Table of Contents for: 

Plant-Incorporated Protectants (PIP’s) Terms and Conditions 

I. Cry 1Ab and Cry 1F BRAD Registered Products (pp.1-76) 

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 (POCry1Ab)

II. Cry 3Bb1 BRAD Registered Products (pp.77-112) 

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 3Bb

III. Cry 34Ab1 and Cry35Ab1 BRAD Registered Products (pp.113-193) 

a. Reg. # 68467-5 Bt Corn Event DAS-591227-7 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 1507 (PO Cry1F) x DAS-591227-7 (Cry34Ab1 + Cry35Ab1) x 

MON 810 (Cry 1Ab)

f. Reg. # 29964-9 DAS-591227-7 (Cry34Ab1 + Cry35Ab1) x MON 810 (Cry1Ab)

IV. mCry3A BRAD Registered Products (pp.194-213) 

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.214-242) 

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.243-258) 

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
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Registrant Registration # Active Ingredients 

Date 

Registered

Date 

Expired

Syngenta 67979-1 Bt corn Event Bt11 with Cry1Ab 

( field corn – AgriSure CB) 

Feb-98 30-Sep-10 

Expiration Date:

The subject registration will automatically expire on midnight September 30, 2010. 

Data:

You must submit the following data in the time frames specified. 

1. The Agency is requiring Syngenta Seeds, Inc. to submit an analytical method for the detection 

of Cry1Ab protein in corn grain and a thorough characterization of the antisera used in the 

method(s). The method must be validated by an independent laboratory validation. Both the 

method and the validation must be submitted to EPA by June 1, 2002. 

2. Data for Bt11 Cry1Ab protein which compares the amino acid sequence of the Cry1Ab protein 

expressed in field corn with known toxins and allergens must be submitted to the Agency for 

evaluation. For allergens, these data must also include a stepwise 8 amino acid analysis of the 

subject protein against available allergen sequence databases. These additional data are required 

to augment the health effects database for Cry1Ab expressed in corn. These data must be 

submitted on or before March 15, 2003. 

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

protein present in the given tissue. 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 March 15, 2003. 

4. The Agency is requiring testing of Cry1Ab protein in soil under a range of conditions typical 

of Bt corn cultivation. EPA requires Syngenta or Syngenta in cooperation with other registrants 

to submit test protocols before the studies are actually conducted. In general, the Agency 

anticipates that soils would be sampled from fields where Bt corn has been grown continuously 

for at least 3 years compared with fields where no Bt crop has been grown. These paired fields 

would include several locations throughout the corn growing area of the US representing 

different soil and climatic variations. The Agency anticipates that samples would need to be 

taken 2 or 3 times during the growing season. The registrant is required to submit a protocol on 

or before March 15, 2002. An interim report is due 12 months after the protocol is approved and 

a final report is due 24 months after the final protocol is approved. 

5. EPA is requiring confirmatory field data for possible impacts on non-target insects. Either 
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existing studies must be submitted or the registrants must submit a protocol for field survey 

studies on or before March 15, 2002 with an interim report submitted 12 months after approval 

of the protocol and a final report submitted 36 months after approval of the protocol. 

6. Based upon research recently published in the Proceedings of the National Academy of 

Sciences and upon the response of the Agricultural Biotechnology Stewardship Technical 

Committee to the December 1999 Bt corn Data Call-in Notice, EPA has concluded that the 

weight of scientific data indicate that Bt corn poses no unreasonable adverse impact on monarch 

butterfly populations. However, it has been identified in one of these papers, (Stanley-Horne, et 

al, 2001) that the published data only cover acute exposure and longer term exposure to Bt corn 

pollen should be considered. EPA is aware that studies are underway to assess the potential for 

longer-term exposure to Bt corn pollen to adversely impact monarch populations. Syngenta must 

report the results of these studies to EPA as soon as the results are available publicly or Syngenta 

must provide valid scientific studies to address this issue by January 31, 2003. The report must 

be able to be made available to the public at the time it is submitted to EPA. 

7. Submitted avian toxicity data on Cry1Ab Bt corn was scientifically sound and no treatment 

mortality or behavior change was observed between the dosed and control replicates. However, 

these data from repeated exposure(s) to higher doses of Bt corn are needed to make a hazard 

assessment. A supplemental study is required. The study must be of appropriate duration to 

represent the start and growing periods of the test species such as six weeks in meat-type 

chickens. Balanced diets should be formulated according to the National Research Council 

guidelines (“Nutrient Requirements of Poultry,” Ninth Revised Edition, 1994) with the energy 

requirements of the test species being met by the inclusion of corn in the diet to assess hazards 

from chronic exposure of wild or domesticated fowl. A protocol for poultry studies must be 

submitted on or before March 15, 2002 with a final report submitted 18 months after approval of 

the protocol. 

8. Studies are required to evaluate the impacts of north-south movement of Helicoverpa zea from 

corn-growing regions to cotton-growing regions on the resistance management of corn earworm, 

including field studies, as needed, to determine the adequacy of the current resistance 

management program. Either existing studies must be submitted or a protocol for field studies 

must be submitted on or before March 15, 2002 with an interim report submitted 12 months after 

approval of the protocol and a final report submitted 24 months after approval of the protocol. 

9. Research on the impacts of insecticidal sprays on the effectiveness of the refuge are required. 

Syngenta must submit either a copy of the NC-205 protocol or a protocol of its own to the 

Agency by March 15, 2002. An interim report is due in 12 months after submitting the NC-205 

protocol or approval of the registrant’s protocol and a final report is due 24 months after 

submitting the NC-205 protocol or approval of the registrant’s protocol. 

10. 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. 
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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” which impose binding contractual obligations on the grower to comply with the 

refuge requirements; 

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

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

requirements; 

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

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

insects; 

6] Requirements regarding a “remedial action plan” which 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. 

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

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

 

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

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

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

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

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

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

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

2) Cotton-Growing Area Refuge Requirements for Bt Corn 

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

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

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

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

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

needed to control lepidopteran stalk-boring and other pests. 

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

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). 
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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 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] 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 which 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 
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coordinate its education programs with educational efforts of other registrants and other 

organizations, such as the National Corn Grower Association and state extension programs. 

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

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

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

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

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

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

working group (ABSTC). 

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

evaluate the extent to which growers purchasing its Bt corn product are complying with the IRM 

program and that takes such actions as are reasonably needed to assure that growers who have 

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

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 
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educational tools and initiatives. 

9] The registrant shall provide a written summary of the results of the prior year's survey 

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

EPA by January 31st of each year. The registrant shall confer with other registrants and EPA on 

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

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

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

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

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

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

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

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

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

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

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. 

d. 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; 
8

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 

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 
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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 
10

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 

registrant: 
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• 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. 

 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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Registrant Registration # Active Ingredients 

Date 

Registered

Date 

Expired

Syngenta 65268-1 Bt corn Event Bt11 with Cry1Ab ( sweet 

corn - Attribute--no refugia for sweet corn) 

Feb-98 30-Sep-10 

Expiration Date:

The subject registration will automatically expire on midnight September 30, 2010. 

Data:

You must submit the following data in the time frames specified. 

1. The Agency is requiring Syngenta Seeds, Inc. to submit an analytical method for the detection 

of Cry1Ab protein in corn grain and a thorough characterization of the antisera used in the 

method(s). The method must be validated by an independent laboratory. Both the method and 

the validation must be submitted to EPA by June 1, 2002. 

2. Data comparing the amino acid sequence of the Bt11 Cry1Ab protein expressed in sweet corn 

with known toxins and allergens must be submitted to the Agency for evaluation. For allergens, 

these data must also include a stepwise 8 amino acid analysis of the subject protein against 

available allergen sequence databases. These additional data are required to augment the health 

effects database for Cry1Ab expressed in corn. These data must be submitted on or before 

March 15, 2003. 

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

protein present in the given tissue. 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 March 15, 2003. 

4. The Agency is requiring testing of Cry1Ab protein in soil under a range of conditions typical 

of Bt corn cultivation. EPA requires Syngenta or Syngenta in cooperation with other registrants 

to submit test protocols before the studies are actually conducted. In general, the Agency 

anticipates that soils would be sampled from fields where Bt corn has been grown continuously 

for at least 3 years compared with fields where no Bt crop has been grown. These paired fields 

would include several locations throughout the corn growing area of the US representing 

different soil and climatic variations. The Agency anticipates that samples would need to be 

taken 2 or 3 times during the growing season. The registrant is required to submit a protocol on 

or before March 15, 2002. An interim report is due 12 months after the protocol is approved and 

a final report is due 24 months after the final protocol is approved. 

5. Based upon research recently published in the Proceedings of the National Academy of 
13

Sciences and upon the response of the Agricultural Biotechnology Stewardship Technical 

Committee to the December 1999 Bt corn Data Call-in Notice, EPA has concluded that the 

weight of scientific data indicate that Bt corn poses no unreasonable adverse impact on monarch 

butterfly populations. However, it has been identified in one of these papers, (Stanley-Horne, et 

al, 2001) that the published data only cover acute exposure and longer term exposure to Bt corn 

pollen should be considered. EPA is aware that studies are underway to assess the potential for 

longer-term exposure to Bt corn pollen to adversely impact monarch populations. Syngenta must 

report the results of these studies to EPA as soon as the results are available publicly or Syngenta 

must provide valid scientific studies to address this issue by January 31, 2003. The report must 

be able to be made available to the public at the time it is submitted to EPA. 

6. Submitted avian toxicity data on Cry1Ab Bt corn was scientifically sound and no treatment 

mortality or behavior change was observed between the dosed and control replicates. However, 

data from repeated exposure(s) to higher doses of Bt corn are needed to make a hazard 

assessment. A supplemental study is required. The study must be of appropriate duration to 

represent the starter and growing periods of the test species such as six weeks in meat-type 

chickens. Balanced diets should be formulated according to the National Research Council 

guidelines (“Nutrient Requirements of Poultry,” Ninth Revised Edition, 1994) with the energy 

requirements of the test species being met by the inclusion of corn in the diet to assess hazards 

from chronic exposure of wild or domesticated fowl. A protocol for poultry studies must be 

submitted on or before March 15, 2002 with a final report submitted 18 months after approval of 

the protocol. 

7. 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. 

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” which impose binding contractual obligations on the 

grower to comply with the refuge requirements; 

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

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

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

or educators for use on less than 20 acres); 

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

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

insects; 

5] Requirements regarding a “remedial action plan” which contains measures the registrants 
14

would take in the event that any field relevant insect resistance was detected as well as to report 

on activity under the plan to EPA; 

6] Submit annual reports on units sold by state (units sold by county level will be made available 

to the Agency upon request), IRM grower agreements results, and the compliance assurance 

program including the education program on or before January 31st each year. 

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

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

January 31st each year. 

 

a. Sweet Corn Post-Harvest Requirements 

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

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

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

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

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

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

Hybrids for sale to home gardeners. 

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

days. 

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

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

destruction methods are intended to protect against development of insect resistance 

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

gardeners or educators for use on less than 20 acres)

1] Persons purchasing the Bt corn product must sign a grower agreement. The term “grower 

agreement” refers to any grower purchase contract, license agreement, or similar legal document. 

2] The grower agreement and/or specific stewardship documents referenced in the grower 

agreement must clearly set forth the terms of the current IRM program. By signing the grower 

agreement, a grower must be contractually bound to comply with the requirements of the IRM 

program. 

3] The registrant 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] 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 
15

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

5] The registrant must maintain a system which 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 

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. 
16

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. 

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 

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 
17

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. 

d. 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. 

(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 
18

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 

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); 
19

• 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

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: 
20

• 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. 

• 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 
21

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. 

 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.
22

Registrant Registration # Active Ingredients 

Date 

Registered

Date 

Expired

Monsanto 524-489 

Bt corn Event MON810 Cry1Ab 

(YieldGard) Dec-96 30-Sep-10 

Expiration Date:

The subject registration will automatically expire on midnight September 30, 2010. 

Data:

You must submit the following data in the time frames specified. 

1. The Agency is requiring Monsanto to submit an analytical method for the detection of 

Cry1Ab protein in corn grain and a thorough characterization of the antisera used in the 

method(s). The method must be validated by an independent laboratory validation. Both the 

method and the validation must be submitted to EPA by June 1, 2002. 

2. Amino acid sequence data submitted indicate that there are no similarities between Cry1Ab 

protein and any known toxins or allergens. However, since the initial registration, the value of 

comparing the amino acid sequence to known toxins and allergens has been highlighted and 

therefore a stepwise 8 amino acid analysis of the subject protein against newly available known 

allergen sequence databases is required. In addition, a processing and/or heat stability study 

must also be conducted. These additional data are required to augment the health effects 

database for Cry1Ab corn by March 15, 2003. 

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

protein present in the given tissue. 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 March 15, 2003. 

4. The Agency is requiring testing of Cry1Ab protein in soil under a range of conditions typical 

of Bt corn cultivation. EPA requires Monsanto or Monsanto in cooperation with other registrants 

to submit test protocols before the studies are actually conducted. In general, the Agency 

anticipates that soils would be sampled from fields where Bt corn has been grown continuously 

for at least 3 years compared with fields where no Bt crop has been grown. These paired fields 

would include several locations throughout the corn growing area of the US representing 

different soil and climatic variations. The Agency anticipates that samples would need to be 

taken 2 or 3 times during the growing season. Monsanto is required to submit a protocol on or 

before March 15, 2002. An interim report is due 12 months after the protocol is approved and a 

final report is due 24 months after the final protocol is approved. 

5. EPA is requiring confirmatory field data for possible impacts on non-target insects. Either 
23

existing studies must be submitted or the registrants must submit a protocol for field survey 

studies on or before March 15, 2002 with an interim report submitted 12 months after approval 

of the protocol and a final report submitted 36 months after approval of the protocol. 

6. Based upon research recently published in the Proceedings of the National Academy of 

Sciences and upon the response of the Agricultural Biotechnology Stewardship Technical 

Committee to the December 1999 Bt corn Data Call-in Notice, EPA has concluded that the 

weight of scientific data indicate that Bt corn poses no unreasonable adverse impact on monarch 

butterfly populations. However, it has been identified in one of these papers, (Stanley-Horne, et 

al, 2001) that the published data only cover acute exposure and longer term exposure to Bt corn 

pollen should be considered. EPA is aware that studies are underway to assess the potential for 

longer-term exposure to Bt corn pollen to adversely impact monarch populations. Monsanto 

must report the results of these studies to EPA as soon as the results are available publicly or 

Monsanto must provide valid scientific studies to address this issue by January 31, 2003. The 

report must be able to be made available to the public at the time it is submitted to EPA. 

7. Submitted avian toxicity data on Cry1Ab Bt corn was scientifically sound and no treatment 

mortality or behavior change was observed between the dosed and control replicates. However, 

data from repeated exposure(s) to higher doses of Bt corn are needed to make a hazard 

assessment. A supplemental study is required. The study must be of appropriate duration to 

represent the start and growing periods of the test species such as six weeks in meat-type 

chickens. Balanced diets should be formulated according to the National Research Council 

guidelines (“Nutrient Requirements of Poultry,” Ninth Revised Edition, 1994) with the energy 

requirements of the test species being met by the inclusion of corn in the diet to assess hazards 

from chronic exposure of wild or domesticated fowl. A protocol for poultry studies must be 

submitted on or before March 15, 2002 with a final report submitted 18 months after approval of 

the protocol. 

8. Studies are required to evaluate the impacts of north-south movement of Helicoverpa zea from 

corn-growing regions to cotton-growing regions on the resistance management of corn earworm, 

including field studies, as needed, to determine the adequacy of the current resistance 

management program. Either existing studies must be submitted or a protocol for field studies 

must be submitted on or before March 15, 2002 with an interim report submitted 12 months after 

approval of the protocol and a final report submitted 24 months after approval of the protocol. 

