### Proposed Terms and Conditions for

Bt Corn Registrations Se t to Expire in Fall 2010

Table of Contents

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

a. Reg. # 67979-1 Bt Corn Event Bt 11 with Cry 1Ab (Field Corn)

b. Reg. # 65268-1 Bt Corn Event Bt 11 with Cry 1Ab (Sweet Corn)

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

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

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

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

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


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

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

b. Reg. # 524-545 Bt Corn Stack Events MON 863 + MON 810 with Cry3Bb1 + Cry1Ab

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

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

3Bb1


### III. Cry 34Ab1/Cry35Ab1 BRAD Regist ered Products (pp.106-190)

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


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



### c. Reg. # 68467-6 Bt Corn Event DAS-59122-7 + TC1507 with Cry34Ab1/Cry35Ab1 + PO Cry1F


### d. Reg. # 29964-5 Bt Corn Event DAS-59122-7 + TC1507 with Cry34Ab1/Cry35Ab1 + PO Cry1F



### e. Reg. # 29964-8 TC1507 (PO Cry1F) x DAS -59122 (PO Cry34Ab1/Cry35Ab1) x MON 810 (Cry 1Ab)


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


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

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


### b. Reg. # 67979-8 Bt Corn Events MIR 604 + Bt 11 with modified Cry3A + Cry1Ab


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

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

b. Reg. # 524-576 Bt Corn Events MON 89034 + 88017 with Cry1A.105 + Cry2Ab2 + Cry 3Bb1


### VI. OAM BRAD Registered Pr oducts (pp.241-263)

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

b. Reg. # 29964-6 Optimum AcreMax RW Seed Blend of Herculex RW + Non- Bt

corn

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

Date Registered Date Expired Registrant Registration # Active Ingredients

Syngenta 67979-1 Bt corn Event Bt 11 with Cry1Ab (field corn – AgriSure CB) Feb-98 30-Sep-15

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

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

1Ab for use in field corn.

3] Submit/cite all data required for registrati on of your product under FIFRA § 3(c)(5) when the Agency requires registrants of si milar 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 register ed plant-incorporated protectants to produce inbred corn lines and hybrid corn varie ties with combined pesticidal traits.

5] In light of recently published laboratory st udies showing reduced growth in shredding caddis flies exposed to anti-lepidopteran Cry1A protei n corn litter (Rosi-Marshall, et al. 2007), additional aquatic invertebrate da ta are required. A 7 to 14 day Daphnia magna study as per the 885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, representing the functional group of a leaf shre dder in headwater streams must be submitted by January 31, 2012.

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

Insect Resistance Management:

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

1] Requirements relatin g 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 B t corn users to sign “grower agreements” that impose binding contractual obliga tions on the grower to comply with the refuge requirements;

3] Requirements regarding programs to e ducate 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

1insects;

6] Requirements regarding a “remed ial action plan” that contains measures the registrants would take in the event that any field relevant insect resistance was detected as well as to report on activity under the plan to EPA;

7] Submit annual reports on units so ld by state (units sold by count y level will be made available to the Agency upon request), IRM grower agre ements 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 pr opagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

1] Corn-Belt Refuge Requirements

Field corn grown outside cotton- growing areas (e.g., the Corn Belt), grower agreements (also known as stewardship agreements) will specify that growers must adhere to the refuge requirements as described in th e grower guide/product use guide and/or in supplements to the grower guide/product use guide.

· Specifically, growers must plant a stru ctured 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 stal k-boring and other pests.

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

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

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

· Insecticide treatments for cont rol of ECB, CEW, Southwestern corn borer (SWCB) and other lepidopteran target pest s 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., Extens ion Service agents, crop consultants). Instructions to growers w ill specify that microbial Bt insecticides must not be applied to

non- Bt corn and/or non-le pidopteran resistant Bt corn refuges.

2] Cotton-Growing Area Refuge Requirements for Bt Corn

2For Bt field corn grown in cotton-growing areas, gr ower 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 supplem ents to the grower guide/product use guide.

· Specifically, growers in these areas must plan t 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 fi elds, 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 fiel d, refuges must be at least 4 rows wide.

· Insecticide treatments for control of ECB, CEW, Southwestern co rn borer (SWCB), and other lepidopteran target pest s 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., Extens ion Service agents, crop consultants). Instructions to growers w ill specify that microbial Bt insecticides must not be applied to

non- Bt corn and/or non-le pidopteran resistant Bt corn refuges.

· Cotton-growing areas include the following stat es: Alabama, Arkansas, Georgia, Florida, Louisiana, North Carolina, Mi ssissippi, South Carolina, Oklahom a (only the counties of Beckham, Caddo, Comanche, Cu ster, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, Washita), Tennessee (only the counties of Ca rroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Hayw ood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), Texa s (except the counties of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, M oore, 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 stew ardship 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 bou nd to comply with the requirements of the IRM

program.

3] The registrant must maintain a system that is reasonably likely to assure that persons purchasing the Bt corn product will affirm annually that they are contractually bound to comply with the requirements of the IRM program.

34] The registrant must continue to use their current grower agreemen t. If the registrant wishes to change any part of the grower agreement or any specific stewardship documents referenced in the grower agreement that woul d 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 th e terms and conditions of the amendment.

5] The registrant must maintain a system that is reasonably likely to assure that persons purchasing the Bt corn sign grower agreement(s).

6] The registrant shall maintain records of all Bt corn grower agreements for a period of three years from December 31 of the year in which the agreement was signed.

7] The registrant shall provi de EPA with a report showin g 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 name s, personal information, and grower license number, will be protected.

c. IRM Education and IRM Co mpliance Monitoring Programs

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

convey to Bt corn users the importance of complyi ng with the IRM program. The education program shall involve the use of multiple medi a, e.g. face-to-face meetings, mailing written materials, EPA reviewed language on IRM requirem ents on the bag or bag tag, and electronic communications such as by Internet, radio, or te levision commercials. Copies of the materials will be provided to EPA for its records. Th e 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 curre nt IRM requirements. The registrant shall coordinate its education programs with educa tional efforts of other registrants and other organizations, such as the National Corn Grow er Association and stat e extension programs.

2] Annually, the registrant shall revise, and expand as necessary, its education program to take into account the information collected through th e compliance survey required and from other sources. The changes shall address aspects of gr ower compliance that are not sufficiently high.

3] Annually, each January 31st, the registrant mu st provide EPA any substantive changes to its grower education activities as part of the overall IRM complianc e assurance program report. The registrant must either submit a separate repo rt 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 wh ich growers purchasing its Bt corn product are complying with the IRM program and that takes such actions as are reas onably needed to assure that growers who have

4not 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 wi ll 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 r ecognizing that for reasons of di fference in busin ess 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 grow er or for all growers in a specific region. An individual grow er found to be significantly ou t of compliance two years in a row would be denied sales of the product the ne xt year. Similarly, s eed dealers who are not fulfilling their obligations to inform/educate grow ers 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 th e potential impact of non-response. The sample size and geographical resolution may be ad justed annually, based upon input from the independent marketing research firm and academic scientists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasonable sensitivity for comparing results across the U.S.

i. A third party is classified as a party ot her than the registrant, the grower, or anyone else with a direct interest in IRM compliance for Bt corn.

7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potenti al biological significance of any implementation deviations.

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

educational tools and initiatives.

9] The registrant shall provide a written summary of the result s of the prior year's survey (together with a description of the regions, the methodology us ed, 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 surv ey prior to its implementation.

10] Annually, the registrant sh all revise, and expand as necessary, its compliance assurance program to take into account the information co llected through the comp liance survey and from other sources. The changes shall address aspect s of grower compliance th at are not sufficiently high. The registrants must confer with the Agency prior to adopting any changes.

511] 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 acti on, consistent with its “pha sed compliance approach.”

13] If a grower, who purchases Bt corn for planting, was specifica lly identified as not being in compliance during the previous year, the registra nt shall visit with the grower and evaluate whether that the grower is in compliance w ith the IRM program for the current year.

14] Each registrant shall annually provide a report to EPA summa rizing 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 re port will include information regarding grower interactions (including, but not li mited to, on-farm visits, verified tips and complaints, grower meetings and letters), the extent of non-comp liance, corrective measures to address the noncompliance, and any follow-up actions taken. The registrants may el ect to coordinate information and report collectively the result s of their compliance assurance programs.

15] The registrant and the seed corn dealers fo r the registrant must allow a review of the compliance records by EPA or by a State pesticid e regulatory agency if the State agency can

demonstrate that confidential business information, including the names, personal information, and grower license number of the growers will be protected.

16] The registrant shall revise and expand its existing Compliance Assurance Program to include the following elements. The registrant must prepare and submit by January 31, 2011, a written description of its revised Comp liance Assurance Program. The regi strant may coordinate with other registrants in designing and implem enting its Compliance Assurance Program.

17] The registrant will enha nce the refuge education prog ram throughout the seed delivery

channel:

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of correct refuge implementation and pot ential consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the next three growing seas ons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

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

risks for resistance:

6i. Use Bt corn adoption, pest pressu re information, and other available information to identify regions where the risk of resistance is greatest;

ii. Focus approximately two-thir ds of on-farm assessments on these regions, with the remaining assessments conducted across other regions where the product is used.

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

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

i. Identify for potential on-farm assessment growers whose sales informati on indicates they have purchased the Bt corn product but may have purchased little or no refuge seed from the registrant, licensee, or affiliated company.

20] The registrant will contract with third part ies to perform on-farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all firs t-time on-farm assessments as well as second-year on-farm assessments of those growers found out of compliance in a first-time assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and level of refuge compliance for the product.

22] The registrant will follow up with grower s who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

i. All growers found to be signif icantly out of compliance in a pr ior year will annually be sent additional refuge assistance info rmation for a minimum of two years by the registrant, seed supplier, or third party assessor, afte r completing the assessment process;

ii. The registrant will conduct follow-up checks on growers found to be significantly out of compliance within three year s after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a five-year period will be denied access to the Bt corn product in the subsequent year.

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

d. Insect Resistance Monitori ng and Remedial Action Plan

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

The registrant will monitor for resistance to its lepidopteran-resistant Bt corn. The monitoring program shall consist of two a pproaches: (1) focused population sampling and laboratory testing; and (2) investigation of reports of less-than ex pected control of labeled insects. Should fieldrelevant resistance be confirmed, an appropri ate resistance management action plan will be implemented.

7(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 th e target pests will be focused

in areas identified as those with the highest risk of re sistance development (e.g., where lepidopteran-active Bt hybrids are planted on a high proportion of the co rn acres, and where the insect species are regarded as key pests of corn). Bioassay met hods must be appropriate for the goal of detecting field-relevant shifts in population response to lepidopteran resistant Bt corn and/or changes in resist ance allele frequency in response to the use of Bt corn and, as far as possible, should be consistent ac ross sampling years to enable co mparisons with historical data.

The number of populations to be collected shall reflect the regional im portance of the insect species as a pest, and specific collection region s will be identified for each pest. For ECB, a minimum of 12 populations across the sampling re gion 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 allele s before they become common enough to cause measurable field damage, each population collectio n 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 in sect populations or genomes due to factors such as natural fluctuations in pest density, environmental conditions, and area-wid e pest suppression.

The sampling program and geographic range of co llections may be modi fied 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 sh all be investigated as soon as possible to understand a ny field relevance of such a fi nding. 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 Ag ency annually before A ugust 31. The investigative steps will include:

1. Re-test progeny of the collected population to determine whether the unusual bioassay response is reproducible and herita ble. If it is not reproducible a nd heritable, no further action is required.

2. If the unusual response is re producible and heritable, proge ny of insects that survive the diagnostic concentration will be tested using me thods that are representative of exposure to Bt corn hybrids under field conditions. If progeny do not survive to ad ulthood, any suspected

resistance is not fiel d relevant and no furthe r action is required.

3. If insects survive steps 1 and 2, resistance is confirmed, and further steps will be taken to

8evaluate 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 freq uency in the original population;

• determining whether the resistance-allele frequency is increasi ng 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 th e 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 Ag ency to develop and implement a case-specific resistance management action plan.

(2) Investigation of Reports of Unexpect ed Levels of Damage by the Target

Pests:

The registrant will follow up on gr ower, extension specialist or c onsultant reports of unexpected levels of damage by the lepidopteran pests list ed on the pesticide label. The registrant will

instruct its customers to contact them if such in cidents occur. The registra nt will investigate all legitimate reports submitted to the comp any 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 registra nt 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 unexpect ed levels of insect feeding damage for which:

• the corn in question has been c onfirmed to be lepidopteran-active Bt corn;

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

• the relevant plant tissues are ex pressing the expected level of Bt protein; and

• it has been ruled out th at species not susceptible to the protein could be responsible for the damage, that no climatic or cultural reas ons could be responsible for the damage, and

that that there could be no othe r reasonable causes for the damage.

The Agency does not interpret suspected resistance to mean grower report s of possible control

9failures or suspicious results fr om annual insect monitoring assa ys, 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 fiel ds 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 pr actices to minimize the possibility of resistant insects over-wintering and contribu ting to the next season's target pest population.

Additionally, if possible, and prior to the app lication of alternative control measures or destruction of crop residue, the re gistrant will collect samples of the insect population in the affected fields for laboratory rearing and testin g. Such rearing and testing shall be conducted as expeditiously as practical.

Confirmed resistance

EPA defines confirmed resistance to mean, in the case of field re ports of unexpected levels of damage from the key target pests, th at all the following criteria are met:

• There is > 30% insect survival and commensurate ins ect 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 th ere may be a resistance allele frequency of ≥ 0.1 in the sampled population.

• In standardized labora tory bioassays, the LC 50 exceeds the upper limit of the 95%

confidence interval of the LC 50 for susceptible populations su rveyed both in the original baselines developed for this pest species and in previous years of field monitoring.

(3) Response to Confirmed Resistance in a Ke y 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 wi ll be notified about confirmed resistance

10within 30 days;

• Monitoring will be increased in the affected ar ea 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 availab ility of suitable alternative control measures), alternative control measur es will be employed to reduce or control target pest populations in th e affected area. Alternative control measures may include advising customers and extensi on agents in the affected area to incorporate crop residues into the soil following harvest to minimi ze 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, consulta nts, extension agents , seed distributors, university cooperators and state/ federal authorities as approp riate) in the region of the resistance situation and approved action plan; and

• In subsequent growing seasons, maintain sa les 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 resistan ce management plan is in place to mitigate the resistance.

A report on results of resistan ce monitoring and investigations of damage reports must be submitted to the Agency annually by August 31 st each year for the duration of the conditional registration.

e. Annual Reports

1] Annual Sales: reported and summed by state (county level data availa ble by request), January 31st each year;

2] Grower Agreement: number of units of Bt corn seeds shipped or sold and not returned, and the number of such units that were sold to persons who have signed grower agreements, January 31st each year;

3] Grower Education: substantive changes to education program completed the previous year, January 31st each year;

114] Compliance Assurance Plan: Compliance Assu rance Program activities and results, January 31st each year;

5] Compliance: to includ e annual survey resu lts and plans for the next year; full report January 31st each year;

6] Insect Resistance Monitoring Results: results of monitoring and inves tigations of damage reports, August 31st each year.

If these conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA section 6(e). Your release for shipment of Bt 11 field corn constitutes acceptance of these conditions.

12Date Registered Date Expired Registrant Registration # Active Ingredients

Syngenta 65268-1 Bt corn Event Bt 11 with Cry1Ab ( sweet corn - Attribute--no refugia for sweet corn) Feb-98 30-Sep-15

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

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

1Ab for use in sweet corn.

3] Submit/cite all data required for registrati on of your product under FIFRA § 3(c)(5) when the Agency requires registrants of si milar 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 register ed plant-incorporated protectants to produce inbred corn lines and hybrid corn varie ties with combined pesticidal traits.

5] In light of recently published laboratory st udies showing reduced growth in shredding caddis flies exposed to anti-lepidopteran Cry1A protei n corn litter (Rosi-Marshall, et al. 2007), additional aquatic invertebrate da ta are required. A 7 to 14 day Daphnia magna study as per the 885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, representing the functional group of a leaf shre dder in headwater streams must be submitted by January 31, 2012.

6] The Agency is requiring prot ein expression data in terms of dry weight, as the amount of protein present in the give n tissue, specifically for Bt 11 sweet corn. Tissues for which expression data must be provided include: leaf, root, pollen, seed, and whole plant. In addition, data for each of these tissues should be pr ovided for young plants in rapid growth, during flowering, and mature plants before harvest when th at part of the plant is present. Data are due on or before January 31, 2012.

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

Insect Resistance Management:

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

1] Requirements (except for home garden use or educational use, i.e., marketed to home gardeners or educators for use on less than 20 acre s) for the registrants to prepare and require B t corn users to sign “grower agreements” that impose binding contractual obligations on the grower to comply with the refuge requirements;

2] Requirements regarding programs to e ducate growers about IRM requirements;

133] Requirements regarding programs to evaluate and promote growers’ compliance with IRM requirements (except for home garden use or edu cational 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 “remed ial action plan” that contains measures the registrants would take in the event that any field relevant insect resistance was detected as well as to report on activity under the plan to EPA;

6] Submit annual reports on units so ld by state (units sold by count y level will be made available to the Agency upon request), IRM grower agre ements 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 a nnual reports on total number of estimated acres sold and the compliance assurance program incl uding the education program on or before January 31 st each year.

a. Sweet Corn Post-Harvest Requirements

Sweet corn is harvested long before field corn. Th erefore, if the sweet corn stalks remaining in the field and any insects remaining in the stalks are destroyed shortly afte r harvest, a refuge is not needed as a part of the IR M program for sweet corn. Growers must adhere to the following types of crop destruction requirements as descri bed in the grower guide/product use guide and/or in supplements to the grower gui de/product use guide, and in the case of home gardeners on the seed packet, in seed catalogues, and on websites offering Attribut e 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: rota ry 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 stew ardship 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 bou nd to comply with the requirements of the IRM

program.

143] The registrant must maintain a system that is reasonably likely to assure that persons purchasing the Bt corn product will affirm annually that they are contractually bound to comply with the requirements of the IRM program.

4] The registrant must continue to use their current grower agreemen t. If the registrant wishes to change any part of the grower agreement or any specific stewardship documents referenced in the grower agreement that woul d 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 th e terms and conditions of the amendment.

5] The registrant must maintain a system that is reasonably likely to assure that persons purchasing the Bt corn sign grower agreement(s).

6] The registrant shall maintain records of all Bt corn grower agreements for a period of three years from December 31 of the year in which the agreement was signed.

7] The registrant shall provi de EPA with a report showin g 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 name s, personal information, and grower license number, will be protected.

c. IRM Education and IRM Co mpliance Monitoring Programs

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

convey to Bt corn users the importance of complyi ng with the IRM program. The education program shall involve the use of multiple medi a, e.g. face-to-face meetings, mailing written materials, EPA reviewed language on IRM requirem ents on the bag or bag tag, and electronic communications such as by Internet, radio, or te levision commercials. Copies of the materials will be provided to EPA for its records. Th e 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 e ducation programs with educational efforts of other regi strants 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 th e compliance survey required and from other sources. The changes shall address aspects of gr ower compliance that are not sufficiently high.

3] Annually, each January 31st, the registrant mu st provide EPA any substantive changes to its grower education activities as part of the overall IRM complianc e assurance program report. The registrant must either submit a separate repo rt or contribute to the report from the industry

15working group (ABSTC).

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

evaluate the extent to wh ich growers purchasing its Bt corn product are complying with the IRM program and that takes such actions as are reas onably 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 regist rants in designing and implem enting its compliance assurance

program.

The following IRM Education and IRM Comp liance 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 wi ll 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 r ecognizing that for reasons of di fference in busin ess 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 grow er or for all growers in a specific region. An individual grow er found to be significantly ou t of compliance two years in a row would be denied sales of the product the ne xt year. Similarly, s eed dealers who are not fulfilling their obligations to inform/educate grow ers 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 Bt 11 sweet corn. The survey shall measure the degree of compliance with the IRM program, identif y the response rate (e.g., the percent of Bt sweet corn acres covered by the responses), and cons ider the potential impact of non-response. An independent third party will participate in the de sign and implementation of the survey. Data and information derived from the annual survey wi ll be audited by an independent third party.

i. A third party is classified as a party ot her than the registrant, the grower, or anyone else with a direct interest in IRM compliance for Bt corn.

7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potenti al biological significance of any implementation deviations.

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

educational tools and initiatives.

9] The registrant shall provide a written summary of the result s 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 cha nges to the design and content of the survey prio r to its implementation.

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

16program to take into account the information co llected through the comp liance survey and from other sources. The changes shall address aspect s of grower compliance th at are not sufficiently high. The registrants must confer with the Agency prior to adopting any changes.

11] The registrant shall train its repres entatives who make on-farm visits with Bt corn growers to perform assessments of compliance with IRM requirements. In the ev ent 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, consiste nt with its "phased co mpliance 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 acti on, consistent with its “pha sed compliance approach.”

13] If a grower, who purchases Bt corn for planting, was specifica lly identified as not being in compliance during the previous year, the registra nt shall visit with the grower and evaluate whether that the grower is in compliance w ith the IRM program for the current year.

14] Each registrant shall annually provide a report to EPA summa rizing 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 re port will include information regarding grower interactions (including, but not li mited to, on-farm visits, verified tips and complaints, grower meetings and letters), the extent of non-comp liance, corrective measures to address the noncompliance, and any follow-up actions taken. The registrants may el ect to coordinate information and report collectively the result s of their compliance assurance programs.

15] The registrant and the seed corn dealers fo r the registrant must allow a review of the compliance records by EPA or by a State pesticid e regulatory agency if the State agency can

demonstrate that confidential business information, including the names, personal information, and grower license number of the growers will be protected.

16] The registrant shall revise and expand its existing Compliance Assurance Program to include the following elements. The registrant must prepare and submit by January 31, 2011, a written description of its revised Comp liance Assurance Program. The regi strant may coordinate with other registrants in designing and implem enting its Compliance Assurance Program.

17] The registrant will enha nce the refuge education prog ram throughout the seed delivery

channel:

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of correct refuge implementation and pot ential consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the next three growing seas ons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

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

17risks for resistance:

i. Use Bt corn adoption, pest pressu re information, and other available information to identify regions where the risk of resistance is greatest;

ii. Focus approximately two-thir ds of on-farm assessments on these regions, with the remaining assessments conducted across other regions where the product is used.

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

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

i. Identify for potential on-farm assessment growers whose sales informati on indicates they have purchased the Bt corn product but may have purchased little or no refuge seed from the registrant, licensee, or affiliated company.

20] The registrant will contract with third part ies to perform on-farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all firs t-time on-farm assessments as well as second-year on-farm assessments of those growers found out of compliance in a first-time assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and level of refuge compliance for the product.

22] The registrant will follow up with grower s who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

i. All growers found to be signif icantly out of compliance in a pr ior year will annually be sent additional refuge assistance info rmation for a minimum of two years by the registrant, seed supplier, or third party assessor, afte r completing the assessment process;

ii. The registrant will conduct follow-up checks on growers found to be significantly out of compliance within three year s after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a five-year period will be denied access to the Bt corn product in the subsequent year.

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

d. Insect Resistance Monitori ng and Remedial Action Plan

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

The registrant will monitor for resistance to its lepidopteran-resistant Bt corn. The monitoring program shall consist of two a pproaches: (1) focused population sampling and laboratory testing; and (2) investigation of reports of less-than ex pected control of labeled insects. Should field18relevant resistance be confirmed, an appropri ate resistance management action plan will be implemented.

(2) Focused Population Sampling

The registrant will develop and ensure the implementation of a pl an 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 capab le 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 m onitoring plan must be submitted to EPA by January 31 of the year following that in which Cry lAb sweet corn acr eage 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 impl emented 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 identifie d as those with the highe st 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 rega rded 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 a llele frequency in response to the use

of Bt corn and, as far as possible, should be c onsistent across samp ling years to enable comparisons with historical data.

The number of populations to be collected shall reflect the regional im portance of the insect species as a pest, and specific collection region s will be identified for each pest. For ECB, a minimum of 12 populations across the sampling re gion will be targeted for collection at each annual sampling. For CEW, the target will be a minimum of 10 popula tions. 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 masse s, larvae, mated females, and/or mixed-sex adults), but a successful populat ion collection will contain a minimum of 100 genomes. It is recognized that it may not be pos sible to collect the target numb er 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 co llections may be modi fied 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 sh all be investigated as

19soon as possible to understand a ny field relevance of such a fi nding. 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 Ag ency annually before A ugust 31. The investigative steps will include:

1. Re-test progeny of the collected population to determine whether the unusual bioassay response is reproducible and herita ble. If it is not reproducible a nd heritable, no further action is required.

2. If the unusual response is re producible and heritable, proge ny of insects that survive the diagnostic concentration will be tested using me thods that are representative of exposure to Bt corn hybrids under field conditions. If progeny do not survive to ad ulthood, any suspected

resistance is not fiel d relevant and no furthe r 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 freq uency in the original population;

• determining whether the resistance-allele Fr equency 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 th e 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 Ag ency 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 gr ower, extension specialist or c onsultant reports of unexpected levels of damage by the lepidopteran pests list ed on the pesticide label. The registrant will

instruct its customers to contact them if such in cidents occur. The registra nt will investigate all legitimate reports submitted to the comp any 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

20EPA defines suspected resistance to mean field reports of unexpect ed levels of insect feeding damage for which:

• the corn in question has been c onfirmed to be lepidopteran-active Bt corn;

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

• the relevant plant tissues are ex pressing the expected level of Bt protein; and

• it has been ruled out th at species not susceptible to the protein could be responsible for the damage, that no climatic or cultural reas ons could be responsible for the damage, and

that that there could be no othe r reasonable causes for the damage.

The Agency does not interpret suspected resistance to mean grower report s of possible control failures or suspicious results fr om annual insect monitoring assa ys, 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 fiel ds 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 pr actices to minimize the possibility of resistant insects over-wintering and contribu ting to the next season's target pest population.

Additionally, if possible, and prior to the app lication of alternative control measures or destruction of crop residue, the re gistrant will collect samples of the insect population in the affected fields for laboratory rearing and testin g. Such rearing and testing shall be conducted as expeditiously as practical.

Confirmed resistance

EPA defines confirmed resistance to mean, in the case of field re ports of unexpected levels of damage from the key target pests, th at all the following criteria are met:

• There is > 30% insect survival and commensurate ins ect 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 th ere may be a resistance allele frequency of ≥ 0.1 in the sampled population.

21• In standardized labora tory bioassays, the LC 50 exceeds the upper limit of the 95%

confidence interval of the LC 50 for susceptible populations su rveyed both in the original baselines developed for this pest species and in previous years of field monitoring.

(3) Response to Confirmed Resistance in a Ke y 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 wi ll be notified about confirmed resistance within 30 days;

• Monitoring will be increased in the affected ar ea 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 availab ility of suitable alternative control measures), alternative control measur es will be employed to reduce or control target pest populations in th e affected area. Alternative control measures may include advising customers and extensi on agents in the affected area to incorporate crop residues into the soil following harvest to minimi ze 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, consulta nts, extension agents , seed distributors, university cooperators and state/ federal authorities as approp riate) in the region of the resistance situation and approved action plan; and

• In subsequent growing seasons, maintain sa les 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 resistan ce management plan is in place to mitigate the resistance.

A report on results of resistan ce monitoring and investigations of damage reports must be submitted to the Agency annually by August 31 st each year for the duration of the conditional registration.

22e. Annual Reports

1] Annual Sales: reported and summed by state (county level data availa ble by request), January 31st each year;

2] Grower Agreement: number of units of Bt corn seeds shipped or sold and not returned, and the number of such units that were sold to persons who have signed grower agreements, January 31st each year;

3] Grower Education: substantive changes to education program completed the previous year, January 31st each year;

4] Compliance Assurance Plan: Compliance Assu rance Program activities and results, January 31st each year;

5] Compliance: to includ e annual survey resu lts and plans for the next year; full report January 31st each year;

6] Insect Resistance Monitoring Results: results of monitoring and inves tigations of damage reports, August 31st each year.

If these conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA section 6(e). Your release for shipment of Bt 11 sweet corn constitutes acceptance of these conditions.

23Date Registered Date Expired Registrant Registration # Active Ingredients

Monsanto 524-489 Bt corn Event MON810 Cry1Ab (YieldGard) Dec-96 30-Sep-15

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

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

1Ab.

3] Submit/cite all data required for registrati on of your product under FIFRA § 3(c)(5) when the Agency requires registrants of si milar 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 register ed plant-incorporated protectants to produce inbred corn lines and hybrid corn varie ties with combined pesticidal traits.

5] In light of recently published laboratory st udies showing reduced growth in shredding caddis flies exposed to anti-lepidopteran Cry1A protei n corn litter (Rosi-Marshall, et al. 2007), additional aquatic invertebrate da ta are required. A 7 to 14 day Daphnia magna study as per the 885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, representing the functional group of a leaf shre dder in headwater streams must be submitted by January 31, 2012.

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

Insect Resistance Management:

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

1] Requirements relatin g 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 B t corn users to sign “grower agreements” that impose binding contractual obliga tions on the grower to comply with the refuge requirements;

3] Requirements regarding programs to e ducate 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

24insects;

6] Requirements regarding a “remed ial action plan” that contains measures the registrants would take in the event that any field relevant insect resistance was detected as well as to report on activity under the plan to EPA;

7] Submit annual reports on units so ld by state (units sold by count y level will be made available to the Agency upon request), IRM grower agre ements 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 pr opagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

1] Corn-Belt Refuge Requirements

Field corn grown outside cotton- growing areas (e.g., the Corn Belt), grower agreements (also known as stewardship agreements) will specify that growers must adhere to the refuge requirements as described in th e grower guide/product use guide and/or in supplements to the grower guide/product use guide.

· Specifically, growers must plant a stru ctured 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 stal k-boring and other pests.

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

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

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

· Insecticide treatments for cont rol of ECB, CEW, Southwestern corn borer (SWCB) and other lepidopteran target pest s 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., Extens ion Service agents, crop consultants). Instructions to growers w ill specify that microbial Bt insecticides must not be applied to

non- Bt corn and/or non-le pidopteran resistant Bt corn refuges.

252] Cotton-Growing Area Refuge Requirements for Bt Corn

For Bt field corn grown in cotton-growing areas, gr ower 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 supplem ents to the grower guide/product use guide.

· Specifically, growers in these areas must plan t 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 fi elds, 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 fiel d, refuges must be at least 4 rows wide.

· Insecticide treatments for control of ECB, CEW, Southwestern co rn borer (SWCB), and other lepidopteran target pest s 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., Extens ion Service agents, crop consultants). Instructions to growers w ill specify that microbial Bt insecticides must not be applied to

non- Bt corn and/or non-le pidopteran resistant Bt corn refuges.

· Cotton-growing areas include the following stat es: Alabama, Arkansas, Georgia, Florida, Louisiana, North Carolina, Mi ssissippi, South Carolina, Oklahom a (only the counties of Beckham, Caddo, Comanche, Cu ster, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, Washita), Tennessee (only the counties of Ca rroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Hayw ood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), Texa s (except the counties of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, M oore, 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 stew ardship 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 bou nd to comply with the requirements of the IRM

program.

3] The registrant must maintain a system that is reasonably likely to assure that persons purchasing the Bt corn product will affirm annually that they are contractually bound to comply

26with the requirements of the IRM program.

4] The registrant must continue to use their current grower agreemen t. If the registrant wishes to change any part of the grower agreement or any specific stewardship documents referenced in the grower agreement that woul d 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 th e terms and conditions of the amendment.

5] The registrant must maintain a system that is reasonably likely to assure that persons purchasing the Bt corn sign grower agreement(s).

