Bt corn Events DAS 59122-

7 + TC1507 with Cry 

34Ab1/Cry35Ab1 + PO 

Cry1F (Herculex Xtra) 

(PDF) 

27-Oct-05 30-Sep-15 

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 PHP8999) in Event 

TC1507 corn (OECD Unique Identifier: DAS-Ø15Ø7-1)] X Cry34/35Ab1 [Bacillus 

thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for 

their production (plasmid insert PHP17662) in Event DAS-59122-7 corn (OECD Unique 

Identifier: DAS-59122-7)] corn for use in field corn. 

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

the Agency requires registrants of similar products to submit such data. 

4] Submit/cite all data, determined by the Agency to be acceptable, required to support the 

individual plant-incorporated protectants in Event TC1507 (Herculex® I) and Event 

DAS-59122-7 (Herculex® Rootworm) corn within the timeframes required by the terms 

and conditions of EPA Registration Numbers 68467-2 and 68467-5, 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. 

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

Cry1FxCry34/35Ab1

a) Requirements relating to creation of a refuge for both 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-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 Cry1F component and 

lepidopteran-resistant Bt corn may be planted in the corn rootworm refuge for the 

Cry34/35Ab1 component. 

b) Requirements for the registrants to prepare and require Bt corn users to sign grower 

agreements which impose binding contractual obligations on the grower to comply 

with the refuge requirements; 

c) Requirements for the registrants to develop, implement, and report to EPA on 

programs to educate growers about IRM requirements; 

d) Requirements for the registrants to develop, implement, and report to EPA on 

programs to evaluate and promote growers compliance with IRM requirements (the 

Cry1F x Cry34/35Ab1 Compliance Assurance Program (CAP) must integrate with 

the Cry1 and Cry34/35Ab1 Caps); 

e) Requirements for the registrants 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 Cry1F and Cry34/35Ab1 proteins 

in the target insects; 

f) Requirements for the registrants to develop, and if triggered, to implement a 

remedial action plan that would contain measures the registrants would take in the 

event that any insect resistance was detected as well as to report on activity under 

the plan to EPA; 

g) 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, 

compliance assurance program including the education program, on or before 

January 31st each year, and for resistance monitoring, on or before April 30th each 

year for Cry1F and on or before August 31st each for Cry34/35Ab1. 

6a. Refuge Requirements

The use of Cry1F x Cry34/35Ab1 corn requires accompanying refuge corn for both the Cry1F 

and Cry34/35Ab1 components that meets the requirements of the individual traits, described 

below. The refuge for both traits may be combined by planting non-Bt corn as the refuge (see C. 

below), or the refuge for each trait may be planted separately (see A. and B. below). 

For the separate refuges, corn rootworm-resistant Bt corn (e.g., Herculex RW) may be planted in 

the lepidopteran refuge for the Cry1F component and lepidopteran-resistant Bt corn (e.g., 

Herculex I) 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. 

Possible options include: 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 

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Herculex RW corn can serve as an in-field lepidopteran refuge for one field planted to Cry1F X 

Cry34/35Ab1 and an external lepidopteran refuge for separate fields planted to Cry1F X 

Cry34/35Ab1, while the rootworm refuge is planted as Herculex I corn in an external adjacent 

field. In all options, size and management of each individual refuge must be followed as 

described in A. and B. below. 

Other refuge designs and combinations are permissible as long as in all cases the size and 

management of each refuge are described in A., B., and C., below. 

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. 

A. Lepidopteran refuge for the Cry1F component.

1. Refuge size, Corn-Growing Areas (corn belt and other non corn/cotton-growing 

regions). The use of Cry1F x Cry34/35Ab1 corn requires an accompanying 20% 

refuge consisting of non-Bt corn or non-lepidopteran resistant Bt corn. 

2. Refuge size, (Corn/Cotton-growing areas). * The use Cry1F x Cry34/35Ab1 corn 

requires an accompanying 50% refuge consisting of non-Bt corn or nonlepidopteran resistant Bt corn. 

3. Refuge location. 

• The lepidopteran refuge can be planted in a separate field not more than 1⁄2 mile of 

the Cry1F x Cry34/35Ab1 field. 

• The lepidopteran refuge can be planted within the Cry1F x Cry34/35Ab1 field as 

blocks (e.g. along the edges or headlands) 

• The lepidopteran refuge can be planted within the Cry1F x Cry34/35Ab1 field as 

strips across the field at least four rows wide (six preferred) 

4. Refuge management. 

Insecticide treatments for control of European corn borer, corn earworm, southwestern corn 

borer, fall armyworm, black cutworm, western bean cutworm, lesser corn stalk borer, 

sugarcane borer and southern corn stalk borer 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). Microbial Bt insecticides must not be 

applied to lepidopteran resistant refuges. 

Cotton growing areas 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, 

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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 Dunkin, New Madrid, Pemiscot, Scott, Stoddard). 

B. Corn rootworm refuge for the Cry34/35Ab1 component.

1. Refuge size. The use of Cry1F x Cry34/35Ab1 corn requires an accompanying 20% 

refuge consisting of non-Bt corn or non-corn rootworm-resistant Bt corn. 

2. Refuge location. The rootworm refuge is required to be planted within or adjacent (e.g. 

across the road) to the Cry1F x Cry34/35Ab1 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 may be planted as a single block or as a series 

of strips measuring at least four (4) crop rows wide. 

• Seed mixtures of Cry1F x Cry34/35Ab1 and rootworm refuge corn are not 

permitted. 

• If the rootworm refuge is planted on rotated ground, then Cry1F x Cry34/35Ab1 corn 

must also be planted on rotated ground. 

• If the rootworm refuge is planted in continuous corn, the Cry1F x Cry34/35Ab1 field 

may be planted on either continuous or rotated land (option encouraged where 

WCRW 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 CRW adults, 

the same treatment must also be applied in the same time-frame to Cry1F x 

Cry34/35Ab1 corn. 

• Pests other than adult corn rootworms can be treated on the rootworm refuge acres 

without treating the Cry1F x Cry34/35Ab1 acres only if treatment occurs when 

adult corn rootworms are not present or if a pesticide without activity against adult 

corn rootworms is used. Pests on the Cry1F x Cry34/35Ab1 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 PIPs for 

rootworm control (e.g. lepidopteran-protected Bt corn, herbicide-tolerant corn, or 

conventional corn). 

• The rootworm refuge and Cry1F x Cry34/35Ab1 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 

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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. 

C. 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, as follows 

1.Refuge size shall be 20% in corn-growing areas and 50% in cotton-growing areas 

(see list labeled with " * " under A). 

2. Refuge location. The combined refuge is required to be planted within or adjacent 

(e.g. across the road) to the Cry1F x Cry34/35Ab1 corn field. 

3. Refuge management options 

• The in-field refuge options must be planted as a single block or as a series of 

strips measuring at least four (4) rows wide (six rows preferred). 

• Seed mixtures of Cry1F x Cry34/35Ab1 and refuge corn are not permitted. 

• If the combined refuge is planted on rotated ground, then the Cry1F x 

Cry34/35Ab1 corn must also be planted on rotated ground. 

• If the combined refuge is planted on continuous corn, the Cry1F x Cry34/35Ab1 

field may be planted on either continuous or rotated land (option encouraged 

where WCRW 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 CRW 

adults, the same treatment must also be applied in the same timeframe to Cry1F 

x Cry34/35Ab1 corn. 

• Insecticide treatments in the combined refuge for control of European corn 

borer, corn earworm, southwestern corn borer, fall armyworm, black cutworm, 

western bean cutworm, sugarcane borer, lesser corn stalk borer, or southern 

corn stalk borer 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). These pests can be treated with CRW-labeled 

insecticide on the combined refuge acres without treating the Cry1F x 

Cry34/35Ab1 acres only if treatment occurs when adults corn rootworms are not 

present. Microbial Bt insecticides must not be applied to the common refuges. 

• Pests other than adult corn rootworms may be treated with CRW-labeled 

insecticide on the combined refuge acres without treating the Cry1F x 

Cry34/35Ab1 acres only if treatment occurs when adults corn rootworms are not 

present. Pests on the Cry1F x Cry34/35Ab1 acres may be treated as needed 

without having to treat the refuge. 

• The combined refuge can be planted to any corn hybrid that does not express 

PIPs for lepidopteran or rootworm control (i.e. herbicide tolerant corn or 

conventional corn). 

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• The combined refuge and Cry1F x Cry34/35Ab1 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. 

The description of the refuge requirements in the grower guide must be consistent with 

the preceding requirements. 

6b. 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 develop a system (equivalent to what is already approved for 

Cry1F Bt corn) 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. The proposed system will be submitted to 

EPA by January 31, 2006. 

4. If the registrants wish to change any part of the grower agreement or any specific 

stewardship documents referenced in the grower agreement that would affect either 

the content of the IRM program or the legal enforceability of the provisions of the 

agreement relating to the IRM program, thirty days prior to implementing a 

proposed change, the registrant must submit to EPA the text of such changes to 

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

5. The registrant must establish a system (equivalent to what is already approved for 

Cry1F Bt Corn) 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 31st of the year in which the agreement was signed. 

7. Annually, the registrant shall provide EPA with a report showing the number of 

units of its Cry1F x Cry34/35Ab1 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. 

6c. IRM Education and IRM Compliance Monitoring Programs 

1. The registrants must implement a comprehensive, ongoing IRM education program 

designed to convey to Bt Cry34/35Ab1 corn users the importance of complying 

with the IRM program. The program shall include information encouraging Bt

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Cry1F x Cry34/35Ab1 corn users to pursue optional elements of the IRM program 

relating to refuge configuration and proximity to Bt Cry1F x Cry34/35Ab1 corn 

fields. The education program shall involve the use of multiple media, e.g. face-toface 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 for the first year of commercialization (2006 growing season) 

by January 31, 2007. The program shall involve at least one written communication 

annually to each Bt Cry1F x Cry34/35Ab1 corn user separate from the grower 

technical guide. The communication shall inform the user of the current IRM 

requirements. The registrants shall coordinate their education programs with 

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

Corn Grower Association and state extension programs. 

2. Annually, the registrant shall revise, and expand as necessary, its education 

program to take into account the information collected through the compliance 

survey required under paragraph 6] and from other sources. The changes shall 

address aspects of grower compliance that are not sufficiently high. 

3. Annually, the registrant must provide EPA 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. The registrant must design and implement an ongoing IRM compliance assurance 

program designed to evaluate the extent to which growers purchasing its Cry1F x 

Cry34/35Ab1 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 Cry1F x 

Cry34/35Ab1 Bt corn product. The registrant shall coordinate with other Bt corn 

registrants in designing and implementing its compliance assurance program and 

integrate the Cry1F x Cry34/35Ab1 CAP with the Cry1 Caps. Other required 

features of the program are described in paragraphs 5 - 22 below. 

5. The registrant must establish and publicize a “phased compliance approach,” i.e., a 

guidance document that indicates how the registrant will address instances of noncompliance with the terms of the IRM program and general criteria for choosing 

among options for responding to any non-compliant growers. The options shall 

include withdrawal of the right to purchase Cry1F x Cry34/35Ab1Bt corn for an 

individual grower or for all growers in a specific region. An individual grower 

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

sales of the product the next year. Similarly, seed dealers who are not fulfilling their 

obligations to inform/educate growers of their IRM obligations will lose their 

opportunity to sell Cry1F x Cry34/35Ab1Bt corn. 

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

by an independent third party of a statistically representative sample of Cry1F x 

Cry34/35Ab1Bt corn growers 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 

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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 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 31 of each year. The registrant shall confer with 

EPA on the design and content of the survey prior to its implementation. 

10. Annually, the registrant shall revise, and expand as necessary, its compliance 

assurance program to take into account the information collected through the 

compliance survey required under paragraphs 6 through 8 and from other sources. 

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

high. The registrant must confer with the Agency prior to adopting any significant 

changes. 

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

shall train its representatives who make on-farm visits with Cry1F x 

Cry34/35Ab1Bt 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, 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 Cry1F x Cry34/35Ab1Bt 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. Annually, the registrants shall provide a report to EPA summarizing the activities 

carried out under their compliance assurance program for the prior year including 

changes to the grower education program, 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, third-party grower 

survey, on-farm visitation program, verified tips and complaints, education 

programs (e.g., grower meetings and letters), the extent of non-compliance, 

corrective measures to address the non-compliance (phased-compliance program), 

and any follow-up actions taken. 

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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: 

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. This 

requirement may be phased in over the next three growing seasons, with 50% 

implementation in 2012 and full implementation for the 2013 growing season. 

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

greatest risks for resistance: 

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. 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: 

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 the registrant, licensee, or affiliated company. 

20. The registrant 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. 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: 

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 two 

years by the registrant, seed supplier, or third party assessor, after completing the 

assessment process; 

b. 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; 

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c. 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 Bt corn product in the subsequent year. 

d. The registrant will identify to EPA all growers who are denied access to the Bt

corn product. 

6d. Insect Resistance Monitoring and Remedial Action Plan 

The Agency is imposing the following conditions for the Cry1F and Cry34Ab/35Ab 

toxins expressed in this product: 

A report on results of Cry1F resistance monitoring and investigations of damage reports 

must be submitted to the Agency annually by April 31st each year for the duration 

of the conditional registration. You must provide EPA with an annual Cry34/35Ab1 

resistance monitoring report by August 31st of each year, reporting on populations 

collected the previous year. 

Cry1 F

1. The registrant will monitor for resistance and/or trends in increased tolerance for 

Ostrinia nubilalis (European corn borer), Diatraea grandiosella (Southwestern corn 

borer), and/or Helicoverpa zea (corn earworm). Sampling should be focused in 

those areas in which there is the highest risk of resistance development. The 

ABSTC has identified four regions for its compliance and monitoring programs. 