9. Research on the impacts of insecticidal sprays on the effectiveness of the refuge are required. 

Monsanto must submit either a copy of the NC-205 protocol or a protocol of its own to the 

Agency by March 15, 2002. An interim report is due in 12 months after submitting the NC-205 

protocol or approval of the registrant’s protocol and a final report is due 24 months after 

submitting the NC-205 protocol or approval of the registrant’s protocol. 

10. 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. 
24

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” which impose binding contractual obligations on the grower to comply with the 

refuge requirements; 

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

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

requirements; 

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

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

insects; 

6] Requirements regarding a “remedial action plan” which 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. 

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. 
25

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

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

 

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

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

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

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

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

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

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

2) Cotton-Growing Area Refuge Requirements for Bt Corn 

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

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

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

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

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

needed to control lepidopteran stalk-boring and other pests. 

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

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). 
26

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 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] 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 which 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 
27

user of the current IRM requirements. The registrant shall coordinate its education programs 

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

Grower Association and state extension programs. 

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

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

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

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

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

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

working group (ABSTC). 

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

evaluate the extent to which growers purchasing its Bt corn product are complying with the IRM 

program and that takes such actions as are reasonably needed to assure that growers who have 

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

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. 
28

8] The survey shall be designed to obtain grower feedback on the usefulness of specific 

educational tools and initiatives. 

9] The registrant shall provide a written summary of the results of the prior year's survey 

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

EPA by January 31st of each year. The registrant shall confer with other registrants and EPA on 

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

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

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

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

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

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

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

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

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

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

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. 

d. 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 
29

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; 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 
30

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 
31

• 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 
32

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. 

 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. 
33

Registrant Registration # Active Ingredients

Date 

Registered

Date 

Expired

Dow/Mycogen 68467-2 

Bt corn Event TC1507 with plant 

optimized (PO) Cry1F (Herculex 1) May-01 30-Sep-10 

Expiration Date:

The subject registration will automatically expire on midnight September 30, 2010. 

Data:

You must submit the following data in the time frames specified. 

1. The Agency is requiring Mycogen to submit an analytical method for the detection of Cry1F 

protein in corn grain and a thorough characterization of the antisera used in the method(s). The 

method must be validated by an independent laboratory validation. Both the method and the 

validation must be submitted to EPA by June 1, 2002. 

2. The Agency is requiring testing of Cry1F protein levels in soil under a range of conditions 

typical of Bt corn cultivation. EPA requires Mycogen or Mycogen in cooperation with other 

registrants to submit test protocols before the studies are actually conducted. In general, the 

Agency anticipates that soils would be sampled from fields where Bt corn has been grown 

continuously for at least 3 years compared with fields where no Bt crop has been grown. These 

paired fields would include several locations throughout the corn growing area of the US 

representing different soil and climatic variations. The Agency anticipates that samples would 

need to be taken 2 or 3 times during the growing season. Mycogen is required to submit a 

protocol on or before March 15, 2002. Due dates for any interim reports will be determined at 

the time the protocol is approved. The final data for Cry1F will be submitted no later than 

March 15, 2008, but may be due earlier depending upon the final approved protocol. 

3. EPA is requiring confirmatory field data for possible impacts on non-target insects. Either 

existing studies must be submitted or the registrants must submit a protocol for field survey 

studies on or before March 15, 2002 with an interim report submitted 12 months after approval 

of the protocol and a final report submitted 36 months after approval of the protocol. 

4. Submitted avian toxicity data on Cry1F Bt corn was scientifically sound and no treatment 

mortality or behavior change was observed between the dosed and control replicates. However, 

data from repeated exposure(s) to higher doses of Bt corn are needed to make a hazard 

assessment. A supplemental study is required. The study must be of appropriate duration to 

represent the start and growing periods of the test species such as six weeks in meat-type 

chickens. Balanced diets should be formulated according to the National Research Council 

guidelines (“Nutrient Requirements of Poultry,” Ninth Revised Edition, 1994) with the energy 

requirements of the test species being met by the inclusion of corn in the diet to assess hazards 

from chronic exposure of wild or domesticated fowl. A protocol for poultry studies must be 

submitted on or before March 15, 2002 with a final report submitted 18 months after approval of 

the protocol. 
34

5. Studies are required to evaluate the impacts of north-south movement of Helicoverpa zea from 

corn-growing regions to cotton-growing regions on the resistance management of corn earworm, 

including field studies, as needed, to determine the adequacy of the current resistance 

management program. Either existing studies must be submitted or a protocol for field studies 

must be submitted on or before March 15, 2002 with an interim report submitted 12 months after 

approval of the protocol and a final report submitted 24 months after approval of the protocol. 

6. Research on the impacts of insecticidal sprays on the effectiveness of the refuge are required. 

Mycogen must submit either a copy of the NC-205 protocol or a protocol of its own to the 

Agency by March 15, 2002. An interim report is due in 12 months after submitting the NC-205 

protocol or approval of the registrant’s protocol and a final report is due 24 months after 

submitting the NC-205 protocol or approval of the registrant’s protocol. 

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” which impose binding contractual obligations on the grower to comply with the 

refuge requirements; 

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

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

requirements; 

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

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

6] Requirements regarding a “remedial action plan” which 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. 
35

1) Corn-Belt Refuge Requirements 

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

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

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

grower guide/product use guide. 

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

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

control lepidopteran stalk-boring and other pests. 

 

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

edges or headlands), and strips across the field. 

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

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

 

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

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

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

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

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

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

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

2) Cotton-Growing Area Refuge Requirements for Bt Corn 

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

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

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

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

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

needed to control lepidopteran stalk-boring and other pests. 

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

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). 
36

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 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] 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 which 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 
37

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

number, will be protected. 

c. IRM Education and IRM Compliance Monitoring Programs

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

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

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

relating to refuge configuration and proximity to Bt corn fields. The education program shall 

involve the use of multiple media, e.g. face-to-face meetings, mailing written materials, EPA 

reviewed language on IRM requirements on the bag or bag tag, and electronic communications 

such as by Internet, radio, or television commercials. Copies of the materials will be provided to 

EPA for its records. The program shall involve at least one written communication annually to 

each Bt corn user separate from the grower technical guide. The communication shall inform the 

user of the current IRM requirements. The registrant shall coordinate its education programs 

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

Grower Association and state extension programs. 

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

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

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

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

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

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

working group (ABSTC). 

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

evaluate the extent to which growers purchasing its Bt corn product are complying with the IRM 

program and that takes such actions as are reasonably needed to assure that growers who have 

not complied with the program either do so in the future or lose their access to the 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 
38

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. 

7] The survey shall be designed to provide an understanding of any difficulties growers 

encounter in implementing IRM requirements. An analysis of the survey results must include 

the reasons, extent, and potential biological significance of any implementation deviations. 

8] The survey shall be designed to obtain grower feedback on the usefulness of specific 

educational tools and initiatives. 

9] The registrant shall provide a written summary of the results of the prior year's survey 

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

EPA by January 31st of each year. The registrant shall confer with other registrants and EPA on 

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

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

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

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

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

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

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

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

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

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

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 
39

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. 

d. 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. 

(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. 
40

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. 
41

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: 
42

• 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 
43

• 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 Cry1F corn constitutes 

acceptance of these conditions. 
44

Registrant Registration # Active Ingredients

Date 

Registered

Date 

Expired

Pioneer/Dupont 29964-3 

Bt corn Event TC1507 with POCry1F 

(Herculex 1) May-01 30-Sep-10 

Expiration Date:

The subject registration will automatically expire on midnight September 30, 2010. 

Data:

You must submit the following data in the time frames specified. 

1. The Agency is requiring Pioneer to submit an analytical method for the detection of Cry1F 

protein in corn grain and a thorough characterization of the antisera used in the method(s). The 

method must be validated by an independent laboratory validation. Both the method and the 

validation must be submitted to EPA by June 1, 2002. 

2. The Agency is requiring testing of Cry1F protein levels in soil under a range of conditions 

typical of Bt corn cultivation. EPA requires Pioneer or Pioneer in cooperation with other 

registrants to submit test protocols before the studies are actually conducted. In general, the 

Agency anticipates that soils would be sampled from fields where Bt corn has been grown 

continuously for at least 3 years compared with fields where no Bt crop has been grown. These 

paired fields would include several locations throughout the corn growing area of the US 

representing different soil and climatic variations. The Agency anticipates that samples would 

need to be taken 2 or 3 times during the growing season. Pioneer is required to submit a protocol 

on or before March 15, 2002. Due dates for any interim reports will be determined at the time 

the protocol is approved. The final data for Cry1F will be submitted no later than March 15, 

2008, but may be due earlier depending upon the final approved protocol. 

3. EPA is requiring confirmatory field data for possible impacts on non-target insects. Either 

existing studies must be submitted or the registrants must submit a protocol for field survey 

studies on or before March 15, 2002 with an interim report submitted 12 months after approval 

of the protocol and a final report submitted 36 months after approval of the protocol. 

4. Submitted avian toxicity data on Cry1F Bt corn was scientifically sound and no treatment 

mortality or behavior change was observed between the dosed and control replicates. However, 

data from repeated exposure(s) to higher doses of Bt corn are needed to make a hazard 

assessment. A supplemental study is required. The study must be of appropriate duration to 

represent the start and growing periods of the test species such as six weeks in meat-type 

chickens. Balanced diets should be formulated according to the National Research Council 

guidelines (“Nutrient Requirements of Poultry,” Ninth Revised Edition, 1994) with the energy 

requirements of the test species being met by the inclusion of corn in the diet to assess hazards 
45

from chronic exposure of wild or domesticated fowl. A protocol for poultry studies must be 

submitted on or before March 15, 2002 with a final report submitted 18 months after approval of 

the protocol. 

5. Studies are required to evaluate the impacts of north-south movement of Helicoverpa zea from 

corn-growing regions to cotton-growing regions on the resistance management of corn earworm, 

including field studies, as needed, to determine the adequacy of the current resistance 

management program. Either existing studies must be submitted or a protocol for field studies 

must be submitted on or before March 15, 2002 with an interim report submitted 12 months after 

approval of the protocol and a final report submitted 24 months after approval of the protocol. 

6. Research on the impacts of insecticidal sprays on the effectiveness of the refuge are required. 

Pioneer must submit either a copy of the NC-205 protocol or a protocol of its own to the Agency 

by March 15, 2002. An interim report is due in 12 months after submitting the NC-205 protocol 

or approval of the registrant’s protocol and a final report is due 24 months after submitting the 

NC-205 protocol or approval of the registrant’s protocol. 

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” which impose binding contractual obligations on the grower to comply with the 

refuge requirements; 

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

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

requirements; 

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

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

6] Requirements regarding a “remedial action plan” which 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. 
46

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. 

1) Corn-Belt Refuge Requirements 

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

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

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

grower guide/product use guide. 

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

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

control lepidopteran stalk-boring and other pests. 

 

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

edges or headlands), and strips across the field. 

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

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

 

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

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

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

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

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

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

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

2) Cotton-Growing Area Refuge Requirements for Bt Corn 

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

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

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

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

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

needed to control lepidopteran stalk-boring and other pests. 

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

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. 
47

· 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 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] 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 which 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. 
48

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

seeds sold or shipped and not returned, and the number of such units that were sold to persons 

who have signed grower agreements. The report shall cover the time frame of the twelve-month 

period covering the prior August through July. 

8] The registrant must allow a review of the grower agreements and grower agreement records 

by EPA or by a State pesticide regulatory agency if the State agency can demonstrate that 

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

number, will be protected. 

c. IRM Education and IRM Compliance Monitoring Programs

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

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

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

relating to refuge configuration and proximity to Bt corn fields. The education program shall 

involve the use of multiple media, e.g. face-to-face meetings, mailing written materials, EPA 

reviewed language on IRM requirements on the bag or bag tag, and electronic communications 

such as by Internet, radio, or television commercials. Copies of the materials will be provided to 

EPA for its records. The program shall involve at least one written communication annually to 

each Bt corn user separate from the grower technical guide. The communication shall inform the 

user of the current IRM requirements. The registrant shall coordinate its education programs 

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

Grower Association and state extension programs. 

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

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

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

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

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

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

working group (ABSTC). 

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

evaluate the extent to which growers purchasing its Bt corn product are complying with the IRM 

program and that takes such actions as are reasonably needed to assure that growers who have 

not complied with the program either do so in the future or lose their access to the 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 
49

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. 

7] The survey shall be designed to provide an understanding of any difficulties growers 

encounter in implementing IRM requirements. An analysis of the survey results must include 

the reasons, extent, and potential biological significance of any implementation deviations. 

8] The survey shall be designed to obtain grower feedback on the usefulness of specific 

educational tools and initiatives. 

9] The registrant shall provide a written summary of the results of the prior year's survey 

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

EPA by January 31st of each year. The registrant shall confer with other registrants and EPA on 

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

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

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

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

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

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

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

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

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

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

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.” 
50

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. 

d. 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. 

(5) 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 
51

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 

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 
52

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 

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. 
53

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 

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. 
54

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. 

 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. 
55

Registrant Registration # Active Ingredients

Date 

Registered

Date 

Expired

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-Sep10 

Expiration Date:

The subject registration will automatically expire on midnight September 30, 2010. 

Data:

You must submit the following data in the time frames specified. 

1. The Agency is requiring Mycogen to submit an analytical method for the detection of Cry1F 

protein in corn grain and a thorough characterization of the antisera used in the method(s). The 

method must be validated by an independent laboratory validation. Both the method and the 

validation must be submitted to EPA by June 1, 2002. 

2. The Agency is requiring testing of Cry1F protein levels in soil under a range of conditions 

typical of Bt corn cultivation. EPA requires Mycogen or Mycogen in cooperation with other 

registrants to submit test protocols before the studies are actually conducted. In general, the 

Agency anticipates that soils would be sampled from fields where Bt corn has been grown 

continuously for at least 3 years compared with fields where no Bt crop has been grown. These 

paired fields would include several locations throughout the corn growing area of the US 

representing different soil and climatic variations. The Agency anticipates that samples would 

need to be taken 2 or 3 times during the growing season. Mycogen is required to submit a 

protocol on or before March 15, 2002. Due dates for any interim reports will be determined at 

the time the protocol is approved. The final data for Cry1F will be submitted no later than 

March 15, 2008, but may be due earlier depending upon the final approved protocol. 

3. EPA is requiring confirmatory field data for possible impacts on non-target insects. Either 

existing studies must be submitted or the registrants must submit a protocol for field survey 

studies on or before March 15, 2002 with an interim report submitted 12 months after approval 

of the protocol and a final report submitted 36 months after approval of the protocol. 

4. Submitted avian toxicity data on Cry1F Bt corn was scientifically sound and no treatment 

mortality or behavior change was observed between the dosed and control replicates. However, 

data from repeated exposure(s) to higher doses of Bt corn are needed to make a hazard 

assessment. A supplemental study is required. The study must be of appropriate duration to 

represent the start and growing periods of the test species such as six weeks in meat-type 

chickens. Balanced diets should be formulated according to the National Research Council 

guidelines (“Nutrient Requirements of Poultry,” Ninth Revised Edition, 1994) with the energy 

requirements of the test species being met by the inclusion of corn in the diet to assess hazards 

from chronic exposure of wild or domesticated fowl. A protocol for poultry studies must be 

submitted on or before March 15, 2002 with a final report submitted 18 months after approval of 
56

the protocol. 

5. Studies are required to evaluate the impacts of north-south movement of Helicoverpa zea from 

corn-growing regions to cotton-growing regions on the resistance management of corn earworm, 

including field studies, as needed, to determine the adequacy of the current resistance 

management program. Either existing studies must be submitted or a protocol for field studies 

must be submitted on or before March 15, 2002 with an interim report submitted 12 months after 

approval of the protocol and a final report submitted 24 months after approval of the protocol. 