6] The registrant shall maintain records of all Bt corn grower agreements for a period of three years from December 31 of the year in which the agreement was signed.

7] The registrant shall provi de EPA with a report showin g 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 name s, personal information, and grower license number, will be protected.

c. IRM Education and IRM Co mpliance Monitoring Programs

1] The registrant must mainta in 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 require ments on the bag or bag tag, and electronic communications such as by Internet, radio, or television commercial s. Copies of the materials will be provided to EPA for its records. The progr am shall involve at least one written communication annually to

each Bt corn user separate from the grower techni cal guide. The communication shall inform the user of the current IRM requirements. The regi strant shall coordinate its education programs

with educational efforts of othe r registrants and other organizatio ns, 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 th e compliance survey required and from other sources. The changes shall address aspects of gr ower compliance that are not sufficiently high.

3] Annually, each January 31st, the registrant mu st provide EPA any substantive changes to its grower education activities as part of the overall IRM complianc e assurance program report. The registrant must either submit a separate repo rt or contribute to the report from the industry working group (ABSTC).

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

evaluate the extent to wh ich growers purchasing its Bt corn product are complying with the IRM program and that takes such actions as are reas onably 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 wi ll 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 r ecognizing that for reasons of di fference in busin ess 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 grow er or for all growers in a specific region. An individual grow er found to be significantly ou t of compliance two years in a row would be denied sales of the product the ne xt year. Similarly, s eed dealers who are not fulfilling their obligations to inform/educate grow ers 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 th e potential impact of non-response. The sample size and geographical resolution may be ad justed annually, based upon input from the independent marketing research firm and academic scientists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasonable sensitivity for comparing results across the U.S.

i. A third party is classified as a party ot her than the registrant, the grower, or anyone else with a direct interest in IRM compliance for Bt corn.

7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potenti al biological significance of any implementation deviations.

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

educational tools and initiatives.

9] The registrant shall provide a written summary of the result s of the prior year's survey (together with a description of the regions, the methodology us ed, 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 surv ey prior to its implementation.

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

28program to take into account the information co llected through the comp liance survey and from other sources. The changes shall address aspect s of grower compliance th at 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 acti on, consistent with its “pha sed compliance approach.”

13] If a grower, who purchases Bt corn for planting, was specifica lly identified as not being in compliance during the previous year, the registra nt shall visit with the grower and evaluate whether that the grower is in compliance w ith the IRM program for the current year.

14] Each registrant shall annually provide a report to EPA summa rizing 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 re port will include information regarding grower interactions (including, but not li mited to, on-farm visits, verified tips and complaints, grower meetings and letters), the extent of non-comp liance, corrective measures to address the noncompliance, and any follow-up actions taken. The registrants may el ect to coordinate information and report collectively the result s of their compliance assurance programs.

15] The registrant and the seed corn dealers fo r the registrant must allow a review of the compliance records by EPA or by a State pesticid e regulatory agency if the State agency can

demonstrate that confidential business information, including the names, personal information, and grower license number of the growers will be protected.

16] The registrant shall revise and expand its existing Compliance Assurance Program to include the following elements. The registrant must prepare and submit by January 31, 2011, a written description of its revised Comp liance Assurance Program. The regi strant may coordinate with other registrants in designing and implem enting its Compliance Assurance Program.

17] The registrant will enha nce the refuge education prog ram throughout the seed delivery

channel:

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of correct refuge implementation and pot ential consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the next three growing seas ons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

2918] The registrant will focus the majority of on-farm assessments on regions with the greatest

risks for resistance:

i. Use Bt corn adoption, pest pressu re information, and other available information to identify regions where the risk of resistance is greatest;

ii. Focus approximately two-thir ds of on-farm assessments on these regions, with the remaining assessments conducted across other regions where the product is used.

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

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

i. Identify for potential on-farm assessment growers whose sales informati on indicates they have purchased the Bt corn product but may have purchased little or no refuge seed from the registrant, licensee, or affiliated company.

20] The registrant will contract with third part ies to perform on-farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all firs t-time on-farm assessments as well as second-year on-farm assessments of those growers found out of compliance in a first-time assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and level of refuge compliance for the product.

22] The registrant will follow up with grower s who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

i. All growers found to be signif icantly out of compliance in a pr ior year will annually be sent additional refuge assistance info rmation for a minimum of two years by the registrant, seed supplier, or third party assessor, afte r completing the assessment process;

ii. The registrant will conduct follow-up checks on growers found to be significantly out of compliance within three year s after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a five-year period will be denied access to the Bt corn product in the subsequent year.

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

d. Insect Resistance Monitori ng and Remedial Action Plan

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

The registrant will monitor for resistance to its lepidopteran-resistant Bt corn. The monitoring program shall consist of two a pproaches: (1) focused population sampling and laboratory testing;

30and (2) investigation of reports of less-than ex pected control of labeled insects. Should fieldrelevant resistance be confirmed, an appropri ate 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 fo r the target pests will be

focused in areas identified as those with the hi ghest risk of resistance development (e.g., where lepidopteran-active Bt hybrids are planted on a high proportion of the co rn acres, and where the insect species are regarded as key pests of corn). Bioassay met hods must be appropriate for the goal of detecting field-relevant shifts in population response to lepidopteran resistant Bt corn and/or changes in resist ance allele frequency in response to the use of Bt corn and, as far as possible, should be consistent ac ross sampling years to enable co mparisons with historical data.

The number of populations to be collected shall reflect the regional im portance of the insect species as a pest, and specific collection region s will be identified for each pest. For ECB, a minimum of 12 populations across the sampling re gion 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 allele s before they become common enough to cause measurable field damage, each population collectio n 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 in sect populations or genomes due to factors such as natural fluctuations in pest density, environmental conditions, and area-wid e pest suppression.

The sampling program and geographic range of co llections may be modi fied 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 sh all be investigated as soon as possible to understand a ny field relevance of such a fi nding. 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 Ag ency annually before A ugust 31. The investigative steps will include:

1. Re-test progeny of the collected population to determine whether the unusual bioassay response is reproducible and herita ble. If it is not reproducible a nd heritable, no further action is required.

2. If the unusual response is re producible and heritable, proge ny of insects that survive the diagnostic concentration will be tested using me thods that are representative of exposure to Bt

31corn hybrids under field conditions. If progeny do not survive to ad ulthood, any suspected

resistance is not fiel d relevant and no furthe r 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 freq uency in the original population;

• determining whether the resistance-allele Fr equency 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 th e 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 Ag ency 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 gr ower, extension specialist or c onsultant reports of unexpected levels of damage by the lepidopteran pests list ed on the pesticide label. The registrant will

instruct its customers to contact them if such in cidents occur. The registra nt will investigate all legitimate reports submitted to the comp any 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 registra nt 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 unexpect ed levels of insect feeding damage for which:

• the corn in question has been c onfirmed to be lepidopteran-active Bt corn;

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

• the relevant plant tissues are ex pressing the expected level of Bt protein; and

• it has been ruled out th at species not susceptible to the protein could be responsible for the damage, that no climatic or cultural reas ons could be responsible for the damage, and

32that that there could be no othe r reasonable causes for the damage.

The Agency does not interpret suspected resistance to mean grower report s of possible control failures or suspicious results fr om annual insect monitoring assa ys, 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 fiel ds 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 pr actices to minimize the possibility of resistant insects over-wintering and contribu ting to the next season's target pest population.

Additionally, if possible, and prior to the app lication of alternative control measures or destruction of crop residue, the re gistrant will collect samples of the insect population in the affected fields for laboratory rearing and testin g. Such rearing and testing shall be conducted as expeditiously as practical.

Confirmed resistance

EPA defines confirmed resistance to mean, in the case of field re ports of unexpected levels of damage from the key target pests, th at all the following criteria are met:

• There is > 30% insect survival and commensurate ins ect 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 th ere may be a resistance allele frequency of ≥ 0.1 in the sampled population.

• In standardized labora tory bioassays, the LC 50 exceeds the upper limit of the 95%

confidence interval of the LC 50 for susceptible populations su rveyed both in the original baselines developed for this pest species and in previous years of field monitoring.

(3) Response to Confirmed Resistance in a Ke y Target Pest as the Cause of Unexpected Levels of Damage in the Field

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

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

• Affected customers and extension agents wi ll be notified about confirmed resistance within 30 days;

• Monitoring will be increased in the affected ar ea 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 availab ility of suitable alternative control measures), alternative control measur es will be employed to reduce or control target pest populations in th e affected area. Alternative control measures may include advising customers and extensi on agents in the affected area to incorporate crop residues into the soil following harvest to minimi ze 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, consulta nts, extension agents , seed distributors, university cooperators and state/ federal authorities as approp riate) in the region of the resistance situation and approved action plan; and

• In subsequent growing seasons, maintain sa les 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 resistan ce management plan is in place to mitigate the resistance.

A report on results of resistan ce monitoring and investigations of damage reports must be submitted to the Agency annually by August 31 st each year for the duration of the conditional registration.

e. Annual Reports

1] Annual Sales: reported and summed by state (county level data availa ble 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;

343] Grower Education: substantive changes to education program completed the previous year, January 31st each year;

4] Compliance Assurance Plan: Compliance Assu rance Program activities and results, January 31st each year;

5] Compliance: to includ e annual survey resu lts and plans for the next year; full report January 31st each year;

6] Insect Resistance Monitoring Results: results of monitoring and inves tigations of damage reports, August 31st each year.

If these conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA section 6(e). Your re lease for shipment of Cry1Ab corn constitutes acceptance of these conditions.

35Date Registered Date Expired Registrant Registration # Active Ingredients

Dow/Mycogen 68467-2 Bt corn Event TC1507 with plant optimized (PO) Cry1F (Herculex 1) May-01 30-Sep-15

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

2] The subject registra tion will be limited to Bacillus thuringiensis corn Event TC1507 with PO Cry 1F.

3] Submit/cite all data required for registrati on of your product under FIFRA § 3(c)(5) when the Agency requires registrants of si milar 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 register ed plant-incorporated protectants to produce inbred corn lines and hybrid corn varie ties with combined pesticidal traits.

5] In light of recently published laboratory st udies showing reduced growth in shredding caddis flies exposed to anti-lepidopteran Cry1A protei n corn litter (Rosi-Marshall, et al. 2007), additional aquatic invertebrate da ta are required. A 7 to 14 day Daphnia magna study as per the 885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, representing the functional group of a leaf shre dder in headwater streams must be submitted by January 31, 2012.

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

Insect Resistance Management:

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

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

1] Requirements relatin g 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 B t corn users to sign “grower agreements” that impose binding contractual obliga tions on the grower to comply with the refuge requirements;

3] Requirements regarding programs to e ducate 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 targ et insect susceptibility to Cry1F protein in the target insects;

366] Requirements regarding a “remed ial action plan” that contains measures the registrants would take in the event that any field relevant insect resistance was detected as well as to report on activity under the plan to EPA;

7] Submit annual reports on units so ld by state (units sold by count y level will be made available to the Agency upon request), IRM grower agre ements 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 pr opagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

1] Corn-Belt Refuge Requirements

Field corn grown outside cotton- growing areas (e.g., the Corn Belt), grower agreements (also known as stewardship agreements) will specify that growers must adhere to the refuge requirements as described in th e grower guide/product use guide and/or in supplements to the grower guide/product use guide.

· Specifically, growers must plant a stru ctured 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 stal k-boring and other pests.

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

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

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

· Insecticide treatments for cont rol of ECB, CEW, Southwestern corn borer (SWCB) and other lepidopteran target pest s 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., Extens ion Service agents, crop consultants). Instructions to growers w ill specify that microbial Bt insecticides must not be applied to

non- Bt corn and/or non-le pidopteran resistant Bt corn refuges.

2] Cotton-Growing Area Refuge Requirements for Bt Corn

37For Bt field corn grown in cotton-growing areas, gr ower 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 supplem ents to the grower guide/product use guide.

· Specifically, growers in these areas must plan t 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 fi elds, 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 fiel d, refuges must be at least 4 rows wide.

· Insecticide treatments for control of ECB, CEW, Southwestern co rn borer (SWCB), and other lepidopteran target pest s 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., Extens ion Service agents, crop consultants). Instructions to growers w ill specify that microbial Bt insecticides must not be applied to

non- Bt corn and/or non-le pidopteran resistant Bt corn refuges.

· Cotton-growing areas include the following stat es: Alabama, Arkansas, Georgia, Florida, Louisiana, North Carolina, Mi ssissippi, South Carolina, Oklahom a (only the counties of Beckham, Caddo, Comanche, Cu ster, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, Washita), Tennessee (only the counties of Ca rroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Hayw ood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), Texa s (except the counties of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, M oore, 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 stew ardship 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 bou nd to comply with the requirements of the IRM

program.

3] The registrant must maintain a system that is reasonably likely to assure that persons purchasing the Bt corn product will affirm annually that they are contractually bound to comply with the requirements of the IRM program.

384] The registrant must continue to use their current grower agreemen t. If the registrant wishes to change any part of the grower agreement or any specific stewardship documents referenced in the grower agreement that woul d 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 th e terms and conditions of the amendment.

5] The registrant must maintain a system that is reasonably likely to assure that persons purchasing the Bt corn sign grower agreement(s).

6] The registrant shall maintain records of all Bt corn grower agreements for a period of three years from December 31 of the year in which the agreement was signed.

7] The registrant shall provi de EPA with a report showin g 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 name s, personal information, and grower license number, will be protected.

c. IRM Education and IRM Co mpliance Monitoring Programs

1] The registrant must mainta in 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 require ments on the bag or bag tag, and electronic communications such as by Internet, radio, or television commercial s. Copies of the materials will be provided to EPA for its records. The progr am shall involve at least one written communication annually to

each Bt corn user separate from the grower techni cal guide. The communication shall inform the user of the current IRM requirements. The regi strant shall coordinate its education programs

with educational efforts of othe r registrants and other organizatio ns, 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 th e compliance survey required and from other sources. The changes shall address aspects of gr ower compliance that are not sufficiently high.

3] Annually, each January 31st, the registrant mu st provide EPA any substantive changes to its grower education activities as part of the overall IRM complianc e assurance program report. The registrant must either submit a separate repo rt or contribute to the report from the industry working group (ABSTC).

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

evaluate the extent to wh ich growers purchasing its Bt corn product are complying with the IRM program and that takes such actions as are reas onably 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 wi ll 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 r ecognizing that for reasons of di fference in busin ess 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 grow er or for all growers in a specific region. An individual grow er found to be significantly ou t of compliance two years in a row would be denied sales of the product the ne xt year. Similarly, s eed dealers who are not fulfilling their obligations to inform/educate grow ers 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 th e potential impact of non-response. The sample size and geographical resolution may be ad justed annually, based upon input from the independent marketing research firm and academic scientists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasonable sensitivity for comparing results across the U.S.

i. A third party is classified as a party ot her than the registrant, the grower, or anyone else with a direct interest in IRM compliance for Bt corn.

7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potenti al biological significance of any implementation deviations.

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

educational tools and initiatives.

9] The registrant shall provide a written summary of the result s of the prior year's survey (together with a description of the regions, the methodology us ed, 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 surv ey prior to its implementation.

10] Annually, the registrant sh all revise, and expand as necessary, its compliance assurance program to take into account the information co llected through the comp liance survey and from

40other sources. The changes shall address aspect s 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 acti on, consistent with its “pha sed compliance approach.”

13] If a grower, who purchases Bt corn for planting, was specifica lly identified as not being in compliance during the previous year, the registra nt shall visit with the grower and evaluate whether that the grower is in compliance w ith the IRM program for the current year.

14] Each registrant shall annually provide a report to EPA summa rizing 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 re port will include information regarding grower interactions (including, but not li mited to, on-farm visits, verified tips and complaints, grower meetings and letters), the extent of non-comp liance, corrective measures to address the noncompliance, and any follow-up actions taken. The registrants may el ect to coordinate information and report collectively the result s of their compliance assurance programs.

15] The registrant and the seed corn dealers fo r the registrant must allow a review of the compliance records by EPA or by a State pesticid e regulatory agency if the State agency can

demonstrate that confidential business information, including the names, personal information, and grower license number of the growers will be protected.

16] The registrant shall revise and expand its existing Compliance Assurance Program to include the following elements. The registrant must prepare and submit by January 31, 2011, a written description of its revised Comp liance Assurance Program. The regi strant may coordinate with other registrants in designing and implem enting its Compliance Assurance Program.

17] The registrant will enha nce the refuge education prog ram throughout the seed delivery

channel:

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of correct refuge implementation and pot ential consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the next three growing seas ons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

4118] The registrant will focus the majority of on-farm assessments on regions with the greatest

risks for resistance:

i. Use Bt corn adoption, pest pressu re information, and other available information to identify regions where the risk of resistance is greatest;

ii. Focus approximately two-thir ds of on-farm assessments on these regions, with the remaining assessments conducted across other regions where the product is used.

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

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

i. Identify for potential on-farm assessment growers whose sales informati on indicates they have purchased the Bt corn product but may have purchased little or no refuge seed from the registrant, licensee, or affiliated company.

20] The registrant will contract with third part ies to perform on-farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all firs t-time on-farm assessments as well as second-year on-farm assessments of those growers found out of compliance in a first-time assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and level of refuge compliance for the product.

22] The registrant will follow up with grower s who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

i. All growers found to be signif icantly out of compliance in a pr ior year will annually be sent additional refuge assistance info rmation for a minimum of two years by the registrant, seed supplier, or third party assessor, afte r completing the assessment process;

ii. The registrant will conduct follow-up checks on growers found to be significantly out of compliance within three year s after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a five-year period will be denied access to the Bt corn product in the subsequent year.

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

d. Insect Resistance Monitori ng and Remedial Action Plan

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

The registrant will monitor for resistance to its lepidopteran-resistant Bt corn. The monitoring program shall consist of two a pproaches: (1) focused population sampling and laboratory testing;

42and (2) investigation of reports of less-than ex pected control of labeled insects. Should fieldrelevant resistance be confirmed, an appropri ate 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 fo r the target pests will be

focused in areas identified as those with the hi ghest risk of resistance development (e.g., where lepidopteran-active Bt hybrids are planted on a high proportion of the co rn acres, and where the insect species are regarded as key pests of corn). Bioassay met hods must be appropriate for the goal of detecting field-relevant shifts in population response to lepidopteran resistant Bt corn and/or changes in resist ance allele frequency in response to the use of Bt corn and, as far as possible, should be consistent ac ross sampling years to enable co mparisons with historical data.

The number of populations to be collected shall reflect the regional im portance of the insect species as a pest, and specific collection region s will be identified for each pest. For ECB, a minimum of 12 populations across the sampling re gion 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 allele s before they become common enough to cause measurable field damage, each population collectio n 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 in sect populations or genomes due to factors such as natural fluctuations in pest density, environmental conditions, and area-wid e pest suppression.

The sampling program and geographic range of co llections may be modi fied 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 sh all be investigated as soon as possible to understand a ny field relevance of such a fi nding. 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 Ag ency annually before A ugust 31. The investigative steps will include:

1. Re-test progeny of the collected population to determine whether the unusual bioassay response is reproducible and herita ble. If it is not reproducible a nd heritable, no further action is required.

2. If the unusual response is re producible and heritable, proge ny of insects that survive the diagnostic concentration will be tested using me thods that are representative of exposure to Bt

43corn hybrids under field conditions. If progeny do not survive to ad ulthood, any suspected

resistance is not fiel d relevant and no furthe r 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 freq uency in the original population;

• determining whether the resistance-allele Fr equency 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 th e 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 Ag ency to develop and implement a case-specific resistance management action plan.

(2) Investigation of Reports of Unexpect ed Levels of Damage by the Target

Pests:

The registrant will follow up on gr ower, extension specialist or c onsultant reports of unexpected levels of damage by the lepidopteran pests list ed on the pesticide label. The registrant will

instruct its customers to contact them if such in cidents occur. The registra nt will investigate all legitimate reports submitted to the comp any 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 registra nt 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 unexpect ed levels of insect feeding damage for which:

• the corn in question has been c onfirmed to be lepidopteran-active Bt corn;

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

• the relevant plant tissues are ex pressing the expected level of Bt protein; and

44• it has been ruled out th at species not susceptible to the protein could be responsible for the damage, that no climatic or cultural reas ons could be responsible for the damage, and

that that there could be no othe r reasonable causes for the damage.

The Agency does not interpret suspected resistance to mean grower report s of possible control failures or suspicious results fr om annual insect monitoring assa ys, 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 fiel ds 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 pr actices to minimize the possibility of resistant insects over-wintering and contribu ting to the next season's target pest population.

Additionally, if possible, and prior to the app lication of alternative control measures or destruction of crop residue, the re gistrant will collect samples of the insect population in the affected fields for laboratory rearing and testin g. Such rearing and testing shall be conducted as expeditiously as practical.

Confirmed resistance

EPA defines confirmed resistance to mean, in the case of field re ports of unexpected levels of damage from the key target pests, th at all the following criteria are met:

• There is > 30% insect survival and commensurate ins ect 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 th ere may be a resistance allele frequency of ≥ 0.1 in the sampled population.

• In standardized labora tory bioassays, the LC 50 exceeds the upper limit of the 95%

confidence interval of the LC 50 for susceptible populations su rveyed both in the original baselines developed for this pest species and in previous years of field monitoring.

(3) Response to Confirmed Resistance in a Ke y Target Pest as the Cause of Unexpected Levels of Damage in the Field

45When 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 wi ll be notified about confirmed resistance within 30 days;

• Monitoring will be increased in the affected ar ea 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 availab ility of suitable alternative control measures), alternative control measur es will be employed to reduce or control target pest populations in th e affected area. Alternative control measures may include advising customers and extensi on agents in the affected area to incorporate crop residues into the soil following harvest to minimi ze 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, consulta nts, extension agents , seed distributors, university cooperators and state/ federal authorities as approp riate) in the region of the resistance situation and approved action plan; and

• In subsequent growing seasons, maintain sa les 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 resistan ce management plan is in place to mitigate the resistance.

A report on results of resistan ce monitoring and investigations of damage reports must be submitted to the Agency annually by August 31 st each year for the duration of the conditional registration.

e. Annual Reports

1] Annual Sales: reported and summed by state (county level data availa ble by request), January 31st each year;

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

46number of such units that were sold to persons who have signed grower agreements, January 31st each year;

3] Grower Education: substantive changes to education program completed the previous year, January 31st each year;

4] Compliance Assurance Plan: Compliance Assu rance Program activities and results, January 31st each year;

5] Compliance: to includ e annual survey resu lts and plans for the next year; full report January 31st each year;

6] Insect Resistance Monitoring Results: results of monitoring and inves tigations of damage reports, August 31st each year.

If these conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA section 6(e). Your rel ease for shipment of Cry1F corn constitutes acceptance of these conditions.

47Date Registered Date Expired Registrant Registration # Active Ingredients

Pioneer/Dupont 29964-3 Bt corn Event TC1507 with POCry1F (Herculex 1) May-01 30-Sep-15

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

2] The subject registra tion will be limited to Bacillus thuringiensis corn Event TC1507 with PO Cry 1F.

3] Submit/cite all data required for registrati on of your product under FIFRA § 3(c)(5) when the Agency requires registrants of si milar 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 register ed plant-incorporated protectants to produce inbred corn lines and hybrid corn varie ties with combined pesticidal traits.

5] In light of recently published laboratory st udies showing reduced growth in shredding caddis flies exposed to anti-lepidopteran Cry1A protei n corn litter (Rosi-Marshall, et al. 2007), additional aquatic invertebrate da ta are required. A 7 to 14 day Daphnia magna study as per the 885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, representing the functional group of a leaf shre dder in headwater streams must be submitted by January 31, 2012.

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

Insect Resistance Management:

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

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

1] Requirements relatin g 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 B t corn users to sign “grower agreements” that impose binding contractual obliga tions on the grower to comply with the refuge requirements;

3] Requirements regarding programs to e ducate growers about IRM requirements;

484] 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 targ et insect susceptibility to Cry1F protein in the target insects;

6] Requirements regarding a “remed ial action plan” that contains measures the registrants would take in the event that any field relevant insect resistance was detected as well as to report on activity under the plan to EPA;

7] Submit annual reports on units so ld by state (units sold by count y level will be made available to the Agency upon request), IRM grower agre ements 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 pr opagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

1] Corn-Belt Refuge Requirements

Field corn grown outside cotton- growing areas (e.g., the Corn Belt), grower agreements (also known as stewardship agreements) will specify that growers must adhere to the refuge requirements as described in th e grower guide/product use guide and/or in supplements to the grower guide/product use guide.

· Specifically, growers must plant a stru ctured 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 stal k-boring and other pests.

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

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

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

· Insecticide treatments for cont rol of ECB, CEW, Southwestern corn borer (SWCB) and other lepidopteran target pest s 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., Extens ion Service agents, crop consultants).

49Instructions to growers w ill specify that microbial Bt insecticides must not be applied to

non- Bt corn and/or non-le pidopteran resistant Bt corn refuges.

2] Cotton-Growing Area Refuge Requirements for Bt Corn

For Bt field corn grown in cotton-growing areas, gr ower 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 supplem ents to the grower guide/product use guide.

· Specifically, growers in these areas must plan t 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 fi elds, 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 fiel d, refuges must be at least 4 rows wide.

· Insecticide treatments for control of ECB, CEW, Southwestern co rn borer (SWCB), and other lepidopteran target pest s 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., Extens ion Service agents, crop consultants). Instructions to growers w ill specify that microbial Bt insecticides must not be applied to

non- Bt corn and/or non-le pidopteran resistant Bt corn refuges.

· Cotton-growing areas include the following stat es: Alabama, Arkansas, Georgia, Florida, Louisiana, North Carolina, Mi ssissippi, South Carolina, Oklahom a (only the counties of Beckham, Caddo, Comanche, Cu ster, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, Washita), Tennessee (only the counties of Ca rroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Hayw ood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), Texa s (except the counties of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, M oore, 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 stew ardship 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 bou nd to comply with the requirements of the IRM

program.

503] The registrant must maintain a system that is reasonably likely to assure that persons purchasing the Bt corn product will affirm annually that they are contractually bound to comply with the requirements of the IRM program.

4] The registrant must continue to use their current grower agreemen t. If the registrant wishes to change any part of the grower agreement or any specific stewardship documents referenced in the grower agreement that woul d 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 th e terms and conditions of the amendment.

5] The registrant must maintain a system that is reasonably likely to assure that persons purchasing the Bt corn sign grower agreement(s).

6] The registrant shall maintain records of all Bt corn grower agreements for a period of three years from December 31 of the year in which the agreement was signed.

7] The registrant shall provi de EPA with a report showin g 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 name s, personal information, and grower license number, will be protected.

c. IRM Education and IRM Co mpliance Monitoring Programs

1] The registrant must mainta in 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 require ments on the bag or bag tag, and electronic communications such as by Internet, radio, or television commercial s. Copies of the materials will be provided to EPA for its records. The progr am shall involve at least one written communication annually to

each Bt corn user separate from the grower techni cal guide. The communication shall inform the user of the current IRM requirements. The regi strant shall coordinate its education programs

with educational efforts of othe r registrants and other organizatio ns, 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 th e compliance survey required and from other sources. The changes shall address aspects of gr ower compliance that are not sufficiently high.

3] Annually, each January 31st, the registrant mu st provide EPA any substantive changes to its grower education activities as part of the overall IRM complianc e assurance program report.

51The registrant must either submit a separate repo rt 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 wh ich growers purchasing its Bt corn product are complying with the IRM program and that takes such actions as are reas onably 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 wi ll 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 r ecognizing that for reasons of di fference in busin ess 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 grow er or for all growers in a specific region. An individual grow er found to be significantly ou t of compliance two years in a row would be denied sales of the product the ne xt year. Similarly, s eed dealers who are not fulfilling their obligations to inform/educate grow ers 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 th e potential impact of non-response. The sample size and geographical resolution may be ad justed annually, based upon input from the independent marketing research firm and academic scientists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasonable sensitivity for comparing results across the U.S.

i. A third party is classified as a party ot her than the registrant, the grower, or anyone else with a direct interest in IRM compliance for Bt corn.

7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potenti al biological significance of any implementation deviations.

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

educational tools and initiatives.

9] The registrant shall provide a written summary of the result s of the prior year's survey (together with a description of the regions, the methodology us ed, 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 surv ey prior to its implementation.

5210] Annually, the registrant sh all revise, and expand as necessary, its compliance assurance program to take into account the information co llected through the comp liance survey and from other sources. The changes shall address aspect s of grower compliance th at 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 acti on, consistent with its “pha sed compliance approach.”

13] If a grower, who purchases Bt corn for planting, was specifica lly identified as not being in compliance during the previous year, the registra nt shall visit with the grower and evaluate whether that the grower is in compliance w ith the IRM program for the current year.

14] Each registrant shall annually provide a report to EPA summa rizing 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 re port will include information regarding grower interactions (including, but not li mited to, on-farm visits, verified tips and complaints, grower meetings and letters), the extent of non-comp liance, corrective measures to address the noncompliance, and any follow-up actions taken. The registrants may el ect to coordinate information and report collectively the result s of their compliance assurance programs.

15] The registrant and the seed corn dealers fo r the registrant must allow a review of the compliance records by EPA or by a State pesticid e regulatory agency if the State agency can

demonstrate that confidential business information, including the names, personal information, and grower license number of the growers will be protected.

16] The registrant shall revise and expand its existing Compliance Assurance Program to include the following elements. The registrant must prepare and submit by January 31, 2011, a written description of its revised Comp liance Assurance Program. The regi strant may coordinate with other registrants in designing and implem enting its Compliance Assurance Program.

17] The registrant will enha nce the refuge education prog ram throughout the seed delivery

channel:

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of correct refuge implementation and pot ential consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the next three growing seas ons, with 50% implementation in 2012 and full

53implementation for the 2013 growing season.

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

risks for resistance:

i. Use Bt corn adoption, pest pressu re information, and other available information to identify regions where the risk of resistance is greatest;

ii. Focus approximately two-thir ds of on-farm assessments on these regions, with the remaining assessments conducted across other regions where the product is used.

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

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

i. Identify for potential on-farm assessment growers whose sales informati on indicates they have purchased the Bt corn product but may have purchased little or no refuge seed from the registrant, licensee, or affiliated company.

20] The registrant will contract with third part ies to perform on-farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all firs t-time on-farm assessments as well as second-year on-farm assessments of those growers found out of compliance in a first-time assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and level of refuge compliance for the product.

22] The registrant will follow up with grower s who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

i. All growers found to be signif icantly out of compliance in a pr ior year will annually be sent additional refuge assistance info rmation for a minimum of two years by the registrant, seed supplier, or third party assessor, afte r completing the assessment process;

ii. The registrant will conduct follow-up checks on growers found to be significantly out of compliance within three year s after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a five-year period will be denied access to the Bt corn product in the subsequent year.

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

d. Insect Resistance Monitori ng and Remedial Action Plan

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

54The registrant will monitor for resistance to its lepidopteran-resistant Bt corn. The monitoring program shall consist of two a pproaches: (1) focused population sampling and laboratory testing; and (2) investigation of reports of less-than ex pected control of labeled insects. Should fieldrelevant resistance be confirmed, an appropri ate resistance management action plan will be implemented.

(1) Focused Population Sampling

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

nubilalis (European corn borer; ECB), Diatraea grandiosella (Southwestern corn borer; S WCB), and Helicoverpa zea (corn earworm; CE W). Sampling fo r the target pests will be

focused in areas identified as those with the hi ghest risk of resistance development (e.g., where lepidopteran-active Bt hybrids are planted on a high proportion of the co rn acres, and where the insect species are regarded as key pests of corn). Bioassay met hods must be appropriate for the goal of detecting field-relevant shifts in population response to lepidopteran resistant Bt corn and/or changes in resist ance allele frequency in response to the use of Bt corn and, as far as possible, should be consistent ac ross sampling years to enable co mparisons with historical data.