2. The registrant shall provide to EPA a description of its Cry1F resistance monitoring 

plan by January 31, 2006. The description shall include: sampling (number of 

locations and samples per locations), sampling methodology, bioassay 

methodology, standardization procedures, detection technique and sensitivity, and 

the statistical analysis of the probability of detecting resistance. 

3. The registrant must follow up on grower, extension specialist or consultant reports 

of less than expected results or control failures for the target lepidopteran pests 

Ostrinia nubilalis (ECB), Diatraea grandiosella (SWCB), Helicoverpa zea

(CEW/CBW), Spodoptera frugiperda (FAW), Agrotis ipsilon (BCW), and Richia 

albicosta (WBCW), 

Sugar cane borer Diatraea saccharalis; southern corn stalk borer, Diatraea 

crambidoides; lesser corn stalk borer, Elasmopalpus lignosellus. The registrant will 

instruct its customers (growers and seed distributors) to contact them (e.g., via a toll 

free customer service number) if incidents of unexpected levels of damage occurs 

from these target pests. The registrant will investigate all damage reports submitted 

to the company or the company’s representatives. See Remedial Action Plans 

section below. 

Cry34/35Ab1

The registrant must monitor for Cry34Ab1/35Ab1 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. 

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1. The resistance monitoring plan must include: baseline sensitivity data, sampling 

(number of locations, samples per locations), sampling methodology and lifestage 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. 

2. The registrant must work to develop a diagnostic assay for corn rootworm 

resistance monitoring to detect potentially resistant individuals. As part of this 

effort, the registrant must investigate the feasibility of using the Sublethal 

Seedling AssayV as a diagnostic assay. A report on this requirement must be 

submitted to the Agency 6 months from the date of the amended registration. 

 

3. The registrant 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 Cry3Bb1. A report on 

this requirement must be submitted to the Agency 6 months from the date of the 

amended registration. 

4. The registrant must follow-up on grower, extension specialist or consultant 

reports of unexpected damage or control failures for corn rootworm. 

6e. Remedial Action Plans

Cry1F

A Remedial Action Plan covering both suspected and confirmed resistance for European 

corn borer, corn earworm, and southwestern corn borer follows. If resistance involves 

any of these three target pests, the registrant must implement this Remedial Action 

Plan. The registrant must obtain approval from EPA before modifying the Remedial 

Action Plan for Lepidopteran-Protected Corn. 

Remedial Action Plan for Responding to Resistance in European Corn Borer Corn 

Earworm and/or Southwestern Corn Borer (October 15, 2001) 

7. Definitions 

Suspected resistance

EPA defines "suspected" resistance to mean, in the case of reported product failure, 

that: the corn in question has been confirmed to be Bt corn 

 V Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and 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) 

137
• 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 other reasonable causes for the observed product failure have 

been ruled out. The Agency does not interpret "suspected resistance" to mean 

grower reports of possible control failures, nor does the Agency intend that 

extensive field studies and testing to confirm scientifically insect resistance be 

completed before responsive measures are undertaken. 

If resistance is “suspected,” the registrant must instruct growers to do the following: 

• Use alternate control measures to control the pest suspected of resistance to Bt

corn in the affected region. 

• Destroy crop residues in the affected region immediately after harvest (i.e. within 

one month) with a technique appropriate for local production practices to 

minimize the possibility of resistant insects overwintering and contributing to the 

next season's pest population. 

Confirmed Resistance

The registrant assumes responsibility for the implementation of resistance mitigation 

actions undertaken in response to the occurrence of resistance during the growing 

season. When resistance has been confirmed, the registrant must immediately stop 

sale and distribution of Bt corn in the remedial action zone (may be less than a single 

county, single county, or multiple counties) where the resistance has been shown until 

an effective local mitigation plan approved by EPA has been implemented. 

A resistance event becomes confirmed if the progeny of the sampled ECB, CEW, or 

SWCB population would exhibit all of the following characteristics in bioassays 

initiated with neonates: 

1. If there is > 30% survival and > 25% leaf area damaged in a 5-day bioassay using 

Cry1Ab-positive or Cry1F-positive leaf tissue under controlled laboratory 

conditions. 

2. If standardized laboratory bioassays using diagnostic doses for ECB (Marçon et 

al. 2000), SWCB (Trisyono and Chippendale 1999), or CEW/CBW 

(USDA/ARS/SIMRU, unpublished) demonstrate resistance has a genetic basis 

and survivorship in excess of 1% (gene frequency of population ?0.1). 

3. If an LC50 in a standard Cry1Ab or Cry1F diet bioassay exceeds the upper limit 

of the 95% confidence interval of the standard unselected laboratory population 

LC50 for susceptible ECB, SWCB, or CEW populations, as established by the 

ongoing baseline monitoring program. 

 Remedial Action 

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The registrant assumes responsibility for the implementation of resistance mitigation 

actions undertaken in response to the occurrence of resistance during the growing 

season. In cases of "confirmed" resistance, the following strategy for Cry1Ab and/or 

Cry1F Bt corn hybrids: 

The registrant will report all instances of confirmed pest resistance, as defined above, to 

the Agency within 30 days. Upon identification of a confirmed instance of resistance, 

registrants will take the following immediate mitigation measures: 

1. Notify customers and extension agents in the affected area, 

2. Require to customers and extension agents in the affected area the use of 

alternative control measures to reduce or control the local target pest population, 

3. Where appropriate, require to customers and extension agents in the affected area 

that crop residues be incorporated into the soil following harvest, to minimize the 

possibility of overwintering insects. 

4. Immediately stop sale and distribution of Bt corn in the remedial action zone (may 

be a single or multiple counties) where the resistance has been shown until an 

effective local mitigation plan approved by EPA has been implemented. 

Within 90 days of a confirmed instance of pest resistance, as defined above, registrants 

will: 

5. Notify the Agency of the immediate mitigation measures that were implemented, 

6. Submit to the Agency a proposed long-term resistance management action plan 

for the affected area, 

7. Submit to the Agency a proposed long-term resistance management action plan 

for the affected area, 

8. Implement an action plan that is approved by EPA and that consists of some or all 

the following elements, as warranted: 

9. Informing customers and extension agents in the affected area of pest resistance, 

10. Increasing monitoring in the affected area, and ensuring that local target pest 

populations are sampled on an annual basis, 

11. Recommending alternative measures to reduce or control target pest populations 

in the affected area, 

12. Implementing intensified local IRM measures in the affected area based on the 

latest research results. The implementation of such measures will be coordinated 

by the Agency with other registrants; and 

13. The implementation of the remedial action strategy will be coordinated by the 

Agency with other registrants and stakeholders. 

For mitigation of resistance in the growing season(s) following a confirmed resistance 

incident(s), use of the following procedures: 

14. Maintenance of the sales suspension of all Bt corn hybrids (with the same protein 

or similar Bt proteins as the Bt corn hybrids with the resistant population) in the 

affected region would remain in place until an EPA-approved local resistance 

management plan is in place to mitigate resistance in the affected region(s). 

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15. The development and recommendation of alternative resistance management 

strategies for controlling the resistant pest(s) on corn in the affected region. 

16. Notification of all relevant personnel (e.g., growers, consultants, extension agents, 

seed distributors, processors, university cooperators, and state/federal authorities) 

in the affected region of the resistance situation. 

Cry34/35Ab1

The remedial action plan is designed as a tiered approach for mitigating WCRW, NCRW, and 

MCRW resistance development to the Cry34/35Ab1 protein. 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. However, the levels of "expected" damage cannot be 

identified until baseline sensitivity is determined. EPA requires that the registrants establish the 

baseline sensitivity by January 31, 2008, so that expected levels of crop damage and target pest 

resistance can be established, and a remedial action plan initiated when needed. 

1. Definition of Suspected Resistance: Resistance will be suspected if investigations of 

unexpected damage reports show that: 

a) implicated corn plant roots were expressing Cry34/35Ab1 proteins at the expected 

levels; 

b) the seed used was not mixed with non-Cry34/35Ab1 seed; 

c) 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; 

d) the level of damage exceeds guidelines for expected damage. 

If resistance is "suspected", the registrant 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. 

2. 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 Cry34/35Ab1 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; 

d) Cry34/35Ab1 plant assays determine that damage caused by surviving insects 

would exceed economic thresholds; 

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e) if subsequent collections in the affected field area demonstrate similar bioassay 

results. 

3. Response to Confirmed Resistance: When resistance is "confirmed", the following steps 

will be taken: 

a) EPA will receive notification within 30 days of confirming resistance; 

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 Cry34/35Ab1 corn 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. 

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Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Pioneer/Dupont 29964-5 

Bt corn Events DAS 59122-

7 + TC1507 with Cry 

34Ab1/Cry35Ab1 + PO 

Cry1F (Herculex Xtra) 

(PDF) 

27-Oct-05 30-Sep-15 

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 PHP8999) in Event 

TC1507 corn (OECD Unique Identifier: DAS-Ø15Ø7-1)] X Cry34/35Ab1 [Bacillus 

thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for 

their production (plasmid insert PHP17662) in Event DAS-59122-7 corn (OECD Unique 

Identifier: DAS-59122-7] corn for use in field corn. 

3. Submit/cite all data required for registration of this product under FIFRA § 3(c)(5) when 

the Agency requires registrants of similar products to submit such data. 

4. Submit/cite all data, determined to by the Agency to be acceptable, required to support 

the individual plant-incorporated protectants in Event TC1507 (Herculex® I) and Event 

DAS-59122-7 (Herculex® Rootworm) corn within the timeframes required by the terms 

and conditions of EPA Registration Numbers 29964-3 and 29964-4, 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 Program:

The required IRM program for Cry1FxCry34/35Ab1 corn has the following elements: 

a) Requirements relating to creation of a refuge for both 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-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 Cry1F component and 

lepidopteran-resistant Bt corn may be planted in the corn rootworm refuge for the 

Cry34/35Ab1 component. 

b) 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; 

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c) Requirements for the registrants to develop, implement, and report to EPA on 

programs to educate growers about IRM requirements; 

d) Requirements for the registrants to develop, implement, and report to EPA on 

programs to evaluate and promote growers compliance with IRM requirements (the 

Cry1F x Cry34/35Ab1 Compliance Assurance Program (CAP) must integrate with 

the Cry1 and Cry34/35Ab1 Caps); 

e) Requirements for the registrants 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 Cry1F and Cry34/35Ab1 proteins 

in the target insects; 

f) Requirements for the registrants to develop, and if triggered, to implement a 

remedial action plan that would contain measures the registrants would take in the 

event that any insect resistance was detected as well as to report on activity under 

the plan to EPA; 

g) 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, 

compliance assurance program including the education program, on or before 

January 31st each year, and for resistance monitoring, on or before April 30th each 

year for Cry1F and on or before August 31st each for Cry34/35Ab1. 

5a. Refuge Requirements

The use of Cry1F x Cry34/35Ab1 corn requires accompanying refuge corn for both the 

Cry1F and Cry34/35Ab1 components that meets the requirements of the individual 

traits, described below. The refuge for both traits may be combined by planting nonBt corn as the refuge (see C. below), or the refuge for each trait may be planted 

separately (see A. and B. below). 

For the separate refuges, corn rootworm-resistant Bt corn (e.g., Herculex RW) may be 

planted in the lepidopteran refuge for the Cry1F component and lepidopteran-resistant 

Bt corn (e.g., Herculex I) 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. Possible options include: 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 

corn can serve as an in-field lepidopteran refuge for one field planted to Cry1F X 

Cry34/35Ab1 and an external lepidopteran refuge for separate fields planted to Cry1F 

X Cry34/35Ab1, while the rootworm refuge is planted as Herculex I corn in an 

external adjacent field. In all options, size and management of each individual refuge 

must be followed as described in A. and B. below. 

Other refuge designs and combinations are permissible as long as in all cases the size and 

management of each refuge are described in A., B., and C., below. 

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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. 

A. Lepidopteran refuge for the Cry1F component.

• Refuge size, Corn-Growing Areas (corn belt and other non corn/cotton-growing 

regions). The use of Cry1F x Cry34/35Ab1 corn requires an accompanying 20% 

refuge consisting of non-Bt corn or non-lepidopteran resistant Bt corn. 

• Refuge size, (Corn/Cotton-growing areas). * The use Cry1F x Cry34/35Ab1 

corn requires an accompanying 50% refuge consisting of non-Bt corn or nonlepidopteran resistant Bt corn. 

• Refuge location. 

• The lepidopteran refuge can be planted in a separate field not more than 1⁄2 mile 

of the Cry1F x Cry34/35Ab1 field. 

• The lepidopteran refuge can be planted within the Cry1F x Cry34/35Ab1 field 

as blocks (e.g. along the edges or headlands) 

• The lepidopteran refuge can be planted within the Cry1F x Cry34/35Ab1 field 

as strips across the field at least four rows wide (six preferred) 

• Refuge management. 

Insecticide treatments for control of European corn borer, corn earworm, southwestern 

corn borer, fall armyworm, black cutworm, western bean cutworm, lesser corn stalk 

borer, sugarcane borer and southern corn stalk borer 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). Microbial Bt insecticides must not be 

applied to lepidopteran resistant refuges. 

Cotton growing areas 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 Dunkin, New Madrid, Pemiscot, Scott, 

Stoddard). 

B. Corn rootworm refuge for the Cry34/35Ab1 component.

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1. Refuge size. The use of Cry1F x Cry34/35Ab1 corn requires an accompanying 

20% refuge consisting of non-Bt corn or non-corn rootworm-resistant Bt corn. 

2. Refuge location. The rootworm refuge is required to be planted within or 

adjacent (e.g. across the road) to the Cry1F x Cry34/35Ab1 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 may be planted as a single block or 

as a series of strips measuring at least four (4) crop rows wide. 