6. Research on the impacts of insecticidal sprays on the effectiveness of the refuge are required. 

Mycogen must submit either a copy of the NC-205 protocol or a protocol of its own to the 

Agency by March 15, 2002. An interim report is due in 12 months after submitting the NC-205 

protocol or approval of the registrant’s protocol and a final report is due 24 months after 

submitting the NC-205 protocol or approval of the registrant’s protocol. 

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” which impose binding contractual obligations on the grower to comply with the 

refuge requirements; 

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

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

requirements; 

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

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

insects; 

6] Requirements regarding a “remedial action plan” which 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. 
57

1) Corn-Belt Refuge Requirements 

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

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

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

grower guide/product use guide. 

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

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

control lepidopteran stalk-boring and other pests. 

 

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

edges or headlands), and strips across the field. 

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

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

 

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

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

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

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

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

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

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

2) Cotton-Growing Area Refuge Requirements for Bt Corn 

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

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

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

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

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

needed to control lepidopteran stalk-boring and other pests. 

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

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 
58

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 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] 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 which 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 
59

by EPA or by a State pesticide regulatory agency if the State agency can demonstrate that 

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

number, will be protected. 

c. IRM Education and IRM Compliance Monitoring Programs

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

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

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

relating to refuge configuration and proximity to Bt corn fields. The education program shall 

involve the use of multiple media, e.g. face-to-face meetings, mailing written materials, EPA 

reviewed language on IRM requirements on the bag or bag tag, and electronic communications 

such as by Internet, radio, or television commercials. Copies of the materials will be provided to 

EPA for its records. The program shall involve at least one written communication annually to 

each Bt corn user separate from the grower technical guide. The communication shall inform the 

user of the current IRM requirements. The registrant shall coordinate its education programs 

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

Grower Association and state extension programs. 

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

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

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

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

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

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

working group (ABSTC). 

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

evaluate the extent to which growers purchasing its Bt corn product are complying with the IRM 

program and that takes such actions as are reasonably needed to assure that growers who have 

not complied with the program either do so in the future or lose their access to the 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 
60

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. 

7] The survey shall be designed to provide an understanding of any difficulties growers 

encounter in implementing IRM requirements. An analysis of the survey results must include 

the reasons, extent, and potential biological significance of any implementation deviations. 

8] The survey shall be designed to obtain grower feedback on the usefulness of specific 

educational tools and initiatives. 

9] The registrant shall provide a written summary of the results of the prior year's survey 

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

EPA by January 31st of each year. The registrant shall confer with other registrants and EPA on 

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

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

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

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

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

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

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

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

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

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

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 
61

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. 

d. 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. 

(6) 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. 
62

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. 
63

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: 

• 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 
64

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 

• In subsequent growing seasons, maintain sales suspension and alternative resistance 
65

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. 
66

Registrant Registration # Active Ingredients

Date 

Registered

Date 

Expired

Pioneer/Dupont 29964-7 

1507 (PO Cry1F) x MON 

810 (PO Cry1Ab) 

February 24, 

2010 30-Sep-10 

1. The subject registration will automatically expire September 30, 2010. 

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. You must submit the following data and/or information in the time frames listed: 

Study Type Required Data Due Date 

Insect Resistance 

Management - Grower 

Agreement 

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, must 

be submitted. 

Within 90 days of 

the date of 

registration 

6. 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; 

• Requirements for Pioneer 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 regarding programs to educate growers about IRM requirements; 
67

• 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, which 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 

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. 

• 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. 
68

• 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). 

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 
69

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 

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 take 

into account the information collected through the compliance survey required under 
70

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 

be denied sales of 1507xMON810 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 1507xMON810 corn. 

6. Pioneer must maintain an IRM compliance assurance program (CAP) which 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 
71

sensitivity for comparing results across the U.S. 

7. The survey shall be designed to provide an understanding of any difficulties growers 

encounter in implementing IRM requirements. An analysis of the survey results must 

include the reasons, extent, and potential biological significance of any implementation 

deviations. 

8. The survey shall be designed to obtain grower feedback on the usefulness of specific 

educational tools and initiatives. 

9. The registrant shall provide a 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 

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. 
72

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. 

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 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; 

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. 
73

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. 

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 
74

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 

• 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: 
75

• 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, 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 
76

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 

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. 

 
77

Registrant Registration # Active Ingredients 

Date 

Registered

Date 

Expired

Monsanto 524-528 

Bt Corn Event MON863 with Cry3Bb1 

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

 

MON 863

Monsanto is required to do the following as terms and conditions of the registration. 

1) The subject registration will automatically expire on midnight September 30, 2010. 

2) The subject registration will be limited to Bacillus thuringiensis Cry3Bb1 Protein and the 

Genetic Material Necessary for its Production (Vector ZMIR13L) in Event MON863 Corn 

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 production information for this product to Mr. Owen Beeder of Office of Pesticide 

Programs, Registration Division (mail code 7505C) for the fiscal year in which this product 

is conditionally registered, in accordance with FIFRA § 29. The fiscal year begins October 1 

and ends September 30. Production information will be submitted to the Agency no later than 

December 15, following the end of the preceding fiscal year. 

5) Submit independent laboratory method validation (under OPPTS Guidelines 860.1340) to 

complete the database for Cry3Bb1 corn within 12 months of the date of registration. Provide 

to the EPA laboratory (Ft. Meade, MD) methodology and/or reagents necessary for 

validation of a Cry3Bb1 analytical method once requested by EPA’s Ft. Meade laboratory. 

The extraction and detection method as described for Cry3Bb1 protein appears to be 

adequate for analysis of Cry3Bb1 protein in corn grain. However, this method must be 

validated by both an independent laboratory and the EPA Biological and Economic Analysis 

Division laboratory before it can be considered a valid method. In addition, to assure that 

grain handlers have a test method in place prior to harvest, Monsanto must make available 

Cry3Bb1 strip tests to grain handlers and demonstrate to the Agency this provision prior to 

September 2003. EPA understands that these are 'qualitative' test kits and that Monsanto is in 

discussions with USDA/GIPSA about providing methodology and reagents for their use in 

developing a validated 'quantitative' method for MON 863 and that this transfer of materials 

will take place once registration occurs. Data requirement satisfied. Validation by EPA’s 

Biological and Economic Analysis Division Laboratory pending. 

6) Submit expression data in terms of dry weight, as the amount of protein present in the given 

tissue. 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 obtained for roots should also include typical times when corn 

rootworm would be feeding. Data requirement satisfied. 

7) Submit field degradation studies evaluating accumulation and persistence of Cry3Bb1 in 

several different soils in various strata. Representative fields must have been planted with 

MON863 and include both conventional tillage and no-till samples and be harvested under 
78

typical agronomic conditions. Sampling must continue until the limit of detection is reached. 

Studies should include soils with high levels of a variety of clays. Both ELISA and insect 

bioassays need to be conducted and compared to determine if Cry3Bb1 is accumulating or 

persisting in soil samples. Data requirement satisfied provided three (3) year YieldGard Plus 

(EPA Reg. No. 524-545) fate data submitted and found acceptable. 

8) Submit laboratory toxicity tests with Orius insidiosus (minute pirate bug), and carabid (ground 

beetle), within 24 months of the date of registration, provided the registration is amended to 

extend the registration date. Data submitted and under review. Protocols are due within 120 

days of the date of registration. We note that further investigation of the biology and life 

cycle of the red milkweed beetle demonstrates that there will be little or no exposure of 

larvae under natural conditions. Although adults may be exposed to Bt corn pollen while 

feeding on milkweed leaves, Bt is typically less toxic to adults than larvae. There is also no 

protocol for rearing red milkweed beetles in the laboratory and the development of such a 

laboratory assay would be difficult due to the red milkweed beetle’s long development time. 

Therefore, on October 1, 2003, the Agency granted Monsanto’s request and the waived 

requirement for conducting a red milkweed beetle study set forth in the notice of registration. 

9) Full-scale field or semi-field studies with appropriate end points and statistical power must be 

conducted. Submit intermediate and multi-year non-target organism field studies with 

statistical power. You must submit final results to field studies previously summarized in 

MRID No.456530-03 (The carabid and nematode data are of particular interest.) and annual 

reports each year of this registration every April 30th. Data submitted and under review. 

10) Submit a six week broiler dietary study with 60% - 70% MON 863 corn in the diet that is of 

appropriate duration to represent the start and growing periods of the test species. Balanced 

diets should be formulated according to the National Research Council guidelines 

(““Nutrient Requirements of Poultry,”” Ninth Revised Edition, 1994) with the energy 

requirements of the test species being met by the inclusion of corn in the diet to assess 

hazards from chronic exposure of wild or domesticated fowl. A protocol for poultry studies 

must be submitted within 90 days of the date of registration with a final report submitted 18 

months after approval of the protocol. Data submitted and under review. 

11) Submit the following insect resistance management/pest biology data. Protocols and data sets 

identified in Monsanto’’s 12/13/2002 letter must be submitted within 90 days of the date of 

registration. A progress report must be submitted by January 31, 2004. The final reports must 

be submitted by January 31, 2006. Data requirement satisfied. 

- Research regarding adult and larval movement and dispersal, mating habits, ovipositional 

patterns, number of times a female can mate and fecundity. 

- Research to determine if IRM strategies designed for WCRW and NCRW are appropriate for 

MCRW 

- Research regarding the mechanism of potential resistance of CRW to MON 863 is necessary to 

develop an appropriate long-term IRM strategy. Monsanto must attempt to develop resistant 

CRW colonies to aid in determining selection intensity. 

- Research regarding the effect of WCRW ovipositing in soybean prior to overwintering and 

extended diapause in NCRW on an IRM strategy needs further investigation. 
79

- Detailed summaries of the four data-sets identified in Monsanto’’s December 13, 2002 letter 

should be submitted to the Agency to support their conclusion that the initial resistance allele 

frequency is? 0.01. 

- Baseline susceptibility studies currently underway should be continued for WCRW and 

initiated for NCRW and monitoring techniques such as discriminating dose concentration 

assays need to be thoroughly investigated for their feasibility as resistance monitoring tools. 

12) BPPD strongly urges Monsanto to submit data and information cited in the benefits 

assessment to help measure the impacts and potential benefits of the use of MON 863 corn 

on a wide scale. [Note that this is not a required term or condition of the registration.] No 

information submitted, but not required. 

13) Monsanto must implement the following Insect Resistance Management Program: 

The required IRM program for Cry3Bb1 Bt corn has the following elements: 

1] Requirements relating to creation of a non-Cry3Bb1 Bt corn refuge in conjunction with the 

planting of any acreage of commercial Cry3Bb1 Bt corn; 

2] Requirements for the registrants to prepare and require Cry3Bb1 Bt corn users to sign 

““grower agreements”” which impose binding contractual obligations on the grower to 

comply with the refuge requirements; 

3] Requirements for the registrants to develop, implement, and report to EPA on programs to 

educate growers about IRM requirements; 

4] Requirements for the registrants to develop, implement, and report to EPA on programs to 

evaluate and promote growers’’ compliance with IRM requirements (the Cry3Bb1 

Compliance Assurance Program (CAP) must integrate with the CAP already approved for 

MON810, EPA Registration Number 524-489); 

5] 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 Cry3Bb1 protein in the target insects; 

6] Requirements for the registrants to develop, and if triggered, to implement a ““remedial action 

plan”” which would contain measures the registrants would take in the event that any insect 

resistance was detected as well as to report on activity under the plan to EPA; 

7] Submit annual reports on units sold by state (units sold by county level will be made available 

to the Agency upon request), IRM grower agreements results, compliance and assurance 

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

a. 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. 

- 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. 

- Refuge planting options include: refuge acres should be planted as blocks adjacent to MON 863 

corn fields or as in-field strips. 
80

- External refuges must be planted adjacent to Cry3Bb1 MON 863 fields. 

- When planting the refuge in strips across the field, refuges must be at least 4 consecutive rows 

wide. 

- Insecticide treatments for control of corn rootworm larvae may be applied. Instructions to 

growers will specify that insecticides labeled for control of corn rootworm adults 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 develop a system (equivalent to what is already approved for MON 810, 

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

corn product will affirm annually that they are contractually bound to comply with the 

requirements of the IRM program. The proposed system will be submitted to EPA within 90 

days from the date of registration. 

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

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

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

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

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

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

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

the terms and conditions of the amendment. 

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

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

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

registration a written description of that system. 

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

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

7] Beginning on January 31, 2004 and annually thereafter, the registrant shall provide EPA with 

a report showing the number of units of its Bt MON863 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. 
81

c. IRM Education and IRM Compliance Monitoring Programs 

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

designed to convey to Bt MON863 corn users the importance of complying with the IRM 

program. The program shall include information encouraging Bt MON863 corn users to 

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

to Bt MON863 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. The program 

shall involve at least one written communication annually to each Bt MON863 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] Beginning January 31, 2004 and 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 registrant must either submit a separate report or contribute to 

the report from the industry working group (ABSTC). 

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

designed to evaluate the extent to which growers purchasing its MON863 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 MON863 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] - 15] below. 

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

guidance document that indicates how the registrant will address instances of 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 MON863 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 MON863 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 
82

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 corncotton areas.. The survey shall measure the degree of compliance with the IRM program by 

growers in different regions of the country and consider the potential impact of non-response. 

The sample size and geographical resolution may be adjusted annually, based upon input 

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

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

reasonable sensitivity for comparing results across the U.S. 

7] The survey shall be designed to provide an understanding of any difficulties growers 

encounter in implementing IRM requirements. An analysis of the survey results must include 

the reasons, extent, and potential biological significance of any implementation deviations. 

8] The survey shall be designed to obtain grower feedback on the usefulness of specific 

educational tools and initiatives. 

9] The registrant shall provide a 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 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 it’s ““phased compliance approach.”” 

13] If a grower, who purchases MON863 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] Beginning January 31, 2004 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 noncompliance, corrective measures to address the non-compliance, and any follow-up actions 

taken. 
83

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

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

demonstrate that confidential business information, including the names, personal 

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

d. Insect Resistance Monitoring 

The Agency is imposing the following conditions for this product: 

1) The registrants will monitor for 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. You must submit a protocol within 90 days of the date of 

registration. 

2) The registrant shall provide to EPA a description of its resistance monitoring plan by January 

31, 2004. 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 corn rootworm. 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. 

5) 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. Remedial Action Plans 

A Remedial Action Plan covering both suspected and confirmed resistance for corn rootworm 

must be submitted by 1/31/2004. If resistance is confirmed, all MON863 acres (including 

MON863 Bt fields and non-MON863 Bt refuges) must be treated with insecticides targeted at 

CRW adults as well as larvae. Remedial Action Plan submitted and found acceptable.

Annual Reports: 

The registrant will provide annual reports to EPA by January 31st each year based on the 

following table. 

Report Description

Annual Sales

Reported by state 

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
84

 who have signed grower agreements 

Grower 

Education Significant changes in grower education plan 

Compliance 

Assurance 

Plan Compliance Assurance Program activities and results 

Compliance Annual survey results and plans for the next year 

Additionally, at least 30 days before any changes related to IRM are expected to be imposed (e.g. 

grower agreement); a report of such changes must be submitted to EPA. Results of insect 

resistance monitoring and investigations of damage reports must be submitted by April 30th each 

year. 
85

Registrant Registration # Active Ingredients 

Date 

Registered

Date 

Expired

Monsanto 524-545 

Bt corn Stack Event MON 863 + MON 

810 with Cry 3Bb1 + Cry1Ab 

(YieldGard Plus) 

31-Oct-03 30-Sep-10 

YieldGard Plus

Monsanto is required to do the following as terms and conditions of the registration. 

1) The subject registration will automatically expire on midnight September 30, 2010. 

2) The subject registration will be limited to the use of a) Bacillus thuringiensis Cry3Bb1 Protein 

and the Genetic Material Necessary for its Production (Vector ZMIR13L) in MON 863 corn 

and b) Bacillus thuringiensis Cry1Ab1 Protein and the Genetic Material Necessary for its 

Production in corn in YieldGard® Plus field corn produced via the conventional breeding of 

MON 810 and MON 863 corn. 