The number of populations to be collected shall reflect the regional im portance of the insect species as a pest, and specific collection region s will be identified for each pest. For ECB, a minimum of 12 populations across the sampling regi on will be targeted fo r 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 allele s before they become common enough to cause measurable field damage, each population collectio n 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 in sect populations or genomes due to factors such as natural fluctuations in pest density, environmental conditions, and area-wid e pest suppression.

The sampling program and geographic range of co llections may be modi fied 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 sh all be investigated as soon as possible to understand a ny field relevance of such a fi nding. Such investigations shall proceed in a stepwise manner until the field relevance can be ei ther confirmed or refuted, and

results of these shall be reported to the Ag ency annually before A ugust 31. The investigative steps will include:

1. Re-test progeny of the collected population to determine whether the unusual bioassay response is reproducible and herita ble. If it is not reproducible a nd heritable, no further action is required.

552. If the unusual response is re producible and heritable, proge ny of insects that survive the diagnostic concentration will be tested using me thods that are representative of exposure to Bt corn hybrids under field conditions. If progeny do not survive to ad ulthood, any suspected

resistance is not fiel d relevant and no furthe r 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 freq uency in the original population;

• determining whether the resistance-allele Fr equency 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 th e 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 Ag ency to develop and implement a case-specific resistance management action plan.

(2) Investigation of Reports of Unexpect ed Levels of Damage by the Target

Pests:

The registrant will follow up on gr ower, extension specialist or c onsultant reports of unexpected levels of damage by the lepidopteran pests list ed on the pesticide label. The registrant will

instruct its customers to contact them if such in cidents occur. The registra nt will investigate all legitimate reports submitted to the comp any 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 registra nt 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 unexpect ed levels of insect feeding damage for which:

• the corn in question has been c onfirmed to be lepidopteran-active Bt corn;

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

• the relevant plant tissues are ex pressing the expected level of Bt protein; and

56• it has been ruled out th at species not susceptible to the protein could be responsible for the damage, that no climatic or cultural reas ons could be responsible for the damage, and

that that there could be no othe r reasonable causes for the damage.

The Agency does not interpret suspected resistance to mean grower report s of possible control failures or suspicious results fr om annual insect monitoring assa ys, 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 fiel ds 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 pr actices to minimize the possibility of resistant insects over-wintering and contribu ting to the next season's target pest population.

Additionally, if possible, and prior to the app lication of alternative control measures or destruction of crop residue, the re gistrant will collect samples of the insect population in the affected fields for laboratory rearing and testin g. Such rearing and testing shall be conducted as expeditiously as practical.

Confirmed resistance

EPA defines confirmed resistance to mean, in the case of field re ports of unexpected levels of damage from the key target pests, th at all the following criteria are met:

• There is > 30% insect survival and commensurate ins ect 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 labora tory bioassays, the LC 50 exceeds the upper limit of the 95%

confidence interval of the LC 50 for susceptible populations su rveyed both in the original baselines developed for this pest species and in previous years of field monitoring.

(3) Response to Confirmed Resistance in a Ke y Target Pest as the Cause of Unexpected Levels of Damage in the Field

57When 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 wi ll be notified about confirmed resistance within 30 days;

• Monitoring will be increased in the affected ar ea 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 availab ility of suitable alternative control measures), alternative control measur es will be employed to reduce or control target pest populations in th e affected area. Alternative control measures may include advising customers and extensi on agents in the affected area to incorporate crop residues into the soil following harvest to minimi ze 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, consulta nts, extension agents , seed distributors, university cooperators and state/ federal authorities as approp riate) in the region of the resistance situation and approved action plan; and

• In subsequent growing seasons, maintain sa les 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 resistan ce management plan is in place to mitigate the resistance.

A report on results of resistan ce monitoring and investigations of damage reports must be submitted to the Agency annually by August 31 st each year for the duration of the conditional registration.

e. Annual Reports

1] Annual Sales: reported and summed by state (county level data availa ble by request), January 31st each year;

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

58number of such units that were sold to persons who have signed grower agreements, January 31st each year;

3] Grower Education: substantive changes to education program completed the previous year, January 31st each year;

4] Compliance Assurance Plan: Compliance Assu rance Program activities and results, January 31st each year;

5] Compliance: to includ e annual survey resu lts and plans for the next year; full report January 31st each year;

6] Insect Resistance Monitoring Results: results of monitoring and inves tigations of damage reports, August 31st each year.

If these conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA section 6(e). Your rel ease for shipment of Cry1F corn constitutes acceptance of these conditions.

59Registration

# Date Registered Date Expired Registrant Active Ingredients

Dow Agrosciences 68467-4 Bt corn Event DAS-06275-8 with MOCry1F (Mycogen Brand Bt Cry1F Event DAS-06274-8 corn) 27-May-05 30-Sep-15

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

2] The subject registration will be limited to Bacillus thuringiensis corn Event DAS-06275-8 with MO Cry 1F.

3] Submit/cite all data required for registrati on of your product under FIFRA § 3(c)(5) when the Agency requires registrants of si milar 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 register ed plant-incorporated protectants to produce inbred corn lines and hybrid corn varie ties with combined pesticidal traits.

5] In light of recently published laboratory st udies showing reduced growth in shredding caddis flies exposed to anti-lepidopteran Cry1A protei n corn litter (Rosi-Marshall, et al. 2007), additional aquatic invertebrate da ta are required. A 7 to 14 day Daphnia magna study as per the 885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, representing the functional group of a leaf shre dder in headwater streams must be submitted by January 31, 2012.

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

Insect Resistance Management:

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

1] Requirements relatin g 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 B t corn users to sign “grower agreements” that impose binding contractual obliga tions on the grower to comply with the refuge requirements;

3] Requirements regarding programs to e ducate 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

60insects;

6] Requirements regarding a “remed ial action plan” that contains measures the registrants would take in the event that any field relevant insect resistance was detected as well as to report on activity under the plan to EPA;

7] Submit annual reports on units so ld by state (units sold by count y level will be made available to the Agency upon request), IRM grower agre ements 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 pr opagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

1] Corn-Belt Refuge Requirements

Field corn grown outside cotton- growing areas (e.g., the Corn Belt), grower agreements (also known as stewardship agreements) will specify that growers must adhere to the refuge requirements as described in th e grower guide/product use guide and/or in supplements to the grower guide/product use guide.

· Specifically, growers must plant a stru ctured 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 stal k-boring and other pests.

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

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

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

· Insecticide treatments for cont rol of ECB, CEW, Southwestern corn borer (SWCB) and other lepidopteran target pest s 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., Extens ion Service agents, crop consultants). Instructions to growers w ill specify that microbial Bt insecticides must not be applied to

non- Bt corn and/or non-le pidopteran resistant Bt corn refuges.

2] Cotton-Growing Area Refuge Requirements for Bt Corn

61For Bt field corn grown in cotton-growing areas, gr ower 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 supplem ents to the grower guide/product use guide.

· Specifically, growers in these areas must plan t 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 fi elds, 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 fiel d, refuges must be at least 4 rows wide.

· Insecticide treatments for control of ECB, CEW, Southwestern co rn borer (SWCB), and other lepidopteran target pest s listed on the label, grower guides, or other educational material may be applied only if economic thresholds are reache d for one or more of these target pests. Economic thresholds will be determined using methods recommended by local or regional professionals (e.g., Extens ion Service agents, crop consultants). Instructions to growers w ill specify that microbial Bt insecticides must not be applied to

non- Bt corn and/or non-le pidopteran resistant Bt corn refuges.

· Cotton-growing areas include the following stat es: Alabama, Arkansas, Georgia, Florida, Louisiana, North Carolina, Mi ssissippi, South Carolina, Oklahom a (only the counties of Beckham, Caddo, Comanche, Cu ster, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, Washita), Tennessee (only the counties of Ca rroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Hayw ood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), Texa s (except the counties of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, M oore, 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 stew ardship 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 bou nd to comply with the requirements of the IRM

program.

3] The registrant must maintain a system that is reasonably likely to assure that persons purchasing the Bt corn product will affirm annually that they are contractually bound to comply with the requirements of the IRM program.

624] The registrant must continue to use their current grower agreemen t. If the registrant wishes to change any part of the grower agreement or any specific stewardship documents referenced in the grower agreement that woul d 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 th e terms and conditions of the amendment.

5] The registrant must maintain a system that is reasonably likely to assure that persons purchasing the Bt corn sign grower agreement(s).

6] The registrant shall maintain records of all Bt corn grower agreements for a period of three years from December 31 of the year in which the agreement was signed.

7] The registrant shall provi de EPA with a report showin g 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 name s, personal information, and grower license number, will be protected.

c. IRM Education and IRM Co mpliance Monitoring Programs

1] The registrant must mainta in 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 require ments on the bag or bag tag, and electronic communications such as by Internet, radio, or television commercial s. Copies of the materials will be provided to EPA for its records. The progr am shall involve at least one written communication annually to

each Bt corn user separate from the grower techni cal guide. The communication shall inform the user of the current IRM requirements. The regi strant shall coordinate its education programs

with educational efforts of othe r registrants and other organizatio ns, 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 th e compliance survey required and from other sources. The changes shall address aspects of gr ower compliance that are not sufficiently high.

3] Annually, each January 31st, the registrant mu st provide EPA any substantive changes to its grower education activities as part of the overall IRM complianc e assurance program report. The registrant must either submit a separate repo rt or contribute to the report from the industry working group (ABSTC).

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

63evaluate the extent to wh ich growers purchasing its Bt corn product are complying with the IRM program and that takes such actions as are reas onably 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 wi ll 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 r ecognizing that for reasons of di fference in busin ess 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 grow er or for all growers in a specific region. An individual grow er found to be significantly ou t of compliance two years in a row would be denied sales of the product the ne xt year. Similarly, s eed dealers who are not fulfilling their obligations to inform/educate grow ers 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 th e potential impact of non-response. The sample size and geographical resolution may be ad justed annually, based upon input from the independent marketing research firm and academic scientists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasonable sensitivity for comparing results across the U.S.

i. A third party is classified as a party ot her than the registrant, the grower, or anyone else with a direct interest in IRM compliance for Bt corn.

7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potenti al biological significance of any implementation deviations.

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

educational tools and initiatives.

9] The registrant shall provide a written summary of the result s of the prior year's survey (together with a description of the regions, the methodology us ed, 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 surv ey prior to its implementation.

10] Annually, the registrant sh all revise, and expand as necessary, its compliance assurance program to take into account the information co llected through the comp liance survey and from other sources. The changes shall address aspect s of grower compliance th at are not sufficiently

64high. 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 acti on, consistent with its “pha sed compliance approach.”

13] If a grower, who purchases Bt corn for planting, was specifica lly identified as not being in compliance during the previous year, the registra nt shall visit with the grower and evaluate whether that the grower is in compliance w ith the IRM program for the current year.

14] Each registrant shall annually provide a report to EPA summa rizing 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 re port will include information regarding grower interactions (including, but not li mited to, on-farm visits, verified tips and complaints, grower meetings and letters), the extent of non-comp liance, corrective measures to address the noncompliance, and any follow-up actions taken. The registrants may el ect to coordinate information and report collectively the result s of their compliance assurance programs.

15] The registrant and the seed corn dealers fo r the registrant must allow a review of the compliance records by EPA or by a State pesticid e regulatory agency if the State agency can

demonstrate that confidential business information, including the names, personal information, and grower license number of the growers will be protected.

16] The registrant shall revise and expand its existing Compliance Assurance Program to include the following elements. The registrant must prepare and submit by January 31, 2011, a written description of its revised Comp liance Assurance Program. The regi strant may coordinate with other registrants in designing and implem enting its Compliance Assurance Program.

17] The registrant will enha nce the refuge education prog ram throughout the seed delivery

channel:

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of correct refuge implementation and pot ential consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the next three growing seas ons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

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

65risks for resistance:

i. Use Bt corn adoption, pest pressu re information, and other available information to identify regions where the risk of resistance is greatest;

ii. Focus approximately two-thir ds of on-farm assessments on these regions, with the remaining assessments conducted across other regions where the product is used.

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

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

i. Identify for potential on-farm assessment growers whose sales informati on indicates they have purchased the Bt corn product but may have purchased little or no refuge seed from the registrant, licensee, or affiliated company.

20] The registrant will contract with third part ies to perform on-farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all firs t-time on-farm assessments as well as second-year on-farm assessments of those growers found out of compliance in a first-time assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and level of refuge compliance for the product.

22] The registrant will follow up with grower s who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

i. All growers found to be signif icantly out of compliance in a pr ior year will annually be sent additional refuge assistance info rmation for a minimum of two years by the registrant, seed supplier, or third party assessor, afte r completing the assessment process;

ii. The registrant will conduct follow-up checks on growers found to be significantly out of compliance within three year s after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a five-year period will be denied access to the Bt corn product in the subsequent year.

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

d. Insect Resistance Monitori ng and Remedial Action Plan

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

The registrant will monitor for resistance to its lepidopteran-resistant Bt corn. The monitoring program shall consist of two a pproaches: (1) focused population sampling and laboratory testing; and (2) investigation of reports of less-than ex pected control of labeled insects. Should field66relevant resistance be confirmed, an appropri ate resistance management action plan will be implemented.

(2) Focused Population Sampling

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

nubilalis (European corn borer; ECB), Diatraea grandiosella (Southwestern corn borer; S WCB), and Helicoverpa zea (corn earworm; CE W). Sampling fo r the target pests will be

focused in areas identified as those with the hi ghest risk of resistance development (e.g., where lepidopteran-active Bt hybrids are planted on a high proportion of the co rn acres, and where the insect species are regarded as key pests of corn). Bioassay met hods must be appropriate for the goal of detecting field-relevant shifts in population response to lepidopteran resistant Bt corn and/or changes in resist ance allele frequency in response to the use of Bt corn and, as far as possible, should be consistent ac ross sampling years to enable co mparisons with historical data.

The number of populations to be collected shall reflect the regional im portance of the insect species as a pest, and specific collection region s will be identified for each pest. For ECB, a minimum of 12 populations across the sampling re gion 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 allele s before they become common enough to cause measurable field damage, each population collectio n 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 in sect populations or genomes due to factors such as natural fluctuations in pest density, environmental conditions, and area-wid e pest suppression.

The sampling program and geographic range of co llections may be modi fied 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 sh all be investigated as soon as possible to understand a ny field relevance of such a fi nding. 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 Ag ency annually before A ugust 31. The investigative steps will include:

1. Re-test progeny of the collected population to determine whether the unusual bioassay response is reproducible and herita ble. If it is not reproducible a nd heritable, no further action is required.

2. If the unusual response is re producible and heritable, proge ny of insects that survive the diagnostic concentration will be tested using me thods that are representative of exposure to Bt

67corn hybrids under field conditions. If progeny do not survive to ad ulthood, any suspected

resistance is not fiel d relevant and no furthe r 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 freq uency in the original population;

• determining whether the resistance-allele Fr equency 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 th e 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 Ag ency to develop and implement a case-specific resistance management action plan.

(2) Investigation of Reports of Unexpect ed Levels of Damage by the Target

Pests:

The registrant will follow up on gr ower, extension specialist or c onsultant reports of unexpected levels of damage by the lepidopteran pests list ed on the pesticide label. The registrant will

instruct its customers to contact them if such in cidents occur. The registra nt will investigate all legitimate reports submitted to the comp any 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 registra nt 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 unexpect ed levels of insect feeding damage for which:

• the corn in question has been c onfirmed to be lepidopteran-active Bt corn;

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

• the relevant plant tissues are ex pressing the expected level of Bt protein; and

68• it has been ruled out th at species not susceptible to the protein could be responsible for the damage, that no climatic or cultural reas ons could be responsible for the damage, and

that that there could be no othe r reasonable causes for the damage.

The Agency does not interpret suspected resistance to mean grower report s of possible control failures or suspicious results fr om annual insect monitoring assa ys, 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 fiel ds 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 pr actices to minimize the possibility of resistant insects over-wintering and contribu ting to the next season's target pest population.

Additionally, if possible, and prior to the app lication of alternative control measures or destruction of crop residue, the re gistrant will collect samples of the insect population in the affected fields for laboratory rearing and testin g. Such rearing and testing shall be conducted as expeditiously as practical.

Confirmed resistance

EPA defines confirmed resistance to mean, in the case of field re ports of unexpected levels of damage from the key target pests, th at all the following criteria are met:

• There is > 30% insect survival and commensurate ins ect 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 th ere may be a resistance allele frequency of ≥ 0.1 in the sampled population.

• In standardized labora tory bioassays, the LC 50 exceeds the upper limit of the 95%

confidence interval of the LC 50 for susceptible populations su rveyed both in the original baselines developed for this pest species and in previous years of field monitoring.

(3) Response to Confirmed Resistance in a Ke y 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

69registrant:

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

• Affected customers and extension agents wi ll be notified about confirmed resistance within 30 days;

• Monitoring will be increased in the affected ar ea 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 availab ility of suitable alternative control measures), alternative control measur es will be employed to reduce or control target pest populations in th e affected area. Alternative control measures may include advising customers and extensi on agents in the affected area to incorporate crop residues into the soil following harvest to minimi ze 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, consulta nts, extension agents , seed distributors, university cooperators and state/ federal authorities as approp riate) in the region of the resistance situation and approved action plan; and

• In subsequent growing seasons, maintain sa les 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 resistan ce management plan is in place to mitigate the resistance.

A report on results of resistan ce monitoring and investigations of damage reports must be submitted to the Agency annually by August 31 st each year for the duration of the conditional registration.

e. Annual Reports

1] Annual Sales: reported and summed by state (county level data availa ble 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

70each year;

3] Grower Education: substantive changes to education program completed the previous year, January 31st each year;

4] Compliance Assurance Plan: Compliance Assu rance Program activities and results, January 31st each year;

5] Compliance: to includ e annual survey resu lts and plans for the next year; full report January 31st each year;

6] Insect Resistance Monitoring Results: results of monitoring and inves tigations of damage reports, August 31st each year.

If these conditions are not complied with, the registration will be subj ect to cancellation in accordance with FIFRA section 6(e). Your re lease for shipment of Cry1Ab corn constitutes acceptance of these conditions.

71Date Registered Date Expired Registrant Registration # Active Ingredients

Pioneer/Dupont 29964-7 1507 (PO Cry1F) x MON 810 (Cry1Ab) February 24,

2010 31-Oct-22

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

2. The subject registration will be limited to Bacillus thuringiensis Cry1F protein and the genetic material (PHI8999) necessary for it s production in corn event TC 1507 (OECD Unique Identifier DAS- Ø 15 Ø 7-1) x Bacillus thuringiensis Cry1Ab protein and the genetic material (PV-ZMBK07) necessary for it production in corn event MON 810 (OECD Unique Identifier MON- ØØ 81 Ø-6) for use in field corn.

3. Submit/cite all data required for registrati on of your product under FI FRA § 3(c)(5) when the Agency requires all registrants of si milar 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 th e registrant submits/cites any data required to support the PIP registrations of the individual parental events TC1507 (DASØ 15 Ø 7-1) and MON810 (MON- ØØ 81 Ø-6) in corn, within the time frames required by the terms and conditions of EPA Regi stration Numbers 29964-3 and 524-489.

5. In light of recently published laboratory studies showing reduced growth in shredding caddis flies exposed to anti-lepidopteran Cry1A protein corn litter (R osi-Marshall, et al. 2007), additional aquatic invertebrate data are required. A 7 to 14 day Daphnia magna study as per the 885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, represen ting the functional group of a leaf shredder in headwater streams must be submitted by January 31, 2012.

6. A copy of the grower agreement, associ ated stewardship documents, and written description of a system, which assures that growers will sign gr ower agreements and persons purchasing 1507xMON810 corn will annually affirm th at they are contractually bound to comply with the requirements of the insect resistance management (IRM) program, has been submitted and is currently being reviewed.

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

follows.

The required IRM program for 1507xMON810 co rn must have the following elements:

• Requirements relating to creation of a non- Bt corn and/or non-le pidopteran resistant Bt corn refuge in conjunction with the planting of any acreage of Bt corn;

72• Requirements for Pioneer to prepare and require Bt corn users to sign “grower agreements,” that impose binding contractual ob ligations on the grower to comply with the refuge requirements;

• Requirements regarding programs to edu cate growers about IRM requirements;

• Requirements regarding programs to evaluate and promote growers’ compliance with IRM requirements;

• Requirements regarding programs to evaluate whether there are statistically significant and biologically relevant changes in target insect susceptibility to Cry1F and Cry1Ab proteins in the target insects;

• Requirements regarding a remedial action plan that contains measures Pioneer would take in the event that any field-relevant ins ect 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 agreem ents results, and compliance assurance program, including the educational program on or before January 31st each year, beginning in 2011.

a) Refuge Requirements

These refuge requirements do not apply to seed pr opagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

1. Corn Belt Refuge Requirements for Bt corn. Bt field corn grown out side cotton-growing areas (e.g., the Corn Belt), grower agreemen ts (also known as stewardship agreements) will specify that growers must adhere to th e refuge requirements as described in the grower guide/product use guide and/or in s upplements to the grow er guide/product use guide.

• Specifically, growers must plant a stru ctured 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 stal k-boring and other pests.

• Refuge planting options include: separate fi elds, blocks within fields (e.g., along the edges or headlands), and st rips across the field.

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

73• When planting the refuge in strips across the fi eld, refuges must be at least 4 rows wide.

• Insecticide treatments for cont rol of ECB, CEW, Southwestern corn borer (SWCB) and other lepidopteran target pest s 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., Extens ion Service agents, crop consultants). Instructions to growers w ill specify that microbial Bt insecticides must not be applied to

non- Bt corn and/or non-le pidopteran 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 ref uge 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 plan t 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 fi elds, 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 fiel d, refuges must be at least 4 rows wide.

• Insecticide treatments for control of ECB, CEW, Southwestern co rn borer (SWCB), and other lepidopteran target pest s 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., Extens ion Service agents, crop consultants). Instructions to growers w ill specify that microbial Bt insecticides must not be applied to

non- Bt corn and/or non-le pidopteran resistant Bt corn refuges.

• Cotton-growing areas include the following stat es: Alabama, Arkansas, Georgia, Florida, Louisiana, North Carolina, Mi ssissippi, South Carolina, Oklahom a (only the counties of Beckham, Caddo, Comanche, Cu ster, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, Washita), Tennessee (only the counties of Ca rroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Hayw ood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), Texa s (except the counties of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, M oore, 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).

74b) 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 cont ractually bound to comply with the requirements of the IRM program.

4. Pioneer must use an approved grower agreemen t 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 stewar dship 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 e quivalent to what is already approved for previously registered Pioneer Bt corn products, which is reasonably likely to assure that persons purchasing 1507xMON810 corn sign grow er 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 1507xM ON810 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 ther eafter, Pioneer shall provide EPA with a report showing the numb er of units of its Bt corn seeds sold or shipped and not returned, and the number of such units that were sold to pe rsons 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 exte nding 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 na mes, 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

75convey to Bt corn users the importance of comp lying with the IRM program for all Bt corn products contain the Cry1F and Cry1A b proteins. The program shall include information encouraging Bt corn users to pursue optional elements of the IRM program relating to refuge confi guration 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 provi ded 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 coordina te its education programs with educational efforts of other registrants and other organi zations, such as the National Corn Grower Association and state extension programs.

2. Annually, Pioneer shall revise, and expand as necessary, its education program to account for the information collected through the co mpliance survey required under paragraph 6 and from other sources. The registrant shall identify deficiencies in grower compliance and revise the education program to address those deficiencies.

3. Beginning January 31, 2011, Pioneer must provide a report to EPA summarizing the

activities it carri ed out under its education program for the prior year. Annually thereafter, Pioneer must provide EPA any s ubstantive changes to its grower education activities as part of the over all IRM compliance assurance pr ogram report. Pioneer must either submit a separate report or contribut e 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 approv ed 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 w ho have not complied with the program either

do so in the future or lose their access to the Bt corn product. Pion eer shall coordinate

with other Bt corn registrants in designing and implementing its compliance assurance program and integrate this re gistration into the current compliance assurance program

used for their other Bt corn PIPs. Other requ ired 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-comp liance with the terms of the IRM program and general criteria for choosing among op tions 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 mu st be reasonable designed to assure that persons purchasing 1507x MON810 corn comply with th e IRM program. While recognizing that

for reasons of difference in business practices there are needs for flexibility between different companies, Pioneer must use a cons istent 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 y ears in a row would

766. Pioneer must maintain an IRM compliance assurance program (CAP) that shall include an annual survey conducted by an independent third party of a statistically representative sample of growers of Bt corn borer protected products w ho 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 approv ed 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 ar eas. 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-resp onse. The sample size and geographical resolution may be adjusted a nnually, based upon input from the independent marketing research firm and academic scie ntists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasonable sensitivity for comparing results across the U.S.

i. A third party is classified as a party ot her than the registrant, the grower, or anyone else with a direct interest in IRM compliance for Bt corn.

7. The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potential bi ological significance of any implementation

deviations.

8. The survey shall be designed to obtain grow er feedback on the us efulness 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 descripti on of the regions, the methodol ogy 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 fr om other sources. The registrant shall identify deficiencies in grower compliance and revise the education program to address those deficiencies. The registrants must conf er with the Agency prior to adopting any changes.

11. The registrant shall conduct an annual on-fa rm 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 progr am. 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 th e IRM program, the registrant shall take appropriate action, consistent with its "phase d compliance approach," to

77promote 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 w ho is not in compliance with the IRM program, the registrant shall take a ppropriate 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 re gistrant shall visit with the grower and evaluate whether that the grower is in co mpliance with the IRM program for the current

year.

14. Each registrant shall annually provide a report to EPA summ arizing the activities carried out under their compliance assu rance program for the prior year and the plans for the compliance assurance program during the cu rrent 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-comp liance, and any follow-up actions taken. The registrants may elect to coordinate inform ation 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 pesticid e regulatory agency if the State agency

can demonstrate that confid ential business information, including the names, personal information, and grower license number of the growers will be protected.

16. The registrant shall revise and expand its existing Comp liance Assurance Program to include the following elements. The registra nt must prepare and submit by January 31, 2011, a written description of its revised Compliance Assura nce Program. The registrant may coordinate with other registrants in designing and implementing its Compliance Assurance Program.

17. The registrant will enhance the refuge e ducation program througho ut the seed delivery

channel:

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of correct refuge implementation and potenti al consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the ne xt three growing seasons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

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

risks for resistance:

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

78regions where the risk of resistance is greatest;

ii. Focus approximately two-thirds of on-fa rm assessments on these regions, with the remaining assessments conducted across othe r regions where the product is used.

19] The registrant will use its available Bt sales records and other information to refine grower lists for on-farm assessments of th eir compliance with re fuge requirement:

i. Identify for potential on-farm assessment gr owers whose sales information indicates they have purchased the Bt corn product but may have purchas ed little or no refuge seed from the registrant, licensee, or affiliated company.

20] The registrant will contract with thir d parties to perform on-farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all first-time on-farm assessments as well as secondyear on-farm assessments of those grower s found out of compliance in a first-time

assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and leve l of refuge compliance for the product.

22] The registrant will follow up with grower s who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

i. All growers found to be significantly out of co mpliance in a prior year will annually be sent additional refuge assistance in formation for a minimum of two years by the registrant, seed supplier, or third pa rty assessor, after completing the assessment process;

ii. The registrant will conduct follow-up check s on growers found to be significantly out of compliance within three year s after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a fi ve-year period will be denied access to the

Bt corn product in the subsequent year.

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

d) Insect Resistance Monitoring

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

1507xMON810 corn:

The registrant will monitor for resistance to its lepidopteran-resistant Bt corn. The monitoring program shall consist of two a pproaches: (1) focused population sampling and laboratory testing; and (2) investigation of reports of less-than-expected control of labeled insects. Should field79relevant resistance be confirmed, an appropri ate 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 propor tion of the corn acres, and where the insect species are regarded as ke y 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 al lele 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 regi onal 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 regi on 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 di fferent geographies and agronomic conditions. To obtain sufficient sensitivity to detect re sistance alleles before they become common enough to cause measurable field damage, each population collection sha ll 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 targ et number of insect popul ations 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 co llections 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 st 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 repor ted to the Agency annually before August 31 st . The investigative steps will include:

1. Re-test progeny of the collected populati on to determine whether the unusual bioassay response is reproducible and heri table. If it is not reproducib le and heritable, no further action is required.

802. If the unusual response is reproducible a nd 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 freq uency in the original population;

• determining whether the resistance-allele frequency is increasing by analyzing field collections in subsequent years sampled fr om 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 site s 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, exte nsion specialist or c onsultant reports of unexpected levels of damage by the lepidopteran pests listed on the pesticide label. The registrant will instruct its customers to contac t them if such incident s occur. The registrant will investigate all legitimate reports subm itted 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 c onfirmed to be lepidopteran-active Bt corn;

• the seed used had the proper percentage of corn expressing Bt proteins;

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

81• it has been ruled out th at species not susceptible to the protein could be responsible for the damage, that no climatic or cultural reas ons could be responsible for the damage, and

that that there could be no othe r 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 contribu ting to the next season's target pest population.

Additionally, if possible, and prior to the appl ication 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. Su ch 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 commensur ate 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 th ere may be a resistance allele frequency of ≥ 0.1 in the sampled population.

• In standardized labora tory bioassays, the LC 50 exceeds the upper limit of the 95%

confidence interval of the LC 50 for susceptible populations su rveyed 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

82When 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 wi ll be notified about confirmed resistance within 30 days;

• Monitoring will be increased in the affected ar ea 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 availab ility of suitable alternative control measures), alternative control measur es will be employed to reduce or control target pest populations in th e affected area. Alternative control measures may include advising customers and extensi on agents in the affected area to incorporate crop residues into the soil following harvest to minimi ze the possibility of over-wintering insects, and/or applications of chemical insecticides;

• Unless otherwise agreed with EPA, the registra nt will stop sale a nd distribution of the relevant lepidopteran-active Bt corn hybrids in the affected area immediately until an effective local mitigation plan approved by EPA has been implemented;

• The registrant will develop a case-specific resistance management action plan within 90 days according to the characteristics of the resistance event and local agronomic needs. The registrant will consult with appropriate stakeholders in the development of the action plan, and the details of such a plan shall be approved by EPA prior to implementation;

• The registrant will notify affected parties (e .g. growers, consultants, extension agents, seed distributors, university cooperators and state/federal authorities as appropriate) in the region of the resistance situat ion and approved action plan; and

• In subsequent growing seasons, the regist rant will maintain sales suspension and alternative resistance management strategi es 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 resistan ce monitoring and investigations of damage reports must be submitted to the Agency annually by August 31 st each year for the duration of the conditional registration.

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

83sold and not returned, and the number of su ch units that were sold to persons who have signed grower agreements, Janua ry 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: complian ce 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 re port 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 re lease for shipment of the product constitutes acceptance of these conditions.

84II. 

### Cry 3Bb1 BRAD Registered Products

Date Registered Date Expired Registrant Registration # Active Ingredients

Monsanto 524-528 Bt Corn Event MON863 with Cry3Bb1 (YieldGard RW) Feb-03 30-Sep-10

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

extension for Bt Corn Event MON863 with Cry3Bb1. Failure to receive a request prior to the expiration date, September 30, 2010, will result in a cancellation of the currently registered product(s) (EPA Registration # 524-528).

85Date Registered Date Expired Registrant Registration # Active Ingredients

Monsanto 524-545 Bt corn Stack Event MON 863 + MON 810 with Cry 3Bb1 + Cry1Ab (YieldGard Plus) 31-Oct-03 30-Sep-10

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

extension for Bt Corn Event MON863 with Cry3Bb1. Failure to receive a request prior to the expiration date, September 30, 2010, will result in a cancellation of the currently registered product(s) (EPA Registration # 524-545).