• Seed mixtures of Cry1F x Cry34/35Ab1 and rootworm refuge corn are not 

permitted. 

• If the rootworm refuge is planted on rotated ground, then Cry1F x 

Cry34/35Ab1 corn must also be planted on rotated ground. 

• If the rootworm refuge is planted in continuous corn, the Cry1F x 

Cry34/35Ab1 field may be planted on either continuous or rotated land 

(option encouraged where WCRW 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 

CRW adults, the same treatment must also be applied in the same timeframe to Cry1F x Cry34/35Ab1 corn. 

• Pests other than adult corn rootworms may be treated on the rootworm 

refuge acres without treating the Cry1F x Cry34/35Ab1 acres only if 

treatment occurs when adult corn rootworms are not present or if a 

pesticide without activity against adult corn rootworms is used. Pests on 

the Cry1F x Cry34/35Ab1 acres may 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 PIPs for rootworm control (e.g. lepidopteran-protected Bt corn, 

herbicide-tolerant corn, or conventional corn). 

• The rootworm refuge and Cry1F x Cry34/35Ab1 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. 

C. 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 

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managed such that it is consistent with the requirements of the two individual 

traits, as follows 

1. Refuge size shall be 20% in corn-growing areas and 50% in cottongrowing areas (see list labeled with " * " under A). 

2. Refuge location. The combined refuge is required to be planted within or 

adjacent (e.g. across the road) to the Cry1F x Cry34/35Ab1 corn field. 

3. Refuge management options 

• The in-field refuge options must be planted as a single block or as a series 

of strips measuring at least four (4) rows wide (six rows preferred). 

• Seed mixtures of Cry1F x Cry34/35Ab1 and refuge corn are not permitted. 

• If the combined refuge is planted on rotated ground, then the Cry1F x 

Cry34/35Ab1 corn must also be planted on rotated ground. 

• If the combined refuge is planted on continuous corn, the Cry1F x 

Cry34/35Ab1 field may be planted on either continuous or rotated land 

(option encouraged where WCRW 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 

CRW adults, the same treatment must also be applied in the same 

timeframe to Cry1F x Cry34/35Ab1 corn. 

• Insecticide treatments in the combined refuge for control of European corn 

borer, corn earworm, southwestern corn borer, fall armyworm, black 

cutworm, western bean cutworm, sugarcane borer, lesser corn stalk borer, 

or southern corn stalk borer 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). These 

pests can be treated with CRW-labeled insecticide on the combined refuge 

acres without treating the Cry1F x Cry34/35Ab1 acres only if treatment 

occurs when adults corn rootworms are not present. Microbial Bt

insecticides must not be applied to the common refuges. 

• Pests other than adult corn rootworms can be treated with CRW-labeled 

insecticide on the combined refuge acres without treating the Cry1F x 

Cry34/35Ab1 acres only if treatment occurs when adults corn rootworms 

are not present. Pests on the Cry1F x Cry34/35Ab1 acres can be treated as 

needed without having to treat the refuge. 

• The combined refuge can be planted to any corn hybrid that does not 

express PIPs for lepidopteran or rootworm control (i.e. herbicide tolerant 

corn or conventional corn). 

• The combined refuge and Cry1F x Cry34/35Ab1 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. 

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The description of the refuge requirements in the grower guide must be consistent with 

the preceding requirements. 

5b. 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 develop a system (equivalent to what is already approved for 

Cry1F Bt corn) 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. If the registrants wish to change any part of the grower agreement or any specific 

stewardship documents referenced in the grower agreement that would affect 

either the content of the IRM program or the legal enforceability of the provisions 

of the agreement relating to the IRM program, thirty days prior to implementing a 

proposed change, the registrant must submit to EPA the text of such changes to 

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

5. The registrant must establish a system (equivalent to what is already approved for 

Cry1F Bt Corn) 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 31st of the year in which the agreement was signed. 

7. Annually, the registrant shall provide EPA with a report showing the number of 

units of its Cry1F x Cry34/35Ab1 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. 

5c. IRM Education and IRM Compliance Monitoring Programs 

1. The registrants must implement a comprehensive, ongoing IRM education 

program designed to convey to Bt Cry34/35Ab1 corn users the importance of 

complying with the IRM program. The program shall include information 

encouraging Bt Cry1F x Cry34/35Ab1 corn users to pursue optional elements of 

the IRM program relating to refuge configuration and proximity to Bt Cry1F x 

Cry34/35Ab1 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 

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communications such as by Internet, radio, or television commercials. Copies of 

the materials will be provided to EPA for its records for the first year of 

commercialization (2006 growing season) by January 31, 2007. The program 

shall involve at least one written communication annually to each Bt Cry1F x 

Cry34/35Ab1 corn user separate from the grower technical guide. The 

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

registrants shall coordinate their education programs with educational efforts of 

other registrants and other organizations, such as the National Corn Grower 

Association and state extension programs. 

2. Annually, the registrant shall revise, and expand as necessary, its education 

program to take into account the information collected through the compliance 

survey required under paragraph 6] and from other sources. The changes shall 

address aspects of grower compliance that are not sufficiently high. 

3. Annually, the registrant must provide EPA 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. The registrant must design and implement an ongoing IRM compliance assurance 

program designed to evaluate the extent to which growers purchasing its Cry1F x 

Cry34/35Ab1 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 

Cry1F x Cry34/35Ab1 Bt corn product. The registrant shall coordinate with other 

Bt corn registrants in designing and implementing its compliance assurance 

program and integrate the Cry1F x Cry34/35Ab1 CAP with the Cry1 Caps. Other 

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

5. The registrant must establish and publicize a “phased compliance approach,” i.e., 

a guidance document that indicates how the registrant will address instances of 

non-compliance with the terms of the IRM program and general criteria for 

choosing among options for responding to any non-compliant growers. The 

options shall include withdrawal of the right to purchase Cry1F x Cry34/35Ab1Bt

corn for an individual grower or for all growers in a specific region. An individual 

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

denied sales of the product the next year. Similarly, seed dealers who are not 

fulfilling their obligations to inform/educate growers of their IRM obligations will 

lose their opportunity to sell Cry1F x Cry34/35Ab1Bt corn. 

6. The IRM compliance assurance program shall include an annual survey 

conducted by an independent third party of a statistically representative sample of 

Cry1F x Cry34/35Ab1Bt corn growers 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 

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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. 7The 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 31 of each year. The registrant shall confer 

with EPA on the design and content of the survey prior to its implementation. 

10. Annually, the registrant shall revise, and expand as necessary, its compliance 

assurance program to take into account the information collected through the 

compliance survey required under paragraphs 6 through 8 and from other sources. 

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

high. The registrant must confer with the Agency prior to adopting any significant 

changes. 

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

registrant shall train its representatives who make on-farm visits with Cry1F x 

Cry34/35Ab1Bt 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, 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 Cry1F x Cry34/35Ab1Bt 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. Annually, the registrants shall provide a report to EPA summarizing the activities 

carried out under their compliance assurance program for the prior year including 

changes to the grower education program, 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, third-party grower 

survey, on-farm visitation program, verified tips and complaints, education 

programs (e.g., grower meetings and letters), the extent of non-compliance, 

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corrective measures to address the non-compliance (phased-compliance program), 

and any follow-up actions taken. 

15. The registrant and the seed corn dealers for the registrant must allow a review of 

the compliance records by EPA or by a State pesticide regulatory agency if the 

State agency can demonstrate that confidential business information, including the 

names, personal information, and grower license number of the growers will be 

protected. 

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. This 

requirement may be phased in over the next three growing seasons, with 50% 

implementation in 2012 and full implementation for 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 

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. 

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 

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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 Bt corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt

corn product. 

5d. Insect Resistance Monitoring and Remedial Action Plan 

The Agency is imposing the following conditions for the Cry1F and Cry34Ab/35Ab 

toxins expressed in this product: 

A report on results of Cry1F resistance monitoring and investigations of damage reports 

must be submitted to the Agency annually by April 31st each year for the duration of 

the conditional registration. You must provide EPA with an annual Cry34/35Ab1 

resistance monitoring report by August 31st of each year, reporting on populations 

collected the previous year. 

Cry1 F

1. The registrant will monitor for resistance and/or trends in increased tolerance for 

Ostrinia nubilalis (European corn borer), Diatraea grandiosella (Southwestern 

corn borer), and/or Helicoverpa zea (corn earworm). Sampling should be focused 

in those areas in which there is the highest risk of resistance development. The 

ABSTC has identified four regions for its compliance and monitoring programs. 

2. The registrant shall provide to EPA a description of its Cry1F resistance 

monitoring plan by January 31, 2006. The description shall include: sampling 

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(number of locations and samples per locations), sampling methodology, bioassay 

methodology, standardization procedures, detection technique and sensitivity, and 

the statistical analysis of the probability of detecting resistance. 

3. The registrant must follow up on grower, extension specialist or consultant reports 

of less than expected results or control failures for the target lepidopteran pests 

Ostrinia nubilalis (ECB), Diatraea grandiosella (SWCB), Helicoverpa zea

(CEW/CBW), Spodoptera frugiperda (FAW), Agrotis ipsilon (BCW), and Richia 

albicosta (WBCW), 

Sugar cane borer Diatraea saccharalis; southern corn stalk borer, Diatraea 

crambidoides; lesser corn stalk borer, Elasmopalpus lignosellus. The registrant 

will instruct its customers (growers and seed distributors) to contact them (e.g., 

via a toll free customer service number) if incidents of unexpected levels of 

damage occurs from these target pests. The registrant will investigate all damage 

reports submitted to the company or the company’s representatives. See Remedial 

Action Plans section below. 

Cry34/35Ab1

The registrant must monitor for Cry34Ab1/35Ab1 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. 

1. The resistance monitoring plan must include: baseline sensitivity data, sampling 

(number of locations, samples per locations), sampling methodology and lifestage 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. 

2. The registrant must work to develop a diagnostic assay for corn rootworm 

resistance monitoring to detect potentially resistant individuals. As part of this 

effort, the registrant must investigate the feasibility of using the Sublethal 

Seedling AssayVI as a diagnostic assay. A report on this requirement must be 

submitted to the Agency 6 months from the date of the amended registration. 

 

3. The registrant 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 Cry3Bb1. A report on 

this requirement must be submitted to the Agency 6 months from the date of the 

amended registration. 

 VI Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and 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) 

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4. The registrant must follow-up on grower, extension specialist or consultant 

reports of unexpected damage or control failures for corn rootworm. 

5e. Remedial Action Plans

Cry1F

A Remedial Action Plan covering both suspected and confirmed resistance for European 

corn borer, corn earworm, and southwestern corn borer follows. If resistance involves 

any of these three target pests, the registrant must implement this Remedial Action 

Plan. The registrant must obtain approval from EPA before modifying the Remedial 

Action Plan for Lepidopteran-Protected Corn. 

Remedial Action Plan for Responding to Resistance in European Corn Borer Corn 

Earworm and/or Southwestern Corn Borer (October 15, 2001) 

6. Definitions 

Suspected resistance

EPA defines "suspected" resistance to mean, in the case of reported product failure, 

that: the corn in question has been confirmed to be 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 other reasonable causes for the observed product failure have 

been ruled out. The Agency does not interpret "suspected resistance" to mean 

grower reports of possible control failures, nor does the Agency intend that 

extensive field studies and testing to confirm scientifically insect resistance be 

completed before responsive measures are undertaken. 

If resistance is “suspected,” the registrant must instruct growers to do the following: 

• Use alternate control measures to control the pest suspected of resistance to Bt

corn in the affected region. 

• Destroy crop residues in the affected region immediately after harvest (i.e. within 

one month) with a technique appropriate for local production practices to 

minimize the possibility of resistant insects overwintering and contributing to the 

next season's pest population. 

Confirmed Resistance

The registrant assumes responsibility for the implementation of resistance mitigation 

actions undertaken in response to the occurrence of resistance during the growing 

season. When resistance has been confirmed, the registrant must immediately stop 

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sale and distribution of Bt corn in the remedial action zone (may be less than a single 

county, single county, or multiple counties) where the resistance has been shown until 

an effective local mitigation plan approved by EPA has been implemented. 

A resistance event becomes confirmed if the progeny of the sampled ECB, CEW, or 

SWCB population would exhibit all of the following characteristics in bioassays 

initiated with neonates: 

1. If there is > 30% survival and > 25% leaf area damaged in a 5-day bioassay using 

Cry1Ab-positive or Cry1F-positive leaf tissue under controlled laboratory 

conditions. 

2. If standardized laboratory bioassays using diagnostic doses for ECB (Marçon et 

al. 2000), SWCB (Trisyono and Chippendale 1999), or CEW/CBW 

(USDA/ARS/SIMRU, unpublished) demonstrate resistance has a genetic basis 

and survivorship in excess of 1% (gene frequency of population ?0.1). 

3. If an LC50 in a standard Cry1Ab or Cry1F diet bioassay exceeds the upper limit 

of the 95% confidence interval of the standard unselected laboratory population 

LC50 for susceptible ECB, SWCB, or CEW populations, as established by the 

ongoing baseline monitoring program. 

7. Remedial Action 

The registrant assumes responsibility for the implementation of resistance mitigation 

actions undertaken in response to the occurrence of resistance during the growing 

season. In cases of "confirmed" resistance, the following strategy for Cry1Ab and/or 

Cry1F Bt corn hybrids: 

The registrant will report all instances of confirmed pest resistance, as defined above, to 

the Agency within 30 days. Upon identification of a confirmed instance of resistance, 

registrants will take the following immediate mitigation measures: 

1. Notify customers and extension agents in the affected area, 

2. Require to customers and extension agents in the affected area the use of alternative 

control measures to reduce or control the local target pest population, 

3. Where appropriate, require to customers and extension agents in the affected area that 

crop residues be incorporated into the soil following harvest, to minimize the 

possibility of overwintering insects. 