3) Monsanto must submit/cite all data required for registration of their product under FIFRA§ 

3(c) (5) when the Agency requires registrants of similar products to submit such data. 

4) Monsanto must submit production information for this product to the Office of Pesticide 

Programs for the fiscal year in which this product is conditionally registered, in accordance 

with FIFRA § 29. The fiscal year begins October 1 and ends September 30. Production 

information will be submitted to the Agency no later than December 15, following the end of 

the preceding fiscal year. 

5) Monsanto must submit all data required to support the individual plant-incorporated 

protectants in YieldGard® Corn Borer (MON 810) and YieldGard® Rootworm (MON 863) 

corn, EPA Registration Nos. 524-489 & 524-528. 

6) Monsanto must submit small and large-scale field studies conducted with YieldGard® Plus 

Corn with appropriate end points and statistical power to verify there are no adverse 

ecological effects to non-target invertebrate populations. Monsanto must submit annual 

reports each year of this registration every April 30th, beginning in 2005, provided the 

registration expiration date is extended. 

7) Monsanto must submit field degradation studies evaluating accumulation and persistence of 

Cry1Ab and Cry3Bb1 from YieldGard® Plus Corn in several different soils in various strata. 

Representative fields must have been planted with YieldGard® Plus Corn for at least three 

consecutive years and include both conventional tillage and no-till samples and be harvested 

under typical agronomic conditions. Sampling must begin after three consecutive years of 

YieldGard® Plus Corn planting and continue until the limit of detection is reached. Studies 

should include soils with high levels of a variety of clays. Both ELISA and insect bioassays 

need to be conducted and compared to determine if Cry1Ab and Cry3Bb1 are accumulating 

or persisting in soil samples. A protocol is due within 120 days of the date of registration. 

Planting of YieldGard® Plus Corn for the study must begin in 2004, with sampling 

beginning after the 2006 growing season. Provided, the registration and tolerance exemption 

are amended to extend the expiration dates, a final report is due November 15, 2007. 
86

8) 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. 

9) Monsanto must do the following Insect Resistance Management Program: 

The required IRM program for YieldGard Plus® Bt corn has the following elements: 

1] Requirements relating to creation of either common or separate refuges for Cry3Bb1 and 

Cry1Ab in conjunction with the planting of any acreage of commercial YieldGard Plus® Bt 

corn; 

2] Requirements for the registrant to prepare and require YieldGard Plus® Bt corn users to sign 

““grower agreements”” which impose binding contractual obligations on the grower to 

comply with the refuge requirements; 

3] Requirements for the registrant to develop, implement, and report to EPA on programs to 

educate growers about IRM requirements; 

4] Requirements for the registrant to develop, implement, and report to EPA on programs to 

evaluate and promote growers’’ compliance with IRM requirements (the YieldGard Plus® 

Compliance Assurance Program (CAP) must integrate with the Cry1 and Cry3Bb1 Caps); 

5] Requirements for the registrant to develop, implement, and report to EPA on monitoring 

programs to evaluate whether there are statistically significant and biologically relevant 

changes in target insect susceptibility to Cry3Bb1 or Cry1Ab proteins in the target insects; 

6] Requirements for the registrant to develop, and if triggered, to implement a ““remedial action 

plan”” which would contain measures the registrants would take in the event that any insect 

resistance was detected as well as to report on activity under the plan to EPA; 

7] Submit annual reports on units sold by state (units sold by county level will be made available 

to the Agency upon request), IRM grower agreements results, compliance and assurance 

program including the educational 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. 

Grower agreements (also known as stewardship agreements) will specify that growers must 

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

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

Corn Belt / Non-Cotton Growing Region Refuge Requirements 

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

growers. 

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

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

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

grower’s corn acres (i.e. sum of YieldGard Plus acres and refuge acres). It can be planted as a 

block adjacent to the YieldGard Plus field, perimeter strips, or in-field strips. If perimeter strips 

are implemented, the strips must be at least 4 consecutive rows wide. If strips within the 
87

YieldGard Plus field are implemented, then at least 4 consecutive rows should be planted. The 

common refuge can be treated with a soil-applied or seed-applied insecticide to control 

rootworm larvae and other soil pests. The refuge can also be treated with a non-Bt foliar 

insecticide for control of late season pests if pest pressure reaches an economic threshold for 

damage; however, if rootworm adults are present at the time of foliar applications then the 

YieldGard Plus field must be treated in a similar manner. 

The second option is planting separate refuge areas for 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 YieldGard Plus acres and corn borer refuge 

acres), and must be planted within 1⁄2 mile of the YieldGard Plus field. The corn borer refuge can 

be treated with a soil-applied or seed-applied insecticide for corn rootworm larval control, or a 

non- Bt foliar-applied insecticide for corn borer control if pest pressure reaches an economic 

threshold for damage. The corn rootworm refuge must be planted with a non-Bt/corn rootwormprotected hybrid, but can 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 YieldGard 

Plus acres and corn rootworm refuge acres) and can be planted as an adjacent block, perimeter 

strips, or infield strips. The corn rootworm refuge can be treated with a soil-applied or seed-applied 

insecticide to control rootworm larvae and other soil pests. The refuge can also be treated with a 

non-Bt foliar insecticide for control of late season pests; however, if rootworm adults are present 

at the time of foliar applications then the YieldGard Plus field must be treated in a similar 

manner. Growers who fail to comply with the IRM requirements risk losing access to the 

product. 

Cotton Growing Area Refuge Requirements 

For YieldGard Plus corn grown in cotton-growing areas the common refuge and separate refuge 

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

following states: Alabama, Arkansas, Florida, Georgia, Louisiana, North Carolina, Mississippi, 

South Carolina, Oklahoma (only the counties of Beckham, Caddo, Comanche, Custer, Greer, 

Harmon, Jackson, Kay, Kiowa, Tillman, and Washita), Tennessee (only the counties of Carroll, 

Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Haywood, Lake, 

Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), Texas (except the 

counties of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, Moore, Ochiltree, 

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

of Wight, Northampton, Southampton, Suffolk City, Surrey, and Sussex), and Missouri (only the 

counties of Dunkin, New Madrid, Pemiscot, Scott, and Stoddard). 

The first option is planting a common refuge for both corn borers and 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 YieldGard Plus acres and refuge acres). It can be planted as a 

block adjacent to the YieldGard Plus field, perimeter strips, or in-field strips. If perimeter strips 

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

YieldGard Plus field are implemented, then at least 4 consecutive rows should be planted. The 

common refuge can be treated with a soil-applied or seed-applied insecticide to control 

rootworm larvae and other soil pests. The refuge can also be treated with a non-Bt foliar 

insecticide for control of late season pests if pest pressure reaches an economic threshold for 
88

damage; however, if rootworm adults are present at the time of foliar applications then the 

YieldGard Plus field must be treated in a similar manner. 

The second option is planting separate refuge areas for 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 YieldGard Plus acres and corn borer refuge 

acres), and must be planted within 1⁄2 mile of the YieldGard Plus field. The corn borer refuge can 

be treated with a soil-applied or seed-applied insecticide for corn rootworm larval control, or a 

non- Bt foliar-applied insecticide for corn borer control if pest pressure reaches an economic 

threshold for damage. The corn rootworm refuge must be planted with a non-Bt corn/rootwormprotected hybrid, but can 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 YieldGard 

Plus acres and corn rootworm refuge acres) and be planted as an adjacent block, perimeter strips, 

or in-field strips. The corn rootworm refuge can be treated with a soil-applied or seed-applied 

insecticide to control rootworm larvae and other soil pests. The refuge can also be treated with a 

non-Bt foliar insecticide for control of late season pests; however, if rootworm adults are present 

at the time of foliar applications then the YieldGard Plus field must be treated in a similar 

manner. Growers who fail to comply with the IRM requirements risk losing access to the 

product. 

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) which is reasonably likely to assure that persons purchasing the Bt 

corn product will affirm annually that they are contractually bound to comply with the 

requirements of the IRM program. The proposed system will be submitted to EPA within 90 

days from the date of registration. 

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

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

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

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

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

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

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

the terms and conditions of the amendment. 

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

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

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

registration a written description of that system. 

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

years from December 31st of the year in which the agreement was signed. 
89

7] Beginning on January 31, 2005 and annually thereafter, the registrant shall provide EPA with 

a report showing the number of units of its YieldGard Plus® corn seeds sold or shipped and 

not returned, and the number of such units that were sold to persons who have signed grower 

agreements. The report shall cover the time frame of the twelve-month period covering the 

prior August through July. 

8] The registrant must allow a review of the grower agreements and grower agreement records 

by EPA or by a State pesticide regulatory agency if the State agency can demonstrate that 

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

number, will be protected. 

c. IRM Education and IRM Compliance Monitoring Programs 

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

designed to convey to YieldGard Plus corn users the importance of complying with the IRM 

program. The program shall include information encouraging YieldGard Plus corn users to 

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

to YieldGard Plus corn fields. The education program shall involve the use of multiple 

media, e.g. face-to-face meetings, mailing written materials, EPA reviewed language on IRM 

requirements on the bag or bag tag, and electronic communications such as by Internet, radio, 

or television commercials. Copies of the materials will be provided to EPA for its records. 

The program shall involve at least one written communication annually to each YieldGard 

Plus corn user separate from the grower technical guide. The communication shall inform the 

user of the current IRM requirements. Monsanto shall coordinate its education programs with 

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

Grower Association and state extension programs. 

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

into account the information collected through the compliance survey required under 

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

compliance that are not sufficiently high. 

3] Beginning January 31, 2005 and annually thereafter, the 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 design and implement an ongoing IRM compliance assurance program 

designed to evaluate the extent to which growers purchasing its YieldGard® Plus Bt corn 

product are complying with the IRM program and that takes such actions as are reasonably 

needed to assure that growers who have not complied with the program either do so in the 

future or lose their access to the YieldGard® Plus Bt corn product. Monsanto shall ensure 

that the YieldGard® Plus compliance assurance program (CAP) will be consistent with and 

integrated with the Caps for MON 863 and MON 810, EPA Registration Nos. 524-489 and 

524-528. The registrant must prepare and submit within 90 days of the date of registration a 

written description of their compliance assurance program including a summary of the 

program to be implemented in the 2004 growing season. Other required features of the 

program are described in paragraphs 5] - 15] below. 

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

guidance document that indicates how the registrant will address instances of non-
90

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 YieldGard Plus corn for an individual grower or for all growers in a 

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

in a row would be denied sales of the product the next year. Similarly, seed dealers who are 

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

their opportunity to sell YieldGard Plus 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 

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 corncotton areas.. The survey shall measure the degree of compliance with the IRM program by 

growers in different regions of the country and consider the potential impact of non-response. 

The sample size and geographical resolution may be adjusted annually, based upon input 

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

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

reasonable sensitivity for comparing results across the U.S. 

7] The survey shall be designed to provide an understanding of any difficulties growers 

encounter in implementing IRM requirements. An analysis of the survey results must include 

the reasons, extent, and potential biological significance of any implementation deviations. 

8] The survey shall be designed to obtain grower feedback on the usefulness of specific 

educational tools and initiatives. 

9] The registrant shall provide a 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 under paragraphs 6] through 8] and from other sources. The changes shall address 

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

the Agency prior to adopting any changes. 

11] The registrant shall 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 it’s ““phased compliance approach.”” 
91

13] If a grower, who purchases YieldGard Plus corn for planting, was specifically identified as 

not being in compliance during the previous year, the registrant shall visit with the grower 

and evaluate whether that the grower is in compliance with the IRM program for the current 

year. 

14] Beginning January 31, 2005 and annually thereafter, Monsanto shall provide a report to EPA 

summarizing the activities carried out under their compliance assurance program for the prior 

year and the plans for the compliance assurance program during the current year. The report 

will include information regarding grower interactions (including, but not limited to, on-farm 

visits, verified tips and complaints, grower meetings and letters), the extent of noncompliance, corrective measures to address the non-compliance, and any follow-up actions 

taken. 

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

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

demonstrate that confidential business information, including the names, personal 

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

d. Cry3Bb1 Insect Resistance Monitoring 

The Agency is imposing the following conditions for this product: 

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

should be focused in those areas in which there is the highest risk of resistance development. 

Monitoring must be carried out under the same protocols used for the individual trait product 

MON 863, EPA Registration No. 524-528. 

2) The registrant shall provide to EPA a description of its resistance monitoring plan by January 

31, 2005. The description shall include: sampling (number of locations and samples per 

locations), sampling methodology, bioassay methodology, standardization procedures, 

detection technique and sensitivity, and the statistical analysis of the probability of detecting 

resistance. 

3) The registrant must follow up on grower, extension specialist or consultant reports of less than 

expected results or control failures for all pests listed on the label and/or grower guide. The 

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

a toll-free customer service number) if incidents of unexpected levels of damage occurs from 

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

company or the company’s representatives. See Remedial Action Plans section below. 

4) A report on results of resistance monitoring and investigations of damage reports must be 

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

registration, beginning in 2005. 

e. Cry 3Bb1 Remedial Action Plans 

A Remedial Action Plan covering both suspected and confirmed resistance must be submitted by 

1/31/2005. If resistance is confirmed, all acres (YieldGard Plus and refuges) should be treated 

with insecticides targeted at CRW adults as well as larvae. 

Annual Reports: 

The registrant will provide annual reports to EPA by January 31st each year based on the 

following table. 
92

Report Description

Annual Sales

Reported by state 

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 

Grower 

Education Significant changes in grower education plan 

Compliance 

Assurance 

Plan Compliance Assurance Program activities and results 

Compliance Annual survey results and plans for the next year 

Additionally, at least 30 days before any changes related to IRM are expected to be imposed (e.g. 

grower agreement); a report of such changes must be submitted to EPA. Results of insect 

resistance monitoring and investigations of damage reports must be submitted by April 30th each 

year. 

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. 

(7) 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 
93

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 

evaluate the resistance. These steps may include: 

• determining the nature of the resistance (i.e., recessive or dominant, and the level 

of functional dominance); 
94

• 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 

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. 
95

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 

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; 
96

• 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. 

 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. 
97

Registrant Registration # Active Ingredients

Date 

Registered

Date 

Expired

Monsanto 524-551 

Bt corn Event MON 88017 with 

Cry3Bb1 (YieldGard VT RW) 13-Dec-05 30-Sep-10 

MON 88017

1) The subject registration will automatically expire on midnight September 30, 2010. 

 

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

genetic material necessary for its production (Vector 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) Submit all data required to support the individual plant-incorporated protectant in Event 

MON863 (YieldGard Rootworm), 524-528. In the event that the Agency concludes 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. 

5) You must commit to do the following Insect Resistance Management Program: 

a. Refuge Requirements 

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. 

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 
98

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) which is reasonably likely to assure that persons purchasing the Bt 

corn product will affirm annually that they are contractually bound to comply with the 

requirements of the IRM program. The proposed system will be submitted to EPA within 90 

days from the date of registration. 

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

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

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

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

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

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

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

the terms and conditions of the amendment. 

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

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

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

registration a written description of that system. 

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

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

7] Beginning on January 31, 2007 and annually thereafter, 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 

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 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 
99

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] On January 31, 2007, 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]-15] 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] - 15] below. 

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

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

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

any 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. 

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. 

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. 
100

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] Beginning January 31, 2007 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 noncompliance, 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. 

9d. Insect Resistance Monitoring 

The Agency is imposing the following conditions for 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 registrant must provide EPA its resistance monitoring plan for approval. A revised 

monitoring plan must be submitted to the Agency with 3 months of the date of 

registration consisting of a description of the steps to be taken to establish corn rootworm 

baseline sensitivity and damage guidelines. A detailed resistance monitoring plan must be 

submitted to the Agency for review by January 31, 2008. This plan must include: baseline 
101

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 develop and validate an appropriate discriminating or diagnostic 

dose assay by January 31, 2010. 