86Date Registered Date Expired Registrant Registration # Active Ingredients

Monsanto 524-551 Bt corn Event MON 88017 with Cry3Bb1 (YieldGard VT RW) 13-Dec-05 30-Sep-15

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

2] The subject registra tion will be limited to Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (vector PV-ZMIR39) in MON 88017 corn (OECD Unique Identifier: MON-88Ø17-3) for use in field corn.

3] Submit/cite all data required for registrati on of your product under FIFRA § 3(c)(5) when the Agency requires registrants of si milar 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 register ed plant-incorporated protectants to produce inbred corn lines and hybrid corn varie ties with combined pesticidal traits.

5] In light of recently published laboratory st udies showing reduced growth in shredding caddis flies exposed to anti-lepidopteran Cry1A protei n corn litter (Rosi-Marshall, et al. 2007), additional aquatic invertebrate da ta are required. A 7 to 14 day Daphnia magna study as per the 885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, representing the functional group of a leaf shre dder in headwater streams must be submitted by January 31, 2012.

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

a. Refuge Requirements

These refuge requirements do not apply to seed pr opagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

1. Grower agreements (also known as stewards hip 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 struct ured refuge of at least 20% non-Cry3Bb1 Bt corn that may be treated with insecticides as need ed 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 presen t unless the Cry3Bb1 field is treated in a

similar manner.

873. Refuge planting options incl ude: refuge acres should be pl anted as blocks adjacent to

MON 88017 corn fields or as in-field strips. 4. External refuges must be plante d adjacent to Cry3Bb1 MON 88017 fields. 5. When planting the refuge in strips across th e field, refuges must be at least 4 consecutive

rows wide.

6. Insecticide treatments for cont rol of corn rootworm larvae ma y 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 re fuge unless the Cry3Bb1 fi eld 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 stew ardship 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 contract ually bound to comply with the requirements of the IRM program.

3] The registrant must continue to implement a system (equivalent to what is already approved for MON 810, EPA Reg. No. 524-489) that is re asonably likely to a ssure that persons purchasing the Bt corn product will affirm annually th at they are contractually bound to comply with the requirements of the IRM program.

4] If Monsanto wishes to change any part of the grower agreement or any specific stewardship documents referenced in the grower agreement that would affect either the content of the IRM program or the legal enforceability of th e provisions of the agreement relating to the IRM program, thirty days prio r to implementing a proposed ch ange, the registrant must submit to EPA the text of such changes to ensu re that it is consistent with the terms and

conditions of the amendment.

5] The registrant must continue to implement a system (equivalent to what is already approved for MON 810, EPA Reg. No. 524-489) that is re asonably likely to a ssure that persons purchasing the Bt corn sign grower agreement(s), and mu st provide within 90 days from the date of the registration a written description of that system.

6] The registrant shall maintain records of all Bt corn grower agreements for a period of three years from December 31st of the year in which the agreement was signed.

7] Annually, the registrant shall provide EPA with a report sh owing 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 grow er agreements. The report shall cover the time frame of the twelve-month period cove ring 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

88confidential business information, including name s, personal information, and grower license number, will be protected.

c. IRM Education and IRM Compliance Monitoring Programs

1] Monsanto must maintain and implement a comprehensive, ongoing IRM education program designed to convey to Bt MON 88017 corn users the importa nce 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 re lating 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 writ ten materials, EPA re viewed language on IRM requirements on the bag or bag ta g, and electronic communications such as by In ternet, radio, or television commercials. Copies of the materi als will be provided to EPA for its records. The program shall involve at least one written communication annually to each Bt MON 88017 corn user separate from the grower tec hnical guide. The communication shall inform the user of the current IRM requirements. Mons anto shall coordinate its education programs with educational efforts of other registrants and other organizations, such as the National

Corn Growers Association a nd state extension programs. 2] Annually, the registrant shall revise, and expa nd as necessary, its education program to take

into account the information collected th rough the compliance survey required under paragraph 6] and from other sources. The changes shall address aspects of grower compliance that are not sufficiently high. 3] Annually, the registrant must provide a report to EPA summar izing the activities carried out under the education program for the prior year. Annually thereaf ter, the registrant must provide EPA any substantive changes to its grower education activities as part of the overall IRM compliance assurance program report. The required features of the compliance assurance program are described in paragraphs 4-22 below. 4] The registrant must design and implement an ongoing IRM compliance assurance program designed to evaluate the extent to which growers purchasing its MON 88017 Bt corn product are complying with the IRM program and that ta kes such actions as are reasonably needed to assure that growers who have not complied with th e 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 alr eady approved for MON8 10, EPA Registration Number 524-489. The registrant must prepare and submit within 90 days of the date of registration a written description of thei r compliance assurance program including a summary of the program implemented in the 200 3 growing season. Other required features of the program are described in paragraphs 5 - 22 below. 5] The registrant must establish and publicize a “phased compliance approach,” i.e., a guidance document that indicates how the registrant will address instances of non-compliance with the terms of the IRM program and general criteria for choosing among options for responding to any non-compliant growers. The options shall in clude 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. Si milarly, 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.

896] The IRM compliance assurance program shall include an annua l 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 potenti al impact of non-response. The sample size and geographical resolution may be adjust ed annually, based upon input from the independent marketing research firm and a cademic 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 10 0 acres of corn in corn/cotton growing regions.

i. A third party is classified as a party ot her than the registrant, the grower, or anyone else with a direct interest in IRM compliance for Bt corn.

7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potenti al biological significance of any implementation deviations. 8] The survey shall be designed to obtain grow er feedback on the usefulness of specific

educational tools and initiatives. 9] The registrant shall provide a final written su mmary of the results of the prior year’s survey (together with a description of the regions, the methodology us ed, 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 prio r to its implementation. 10] Annually, the registrant sh all revise, and expand as necessary, its compliance assurance program to take into account the informa tion collected through th e compliance survey required under paragraphs 6 th rough 8 and from other sources . The changes shall address aspects of grower compliance that are not suffi ciently high. The registra nt must confer with the Agency prior to adopting any cha nges to a previously approved CAP. 11] The registrant shall trai n its representatives who make on-farm visits with MON 88017 Bt corn growers to perform assessm ents of compliance with IRM re quirements. 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 appr opriate 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 appropria te action, consistent with its “phased compliance approach.” 13] If a grower, who purchases MON 88017 Bt corn for planting, was specifically identified as not being in compliance during the previous year , the registrant shall visit with the grower and evaluate whether that the grower is in compliance with the IRM program for the current

year. 14] Annually, Monsanto shall provide a report to EPA summarizing the activities carried out under their compliance assurance program for the prior year and the plans for the compliance assurance program during the current year. The report will include information regarding grower interactions (including, but not limited to , on-farm visits, verified tips and complaints, grower meetings and letters), the extent of non-compliance, co rrective measures to address the non-compliance, and any follow-up actions taken.

9015] The registrant and the seed corn dealers fo r the registrant must allow a review of the compliance records by EPA or by a State pesticid e regulatory agency if the State agency can

demonstrate that confidential business information, including the names, personal information, and grower license number of the growers will be protected.

16] The registrant shall revise and expand its existing Compliance Assurance Program to include the following elements. The registrant must prepare and submit by January 31, 2011, a written description of its revised Comp liance Assurance Program. The regi strant may coordinate with other registrants in designing and implem enting its Compliance Assurance Program.

17] The registrant will enha nce the refuge education prog ram throughout the seed delivery

channel:

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of correct refuge implementation and pot ential consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the next three growing seas ons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

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

risks for resistance:

i. Use Bt corn adoption, pest pressu re information, and other available information to identify regions where the risk of resistance is greatest;

ii. Focus approximately two-thir ds of on-farm assessments on these regions, with the remaining assessments conducted across other regions where the product is used.

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

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

i. Identify for potential on-farm assessment growers whose sales informati on indicates they have purchased the Bt corn product but may have purchased little or no refuge seed from the registrant, licensee, or affiliated company.

20] The registrant will contract with third part ies to perform on-farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all firs t-time on-farm assessments as well as second-year on-farm assessments of those growers found out of compliance in a first-time assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and level of refuge compliance for the product.

22] The registrant will follow up with grower s who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

91i. All growers found to be signif icantly out of compliance in a pr ior year will annually be sent additional refuge assistance info rmation for a minimum of two years by the registrant, seed supplier, or third party assessor, afte r completing the assessment process;

ii. The registrant will conduct follow-up checks on growers found to be significantly out of compliance within three year s after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a five-year period will be denied access to the Bt corn product in the subsequent year.

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

9d. Insect Resistance Monitori ng and Remedial Action Plan

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

The registrants must monitor for Cry3Bb1 resist ance and/or trends in increased tolerance for corn rootworm. Sampling should be focused in those areas in which there is the highest risk of resist ance development.

1. The resistance monitoring plan must include: baseline sensitivity data, sampling (number of locations, samples per locati ons), 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 de scription of rootworm damage guidelines.

2. The registrant must work to develop a diag nostic assay for corn rootworm resistance monitoring to detect potentially re sistant individuals. As part of this effort, the registrant must investigate the feasibility of using the Sublethal Seedling Assay I as a diagnostic assay. A report on this requirement must be submitted to the Agency 6 months from the date of the amended registration.

3. The registrant must submit revised corn r ootworm damage guidelines (to characterize unexpected pest damage). Th e revised guidelines must take into consideration the

comments and recommendations from EPA’s J une 30, 2010 review of the rootworm resistance monitoring program for Cry3Bb1. A report on this requirement must be submitted to the Agency 6 months from the date of the amended registration.

4. The registrant must follow-up on grower, ex tension specialist or c onsultant reports of unexpected damage or control failures for corn rootworm.

5. The registrant must provide EPA with an annual resistance monitoring report by August 31 st of each year, reporting on populatio ns collected the previous year.

I Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and B.D. Siegfried. 2008. Validation of a novel resist ance monitoring technique for corn rootworm (Coleoptera: Chrysomelidae) and event DAS- 59122-7 maize. J. Appl. Entomol. 132:177-188)

92e. Remedial Action Plans

Once a remedial action plan is approved fo r MON 863, it also must be used for corn rootworm suspected and confirmed resist ance 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 require ments are as follows:

1] Annual Sales: reported a nd 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 pe rsons 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 resu lts and plans for the next year; full report January 31st each year;

6] Insect Resistance Monitoring Results: re sults of monitoring and investigations of damage reports, April 30th each year.

93Date Registered Date Expired Registrant Registration # Active Ingredients

Monsanto 524-552 Bt corn Event MON 88017 + MON 810 with Cry1Ab + Cry3Bb1 (YieldGard VT Plus) 13-Dec-05 30-Sep-15

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

2] The subject registration will be limited to Cry3Bb1 [ Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its pr oduction (vector PV-ZMIR39) in MON 88017 corn (OECD Unique Identifier: MON-88Ø17-3)] x Cry1Ab [ Bacillus thuringiensis Cry1Ab protein and the genetic material (PV-ZMBK07) necessa ry for it production in corn event MON 810 (OECD Unique Identifier: MON-ØØ 81Ø-6)] for use in field corn.

3] Submit/cite all data required for registrati on of your product under FIFRA § 3(c)(5) when the Agency requires registrants of si milar products to submit such data.

4] Submit/cite all data, determined by the Agency to be acceptable, and required to support the individual plant-incorporated protectants in MON 88017 and MON 810 within the timeframes required by the terms and conditions of EPA Registration Numbers 524-551 and 524-489, respectively.

5] The subject plant-incorporat ed protectant may be combin ed through conventional breeding with other registered plant-incorporated prot ectants that are similarly approved for use in combination, through conventiona l breeding, with other plant- incorporated protectants to produce inbred corn lines and hybrid corn va rieties with combined pesticidal traits.

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

a. Refuge Requirements

These refuge requirements do not apply to seed pr opagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

Grower agreements (also known as stewardship agreements) will specify that growers must adhere to the following refuge re quirements as described in the grower guide/product use guide and/or in supplements to the gr ower guide/product use guide.

Corn Belt / Non-Cotton Growi ng Region Refuge Requirements

94For corn grown in the US Corn Belt two options for deployment of the re fuge are available to

growers.

The first option is planting a common refuge fo r 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 represen t at least 20% of the grower’s corn acres (i.e. sum of [MON 88017 x MON 810] acres and refuge acres). It may be planted as a block adjacent to the [MON 88017 x MON 810] field, perimeter strips, or in-field strips. If perimeter strips are im plemented, the strips must be at least 4 consecutive rows wide. If strips within the [MON 88017 x MON 810] field ar e implemented, then at least 4 consecutive rows should be planted. The common refuge may be treated with a soil -applied or seed-applied

insecticide to control rootworm larvae and other soil pests. The refuge may also be treated with a

non- Bt foliar insecticide for control of late season pests if pest pressure reaches an economic threshold for damage; however, if rootworm adults are present at the time of foliar applications then the [MON 88017 x MON 810] field must be treated in a similar manner.

The second option is planting separate refuge areas for corn borers and corn rootworms. The corn borer refuge must be planted with a non- Bt /lepidopteran-protected hybrid, must represent at least 20% of the grower’s corn acres (i.e. sum of [MON 88017 x MON 810] acres and corn borer refuge acres), and must be planted within 1⁄2 mile of the [MON 88017 x MON 810] field. The corn borer refuge may be treated with a soil -applied or seed-applied insecticide for corn

rootworm larval control or a non- Bt foliar-applied insecticide for corn borer control if pest pressure reaches an economic threshold for damage . The corn rootworm refuge must be planted

with a non- Bt /corn rootworm-protected hybri d, but may be planted with Bt corn hybrids that control corn borers. The corn rootworm refuge mu st represent at least 20% of the grower’s corn acres (i.e. sum of [MON 88017 x MON 810] acres a nd corn rootworm refuge acres) and may be planted as an adjacent block, perimeter strips, or in-field strips. The corn rootworm refuge may be treated with a soil-applied or seed-applied in secticide to control rootworm larvae and other soil pests. The refuge may also be treated with a non- Bt foliar insecticide for control of late season pests; however, if rootworm adults are pres ent 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 cotto n-growing areas the common refuge and separate refuge options are also available, how ever, the refuge area is larger. Cotton-growing areas include the following states: Alabama, Ar kansas, Florida, Georgia, Louisiana, North Carolina, Mississippi, South Ca rolina, Oklahoma (only the c ounties 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, Ma dison, Obion, Rutherford, Shelby, and Tipton), Texas (except the counties of Carson, Dallam, Ha nsford, Hartley, Hutchinson, Lipscomb, Moore, Ochiltree, Roberts, and Sherman) Virginia ( only the counties of Dinw iddie, Franklin City, Greensville, Isle of Wight, Northampton, Sout hampton, Suffolk City, Surrey, and Sussex), and Missouri (only the counties of Dunkin, New Madrid, Pemiscot, Scott, and Stoddard).

95The first option is planting a common refuge fo r 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 represen t at least 50% of the grower’s corn acres (i.e. su m of [MON 88017 x MON 810] acres and refuge acres). It may be planted as a block adjacent to the [MON 88017 x MON 810] field, perimeter strips, or in-field strips. If perimeter strips are im plemented, the strips must be at least 4 consecutive rows wide. If strips within the [MON 88017 x MON 810] field are implemented, then at least 4 consecutive rows should be planted. The common refuge may be treated with a soil -applied or seed-applied

insecticide to control rootworm larvae and other soil pests. The refuge may also be treated with a

non- Bt foliar insecticide for control of late season pests if pest pressure reaches an economic threshold for damage; however, if rootworm adults are present at the time of foliar applications then the [MON 88017 x MON 810] field must be treated in a similar manner.

The second option is planting separate refuge areas for corn borers and corn rootworms. The corn borer refuge must be planted with a non- Bt /lepidopteran-protected hybrid, must represent at least 50% of the grower’s corn acres (i.e. sum of [MON 88017 x MON 810] acres and corn borer refuge acres), and must be planted within 1⁄2 mile of the [MON 88017 x MON 810] field. The corn borer refuge may be treated with a soil -applied or seed-applied insecticide for corn

rootworm larval control or a non- Bt foliar-applied insecticide for corn borer control if pest pressure reaches an economic threshold for damage . The corn rootworm refuge must be planted

with a non- Bt corn/rootworm-protected hybri d, but may be planted with Bt corn hybrids that control corn borers. The corn rootworm refuge mu st represent at least 20% of the grower’s corn acres (i.e. sum of [MON 88017 x MON 810] acres and corn rootwo rm refuge acres) and be planted as an adjacent block, perimeter strips, or in-field strips. The corn rootworm refuge may be treated with a soil-applied or seed-applied in secticide to control rootworm larvae and other soil pests. The refuge may also be treated with a non- Bt foliar insecticide for control of late season pests; however, if rootworm adults are pres ent 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 stew ardship 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 bou nd to comply with the requirements of the IRM

program. 3] The registrant must develop a system (equi valent to what is already approved for MON 810, EPA Reg. No. 524-489) that is reasonably likel y to assure that persons purchasing the Bt corn product will affirm annually that they are cont ractually 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 a nd submit to EPA within 90 days from the date of registration a copy of that agreement and any sp ecific 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 w ould affect either the content of the IRM program or the legal enfo rceability of the provisions of the agreement

96relating to the IRM program, thirty days prior to implementing a proposed change, the registrant must submit to EPA the text of such changes to en sure that it is consistent with the terms and

conditions of the amendment. 5] The registrant must establish a system (equi valent to what is alr eady approved for MON 810, EPA Reg. No. 524-489) that is reasonably likel y to assure that persons purchasing the Bt corn sign grower agreement(s), and must provide within 90 days from the date of the registration a written description of that system. 6] The registrant shall maintain records of all Bt corn grower agreements for a period of three years from December 31st of the year in which the agreement was signed. 7] Annually, the registrant shall provide EPA w ith a report showing the number of units of its [MON 88017 x MON 810] corn seeds sold or shippe d and not returned, and the number of such units that were sold to persons who have signe d grower agreements. The report shall cover the time frame of the twelve-month period c overing 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 name s, 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] co rn users the importance of complying with the IRM program. The program shall in clude information encouraging [MON 88017 x MON 810] corn users to pursue optional elemen ts 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 medi a, 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 reco rds. 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 ed ucation 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 th rough the compliance survey required under paragraph 6] and from other sources. The changes shall address aspects of grower compliance that are not sufficiently high. 3] Annually, the registrant must provide EPA a ny substantive changes to its grower education activities as part of the overall IRM complia nce assurance program report. The required features of the compliance assurance program are described in para graphs 4-22 below. 4] The registrant must design and implement an ongoing IRM compliance assurance program designed to evaluate the extent to whic h growers purchasing its [MON 88017 x MON 810]

Bt corn product are complying with the IRM pr ogram 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 thei r 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 integrat e the Cry3Bb1 CAP with the CAP already

97approved for MON810, EPA Registration Number 524-489. The registrant must prepare and submit within 90 days of the da te of registration a written description of their compliance assurance program including a summary of the program implemented in the 2003 growing season. Other required features of the program are described in paragraphs 5 - 22 below. 5] The registrant must establish and publicize a “phased compliance approach,” i.e., a guidance document that indicates how the registrant will address instances of non-compliance with the terms of the IRM program and general criteria for choosing among options for responding to any non-compliant growers. The options shall in clude 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 grow ers 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 annua l 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 potenti al impact of non-response. The sample size and geographical resolution may be adjust ed annually, based upon input from the independent marketing research firm and a cademic 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 10 0 acres of corn in corn/cotton growing regions. i. A third party is classified as a party ot her than the registrant, the grower, or anyone else with a direct interest in IRM compliance for Bt corn. 7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potenti al biological significance of any implementation deviations. 8] The survey shall be designed to obtain grow er feedback on the usefulness of specific

educational tools and initiatives. 9] The registrant shall provide a final written su mmary of the results of the prior year’s survey (together with a description of the regions, the methodology us ed, 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 prio r to its implementation. 10] Annually, the registrant sh all revise, and expand as necessary, its compliance assurance program to take into account the informa tion collected through th e compliance survey required under paragraphs 6 th rough 8 and from other sources . The changes shall address aspects of grower compliance that are not suffi ciently high. The registra nt must confer with the Agency prior to adopting any cha nges to a previously approved CAP. 11] The registrant shall train its representatives who make on-farm visits with [MON 88017 x MON 810] corn growers to perform assessments of compliance with IRM requirements. In the event that any of these visits result in the identification of a grower who is not in compliance with the IRM program, the registrant shall take appropriate action, consistent with its “phased compliance approach,” to promote compliance. This on-farm assessment program will have no minimum acreage threshold for growers. 12] The registrant shall carry out a program for investigating legitimate “tips and complaints” that its growers are not in compliance with the IRM program. Whenever an investigation

98results in the identification of a grower who is not in compliance with the IRM program, the registrant shall take appropria te 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 whethe r that the grower is in comp liance with the IRM program for the current year. 14] Annually, Monsanto shall provide a report to EPA summarizing the activities carried out under their compliance assurance program for the prior year and the plans for the compliance assurance program during the current year. The report will include information regarding grower interactions (including, but not limited to , on-farm visits, verified tips and complaints, grower meetings and letters), the extent of non-compliance, co rrective measures to address the non-compliance, and any follow-up actions taken. 15] The registrant and the seed corn dealers fo r the registrant must allow a review of the compliance records by EPA or by a State pesticid e regulatory agency if the State agency can

demonstrate that confidential business information, including the names, personal information, and grower license number of the growers will be protected. 16] The registrant shall revise and expand its existing Compliance Assurance Program to include the following elements. The registrant mu st prepare and submit by January 31, 2011, a written description of its revised Complia nce Assurance Program. The registrant may coordinate with other registrants in desi gning and implementing its Compliance Assurance Program. 17] The registrant will enha nce the refuge education prog ram throughout the seed delivery

channel: i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of correct refuge implementation and potential consequences of failure to plant the required refuge; ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the next three growing seasons, with 50% implementation in 2012 and full implementation for the 2013 growing season. 18] The registrant will focus the majority of on-farm assessments on regions with the greatest

risks for resistance:

i. Use Bt corn adoption, pest pressure information, a nd other available information to identify regions where the risk of resistance is greatest; ii. Focus approximately two-thirds of on-fa rm assessments on these regions, with the remaining assessments conducted across othe r regions where the product is used. 19] The registrant will use its available Bt sales records and other info rmation to refine grower

lists for on-farm assessments of their compliance with refuge requirement: i. Identify for potential on-farm assessment gr owers whose sales information indicates they have purchased the Bt corn product but may have purchased little or no refuge seed from the registrant, licensee, or affiliated company. 20] The registrant will contract with third part ies to perform on-farm assessments of compliance with refuge requirements: i. The third-party assessors will conduct all first-time on-farm assessments as well as secondyear on-farm assessments of those grower s found out of compliance in a first-time

assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and level of refuge compliance for the product.

9922] The registrant will follow up with grower s who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year: i. All growers found to be significantly out of co mpliance in a prior year will annually be sent additional refuge assistance information for a mi nimum of two years by the registrant, seed supplier, or third party assessor, afte r completing the assessment process; ii. The registrant will conduct follow-up check s on growers found to be significantly out of compliance within three year s after they are found to be back in compliance; iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a five-year pe riod will be denied access to the Bt corn product in the subsequent year. iv. The registrant will identify to EPA all growers who are denied access to the Bt corn product.

d. Cry 3Bb1 Insect Resistance Monitoring

The Agency is imposing the following conditions for this product:

1] Monitoring must be carried out under the same protocols used for the products MON 810 524- 528. The registrants must monitor for Cry3B b1 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 resist ance development.

2] The resistance monitoring plan must include: baseline sensitivity data, sampling (number of locations, samples per locations), sampli ng methodology and life-stage sampled, bioassay methodology, standardization procedures (inclu ding QA/QC provisions), detection technique and sensitivity, the statistical analysis of th e probability of detecting resistance, and an interim description of ro otworm damage guidelines. 3] The registrant must work to develop a diagnostic assay for corn rootworm resistance monitoring to detect po tentially resistant indivi duals. As part of this effort, the registrant must investigate the feasibility of using the Sublethal Seedling Assay II as a diagnostic assay. A report on this requirement must be submitted to the Agency 6 months from the date of the amended registration.

4] The registrant must submit revised corn rootworm damage guidelines (to characterize unexpected pest damage). The revised guidelines must take into consideration the comments and recommendations from EPA’s June 30, 2010 review of the rootworm resistance monitoring program for Cry3Bb1. A report on this requirement must be submitted to the Agency 6 months from the date of the amended registration.

5] The registrant must follow-up on grower, ex tension specialist or c onsultant reports of unexpected damage or control failures for corn rootworm.

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

, reporting on populations colle cted the previous year.

II Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and B.D. Siegfried. 2008. Validation of a novel resist ance monitoring technique for corn rootworm (Coleoptera: Chrysomelidae) and event DAS- 59122-7 maize. J. Appl. Entomol. 132:177-188)

100e. 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 resist ance in. [MON 88017 x MON 810]. If corn rootworm resistance is confirmed, all acres ([MON 88017 x MON 810] and refuges) must be trea ted 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 a pproaches: (1) focused population sampling and laboratory testing; and (2) investigation of reports of less-than ex pected control of labeled insects. Should fieldrelevant resistance be confirmed, an appropri ate resistance management action plan will be implemented.

(3) Focused Population Sampling

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

nubilalis (European corn borer; ECB), Diatraea grandiosella (Southwestern corn borer; S WCB), and Helicoverpa zea (corn earworm; CEW). Sampling for th e target pests will be focused

in areas identified as those with the highest risk of re sistance development (e.g., where lepidopteran-active Bt hybrids are planted on a high proportion of the co rn acres, and where the insect species are regarded as key pests of corn). Bioassay met hods must be appropriate for the goal of detecting field-relevant shifts in population response to lepidopteran resistant Bt corn and/or changes in resist ance allele frequency in response to the use of Bt corn and, as far as possible, should be consistent ac ross sampling years to enable co mparisons with historical data.

The number of populations to be collected shall reflect the regional im portance of the insect species as a pest, and specific collection region s will be identified for each pest. For ECB, a minimum of 12 populations across the sampling regi on will be targeted fo r 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 allele s before they become common enough to cause measurable field damage, each population collectio n 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 in sect populations or genomes due to factors such as natural fluctuations in pest density, environmental conditions, and area-wid e pest suppression.

The sampling program and geographic range of co llections may be modi fied 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.

101The 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 sh all be investigated as soon as possible to understand a ny field relevance of such a fi nding. Such investigations shall proceed in a stepwise manner until the field relevance can be ei ther confirmed or refuted, and

results of these shall be reported to the Ag ency annually before A ugust 31. The investigative steps will include: 1. Re-test progeny of the collected population to determine whether the unusual bioassay response is reproducible and herita ble. If it is not reproducible a nd heritable, no further action is required.

2. If the unusual response is re producible and heritable, proge ny of insects that survive the diagnostic concentration will be tested using me thods that are representative of exposure to Bt corn hybrids under field conditions. If progeny do not survive to ad ulthood, any suspected

resistance is not fiel d relevant and no furthe r 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 freq uency in the original population;

• determining whether the resistance-allele Fr equency 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 th e 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 Ag ency to develop and implement a case-specific resistance management action plan.

(2) Investigation of Reports of Unexpect ed Levels of Damage by the Target

Pests:

The registrant will follow up on gr ower, extension specialist or c onsultant reports of unexpected levels of damage by the lepidopteran pests list ed on the pesticide label. The registrant will

instruct its customers to contact them if such in cidents occur. The registrant will investigate all legitimate reports submitted to the comp any or the company' s representatives.

102If reports of unexpected levels of damage lead to the suspicion of resistance in any of the key target pests (ECB, SWCB, and CEW), the registra nt 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 unexpect ed levels of insect feeding damage for which:

• the corn in question has been c onfirmed to be lepidopteran-active Bt corn;

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

• the relevant plant tissues are ex pressing the expected level of Bt protein; and

• it has been ruled out th at species not susceptible to the protein could be responsible for the damage, that no climatic or cultural reas ons could be responsible for the damage, and

that that there could be no othe r reasonable causes for the damage.

The Agency does not interpret suspected resistance to mean grower report s of possible control failures or suspicious results fr om annual insect monitoring assa ys, 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 fiel ds 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 pr actices to minimize the possibility of resistant insects over-wintering and contribu ting to the next season's target pest population.

Additionally, if possible, and prior to the app lication of alternative control measures or destruction of crop residue, the re gistrant will collect samples of the insect population in the affected fields for laboratory rearing and testin g. Such rearing and testing shall be conducted as expeditiously as practical.

Confirmed resistance

EPA defines confirmed resistance to mean, in the case of field re ports of unexpected levels of damage from the key target pests, th at all the following criteria are met:

103• There is > 30% insect survival and commensurate ins ect 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 labora tory bioassays, the LC 50 exceeds the upper limit of the 95%

confidence interval of the LC 50 for susceptible populations su rveyed both in the original baselines developed for this pest species and in previous years of field monitoring.

(3) Response to Confirmed Resistance in a Ke y 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 wi ll be notified about confirmed resistance within 30 days;

• Monitoring will be increased in the affected ar ea 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 availab ility of suitable alternative control measures), alternative control measur es will be employed to reduce or control target pest populations in th e affected area. Alternative control measures may include advising customers and extensi on agents in the affected area to incorporate crop residues into the soil following harvest to minimi ze 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, consulta nts, extension agents , seed distributors, university cooperators and state/ federal authorities as approp riate) in the region of the resistance situation and approved action plan; and

104• In subsequent growing seasons, maintain sa les 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 resistan ce management plan is in place to mitigate the resistance.

A report on results of resistan ce monitoring and investigations of damage reports must be submitted to the Agency annually by August 31 st each year for the duration of the conditional registration. If these conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA section 6(e). Your re lease for shipment of Cry1Ab corn constitutes acceptance of these conditions.

105

### III. Cry 34Ab1/Cry35Ab1 BRAD Registered Products

Date Registered Date Expired Registrant Registration # Active Ingredients

Dow AgroSciences 68467-5 Bt corn Event DAS-59122-7 with Cry 34Ab1/Cry35Ab1 (Herculex RW) 31-Aug-05 30-Sep-15

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

2] The subject registration will be limited to Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessa ry for their production (plasmid insert PHP17662) in Event DAS-59122-7 corn (OECD Unique Identifier: DAS-59122-7) use in

field corn.

3] Submit/cite all data required for registration of your product under FIFRA § 3(c)(5) when the Agency requires registrants of si milar products to submit such data.

4] This plant-incorporated protectant may be combined through conventional breeding with other registered plant-incor porated protectants that are similarly approved for use in combination, through conventional breeding, w ith other registered plant-incorporated protectants to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits.

5] In light of recently published laboratory studies showing reduced growth in shredding caddis flies exposed to anti-lepidopteran Cry1A protein corn litter (R osi-Marshall, et al. 2007), additional aquatic invertebrate data are required. A 7 to 14 day Daphnia magna study as per the 885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, represen ting the functional group of a leaf shredder in headwater streams must be submitted by January 31, 2012.

6] The following insect resistance management data are recommended.

Additional research on co rn rootworm pest biologyand ecology, genetics and mechanisms of resistance, functional dominance, fitness costs, cross-resistance potential, dose (including the role of density-dependenc e), and mode of action are recommended to evaluate the sustainability of the insect resistance management durability plan and confirm the assumptions made in the simula tion 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 treatmen t option to allow independent treatment of the refuge for pests other than corn rootwo rms, 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.