4. Immediately stop sale and distribution of Bt corn in the remedial action zone (may be 

a single or multiple counties) where the resistance has been shown until an effective 

local mitigation plan approved by EPA has been implemented. 

Within 90 days of a confirmed instance of pest resistance, as defined above, registrants 

will: 

5. Notify the Agency of the immediate mitigation measures that were implemented, 

6. Submit to the Agency a proposed long-term resistance management action plan for 

the affected area, 

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7. Submit to the Agency a proposed long-term resistance management action plan for 

the affected area, 

8. Implement an action plan that is approved by EPA and that consists of some or all the 

following elements, as warranted: 

a. Informing customers and extension agents in the affected area of pest 

resistance, 

b. Increasing monitoring in the affected area, and ensuring that local target pest 

populations are sampled on an annual basis, 

c. Recommending alternative measures to reduce or control target pest 

populations in the affected area, 

d. Implementing intensified local IRM measures in the affected area based on 

the latest research results. The implementation of such measures will be 

coordinated by the Agency with other registrants; and 

e. The implementation of the remedial action strategy will be coordinated by the 

Agency with other registrants and stakeholders. 

For mitigation of resistance in the growing season(s) following a confirmed resistance 

incident(s), use of the following procedures: 

9. Maintenance of the sales suspension of all Bt corn hybrids (with the same protein 

or similar Bt proteins as the Bt corn hybrids with the resistant population) in the 

affected region would remain in place until an EPA-approved local resistance 

management plan is in place to mitigate resistance in the affected region(s). 

10. The development and recommendation of alternative resistance management 

strategies for controlling the resistant pest(s) on corn in the affected region. 

11. Notification of all relevant personnel (e.g., growers, consultants, extension agents, 

seed distributors, processors, university cooperators, and state/federal authorities) 

in the affected region of the resistance situation. 

Cry34/35Ab1

The remedial action plan is designed as a tiered approach for mitigating WCRW, NCRW, 

and MCRW resistance development to the Cry34/35Ab1 protein. 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. However, 

the levels of "expected" damage cannot be identified until baseline sensitivity is 

determined. EPA requires that the registrants establish the baseline sensitivity by 

January 31, 2008, so that expected levels of crop damage and target pest resistance 

can be established, and a remedial action plan initiated when needed. 

1. Definition of Suspected Resistance: Resistance will be suspected if investigations 

of unexpected damage reports show that: 

a. implicated corn plant roots were expressing Cry34/35Ab1 proteins at the expected 

levels; 

b. the seed used was not mixed with non-Cry34/35Ab1 seed; 

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c. 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; 

d. the level of damage exceeds guidelines for expected damage. 

If resistance is "suspected", the registrant 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. 

2. 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 Cry34/35Ab1 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; 

d. Cry34/35Ab1 plant assays determine that damage caused by surviving insects 

would exceed economic thresholds; 

e. if subsequent collections in the affected field area demonstrate similar 

bioassay results. 

3. Response to Confirmed Resistance: When resistance is "confirmed", the following 

steps will be taken: 

a. EPA will receive notification within 30 days of confirming resistance; 

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 Cry34/35Ab1 corn 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. 

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Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Pioneer/Dupont 29964-8 

TC1507 (PO Cry1F) x DAS-59122 

(Cry34Ab1/Cry35Ab1) x MON810 

(Cry1Ab) 

24-Feb-10 31-Oct-15 

1. The subject registration will automatically expire on midnight October 31, 2015. 

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

genetic material (PHP8999) necessary for its production in corn event TC 1507 (OECD 

Unique Identifier: DAS-Ø15Ø7-1) x Bacillus thuringiensis Cry34Ab1 protein and the 

genetic material (PHP17662) necessary for its production in corn event 59122 (OECD 

Unique Identifier: DAS-59122-7) x Bacillus thuringiensis Cry35Ab1 protein and the 

genetic material (PHP17662) necessary for its production in corn event 59122 (OECD 

Unique Identifier: DAS-59122-7) x Bacillus thuringiensis Cry1Ab protein and the 

genetic material (PV-ZMBK07) necessary for it production in corn event MON 810 

(OECD Unique Identifier: MON-ØØ81Ø-6) for use in field corn. 

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

the Agency requires all registrants of similar products to submit such data. 

4. The data submitted by Pioneer are sufficient to support registration for the combination 

PIP corn product,1507x59122xMON810, provided that the registrant submits/cites any 

data, determined by the Agency to be acceptable, required to support the PIP registrations 

of the individual parental events, TC1507 (DAS-Ø15Ø7-1), 59122 (DAS-59122-7), and 

MON810 (MON-ØØ81Ø-6) in corn, as well as the combination PIP product TC1507 

(DAS-Ø15Ø7-1) x DAS-59122-7 (DAS-59122-7), within the timeframes required by the 

terms and conditions of EPA Registration Numbers 29964-3, 29964-4, 524-489, and 

29964-5, 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. The insect resistance management terms and conditions for 1507x59122xMON810 corn 

are as follows. 

The required IRM program for 1507x59122xMON810 corn must have the following 

elements: 

• Requirements relating to creation of a refuge for the Cry1F, Cry1Ab and 

Cry34/35Ab1 components that meets the requirements of the individual traits. The 

refuge for all three traits may be combined by planting non-Bt corn as the refuge, or 

the refuge for each trait may be planted separately. In the latter case, corn rootworm157
resistant Bt corn may be planted in the lepidopteran refuge for the Cry1F and Cry1Ab 

component(s) and lepidopteran-resistant Bt corn may be planted in the corn rootworm 

refuge for the Cry34/35Ab1 component; 

• Requirements for the registrants to prepare and require Bt corn users to sign grower 

agreements which impose binding contractual obligations on the grower to comply 

with the refuge requirements; 

• Requirements for the registrants to develop, implement, and report to EPA on 

programs to educate growers about IRM requirements; 

• Requirements for the registrants to develop, implement, and report to EPA on 

programs to evaluate and promote growers compliance with IRM requirements (the 

1507x59122xMON810 Compliance Assurance Program (CAP) must integrate with 

the CAPS for the individually registered and combination products expressing Cry1F, 

Cry34/35Ab1 and Cry1Ab); 

• Requirements for the registrants 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 Cry1F, Cry1Ab and Cry34/35Ab1 

proteins in the target insects; 

• Requirements for the registrants to develop, and if triggered, to implement a 

remedial action plan that would contain measures the registrants would take in the 

event that any insect resistance was detected as well as to report on activity under the 

plan to EPA; 

• 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 

compliance assurance program including the education program, on or before January 

31st each year, and for resistance monitoring, on or before January 31st each year for 

Cry1F and Cry1Ab beginning in 2011 and on or before August 31st each year for 

Cry34/35Ab1, beginning in 2010. 

7a. Refuge Requirements 

The use of 1507x59122xMON810 corn (Cry1F x Cry34/35Ab1 x Cry1Ab) corn requires 

accompanying corn refuge(s) for the Cry1F, Cry1Ab and Cry34/35Ab1 components 

that meets the requirements of the individual traits, described below. The refuge(s) 

for all three traits may be combined by planting non-Bt corn as the refuge (see C. 

below), or the refuges for the lepidopteran resistant traits and the corn rootwormresistant traits may be planted separately (see A. and B. below). 

For the separate refuges, corn rootworm-resistant Bt corn (e.g., Herculex RW) may be 

planted in the lepidopteran refuge for the Cry1F and Cry1Ab component and 

lepidopteran-resistant Bt corn (e.g., Herculex I or YieldGard) may be planted in the 

corn rootworm refuge for the Cry34/35Ab1 component. Depending on cropping 

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practices, pest problems, and pest management options employed on any given farm, 

growers may need to choose different refuge arrangements for different fields. 

Possible options include: 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 corn can serve as an in-field lepidopteran refuge for one 

field planted to Cry1F x Cry34/35Ab1 x Cry1Ab and an external lepidopteran refuge 

for separate fields planted to Cry1F x Cry34/35Ab1x Cry1Ab, while the rootworm 

refuge is planted as Herculex I corn or YieldGard in an external adjacent field. In all 

options, size and management of each individual refuge must be followed as 

described in A. and B. below. 

Other refuge designs and combinations are permissible as long as in all cases the size and 

management of each refuge are described in A., B., and C., below. 

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. 

A. Lepidopteran refuge for the Cry1F and Cry1Ab component. 

1. Refuge size, Corn-Growing Areas (i.e., corn belt and other non corn/cotton-growing 

regions). The use of 1507x59122xMON810 corn requires an accompanying 20% refuge 

consisting of non-Bt corn or non-lepidopteran resistant Bt corn. 

2. Refuge size, Corn/Cotton-growing areas*. The use of 1507x59122xMON810 corn 

requires an accompanying 50% refuge consisting of non-Bt corn or non-lepidopteran 

resistant Bt corn. 

3. Refuge location.

a. The lepidopteran refuge can be planted in a separate field not more than 1⁄2 

mile of the 1507x59122xMON810 field 

b. The lepidopteran refuge can be planted within the 1507x59122xMON810 field 

as blocks (e.g. along the edges or headlands) 

c. The lepidopteran refuge can be planted within the 1507x59122xMON810 field 

as strips across the field at least four rows wide (six preferred). 

4. Refuge management. 

Insecticide treatments for control of European corn borer, corn earworm, southwestern 

corn borer, fall armyworm, black cutworm, western bean cutworm, lesser corn stalk 

borer, sugarcane borer and southern corn stalk borer 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). Microbial Bt insecticides must not be 

applied to lepidopteran resistant refuges. 

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* Cotton growing areas 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 Dunkin, New Madrid, Pemiscot, Scott, Stoddard). 

B. Corn rootworm refuge for the Cry34/35Ab1 component. 

1. Refuge size. The use of 1507x59122xMON810 corn requires an accompanying 20% 

refuge consisting of non-Bt corn or non-corn rootworm-resistant Bt corn. 

2. Refuge location. The rootworm refuge is required to be planted within or adjacent (e.g. 

across the road) to the 1507x59122xMON810 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. 

a. The in-field rootworm refuge options may be planted as a single block or as a 

series of strips measuring at least four (4) crop rows wide. 

b. Seed mixtures of 1507x59122xMON810 and rootworm refuge corn are not 

permitted. 

c. If the rootworm refuge is planted on rotated ground, then 

1507x59122xMON810 corn must also be planted on rotated ground. 

d. If the rootworm refuge is planted in continuous corn, the 

1507x59122xMON810 field may be planted on either continuous or rotated 

land (option encouraged where WCRW rotation-resistant biotype may be 

present). 

e. Application of soil insecticide is permitted in the rootworm refuge. 

f. Seed treatment is permitted in the rootworm refuge, either at a rate for 

rootworm protection or at a rate for controlling secondary soil pests. 

g. If aerial insecticides are applied to the rootworm refuge for control of CRW 

adults, the same treatment must also be applied in the same time-frame to 

1507x59122xMON810 corn. 

h. Pests other than adult corn rootworms can be treated on the rootworm refuge 

acres without treating the 1507x59122xMON810 acres only if treatment 

occurs when adult corn rootworms are not present or if a pesticide without 

activity against adult corn rootworms is used. Pests on the 

1507x59122xMON810 acres can be treated as needed without having to treat 

the rootworm refuge. 

i. The rootworm refuge can be planted to any corn hybrid that does not express 

PIPs for rootworm control (e.g. lepidopteran-protected Bt corn, herbicidetolerant corn, or conventional corn). 

j. The rootworm refuge and 1507x59122xMON810 corn should be sown on the 

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same day, or with the shortest window possible between planting dates, to 

ensure that corn root development is similar among varieties. 

k. 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. 

C. 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, as follows: 

1. Refuge size shall be 20% in corn-growing areas and 50% in cotton-growing areas (see list 

labeled with “*” under A). 

2. Refuge location. The combined refuge is required to be planted within or adjacent (e.g. 

across the road) to the 1507x59122xMON810 corn field. 

3. Refuge management options

a. The in-field refuge options must be planted as a single block or as a series of 

strips measuring at least four (4) rows wide (six rows preferred). 

b. Seed mixtures of 1507x59122xMON810 and refuge corn are not permitted. 

c. If the combined refuge is planted on rotated ground, then the 

1507x59122xMON810 corn must also be planted on rotated ground. 

d. If the combined refuge is planted on continuous corn, the 

1507x59122xMON810 field may be planted on either continuous or rotated 

land (option encouraged where WCRW rotation-resistant biotype may be 

present). 

e. Application of soil insecticide for corn rootworm control is permitted in the 

combined refuge. 

f. Seed treatment is permitted in the combined refuge, either at a rate for 

rootworm protection or at a rate for controlling secondary soil pests. 

g. If aerial insecticides are applied to the combined refuge for control of CRW 

adults, the same treatment must also be applied in the same timeframe to 

1507x59122xMON810 corn. 

h. Insecticide treatments in the combined refuge for control of European corn 

borer, corn earworm, southwestern corn borer, fall armyworm, black cutworm, 

western bean cutworm, sugarcane borer, lesser corn stalk borer, or southern 

corn stalk borer may be applied only if economic thresholds are reached for 

one or more of these target pests. Economic thresholds will be determined 

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using methods recommended by local or regional professionals (e.g. Extension 

Service Agents, crop consultants). These pests may be treated with CRWlabeled insecticide on the combined refuge acres without treating the 

1507x59122xMON810 acres only if treatment occurs when adult corn 

rootworms are not present. Microbial Bt insecticides must not be applied to 

the common refuges. 

i. Pests other than adult corn rootworms may be treated with CRW-labeled 

insecticide on the combined refuge acres without treating the 

1507x59122xMON810 acres only if treatment occurs when adult corn 

rootworms are not present. Pests on the 1507x59122xMON810 acres may be 

treated as needed without having to treat the refuge. 

j. The combined refuge can be planted to any corn hybrid that does not express 

PIPs for lepidopteran or rootworm control (i.e. herbicide tolerant corn or 

conventional corn). 

k. The combined refuge and 1507x59122xMON810 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. 

l. The description of the refuge requirements in the grower guide must be 

consistent with the preceding requirements. 