3. You must finalize rootworm damage guidelines and submit these to BPPD by January 

31, 2010. 

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 beginning with 2007, reporting on populations collected the 

previous year. 

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. 
102

Registrant Registration # Active Ingredients

Date 

Registered

Date 

Expired

Monsanto 524-552 

Bt corn Event MON 88017 + MON 810 

with Cry1Ab + Cry3Bb (YieldGard VT 

Plus) 13-Dec-05 

30-Sep10 

MON 88017 x MON 810

1) The subject registration will automatically expire on midnight September 30, 2010. 

 

2) The subject registration will be limited to Cry3Bb1 [Bacillus thuringiensis Cry3Bb1 protein 

and the genetic material necessary for its production (Vector ZMIR39) in MON 88017 corn 

(OECD Unique Identifier: MON-88Ø17-3)] X Cry1Ab [Bacillus thuringiensis Cry1Ab deltaendotoxin and the genetic material necessary for its production in corn] corn 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 all data required to support the individual plant-incorporated protectants in MON 810 

(YieldGard), Event MON863 (YieldGard Rootworm), MON 88017 corn; EPA Registration Nos. 

524-489, 524-528. In the event that the Agency concludes MON 863 (YieldGard Rootworm) 

studies do not sufficiently demonstrate a lack of significant adverse effects, additional data with 

MON 88017 x MON 810 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. 

5) Submit expression level data regarding Cry1Ab protein levels in MON 810 and MON 88017 x 

MON 810 young root and forage root within 12 months of the date of registration. 

6) 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. 

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. 

 

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. 
103

Corn Belt / Non-Cotton Growing Region Refuge Requirements

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

growers. 

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

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

control of corn rootworms or corn borers. 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 can 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 can be treated with a soil-applied or seed-applied 

insecticide to control rootworm larvae and other soil pests. The refuge can also be treated with a 

non-Bt foliar insecticide for control of late season pests if pest pressure reaches an economic 

threshold for damage; however, if rootworm adults are present at the time of foliar applications 

then the [MON 88017 x MON 810] field must be treated in a similar manner. 

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

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

an economic threshold for damage. The corn rootworm refuge must be planted with a nonBt/corn rootworm-protected hybrid, but can 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 can be planted as 

an adjacent block, perimeter strips, or in-field strips. The corn rootworm refuge can be treated 

with a soil-applied or seed-applied insecticide to control rootworm larvae and other soil pests. 

The refuge can also be treated with a non-Bt foliar insecticide for control of late season pests; 

however, if rootworm 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). 
104

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 can 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 can be treated with a soil-applied or seed-applied 

insecticide to control rootworm larvae and other soil pests. The refuge can also be treated with a 

non-Bt foliar insecticide for control of late season pests if pest pressure reaches an economic 

threshold for damage; however, if rootworm adults are present at the time of foliar applications 

then the [MON 88017 x MON 810] field must be treated in a similar manner. 

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

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

an economic threshold for damage. The corn rootworm refuge must be planted with a non-Bt 

corn/rootworm-protected hybrid, but can 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 can be treated with 

a soil-applied or seed-applied insecticide to control rootworm larvae and other soil pests. The 

refuge can also be treated with a non-Bt foliar insecticide for control of late season pests; 

however, if rootworm adults are present at the time of foliar applications then the [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) which is reasonably likely to assure that persons purchasing the Bt corn 

product will affirm annually that they are contractually bound to comply with the requirements 

of the IRM program. The proposed system will be submitted to EPA within 90 days from the 

date of registration. 

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

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

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

specific stewardship documents referenced in the grower agreement that would affect either the 
105

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

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

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

conditions of the amendment. 

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

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

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

written description of that system. 

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

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

7] Beginning on January 31, 2007 and annually thereafter, 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] On January 31, 2007, 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]-15] 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 
106

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 

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] - 15] below. 

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

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

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

any 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. 

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. 
107

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 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] Beginning January 31, 2007 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 noncompliance, corrective measures to address the non-compliance, and any follow-up actions 

taken. 

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

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

demonstrate that confidential business information, including the names, personal 

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

d. 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) For the Cry3Bb1 portion of the product, the registrant must provide EPA its resistance 

monitoring plan for approval. A revised monitoring plan must be submitted to the Agency 

with 3 months of the date of registration consisting of a description of the steps to be taken to 

establish corn rootworm baseline sensitivity and damage guidelines. A detailed resistance 

monitoring plan must be submitted to the Agency for review by January 31, 2008. This 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) For the Cry3Bb1 portion of the product, the registrant must develop and validate an 

appropriate discriminating or diagnostic dose assay by January 31, 2010. 

4) For the Cry3Bb1 portion of the product, the registrant must finalize rootworm damage 

guidelines and submit these to BPPD by January 31, 2010. 

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

unexpected damage or control failures for corn rootworm. 
108

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

of each year beginning with 2007, reporting on populations collected the previous year. 

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. 

(8) 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. 
109

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. 
110

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: 
111

• 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 
112

• 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. 

 
113

Registrant Registration # Active Ingredients 

Date 

Registered

Date 

Expired

Dow 

AgroSciences 68467-5 

Bt corn Event DAS-591227-

7 with Cry 34Ab1 + 

Cry35Ab1 (Herculex RW) 31-Aug-05 30-Sep-10 

Terms and Conditions of the Registration 

1) The subject registrations will automatically expire on midnight September 30, 2010. Based on 

the Agency’s review of the data submitted and cited in support of this application, the Agency 

anticipates at this me that an expiration date five years from the initial date of registration for this 

product would be appropriate. 

2) The subject registrations 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 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) Provide to the EPA laboratory (Ft. Meade, MD) methodology and/or reagents necessary for 

validation of a Cry34/35Ab1 analytical method within 6 months of the date of registration. 

5) Submit field degradation studies evaluating accumulation and persistence of Cry34/35Ab1 in 

several different soils in various strata. Representative fields must have been planted with 

Cry34/35Ab1 corn and include both conventional tillage and no-till samples and be harvested 

under typical agronomic conditions. Sampling must continue until the limit of detection is 

reached. Studies should include soils with high levels of a variety of clays. Both ELISA and 

insect bioassays need to be conducted and compared to determine if Cry34/35Ab1 is 

accumulating or persisting in soil samples. A protocol is due within 90 days of the date of 

registration. A final report regarding data from fields that have had three continuous years of 

cultivation of Event DAS-59122-7 corn is due by January 31, 2010. 

6) Submit laboratory toxicity tests with Orius insidiosus (minute pirate bug), carabid (ground 

beetle), within 24 months of the date of registration. Protocols are due within 120 days of the 

date of registration. 

 

7) Additional 3 year full-scale field or semi-field studies for evaluation of Cry34/35Ab1 Event 

DAS-59122-7 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). The previously submitted two-year field study is not sufficient to determine if 

Cry34/35Ab1 corn will have long term impact on non-target invertebrates. A protocol is due 

within 90 days of the date of registration. A final report is due September 30, 2009. 

8) The following insect resistance management data are recommended. 
114

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. 

9) 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” 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 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” which would contain measures the registrants would take in the event that any insect 

resistance was detected as well as to report on activity under the plan to EPA; 

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 

beginning in 2007. 

 

9a. 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 
115

supplements to the grower guide/product use guide. 

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 rotation-resistant 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 can be treated as needed without 

having to treat the refuge. 

 

• The rootworm refuge can be planted to any corn hybrid that does not express PIPs for 

rootworm control (e.g. lepidopteran-protected Bt corn, herbicide-tolerant 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. 
116

 9b. 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) which is reasonably likely to assure that persons purchasing the Bt corn product will affirm 

annually that they are contractually bound to comply with the requirements of the IRM program. 

The proposed system will be submitted to EPA by January 31, 2006. 

 

4] The registrant must use grower agreements and submit to EPA by January 31, 2006 a copy of 

that agreement and any specific stewardship documents referenced in the grower agreement. If 

either 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) which is reasonably likely to assure that persons purchasing the Bt corn sign grower 

agreement(s), and must provide by January 31, 2006 a written description of that system. 

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

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

7] Beginning on January 31, 2007 and annually thereafter, 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.

9c. 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
117

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 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 take 

into account the information collected through the compliance survey required under paragraph 

6] and from other sources. The changes shall address aspects of grower compliance that are not 

sufficiently high. 

3] Beginning January 31, 2008 and 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]-15] 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. The registrant must prepare and submit by January 

31, 2006 a written description of their compliance assurance program including a summary of 

the program implemented in the 2006 growing season. Other required features of the program 

are described in paragraphs 5] - 15] below. 

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

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

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

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 
118

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

resolution may be adjusted annually, based upon input from the independent marketing research 

firm and academic scientists, to allow analysis of compliance behavior within regions or between 

regions. The sample size must provide a reasonable sensitivity for comparing results across the 

U.S. 

7] The survey shall be designed to provide an understanding of any difficulties growers 

encounter in implementing IRM requirements. An analysis of the survey results must include 

the reasons, extent, and potential biological significance of any implementation deviations. 

8] The survey shall be designed to obtain grower feedback on the usefulness of specific 

educational tools and initiatives. 

9] The registrant shall provide a 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, beginning with 2007. 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. 

14] Beginning January 31, 2007 and annually thereafter, 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-
119

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. 

9d. Insect Resistance Monitoring 

The Agency is imposing the following conditions for 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 registrants must provide EPA its resistance monitoring plan for approval. A 

preliminary plan must be submitted to the Agency by January 31, 2006 consisting of a 

description of the steps to be taken to establish corn rootworm baseline sensitivity and 

damage guidelines. A detailed resistance monitoring plan must be submitted to the 

Agency for review by January 31, 2008. This 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 registrants must develop and validate an appropriate discriminating or diagnostic 

dose assay by January 31, 2010. Further you must provide BPPD with a detailed 

explanation and validation (steps for) of the “high-throughput diagnostic screen” if it is to 

be considered an acceptable diagnostic dose assay. 

3. You must finalize rootworm damage guidelines and submit these to BPPD by January 

31, 2010. 

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 beginning with 2008, reporting on populations collected the previous 

year. 

9e. 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 
120

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”: 

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. 

10) Annual Reports:

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

based on the following table. 
121

 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 

Proposed 

Compliance Plan 

Written description of Compliance 

Assurance Program 

January 31, 2006 

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 Plan 

Description of the steps to be taken to 

establish corn rootworm baseline sensitivity 

and damage guidelines 

January 31, 2006 

Insect Resistance 

Monitoring Plan 

Submission of plan. Description of the 

program including baseline sensitivity, 

sampling (number of locations and samples 

per locations), sampling methodology, 

bioassay methodology, standardization 

procedures, detection technique, sensitivity, 

and the statistical analysis of the probability 

of detecting resistance, and an interim 

description of rootworm damage guidelines 

January 31, 2008 

Insect Resistance 

Monitoring 

Submission of rootworm damage guidelines January 31, 2010 

Insect Resistance 

Monitoring 

Development of diagnostic dose assay/high 

through-put screen 

January 31, 2008 
122

 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 as described in the following table: 

IRM Grower 

Agreements 

Proposed system to assure growers 

sign grower agreements 

January 31, 2006 

IRM Affirmation 

Plan 

System to assure annual affirmation 

by growers of their IRM obligations 

January 31, 2006 

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. 

Grower Agreement Submission of grower agreement and 

any specific stewardship documents 

referenced in the grower agreement 

January 31, 2006 
123

Registrant Registration # Active Ingredients 

Date 

Registered

Date 

Expired

Pioneer/Dupont 29964-4 

Bt corn Event DAS-591227-

7 with Cry 34Ab1 + 

Cry35Ab1 (Herculex RW) 31-Aug-05 30-Sep-10 

Terms and Conditions of the Registration 

1) The subject registrations will automatically expire on midnight September 30, 2010. Based on 

the Agency’s review of the data submitted and cited in support of this application, the Agency 

anticipates at this time that an expiration date five years from the initial date of registration for 

this product would be appropriate. 

2) The subject registrations 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 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) Provide to the EPA laboratory (Ft. Meade, MD) methodology and/or reagents necessary for 

validation of a Cry34/35Ab1 analytical method within 6 months of the date of registration. 

5) Submit field degradation studies evaluating accumulation and persistence of Cry34/35Ab1 in 

several different soils in various strata. Representative fields must have been planted with 

Cry34/35Ab1 corn and include both conventional tillage and no-till samples and be harvested 

under typical agronomic conditions. Sampling must continue until the limit of detection is 

reached. Studies should include soils with high levels of a variety of clays. Both ELISA and 

insect bioassays need to be conducted and compared to determine if Cry34/35Ab1 is 

accumulating or persisting in soil samples. A protocol is due within 90 days of the date of 

registration. A final report regarding data from fields that have had three continuous years of 

cultivation of Event DAS-59122-7 corn is due by January 31, 2010. 

6) Submit laboratory toxicity tests with Orius insidiosus (minute pirate bug), carabid (ground 

beetle), within 24 months of the date of registration. Protocols are due within 120 days of the 

date of registration. 

 

7) Additional 3 year full-scale field or semi-field studies for evaluation of Cry34/35Ab1 Event 

DAS-59122-7 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). The previously submitted two-year field study is not sufficient to determine if 

Cry34/35Ab1 corn will have long term impact on non-target invertebrates. A protocol is due 

within 90 days of the date of registration. A final report is due September 30, 2009. 

8) The following insect resistance management data are recommended. 
124

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. 

9) 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” 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 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” which would contain measures the registrants would take in the event that any insect 

resistance was detected as well as to report on activity under the plan to EPA; 

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 

beginning in 2007. 

 

9a. Refuge Requirements 

Grower agreements (also known as stewardship agreements) will specify that growers must 
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adhere to the refuge requirements as described in the grower guide/product use guide and/or in 

supplements to the grower guide/product use guide. 

1. Refuge size. The use of 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 rotation-resistant 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 can be treated as needed without 

having to treat the refuge. 

 

• The rootworm refuge can be planted to any corn hybrid that does not express PIPs for 

rootworm control (e.g. lepidopteran-protected Bt corn, herbicide-tolerant 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 
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and for growers who grow continuous corn. However, for those growers who need to 

employ crop rotation, a fixed refuge would be impractical. 

 

9b. 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) which is reasonably likely to assure that persons purchasing the Bt corn product will affirm 

annually that they are contractually bound to comply with the requirements of the IRM program. 

The proposed system will be submitted to EPA by January 31, 2006. 

 

4] The registrant must use grower agreements and submit to EPA by January 31, 2006 a copy of 

that agreement and any specific stewardship documents referenced in the grower agreement. If 

either 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) which is reasonably likely to assure that persons purchasing the Bt corn sign grower 

agreement(s), and must provide by January 31, 2006 a written description of that system. 

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

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

7] Beginning on January 31, 2007 and annually thereafter, 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.

9c. IRM Education and IRM Compliance Monitoring Programs

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

into account the information collected through the compliance survey required under paragraph 

6] and from other sources. The changes shall address aspects of grower compliance that are not 

sufficiently high. 

3] Beginning January 31, 2008 and 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]-15] 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. The registrant must prepare and submit by January 

31, 2006 a written description of their compliance assurance program including a summary of 

the program implemented in the 2006 growing season. Other required features of the program 

are described in paragraphs 5] - 15] below. 

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

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

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

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 
128

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. 

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, beginning with 2007. 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. 

14] Beginning January 31, 2007 and annually thereafter, 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 
129

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 (phasedcompliance 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. 

9d. Insect Resistance Monitoring 

The Agency is imposing the following conditions for 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. 

6. The registrants must provide EPA its resistance monitoring plan for approval. A 

preliminary plan must be submitted to the Agency by January 31, 2006 consisting of a 

description of the steps to be taken to establish corn rootworm baseline sensitivity and 

damage guidelines. A detailed resistance monitoring plan must be submitted to the 

Agency for review by January 31, 2008. This 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. 