1067) You must commit to do the following Insect Resistance Management Program which has the following elements:

a) Requirements relating to creation of a non-(corn rootworm-protected PIP) corn refuge in conjunction with the planting of any acreage of commercial Cry34/35Ab1

Bt corn;

b) Requirements for the registrants to prepare and require Cry34/35Ab1 Bt corn users to sign “grower agreements” that impose binding contractual obligations on the grower to comply with the refuge requirements;

c) Requirements for the registrants to develop, implement, and report to EPA on programs to educate growers about IRM requirements;

d) Requirements for the registrants to de velop, implement, and report to EPA on programs to evaluate and promote grow ers’ compliance with IRM requirements (the Cry34/35Ab1 Compliance Assurance Prog ram (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 susceptib ility to Cry34/35Ab1 proteins in the target insects;

f) Requirements for the registrants to de velop, and if triggered, to implement a “remedial action plan” that would contain measures the registrants would take in the event that any insect resistance was de tected 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), IR M grower agreements results, compliance assurance program including the educati on program, and resistance monitoring on or before January 31 st each year.

7a. Refuge Requirements

Grower agreements (also known as stewardship agreements) will specify that growers must adhere to the refuge requirements as described in the grower guide/produ ct use guide and/or in supplements to the grower guide/product use guide.

These refuge requirements do not apply to seed pr opagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

1071. 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 with in 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 root worms, 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 Cr y34/35 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 (op tion encouraged where WCRW rotationresistant biotype may be present).

• Application of soil insecticide is permitted in the refuge.

• Seed treatment is permitted in the refuge , either for rootworm protection or for controlling secondary soil pests.

• If aerial insecticides are applied to the refuge for control of CRW adults, the same treatment must also be applied in the same time-frame to Cry34/35 corn.

Pests other than adult corn rootworms may only be treated with CRW-labeled insecticide on the refuge acres without treating the Cry34/35 acres if treatment occurs when adult corn rootworms are not present. Pests on the Cry34/35 acres may be treated as needed without having to treat the refuge.

• The rootworm refuge may be planted to any corn hybrid that does not express

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

• The refuge and Cry34/35 corn should be sown on the same date, or with the shortest window possible between planting dates, to ensure that corn root development is similar among varieties.

• Growers are encouraged to plant the rootworm refuge in the same location each year, as it allows the rootworm populati on to remain high and the durability of the trait is extended. This option may be preferable to growers who wish to only think of their refuge design once and for growers who grow continuous corn. It is recognized, however, that for those growers who need to employ crop rotation, a fixed refuge would be impractical.

1087 b. Grower Agreements

1] Persons purchasing the Bt corn product must sign a grow er 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 clearl y set forth the terms of the current IRM program. By signing the grower agreemen t, a grower must be contractually bound to comply with the requirements of the IRM program.

3] The registrant must deve lop a system (equivalent to what is already approved for Cry1F Bt corn) that is reasonably likely to assure that persons purchasing the Bt corn product will affirm annually that th ey are contractually bound to comply with the requirements of the IRM program.

4] If the registrant wishes to change any pa rt of the grower agreement or any specific stewardship documents referenced in the gr ower 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 subm it to EPA the text of such changes to

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

5] The registrant must establish a system (equivalent to what is already approved for Cry1F Bt Corn) that is reasonably likely to assure that persons purchasing the Bt corn sign grower agreement(s).

6] The registrant shall maintain records of all Bt corn grower agreements for a period of three years from December 31st of the y ear in which the agreement was signed.

7] Annually, the registrant shal l provide EPA with a report showing the number of units of its Cry34/35Ab1 corn seeds sold or shi pped 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 th e 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 regul atory agency if the State agency can

demonstrate that confidential business information, including names, personal information, and grower license number, will be protected.

7c. IRM Education and IRM Co mpliance Monitoring Programs

1] The registrants must implement a comp rehensive, ongoing IRM education program designed to convey to Bt Cry34/35Ab1 corn users the importance of complying with the IRM program. The program shall include information encouraging Bt Cry34/35Ab1 corn users to pursue optional elements of the IRM program relating to refuge configuration and proximity to Bt Cry34/35Ab1 corn fields. The

109education program shall involve the use of multiple media, e.g. face-to-face meetings, mailing written materials, EP A reviewed language on IRM requirements on the bag or bag tag, and elec tronic communications such as by Internet, radio, or television commercials. The program shall involve at least one written communication annually to each Bt Cry34/35Ab1 corn user separate from the grower technical guide. The communicati on shall inform the user of the current IRM requirements. The registrants shall c oordinate their educa tion programs with

educational efforts of other registrants and othe r organizations, such as the National Corn Grower Association and state extension programs.

2] Annually, the registrant sh all revise, and expa nd as necessary, its education program

to account for the information collected through the complianc e survey required under paragraph 6] and from other sources. The changes shall address aspects of grower compliance that ar e not sufficiently high.

3] Annually, the registrant must provide EP A any substantive cha nges to its grower education activities as part of the ove rall IRM compliance assurance program report. The required features of the comp liance assurance program are described in paragraphs 4-22 below.

4] The registrant must design and implement an ongoing IRM compliance assurance program designed to evaluate the exte nt 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 futu re or lose their access to the Cry34/35Ab1

Bt corn product. The registrant shall coordinate with other Bt corn registrants in designing and implementing its compliance assurance program and integrate the Cry34/35Ab1 CAP with the Cry1 Caps. Other required features of the program are described in paragraphs 5 - 22 below.

5] The registrant must establish and public ize 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 pr ogram and general criteria for choosing among options for responding to any non-compliant growers. The options shall

include withdrawal of the ri ght to purcha se Cry34/35Ab1 Bt corn for an individual grower or for all growers in a specific re gion. An individual grower found to be significantly out of complianc e 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 stat istically representative sample of Cry34/35Ab1 Bt corn growers who plant the vast ma jority 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-cot ton areas. The survey shall measure the degree of compliance with the IRM program by growers in different regions of the

110country and consider the pot ential impact of non-response. The sample size and geographical resolution may be adjust ed annually, based upon input from the independent marketing research firm and academic scientists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasonable sensitivity for comparing results across the U.S.

i. A third party is classified as a part y other than the regist rant, the grower, or anyone else with a direct in terest in IRM compliance for Bt corn.

7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements . An analysis of the survey results must include the reasons, extent, and potential biological significance of any implementation deviations.

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

educational tools and initiatives.

9] The registrant shall provide a written su mmary of the results of the prior year’s survey (together with a de scription of the regions, the methodology used, and the supporting data) to EPA by January 31 of eac h 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 co llected through the compliance survey required under paragraphs 6 through 8 and from other sources. The changes shall address as pects 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 conduc t an annual on-farm assessment program. The registrant shall train its represen tatives who make on-farm visits with Cry34/35Ab1 Bt corn growers to perform assessments of complia nce 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 appropr iate action, consistent with its “phased compliance approach,” to promote compliance.

12] The registrant shall carry out a program for investig ating 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 regi strant 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 durin g 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.

11114] Annually, The registrants shall provide a report to EPA summarizing the activities carried out under their compliance assuranc e 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 interacti ons (including, but not limite d to, third-party grower survey, on-farm visitation program, ve rified tips and complaints, education programs (e.g., grower meetings and lette rs), the extent of non-compliance,

corrective measures to address the non- compliance (phased-compliance program), and any follow-up actions taken.

15] The registrant and the seed corn dealers for the registrant must allow a review of the compliance records by EPA or by a State pesticide regulatory agency if the State agency can demonstrate that conf idential business information, including the names, personal information, and grower license number of the growers will be protected.

16] The registrant shall revise and expa nd its existing Compliance Assurance Program to include the following elements. The registrant must prepare and submit by January 31, 2011, a written description of its revised Compliance Assurance Program. The registrant may coordinate with other registrants in designing and implementing its Compliance Assurance Program.

17] The registrant will enhance the ref uge education program throughout the seed delivery channel:

i. Ensure sales representatives, licensees , seed dealers, and growers recognize the importance of correct refuge implementati on and potential consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the next three growing seasons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

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

i. Use Bt corn adoption, pest pre ssure information, and other available information to identify regions where the risk of resistance is greatest;

ii. Focus approximately two-thirds of on-fa rm assessments on these regions, with the remaining assessments conducted across othe r regions where the product is used.

19] The registrant will use its available Bt sales records and other information to refine grower lists for on-farm assessments of th eir compliance with re fuge requirement:

i. Identify for potential on-farm assessment growers whose sales in formation indicates they have purchased the Bt corn product but may have pur chased little or no refuge seed from the registrant, licen see, or affiliated company.

11220] The registrant will contract with thir d parties to perform on- farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all first-time on-farm assessments as well as second-year on-farm assessments of thos e growers found out of compliance in a

first-time assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and leve l of refuge compliance for the product.

22] The registrant will follow up with grow ers who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

i. All growers found to be signi ficantly out of compliance in a prior year will annually be sent additional refuge assistance info rmation for a minimum of two years by the registrant, seed supplier, or third part y assessor, after completing the assessment

process;

ii. The registrant will conduct follow-up checks on growers found to be significantly out of compliance within thr ee years after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a five-year period will be denied access

to the Bt corn product in the subsequent year.

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

7d. Insect Resistance Monitoring and Remedial Action Plan

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

The registrants must monitor for Cry34Ab1/35Ab1 resistance and/or tr ends in increased tolerance for corn rootworm. Sampling should be focused in those areas in which there is the highest risk of resistan ce development.

1. The resistance monitoring plan must include: baseline sensitivity data, sampling (number of locations, samples per loca tions), sampling methodology and life-stage sampled, bioassay methodology, standardiz ation procedures (including QA/QC provisions), detection techni que and sensitivity, the statistical analysis of the probability of detecting resistance, and an interim description of rootworm damage guidelines.

2. The registrant must work to develop a diag nostic assay for corn rootworm resistance monitoring to detect potentially resistant in dividuals. As part of this effort, the

113registrant must investigate the feasibility of using the Sublethal Seedling Assay III as a diagnostic assay. A report on this require ment must be submitted to the Agency 6 months from the date of the amended registration.

3. The registrant must submit revised corn r ootworm damage guidelines (to characterize unexpected pest damage). The revised guide lines must take into consideration the

comments and recommendations from EPA’ s June 30, 2010 review of the rootworm resistance monitoring program for Cry3Bb1. A report on this requirement must be submitted to the Agency 6 months from the date of the amended registration.

4. The registrants must follow-up on grower, exte nsion 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 31 st of each year, reporting on populatio ns collected the previous year.

7e. Remedial Action Plans

The remedial action plan is designed as a tiered approach for mitigating WCRW, NCRW, and MCRW resistance development to th e Cry34/35Ab1 protein. The following program summary describes, in order of events, the step s 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. EP A 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 in itiated when needed.

1. Definition of Suspected Resistance: Resistance will be suspec ted if investigations of

u nexpected 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 pe st insect species, weather, physical damage, larval movement from a lternate 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 meas ures are intended to re duce the possibility of potentially resistant insects contributi ng to the following year’s pest population.

2. Confirmation of Resistance : Resistance will be confirmed if all of the following criteria are

et by progeny from the target pest species sampled from the area of “suspected resistance”: m

III Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and B.D. Siegfried. 2008. Validation of a novel resist ance monitoring technique for corn rootworm (Coleoptera: Chrysomelidae) and event DAS- 59122-7 maize. J. Appl. Entomol. 132:177-188)

114a. the proportion of larvae that can feed and survive on Cry34/35Ab1 roots from neonate to adult is significantly higher than the baseli ne proportion (currently being established);

b. the LC50 of the test populati on exceeds the upper limit of the 95% confidence interval for the LC50 of a standard unselected populatio n, 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 fi eld 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 act ion plan will be devised according to the

characteristics of the resistance ev ent and local agronomic needs.

8) Annual Reports:

The registrant must provide annual reports to EPA on its Cry34/35Ab1 PIP expressed in corn based on the following table.

Report Description Due Date

Annual Sales Units sold by state (county information is available upon request by the Agency) January 31 st 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 31 st 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 31 st ,each year beginning in 2008 as part of the Compliance Assurance Program Report

Compliance Assurance Program Compliance Assurance Program Activitiesand Results: third-party grower survey, onfarm visitation program, phased-compliance report, tips and complaints, and grower education programs January 31 st each year starting

in 2007

Insect Resistance Monitoring Annual report of the insect resistance monitoring program. Results of monitoring and investigations of damage reports August 31st each year beginning in 2008

115Additional reports are due to EPA on its Cry3 4/35Ab1 PIP expressed in corn based on the following table as described in the following table:

Report Description Due Date

Changes to Grower Agreement and/or

IRM documents Current grower agreemen t(s) and any specific stewardship documents At least 30 days before any changes related to IRM are expected to be imposed.

116Date Registered Date Expired Registrant Registration # Active Ingredients

Pioneer/Dupont 29964-4 Bt corn Event DAS-591227- 7 with Cry 34Ab1/Cry35Ab1 (Herculex RW) 31-Aug-05 30-Sep-15

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

2] The subject registration will be limited to Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material n ecessary for their produc tion (plasmid insert PHP17662) in Event DAS-59122-7 corn (OEC D Unique Identifier: DAS-59122-7) for

use in field corn.

3] Submit/cite all data required for registration of your product under FIFRA § 3(c)(5) when the Agency requires registrants of si milar products to submit such data.

4] This plant-incorporated protectant may be combined through conventional breeding with other registered plant-incor porated protectants that are similarly approved for use in combination, through conventional breeding, w ith other registered plant-incorporated protectants to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits.

5] In light of recently published laboratory studies showing reduced growth in shredding caddis flies exposed to anti-lepidopteran Cry1A protein corn litter (R osi-Marshall, et al. 2007), additional aquatic invertebrate data are required. A 7 to 14 day Daphnia magna study as per the 885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, represen ting the functional group of a leaf shredder in headwater streams must be submitted by January 31, 2012.

6] The following insect resistance management data are recommended.

Additional research on co rn rootworm pest biologyand ecology, genetics and mechanisms of resistance, functional dominance, fitness costs, cross-resistance potential, dose (including the role of density-dependenc e), and mode of action are recommended to evaluate the sustainability of the insect resistance management durability plan and confirm the assumptions made in the simula tion 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 treatmen t option to allow independent treatment of the refuge for pests other than corn rootwo rms, data would be required regarding the impact of independent treatment of the refuge for other pests (not corn rootworm, e.g., corn borers, spider mites) on corn rootworm resistance management.

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

117the following elements:

a) Requirements relating to creation of a non-(corn rootworm-protected PIP) corn refuge in conjunction with the planting of any acreage of commercial Cry34/35Ab1

Bt corn;

b) Requirements for the registrants to prepare and require Cry34/35Ab1 Bt corn users to sign “grower agreements” that impose binding contractual obligations on the grower to comply with the refuge requirements;

c) Requirements for the registrants to develop, implement, and report to EPA on programs to educate growers about IRM requirements;

d) Requirements for the registrants to de velop, implement, and report to EPA on programs to evaluate and promote grow ers’ compliance with IRM requirements (the Cry34/35Ab1 Compliance Assurance Prog ram (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 susceptib ility to Cry34/35Ab1 proteins in the target insects;

f) Requirements for the registrants to de velop, and if triggered, to implement a “remedial action plan” that would contain measures the registrants would take in the event that any insect resistance was de tected 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), IR M grower agreements results, compliance assurance program including the educati on program, and resistance monitoring on or before January 31 st each year.

7a. Refuge Requirements

Grower agreements (also known as stewardship agreements) will specify that growers must adhere to the refuge requirements as described in the grower guide/produ ct use guide and/or in supplements to the grower guide/product use guide.

These refuge requirements do not apply to seed pr opagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

1181. 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 with in 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 root worms, 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 Cr y34/35 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 (op tion encouraged where WCRW rotationresistant biotype may be present).

• Application of soil insecticide is permitted in the refuge.

• Seed treatment is permitted in the refuge , either for rootworm protection or for controlling secondary soil pests.

• If aerial insecticides are applied to the refuge for control of CRW adults, the same treatment must also be applied in the same time-frame to Cry34/35 corn.

Pests other than adult corn rootworms can only be treated with CRW-labeled insecticide on the refuge acres without treating the Cry34/35 acres if treatment occurs when adult corn rootworms are not present. Pests on the Cry34/35 acres may be treated as needed without having to treat the refuge.

• The rootworm refuge may be planted to any corn hybrid that does not express

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

• The refuge and Cry34/35 corn should be sown on the same date, or with the shortest window possible between planting dates, to ensure that corn root development is similar among varieties.

• Growers are encouraged to plant the rootworm refuge in the same location each year, as it allows the rootworm populati on 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.

1197b. Grower Agreements

1] Persons purchasing the Bt corn product must sign a grow er 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 clearl y set forth the terms of the current IRM program. By signing the grower agreemen t, a grower must be contractually bound to comply with the requirements of the IRM program.

3] The registrant must deve lop a system (equivalent to what is already approved for Cry1F Bt corn) that is reasonably likely to assure that persons purchasing the Bt corn product will affirm annually that th ey are contractually bound to comply with the requirements of the IRM program.

4] If the registrant wishes to change any pa rt of the grower agreement or any specific stewardship documents referenced in the gr ower 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 subm it to EPA the text of such changes to

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

5] The registrant must establish a system (equivalent to what is already approved for Cry1F Bt Corn) that is reasonably likely to assure that persons purchasing the Bt corn sign grower agreement(s).

6] The registrant shall maintain records of all Bt corn grower agreements for a period of three years from December 31st of the y ear in which the agreement was signed.

7] Annually, the registrant shal l provide EPA with a report showing the number of units of its Cry34/35Ab1 corn seeds sold or shi pped 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 th e 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 regul atory agency if the State agency can

demonstrate that confidential business information, including names, personal information, and grower license number, will be protected.

7c. IRM Education and IRM Co mpliance Monitoring Programs

1] The registrants must implement a comp rehensive, ongoing IRM education program designed to convey to Bt Cry34/35Ab1 corn users the importance of complying with the IRM program. The program shall include information encouraging Bt Cry34/35Ab1 corn users to pursue optional elements of the IRM program relating to refuge configuration and proximity to Bt Cry34/35Ab1 corn fields. The

120education program shall involve the use of multiple media, e.g. face-to-face meetings, mailing written materials, EP A reviewed language on IRM requirements on the bag or bag tag, and elec tronic communications such as by Internet, radio, or television commercials. Copies of the materials will be pr ovided to EPA for its records for the first year of commercia lization (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 sh all revise, and expa nd as necessary, its education program

to account for the information collected through the complianc e survey required under paragraph 6] and from other sources. The changes shall address aspects of grower compliance that ar e not sufficiently high.

3] Annually, the registrant must provide EP A any substantive cha nges to its grower education activities as part of the ove rall IRM compliance assurance program report. The required features of the comp liance assurance program are described in paragraphs 4-22 below.

4] The registrant must design and implement an ongoing IRM compliance assurance program designed to evaluate the exte nt 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 futu re or lose their access to the Cry34/35Ab1

Bt corn product. The registrant shall coordinate with other Bt corn registrants in designing and implementing its compliance assurance program and integrate the Cry34/35Ab1 CAP with the Cry1 Caps. Other required features of the program are described in paragraphs 5 - 22 below.

5] The registrant must establish and public ize 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 pr ogram and general criteria for choosing among options for responding to any non-compliant growers. The options shall

include withdrawal of the ri ght to purcha se Cry34/35Ab1 Bt corn for an individual grower or for all growers in a specific re gion. An individual grower found to be significantly out of complianc e 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 stat istically representative sample of Cry34/35Ab1 Bt corn growers who plant the vast ma jority 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

121plant 100 or more acres of corn in corn-cot ton areas. The survey shall measure the degree of compliance with the IRM program by growers in different regions of the country and consider the pot ential impact of non-response. The sample size and geographical resolution may be adjust ed annually, based upon input from the independent marketing research firm and academic scientists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasonable sensitivity for comparing results across the U.S.

i. A third party is classified as a part y other than the regist rant, the grower, or anyone else with a direct in terest in IRM compliance for Bt corn.

7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements . An analysis of the survey results must include the reasons, extent, and potential biological significance of any implementation deviations.

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

educational tools and initiatives.

9] The registrant shall provide a written su mmary of the results of the prior year’s survey (together with a de scription of the regions, the methodology used, and the supporting data) to EPA by January 31 of eac h 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 co llected through the compliance survey required under paragraphs 6 through 8 and from other sources. The changes shall address as pects 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 conduc t an annual on-farm assessment program. The registrant shall train its represen tatives who make on-farm visits with Cry34/35Ab1 Bt corn growers to perform assessments of complia nce 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 appropr iate action, consistent with its “phased compliance approach,” to promote compliance.

12] The registrant shall carry out a program for investig ating 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 durin g the previous year, the registrant shall

122visit with the grower and evaluate whether that the grower is in compliance with the IRM program for the current year.

14] Annually, the registrants sh all provide a report to EPA summarizing the activities carried out under their compliance assuranc e 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 interacti ons (including, but not limite d to, third-party grower survey, on-farm visitation program, ve rified tips and complaints, education programs (e.g., grower meetings and lette rs), the extent of non-compliance,

corrective measures to address the non- compliance (phased-compliance program), and any follow-up actions taken.

15] The registrant and the seed corn dealers for the registrant must allow a review of the compliance records by EPA or by a State pesticide regulatory agency if the State agency can demonstrate that conf idential business information, including the names, personal information, and grower license number of the growers will be protected.

16] The registrant shall revise and expa nd its existing Compliance Assurance Program to include the following elements. The registrant must prepare and submit by January 31, 2011, a written description of its revised Compliance Assurance Program. The registrant may coordinate with other registrants in designing and implementing its Compliance Assurance Program.

17] The registrant will enhance the ref uge education program throughout the seed delivery channel:

i. Ensure sales representatives, licensees , seed dealers, and growers recognize the importance of correct refuge implementati on and potential consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the next three growing seasons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

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

i. Use Bt corn adoption, pest pre ssure information, and other available information to identify regions where the risk of resistance is greatest;

ii. Focus approximately two-thirds of on-fa rm assessments on these regions, with the remaining assessments conducted across othe r regions where the product is used.

19] The registrant will use its available Bt sales records and other information to refine grower lists for on-farm assessments of th eir compliance with re fuge requirement:

123i. Identify for potential on-farm assessment growers whose sales in formation indicates they have purchased the Bt corn product but may have pur chased little or no refuge seed from the registrant, licen see, or affiliated company.

20] The registrant will contract with thir d parties to perform on- farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all first-time on-farm assessments as well as second-year on-farm assessments of thos e growers found out of compliance in a

first-time assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and leve l of refuge compliance for the product.

22] The registrant will follow up with grow ers who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

i. All growers found to be signi ficantly out of compliance in a prior year will annually be sent additional refuge assistance info rmation for a minimum of two years by the registrant, seed supplier, or third part y assessor, after completing the assessment

process;

ii. The registrant will conduct follow-up checks on growers found to be significantly out of compliance within thr ee years after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a five-year period will be denied access

to the Bt corn product in the subsequent year.

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

9d. Insect Resistance Monitoring and Remedial Action Plan

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

The registrants must monitor for Cry34Ab1/35Ab1 resistance and/or tr ends in increased tolerance for corn rootworm. Sampling should be focused in those areas in which there is the highest risk of resistan ce development.

1. The resistance monitoring plan must in clude: baseline sensitivity data, sampling (number of locations, samp les per locations), sampli ng methodology and life-stage sampled, bioassay methodology, standardiz ation procedures (including QA/QC provisions), detection technique and sensit ivity, the statistical analysis of the probability of detecting resistance, and an interim description of rootworm damage guidelines.

1242. The registrant must work to develop a dia gnostic assay for corn rootworm resistance monitoring to detect po tentially resistant individuals. As part of this effort, the registrant must investigate the feasibility of using the Sublethal Seedling Assay IV as a diagnostic assay. A report on this require ment must be submitted to the Agency 6 months from the date of the amended registration.

3. The registrant must submit revised corn rootworm damage guidelines (to characterize unexpected pest damage). The revised guidelines must take into

consideration the comments and reco mmendations from EPA’s June 30, 2010

review of the rootworm resistance m onitoring program for Cry3Bb1. A report on this requirement must be submitted to the Agency 6 months from the date of the amended registration.

4. The registrants must follow-up on grower, extension specialist or consultant reports of unexpected damage or control failures for corn rootworm.

5. The registrants must provide EPA with an annual resistance monitoring report by January 31 st of each year, reporting on populatio ns collected the previous year.

7e. Remedial Action Plans

The remedial action plan is designed as a tiered approach for mitigating WCRW, NCRW, and MCRW resistance development to th e Cry34/35Ab1 protein. The following program summary describes, in order of events, the step s 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. EP A 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 in itiated when needed.

1. Definition of Suspected Resistance: Resistance will be suspec ted if investigations of

nexpected damage reports show that: u

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 pe st insect species, weather, physical damage, larval movement from a lternate 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 meas ures are intended to re duce the possibility of potentially resistant insects contributi ng to the following year’s pest population.

IV Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and B.D. Siegfried. 2008. Validation of a novel resist ance monitoring technique for corn rootworm (Coleoptera: Chrysomelidae) and event DAS- 59122-7 maize. J. Appl. Entomol. 132:177-188)

1252. Confirmation of Resistance : Resistance will be confirmed if all of the following criteria are et by progeny from the target pest species sampled from the area of “suspected resistance”: m f. the proportion of larvae that can feed and survive on Cry34/35Ab1 roots from neonate to adult is significantly higher than the baseli ne proportion (currently being established);

g. the LC50 of the test populati on exceeds the upper limit of the 95% confidence interval for the LC50 of a standard unselected populatio n, 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 fi eld 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 act ion plan will be devised according to the

characteristics of the resistance ev ent and local agronomic needs.

8) Annual Reports:

The registrant must provide annual reports to EPA on its Cry34/35Ab1 PIP expressed in corn based on the following table.

Report Description Due Date

Annual Sales Units sold by state (county information is available upon request by the Agency) January 31 st 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 31 st 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

31 st ,each year beginning in 2008 as part of the Compliance Assurance Program Report

Compliance Assurance Program Compliance Assurance Program Activities and Results: third-party grower survey, on-farm visitation program, phased-compliance report, tips and complaints, and grower education programs January 31 st each year starting in 2007

126Report Description Due Date

Insect Resistance Monitoring Annual report of the inse ct resistance monitoring program. Results of monitoring and investigations of damage reports August 31st each year beginning in 2008

Additional reports are due to EPA on its Cry3 4/35Ab1 PIP expressed in corn based on the following table as described in the following table:

Report Description Due Date

Changes to Grower Agreement and/or IRM

documents Current grower agreemen t(s) and any specific stewardship documents At least 30 days before any changes related to IRM are expected to be imposed.

Date Registered Date Expired Registrant Registration # Active Ingredients

Dow AgroSciences 68467-6 Bt corn Events DAS 59122-

7 + TC1507 with Cry 34Ab1/Cry35Ab1 + PO Cry1F (Herculex Xtra) (PDF) 27-Oct-05 30-Sep-15

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

2] The subject registration will be limited to Cry1F [ Bacillus thuringiensis Cry1F protein and the genetic material necessary for its pr oduction (plasmid insert PHP8999) in Event TC1507 corn (OECD Unique Identifie r: DAS-Ø15Ø7-1)] X Cry34/35Ab1 [ Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and th e genetic material necessary for their production (plasmid insert PHP17662) in Event DAS-59122-7 corn (OECD Unique Identifier: DAS-59122-7)] corn for use in field corn.

3] Submit/cite all data required for registra tion of this product under FIFRA § 3(c)(5) when the Agency requires registrants of si milar products to submit such data.

4] Submit/cite all data, determined by the Agency to be acceptable, required to support the individual plant-incorporat ed protectants in Event TC 1507 (Herculex® I) and Event DAS-59122-7 (Herculex® Rootworm) corn w ithin the timeframes required by the terms and conditions of EPA Registration Numbers 68467-2 and 68467-5, respectively

5] This plant-incorporated protectant may be combined through conventional breeding with other registered plant-incor porated protectants that are similarly approved for use in combination, through conventional breeding, w ith other registered plant-incorporated protectants to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits.

1276] You must commit to do the followi ng Insect Resistance Management Program for Cry1FxCry34/35Ab1

a) Requirements relating to cr eation of a refuge for bot h 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 contractua l obligations on the grower to comply with the refuge requirements; c) Requirements for the registrants to deve lop, implement, and report to EPA on programs to educate growers about IRM requirements; d) Requirements for the registrants to deve lop, implement, and report to EPA on programs to evaluate and promote grower s 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 deve lop, 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 deve lop, and if triggered, to implement a remedial action plan that w ould contain measures the regi strants 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 stat e (units sold by county level will be made available to the Agency upon reque st), IRM grower ag reements results, compliance assurance program including th e education program, on or before January 31st each year, and for resistance monitoring, on or before April 30th each year for Cry1F and on or before August 31st each for Cry34/35Ab1.

6a. Refuge Requirements

The use of Cry1F x Cry34/35Ab1 corn requires accompanying refuge corn for both the Cry1F and Cry34/35Ab1 components that meets the require ments of the individual traits, described below. The refuge for both traits may be combined by planting non- Bt corn as the refuge (see C. below), or the refuge for each trait may be planted separately (see A. and B. below).

For the separate refuges, corn rootworm-resistant Bt corn (e.g., Herculex RW) may be planted in the lepidopteran refuge for the Cry1F component and lepidopteran-resistant Bt corn (e.g., Herculex I) may be planted in the corn rootworm refuge for the Cry34/35Ab1 component. Depending on cropping practices, pest problems, and pest management options employed on any given farm, growers may need to choose different refuge arra ngements for different fields. Possible options include: two refuge blocks (o ne for rootworm, one for Lepidoptera) can be planted within one field, or stri ps can be used for either ref uge. Alternatively, a block of

128Herculex RW corn can serve as an in-field lepi dopteran 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 combin ations are permissible as long as in all cases the size and management of each refuge are described in A., B., and C., below.

These refuge requirements do not apply to seed pr opagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

A. Lepidopteran refuge for the Cry1F component.

1. Refuge size, Corn-Growing Areas (corn belt and other non corn/cotton-growing regions). The use of Cry1F x Cry34/35Ab1 corn requires an accompanying 20% refuge consisting of non- Bt corn or non-lepidopteran resistant Bt corn. 2. Refuge size, (Corn/Cotton- growing areas). * The us e Cry1F x Cry34/35Ab1 corn requires an accompanying 50% refuge consisting of non- Btcorn or nonlepidopteran resistant Bt corn. 3. Refuge location.

• The lepidopteran refuge can be planted in a separate fiel d 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 f our rows wide (six preferred)

4. Refuge management.

Insecticide treatments for control of European corn borer, corn earworm, southwestern corn borer, fall armyworm, black cutworm, wester n bean cutworm, lesse r corn stalk borer, sugarcane borer and southern corn stalk borer may be applied only if economic

thresholds are reached for one or more of thes e target pests. Economic thresholds will be determined using methods recommended by local or regional professionals (e.g. Extension Service Agents, cr op consultants). Microbial Bt insecticides must not be applied to lepidopteran resistant refuges.

Cotton growing areas consist of the following st ates Alabama, Arkansas, Georgia, Florida, Louisiana, North Carolina, Mi ssissippi, South Carolina, Okla homa (only the counties of Beckham, Caddo, Comanche, Cu ster, Greer, Harmon, Jackson, Kay, Kiowa, Tillman,

129Washita), Tennessee (only the counties of Ca rroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Hayw ood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), Texa s (except the counties of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, M oore, 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 requir ed to be planted within or adjacent (e.g. across the road) to the Cr y1F x Cry34/35Ab1 corn field.

3. Refuge management options. The rootworm re fuge 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 leas t 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 ro tated ground, then Cry1F x Cry34/35Ab1 corn must also be planted on rotated ground.