7b. Grower Agreement 

1. Persons purchasing 1507x59122xMON810 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 Bt corn products containing the previously registered events 

1507, 59122 and MON810, which is reasonably likely to assure that persons 

purchasing 1507x59122xMON810 corn will affirm annually that they are 

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

description of the system must be submitted to EPA within 90 days from the date 

of registration 

4. Pioneer must use an approved grower agreement and must submit to EPA, within 

90 days from the date of registration, a copy of that agreement and any specific 

stewardship documents referenced in the grower agreement. If 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 

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the IRM program, thirty 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 registration. 

5. Pioneer must implement an approved system equivalent to what is already 

approved for previously registered Bt corn products containing the previously 

registered events 1507, 59122 and MON810), which is reasonably likely to assure 

that persons purchasing 1507x59122xMON810 corn sign grower agreement(s). A 

description of the system must be submitted to EPA within 90 days from the date 

of registration. 

6. Pioneer shall maintain records of all 1507x59122xMON810 corn grower 

agreements for a period of three years from December 31st of the year in which the 

agreement was signed. 

7. Beginning on January 31, 2011, and annually thereafter, Pioneer shall provide 

EPA with a report on the number of units of 1507x59122xMON810 corn seed 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 a 

twelve-month period. Note: The first report shall contain the specified information 

from the time frame starting with the date of registration and extending through the 

2010 growing season. 

8. 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. 

7c. IRM Education and IRM Compliance Monitoring Program 

1. Pioneer must maintain a comprehensive, ongoing IRM education program 

designed to convey to 1507x59122xMON810 corn users the importance of 

complying with the IRM program for all Bt corn products containing the Cry1F, 

Cry1Ab and Cry34/45Ab1events. The program shall include information 

encouraging 1507x59122xMON810 corn users to pursue optional elements of the 

IRM program relating to refuge configuration and proximity to 

1507x59122xMON810 corn 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 their records. The program shall involve 

at least one written communication annually to each 1507x59122xMON810 corn 

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

the user of the current IRM requirements. 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. Annually, Pioneer shall revise, and expand as necessary, its education program to 

163
take into account the information collected through the compliance survey required 

under paragraph F and from other sources. The registrant shall identify 

deficiencies in grower compliance and revise the education program to address 

those deficiencies. 

3. 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, Agricultural Biotechnology Stewardship 

Technical Committee (ABSTC). 

4. Pioneer must maintain an ongoing IRM compliance assurance program (CAP) 

equivalent to what is already approved for previously registered Pioneer Bt corn 

products, designed to evaluate the extent to which growers purchasing 

1507x59122xMON810 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 

1507x59122xMON810 corn. Pioneer shall coordinate with other Bt corn 

registrants in designing and implementing its compliance assurance program and 

integrate this registration into the current compliance assurance program used for 

their other Bt corn PIPs. Pioneer must prepare and submit within 90 days of the 

date of registration a written description of the compliance assurance program. 

Other required features of the program are described in paragraphs E through O 

below. 

5. Pioneer must maintain and publicize a “phased compliance approach” guidance 

document that indicates how they 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. It must be equivalent to what is already 

approved for previously registered Pioneer Bt corn products. 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. The options shall include withdrawal of the right 

to purchase 1507x59122xMON810 corn for an individual grower or for all 

growers in a specific region. An individual grower found to be significantly out of 

compliance two years in a row would be denied sales of 1507x59122xMON810 

corn 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 1507x59122xMON810 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 

1507x59122xMON810 corn who plant the vast majority of all corn in the United 

States and in areas in which the selection intensity is the greatest. The survey shall 

consider only those growers who plant 200 or more acres of corn in the Corn-Belt 

or who plant 100 or more acres of corn in corn-cotton growing areas. The survey 

164
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. 

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 by January 31st of each year, beginning with 2011. 

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 F through H) and from other sources. The 

registrant shall identify deficiencies in grower compliance and revise the education 

program to address those deficiencies. Pioneer must confer with the Agency 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 growers of 

1507x59122xMON810 corn 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 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, Pioneer shall take appropriate action, consistent with its “phased 

compliance approach.” 

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13. If a grower, who purchases 1507x59122xMON810 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 grower is in compliance with 

the IRM program for the current year. 

14. Beginning January 31, 2011, and annually thereafter, Pioneer shall provide a report 

to EPA summarizing the activities carried out under their compliance assurance 

program for the prior year and the plans for the compliance assurance program 

during the current year. The report will include information regarding grower 

interactions (including, but not limited to, on-farm visits, verified tips and 

complaints, education programs, grower meetings and letters), the extent of noncompliance, corrective measures to address the non-compliance, and any follow-up 

actions taken. 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 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. This 

requirement may be phased in over the next three growing seasons, with 50% 

implementation in 2012 and full implementation for 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 requirement: 

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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 Bt corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt corn 

product. 

7d. Insect Resistance Monitoring and Remedial Action Plans 

A. Lepidopteran Resistance Monitoring. The Agency is imposing the following 

conditions for the Cry1Ab and Cry1F toxins expressed in 1507x59122xMON810 

corn: 

Pioneer will monitor for resistance to Cry1Ab and Cry1F toxins expressed in 

1507x59122xMON810 corn. The monitoring program shall consist of two approaches: (i) 

focused population sampling and laboratory testing and (ii) investigation of reports of lessthan expected control of labeled insects. Should field-relevant resistance be confirmed, an 

appropriate resistance management action plan will be implemented. 

1. Focused Population Sampling 

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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 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 

1507x59122xMON810 corn and/or changes in resistance-allele frequency in response to the 

use of 1507x59122xMON810 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 areawide pest suppression. 

The registrant must work to develop a diagnostic assay for corn rootworm resistance 

monitoring to detect potentially resistant individuals. As part of this effort, the registrant 

must investigate the feasibility of using the Sublethal Seedling AssayVII as a diagnostic 

assay. A report on this requirement must be submitted to the Agency 6 months from the date 

of the amended registration. 

 

 

The registrant 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 Cry3Bb1. A report on this requirement must be submitted to the 

Agency 6 months from the date of the amended registration. 

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 1507x59122xMON810 

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

Pioneer will report to the Agency by August 31st of each year, beginning in 2010, the results 

of the population sampling and bioassay monitoring program. 

VII Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and 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) 

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Any incidence of unusually low sensitivity to the Cry1Ab and Cry1F 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 31st, beginning in 2010. The investigative steps will include: 

i. 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. 

ii. 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 1507x59122xMON810 corn under field conditions. If progeny do not 

survive to adulthood, any suspected resistance is not field-relevant and no further 

action is required. 

iii. 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, Pioneer will consult with the Agency to develop and implement a casespecific resistance management action plan. 

2. Investigation of Reports of Unexpected Levels of Damage by the Target Lepidopteran 

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 

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

resistance. 

3. Suspected resistance

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

feeding damage for which: 

i. The corn in question has been confirmed to be lepidopteran-active Bt corn; 

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

iii. The relevant plant tissues are expressing the expected level of Bt protein; and 

iv. 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 

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 1507x59122xMON810 corn in 

commercial production fields before responsive measures are undertaken. 

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

i. Use alternative control measures in 1507x59122xMON810 corn fields in the 

affected region to control the target pest during the immediate growing season. 

ii. Destroy 1507x59122xMON810 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, 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. 

4. 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: 

i. 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). 

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ii. 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. 

iii. 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. 

5. 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: 

i. EPA will receive notification within 30 days of resistance confirmation; 

ii. Affected customers and extension agents will be notified about confirmed 

resistance within 30 days; 

iii. 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; 

iv. 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; 

v. Unless otherwise agreed with EPA, Pioneer will 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; 

vi. 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; 

vii. Pioneer 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 

viii. In subsequent growing seasons, Pioneer will maintain sales suspension and 

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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. 

B. Corn Rootworm Monitoring. The Agency is imposing the following conditions for the 

Cry34/35Ab1 toxin expressed in 1507x59122xMON810: 

Pioneer must monitor for Cry34/35Ab1 resistance and/or trends in increased tolerance for corn 

rootworm using the existing corn rootworm monitoring program developed for previously 

registered Pioneer Bt corn products. Sampling should be focused in those areas in which there is 

the highest risk of resistance development. In addition to mortality assays, consider utilizing 

sublethal bioassays (e.g., head capsule measurements) and molecular marker methods for corn 

rootworm monitoring. 

1. Pioneer must follow-up on grower, extension specialist or consultant reports of 

unexpected damage or control failures for corn rootworm. 

2. Pioneer must provide EPA with an annual resistance monitoring report by August 31st

each year, beginning in 2010, reporting on populations collected the previous year. 

3. The following program summary describes, in order of events, the steps that must be 

taken to implement a remedial action plan if resistance to corn rootworm is confirmed 

(this general process has been implemented for other lepidopteran and corn rootworm Bt

corn products). 

i. Definition of Suspected Resistance. Resistance will be suspected if investigations of 

unexpected damage reports show that: 

• implicated maize plant roots were expressing the Cry34/35Ab1 protein at the 

expected level; 

• 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; 

• 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. 

ii. 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”: 

 

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• the proportion of larvae that can feed and survive on Cry34/35Ab1 roots from 

neonate to adult is significantly higher than the baseline proportion (currently 

being established); 

• 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; 

• the ability to survive is heritable; 

• Cry34/35Ab1 plant assays determine that damage caused by surviving insects 

would exceed economic thresholds; and 

• 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. 

iii. Response to Confirmed Resistance. When resistance is “confirmed,” the following steps 

will be taken: 

• EPA will receive notification within 30 days of resistance confirmation; 

• affected customers and extension agents will be notified about confirmed 

resistance; 

• affected customers and extension agents will be encouraged to employ alternative 

corn rootworm control measures; 

• sale and distribution of Cry34/35Ab1 corn in the affected area will cease 

immediately; and 

• 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 approved by EPA and all appropriate 

stakeholders. 

7e. Annual Reporting Requirements 

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 1507x59122xMON810 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; 

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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. 

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 the product constitutes 

acceptance of these conditions. 

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Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Pioneer/Dupont 29964-9 

DAS-59122 

(PO Cry34Ab1/Cry35Ab1) x MON810 

(Cry1Ab) 

24-Feb-10 31-Oct-15 

1. The subject registration will automatically expire on midnight October 31, 2015. 

2. The subject registration will be limited to Bacillus thuringiensis Cry34Ab1 protein and 

the genetic material (PHP17662) necessary for its production in corn event 59122 (OECD 

Unique Identifier DAS-59122-7) x Bacillus thuringiensis Cry35Ab1 protein and the 

genetic material (PHP17662) necessary for its production in corn event 59122 (OECD 

Unique Identifier DAS-59122-7) x Bacillus thuringiensis Cry1Ab protein and the genetic 

material (PV-ZMBK07) necessary for it production in corn event MON 810 (OECD 

Unique Identifier MON-ØØ81Ø-6) for use in field corn. 

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

the Agency requires all registrants of similar products to submit such data. 

4. The data submitted by Pioneer are sufficient to support registration for the combination 

PIP corn product: 59122xMON810, provided that the registrant submits/cites any data 

required to support the PIP registrations of the individual parental events: 59122 (DAS59122-7) and MON810 (MON-ØØ81Ø-6) in corn, within the time frames required by 

the terms and conditions of EPA Registration Numbers 29964-4 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. The insect resistance management terms and conditions for 59122xMON810 corn are as 

follows: 

The required IRM program for 59122xMON810 corn must have the following elements: 

• Requirements relating to creation of a refuge for the Cry1Ab and Cry34/35Ab1 

components that meets the requirements of the individual traits. The refuge for both 

traits may be combined by planting non-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 

lepidopteran-resistant Bt corn may be planted in the corn rootworm refuge for the 

Cry34/35Ab1 component; 

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• Requirements for the registrants to prepare and require Bt corn users to sign grower 

agreements which impose binding contractual obligations on the grower to comply 

with the refuge requirements; 

• Requirements for the registrants to develop, implement, and report to EPA on 

programs to educate growers about IRM requirements; 

• Requirements for the registrants to develop, implement, and report to EPA on 

programs to evaluate and promote growers compliance with IRM requirements (the 

59122xMON810 Compliance Assurance Program (CAP) must integrate with the 

CAPS for the individually registered and combination products expressing 

Cry34/35Ab1 and Cry1Ab); 

• Requirements for the registrants 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 Cry34/35Ab1 and Cry1Ab proteins 

in the target insects; 

• Requirements for the registrants to develop, and if triggered, to implement a remedial 

action plan that would contain measures the registrants would take in the event that 

any insect resistance was detected as well as to report on activity under the plan to 

EPA; 

• 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 

compliance assurance program, including the education program, on or before 

January 31st each year, and for resistance monitoring, on or before January 31st each 

year for Cry1Ab beginning in 2011, and on or before August 31st each year for 

Cry34/35Ab1, beginning in 2010. 

I. Refuge Requirements 

The use of 59122xMON810 corn (Cry34/35Ab1 x Cry1Ab) corn requires accompanying corn 

refuge for both the Cry34/35Ab1 and Cry1Ab components that meets the requirements of the 

individual traits, described below. The refuge for both traits may be combined by planting nonBt corn as the refuge (see C. below), or the refuges for the lepidopteran resistant traits and the 

corn rootworm-resistant traits may be planted separately (see A. and B. below). 