7. The registrants must develop and validate an appropriate discriminating or diagnostic 

dose assay by January 31, 2010. Further you must provide BPPD with a detailed 

explanation and validation (steps for) of the “high-throughput diagnostic screen” if it is to 

be considered an acceptable diagnostic dose assay. 

8. You must finalize rootworm damage guidelines and submit these to BPPD by January 

31, 2010. 

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

unexpected damage or control failures for corn rootworm. 

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

31st of each year beginning with 2008, reporting on populations collected the previous 

year. 

9e. 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 
130

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. 

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. 

10) Annual Reports:

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

based on the following table. 
131

 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 

Proposed 

Compliance Plan 

Written description of Compliance 

Assurance Program 

January 31, 2006 

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 Plan 

Description of the steps to be taken to 

establish corn rootworm baseline sensitivity 

and damage guidelines 

January 31, 2006 

Insect Resistance 

Monitoring Plan 

Submission of plan. Description of the 

program including baseline sensitivity, 

sampling (number of locations and samples 

per locations), sampling methodology, 

bioassay methodology, standardization 

procedures, detection technique, sensitivity, 

and the statistical analysis of the probability 

of detecting resistance, and an interim 

description of rootworm damage guidelines 

January 31, 2008 

Insect Resistance 

Monitoring 

Submission of rootworm damage guidelines January 31, 2010 

Insect Resistance 

Monitoring 

Development of diagnostic dose assay/high 

through-put screen 

January 31, 2008 
132

 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 as described in the following table: 

IRM Grower 

Agreements 

Proposed system to assure growers 

sign grower agreements 

January 31, 2006 

IRM Affirmation 

Plan 

System to assure annual affirmation 

by growers of their IRM obligations 

January 31, 2006 

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. 

Grower Agreement Submission of grower agreement and 

any specific stewardship documents 

referenced in the grower agreement 

January 31, 2006 
133

Registrant Registration # Active Ingredients 

Date 

Registered

Date 

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-10 

Terms and Conditions of the Registration 

1. The subject registrations will automatically expire on midnight September 30, 2010. 

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

and the genetic material necessary for its production (plasmid insert PHI8999) in Event 

TC1507 corn] 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] 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 all data required to support the individual plant-incorporated protectants in Event 

TC1507 (Herculex I) and Event DAS-59122-7 (Herculex Rootworm) corn. In the event 

that the Agency concludes Cry34/35Ab1 (Herculex Rootworm) studies do not 

sufficiently demonstrate a lack of long range adverse effects, additional data with 

Herculex? XTRA 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. 

5. You must commit to do the following Insect Resistance Management Program:

The required IRM program for Cry1FxCry34/35Ab1 corn has the following elements: 

1. 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. 

2. 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; 

3. Requirements for the registrants to develop, implement, and report to EPA on 

programs to educate growers about IRM requirements; 

4. 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); 
134

5. 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; 

6. Requirements for the registrants to develop, and if triggered, to implement a remedial 

action plan which would contain measures the registrants would take in the event that 

any insect resistance was detected as well as to report on activity under the plan to 

EPA; 

7. Submit annual reports on 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, beginning in 2007. 

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. 

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 non-lepidopteran 

resistant Bt corn. 
135

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, 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). 
136

 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 

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. 
137

 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. 

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

the preceding requirements. 

5b. Grower Agreements 

4. 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. 

5. 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. 

6. The registrant must develop a system (equivalent to what is already approved for 

Cry1F Bt corn) which is reasonably likely to assure that persons purchasing the Bt 

corn product will affirm annually that they are contractually bound to comply with 

the requirements of the IRM program. The proposed system will be submitted to EPA 

by January 31, 2006. 

7. The registrant must use grower agreements and submit to EPA by January 31, 2006 a 

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

grower agreement. 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 
138

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

amendment. 

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

Cry1F Bt Corn) which is reasonably likely to assure that persons purchasing the Bt 

corn sign grower agreement(s), and must provide by January 31, 2006 a written 

description of that system. 

9. 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. 

10. Beginning on January 31, 2007 and annually thereafter, 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. 

11. 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 

12. 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 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. 

13. 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. 

14. Beginning January 31, 2008 and 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]-15] below. 

15. 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 
139

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. The registrant must 

prepare and submit by January 31, 2006 a written description of their compliance 

assurance program including a summary of the program implemented in the 2006 

growing season. Other required features of the program are described in paragraphs 

5] - 15] below. 

16. 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. 

17. 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 sample size must provide a 

reasonable sensitivity for comparing results across the U.S. 

18. 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. 

19. The survey shall be designed to obtain grower feedback on the usefulness of specific 

educational tools and initiatives. 

20. 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, beginning with 2007. The registrant shall 

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

21. 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. 

22. 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 
140

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. 

23. 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.” 

24. 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. 

25. Beginning January 31, 2007 and annually thereafter, 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 noncompliance, corrective measures to address the non-compliance (phased-compliance 

program), and any follow-up actions taken. 

26. 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. 

5d. Insect Resistance Monitoring 

The Agency is imposing the following conditions for 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 beginning with 2008, 

reporting on populations collected the previous year. 

Cry1 F

27. The registrants 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. 
141

28. 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. 

29. 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 registrant must provide EPA its resistance monitoring plan for approval. A 

preliminary plan must be submitted to the Agency by January 31, 2006 consisting of 

a description of the steps to be taken to establish corn rootworm baseline sensitivity 

and damage guidelines. A detailed resistance monitoring plan must be submitted to 

the Agency for review by January 31, 2008. This 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 develop and validate an appropriate discriminating or diagnostic 

dose assay by January 31, 2010. Further the registrant must provide BPPD with a 

detailed explanation and validation (steps for) of the "high-throughput diagnostic 

screen" if it is to be considered an acceptable diagnostic dose assay. 

3. The registrant must finalize rootworm damage guidelines and submit these to BPPD 

by January 31, 2010 should the registration be extended. 

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

unexpected damage or control failures for corn rootworm. 
142

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) 

XXX. 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 

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. 
143

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: 

5. 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. 

6. 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). 

7. 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 

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: 

8. Notify customers and extension agents in the affected area, 

9. 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, 

10. 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. 

11. 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: 

12. Notify the Agency of the immediate mitigation measures that were implemented, 

13. Submit to the Agency a proposed long-term resistance management action plan for 

the affected area, 

14. Submit to the Agency a proposed long-term resistance management action plan for 

the affected area, 
144

15. 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: 

16. 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). 

17. The development and recommendation of alternative resistance management 

strategies for controlling the resistant pest(s) on corn in the affected region. 

18. 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. 

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

unexpected damage reports show that: 

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

levels; 

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

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. 
145

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. 

9. 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); 

a. 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; 

b. the ability to survive is heritable; 

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

exceed economic thresholds; 

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

results. 

10. 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. 
146

Registrant Registration # Active Ingredients 

Date 

Registered

Date 

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-10 

Terms and Conditions of the Registration 

6. The subject registrations will automatically expire on midnight September 30, 2010. 

7. The subject registration will be limited to Cry1F [Bacillus thuringiensis Cry1F protein 

and the genetic material necessary for its production (plasmid insert PHI8999) in Event 

TC1507 corn] 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] corn for use in field corn. 

8. 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. 

9. Submit all data required to support the individual plant-incorporated protectants in Event 

TC1507 (Herculex I) and Event DAS-59122-7 (Herculex Rootworm) corn. In the event 

that the Agency concludes Cry34/35Ab1 (Herculex Rootworm) studies do not 

sufficiently demonstrate a lack of long range adverse effects, additional data with 

Herculex? XTRA 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. 

10. 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 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; 
147

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 which would contain measures the registrants would take in 

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

under the plan to EPA; 

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, 

beginning in 2007. 

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. 

A. Lepidopteran refuge for the Cry1F component.
148

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 non-lepidopteran 

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, 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. 
149

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 

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. 
150

 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. 

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

the preceding requirements. 

 

5b. Grower Agreements 

4. 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. 

5. 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. 
151

6. The registrant must develop a system (equivalent to what is already approved for 

Cry1F Bt corn) which is reasonably likely to assure that persons purchasing the Bt 

corn product will affirm annually that they are contractually bound to comply with 

the requirements of the IRM program. The proposed system will be submitted to EPA 

by January 31, 2006. 

7. The registrant must use grower agreements and submit to EPA by January 31, 2006 a 

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

grower agreement. 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. 

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

Cry1F Bt Corn) which is reasonably likely to assure that persons purchasing the Bt 

corn sign grower agreement(s), and must provide by January 31, 2006 a written 

description of that system. 

9. 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. 

10. Beginning on January 31, 2007 and annually thereafter, 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. 

11. 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 

12. 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 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 
152

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. 

13. 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. 

14. Beginning January 31, 2008 and 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]-15] below. 

15. 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. The registrant must 

prepare and submit by January 31, 2006 a written description of their compliance 

assurance program including a summary of the program implemented in the 2006 

growing season. Other required features of the program are described in paragraphs 

5] - 15] below. 

16. 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. 

17. 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 
153

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

reasonable sensitivity for comparing results across the U.S. 

18. 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. 

19. The survey shall be designed to obtain grower feedback on the usefulness of specific 

educational tools and initiatives. 

20. 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, beginning with 2007. The 

registrant shall confer with EPA on the design and content of the survey prior to its 

implementation. 

21. 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. 

22. 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. 

23. 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.” 

24. 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. 

25. Beginning January 31, 2007 and annually thereafter, 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 noncompliance, corrective measures to address the non-compliance (phased-compliance 

program), and any follow-up actions taken. 

26. 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. 
154

5d. Insect Resistance Monitoring 

The Agency is imposing the following conditions for 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 beginning with 2008, 

reporting on populations collected the previous year. 

Cry1 F

27. The registrants 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. 

28. 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. 

29. 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 registrant must provide EPA its resistance monitoring plan for approval. A 

preliminary plan must be submitted to the Agency by January 31, 2006 consisting of 

a description of the steps to be taken to establish corn rootworm baseline sensitivity 

and damage guidelines. A detailed resistance monitoring plan must be submitted to 

the Agency for review by January 31, 2008. This plan must include: baseline 

sensitivity data, sampling (number of locations, samples per locations), sampling 
155

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 develop and validate an appropriate discriminating or diagnostic 

dose assay by January 31, 2010. Further the registrant must provide BPPD with a 

detailed explanation and validation (steps for) of the "high-throughput diagnostic 

screen" if it is to be considered an acceptable diagnostic dose assay. 

3. The registrant must finalize rootworm damage guidelines and submit these to BPPD 

by January 31, 2010 should the registration be extended. 

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) 

XXX. 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. 
156

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: 

5. 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. 

6. 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). 

7. 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. 

 

XXXI. 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: 

0. Notify customers and extension agents in the affected area, 
157

1. 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, 

2. 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. 

3. 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: 

4. Notify the Agency of the immediate mitigation measures that were implemented, 

5. Submit to the Agency a proposed long-term resistance management action plan for 

the affected area, 

6. Submit to the Agency a proposed long-term resistance management action plan for 

the affected area, 

7. 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: 

8. 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). 

9. The development and recommendation of alternative resistance management 

strategies for controlling the resistant pest(s) on corn in the affected region. 

10. 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
158

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. 

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

unexpected damage reports show that: 

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

levels; 

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

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 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. 

9. 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); 

a. 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; 

b. the ability to survive is heritable; 

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

exceed economic thresholds; 

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

results. 

10. Response to Confirmed Resistance: When resistance is "confirmed", the following 

steps will be taken: 
159

 . 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. 
160

Registrant Registration # Active Ingredients 

Date 

Registered

Date 

Expired

Pioneer/Dupont 29964-8 

1507 (PO Cry1F) x 59122 (PO 

Cry34Ab1 + Cry35Ab1) x MON810 

(PO Cry1Ab) 24-Feb-10 31-Oct-10 

Terms and Conditions of the Registration 

1. The subject registration will automatically expire October 31, 2010. 

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 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 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, within 

the time frames required by the terms and conditions of EPA Registration Numbers 

29964-3, 29964-4, 524-489 and 29964-5, respectively. 

5. You must submit the following data and/or information in the time frames listed: 

Study Type Required Data Due Date 

Insect Resistance 

Management - Grower 

Agreement 

A copy of the grower agreement, associated stewardship documents, and 

written description of a system, which assure that growers will sign 

grower agreements and persons purchasing 1507x59122xMON810 corn 

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

requirements of the insect resistance management (IRM) program, must 

be submitted. 

Within 90 days of 

the date of 

registration 

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: 
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• 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 rootworm-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, which would contain measures the registrants would take in the event that 

any insect resistance was detected as well as to report on activity under the plan to EPA; 

• 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. 

I. 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 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 Cry1F and Cry1Ab component and lepidopteran-resistant Bt corn 
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(e.g., Herculex I or 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 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. 

A. Lepidopteran refuge for the Cry1F and Cry1Ab component. 

1. Refuge size, Corn-Growing Areas (i.e., cornbelt 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.

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

of the 1507x59122xMON810 field 

ii. The lepidopteran refuge can be planted within the 1507x59122xMON810 field 

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

iii. 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. 

* 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, 
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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. 

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 1507x59122xMON810 and rootworm refuge corn are not 

permitted. 

iii. If the rootworm refuge is planted on rotated ground, then 

1507x59122xMON810 corn must also be planted on rotated ground. 

iv. 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). 

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 

1507x59122xMON810 corn. 

viii. 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. 

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, herbicidetolerant corn, or conventional corn). 

x. The rootworm 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. 

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. 
164

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

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 1507x59122xMON810 and refuge corn are not permitted. 

iii. If the combined refuge is planted on rotated ground, then the 

1507x59122xMON810 corn must also be planted on rotated ground. 

iv. 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). 

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 

1507x59122xMON810 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, 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 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. 

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

insecticide on the combined refuge acres without treating the 

1507x59122xMON810 acres only if treatment occurs when adult corn 
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rootworms are not present. Pests on the 1507x59122xMON810 acres can 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 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. 

xii. The description of the refuge requirements in the grower guide must be 

consistent with the preceding requirements. 

II. Grower Agreement 

A. 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. 

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 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 

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 

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 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. 

F. Pioneer shall maintain records of all 1507x59122xMON810 corn grower agreements for 
166

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 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. 

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 

A. 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. 

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

compliance and revise the education program to address those deficiencies. 

C. 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). 

D. 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 
167

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. 

E. 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 

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. 

F. 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 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. 

G. 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. 

H. The survey shall be designed to obtain grower feedback on the usefulness of specific 

educational tools and initiatives. 

I. 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 
168

with other registrants and EPA on the design and content of the survey prior to its 

implementation. 

J. 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. 

K. 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. 

L. 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.” 

M. 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. 

N. 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. 

O. 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. 

IV. 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: 
169

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 

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 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. 

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 
170

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 

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; 
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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). 

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 
172

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 

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 
173

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). 
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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); 

• 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 
175

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 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; 

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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Registrant Registration # Active Ingredients 

Date 

Registered

Date 

Expired

Pioneer/Dupont 29964-9 

59122 (PO Cry34Ab1 + Cry35Ab1) x 

MON810 (PO Cry1Ab) 24-Feb-10 31-Oct-10 

Terms and Conditions of the Registration 

1. The subject registration will automatically expire October 31, 2010. 

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. You must submit the following data and/or information in the time frames listed: 

Study Type Required Data Due Date 

Insect Resistance 

Management - 

Grower 

Agreement 

A copy of the grower agreement, associated stewardship documents, and 

written description of a system, which assure that growers will sign 

grower agreements and persons purchasing 59122xMON810 corn will 

annually affirm that they are contractually bound to comply with the 

requirements of the insect resistance management (IRM) program, must 

be submitted. 