• If the rootworm refuge is planted in continuous corn, the Cr y1F x Cry34/35Ab1 field may be planted on either continuous or rotated land (opti on encouraged where

WCRW rotation-resistant bi otype 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 c ontrolling secondary soil pests.

• If aerial insecticides are applied to the r ootworm 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 Cr y1F x Cry34/35Ab1 acres can be treated as needed without having to tr eat 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-to lerant corn, or conventional corn).

• The rootworm refuge and Cry1F x Cry34/35A b1 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 rema in high and the durabili ty of the trait is extended. This option may be preferable to growers who wish to only think of their

130refuge design once and for growers who gr ow 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 le pidopteran refuge combined with the rootworm refuge by planting non- Bt corn), the refuge must be plan ted 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 re quired 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 plan ted 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 conti nuous 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 fo r controlling secondary soil pests.

• If aerial insecticides are applied to th e 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 regi onal professionals (e.g. Extension Service Agents, crop consultants). These pests can be treated with CRW-labeled insecticide on the combined refuge acres without treating the Cry1F x Cry34/35Ab1 acres only if treatment occurs when adults corn rootworms are not present. Microbial Bt insecticides must not be applied to the common refuges.

• Pests other than adult corn rootworms may be treated with CRW-labeled insecticide on the combined refuge acres without treating the Cry1F x Cry34/35Ab1 acres only if treatment occurs when adults corn rootworms are not present. Pests on the Cry1F x Cry34/35Ab1 acres may be treated as needed without having to treat the refuge.

• The combined refuge can be planted to any corn hybrid that does not express PIPs for lepidopteran or rootworm cont rol (i.e. herbicide tolerant corn or conventional corn).

131• The combined refuge and Cry1F x Cr y34/35Ab1 corn should be sown on the same day, or with the shortest window possible between pl anting dates, to ensure that corn root developmen t is similar among varieties.

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

6b. Grower Agreements

1. Persons purchasing the Bt corn product must sign a grower agreement. The term "grower agreement" refers to any grower purchase contract, license agreement, or similar legal document.

2. The grower agreement and/or specific st ewardship documents referenced in the grower agreement must clearly set forth the terms of the current IRM program. By signing the grower agreemen t, a grower must be contractually bound to comply with the requirements of the IRM program.

3. The registrant must develop a system (equi valent to what is already approved for Cry1F Bt corn) that is reasonably likely to assure that persons purchasing the Bt corn product will affirm annually that th ey are contractually bound to comply with the requirements of the IRM program. The proposed system will be submitted to EPA by January 31, 2006.

4. If the registrants wish to change any part of the grow er agreement or any specific stewardship documents referenced in the gr ower 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 subm it to EPA the text of such changes to

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

5. The registrant must establish a system (e quivalent to what is already approved for Cry1F Bt Corn) that is reasonably likely to assure that persons purchasing the Bt corn sign grower agreement(s).

6. The registrant shall maintain records of all Bt corn grower agreements for a period of three years from December 31st of the year in which the agreement was signed.

7. Annually, the registrant shall provide EP A with a report show ing the number of units of its Cry1F x Cry34/35A b1 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 agreem ents and grower agreement records by EPA or by a State pesticide regul atory agency if the State agency can

demonstrate that confidential business information, including names, personal information, and grower license number, will be protected.

6c. IRM Education and IRM Compliance Monitoring Programs

1. The registrants must implement a comp rehensive, ongoing IRM education program designed to convey to Bt Cry34/35Ab1 corn users the importance of complying with the IRM program. The program sh all include information encouraging Bt

132Cry1F x Cry34/35Ab1 corn users to pursue optional elements of the IRM program relating to refuge configuration and proximity to Bt Cry1F x Cry34/35Ab1 corn fields. The education program shall involve the use of multiple media, e.g. face-toface meetings, mailing written materi als, 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 coor dinate their education programs with

educational efforts of other registrants and othe r 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 info rmation collected through the compliance survey required under paragraph 6] and from other sources. The changes shall address aspects of grower complian ce that are not sufficiently high.

3. Annually, the registrant must provide EPA any substantive changes to its grower education activities as part of the ove rall IRM compliance assurance program report. The required features of the compliance assurance program are described in paragraphs 4-22 below.

4. The registrant must design and implem ent 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 fu ture 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 w ith the Cry1 Caps. Other required features of the program are descri bed in paragraphs 5 - 22 below.

5. The registrant must establish and publici ze 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 pr ogram and general criteria for choosing among options for responding to any non-co mpliant growers. The options shall include withdrawal of the right to purchase Cry1F x 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 complian ce two years in a row would be denied sales of the product the next year. Similarl y, seed dealers who are not fulfilling their obligations to inform/educate growers of their IRM obligations will lose their opportunity to sell Cry1F x Cry34/35Ab1 Bt corn. 6. The IRM compliance assurance program shall include an annual survey conducted by an independent third party of a statisti cally representative sample of Cry1F x Cry34/35Ab1 Bt corn growers who plant the vast majo rity 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 surv ey shall measure the degree of compliance with the IRM program by grow ers in different regions of the country and consider the poten tial impact of non-respons e. The sample size and

133geographical resolution may be adjust ed annually, based upon input from the independent marketing research firm and academic scientists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasonable sensitivity for comparing results across the U.S.

a. A third party is classified as a party other than the regi strant, the grower, or anyone else with a direct interest in IRM compliance for Bt corn.
7. The survey shall be designed to provi de an understanding of any difficulties growers encounter in impleme nting IRM requirements. An analysis of the survey results must include the reasons, extent, a nd 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 summ ary of the results of the prior year's survey (together with a de scription 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 co llected through the compliance survey required under paragraphs 6 through 8 and from other sources. The changes shall address as pects of grower compliance that are not sufficiently high. The registrant must confer with th e Agency prior to adopting any significant changes.

11. The registrant shall conduct an annual on- farm assessment program. The registrant shall train its representatives who make on-farm visits with Cry1F x Cry34/35Ab1 Bt corn growers to perform asse ssments of compliance with IRM requirements. There is no minimum corn ac reage 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 gr ower who is not in compliance with the IRM program, the regi strant 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 regi strant shall take appropriate action, consistent with its “phased compliance approach.”

13. If a grower, who purchases Cry1F x 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. Annually, the registrants shall provide a re port to EPA summar izing the activities carried out under their compliance assuranc e 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 interacti ons (including, but not limite d to, third-party grower survey, on-farm visitation program, veri fied tips and complaints, education programs (e.g., grower meetings and lette rs), the extent of non-compliance,

corrective measures to address the non- compliance (phased-compliance program), and any follow-up actions taken.

13415. The registrant and the seed co rn dealers for the registrant must allow a review of the compliance records by EPA or by a State pesticide regulatory agency if the State agency can demonstrate that confidential business information, including the names, personal information, and grower license number of the growers will be protected.

16. The registrant shall revise and expand its existing Compliance Assurance Program to include the following elements. The registrant must prepare and submit by January 31, 2011, a written description of its revised Compliance Assurance Program. The registrant may coordinate with other registrants in designing and implementing its Compliance Assurance Program.

17. The registrant will enhan ce the refuge education program throughout the seed delivery channel:

a. Ensure sales representatives, licensees, s eed dealers, and growers recognize the importance of correct refuge implemen tation and potential consequences of failure to plant the required refuge;

b. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the next three growing seasons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

18. The registrant will focus the majority of on-farm assessments on regions with the greatest risks for resistance:

a. Use Bt corn adoption, pest pressure inform ation, and other available information to identify regions where the risk of resistance is greatest;

b. Focus approximately two-thirds of on-far m assessments on these regions, with the remaining assessments conducted across othe r regions where the product is used.

19. The registrant will use its available Bt sales records and other information to refine grower lists for on-farm assessments of th eir compliance with re fuge requirement:

a. Identify for potential on-farm assessm ent growers whose sales information indicates they have purchased the Bt corn product but may have purchased little or no refuge seed from the registrant, licensee, or affiliated company.

20. The registrant will contract with third parties to perform on-farm assessments of compliance with refuge requirements:

a. The third-party assessors will conduct all first-time on-farm assessments as well as second-year on-f arm assessments of those grow ers found out of compliance in

a first-time assessment

21. The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and leve l of refuge compliance for the product.

22. The registrant will follow up with growers who have been found significantly out of compliance under the on-farm assessment pr ogram and are found to be back in compliance the following year:

a. All growers found to be si gnificantly out of compliance in a prior year will annually be sent additional refuge assi stance information for a minimum of two years by the registrant, seed supplier, or third party assessor, after completing the

assessment process;
b. The registrant will conduct follow-up ch ecks on growers found to be significantly out of compliance within three years after they are found to be back in compliance;

135c. A grower found with a second incident of significant non-comp liance with refuge requirements for the Bt corn product within a five -year period will be denied

access to the Bt corn product in the subsequent year.

d. The registrant will identify to EPA a ll growers who are denied access to the Bt corn product.

6d. Insect Resistance Monitori ng and Remedial Action Plan

The Agency is imposing the following c onditions for the Cry1F and Cry34Ab/35Ab toxins expressed in this product:

A report on results of Cry1F re sistance monitoring and inves tigations of damage reports must be submitted to the Agency annually by April 31st each year for the duration of the conditional regist ration. You must provide EPA with an annual Cry34/35Ab1 resistance monitoring report by August 31s t of each year, reporting on populations collected the previous year.

Cry1 F

1. The registrant will monitor for resistance and/or trends in increased tolerance for Ostrinia nubilalis (European corn borer), Di atraea grandiosella (Southwestern corn borer), and/or Helicoverpa zea (corn earwo rm). Sampling should be focused in those areas in which there is the highest risk of resistance development. The ABSTC has identified four regions for its compliance and monitoring programs.

2. The registrant shall provide to EPA a description of its Cry1F resistance monitoring plan by January 31, 2006. The descriptio n shall include: sampling (number of locations and samples per locati ons), sampling methodology, bioassay methodology, standardization procedures, detection technique and sensitivity, and the statistical analysis of the pr obability of detecting resistance.

3. The registrant must follow up on grower, exte nsion 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 wi ll investigate all damage reports submitted to the company or the company’s repres entatives. See Remedial Action Plans

section below.

Cry34/35Ab1

The registrant must monitor for Cry34Ab1/35A b1 resistance and/or trends in increased tolerance for corn rootworm. Sampling shoul d be focused in th ose areas in which there is the highest risk of resistance development.

1361. The resistance monitoring plan must include: baseline sensitivity data, sampling (number of locations, samples per lo cations), sampling methodology and lifestage sampled, bioassay methodology, sta ndardization procedures (including QA/QC provisions), detection technique and sensitivity, the statistical analysis of the probability of detecting resistance, and an interim description of rootworm damage guidelines.

2. The registrant must work to develop a diagnostic assay for corn rootworm resistance monitoring to detect potentially re sistant individuals. As part of this effort, the registrant must investigate the feasibility of using the Sublethal Seedling Assay V as a diagnostic assay. A report on this requirement must be submitted to the Agency 6 months from the date of the amended registration.

3. The registrant must submit revised corn rootworm damage guidelines (to characterize unexpected pest damage). The revised guidelines must take into consideration the comments and recommendations from EPA’s June 30, 2010

review of the rootworm resistance m onitoring program for Cry3Bb1. A report on this requirement must be submitted to the Agency 6 months from the date of the amended registration.

4. The registrant must follow-up on grow er, extension specia list or consultant reports of unexpected damage or c ontrol failures for corn rootworm.

6e. Remedial Action Plans

Cry1F

A Remedial Action Plan covering both suspec ted 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 Re sistance in European Corn Borer Corn

Earworm and/or Southwestern Corn Borer (October 15, 2001)

7. Definitions

Suspected resistance

EPA defines "suspected" resistance to mea n, in the case of reported product failure, that: the corn in question has been confirmed to be Bt corn

V Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and B.D. Siegfried. 2008. Validation of a novel resist ance monitoring technique for corn rootworm (Coleoptera: Chrysomelidae) and event DAS- 59122-7 maize. J. Appl. Entomol. 132:177-188)

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

• the relevant plant tissues are e xpressing the expected level of Bt protein; and it has been ruled out that species not susceptible to the protein coul d be responsible for the damage, that no climatic or cultural reasons could be responsible for the damage, and that other reasonable cause s for the observed product failure have been ruled out. The Agency does not inte rpret "suspected resistance" to mean grower reports of possible control failu res, 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 measur es to control the pest su spected of resistance to Bt corn in the affected region.

• Destroy crop residues in the affected re gion immediately after harvest (i.e. within one month) with a technique appropria te for local production practices to minimize the possibility of resistant inse cts 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 o ccurrence of resistance during the growing

season. When resistance has been confirme d, 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 exhib it all of the following characteristics in bioassays

initiated with neonates:

1. If there is > 30% survival and > 25% l eaf area damaged in a 5-day bioassay using Cry1Ab-positive or Cry1F-positive leaf tissue under controlled laboratory

conditions.

2. If standardized laboratory bioassays usi ng diagnostic doses for ECB (Marçon et al. 2000), SWCB (Trisyono and Ch ippendale 1999), or CEW/CBW (USDA/ARS/SIMRU, unpublished) demonstr ate resistance ha s a genetic basis and survivorship in excess of 1% (g ene frequency of population ?0.1).

3. If an LC50 in a standard Cry1Ab or Cr y1F diet bioassay exceeds the upper limit

of the 95% confidence interval of the st andard unselected laboratory population LC50 for susceptible ECB, SWCB, or CE W populations, as established by the ongoing baseline monitoring program.

Remedial Action

138The registrant assumes responsibility for the implementation of resistance mitigation actions undertaken in response to the oc currence 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 in stances of confirmed pest resi stance, as defined above, to the Agency within 30 days. U pon identification of a confirmed instan ce of resistance, registrants will take the followi ng immediate mitigation measures:

1. Notify customers and extension agents in the affected area,

2. Require to customers and extension agen ts in the affected area the use of

alternative control measures to reduce or control the loca l target pest population,

3. Where appropriate, require to customers and extension agents in the affected area that crop residues be incorporated into the soil following harvest, to minimize the possibility of overwintering insects.

4. Immediately stop sale and distribution of Bt corn in the remedial action zone (may be a single or multiple coun ties) 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 pe st resistance, as defi ned above, registrants

will:

5. Notify the Agency of the immediate mitiga tion measures that were implemented,

6. Submit to the Agency a proposed long-te rm resistance management action plan for the affected area,

7. Submit to the Agency a proposed long-te rm resistance management action plan for the affected area,

8. Implement an action plan that is approved by EPA and that consists of some or all the following elements, as warranted:

9. Informing customers and extension agents in the affected area of pest resistance,

10. Increasing monitoring in the affected ar ea, and ensuring that local target pest populations are sampled on an annual basis,

11. Recommending alternative measures to redu ce or control target pest populations in the affected area,

12. Implementing intensified local IRM measur es in the affected area based on the latest research results. The implementation of such measures will be coordinated by the Agency with other registrants; and

13. The implementation of the remedial acti on strategy will be coordinated by the Agency with other registrants and stakeholders.

For mitigation of resistance in the growing season(s) following a confirmed resistance incident(s), use of the following procedures:

14. Maintenance of the sales suspension of all Bt corn hybrids (with the same protein

or similar Bt proteins as the Bt corn hybrids with the resistant population) in the affected region would remain in place until an EPA-approved local resistance management plan is in place to mitigate resistance in the affected region(s).

13915. The development and recommendation of alternative resistance management strategies for controlling the resistant pest(s) on corn in the affected region.

16. Notification of all relevant personnel (e.g., growers, consultants, extension agents, seed distributors, processors, university c ooperators, and state/fe deral authorities) in the affected region of the resistance situation.

Cry34/35Ab1

The remedial action plan is designed as a ti ered approach for mitigating WCRW, NCRW, and MCRW resistance development to the Cry34/35 Ab1 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 determine d. EPA requires that the registrants establish the baseline sensitivity by January 31, 2008, so that expected levels of crop damage and target pest resistance can be established, and a remedial action plan initiated when needed.

1. Definition of Suspected Resistance: Resistance will be suspected if investigations of unexpected damage reports show that:

a) implicated corn plant roots were expre ssing Cry34/35Ab1 proteins at the expected levels; b) the seed used was not mixed with non-Cry34/35Ab1 seed; c) alternative causes of dama ge or lodging, such as non-t arget pest insect species, weather, physical damage, larval moveme nt from alternate hosts, planting errors,

and other reasonable causes for the observations, have been ruled out; d) the level of damage exceeds guidelines for expected damage.

If resistance is "suspected", the registrant will instruct affected grower s to use alternate pest control measures such as adulticide treatment, crop rotation the following year, or use of soil or seed insecticides the following y ear. These measures are intended to reduce the possibility of potentially resistant insect s 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 speci es 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 th e 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 ong oing 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;

140e) if subsequent collections in the affected field area demonstrate similar bioassay

results.

3. Response to Confirmed Resistance: When resi stance is "confirmed", the following steps

will be taken:

a) EPA will receive notification within 30 days of confirming resistance; b) affected customers and extension agen ts will be notified about confirmed resistance; c) affected customers and extension agents will be encouraged to employ alternative CRW control measures; d) sale and distribution of Cry34/35Ab1 co rn 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.

141Date Registered Date Expired Registrant Registration # Active Ingredients

Pioneer/Dupont 29964-5 Bt corn Events DAS 59122-

7 + TC1507 with Cry 34Ab1/Cry35Ab1 + PO Cry1F (Herculex Xtra) (PDF) 27-Oct-05 30-Sep-15

1. The subject registration will automatical ly expire on midnight September 30, 2015.

2. The subject registration will be limited to Cry1F [Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (plasmid insert PHP8999) in Event TC1507 corn (OECD Unique Identifier : DAS-Ø15Ø7-1)] X Cry34/35Ab1 [Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their production (plasmid insert PHP17662) in Event DAS-59122-7 corn (OECD Unique Identifier: DAS-59122-7] corn for use in field corn.

3. Submit/cite all data required for registration of this product under FIFRA § 3(c)(5) when the Agency requires registrants of si milar products to submit such data.

4. Submit/cite all data, determined to by the Agency to be acceptable, required to support the individual plant-incorpor ated protectants in Event TC1507 (Herculex® I) and Event DAS-59122-7 (Herculex® Rootworm) corn w ithin the timeframes required by the terms and conditions of EPA Registration Numbers 29964-3 and 29964-4, respectively.

5. This plant-incorporated prot ectant may be combined through conventional breeding with other registered plant-incorporated protectan ts that are similarly approved for use in combination, through conventional breeding, with other registered plant-incorporated protectants to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits.

6. You must commit to do the following In sect Resistance Management Program:

The required IRM program for Cry1FxCry34/ 35Ab1 corn has the following elements:

a) Requirements relating to cr eation of a refuge for bot h the Cry1F and Cry34/35Ab1 components that meets the requirements of the individual traits. The refuge for both traits may be combined by planting non- Bt corn as the refuge, or the refuge for each trait may be planted separately. In the latter case, corn rootworm-resistant Bt corn may be planted in the lepidopteran refuge for the Cry1F component and lepidopteran-resistant Bt corn may be planted in the corn rootworm refuge for the Cry34/35Ab1 component. b) Requirements for the registrants to prepare and require Bt corn users to sign grower agreements that impose binding contractual obligations on the grower to comply with the refuge requirements;

142c) Requirements for the registrants to deve lop, implement, and report to EPA on programs to educate growers about IRM requirements; d) Requirements for the registrants to deve lop, implement, and report to EPA on programs to evaluate and promote grower s 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 deve lop, 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 deve lop, and if triggered, to implement a remedial action plan that w ould contain measures the regi strants 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 stat e (units sold by county level will be made available to the Agency upon reque st), IRM grower ag reements results, compliance assurance program including th e education program, on or before January 31st each year, and for resistance monitoring, on or before April 30th each year for Cry1F and on or before August 31st each for Cry34/35Ab1.

5a. Refuge Requirements

The use of Cry1F x Cry34/35Ab1 corn require s accompanying refuge corn for both the Cry1F and Cry34/35Ab1 components that meet s 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 re fuge 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 gi ven farm, growers may need to choose different refuge arrangements for differe nt fields. Possible options include: two refuge blocks (one for rootworm, one fo r Lepidoptera) can be planted within one field, or strips can be used for either re fuge. 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 lepi dopteran refuge for separate fields planted to Cry1F X Cry34/35Ab1, while the rootworm refuge is planted as Hercul ex 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 permi ssible as long as in all cases the size and management of each refuge are described in A., B., and C., below.

143These refuge requirements do not apply to seed pr opagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

A. Lepidopteran refuge for the Cry1F component.

• Refuge size, Corn-Growing Areas (corn be lt and other non co rn/cotton-growing regions). The use of Cry1F x Cry34/35A b1 corn requires an accompanying 20% refuge consisting of non- Bt corn or non-lepidopteran resistant Bt corn.

• Refuge size, (Corn/Cotton-growing areas). * The use Cry1F x Cry34/35Ab1 corn requires an accompanying 50% refuge consisting of non- Btcorn or nonlepidopteran resistant Bt corn.

• Refuge location.

• The lepidopteran refuge can be planted in a separate fi eld not more than 1⁄2 mile of the Cry1F x Cry34/35Ab1 field.

• The lepidopteran refuge can be plante d within the Cry1F x Cry34/35Ab1 field as blocks (e.g. along the edges or headlands)

• The lepidopteran refuge can be plante d within the Cry1F x Cry34/35Ab1 field as strips across the field at least four rows wide (six preferred)

• Refuge management.

Insecticide treatments for control of Europ ean corn borer, corn earworm, southwestern corn borer, fall armyworm, black cutworm, western bean cutworm, lesser corn stalk borer, sugarcane borer and sout hern corn stalk borer may be applied only if economic

thresholds are reached for one or more of these target pests. Ec onomic 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 followi ng states Alabama, Arkansas, Georgia, Florida, Louisiana, North Carolina, Mississi ppi, South Carolina, Oklahoma (only the counties of Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, Washita), Tennessee (only th e counties of Carroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardem an, Hardin, Haywood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Sh elby, 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.

1441. Refuge size. The use of Cry1F x Cr y34/35Ab1 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 plante d in continuous co rn, the Cry1F x Cry34/35Ab1 field may be planted on e ither continuous or rotated land (option encouraged where WCRW ro tation-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 fo r controlling secondary soil pests.

• If aerial insecticides are applied to the rootworm refuge for control ofCRW adults, the same treatment must also be applied in the same timeframe to Cry1F x Cry34/35Ab1 corn.

• Pests other than adult corn rootwo rms may be treated on the rootworm refuge acres without treating th e Cry1F x Cry34/35Ab1 acres only if

treatment occurs when adult corn rootworms are not present or if a pesticide without activity against adult corn rootworms is used. Pests on the Cry1F x Cry34/35Ab1 acres may be treated as needed without having to treat the rootworm refuge.

• The rootworm refuge can be plante d to any corn hybrid that does not express PIPs for rootworm cont rol (e.g. lepidopteran-protected Bt corn, herbicide-tolerant corn, or conventional corn).

• The rootworm refuge and Cry1F x Cr y34/35Ab1 corn should be sown on the same day, or with the shortest window possible between planting dates, to ensure that corn root de velopment is simila r among varieties.

• Growers are encouraged to plant the r ootworm 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. th e lepidopteran refuge combined with the rootworm refuge by planting non- Bt corn), the refuge must be planted and

145managed such that it is consistent with the requirements of the two individual traits, as follows

1. Refuge size shall be 20% in corn -growing areas and 50% in cottongrowing areas (see list labe led 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 si ngle 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 plante d 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 e ither continuous or rotated land (option encouraged where WCRW ro tation-resistant biotype may be present).

• Application of soil insecticide for co rn rootworm control is permitted in the combined refuge.

• Seed treatment is permitted in the comb ined refuge, either at a rate for rootworm protection or at a rate fo r controlling secondary soil pests.

• If aerial insecticides ar e 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 co rn borer, fall armyworm, black cutworm, western bean cutworm, suga rcane 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-labele d 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 app lied to the common refuges.

• Pests other than adult corn rootworm s 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 plante d to any corn hybrid that does not express PIPs for lepidopteran or root worm control (i.e. herbicide tolerant corn or conventional corn).

• The combined refuge and Cry1F x Cr y34/35Ab1 corn should be sown on the same day, or with the shortest window possible between planting dates, to ensure that corn root de velopment is simila r among varieties.

146The description of the refuge requirements in the grower guide must be consistent with the preceding requirements.

5b. Grower Agreements

1. Persons purchasing the Bt corn product must sign a grower agreement. The term "grower agreement" refers to any grower purchase contract, license agreement, or similar legal document.

2. The grower agreement and/or specific st ewardship documents referenced in the grower agreement must clea rly 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 (equi valent to what is already approved for Cry1F Bt corn) that is reasonabl y likely to assure that persons purchasing the Bt corn product will affirm annually that they are contractually bound to comply with the requirements of the IRM program.

4. If the registrants wish to change any part of the grower agreement or any specific stewardship documents referenced in the grower agreement that would affect either the content of the IRM program or the legal enforceability of the provisions of the agreement relating to the IRM program, thirty days prior to implementing a proposed change, the registrant must subm it to EPA the text of such changes to

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

5. The registrant must establish a system (e quivalent to what is already approved for Cry1F Bt Corn) that is reasonably likely to assure that persons purchasing the Bt corn sign grower agreement(s).

6. The registrant shall maintain records of all Bt corn grower agreements for a period of three years from December 31st of the year in which the agreement was signed.

7. Annually, the registrant sha ll provide EPA with a report showing the number of units of its Cry1F x Cry34/35Ab1 corn seed s 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 pe sticide regulatory agency if the State agency can demonstrate that confidentia l business information, including names, personal information, and grower license number, will be protected.

5c. IRM Education and IRM Compliance Monitoring Programs

1. The registrants must implement a comprehensive, ongoing IRM education program designed to convey to Bt Cry34/35Ab1 corn users the importance of complying with the IRM program. The program shall include information encouraging Bt Cry1F x Cry34/35Ab1 corn users to pursue optional elements of the IRM program relating to refuge configuration and proximity to Bt Cry1F x Cry34/35Ab1 corn fields. The education progr am 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

147communications such as by Internet, radi o, or television commercials. Copies of the materials will be provided to EPA fo r its records for the first year of commercialization (2006 growing seas on) 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 educatio n programs with educ ational 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 para graph 6] and from other sources. The changes shall address aspects of grower complian ce that are not sufficiently high.

3. Annually, the registrant must provide EPA any substantive changes to its grower education activities as pa rt of the overall IRM co mpliance assurance program report. The required features of the co mpliance assurance program are described in paragraphs 4-22 below.

4. The registrant must design and implem ent an ongoing IRM compliance assurance program designed to evaluate the extent to which growers purc hasing 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 de signing and implementing its compliance assurance program and integrate the Cry1F x Cr y34/35Ab1 CAP with the Cry1 Caps. Other required features of the program are de scribed in paragraphs 5 - 22 below.

5. The registrant must establish and public ize a “phased compliance approach,” i.e., a guidance document that indicates how th e 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 th e right to purchase Cry1F x 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 ye ar. 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 Cry34/35Ab1 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 Cry1F x Cry34/35Ab1 Bt corn growers who plant the vast majority of all corn in

the U.S. and in areas in which the selecti on 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 th e IRM program by growers in different regions of the country and consider th e potential impact of non-response. The sample size and geographical resoluti on may be adjusted annually, based upon input from the independent marketing res earch firm and academic scientists, to allow analysis of compliance behavior within regions or between regions. The

148sample size must provide a reasonable sens itivity for comparing results across the

U.S.

i. A third party is classified as a part y other than the registrant, the grower, or anyone else with a direct in terest in IRM compliance for Bt corn.

7. The survey shall be designed to provi de an understanding of any difficulties growers encounter in implem enting IRM requirements. An analysis of the survey results must include the reasons, extent, and potential biological significance of any implementation deviations.

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

9. 7The registrant shall provide a written su mmary of the results of the prior year's survey (together with a de scription of the regions, the methodology used, and the supporting data) to EPA by January 31 of eac h 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 co llected through the compliance survey required under paragraphs 6 through 8 and from other sources. The changes shall address aspects of grow er compliance that are not sufficiently high. The registrant must confer with th e Agency prior to adopting any significant changes.

11. The registrant shall conduct an annua l on-farm assessment program. The registrant shall train its representative s who make on-farm visits with Cry1F x Cry34/35Ab1 Bt corn growers to pe rform assessments of compliance with IRM requirements. There is no minimum corn acreage size for this program. Therefore, growers will be selected fo r this program from across all farm sizes. In the event that any of these visits result in the id entification 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 gr ower who is not in compliance with the IRM program, the registrant shall take appropriate action, consistent with its “phased compliance approach.”

13. If a grower, who purchases Cry1F x Cry34/35Ab1 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. Annually, the registrants shall provide a report to EPA summar izing the activities carried out under their compliance assuranc e program for the prior year including changes to the grower education progr am, and the plans for the compliance assurance program during the current year . The report will include information regarding grower interacti ons (including, but not limite d to, third-party grower survey, on-farm visitation program, verified tips and complaints, education programs (e.g., grower meetings and lett ers), the extent of non-compliance,

149corrective measures to address the non- compliance (phased-compliance program), and any follow-up actions taken.

15. The registrant and the seed corn dealers fo r the registrant must allow a review of the compliance records by EPA or by a Stat e pesticide regulatory agency if the State agency can demonstrate that conf idential business information, including the names, personal information, and grower license number of the growers will be protected.

16. The registrant shall revise and expand its existing Complianc e Assurance Program to include the following elements. The registrant must prepare and submit by January 31, 2011, a written description of its revised Compliance Assurance Program. The registrant may coordinate w ith other registrants in designing and implementing its Compliance Assurance Program.

17/ The registrant will enhance the refuge education program throughout the seed delivery channel:

i. Ensure sales representatives, licensees , seed dealers, and growers recognize the importance of correct refuge implemen tation and potential consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the next three growing seasons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

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

i. Use Bt corn adoption, pest pressure informa tion, and other available information to identify regions where the risk of resistance is greatest;

ii. Focus approximately two-th irds of on-farm assessments on these regions, with the remaining assessments conducted across othe r regions where the product is used.

19] The registrant will use its available Bt sales records and other information to refine grower lists for on-farm assessments of their compliance with refuge requirement:

i. Identify for potential on-farm assessment growers whose sales information indicates they have purchased the Bt corn product but may have purchased little or no refuge seed from the registrant, licensee, or affiliated company.

20] The registrant will contract with thir d parties to perform on-farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all first-time on-farm assessments as well as second-year on-farm assessments of thos e growers found out of compliance in a

150first-time assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and level of refuge compliance for the product.

22] The registrant will follow up with gr owers who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

i. All growers found to be significantly out of compliance in a prior year will annually be sent additional refuge assistance in formation for a minimum of two years by the registrant, seed supplier, or thir d party assessor, af ter completing the

assessment process;

ii. The registrant will conduct follow-up ch ecks on growers found to be significantly out of compliance within three years after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a five -year period will be denied

access to the Bt corn product in the subsequent year.

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

5d. Insect Resistance Monitori ng and Remedial Action Plan

The Agency is imposing the following conditions for the Cry1F and Cry34Ab/35Ab toxins expressed in this product:

A report on results of Cry1F resistance monito ring and investigations of damage reports must be submitted to the Agency annually by April 31st each year for the duration of the conditional registrati on. You must provide EPA w ith an annual Cry34/35Ab1 resistance monitoring report by August 31s t of each year, reporting on populations collected the previous year.

Cry1 F

1. The registrant will monitor for resistance and/or trends in increased tolerance for Ostrinia nubilalis (European corn borer), Diatraea grandiosella (Southwestern corn borer), and/or Helicoverpa zea (cor n earworm). Sampling should be focused in those areas in which there is the highest risk of resistance development. The ABSTC has identified four regions for its compliance and monitoring programs.