For the separate refuges, corn rootworm-resistant Bt corn (e.g., Herculex RW) may be planted in 

the lepidopteran refuge for the Cry1Ab component and lepidopteran-resistant Bt corn (e.g., 

YieldGard) 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. 

Possible options include: 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 corn can serve as an in-field lepidopteran refuge for one field planted to 

Cry34/35Ab1 x Cry1Ab and an external lepidopteran refuge for separate fields planted to 

Cry34/35Ab1x Cry1Ab, while the rootworm refuge is planted as YieldGard in an external 

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adjacent field. In all options, size and management of each individual refuge must be followed 

as described in A. and B. below. 

Other refuge designs and combinations are permissible as long as in all cases the size and 

management of each refuge are described in A., B., and C., below. 

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. 

A. Lepidopteran refuge for the Cry1Ab component. 

1. Refuge size, Corn-Growing Areas (i.e., corn belt and other non corn/cotton-growing 

regions). The use of 59122xMON810 corn requires an accompanying 20% refuge 

consisting of non-Bt corn or non-lepidopteran resistant Bt corn. 

2. Refuge size, Corn/Cotton-Growing areas *. The use of 59122xMON810 corn requires an 

accompanying 50% refuge consisting of non-Bt corn or non-lepidopteran resistant Bt

corn. 

3. Refuge location. 

i. The lepidopteran refuge can be planted in a separate field not more than 1⁄2 mile of the 

59122xMON810 field. 

ii. The lepidopteran refuge can be planted within the 59122xMON810 field as blocks 

(e.g. along the edges or headlands). 

iii. The lepidopteran refuge can be planted within the 59122xMON810 field as strips 

across the field at least four rows wide (six preferred). 

4. Refuge management. Insecticide treatments for control of European corn borer, corn 

earworm, southwestern corn borer, fall armyworm, black cutworm, western bean 

cutworm, lesser corn stalk borer, sugarcane borer and southern corn stalk borer 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). Microbial Bt

insecticides must not be applied to lepidopteran resistant refuges. 

* Cotton growing areas 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, 

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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 Dunkin, New Madrid, Pemiscot, Scott, Stoddard). 

B. Corn rootworm refuge for the Cry34/35Ab1 component. 

1. Refuge size. The use of 59122xMON810 corn requires an accompanying 20% refuge 

consisting of non-Bt corn or non-corn rootworm-resistant Bt corn. 

2. Refuge location. The rootworm refuge is required to be planted within or adjacent (e.g. 

across the road) to the 59122xMON810 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. 

i. The in-field rootworm refuge options may be planted as a single block or as a 

series of strips measuring at least four (4) crop rows wide. 

ii. Seed mixtures of 59122xMON810 and rootworm refuge corn are not permitted. 

iii. If the rootworm refuge is planted on rotated ground, then 59122xMON810 corn 

must also be planted on rotated ground. 

iv. If the rootworm refuge is planted in continuous corn, the 59122xMON810 field 

may be planted on either continuous or rotated land (option encouraged where 

WCRW rotation-resistant biotype may be present). 

v. Application of soil insecticide is permitted in the rootworm refuge. 

vi. Seed treatment is permitted in the rootworm refuge, either at a rate for rootworm 

protection or at a rate for controlling secondary soil pests. 

vii. If aerial insecticides are applied to the rootworm refuge for control of CRW 

adults, the same treatment must also be applied in the same time-frame to 

59122xMON810 corn. 

viii. Pests other than adult corn rootworms can be treated on the rootworm refuge 

acres without treating the 59122xMON810 acres only if treatment occurs when 

adult corn rootworms are not present or if a pesticide without activity against 

adult corn rootworms is used. Pests on the 59122xMON810 acres can be treated 

as needed without having to treat the rootworm refuge. 

ix. The rootworm refuge can be planted to any corn hybrid that does not express PIPs 

for rootworm control (e.g. lepidopteran-protected Bt corn, herbicide-tolerant corn, 

or conventional corn). 

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x. The rootworm refuge and 59122xMON810 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. 

xi. 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. 

C. Combined Refuge. 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, as follows 

1. Refuge size shall be 20% in corn-growing areas and 50% in cotton-growing areas (see list 

labeled with “*” under A). 

2. Refuge location. The combined refuge is required to be planted within or adjacent (e.g. 

across the road) to the 59122xMON810 corn field. 

3. Refuge management options

i. The in-field refuge options must be planted as a single block or as a series of 

strips measuring at least four (4) rows wide (six rows preferred). 

ii. Seed mixtures of 59122xMON810 and refuge corn are not permitted. 

iii. If the combined refuge is planted on rotated ground, then the 59122xMON810 

corn must also be planted on rotated ground. 

iv. If the combined refuge is planted on continuous corn, the 59122xMON810 field 

may be planted on either continuous or rotated land (option encouraged where 

WCRW rotation-resistant biotype may be present). 

v. Application of soil insecticide for corn rootworm control is permitted in the 

combined refuge. 

vi. Seed treatment is permitted in the combined refuge, either at a rate for rootworm 

protection or at a rate for controlling secondary soil pests. 

vii. If aerial insecticides are applied to the combined refuge for control of CRW 

adults, the same treatment must also be applied in the same timeframe to 

59122xMON810 corn. 

viii. Insecticide treatments in the combined refuge for control of European corn borer, 

corn earworm, southwestern corn borer, fall armyworm, black cutworm, western 

bean cutworm, lesser corn stalk borer, or southern corn stalk borer may be applied 

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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). These 

pests may be treated with CRW-labeled insecticide on the combined refuge acres 

without treating the 59122xMON810 acres only if treatment occurs when adult 

corn rootworms are not present. Microbial Bt insecticides must not be applied to 

the common refuges. 

ix. Pests other than adult corn rootworms may be treated with CRW-labeled 

insecticide on the combined refuge acres without treating the 59122xMON810 

acres only if treatment occurs when adult corn rootworms are not present. Pests 

on the 59122xMON810 acres may be treated as needed without having to treat the 

refuge. 

x. The combined refuge can be planted to any corn hybrid that does not express PIPs 

for lepidopteran or rootworm control (i.e. herbicide tolerant corn or conventional 

corn). 

xi. The combined refuge and 59122xMON810 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. 

xii. The description of the refuge requirements in the grower guide must be consistent 

with the preceding requirements. 

II. Grower Agreement 

A. Persons purchasing 59122xMON810 corn must sign a grower agreement. The term 

“grower agreement” refers to any grower purchase contract, license agreement, or similar 

legal document. 

B. 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. 

C. Pioneer must implement a system equivalent to what is already approved for previously 

registered Bt corn products containing the previously registered events 59122 and 

MON810, which is reasonably likely to assure that persons purchasing 59122xMON810 

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. 

D. Pioneer must use an approved grower agreement and must submit to EPA, within 90 days 

from the date of registration, a copy of that agreement and any specific stewardship 

documents referenced in the grower agreement. If 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 

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enforceability of the provisions of the agreement relating to the IRM program, thirty 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 registration. 

E. Pioneer must implement an approved system equivalent to what is already approved for 

previously registered Bt corn products containing the previously registered events 59122 

and MON810, which is reasonably likely to assure that persons purchasing 

59122xMON810 corn sign grower agreement(s). A description of the system must be 

submitted to EPA within 90 days from the date of registration.

F. Pioneer shall maintain records of all 59122xMON810 corn grower agreements for a 

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

G. Beginning on January 31, 2011, and annually thereafter, Pioneer shall provide EPA with 

a report on the number of units of 59122xMON810 corn seed 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 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. 

H. 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. 

III. IRM Education and IRM Compliance Monitoring Program 

1. Pioneer must maintain a comprehensive, ongoing IRM education program designed to 

convey to 59122xMON810 corn users the importance of complying with the IRM 

program for all Bt corn products containing the Cry1Ab and Cry34/45Ab1events. The 

program shall include information encouraging 59122xMON810 corn users to pursue 

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

59122xMON810 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 their records. The program shall involve at least one written communication 

annually to each 59122xMON810 corn user separate from the grower technical guide. 

The communication shall inform the user of the current IRM requirements. 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. 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 and from other sources. The registrant shall identify deficiencies in grower 

compliance and revise the education program to address those deficiencies. 

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3. 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, Agricultural Biotechnology Stewardship Technical Committee (ABSTC). 

4. Pioneer must maintain an ongoing IRM compliance assurance program (CAP) equivalent 

to what is already approved for previously registered Pioneer Bt corn products, designed 

to evaluate the extent to which growers purchasing 159122xMON810 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 59122xMON810 corn. Pioneer shall coordinate with other Bt corn registrants 

in designing and implementing its compliance assurance program and integrate this 

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

PIPs. Pioneer must prepare and submit within 90 days of the date of registration a 

written description of the compliance assurance program. Other required features of the 

program are described in paragraphs E. through O. below. 

5. Pioneer must maintain and publicize a “phased compliance approach” guidance 

document that indicates how they 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. It must be equivalent to what is already 

approved for previously registered Pioneer Bt corn products. 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 noncompliance. The options shall include withdrawal of the right to purchase 

59122xMON810 corn for an individual grower or for all growers in a specific region. An 

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

be denied sales of 59122xMON810 corn 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 59122xMON810 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 

59122xMON810 corn who plant the vast majority of all corn in the United States and in 

areas in which the selection intensity is the greatest. The survey shall consider only those 

growers who plant 200 or more acres of corn in the Corn-Belt or who plant 100 or more 

acres of corn in corn-cotton growing 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. 

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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 by January 31st of each year, beginning with 2011. 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 F. through H.) and from other sources. The registrant shall 

identify deficiencies in grower compliance and revise the education program to address 

those deficiencies. Pioneer must confer with the Agency 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 growers of 59122xMON810 corn 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 

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, 

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

13. If a grower, who purchases 59122xMON810 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 grower is in compliance with the IRM program for the current 

year. 

14. Beginning January 31, 2011, and annually thereafter, Pioneer shall provide a report to 

EPA summarizing the activities carried out under their compliance assurance program for 

the prior year and the plans for the compliance assurance program during the current 

year. The report will include information regarding grower interactions (including, but 

not limited to, on-farm visits, verified tips and complaints, education programs, grower 

meetings and letters), the extent of non-compliance, corrective measures to address the 

non-compliance, and any follow-up actions taken. Pioneer may elect to coordinate 

information with other registrants and report collectively the results of compliance 

assurance programs. 

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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 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. This requirement 

may be phased in over the next three growing seasons, with 50% implementation in 2012 

and full implementation for 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 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. 

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 secondyear 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. 

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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 

Bt corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt corn 

product. 

IV. Insect Resistance Monitoring and Remedial Action Plans 

A. Lepidopteran Resistance Monitoring. The Agency is imposing the following conditions 

for the Cry1Ab toxin expressed in 59122xMON810 corn: 

Pioneer will monitor for resistance to Cry1Ab toxin expressed in 59122xMON810 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 

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 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 59122xMON810 corn and/or changes in resistance-allele frequency in response to the 

use of 59122xMON810 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 

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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 

59122xMON810 corn. The Agency shall be consulted prior to the implementation of 

such modifications. 

The registrant must work to develop a diagnostic assay for corn rootworm resistance 

monitoring to detect potentially resistant individuals. As part of this effort, the registrant 

must investigate the feasibility of using the Sublethal Seedling AssayVIII as a diagnostic 

assay. A report on this requirement must be submitted to the Agency 6 months from the 

date of the amended registration. 

 

The registrant 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 Cry3Bb1. A report on this requirement must be 

submitted to the Agency 6 months from the date of the amended registration. 

Pioneer 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 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 the Agency annually 

before August 31st, beginning in 2010. The investigative steps will include: 

i. 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. 

ii. 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 59122xMON810 corn under field conditions. If 

progeny do not survive to adulthood, any suspected resistance is not field-relevant 

and no further action is required. 

 VIII Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and 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) 

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iii. 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, Pioneer 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

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. 

3. Suspected resistance

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

insect feeding damage for which: 

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

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

iii. the relevant plant tissues are expressing the expected level of Bt protein; and 

iv. 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. 

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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 

59122xMON810 corn in commercial production fields before responsive 

measures are undertaken. 

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

i. Use alternative control measures in 59122xMON810 corn fields in the 

affected region to control the target pest during the immediate growing 

season. 

ii. Destroy 59122xMON810 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, 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. 

4. 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: 

i. 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). 

ii. 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 

iii. 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. 

5. Response to Confirmed Resistance in a Key Target Pest as the Cause of 

Unexpected Levels of Damage in the Field 

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

be taken by Pioneer: 

i. EPA will receive notification within 30 days of resistance confirmation; 

ii. Affected customers and extension agents will be notified about confirmed 

resistance within 30 days; 

iii. 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; 

iv. 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 overwintering insects, and/or applications of chemical insecticides; 

v. Unless otherwise agreed with EPA, Pioneer will 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; 

vi. 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; 

vii. Pioneer 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 

viii. In subsequent growing seasons, Pioneer 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 EPAapproved local resistance management plan is in place to mitigate the 

resistance. 

B. Corn Rootworm Monitoring. The Agency is imposing the following conditions for the 

Cry34Ab1/Cry35Ab1 toxin expressed in 59122xMON810 corn: 

Pioneer must monitor for Cry34/35Ab1 resistance and/or trends in increased tolerance for corn 

rootworm using the existing corn rootworm monitoring program developed for previously 

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registered Pioneer Bt corn products. Sampling should be focused in those areas in which there is 

the highest risk of resistance development. In addition to mortality assays, consider utilizing 

sublethal bioassays (e.g., head capsule measurements) and molecular marker methods for corn 

rootworm monitoring. 

1. Pioneer must follow-up on grower, extension specialist or consultant reports of 

unexpected damage or control failures for corn rootworm. 