Within 90 days of the date of 

registration 

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 
177

trait may be planted separately. In the latter case, corn rootworm-resistant Bt corn may 

be planted in the lepidopteran refuge for the Cry1Ab component and lepidopteranresistant Bt corn may be planted in the corn rootworm refuge for the 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 

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, which would contain measures the registrants would take in the event that 

any insect resistance was detected as well as to report on activity under the plan to EPA; 

• 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 
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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 

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. 

A. Lepidopteran refuge for the Cry1Ab component. 

1. Refuge size, Corn-Growing Areas (i.e., cornbelt 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, 

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). 
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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). 

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 
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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 

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 59122xMON810 acres only if treatment occurs when adult 
181

corn rootworms are not present. Microbial Bt insecticides must not be applied to 

the common refuges. 

ix. Pests other than adult corn rootworms can 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 can 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 

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 
182

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 

P. 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. 

Q. 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. 

R. 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 
183

either submit a separate report or contribute to the report from the industry working 

group, Agricultural Biotechnology Stewardship Technical Committee (ABSTC). 

S. 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. 

T. 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. 

U. 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. 

V. 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. 
184

W. The survey shall be designed to obtain grower feedback on the usefulness of specific 

educational tools and initiatives. 

X. 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. 

Y. 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. 

Z. 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. 

AA. 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.” 

BB. 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. 

CC. 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. 

DD. 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. 
185

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 

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. 

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. 
186

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. 

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. 
187

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 

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). 
188

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 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 
189

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 

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 
190

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 

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. 
191

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 

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. 
192

Registrant Registration # Active Ingredients 

Date 

Registered Date Expired

Syngenta 67979-5 

Bt Corn Event MIR 604 with 

modified Cry3A (Agrisure RW) 3-Oct-06 30-Sep-10 

Terms and Conditions of the Registration 

1) The subject registration will automatically expire on midnight September 30, 2010. 

 

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) Provide to the EPA laboratory (Ft. Meade, MD) methodology and/or reagents necessary for 

validation of a mCry3A analytical method within 6 months from the date that the Agency 

requests them. 

5) Submit field degradation studies evaluating accumulation and persistence of mCry3A in 

several different soils in various strata. Representative fields must have been planted with 

mCry3A corn and include both conventional tillage and no-till samples and be harvested under 

typical agronomic conditions. Sampling must continue until the limit of detection is reached. 

Studies should include soils with high levels of a variety of clays. Both ELISA and insect 

bioassays need to be conducted and compared to determine if mCry3A is accumulating or 

persisting in soil samples. A protocol is due within 90 days of the date of registration. Should the 

registration expiration date be extended, a final report regarding data from fields that have had 

three continuous years of cultivation of Event MIR604 corn is due by January 31, 2011. 

6) 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. 

7) Submit the following data to augment the mCry3A amino acid sequence analysis to known 

toxins and allergens within six months of the date of registration: specification of which version 

of NCBI database was utilized; descriptions of parameters utilized; and dates accessed for the 

BLAST search. 

8) Submit the following insect resistant management data by January 31, 2010. 

a)Initiate establishment of CRW strains that are resistant to mCry3A and investigate the nature, 
193

 inheritance, and fitness costs of specific mechanisms of resistance to the 

 mCry3A protein expressed in MIR604 maize. 

b) Study the behavioral deterrence (avoidance) mechanism further and submit appropriate 

results. 

c) Continue studies on the biological impact of adults surviving on MIR604 maize and submit 

these results. 

9) You must commit to do the following Insect Resistance Management Program:

a. Refuge Requirements 

These refuge requirements do not apply to seed increase/propagation of inbred and hybrid seed 

corn. 

 

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 
194

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 Bt11 field 

corn, EPA Reg. No. 67979-1) which is reasonably likely to assure that persons purchasing the Bt 

corn product will affirm annually that they are contractually bound to comply with the 

requirements of the IRM program. The proposed system will be submitted to EPA within 90 

days from the date of registration. 

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

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

grower agreement. If 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 establish a system (equivalent to what is already approved for Bt11, EPA 

Reg. No. 67979-1) which is reasonably likely to assure that persons purchasing the Bt corn sign 

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

description of that system. 

 

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

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

7] Beginning on January 31, 2008 and annually thereafter, 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] Beginning in January 31, 2008, and annually thereafter, 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 design and implement a comprehensive, ongoing IRM education program 
195

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-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. 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 paragraph 

6] and from other sources. The changes shall address aspects of grower compliance that are not 

sufficiently high. 

 

3] On January 31, 2008, 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]-15] below. 

 

4] The registrant must design and 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. The 

registrant must prepare and submit within 90 days of the date of registration a written description 

of their compliance assurance program. Other required features of the program are described in 

paragraphs 5] - 15] below. 

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

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

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

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 
196

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. 

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, beginning with 2008. 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] Beginning January 31, 2008 and annually thereafter, 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, 
197

verified tips and complaints, grower meetings and letters), the extent of non-compliance, 

corrective measures to address the non-compliance, and any follow-up actions taken. 

 

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

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

demonstrate that confidential business information, including the names, personal information, 

and grower license number of the growers will be protected. 

d. Insect Resistance Monitoring 

The Agency is imposing the following conditions for this product: 

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 registrant must provide EPA its resistance monitoring plan for approval. A revised 

monitoring plan must be submitted to the Agency with 3 months of the date of registration 

consisting of a description of the steps to be taken to establish corn rootworm baseline sensitivity 

and damage guidelines. A detailed resistance monitoring plan must be submitted to the Agency 

for review by January 31, 2008. This 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 develop and validate an appropriate discriminating or diagnostic dose 

assay by January 31, 2010. 

 

3] You must finalize rootworm damage guidelines and submit these to BPPD by January 31, 

2010. 

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 beginning with 2008, 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: 

i. implicated maize plant roots were expressing the mCry3A protein at the expected 

level; 
198

j. 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; 

k. 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” 

k.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); 

l.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; 

m.the ability to survive is heritable; 

n.mCry3A plant assays determine that damage caused by surviving insects would 

exceed economic thresholds; 

o.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; 

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 
199

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, beginning in 2008. 
200

Registrant Registration # Active Ingredients 

Date 

Registered

Date 

Expired

Syngenta 67979-8 

Bt Corn Event MIR 604 + 

Bt11 with modified Cry3A 

+ Cry1Ab (Agrisure 

CB/RW) 24-Jan-07 30-Sep-10 

Terms and Conditions of the Registration 

1) The subject registration will automatically expire on midnight September 30, 2010. 

 

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) Provide to the EPA laboratory (Ft. Meade, MD) methodology and/or reagents necessary for 

validation of a mCry3A analytical method within 6 months from the date that the Agency 

requests them. 

6) Submit field degradation studies evaluating accumulation and persistence of mCry3A in 

several different soils in various strata. Representative fields must have been planted with 

mCry3A corn and include both conventional tillage and no-till samples and be harvested under 

typical agronomic conditions. Sampling must continue until the limit of detection is reached. 

Studies should include soils with high levels of a variety of clays. Both ELISA and insect 

bioassays need to be conducted and compared to determine if mCry3A is accumulating or 

persisting in soil samples. A protocol is due within 90 days of the date of registration. Should the 

registration expiration date be extended, a final report regarding data from fields that have had 

three continuous years of cultivation of Event MIR604 corn is due by January 31, 2011. 

7) 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. 
201

8) Submit the following data to augment the mCry3A amino acid sequence analysis to known 

toxins and allergens within six months of the date of registration: specification of which version 

of NCBI database was utilized; descriptions of parameters utilized; and dates accessed for the 

BLAST search. 

9) Submit the following insect resistant management data by January 31, 2010. 

a)Initiate establishment of CRW strains that are resistant to mCry3A and investigate the nature, 

 inheritance, and fitness costs of specific mechanisms of resistance to the 

 mCry3A protein expressed in MIR604 maize. 

b) Study the behavioral deterrence (avoidance) mechanism further and submit appropriate 

results. 

c) Continue studies on the biological impact of adults surviving on MIR604 maize and submit 

these results. 

9) You must commit to do the following Insect Resistance Management Program:

b. Refuge Requirements 

These refuge requirements do not apply to seed increase/propagation of inbred and hybrid seed 

corn. 

 

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 
202

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 develop a system (equivalent to what is already approved for Bt11 field 

corn, EPA Reg. No. 67979-1) which is reasonably likely to assure that persons purchasing the Bt 

corn product will affirm annually that they are contractually bound to comply with the 

requirements of the IRM program. The proposed system will be submitted to EPA within 90 

days from the date of registration. 

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

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

grower agreement. If 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 establish a system (equivalent to what is already approved for Bt11, EPA 

Reg. No. 67979-1) which is reasonably likely to assure that persons purchasing the Bt corn sign 

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

description of that system. 

 

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

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

7] Beginning on January 31, 2008 and annually thereafter, 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] Beginning in January 31, 2008, and annually thereafter, the registrant shall submit annual 
203

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 design 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-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. 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 paragraph 

6] and from other sources. The changes shall address aspects of grower compliance that are not 

sufficiently high. 

 

3] On January 31, 2008, 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]-15] below. 

 

4] The registrant must design and 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. The 

registrant must prepare and submit within 90 days of the date of registration a written description 

of their compliance assurance program. Other required features of the program are described in 

paragraphs 5] - 15] below. 

5] The registrant must establish and publicize a "phased compliance approach," i.e., a guidance 
204

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 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. 

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, beginning with 2008. 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" 
205

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] Beginning January 31, 2008 and annually thereafter, 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. 

d. Insect Resistance Monitoring 

The Agency is imposing the following conditions for 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 registrant must provide EPA its resistance monitoring plan for approval. A revised 

monitoring plan must be submitted to the Agency with 3 months of the date of registration 

consisting of a description of the steps to be taken to establish corn rootworm baseline sensitivity 

and damage guidelines. A detailed resistance monitoring plan must be submitted to the Agency 

for review by January 31, 2008. This 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 develop and validate an appropriate discriminating or diagnostic dose 

assay by January 31, 2010. 

 

3] You must finalize rootworm damage guidelines and submit these to BPPD by January 31, 

2010. 

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 beginning with 2008, reporting on populations collected the previous year. 
206

 

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: 

l. implicated maize plant roots were expressing the mCry3A protein at the expected level; 

m. 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; 

n. 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”: 

p.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); 

q.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; 

r.the ability to survive is heritable; 

s.mCry3A plant assays determine that damage caused by surviving insects would exceed 

economic thresholds; 

t.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: 

f. EPA will receive notification within 30 days of resistance confirmation; 

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

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

control measures; 

i. sale and distribution of mCry3A maize in the affected area will cease immediately; 

j. 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.] 
207

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. 

(9) 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: 
208

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

EPA defines suspected resistance to mean field reports of unexpected levels of 
209

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. 
210

• 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. 
211

 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, beginning in 2008. 
212

Registrant Registration # Active Ingredients 

Date 

Registered

Date 

Expired

Monsanto 524-575 

Bt corn Event MON 89034 

with Cry1A.105 + CryAb2 10-Jun-08 30-Sep-10 

TERMS AND CONDITIONS OF REGISTRATION 

A. Terms and Conditions for MON 89034 as Amended on December 15, 2008: 

1) The subject registration will automatically expire on midnight September 30, 2010. 

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 data in the time frames listed: 

OPPTS Guideline/ 

Study Type 

Required Data Due Date

Residue Analytical 

Method – Plants 

(OPPTS 860.1340) 

For event MON 89034 corn, an independent lab 

validation of the analytical method for the detection of 

Cry2Ab2 and/or Cry1A.105. You must also agree to 

provide to the EPA laboratory (Ft. Meade, MD) 

methodology and/or reagents necessary for validation of 

such analytical method within 6 months from the date 

that the Agency requests them. 

4/1/2009 

Aquatic 

Invertebrate Acute 

Toxicity Testing, 

Freshwater 

Daphnids (OPPTS 

885.4240) 

A 7-14 day Daphnia study as per the 885 Series OPPTS 

Guidelines needs to be performed. Alternatively, a 

dietary study of the effects on an aquatic invertebrate, 

representing the functional group of a leaf shredder in 

headwater streams, can be performed and submitted in 

lieu of the Daphnia study. 

9/1/2009*

Insect Resistance 

Management – 

Monsanto must provide additional information on crossresistance of Cry1A.105 and Cry1Ac (preferably 7/1/2009*

 
213

OPPTS Guideline/ 

Study Type 

Required Data Due Date

Resistance 

Monitoring 

including binding site models and use of resistant 

colonies) for the target pests and determine how such 

cross-resistance may impact the durability of MON 

89034, including any impacts in the southern cottongrowing areas. The Cry1A.105 protein is a chimeric 

protein consisting of Domains I and II and the Cterminus of Cry1Ac. It is important to address not only 

the likelihood of cross-resistance potential of 

Cry1A.105 and Cry1Ab and, similarly, Cry1A.105 and 

Cry2Ab2 (which was done by Monsanto) but also that 

of Cry1A.105 and Cry1Ac. 
214

OPPTS Guideline/ 

Study Type 

Required Data Due Date 

Insect Resistance 

Management – 

Resistance 

Monitoring 

Baseline susceptibility studies and/or a discriminating 

concentration assay are required for the Cry1A.105 

protein against European corn borer (ECB), 

Southwestern corn borer (SWCB), and corn earworm 

(CEW) and for the Cry2Ab2 protein against SWCB and 

CEW. 

7/1/2009*

for ECB 

and CEW 

8/31/2010* 

for SWCB 

Insect Resistance 

Management – 

Resistance 

Monitoring 

To support sweet corn uses, baseline susceptibility 

studies must be conducted on fall armyworm (FAW) 

populations collected from sweet corn growing areas. 

Monitoring studies will be conducted on FAW 

populations collected from sweet corn distribution areas 

in states in which Monsanto MON 89034 and/or MON 

89034 x MON 88017 sweet corn plantings exceed 5,000 

acres. The collected populations of FAW will be 

monitored for changes in susceptibility to the 

Cry1A.105 and Cry2Ab2 proteins. 

4/1/2010 

*

 Extensions were granted as listed in the above table. 

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,” which impose binding contractual obligations on the grower to comply with 

the refuge requirements; 

• Requirements regarding programs to educate growers about IRM requirements; 

• Requirements regarding programs to evaluate and promote growers’ compliance with 

IRM requirements; 

• Requirements regarding programs to evaluate whether there are statistically significant 

and biologically relevant changes in target insect susceptibility to Cry1A.105 and 

Cry2Ab2 proteins in the target insects; 

• Requirements regarding a “remedial action plan,” which 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; 
215

• 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 

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

product use guide. 
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• 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. 
217

 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 of 
219

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. 

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. 

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 
220

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 noncompliance, 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. 

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: 

 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. 

(10) 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 
221

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. 

 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 
222

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: 

 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; 
223

• 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 

 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. 
224

 (3) Response to Confirmed Resistance in a Key Target Pest as the Cause of Unexpected 

Levels of Damage in the Field 

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

Monsanto: 

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

• Affected customers and extension agents will be notified about confirmed 

resistance within 30 days; 

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

will be sampled annually to determine the extent and impact of resistance; 

• If appropriate (depending on the resistant pest species, the extent of resistance, the 

timing of resistance, and the nature of resistance, and the availability of suitable 

alternative control measures), alternative control measures will be employed to 

reduce or control target pest populations in the affected area. Alternative control 

measures may include advising customers and extension agents in the affected area 

to incorporate crop residues into the soil following harvest to minimize the 

possibility of over-wintering insects, and/or applications of chemical insecticides; 

• Unless otherwise agreed with EPA, stop sale and distribution of the relevant 

lepidopteran-active Bt corn hybrids in the affected area immediately until an 

effective local mitigation plan approved by EPA has been implemented; 

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

days according to the characteristics of the resistance event and local agronomic 

needs. Monsanto will consult with appropriate stakeholders in the development of 

the action plan, and the details of such a plan shall be approved by EPA prior to 

implementation; 

• Notify affected parties (e.g., growers, consultants, extension agents, seed 

distributors, university cooperators and state/federal authorities as appropriate) in 

the region of the resistance situation and approved action plan; and 

• In subsequent growing seasons, maintain sales suspension and alternative resistance 

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

affected by the resistant population until an EPA-approved local resistance 

management plan is in place to mitigate the resistance. 