2. The registrant shall provide to EPA a description of its Cry1F resistance monitoring plan by January 31, 2006. The description shall include: sampling

151(number of locations and samples per locations), sampling methodology, bioassay methodology, standardization procedures, de tection technique and sensitivity, and the statistical analysis of the pr obability of detecting resistance.

3. The registrant must follow up on grower, ex tension 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 s eed 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 co mpany’s representatives. See Remedial

Action Plans section below.

Cry34/35Ab1

The registrant must monitor for Cry34Ab1/35A b1 resistance and/or trends in increased tolerance for corn rootworm. Sampling should be focused in those areas in which there is the highest risk of resistance development.

1. The resistance monitoring plan must include: baseline sensitivity data, sampling (number of locations, samples per lo cations), sampling methodology and lifestage sampled, bioassay methodology, sta ndardization procedures (including QA/QC provisions), detection technique and sensitivity, the statistical analysis of the probability of detecting resistance, and an interim description of rootworm damage guidelines.

2. The registrant must work to develop a diagnostic assay for corn rootworm resistance monitoring to detect potentially re sistant individuals. As part of this effort, the registrant must investigate the feasibility of using the Sublethal Seedling Assay VI as a diagnostic assay. A repor t on this requirement must be submitted to the Agency 6 months from the date of the amended registration.

3. The registrant must submit revised corn rootworm damage guidelines (to characterize unexpected pest damage). The revised guidelines must take into consideration the comments and recommendations from EPA’s June 30, 2010

review of the rootworm resistance m onitoring program for Cry3Bb1. A report on this requirement must be submitted to the Agency 6 months from the date of the amended registration.

VI Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and B.D. Siegfried. 2008. Validation of a novel resist ance monitoring technique for corn rootworm (Coleoptera: Chrysomelidae) and event DAS- 59122-7 maize. J. Appl. Entomol. 132:177-188)

1524. The registrant must follow-up on grow er, extension specia list or consultant reports of unexpected damage or c ontrol failures for corn rootworm.

5e. Remedial Action Plans

Cry1F

A Remedial Action Plan covering both suspec ted 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 Re sistance in European Corn Borer Corn

Earworm and/or Southwestern Corn Borer (October 15, 2001)

6. Definitions

Suspected resistance

EPA defines "suspected" resistance to mea n, 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 e xpressing the expected level of Bt protein; and it has been ruled out that species not susceptible to the protein coul d be responsible for the damage, that no climatic or cultural reasons could be responsible for the damage, and that other reasonable cause s for the observed product failure have been ruled out. The Agency does not inte rpret "suspected resistance" to mean grower reports of possible control failu res, 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 measur es to control the pest su spected of resistance to Bt corn in the affected region.

• Destroy crop residues in the affected re gion immediately after harvest (i.e. within one month) with a technique appropria te for local production practices to minimize the possibility of resistant inse cts 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 o ccurrence of resistance during the growing

season. When resistance has been confirme d, the registrant must immediately stop

153sale 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 exhib it all of the following characteristics in bioassays

initiated with neonates:

1. If there is > 30% survival and > 25% l eaf area damaged in a 5-day bioassay using Cry1Ab-positive or Cry1F-positive leaf tissue under controlled laboratory

conditions.

2. If standardized laboratory bioassays usi ng diagnostic doses for ECB (Marçon et al. 2000), SWCB (Trisyono and Ch ippendale 1999), or CEW/CBW (USDA/ARS/SIMRU, unpublished) demonstr ate resistance ha s a genetic basis and survivorship in excess of 1% (g ene frequency of population ?0.1).

3. If an LC50 in a standard Cry1Ab or Cry1F diet bioassay exceeds the upper limit

of the 95% confidence interval of the st andard unselected laboratory population LC50 for susceptible ECB, SWCB, or CE W populations, as established by the ongoing baseline monitoring program.

7. Remedial Action

The registrant assumes responsibility for the implementation of resistance mitigation actions undertaken in response to the o ccurrence 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 in stances of confirmed pest resi stance, as defined above, to the Agency within 30 days. U pon identification of a confirmed instan ce of resistance, registrants will take the followi ng immediate mitigation measures:

1. Notify customers and extension agents in the affected area,

2. Require to customers and extension agents in the affected area the use of alternative

control measures to reduce or contro l the local target pest population,

3. Where appropriate, require to cu stomers and extension agents in the affected area that crop residues be incorporat ed into the soil following harvest, to minimize the possibility of overwintering insects.

4. Immediately stop sale and distribution of Bt corn in the remedial action zone (may be a single or multiple counties) where the resistance has been shown until an effective local mitigation plan approved by EPA has been implemented.

Within 90 days of a confirmed instance of pe st resistance, as defi ned above, registrants

will:

5. Notify the Agency of the immediate mitiga tion measures that were implemented,

6. Submit to the Agency a proposed long-term resistance management action plan for the affected area,

1547. Submit to the Agency a proposed long-term resistance management action plan for the affected area,

8. Implement an action plan that is approved by EPA and that consists of some or all the following elements, as warranted:

a. Informing customers and extension agents in the affected area of pest resistance,

b. Increasing monitoring in the affected area, and ensuring that local target pest populations are sampled on an annual basis,

c. Recommending alternative measures to reduce or contro l target pest populations in the affected area,

d. Implementing intensified local IRM measures in the affected area based on the latest research results. The implementation of such measures will be coordinated by the Agency with other registrants; and

e. The implementation of the remedial action strategy will be coordinated by the Agency with other registrants and stakeholders.

For mitigation of resistance in the growing season(s) following a confirmed resistance incident(s), use of the following procedures:

9. Maintenance of the sales suspension of all Bt corn hybrids (with the same protein

or similar Bt proteins as the Bt corn hybrids with the resistant population) in the affected region would remain in place until an EPA-approved local resistance management plan is in place to mitigate resistance in the affected region(s).

10. The development and recommendation of alternative resistance management strategies for controlling the resistant pest(s) on corn in the affected region.

11. Notification of all relevant personnel (e.g., growers, consultants, extension agents, seed distributors, processors, university c ooperators, and state/fe deral 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 prot ein. The following program summary describes, in order of events, the steps that must be taken to implement a remedial action plan if resistan ce to target pests is confirmed. However, the levels of "expected" damage cannot be identified until baseline sensitivity is determined. EPA requires that the registrant s 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 ac tion plan initiated when needed.

1. Definition of Suspected Resistance: Resist ance will be suspected if investigations of unexpected damage reports show that:

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

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

155c. alternative causes of damage or lodging, su ch as non-target pest insect species, weather, physical damage, larval moveme nt from alternate hosts, planting errors,

and other reasonable causes for the observations, have been ruled out;

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

If resistance is "suspected", the registrant will instruct affected growers to use alternate pest control measures such as adulticide treatment, crop rotation the following year,

or use of soil or seed insecticides the fo llowing year. These measures are intended to reduce the possibility of pot entially 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 fe ed and survive on Cry34/35Ab1 roots from neonate to adult is significantly higher than the baseline pr oportion (currently being established);

b. the LC50 of the test population exceed s the upper limit of the 95% confidence

interval for the LC50 of a standard uns elected population, a nd/or survival in the diagnostic assay is significantly greater than that of a standard unselected population, as established by the ong oing 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 a ffected field area demonstrate similar bioassay results.

3. Response to Confirmed Resistance: When resistance is "confirmed", the following steps will be taken:

a. EPA will receive notification within 30 days of confirming resistance;

b. affected customers and extension agen ts will be notifie d about confirmed resistance;

c. affected customers and extension agents will be encouraged to employ alternative CRW control measures;

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

e. a long-term resistance management ac tion plan will be devised according to the characteristics of the resistance event and local agronomic needs.

156Date Registered Date Expired Registrant Registration # Active Ingredients

Pioneer/Dupont 29964-8 TC1507 (PO Cry1F) x DAS-59122 (Cry34Ab1/Cry35Ab1) x MON810 (Cry1Ab) 24-Feb-10 31-Oct-15

1. The subject registration will automatical ly expire on midnight October 31, 2015.

2. The subject registration will be limited to Bacillus thuringiensis Cry1F protein and the genetic material (PHP8999) necessary for its production in corn event TC 1507 (OECD Unique Identifier: DAS- Ø 15 Ø 7-1) x Bacillus thuringiensis Cry34Ab1 protein and the genetic material (PHP17662) necessary fo r its production in corn event 59122 (OECD Unique Identifier: DAS-59122-7) x Bacillus thuringiensis Cry35Ab1 protein and the genetic material (PHP17662) necessary fo r its production in corn event 59122 (OECD Unique Identifier: DAS-59122-7) x Bacillus thuringiensis C ry1Ab protein and the genetic material (PV-ZMBK07) necessary for it production in corn event MON 810 (OECD Unique Identifier: MON- ØØ 81 Ø-6) for use in field corn.

3. Submit/cite all data required for registrati on of your product under FI FRA § 3(c)(5) when the Agency requires all registrants of similar products to submit such data.

4. The data submitted by Pioneer are sufficient to support registration for the combination PIP corn product,1507x59122xMON810, provided that the registrant submits/cites any data, determined by the Agency to be acceptabl e, required to support the PIP registrations of the individual parental events, TC1507 (DAS- Ø 15 Ø 7-1), 59122 (DAS-59122-7), and MON810 (MON- ØØ 81 Ø-6) in corn, as well as the combination PIP product TC1507 (DAS- Ø 15 Ø 7-1) x DAS-59122-7 (DAS-59122-7), with in the timeframes required by the terms and conditions of EPA Registration Numbers 29964-3, 29964-4, 524-489, and 29964-5, respectively.

5. This plant-incorporated protectant may be combined through conventional breeding with other registered plant-incor porated protectants that are similarly approved for use in combination, through conventional breeding, w ith other registered plant-incorporated protectants to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits.

6. The insect resistance management terms and conditions for 1507x59122xMON810 corn

are as follows.

The required IRM program for 1507x59122xMON 810 corn must have the following

elements:

• Requirements relating to creation of a refuge for th e Cry1F, Cry1Ab and Cry34/35Ab1 components that meets the require ments of the individual traits. The refuge for all three traits ma y be combined by planting non- Bt corn as the refuge, or the refuge for each trait may be planted separa tely. In the latter case, corn rootworm157resistant Bt corn may be planted in the lepidopteran refuge for the Cry1F and Cry1Ab component(s) and lepi dopteran-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 contractua l obligations on the grower to comply with the refuge requirements;

• Requirements for the registrants to de velop, implement, and report to EPA on programs to educate growers about IRM requirements;

• Requirements for the registrants to de velop, implement, and report to EPA on programs to evaluate and promote grower s 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 de velop, implement, and report to EPA on programs to evaluate whether there are st atistically significant and biologically relevant changes in target insect susceptib ility to Cry1F, Cry1Ab and Cry34/35Ab1 proteins in the target insects;

• Requirements for the regi strants to develop, and if triggered, to implement a remedial action plan that would contain m easures the registrants would take in the event that any insect resist ance was detected as well as to report on acti vity 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 31 st each year for Cry1F and Cry1Ab beginning in 2011 and on or before August 31st each year for Cry34/35Ab1, beginning in 2010.

7a. Refuge Requirements

The use of 1507x59122xMON810 corn (Cry1F x Cry34/35Ab1 x Cry1Ab) corn requires accompanying corn refuge(s) for the Cry1F, Cry1Ab and Cry34/35Ab1 components that meets the requirements of the individua l 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 lepidopteranresistant traits and the corn rootwormresistant traits may be planted sepa rately (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 fo r the Cry1F and Cry1Ab component and lepidopteran-resistant Bt corn (e.g., Herculex I or Yiel dGard) may be planted in the corn rootworm refuge for the Cry3 4/35Ab1 component. Depending on cropping

158practices, pest problems, and pest management options employed on any given farm, growers may need to choose different ref uge 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 re fuge. 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 Cry1A b 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 Yiel dGard 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 combin ations are permissible as long as in all cases the size and management of each refuge are described in A., B., and C., below.

These refuge requirements do not apply to seed pr opagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

A. Lepidopteran refuge for the Cry1F and Cry1Ab component.

1. Refuge size, Corn-Growing Areas (i.e., corn be lt and other non corn/cotton-growing regions). The use of 1507x59122xMON810 corn requires an accompanying 20% refuge consisting of non- Bt corn or non-lepidopteran resistant Bt corn.

2. Refuge size, Corn/Cotton-growing areas*. The use of 1507x59122xMON810 corn requires an accompanying 50% refuge consisting of non- Bt corn or non-lepidopteran

resistant Bt corn.

3. Refuge location.

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

mile of the 1507x59122xMON810 field

b. The lepidopteran refuge can be pl anted within the 1507x59122xMON810 field as blocks (e.g. along the edges or headlands)

c. The lepidopteran refuge can be pl anted within the 1507x59122xMON810 field as strips across the field at least four rows wide (six preferred).

4. Refuge management. Insecticide treatments for control of Europ ean corn borer, corn earworm, southwestern corn borer, fall armyworm, black cutworm, western bean cutworm, lesser corn stalk borer, sugarcane borer and southern corn st alk borer may be appl ied only if economic

thresholds are reached for one or more of thes e target pests. Econo mic thresholds will be determined using methods recommended by local or regional professionals (e.g. Extension Service Agents, cr op consultants). Microbial Bt insecticides must not be applied to lepidopteran resistant refuges.

159* Cotton growing areas consist of the following states Alabama, Arkansas, Georgia, Florida, Louisiana, North Carolina, Mi ssissippi, South Carolina, Ok lahoma (only the counties of Beckham, Caddo, Comanche, Cust er, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, Washita), Tennessee (only the counties of Carroll, Chester, Crockett, Dyer, Faye tte, Franklin, Gibson, Hardeman, Hardin, Haywood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), Texas (except th e counties of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, Moore, Ochiltree, Robe rts, and Sherman), Virginia (only the counties of Dinwiddie, Franklin City, Greensville, Isle of Wight, Northampton, Southampton, Suffolk City, Surrey, Sussex) and Missouri (only the counties of Dunkin, New Madrid, Pemiscot, Scott, Stoddard).

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

1. Refuge size. The use of 1507x59122xMON810 corn requires an accompanying 20% refuge consisting of non- Bt corn or non-corn rootworm-resistant Bt corn.

2. Refuge location. The rootworm refuge is required to be planted within or adjacent (e.g. across the road) to th e 1507x59122xMON810 corn field.

3. Refuge management options. The rootworm refuge can be managed in such a way that there is little or no yield loss to rootworms, but must be managed in a way that it is sufficiently productive of susceptible rootworm adults.

a. The in-field rootworm refuge options may be planted as a single block or as a series of strips measuring at least four (4) crop rows wide.

b. Seed mixtures of 1507x59122xMON810 and rootworm refuge corn are not permitted.

c. If the rootworm refuge is planted on rotated ground, then 1507x59122xMON810 corn must also be planted on rotated ground.

d. If the rootworm refuge is pl anted in continuous corn, the 1507x59122xMON810 field may be planted on either continuous or rotated land (option encouraged where WCRW rotation-resi stant biotype may be present).

e. Application of soil insecticide is permitted in the rootworm refuge.

f. Seed treatment is permitted in the r ootworm refuge, either at a rate for rootworm protection or at a rate fo r controlling secondary soil pests.

g. If aerial insecticides are applied to the rootworm refuge for control of CRW adults, the same treatment must also be applied in the same time-frame to

1507x59122xMON810 corn.

h. Pests other than adult corn rootworms can be treated on the rootworm refuge acres without treating the 1507x59122xM ON810 acres only if treatment

occurs when adult corn rootworms are not present or if a pesticide without activity against adult corn root worms is used. Pests on the

1507x59122xMON810 acres can be treated as n eeded without having to treat the rootworm refuge.

i. The rootworm refuge can be planted to any corn hybrid th at does not express

PIPs for rootworm control (e.g. lepidopteran-protected Btcorn, herbicidetolerant corn, or conventional corn). j. The rootworm refuge and 1507x59122xMON810 corn should be sown on the

160same day, or with the shortest window possible between pl anting dates, to ensure that corn root developm ent is similar among varieties.

k. Growers are encouraged to plant the rootworm refuge in the same location each year, as it allows the rootworm population to remain high and the durability of the trait is extended. This option may be preferable to growers who wish to only think of their refuge design once and for growers who grow continuous corn. However, for thos e 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 th e 1507x59122xMON810 corn field.

3. Refuge management options

a. The in-field refuge options must be plan ted as a single block or as a series of strips measuring at least four (4) rows wide (six rows preferred).

b. Seed mixtures of 1507x59122xMON810 and refuge corn are not permitted.

c. If the combined refuge is pl anted on rotated ground, then the 1507x59122xMON810 corn must also be planted on rotated ground.

d. If the combined refuge is planted on continuous corn, the 1507x59122xMON810 field may be planted on either continuous or rotated land (option encouraged where WCRW rotation-resi stant biotype may be present).

e. Application of soil insecticide for corn rootworm control is permitted in the combined refuge.

f. Seed treatment is permitted in the co mbined refuge, either at a rate for rootworm protection or at a rate fo r controlling secondary soil pests.

g. If aerial insecticides are applied to th e combined refuge for control of CRW adults, the same treatment must also be applied in the same timeframe to

1507x59122xMON810 corn.

h. Insecticide treatments in the combined refuge for control of European corn borer, corn earworm, southwestern corn borer, fall armyworm, black cutworm, western bean cutworm, sugarcane borer, lesser corn stalk borer, or southern corn stalk borer may be applied only if economic thresholds are reached for one or more of these target pests. Economic thresholds will be determined

161using methods recommended by local or regional professionals (e.g. Extension Service Agents, crop consultants). These pests may be treated with CRWlabeled insecticide on the combined refuge acres without treating the 1507x59122xMON810 acres only if treatment occurs when adult corn rootworms are not present. Microbial Bt insecticides must not be applied to the common refuges.

i. Pests other than adult corn rootworm s may be treated with CRW-labeled insecticide on the combined refuge acres without treating the 1507x59122xMON810 acres only if treatment occurs when adult corn rootworms are not present. Pests on the 1507x59122xMON810 acres may be

treated as needed without having to treat the refuge.

j. The combined refuge can be planted to any corn hybrid th at does not express PIPs for lepidopteran or rootworm cont rol (i.e. herbicide tolerant corn or conventional corn).

k. The combined refuge and 1507x59122xMON810 corn should be sown on the same day, or with the shortest window possible between pl anting dates, to ensure that corn root developm ent is similar among varieties.

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

7b. Grower Agreement

1. Persons purchasing 1507x59122xMON810 corn must sign a grower agreement. The term “grower agreement” refers to any grower purchase contract, license agreement, or similar legal document.

2. The grower agreement and/or specific st ewardship documents referenced in the grower agreement must clearl y set forth the terms of th e 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 equiva lent 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 submitte d to EPA within 90 days from the date of registration

4. Pioneer must use an approved grower agreement and must submit to EPA, within 90 days from the date of registration, a copy of that agreement and any specific stewardship documents referenced in the gr ower agreement. If Pioneer wishes to change any part of the gr ower agreement or any specific stewardship documents referenced in the grower agreement that w ould affect either the content of the IRM program or the legal enfor ceability of the provisions of the agreement relating to

162the IRM program, thirty days prior to implementing a proposed change, Pioneer must submit to EPA the text of such changes to ensure that it is consistent with the terms and conditions of this registration

.

5. Pioneer must implement an approved system equivalent to what is already approved for previously registered Bt corn products containing the previously registered events 1507, 59122 and MON810), wh ich is reasonably likely to assure that persons purchasing 1507x59122xMON810 corn sign grower agreement(s). A description of the system must be submitte d to EPA within 90 days from the date of registration.

6. Pioneer shall maintain record s of all 1507x59122xMON810 corn grower agreements for a period of three years from December 31st of the year in which the agreement was signed.

7. Beginning on January 31, 2011, a nd annually thereafter, Pioneer shall provide EPA with a report on the number of un its of 1507x59122xMON810 corn seed sold or shipped and not returned, and the number of such units that we re sold to persons who have signed grower agreements. The report shall cover the time frame of a twelve-month period. Note: The first report shall contain the specified information from the time frame starting with the date of registration and extending through the 2010 growing season.

8. Pioneer must allow a review of the gr ower agreements and grower agreement records by EPA or by a State pesticide regu latory agency if the State agency can

demonstrate that confidential business information, including names, personal information, and grower license number, will be protected.

7c. IRM Education and IRM Compliance Monitoring Program

1. Pioneer must maintain a comprehensive, ongoing IRM education program designed to convey to 1507x59122xMON810 corn users the importance of complying with the IRM program for all Bt corn products containing the Cry1F, Cry1Ab and Cry34/45Ab1events. The pr ogram 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 m eetings, mailing written materials, EPAreviewed language on IRM re quirements on the bag or bag tag, and electronic communications such as by internet, radio, or television commerci als). Copies of the materials will be provided to EPA for their records. The program shall involve

at least one written communicati on 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 Asso ciation and state extension programs.

2. Annually, Pioneer shall revise, and expand as necessary, its education program to

163take 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 re vise 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 ed ucation 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 gr oup, Agricultural Biotechnology Stewardship Technical Committee (ABSTC).

4. Pioneer must maintain an ongoing IR M compliance assurance program (CAP) equivalent to what is al ready approved for previ ously registered Pioneer Bt corn products, designed to evaluate the ex tent to which growers purchasing 1507x59122xMON810 corn are complying with the IRM program, and that takes such actions as are reasonably needed to assure that growers who have not complied with the program either do so in the future or lose their access to

1507x59122xMON810 corn. Pioneer sha ll coordinate with other Bt corn registrants in designing and implementi ng its compliance assu rance program and integrate this registration into the curre nt compliance assuran ce program used for

their other Bt corn PIPs. Pioneer must prepare and submit within 90 days of the date of registration a writ ten description of the compliance assurance program. Other required features of the program are described in paragraphs E through O

below.

5. Pioneer must maintain and publicize a “phased compliance approach” guidance document that indicates how they will ad dress instances of non-compliance with the terms of the IRM program and genera l criteria for choosing among options for responding to any non-compliant gr owers. It must be equiva lent to what is already approved for previously registered Pioneer Bt corn products. While recognizing

that for reasons of difference in business practices there are needs for flexibility between different companies, Pioneer must use a consistent set of standards for responding to non-compliance. The options shall include withdrawal of the right to purchase 1507x59122xMON810 corn for an individual grow er or for all growers in a specific region. An individual grower found to be significantly out of compliance two years in a row woul d 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 ob ligations will lose their opportunity to

sell 1507x59122xMON810 corn.

6. The IRM compliance assurance program sh all include an annual survey, conducted by an independent third party, of a statistically representa tive sample of growers of 1507x59122xMON810 corn who plant the vast majo rity 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

164shall measure the degree of compliance with the IRM progr am by growers in different regions of the country and consid er the potential impa ct of non-response. The sample size and geographical resolu tion 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 sensitivit y for comparing results across the United

States.

i. A third party is classified as a part y other than the registrant, the grower, or anyone else with a direct in terest in IRM compliance for Bt corn.

7. The survey shall be designed to provi de an understanding of any difficulties growers encounter in implementing IRM requi rements. An analysis of the survey results must include the reasons, extent, and potential biological significance of any implementation deviations.

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

9. Pioneer shall provide a final written summ ary 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 registra nts and EPA on the design and content of the survey prior to its implementation.

10. Annually, Pioneer shall revi se, and expand as necessary , its compliance assurance program to take into ac count the information colle cted through the compliance survey (required under paragraphs F th rough H) and from other sources. The registrant shall identify deficiencies in grower compliance and revise the education program to address those deficiencies. Pi oneer must confer with the Agency prior to adopting any changes.

11. Pioneer shall conduct an annual on-farm a ssessment 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 se lected for this program from across all farm sizes. In the event that any of these visits result in the identification of a grower who is not in compliance with the IRM program, Pioneer shall take appropriate action, consistent with its “phased compliance approach” to promote compliance.

12. Pioneer shall carry out a program for invest igating 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 appropr iate action, consistent with its “phased compliance approach.”

16513. If a grower, who purchases 1507x59122xMON810 corn for planting, was specifically identified as not being in co mpliance during the previous year, Pioneer shall visit with the grower and evaluate wh ether that grower is in compliance with the IRM program for the current year.

14. Beginning January 31, 2011, and annually therea fter, Pioneer shall provide a report to EPA summarizing the activities carriedout under their compliance assurance program for the prior year and the plan s 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 m eetings and letters), the extent of noncompliance, corrective measur es to address the non-comp liance, and any follow-up actions taken. Pioneer may elect to coordi nate information with other registrants and report collectively the results of compliance assurance programs.

15. Pioneer and the seed corn dealers for Pioneer must allow a review of the compliance records by EPA or by a State pe sticide regulatory agency if the State agency can demonstrate that confiden tial business information, including the names, personal information, and license number of the growers will be protected.

16. The registrant shall revise and expand its existing Compliance Assurance Program to include the following elements. The registrant must prepare and submit by January 31, 2011, a written description of its revised Compliance Assurance Program. The registrant may coordinate w ith other registrants in designing and implementing its Compliance Assurance Program.

17. The registrant will enhance the ref uge education program throughout the seed delivery channel:

i. Ensure sales representatives, licensees , seed dealers, and growers recognize the importance of correct refuge implemen tation and potential consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the next three growing seasons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

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

i. Use Bt corn adoption, pest pre ssure information, and other available information to identify regions where the risk of resistance is greatest;

ii. Focus approximately two-thirds of on-fa rm assessments on these regions, with the remaining assessments conducted across othe r regions where the product is used. 19] The registrant will use its available Bt sales records and other information to refine grower lists for on-farm assessments of th eir compliance with re fuge requirement:

166i. Identify for potential on-farm assessment growers whose sales in formation indicates they have purchased the Bt corn product but may have purchased little or no refuge seed from the registrant, licensee, or affiliated company.

20] The registrant will contract with thir d parties to perform on- farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all first-time on-farm assessments as well as second-year on-farm assessments of thos e growers found out of compliance in a

first-time assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and leve l of refuge compliance for the product.

22] The registrant will follow up with grow ers who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

i. All growers found to be signi ficantly out of compliance in a prior year will annually be sent additional refuge assistance in formation for a minimum of two years by the registrant, seed supplier, or thir d party assessor, af ter completing the

assessment process;

ii. The registrant will conduct follow-up checks on growers found to be significantly out of compliance within three years after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a five -year period will be denied

access to the Bt corn product in the subsequent year.

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

7d. Insect Resistance Monitori ng and Remedial Action Plans

A. Lepidopteran Resistance Monitoring. The Agency is imposing the following conditions for the Cry1Ab and Cr y1F toxins expressed in 1507x59122xMON810

corn:

Pioneer will monitor for resistance to Cry1Ab and Cry1F toxins expressed in 1507x59122xMON810 corn. The monitoring program sh all consist of tw o approaches: (i) focused population sampling and laboratory testing and (ii) investigation of reports of lessthan expected control of labele d insects. Should field-relevant resistance be confirmed, an appropriate resistance management action plan will be implemented.

1. Focused Population Sampling

167Pioneer 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 fo r 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 propor tion of the corn acres, and where the insect species are regarded as key pests of corn). Bioa ssay methods must be appropriate for the goal of detecting field- relevant shifts in population response to 1507x59122xMON810 corn and/or changes in resistan ce-allele frequency in response to the use of 1507x59122xMON810 corn and, as far as pos sible, should be consistent across sampling years to enable comparisons with historical data.

The number of populations to be collected shall reflect the regi onal 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 regi on 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 shoul d be collected from multiple corn-growing states reflective of di fferent geographies and agronomic conditions. To obtain sufficient sensitivity to detect re sistance alleles before they become common enough to cause measurable field damage, each popul ation collection shall attempt to target 400 insect genomes (egg masses, larvae, mated females, and/or mixed-sex adults), but a successful population co llection will contain a minimum of 100 genomes. It is recognized that it may not be possible to collect the targ et number of insect popul ations or genomes due

to factors such as natural fluctuations in pest density, environmental conditions, and areawide pest suppression.

The registrant must work to develop a dia gnostic assay for corn rootworm resistance monitoring to detect po tentially resistant indivi duals. As part of this effort, the registrant must investigate the feasibility of using the Sublethal Seedling Assay VII as a diagnostic assay. A report on this requirement must be su bmitted to the Agency 6 months from the date of the amended registra tion.

The registrant must submit revised corn ro otworm damage guidelines (to characterize unexpected pest damage). The revised guidelines must take into consideration the comments and recommendations from EPA’s June 30, 2010 review of the rootworm resistance monitoring program for Cry3Bb1. A report on this requirement must be submitted to the Agency 6 months from the date of the amended registration.

The sampling program and geographic range of co llections may be modified as appropriate based on changes in pest importance a nd 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 31 st of each year, beginning in 2010, the results of the population sampling and bioassay monitoring program.

VII Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and B.D. Siegfried. 2008. Validation of a novel resist ance monitoring technique for corn rootworm (Coleoptera: Chrysomelidae) and event DAS- 59122-7 maize. J. Appl. Entomol. 132:177-188)

168Any incidence of unusually low sensitivity to the Cry1Ab and Cry1F proteins in bioassays shall be investigated as soon as possible to unde rstand 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 sha ll be reported to the Ag ency annually before August 31 st , beginning in 2010. The inves tigative steps will include:

i. Re-test progeny of the collected popula tion to determine whether the unusual bioassay response is reproducible and her itable. If it is not reproducible and heritable, no furthe r action is required.

ii. If the unusual response is reproducible and he ritable, progeny of in sects that survive the diagnostic concentr ation will be tested using met hods that are representative of exposure to 1507x59122xMON810 corn under fi eld conditions. If progeny do not survive to adulthood, any susp ected resistance is not fi eld-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 freq uency 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 fro m sites surrounding the site where the resistance allele(s) was originally collected.

Should field-relevant resistan ce be confirmed, and the resistan ce 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 cons ultant 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 comp any 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), Pi oneer will implement the actions described

169below, based on the following definitions of suspected resistance and confirmed

resistance.

3. Suspected resistance

EPA defines suspected resistance to mean field reports of unexpected levels of insect feeding damage for which:

i. The corn in question has been confirmed to be lepidopteran-active Bt corn;

ii. The seed used had the proper pe rcentage 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 clim atic or cultural reasons could be responsible for the damage, and that ther e could be no other re asonable causes for the damage

The Agency does not interpret suspected resistance to mean grower re ports 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 pres ence of insects resistan t 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 tech nique appropriate for local production practices to minimize the possibility of resistant insects over-wintering and contributing to the next s eason’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 fi eld reports of unexpected levels of damage from the key target pest s, 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).

170ii. In standardized laboratory bioassays us ing diagnostic concentrations of the Bt protein suited to the target pest in questi on, the pest exhibits re sistance that has a genetic basis and the level of survivor ship indicates that there may be a resistance-allele frequency of ≥ 0.1 in the sampled population.

iii. In standardized laboratory bioassays, the LC 50 exceeds the upper limit of the 95%

confidence interval of the LC 50 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 Resistanc e 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 follo wing steps will be taken by Pioneer:

i. EPA will receive notification within 30 days of resistance confirmation;

ii. Affected customers and extension agen ts 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 th e extent and impact of resistance;

iv. If appropriate (depending on the resistant pe st 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. Altern ative 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 in sects, 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 aff ected area immediately until an effective local mitigation plan approved by EPA has been implemented;

vi. Pioneer will develop a case-s pecific resistance manageme nt action plan within 90 days according to the charac teristics of the resistance event and local agronomic needs. Pioneer will consult with appropria te stakeholders in the development of the action plan, and the detail s 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 cooperat ors and state/federal authorities as appropriate) in the region of the resistan ce situation and approve d action plan; and

viii. In subsequent growing seasons, Pioneer will maintain sales suspension and

171alternative resistance management strategi es in the affected region(s) for the Bt corn hybrids that are affected by the re sistant population unt il 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 a nd/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 focuse d 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 measurem ents) and molecular marker methods for corn rootworm monitoring.