2. Pioneer must provide EPA with an annual resistance monitoring report by August 31st

each year, beginning in 2010, reporting on populations collected the previous year. 

3. The following program summary describes, in order of events, the steps that must be 

taken to implement a remedial action plan if resistance to corn rootworm is confirmed 

(this general process has been implemented for other lepidopteran and corn rootworm Bt

corn products). 

i. Definition of Suspected Resistance. Resistance will be suspected if 

investigations of unexpected damage reports show that: 

• implicated maize plant roots were expressing the Cry34/35Ab1 protein at 

the expected level; 

• 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; 

• 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. 

ii. 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”: 

 

• the proportion of larvae that can feed and survive on Cry34/35Ab1 roots 

from neonate to adult is significantly higher than the baseline proportion 

(currently being established); 

• he 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 

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monitoring program; 

• the ability to survive is heritable; 

• Cry34/35Ab1 plant assays determine that damage caused by surviving 

insects would exceed economic thresholds; and 

• 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. 

iii. Response to Confirmed Resistance. When resistance is “confirmed,” the 

following steps will be taken: 

• EPA will receive notification within 30 days of resistance confirmation; 

• affected customers and extension agents will be notified about confirmed 

resistance; 

• affected customers and extension agents will be encouraged to employ 

alternative corn rootworm control measures; 

• sale and distribution of Cry34/35Ab1 corn in the affected area will cease 

immediately; and 

• 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 approved by EPA and all 

appropriate stakeholders. 

V. Annual Reporting Requirements 

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 59122xMON810 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 

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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. 

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 the product constitutes 

acceptance of these conditions. 

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IV. mCry3A BRAD Registered Products 

Date 

Registrant Registration # Active Ingredients Registered Date Expired

Syngenta 67979-5 Bt Corn Event MIR 604 with 

modified Cry3A (Agrisure RW) 3-Oct-06 30-Sep-15 

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

2] The subject registration will be limited to mCry3A corn, modified Cry3A protein and the 

genetic material necessary for its production (via elements of pZM26) in Event MIR604 

corn SYN-IR604-8. 

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. Should the registration 

expiration date be extended, a final report is due January 31, 2011. 

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] In light of recently published laboratory studies showing reduced growth in shredding caddis 

flies exposed to anti-lepidopteran Cry1A protein corn litter (Rosi-Marshall, et al. 2007), 

additional aquatic invertebrate data are required. A 7 to 14 day Daphnia magna study as 

per the 885 series OPPTS Guidelines or a dietary study of the effects on an aquatic 

invertebrate, representing the functional group of a leaf shredder in headwater streams 

must be submitted by January 31, 2012. 

7] 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

193
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] 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 rootworm are present unless the 

mCry3A field is treated in a similar manner. 

3] Refuge planting options include: refuge acres should be planted as blocks adjacent to 

mCry3A MIR604 corn fields, perimeter strips, or as in-field strips. 

4] External refuges must be planted adjacent (e.g., across the road) to mCry3A MIR604 

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 mCry3A field is treated in a 

similar manner. 

7] If the refuge is planted in a field that is in a crop rotation system, then MIR604 must also 

be planted in a field that is in a crop rotation system. 

8] If the refuge is planted on continuous corn, then the MIR604 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] The registrant must continue to implement a system (equivalent to what is already 

approved for Bt11 field corn, EPA Reg. No. 67979-1) 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. 

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4] 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 days prior to implementing a proposed change, the 

registrant must submit to EPA the text of such changes to ensure that it is consistent with 

the terms and conditions of the amendment. 

5] The registrant must continue to implement a system (equivalent to what is already 

approved for Bt11, EPA Reg. No. 67979-1) 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 31st of the year in which the agreement was signed. 

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

Bt 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 the registrant 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. 

9] 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] Syngenta must maintain and implement a comprehensive, ongoing IRM education 

program designed to convey to Bt MIR604 corn users the importance of complying with 

the IRM program. The program shall include information encouraging Bt MIR604 corn 

users to pursue optional elements of the IRM program relating to refuge configuration 

and proximity to Bt MIR604 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 MIR604 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 other organizations, such as the National Corn Growers Association and 

state extension programs. 

2] Annually, the registrant shall revise, and expand as necessary, its education program to 

take into account the information collected through the compliance survey required under 

195
paragraph 6] and from other sources. The changes shall address aspects of grower 

compliance that are not sufficiently high. 

 

3] Annually, the registrant 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] The registrant must continue to implement an ongoing IRM compliance assurance 

program designed to evaluate the extent to which growers purchasing its MIR604 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 MIR604 Bt corn product. The registrant shall 

coordinate with other Bt corn registrants in designing and implementing its compliance 

assurance program and integrate the mCry3A CAP with the CAP already approved for 

Bt11, EPA Registration Number 67979-1. Other required features of the program are 

described in paragraphs 5 - 22 below. 

5] The registrant must continue to implement and publicize a "phased compliance approach," 

i.e., a guidance document that indicates how the registrant will address instances of noncompliance with the terms of the IRM program and general criteria for choosing among 

options for responding to any non-compliant growers. The options shall include 

withdrawal of the right to purchase MIR604 Bt corn for an individual grower or for all 

growers in a specific region. An individual grower found to be significantly out of 

compliance two years in a row would be denied sales of the product the next year. 

Similarly, seed dealers who are not fulfilling their obligations to inform/educate growers 

of their IRM obligations will lose their opportunity to sell MIR604 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. 

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. 

196
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 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, the registrant shall revise, and expand as necessary, its compliance assurance 

program to take into account the information collected through the compliance survey 

required under paragraphs 6 through 8 and from other sources. The changes shall address 

aspects of grower compliance that are not sufficiently high. The registrant must confer 

with the Agency prior to adopting any changes to a previously approved CAP. 

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 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 MIR604 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] Annually, Syngenta shall provide a report to EPA summarizing the activities carried out 

under their compliance assurance program for the prior year and the plans for the 

compliance assurance program during the current year. The report will include 

information regarding grower interactions (including, but not limited to, on-farm visits, 

verified tips and complaints, grower meetings and letters), the extent of non-compliance, 

corrective measures to address the non-compliance, and any follow-up actions taken. 

 

15] The registrant and the seed corn dealers for the registrant must allow a review of the 

compliance records by EPA or by a State pesticide regulatory agency if the State agency 

can demonstrate that confidential business information, including the names, personal 

information, and grower license number of the growers will be protected. 

197
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. This requirement 

may be phased in over the next three growing seasons, with 50% implementation in 2012 

and full implementation for 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 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. 

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 secondyear 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 

198
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 

Bt corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt corn 

product. 

d. Insect Resistance Monitoring and Remedial Action Plan 

The Agency is imposing the following conditions for the mCry3A toxin expressed in this 

product: 

The registrant 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. 

1] 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. 

2] The registrant must work to develop a diagnostic assay for corn rootworm resistance 

monitoring to detect potentially resistant individuals. As part of this effort, the registrant 

must investigate the feasibility of using the Sublethal Seedling AssayIX as a diagnostic 

assay. A report on this requirement must be submitted to the Agency within six (6) 

months from the date of the amended registration. 

 

3] The registrant 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 (insert toxin). A report on this requirement must be 

submitted to the Agency within six (6) months from the date of the amended registration. 

4] The registrant must follow-up on grower, extension specialist or consultant reports of 

unexpected damage or control failures for corn rootworm. 

5] The registrant must provide EPA with an annual resistance monitoring report by August 

31st of each year, reporting on populations collected the previous year. 

 IX Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and 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) 

199
 

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. 

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. 

2. 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; 

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. 

3. 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; 

200
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. 

201
Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Syngenta 67979-8 

Bt Corn Event MIR 604 + 

Bt11 with modified Cry3A + 

Cry1Ab (Agrisure CB/RW) 

24-Jan-07 30-Sep-15 

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

2] The subject registration will be limited to mCry3A corn, modified Cry3A protein and the 

genetic material necessary for its production (via elements of pZM26) in Event MIR604 

corn SYN-IR604-8. 

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. Should the registration 

expiration date be extended, 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 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 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] Grower agreements (also known as stewardship agreements) will specify that growers 

202
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 rootworm are present unless the 

mCry3A field is treated in a similar manner. 

3] Refuge planting options include: refuge acres should be planted as blocks adjacent to 

mCry3A MIR604 corn fields, perimeter strips, or as in-field strips. 

4] External refuges must be planted adjacent (e.g., across the road) to mCry3A MIR604 

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 mCry3A field is treated in a 

similar manner. 

7] If the refuge is planted in a field that is in a crop rotation system, then MIR604 must also 

be planted in a field that is in a crop rotation system. 

8] If the refuge is planted on continuous corn, then the MIR604 field may be planted on 

either continuous or in a field that is in a crop rotation system. 

9] 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. 

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 continue to implement a system (equivalent to what is already 

approved for Bt11 field corn, EPA Reg. No. 67979-1) 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. 

203
4] 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 days prior to implementing a proposed change, the 

registrant must submit to EPA the text of such changes to ensure that it is consistent with 

the terms and conditions of the amendment. 

5] The registrant must continue to implement a system (equivalent to what is already 

approved for Bt11, EPA Reg. No. 67979-1) 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 31st of the year in which the agreement was signed. 

7] Annually, the registrant shall provide EPA with a report showing the number of units of its 

Bt 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, the registrant 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. 

9] 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] Syngenta must maintain and implement a comprehensive, ongoing IRM education 

program designed to convey to Bt MIR604 corn users the importance of complying with 

the IRM program. The program shall include information encouraging Bt MIR604 corn 

users to pursue optional elements of the IRM program relating to refuge configuration 

and proximity to Bt MIR604 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 MIR604 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 other organizations, such as the National Corn Growers Association and 

state extension programs. 

2] Annually, the registrant shall revise, and expand as necessary, its education program to 

204
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, the registrant 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] The registrant must continue to implement an ongoing IRM compliance assurance 

program designed to evaluate the extent to which growers purchasing its MIR604 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 MIR604 Bt corn product. The registrant shall 

coordinate with other Bt corn registrants in designing and implementing its compliance 

assurance program and integrate the mCry3A CAP with the CAP already approved for 

Bt11, EPA Registration Number 67979-1. Other required features of the program are 

described in paragraphs 5 - 22 below. 

5] The registrant must continue to implement and publicize a "phased compliance approach," 

i.e., a guidance document that indicates how the registrant will address instances of noncompliance with the terms of the IRM program and general criteria for choosing among 

options for responding to any non-compliant growers. The options shall include 

withdrawal of the right to purchase MIR604 Bt corn for an individual grower or for all 

growers in a specific region. An individual grower found to be significantly out of 

compliance two years in a row would be denied sales of the product the next year. 

Similarly, seed dealers who are not fulfilling their obligations to inform/educate growers 

of their IRM obligations will lose their opportunity to sell MIR604 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. 

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 

205
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 final written summary of the results of the prior year's 

survey (together with a description of the regions, the methodology used, and the 

supporting data) to EPA by January 31 of each year. The registrant shall confer with 

other Bt corn 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 through 8 and from other sources. The changes shall address 

aspects of grower compliance that are not sufficiently high. The registrant must confer 

with the Agency prior to adopting any changes to a previously approved CAP. 

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 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 MIR604 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] Annually, Syngenta shall provide a report to EPA summarizing the activities carried out 

under their compliance assurance program for the prior year and the plans for the 

compliance assurance program during the current year. The report will include 

information regarding grower interactions (including, but not limited to, on-farm visits, 

verified tips and complaints, grower meetings and letters), the extent of non-compliance, 

corrective measures to address the non-compliance, and any follow-up actions taken. 

 

15] The registrant and the seed corn dealers for the registrant must allow a review of the 

compliance records by EPA or by a State pesticide regulatory agency if the State agency 

can demonstrate that confidential business information, including the names, personal 

information, and grower license number of the growers will be protected. 

206
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. This requirement 

may be phased in over the next three growing seasons, with 50% implementation in 2012 

and full implementation for 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 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. 

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 secondyear 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 

207
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 

Bt corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt corn 

product. 

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: 

The registrant 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. 

1] 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. 

2] The registrant must work to develop a diagnostic assay for corn rootworm resistance 

monitoring to detect potentially resistant individuals. As part of this effort, the registrant 

must investigate the feasibility of using the Sublethal Seedling AssayX as a diagnostic 

assay. A report on this requirement must be submitted to the Agency within six (6) 

months from the date of the amended registration. 

 

3] The registrant 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 

submitted to the Agency within six (6) months from the date of the amended registration. 

4] The registrant must follow-up on grower, extension specialist or consultant reports of 

unexpected damage or control failures for corn rootworm. 

5] The registrant must provide EPA with an annual resistance monitoring report by August 

 X Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and 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) 

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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: 

d. implicated maize plant roots were expressing the mCry3A protein at the expected level; 

a. 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; 

b. the level of damage exceeds guidelines for expected damage. 

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. 

2. 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; 

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. 

3. 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; 

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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: 

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. 

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 

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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: 

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

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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, 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. 

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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 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. 

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 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; 

 

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 

Date 

Registered

Date 

Registrant Registration # Active Ingredients Expired

Monsanto 524-575 Bt corn Event MON 89034 

with Cry1A.105 + CryAb2 10-Jun-08 30-Sep-22 

1) The subject registration will automatically expire on midnight September 30, 2022. 

2) The subject registration will be limited to MON 89034 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 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 Insect Resistance Management Resistance Monitoring data in the 

time frames listed: 

6) The Insect Resistance Management (IRM) terms and conditions for this product are as 

follows. 

The required IRM program for MON 89034 must have 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 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 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 Cry1A.105 and 

Cry2Ab2 proteins in the target insects; 

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• 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; 

• 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, beginning in 2010. 

 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. 