 A report on results of resistance monitoring and investigations of damage reports must be 

submitted to the Agency annually by August 31st each year, beginning in 2010, for the duration 

of the conditional registration. 
225

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. 
226

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-10 

1) The subject registration will automatically expire on midnight September 30, 2010. 

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) Submit the following data in the time frames listed: 

OPPTS Guideline/ 

Study Type 

Required Data Due Date 

Residue Analytical 

Method – Plants 

(OPPTS 860.1340) 

For event MON 89034 x MON 88017 corn, an independent 

lab validation of the analytical method for the detection of 

Cry2Ab2 and/or Cry1A.105. You must also agree to provide 

to the EPA laboratory (Ft. Meade, MD) methodology and/or 

reagents necessary for validation of such analytical method 

within 6 months from the date that the Agency requests 

them. 

4/1/2009 

Aquatic 

Invertebrate Acute 

Toxicity Testing, 

Freshwater 

Daphnids (OPPTS 

885.4240) 

A 7-14 day Daphnia study as per the 885 Series OPPTS 

Guidelines needs to be performed. Alternatively, a dietary 

study of the effects on an aquatic invertebrate, representing 

the functional group of a leaf shredder in headwater streams, 

can be performed and submitted in lieu of the Daphnia

study. 

9/1/2009* 
227

Insect Resistance 

Management – 

Resistance 

Monitoring 

Monsanto must provide additional information on crossresistance of Cry1A.105 and Cry1Ac (preferably including 

binding site models and use of resistant colonies) for the 

target pests and determine how such cross-resistance may 

impact the durability of MON 89034, including any impacts 

in the southern cotton-growing areas. The Cry1A.105 

protein is a chimeric protein consisting of Domains I and II 

and the C-terminus of Cry1Ac. It is important to address not 

only the likelihood of cross-resistance potential of 

Cry1A.105 and Cry1Ab and, similarly, Cry1A.105 and 

Cry2Ab2 (which was done by Monsanto) but also that of 

Cry1A.105 and Cry1Ac. 

7/1/2009*

 

Insect Resistance 

Management – 

Resistance 

Monitoring 

Baseline susceptibility studies and/or a discriminating 

concentration assay are required for the Cry1A.105 protein 

against European corn borer (ECB), Southwestern corn borer 

(SWCB), and corn earworm (CEW) and for the Cry2Ab2 

protein against SWCB and CEW. 

7/1/2009* 

For ECB 

and CEW 

8/31/2010* 

For SCWB *

 Extensions were granted as listed in the table above. 

OPPTS Guideline/ 

Study Type 

Required Data Due Date 

Insect Resistance 

Management – 

Resistance 

Monitoring 

To support sweet corn uses, baseline susceptibility studies 

must be conducted on fall armyworm (FAW) populations 

collected from sweet corn growing areas. Monitoring studies 

will be conducted on FAW populations collected from sweet 

corn distribution areas in states in which Monsanto MON 

89034 and/or MON 89034 x MON 88017 sweet corn 

plantings exceed 5,000 acres. The collected populations of 

FAW will be monitored for changes in susceptibility to the 

Cry1A.105 and Cry2Ab2 proteins. 

4/1/2010 

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) The Insect Resistance Management (IRM) terms and conditions for this product are as 

follows. 
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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,” which impose binding contractual obligations on the 

grower to comply with the refuge requirements; 

• Requirements regarding programs to educate growers about IRM requirements; 

• Requirements regarding programs to evaluate and promote growers’ compliance 

with IRM requirements; 

• Requirements regarding programs to evaluate whether there are statistically 

significant and biologically relevant changes in target insect susceptibility to 

Cry1A.105, Cry2Ab2, and Cry3Bb1 proteins in the target insects; 

• Requirements regarding a “remedial action plan,” which 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. 

 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 
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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 can be treated with a soil-applied or seed-applied insecticide to 

control rootworm larvae and other soil pests. The refuge can also be treated with a non-Bt foliar 

insecticide for control of late season pests if pest pressure reaches an economic threshold for 

damage (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 can be treated with a soilapplied 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 

(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 can 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 can be treated with a soil-applied or seed- applied 

insecticide to control rootworm larvae and other soil pests. The refuge can also be treated with a 

non-Bt foliar insecticide for control of late season pests; however, if rootworm adults are present 

at the time of foliar applications, then the 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, 
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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. 

 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 can be treated with a soil-applied or seed-applied insecticide to 

control rootworm larvae and other soil pests. The refuge can also be treated with a non-Bt foliar 

insecticide for control of late season pests if pest pressure reaches an economic threshold for 

damage (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 can be treated with a soilapplied 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 

(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 can 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 can be treated with a soil-applied or seed-applied 

insecticide to control rootworm larvae and other soil pests. The refuge can also be treated with a 

non-Bt foliar insecticide for control of late season pests; however, if rootworm adults are present 

at the time of foliar applications then the 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 
231

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

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

in supplements to the grower guide/product use guide. 

• Crop destruction must occur no later than 30 days following harvest, but 

preferably within 14 days. 

• The allowed crop destruction methods are: rotary mowing, discing, or plow down. 

Crop destruction methods should destroy any surviving resistant insects. 

 c) Grower Agreements for MON 89034 x MON 88017 

1) Persons purchasing MON 89034 x MON 88017 must sign a grower agreement. The term 

“grower agreement” refers to any grower purchase contract, license agreement, or similar 

legal document. 

 2) The grower agreement and/or specific stewardship documents referenced in the grower 

agreement must clearly set forth the terms of the current IRM program. By signing the 

grower agreement, a grower must be contractually bound to comply with the 

requirements of the IRM program. 

3) Monsanto must 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 
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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 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. 
233

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 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. 

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. 
234

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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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 

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 
236

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; 

• 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. 
237

 (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: 

• 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 
238

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 

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 
239

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. 

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 
240

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. 
241

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-10 

OAM 1

1) Submit and/or cite all data required for registration/ registration review of your product under 

FIFRA section 3(c)(5) when the Agency requires all registrants of similar products to submit 

such data. 

2) The subject registration will automatically expire on midnight September 30, 2010. 

3) 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. 

4) Submit or cite all data required to support the Herculex XTRA and the Herculex I plantincorporated protectant products within the timeframes required by the terms and conditions of 

EPA Registration Numbers 29964-3 and 29964-5. 

5) The subject registration will be limited to 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 

attempt to obtain benchmark susceptibility data using the 

Sublethal Seedling Assay for NCRW as well. 

12/1/2010 for 

WCRW 

12/1/11 for 

NCRW 

Insect Resistance 

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 
242

6) Pioneer must commit to do the following Insect Resistance Management Program for 

OAM1. 

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,” 

which 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,” which contains measures Pioneer would take 

in the event that any field-relevant insect resistance was detected as well as to report on activity 

under the plan to EPA; 

Annual reports on units sold by state (units sold by county level will be made available to the 

Agency upon request), IRM grower agreements results, and the compliance assurance program 

including the educational program on or before January 31st of each year, beginning in 2011. 

a) Refuge requirements for OAM1 

Because the refuge for corn rootworm is blended in each bag or box of OAM1 seed, no 

additional corn rootworm refuge is required. A refuge must be planted for corn borers. The 

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

corn borers. Refuge options are based on the planting of OAM1 in cotton or non-cotton growing 

regions and insect pressure present in those locations. The refuge sizes for these regions are 

either 50% in cotton-growing regions (i.e., 50 acres of corn that does not contain Bt technology 

for the control of corn borers for every 50 acres of OAM1) or 20% in non-cotton growing 

regions (i.e., 20 acres of corn that does not contain Bt technology for the control of corn borers 

for every 80 acres of OAM1). Refuge planting options include: separate fields, blocks within 

fields (e.g., along the edges or headlands), and strips across the field. Cotton-growing regions 

consist of the following states Alabama, Arkansas, Georgia, Florida, Louisiana, North Carolina, 

Mississippi, South Carolina, Oklahoma(only the counties of Beckham, Caddo, Comanche, 
243

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). 

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 

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. 
244

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 conduct targeted, on-farm compliance assessments for growers who 

purchase OAM1 seed to ensure growers are compliant with the requirement of a 

20% refuge for lepidopteran pests. For the 2010 growing season, Pioneer must 

conduct at least 500 on-farm assessments or roughly half the number of 

assessments that Pioneer will contribute to the 2010 Agricultural Biotechnology 

Stewardship Technical Committee (ABSTC) compliance assurance program 

assessment for corn borer and stacked products. Beginning in 2011 and annually 

thereafter, Pioneer will 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. 

Number of on-farm assessments conducted by Pioneer 

Products Year: 2010 

Year: 2011, 

annually 

thereafter 
245

Corn Borer and Stacked 

Products 1000 750-1000 

OAM1 500 1500-2000 

Total 1500 2250-3000 

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, January 31, 2011 and annually thereafter. 

3. 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. 

4. 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. 

d) Insect Resistance Monitoring for OAM1 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 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: 
246

• 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 

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. 
247

If resistance is "suspected", Pioneer will inform growers in the area of the potential benefit of 

augmenting CRW control such as adulticide treatment and/or crop rotation or use of soil or seedapplied insecticides at rates providing corn rootworm control the following year. These 

measures are intended to educate growers of the potential for change in efficacy, reduce the 

possibility of grower loss from change in efficacy and reduce potentially resistant insects 

contributing to the following year's pest population. 

2. Confirmed Resistance from Population Monitoring 

Definition of Confirmed Resistance - Resistance will be confirmed if all of the following criteria 

are met by progeny from a subsequent rootworm population collected from the area of 

"suspected resistance" the following year: 

• Injury potential of the subsequent field-collected rootworm population feeding on 

plants containing DAS-59122-7 remains at a level likely to produce repeated 

product failure in field conditions; 

• The change in injury potential has been documented as a heritable characteristic 

of the target pest population; 

• Greenhouse node-injury evaluation confirms product failure; 

• Subsequent populations collected from the area and assayed show that the results 

are repeatable; and 

• Continued monitoring of the area suggests that the change is spreading. 

3. Suspected Resistance – Investigation of Field Reports 

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

product performance due to corn rootworm species listed on the label. The registrants will 

instruct its customers to contact them if such incidents occur. The registrants will investigate all 

such reports submitted to the company or the company’s representatives. 

• Confirm the corn in question is rootworm-active Bt corn; 

• Confirm the field in question contains the correct blend rate of refuge corn; 

• Confirm that species not susceptible to the protein are not responsible for the 

damage, that no climatic or cultural reasons could be responsible for the 

damage, and that all other reasonable causes based on historical experience for 

the observed root damage have been ruled out; 

• If not due to other reasons, the registrant will conduct a thorough investigation 

of the factors known to affect the manifestation of corn rootworm feeding 

damage. 

• If the investigation fails to rule out target pest resistance as the cause, 

resistance is suspected. 

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. 
248

Pioneer will collect insects as soon as possible from the area for laboratory studies to test for 

resistance by comparing with benchmark susceptibility data. These studies will be performed 

following the same laboratory protocols as used for the benchmark determination and monitoring 

programs. 

4. Confirmed Resistance – Investigation of Field Reports 

• Injury potential of the field-collected rootworm population feeding on plants 

containing DAS-59122-7 remains at a level likely to produce repeated product 

failure in field conditions; 

• Subsequent populations collected from the area and assayed show that the results 

are repeatable; 

• The change in injury potential has been documented as a heritable characteristic 

of the target pest population; 

• Greenhouse node-injury evaluation confirms product failure; and

• Continued monitoring of the area suggests that the change is spreading.

5. Remedial Action 

When resistance is "confirmed", the following steps will be taken: 

• The EPA will receive notification within 30 days of confirmed resistance; 

• Affected customers and Extension specialists will be notified about confirmed 

resistance; 

• Affected customers and Extension specialists will be 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; 

• Pioneer and EPA will jointly determine the extent of the mitigation needed and 

determine whether sales should be stopped on an appropriate geographic (i.e., 

county or regional) basis; and 

• Pioneer will develop a case-specific resistance mitigation action plan within 90 

days according to the characteristics of the resistance event and local agronomic 

needs. Pioneer will consult with appropriate stakeholders in the development of 

the action plan, and the details of such a plan shall be approved by the EPA prior 

to implementation. The resistance management plan could include such measures 

layering additional technologies in future OAM1 products. 

f) Remedial Action Plan for lepidopteran pests and OAM1 Corn 

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

registrant: 

• EPA will receive notification within 30 days of resistance confirmation; 
249

• 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; 

• 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. 
250

• 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 

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. 
251

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-10 

OAM RW

1) Submit and/or cite all data required for registration/ registration review of your product under 

FIFRA section 3(c)(5) when the Agency requires all registrants of similar products to submit 

such data. 

2) The subject registration will automatically expire on midnight September 30, 2010. 

3) Submit or cite all data required to support the Herculex RW plant-incorporated protectant 

products within the timeframes required by the terms and conditions of EPA Registration 

Number 29964-4. 

4) 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. 

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. 
252

5) Submit the following data in the timeframes listed: 

Study Type Required Data Due Date 

 

Insect Resistance 

Management 

Pioneer must implement an enhanced resistance 

monitoring plan for OAMRW. Pioneer must provide the 

Agency with a baseline (benchmark) study that shows 

the susceptibility of western corn rootworm populations 

(WCRW) in the Sublethal Seedling Assay prior to the 

large-scale introduction of OAMRW. Although northern 

corn rootworm (NCRW) is difficult to rear, Pioneer must 

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 

 

6) 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,” which 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: 
253

1. Pioneer must monitor for resistance and or changes in target pest susceptibility 

that will lead to increased injury potential in western and northern corn rootworm 

feeding on the rootworm component of OAMRW products. Sampling must be 

focused in the four regions of highest risk of resistance development: Region – 1 

(Illinois, Indiana); Region 2 (Iowa, Missouri), Region 3 (Nebraska and Kansas), 

and Region 4 (Minnesota, South Dakota and Wisconsin). 

2. Pioneer must provide the EPA its detailed western corn rootworm resistance 

monitoring plan for approval by December 1, 2010 and its northern corn 

rootworm resistance monitoring plan for approval by December 1, 2011. These 

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. 
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1. Suspected Resistance from Population Monitoring 

Definition of Suspected Resistance - Resistance will be suspected if investigations of target pest 

injury potential to OAMRW maize from the Sublethal Seedling Assay show that: 

• Injury potential of a target pest population obtained as part of the annual insect 

monitoring program has increased to a level representative of product failure in 

field conditions; 

• The seeds used in the investigation of this population’s injury potential contain 

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; 
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• 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

• Continued monitoring of the area suggests that the change is spreading.

5. Remedial Action 

When resistance is "confirmed", the following steps will be taken: 

• The EPA will receive notification within 30 days of confirmed resistance; 

• Affected customers and Extension specialists will be notified about confirmed 

resistance; 

• Affected customers and Extension specialists will be 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; 

• Pioneer and EPA will jointly determine the extent of the mitigation needed and 

determine whether sales should be stopped on an appropriate geographic (i.e., 

county or regional) basis; and 

• Pioneer will develop a case-specific resistance mitigation action plan within 90 
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days according to the characteristics of the resistance event and local agronomic 

needs. Pioneer will consult with appropriate stakeholders in the development of 

the action plan, and the details of such a plan shall be approved by the EPA prior 

to implementation. The resistance management plan could include such measures 

layering additional technologies in future OAMRW products. 

c) Refuge Assurance Program for OAMRW Corn 

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.