 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 

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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. 

• 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 Dunkin, 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. 

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 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 

grower agreement, a grower must be contractually bound to comply with the 

requirements of the IRM program. 

3) Monsanto must integrate this registration into the current system used for their other Bt 

corn PIPS, which is reasonably likely to assure that persons purchasing MON 89034 will 

affirm annually that they are contractually bound to comply with the requirements of the 

IRM program. 

4) Monsanto must continue to use their current grower agreement. If Monsanto wishes to 

change any part of the grower agreement or any specific stewardship documents 

referenced in the grower agreement that would affect either the content of the IRM 

program or the legal enforceability of the provisions of the agreement relating to the IRM 

program, thirty days prior to implementing a proposed change, 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 integrate this registration into a current system, which is reasonably 

likely to assure that persons purchasing MON 89034 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) Beginning on January 31, 2010, and annually thereafter, 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. Note: The first report shall contain the specified 

information from the time frame starting with the date of registration and ending July 31, 

2009. 

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 design and implement a comprehensive, ongoing IRM education program 

designed to convey to MON 89034 users the importance of complying with the IRM 

program. The program shall include information encouraging MON 89034 users to 

218
pursue optional elements of the IRM program relating to refuge configuration and 

proximity to MON 89034 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 user separate from the grower technical guide. The 

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

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

organizations, such as the National Corn 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) On January 31, 2010, Monsanto must provide a report to EPA summarizing the activities 

carried out under the education program for the prior year. Annually thereafter, 

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 design and implement an ongoing IRM compliance assurance program 

designed to evaluate the extent to which growers purchasing MON 89034 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 MON 89034. Monsanto shall coordinate with other Bt corn registrants in 

designing and implementing its compliance assurance program and integrate this 

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

PIPS. Other required features of the program are described in paragraphs 5 – 15 below. 

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

document that indicates how they 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. 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 noncompliance. The options shall include withdrawal of the right to purchase Monsanto corn 

PIP products for an individual grower or for all growers in a specific region. An 

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

be denied sales of Monsanto corn PIP 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 Monsanto corn PIP products. 

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 

219
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 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 by 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 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 by 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. 

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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, 

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) Beginning January 31, 2010, and annually thereafter, Monsanto shall provide a report to 

EPA summarizing the activities carried out under their compliance assurance program for 

the prior year and the plans for the compliance assurance program during the current 

year. The report will include information regarding grower interactions (including, but 

not limited to, on-farm visits, verified tips and complaints, grower meetings and letters), 

the extent of non-compliance, corrective measures to address the non-compliance, and 

any follow-up actions taken. 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) 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. This requirement 

may be phased in over the next three growing seasons, with 50% implementation in 2012 

and full implementation for the 2013 growing season. 

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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 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. 

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 secondyear 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 

Bt corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt corn 

product. 

e) Insect Resistance Monitoring and Remedial Action Plan for MON 89034 

 The Agency is imposing the following conditions for the Cry1A.105 and Cry2Ab2 toxins 

expressed in MON 89034: 

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 Monsanto will monitor for resistance to Cry1A.105 and Cry2Ab2 expressed in MON 89034. 

 

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 

 Monsanto will 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. 

 

 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 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. 

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 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. 

 The registrant 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 

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 

31st, beginning in 2010. 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. 

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

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 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. 

 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 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 

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

expeditiously as practical. 

 Confirmed resistance 

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 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; 

• 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 

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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), 

January 31st each year, beginning in 2010. 

2) Grower Agreement: 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, January 31st each year, beginning in 2010. 

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

January 31st each year, beginning in 2010. 

4) Compliance Assurance Plan: Compliance Assurance Program activities and results, 

January 31st each year, beginning in 2010. 

5) Compliance Survey Results: to include annual survey results and plans for the next year; 

full report January 31st each year, beginning in 2010. 

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

reports, August 31st each year, beginning in 2010. 

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Registrant Registration # Active Ingredients

Date 

Registered

Date 

Expired

Monsanto 524-576 

Bt corn Event MON 89034 + 

MON 88017 with Cry1A.105 + 

Cry2Ab2 + Cry 3Bb1 

10-Jun-08 30-Sep-15 

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 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 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 or cite all data required to support the individual plant-incorporated protectant in 

Event MON 863 (YieldGard Rootworm), EPA Reg. No. 524-528. In the event that the 

Agency concludes Event MON 863 (YieldGard Rootworm) studies do not sufficiently 

demonstrate a lack of significant adverse effects, additional data with MON 88017 corn 

must be submitted. This data may include a) laboratory toxicity testing with Orius 

insidiosus (minute pirate bug), b) laboratory toxicity testing with a carabid (ground 

beetle), c) long range effects testing on invertebrate populations in the field, and d) long 

range soil persistence testing. 

6) Submit the following Insect Resistance Management Resistance Monitoring data in the 

time frames listed: 

7) The Insect Resistance Management (IRM) terms and conditions for this product are as 

follows. 

The required IRM program for MON 89034 x MON 88017 must have 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 x 

MON 88017 field corn; 

• Requirements for Monsanto to prepare and require MON 89034 x MON 88017 users 

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

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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 

Cry1A.105, Cry2Ab2, and Cry3Bb1 proteins in the target insects; 

• 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; 

• 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, beginning in 2010. 

a) Refuge Requirements for MON 89034 x MON 88017 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 are provided by the registrant to 

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

 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 

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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 

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. 

 

 Growers who fail to comply with the IRM requirements risk losing access to Monsanto corn 

PIP Products. 

 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 Dunkin, New Madrid, Pemiscot, Scott, and 

Stoddard). 

 Two options for the deployment of the refuge are available to growers. 

230
 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 

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. 

 Growers who fail to comply with the IRM requirements risk losing access to Monsanto corn 

PIP products. 

 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. 

231
• 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 integrate this registration into the current system used for their other Bt 

corn PIPS, which is reasonably likely to assure that persons purchasing MON 89034 x 

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 their current grower agreement. If Monsanto wishes to 

change any part of the grower agreement or any specific stewardship documents 

referenced in the grower agreement that would affect either the content of the IRM 

program or the legal enforceability of the provisions of the agreement relating to the IRM 

program, thirty days prior to implementing a proposed change, 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 integrate this registration into a current system, which is reasonably 

likely to assure that persons purchasing MON 89034 x MON 88017 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. 

 

 7) Beginning on January 31, 2010, and annually thereafter, 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. Note: The first report shall 

contain the specified information from the time frame starting with the date of 

registration and ending July 31, 2009. 

 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 

232
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 design and implement a comprehensive, ongoing IRM education 

program designed to convey to MON 89034 x MON 88017 users the importance of 

complying with the IRM program. The program shall include information encouraging 

MON 89034 x MON 88017 users to pursue optional elements of the IRM program 

relating to refuge configuration and proximity to MON 89034 x 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 89034 

x 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 other 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) On January 31, 2010, Monsanto must provide a report to EPA summarizing the activities 

carried out under the education program for the prior year. Annually thereafter, 

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 design and implement an ongoing IRM compliance assurance program 

designed to evaluate the extent to which growers purchasing MON 89034 x 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 MON 89034 x MON 88017. Monsanto shall coordinate 

with other Bt corn registrants in designing and implementing its compliance assurance 

program and integrate this registration into the current compliance assurance program 

used for their other Bt corn PIPS. Other required features of the program are described in 

paragraphs 5 – 15 below. 

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

document that indicates how they 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. While recognizing that for reasons of 

difference in business practices there are needs for flexibility between different 

233
companies, Monsanto must use a consistent set of standards for responding to noncompliance. The options shall include withdrawal of the right to purchase Monsanto 

corn PIP products for an individual grower or for all growers in a specific region. An 

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

be denied sales of Monsanto corn PIP 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 Monsanto corn PIP products. 

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. 

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 by 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. 

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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 by 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) Beginning January 31, 2010, and annually thereafter, Monsanto shall provide a report 

to EPA summarizing the activities carried out under their compliance assurance 

program for the prior year and the plans for the compliance assurance program during 

the current year. The report will include information regarding grower interactions 

(including, but not limited to, on-farm visits, verified tips and complaints, grower 

meetings and letters), the extent of non- compliance, Corrective measures to address the 

non-compliance, and any follow-up actions taken. 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. 

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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. This requirement 

may be phased in over the next three growing seasons, with 50% implementation in 

2012 and full implementation for 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 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. 

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 secondyear 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 

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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 Bt corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt corn 

product. 

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: 

 Monsanto will monitor for resistance to Cry1A.105 and Cry2Ab2 expressed in MON 89034 

x MON 88017. The monitoring program shall consist of two approaches: 

(1) focused population sampling and laboratory testing and (2) investigation of reports of lessthan 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 will 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. 

 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 89034 x MON 88017 

and/or changes in resistance-allele frequency in response to the use of MON 89034 x MON 

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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. 

 The registrant 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, beginning in 2010. 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 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; 

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• 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 

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. 

 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 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: 

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• 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 

 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 

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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: 

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) Monsanto must develop and validate an appropriate discriminating or diagnostic dose 

assay by January 31, 2010. 

iii) Monsanto must finalize rootworm damage guidelines and submit these to EPA by 

January 31, 2010. 

iv) Monsanto must follow-up on grower, extension specialist or consultant reports of 

unexpected damage or control failures for corn rootworm. 

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v) Monsanto must provide EPA with an annual resistance monitoring report by August 31st

each year, beginning with 2010, reporting on populations collected the previous year. 

vi) The current remedial action plan approved for MON 863 must be used for corn rootworm 

suspected and confirmed resistance in MON 89034 x MON 88017. If corn rootworm 

resistance is confirmed, all acres of MON 89034 x MON 88017 and refuges must be 

treated with insecticides targeted at corn rootworm adults as well as larvae. 

f) Annual Reporting Requirements for Mon 89034 x MON 88017 

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

January 31st each year, beginning in 2010; 

2) Grower Agreement: 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, January 31st each year, beginning in 2010; 

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

January 31st each year, beginning in 2010; 

4) Compliance Assurance Plan: Compliance Assurance Program activities and results, 

January 31st each year, beginning in 2010; 

5) Compliance Survey Results: to include annual survey results and plans for the next year; 

full report January 31st each year, beginning in 2010; 

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

reports, August 31st each year, beginning in 2010. 

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VI. OAM BRAD Registered Products 

Registrant Registration # Active Ingredients

Date 

Registered

Date 

Expired

Pioneer/Dupont 29964-6 

Optimum AcreMax 1 (OAM 

1) Seed Blend of Herculex 

Xtra + Herculex I 

30-Apr-10 30-Sep-12 

1] The subject registration will automatically expire on midnight September 30, 2012. 

2] The subject registration will be limited to a seed mix of TC1507 (Cry1F) xDAS-59122-7 

(Cry34Ab1/Cry35Ab1) corn seed blended with not less than 10% TC1507 (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] In light of recently published laboratory studies showing reduced growth in shredding caddis 

flies exposed to anti-lepidopteran Cry1A protein corn litter (Rosi-Marshall, et al. 2007), 

additional aquatic invertebrate data are required. A 7 to 14 day Daphnia magna study as per the 

885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, 

representing the functional group of a leaf shredder in headwater streams must be submitted by 

January 31, 2012. 

6] 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. 

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 

12/1/2010 for 

WCRW 

12/1/11 for 

NCRW 

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attempt to obtain benchmark susceptibility data using the 

Sublethal Seedling Assay for NCRW as well. 

Insect Resistance 

Management 

Pioneer must submit a detailed OAM1-specific resistance 

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. 

12/1/2010 

6] Pioneer must commit to 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 

244
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 

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 Dunkin, 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. 

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 

245
stewardship documents referenced in the grower agreement. 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, 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. 

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 

246
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 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. 

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.oh 

6. 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 

247
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. Include the refuge size requirement on all Bt corn seed bags or bag tags. This 

requirement may be phased in over the next three growing seasons, with 50% 

implementation in 2012 and full implementation for the 2013 growing season. 

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: 

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 

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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 Bt corn product in the subsequent year. 

iv. The registrant will identify to EPA all growers who are denied access to the Bt

corn product. 

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; 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. 

249
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: 

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 

250
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 

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: 

251
• 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; 

• Notify affected parties (e.g. growers, consultants, extension agents, seed distributors, 

university cooperators and state/federal authorities as appropriate) in the region of the 

resistance situation and approved action plan; and 

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• In subsequent growing seasons, maintain sales suspension and alternative 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 currently takes 

place 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. 

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 

253
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 

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; 

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• 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 

• 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

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• 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 7 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 14 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 30 

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 

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; 

256
• 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. 

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 

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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. 

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Registrant Registration # Active Ingredients

Date 

Registered

Date 

Expired

Pioneer/Dupont 29964-6 

Optimum AcreMax RW 

(OAM RW) Seed Blend of 

Herculex RW + Non-Bt

corn 

30-Apr-10 30-Sep-12 

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. 

5] In light of recently published laboratory studies showing reduced growth in shredding caddis 

flies exposed to anti-lepidopteran Cry1A protein corn litter (Rosi-Marshall, et al. 2007), 

additional aquatic invertebrate data are required. A 7 to 14 day Daphnia magna study as per the 

885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, 

representing the functional group of a leaf shredder in headwater streams must be submitted by 

January 31, 2012. 

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. 

259
6] 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 

attempt to obtain benchmark susceptibility data for 

NCRW as well. 

12/1/2010 for 

WCRW 

12/1/11 for 

NCRW 

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 

7] Pioneer must commit to 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 currently takes 

place 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 

260
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 

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 

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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 

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 

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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 

• 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 7 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 14 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 30 

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 

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to implementation. The resistance management plan could include such measures 

layering additional technologies in future OAMRW products. 

c) Refuge Assurance Program for OAMRW Corn 

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.