1. Pioneer must follow-up on grower, extensio n specialist or consultant reports of unexpected damage or control failures for corn rootworm.

2. Pioneer must provide EPA with an annua l resistance monitoring report by August 31 st
each year, beginning in 2010, reporting on popula tions 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 susp ected if invest igations of unexpected damage reports show that:

• implicated maize plant roots were e xpressing the Cry34/35A b1 protein at the expected level;

• alternative causes of damage or lodging, su ch as non-target pest insect species, weather, physical damage, larval moveme nt 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 “sus pected,” Pioneer will instruct a ffected 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 pot entially 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”:

172• the proportion of larvae that can feed and survive on Cry3 4/35Ab1 roots from neonate to adult is significantly higher than the baseline proportion (currently being established);

• the LC 50 of the test population exceeds the upper limit of th e 95% confidence

interval for the LC 50 of a standard unselected populat ion and/or survival in the diagnostic assay is significantly greater than that of a standard unselected population, as established by the ong oing 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 resist ance 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 wi ll 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 a pproved by EPA and all appropriate

stakeholders.

7e. Annual Reporting Requirements

1) Annual Sales: reported and summed by state (county level data available by request) January 31st each year, beginning in 2011;

2) Grower Agreements: number of units of 1507x59122xMON810 corn seed shipped or sold and not returned, and the number of such units that were sold to persons who have signed grower agreements, January 31st each year, beginning in 2011;

1733) Grower Education: substantive changes to education program completed previous year, January 31st each year, beginning in 2011;

4) Compliance Assurance Program: complian ce 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 re port 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 re lease for shipment of the product constitutes acceptance of these conditions.

174Date Registered Date Expired Registrant Registration # Active Ingredients

Pioneer/Dupont 29964-9 DAS-59122 (PO Cry34Ab1/Cry35Ab1) x MON810 (Cry1Ab) 24-Feb-10 31-Oct-15

1. The subject registration will automatical ly expire on midnight October 31, 2015.

2. The subject registration will be limited to Bacillus thuringiensis Cry34Ab1 protein and the genetic material (PHP17662) necessary for its production in corn event 59122 (OECD Unique Identifier DAS-59122-7) x Bacillus thuringiensis Cry35Ab1 protein and the genetic material (PHP17662) necessary fo r 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- ØØ 81 Ø-6) for use in field corn.

3. Submit/cite all data required for registrati on of your product under FI FRA § 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 s ubmits/cites any data required to support the PIP re gistrations of the individua l parental events: 59122 (DAS59122-7) and MON810 (MON- ØØ 81 Ø-6) in corn, within the time frames required by

the terms and conditions of EPA Re gistration Number s 29964-4 and 524-489, respectively.

5. This plant-incorporated protectant may be combined through conventional breeding with other registered plant-incor porated protectants that are similarly approved for use in combination, through conventional breeding, w ith other registered plant-incorporated protectants to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits.

6. The insect resistance management terms and conditions for 59122xMON810 corn are as

follows:

The required IRM program fo r 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 th e individual traits. The refuge for both traits may be combined by planting non- Bt corn as the refuge, or the refuge for each trait may be planted separately. In the latter case, corn rootworm-resistant Bt corn may be planted in the lepidopteran refuge for the Cry1Ab component and lepidopteran-resistant Bt corn may be planted in the corn rootworm refuge for the Cry34/35Ab1 component;

175• Requirements for the registra nts to prepare and require Bt corn users to sign grower agreements which impose binding contractua l obligations on the grower to comply with the refuge requirements;

• Requirements for the registrants to deve lop, implement, and report to EPA on programs to educate growers about IRM requirements;

• Requirements for the registrants to deve lop, implement, and report to EPA on programs to evaluate and promote grower s compliance with IRM requirements (the 59122xMON810 Compliance Assurance Program (CAP) must integrate with the CAPS for the individually registered and combina tion products expressing Cry34/35Ab1 and Cry1Ab);

• Requirements for the registrants to deve lop, implement, and report to EPA on programs to evaluate whether there are st atistically significant and biologically relevant changes in target insect sus ceptibility to Cry34/35Ab1 and Cry1Ab proteins in the target insects;

• Requirements for the registrant s to develop, and if triggere d, to implement a remedial action plan that would contai n measures the regi strants 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 th e education program, on or before January 31st each year, and for resistan ce monitoring, on or before January 31 st 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 Cr y1Ab) corn requires accompanying corn refuge for both the Cry34/35Ab1 and Cry1Ab com ponents that meets the requirements of the individual traits, described belo w. 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 r ootworm 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 arrange ments for different fields. Possible options include: two refuge blocks (o ne for rootworm, one for Lepidoptera) can be planted within one field, or strips can be used for either refuge. Alte rnatively, a block of

Herculex RW corn can serve as an in-field lepidopteran refuge for one field planted to Cry34/35Ab1 x Cry1Ab and an external lepidopteran refuge for separate fields planted to Cry34/35Ab1x Cry1Ab, while the rootworm refuge is planted as YieldGard in an external

176adjacent field. In all options, size and manageme nt of each individual refuge must be followed

as described in A. and B. below.

Other refuge designs and combin ations are permissible as long as in all cases the size and management of each refuge are described in A., B., and C., below.

These refuge requirements do not apply to seed pr opagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

A. Lepidopteran refuge for the Cry1Ab component.

1. Refuge size, Corn-Growing Areas (i.e., corn be lt 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 *. Th e 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 se parate 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 contro l of European corn borer, corn earworm, southwestern corn borer, fall ar myworm, black cutworm, western bean cutworm, lesser corn stalk bore r, sugarcane borer and southe rn 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. Ex tension 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, Mi ssissippi, South Carolina, Ok lahoma (only the counties of Beckham, Caddo, Comanche, Cust er, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, Washita), Tennessee (only the counties of Carroll, Chester, Crockett, Dyer, Faye tte, Franklin, Gibson, Hardeman, Hardin, Haywood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby,

177and Tipton), Texas (except th e counties of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, Moore, Ochiltree, Robe rts, and Sherman), Virginia (only the counties of Dinwiddie, Franklin City, Greensville, Isle of Wight, Northampton, Southampton, Suffolk City, Surrey, Sussex) and Missouri (only the counties of Dunkin, New Madrid, Pemiscot, Scott, Stoddard).

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

1. Refuge size. The use of 59122xMON810 corn requires an accompanying 20% refuge consisting of non- Bt corn or non-corn rootworm-resistant Bt corn.

2. Refuge location. The rootworm refuge is required to be planted within or adjacent (e.g. across the road) to the 59122xMON810 corn field.

3. Refuge management options. The rootworm refuge can be managed in such a way that there is little or no yield loss to rootworms, but must be managed in a way that it is sufficiently productive of susceptible rootworm adults.

i. The in-field rootworm ref uge 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 bi otype 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 c ontrolling secondary soil pests.

vii. If aerial insecticides are applied to th e 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 an y corn hybrid that does not express PIPs for rootworm control (e.g. lepidopteran-protected Bt corn, herbicide-tolerant corn, or conventional corn).

178x. The rootworm refuge and 59122xMON810 corn should be sown on the same day, or with the shortest window possible betw een planting dates, to ensure that corn root development is similar among varieties.

xi. Growers are encouraged to plant the root worm 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 desi gn once and for growers who grow continuous corn. However, for those growers who need to employ crop rotati on, a fixed refuge would be impractical.

C. Combined Refuge. For the combined refuge option (i.e. the lepidopt eran 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 requirem ents 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 plan ted 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 bi otype 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 c ontrolling secondary soil pests.

vii. If aerial insecticides are applied to th e 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 ref uge 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

179only 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 Serv ice Agents, crop consultants). These pests may be treated with CRW-labeled in secticide on the combined refuge acres without treating the 59122xMON8 10 acres only if treatment occurs when adult corn rootworms are not present. Microbial Bt insecticides must not be applied to the common refuges.

ix. Pests other than adult corn rootworms may be treated with CRW-labeled insecticide on the combined refuge acres without treating the 59122xMON810 acres only if treatment occurs when adult corn rootworms are not present. Pests on the 59122xMON810 acres may be treated as needed without having to treat the refuge.

x. The combined refuge can be planted to an y 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 betw een 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 purch ase contract, license agreement, or similar legal document.

B. The grower agreement and/or sp ecific stewardship documents refe renced in the grower agreement must clearly set forth the terms of th e 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 a pproved for previously registered Bt corn products containing the previ ously 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 agreemen t 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 stewar dship documents referenced in the grower agreement that would affect either the content of the IRM program or the legal

180enforceability of the provisions of the agreem ent relating to the IRM program, thirty days prior to implementing a proposed change, Pion eer 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 e quivalent to what is already approved for previously registered Bt corn products containing the prev iously 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 ther eafter, Pioneer shall provide EPA with a report on the number of un its of 59122xMON810 corn seed sold or shipped and not returned, and the number of such units that were sold to pe rsons who have signed grower agreements. The report shall cover the tim e frame of a twelve-month period. Note: The first report shall contain the specified inform ation from the time frame starting with the date of registration and extendi ng 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 na mes, personal information, and grower license number, will be protected.

III. IRM Education and IRM Compliance Monitoring Program

1. Pioneer must maintain a comprehensive, ongoing IRM education program designed to convey to 59122xMON810 corn users the impor tance of complying with the IRM program for all Bt corn products containing the Cry1Ab and Cry34/45Ab1events. The program shall include information enc ouraging 59122xMON810 corn users to pursue optional elements of the IRM program relating to refuge configura tion and proximity to 59122xMON810 corn fields. The education progr am shall involve the use of multiple media (e.g. face-to-face meetings, mailing writ ten materials, EPA-reviewed language on IRM requirements on the bag or bag tag, a nd electronic communications such as by internet, radio, or television commercials). Copies of the materials will be provided to EPA for their records. The program sha ll involve at least one written communication annually to each 59122xMON810 corn user separa te from the grower technical guide.

The communication shall inform the user of the current IRM requirements. Pioneer shall coordinate its education program with the e ducational efforts of other registrants and other organizations, such as the National Co rn Growers Association and state extension

programs.

2. Annually, Pioneer shall revise, and expand as necessary, its education program to take

into account the information collected th rough the compliance survey required under paragraph 6 and from other sources. The regi strant shall identify deficiencies in grower compliance and revise the education pr ogram to address those deficiencies.

1813. Beginning January 31, 2011, Pioneer must provi de a report to EPA summarizing the

activities it carri ed out under its education program for the prior year. Annually thereafter, Pioneer must provide EPA any s ubstantive changes to its grower education activities as part of the over all IRM compliance assurance pr ogram report. Pioneer must either submit a separate report or contribut e to the report from the industry working group, Agricultural Biotechnology Stewardship Technical Committee (ABSTC).

4. Pioneer must maintain an ongoing IRM complia nce assurance program (CAP) equivalent to what is already approved for previously registered Pioneer Bt corn products, designed to evaluate the extent to which grow ers purchasing 159122xMON810 corn are complying with the IRM program, and that takes such acti ons as are reasonably ne eded 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 complianc e assurance program and integrate this registration into the current compliance assurance program used for their other Bt corn PIPs. Pioneer must prepare and submit with in 90 days of the da te of registration a written description of the co mpliance assurance program. Ot her required feat ures of the program are described in para graphs E. through O. below.

5. Pioneer must maintain and publicize a “phased compliance approach” guidance document that indicates how they will addr ess instances of non-compliance with the terms of the IRM program and general cr iteria 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 ther e are needs for flexibility between different companies, Pioneer must use a consiste nt set of standard s for responding to noncompliance. The options shall include withdrawal of the right to purchase 59122xMON810 corn for an individual grower or fo r all growers in a sp ecific region. An individual grower found to be significantly out of compliance two y ears in a row would

be denied sales of 59122xMON810 corn the next year. Similarly, seed dealers who are not fulfilling their obligations to inform/edu cate growers of their IRM obligations will lose their opportunity to sell 59122xMON810 corn.

6. The IRM compliance assurance program shall include an annual survey, conducted by an independent third party, of a statistically representative sample of growers of 59122xMON810 corn who plant the vast majority of all corn in the United States and in areas in which the selection intensity is the gr eatest. The survey sh all consider only those growers who plant 200 or more acres of corn in the Corn-B elt 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, base d upon input from independent marketing research firms and academic scientists, to allow analysis of compliance behavior within regions or between regions. The sample si ze must provide a reasonable sensitivity for comparing results across the United States.

i. A third party is classified as a party ot her than the registrant, the grower, or anyone else with a direct interest in IRM compliance for Bt corn.

1827. 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 bi ological significance of any implementation

deviations.

8. The survey shall be designed to obtain grow er feedback on the us efulness of specific

educational tools and initiatives.

9. Pioneer shall provide a final wr itten summary of the results of the prior year’s survey (together with a descripti on of the regions, the methodol ogy used, and the supporting data) to EPA by January 31st of each year , beginning with 2011. Pi oneer shall confer with other registrants and EPA on the design and content of the survey prior to its implementation.

10. Annually, Pioneer shall revise, and expand as necessary, its compliance assurance program to take into account the information collected through the compliance survey (required under paragraphs F. through H.) and from other sources. The registrant shall identify deficiencies in grower compliance and revise the education program to address

those deficiencies. Pioneer must confer with the Agency prior to adopting any changes.

11. Pioneer shall conduct an annual on-farm asse ssment 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, gr owers will be selected for this program from across all farm sizes. In the event that any of these visits result in the identification of a grower who is not in compliance with the IRM program, Pioneer shall take appropriate action, consistent with its “phased compliance approach ” to promote compliance.

12. Pioneer shall carry out a program for investig ating 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 w ho is not in compliance with the IRM program, Pioneer shall take appropriate action, consis tent with its “phased compliance approach.”

13. If a grower, who purchases 59122xMON810 corn fo r planting, was specifically identified as not being in compliance during the previous year, Pioneer shall vi sit with the grower and evaluate whether that grower is in co mpliance with the IRM program for the current

year.

14. Beginning January 31, 2011, and annually thereafte r, Pioneer shall provide a report to EPA summarizing the activities carried out under their comp liance assurance program for the prior year and the plans for the comp liance assurance program during the current year. The report will include information rega rding grower interactions (including, but not limited to, on-farm visits, verified tips and complaints, education programs, grower meetings and letters), the extent of non-comp liance, corrective measures to address the non-compliance, and any follow-up actions ta ken. Pioneer may elect to coordinate information with other registrants and re port collectively the results of compliance

assurance programs.

18315. Pioneer and the seed corn dealers for Pion eer must allow a review of the compliance records by EPA or by a State pesticide regu latory agency if the State agency can demonstrate that confidential business information, including the names, personal information, and license number of the growers will be protected.

16. The registrant shall revise and expand its existing Comp liance Assurance Program to include the following elements. The registra nt must prepare and submit by January 31, 2011, a written description of its revised Compliance Assura nce Program. The registrant may coordinate with other registrants in designing and implementing its Compliance Assurance Program.

17. The registrant will enhance the refuge e ducation program througho ut the seed delivery

channel:

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of correct refuge implementation and potenti al consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the ne xt three growing seasons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

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

risks for resistance:

i. Use Bt corn adoption, pest pressure information, a nd other available information to identify regions where the risk of resistance is greatest;

ii. Focus approximately two-thirds of on-fa rm assessments on these regions, with the remaining assessments conducted across othe r regions where the product is used.

19] The registrant will use its available Bt sales records and other information to refine grower lists for on-farm assessments of th eir compliance with re fuge requirement:

i. Identify for potential on-farm assessment gr owers whose sales information indicates they have purchased the Bt corn product but may have purchas ed little or no refuge seed from the registrant, licensee, or affiliated company.

20] The registrant will contract with thir d parties to perform on-farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all first-time on-farm assessments as well as secondyear on-farm assessments of those grower s found out of compliance in a first-time

assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and leve l of refuge compliance for the product.

18422] The registrant will follow up with grower s who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

i. All growers found to be significantly out of co mpliance in a prior year will annually be sent additional refuge assistance in formation for a minimum of two years by the registrant, seed supplier, or third pa rty assessor, after completing the assessment process;

ii. The registrant will conduct follow-up check s on growers found to be significantly out of compliance within three year s after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a fi ve-year period will be denied access to the

Bt corn product in the subsequent year.

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

IV. Insect Resistance Monitori ng and Remedial Action Plans

A. Lepidopteran Resistance Monitoring. The Ag ency 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) invest igation 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 re sistance development (e.g., where lepidopteran-active Bt hybrids are planted on a hi gh proportion of the corn acres, and where the insect species are regarded as key pests of corn). Bioassay methods must be appropriate for the goa l of detecting field-relevant shifts in population response

to 59122xMON810 corn and/or chan ges in resistance-allele fr equency in response to the use of 59122xMON810 corn and, as far as possibl e, should be consistent across sampling years to enable comparisons with historical data.

The number of populations to be collected sh all reflect the regional importance of the insect species as a pest, and specific collecti on regions will be identi fied 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

185and 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, la rvae, 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 genom es due to factors such as na tural 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 ch anges in pest importance an d for the adoption levels of 59122xMON810 corn. The Agency shall be cons ulted prior to the implementation of

such modifications.

The registrant must work to develop a dia gnostic assay for corn rootworm resistance monitoring to detect potentially re sistant individuals. As part of this effort, the registrant must investigate the feasibility of using the Sublethal Seedling Assay VIII as a diagnostic assay. A report on this requirement must be submitted to the Agency 6 months from the date of the amended registration.

The registrant must submit revised corn ro otworm damage guideli nes (to characterize unexpected pest damage). Th e revised guidelines must take into consideration the

comments and recommendations from EPA’s J une 30, 2010 review of the rootworm resistance monitoring program for Cry3Bb1. A report on this requirement must be submitted to the Agency 6 months from the date of the amended registration.

Pioneer will report to the Agency by August 31 st of each year, beginning in 2010, the results of the population sampling and bioassay monitoring program.

Any incidence of unusually low sensitivity to the Cry1Ab protein in bioassays shall be investigated as soon as possible to understand any field-relevance of such a finding. Such investigations shall proceed in a stepwise manner until the field-relevance can be either confirmed or refuted, and results of thes e shall be reported to the Agency annually before August 31 st , 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 heri table. If it is not reproducible and heritable, no furthe r action is required.

ii. If the unusual response is re producible and heritable, progeny of insects that survive the diagnostic concentration w ill be tested using methods that are representative of exposure to 59122xMON 810 corn under field conditions. If progeny do not survive to adulthood, any susp ected resistance is not field-relevant and no further action is required.

VIII Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and B.D. Siegfried. 2008. Validation of a novel resist ance monitoring technique for corn rootworm (Coleoptera: Chrysomelidae) and event DAS- 59122-7 maize. J. Appl. Entomol. 132:177-188)

186iii. If insects survive steps 1 and 2, resistan ce 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 freq uency 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 subse quent years from sites surr ounding the site where the resistance allele(s) was originally collected.

Should field-relevant resistance be conf irmed, and the resistance appears to be increasing or spreading, Pioneer will cons ult 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, extensio n specialist or cons ultant reports of unexpected levels of damage by the lepidopte ran pests listed on the pesticide label.

Pioneer will instruct its customers to contact them if such incidents occur. Pioneer will investigate all legitimate reports s ubmitted to the company or the company's representatives.

If reports of unexpected levels of damage lead to the susp icion of resistance in any of the key target pests (ECB, SWCB, and CE W), Pioneer will implement the actions described below, based on th e 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 c onfirmed 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 ex pressing 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 c limatic or cultural reasons could be responsible for the damage, and that th ere could be no othe r reasonable causes for the damage.

187The 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 scie ntifically 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, a nd 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 labor atory 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 fi eld reports of unexpected levels of damage from the key target pest s, that all the following criteria are met:

i. There is > 30% insect survival and commensu rate insect feeding in a bioassay, initiated with neonate larv ae, that uses methods that are representative of exposure to Bt corn hybrids under field conditions (ECB and SWCB only).

ii. In standardized laboratory bioassays us ing diagnostic con centrations of the

Bt protein suited to the target pest in question, the pest e xhibits resistance that has a genetic basis and the level of survivorship indicates that there may be a resistance-a llele frequency of ≥ 0.1 in the sampled population

iii. In standardized laboratory bioassays, the LC 50 exceeds the upper limit of

the 95% confidence interval of the LC 50 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

188When 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 agen ts will be notified about confirmed resistance within 30 days;

iii. Monitoring will be increased in the a ffected area and local target pest populations will be sampled annually to determine the extent and impact of resistance;

iv. If appropriate (depending on the resist ant pest species, the extent of resistance, the timing of resistance, a nd 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 co ntrol measures may include advising customers and extension agents in the affected area to incorporate cropresidues into the soil following harvest to minimize the possibility of overwintering insects, and/or applications of chemical insecticides;

v. Unless otherwise agreed with EPA, Pion eer 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 charac teristics of the resistance event and local agronomic needs. Pioneer will consult with approp riate stakeholders in the development of the action plan, a nd 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 c ooperators and state/federal authorities as appropriate) in the re gion of the resistance situation and approved action plan; and

viii. In subsequent growing seasons, Pioneer will maintain sales suspension and alternative resistance management strategi es 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 a nd/or trends in increased tolerance for corn rootworm using the existing corn rootworm monitoring program developed for previously

189registered Pioneer Bt corn products. Sampling should be focuse d 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 measurem ents) and molecular marker methods for corn rootworm monitoring.

1. Pioneer must follow-up on grower, extensio n specialist or consultant reports of unexpected damage or control failures for corn rootworm.

2. Pioneer must provide EPA with an annua l resistance monitoring report by August 31 st
each year, beginning in 2010, reporting on popula tions 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 e xpressing the Cry34/35Ab1 protein at the expected level;

• alternative causes of damage or lodgi ng, such as non-target pest insect species, weather, physical damage, larv al 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 “sus pected,” Pioneer will instruct a ffected 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 pot entially 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 f eed and survive on Cry34/35Ab1 roots from neonate to adult is significan tly higher than the baseline proportion (currently being established);

• he LC 50 of the test population exceeds the upper limit of the 95%

confidence interval for the LC 50 of a standard unselected population and/or survival in the diagnostic assay is significantly greater than that of a standard unselected po pulation, as established by the ongoing baseline

190monitoring 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 resi stance could lead to widespread product failure if subsequent collectio ns 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 agen ts 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 co rn in the affected area will cease immediately; and

• a long-term resistance management ac tion 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 appr oved by EPA and all appropriate stakeholders.

V. Annual Reporting Requirements

1. Annual Sales: reported and summed by state (county level data available by request) January 31st each year, beginning in 2011;

2. Grower Agreements: number of units of 59122xMON810 corn seed shipped or sold and not returned, and the number of such uni ts 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 as surance 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

191plans for the current year; full report January 31st each year, beginning in 2011;

6. Insect Resistance Monitoring Results: result s of monitoring and investigations of damage reports, August 31st each year, beginning in 2011.

If these conditions are not complied with, the re gistration will be subject to cancellation in accordance with FIFRA section 6(e). Your re lease for shipment of the product constitutes acceptance of these conditions.

192

### IV. mCry3A 

### BRAD Registered Products

Date Registered Registrant Registration # Active Ingredients Date Expired

Syngenta 67979-5 Bt Corn Event MIR 604 with modified Cry3A (Agrisure RW) 3-Oct-06 30-Sep-15

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

2] The subject registration will be limited to mCry3A corn, modified Cry3A protein and the genetic material necessary for its production (v ia elements of pZM26) in Event MIR604

corn SYN-IR604-8.

3] Submit/cite all data required for registrati on of your product under FIFRA § 3(c)(5) when the Agency requires registrants of si milar products to submit such data.

4] Three (3) year full-scale fiel d or semi-field studies for eval uation 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 sample s per plot based on recommendations of the August, 2002 SAP and subsequent relevant research on appropriate study design). A protocol is due within 90 da ys of the date of registra tion. Should the registration expiration date be extended, a fi nal report is due January 31, 2011.

5] The subject plant-incorporat ed protectant may be combin ed through conventional breeding with other registered plant-incorporated prot ectants that are simila rly approved for use in combination, through conventional breeding, with other plant-incorpor ated protectants to produce inbred corn lines and hybrid corn va rieties with combined pesticidal traits.

6] In light of recently published laboratory st udies showing reduced growth in shredding caddis flies exposed to anti-l epidopteran Cry1A protein corn litt er (Rosi-Marshall, et al. 2007), additional aquatic invertebrate da ta are required. A 7 to 14 day Daphnia magna study as per the 885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, representing the functional group of a leaf shredder in headwater streams must be submitted by January 31, 2012.

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

a. Refuge Requirements

These refuge requirements do not apply to seed pr opagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

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

193corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

1] Grower agreements (also known as stewar dship 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 th e grower guide/product use guide.

2] Specifically, growers must pl ant a structured refuge of at least 20% non-corn rootworm protected Bt corn that may be treated with inse cticides 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 adj acent (e.g., across the road ) to mCry3A MIR604

fields.

5] When planting the refuge in strips across the field, refuges mu st be at least 4 consecutive

rows wide.

6] Insecticide treatments for cont rol of corn rootworm larvae ma y 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 re fuge 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 co rn, then the MIR604 field may be planted on

either continuous or in a field th at is in a crop rotation system.

b. Grower Agreements

1] Persons purchasing the Bt corn product must sign a grower agreement. The term "grower agreement" refers to any grower purchase co ntract, license agreement, or similar legal

document.

2] The grower agreement and/or specific stew ardship documents referenced in the grower agreement must clearly set forth the terms of the current IRM program. By signing the grower agreement, a grower must be contractually bound to comply with the requirements of the IRM program.

3] The registrant must continue to implemen t a system (equivalent to what is already approved for Bt 11 field corn, EPA Reg. No. 67979-1) th at 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.

1944] If Syngenta wishes to ch ange any part of the grower agreement or any specific stewardship documents referenced in the grow er agreement that woul d affect either the content of the IRM program or the legal enforceability of th e provisions of the agreement relating to the IRM program, thirty days pr ior to implementing a proposed change, the registrant must submit to EPA the text of such changes to ensure that it is consistent with

the terms and conditions of the amendment.

5] The registrant must continue to implemen t a system (equivalent to what is already approved for Bt 11, EPA Reg. No. 67979-1) that is r easonably likely to assure that persons purchasing the Bt corn sign grower agreement(s).

6] The registrant shall maintain records of all Bt corn grower agreements for a period of three years from December 31st of the year in which the agreement was signed.

7] Annually the registrant shall provide EPA with a report showi ng the number of units of its

Bt MIR604 corn seeds sold or shipped and not re turned, 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 cove ring the prior August through July.

8] Annually the registrant shall submit annual reports on units sold by State (units sold by county level will be made available to the Agency upon request), IRM grower agreement results, and the compliance assurance progr am, including the education program on or before January 31 st each year.

9] The registrant must allow a review of the grower agreements and grower agreement records by EPA or by a State pesticide regu latory agency if the State agency can

demonstrate that confidential business information, including names, personal information, and grower license number, will be protected.

c. IRM Education and IRM Compliance Monitoring Programs

1] Syngenta must maintain and implement a comprehensive, ongoing IRM education program designed to convey to Bt MIR604 corn users the impor tance of complying with the IRM program. The program shall include information encouraging Bt MIR604 corn users to pursue optional elements of the IR M program relating to refuge configuration and proximity to Bt MIR604 corn fields. The education program shall involve the use of multiple media, e.g. face-to-face meetings, mailing written materials, EPA reviewed language on IRM requirements on the bag or bag tag, and electronic communications such as by Internet, radio, or television comm ercials. Copies of the materials will be provided to EPA for its reco rds. The program shall invol ve 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

195paragraph 6] and from other sources. The changes shall address aspects of grower compliance that are not sufficiently high.

3] Annually, the registrant must provide a repo rt to EPA summarizing the activities carried out under the education program for the prior year and any substantive changes to its grower education activities as part of the overall IRM compliance assurance program report. The required features of the compliance assurance program are described in paragraphs 4-22 below.

4] The registrant must continue to implement an ongoing IRM compliance assurance program designed to evaluate the extent to which growers purchasing its MIR604 Bt corn product are complying with the IRM program and that takes such actions as are reasonably needed to assure that growers w ho 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

Bt 11, EPA Registration Number 67979-1. Other required featur es of the program are described in paragraphs 5 - 22 below.

5] The registrant must conti nue to implement and publicize a "phased compliance approach," i.e., a guidance document that indicates how th e registrant will a ddress instances of noncompliance with the terms of the IRM program and general criteria for choosing among options for responding to any non-complia nt growers. The op tions shall include withdrawal of the right to purchase MIR604 Bt corn for an individua l 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 sha ll include an annual survey conducted by an independent third party of a statistically representative sample of growers of Bt corn products who plant th e vast majority of all corn in th e U.S. and in ar eas 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 mo re acres of corn in corn-cotton areas. The survey shall measur e the degree of compliance with the IRM program by growers in different regions of th e country and consider the potential impact of non-response. The sample size and geogr aphical resolution may be adjusted annually, based upon input from the independent marketing research firm and academic scientists, to allow analysis of compliance behavior with in regions or between regions. The sample size must provide a reasonable sensitivit y for comparing results across the U.S.

i. A third party is classified as a party ot her than the registrant, the grower, or anyone else with a direct interest in IRM compliance for Bt corn.

7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potential bi ological significance of any implementation

deviations.

1968] The survey shall be designed to obtain gr ower feedback on the usefulness of specific

educational tools and initiatives.

9] The registrant shall provide a final writte n summary of the results of the prior year's survey (together with a de scription of the regions, the methodology used, and the supporting data) to EPA by January 31.

10] Annually, the registrant sh all 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 su fficiently high. The regi strant must confer with the Agency prior to adopting any changes to a pr eviously approved CAP.

11] The registrant shall conduct an annual on-fa rm 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 co mpliance with the IRM program, the registrant shall take appropriate action, consistent with its "p hased 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 w ho 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 sp ecifically identified as not being in compliance during the previous year, the registrant shall visit with the grower and evaluate whether th at the grower is in complia nce with the IRM program for the current year.

14] Annually, Syngenta shall provide a report to EPA summarizing the activities carried out under their compliance assurance program for the prior year and the plans for the compliance assurance program during the current year. The report will include information regarding grower interactions (including, but not limited to, on-farm visits, verified tips and complaints, grower meetings and letters), the extent of non-compliance,

corrective measures to address the non-co mpliance, and any follow-up actions taken.

15] The registrant and the seed corn dealers fo r the registrant must allow a review of the compliance records by EPA or by a State pesticid e regulatory agency if the State agency

can demonstrate that confid ential business information, including the names, personal information, and grower license number of the growers will be protected.

19716] The registrant shall revi se and expand its existing Comp liance Assurance Program to include the following elements. The registra nt must prepare and submit by January 31, 2011, a written description of its revised Compliance Assura nce Program. The registrant may coordinate with other registrants in designing and implementing its Compliance Assurance Program.

17] The registrant will enhan ce the refuge education progra m throughout the seed delivery

channel:

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of correct refuge implementation and potenti al consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the ne xt three growing seasons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

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

risks for resistance:

i. Use Bt corn adoption, pest pressure information, a nd other available information to identify regions where the risk of resistance is greatest;

ii. Focus approximately two-thirds of on-fa rm assessments on these regions, with the remaining assessments conducted across othe r regions where the product is used.

19] The registrant will use its available Bt sales records and other information to refine grower lists for on-farm assessments of th eir compliance with re fuge requirement:

i. Identify for potential on-farm assessment gr owers whose sales information indicates they have purchased the Bt corn product but may have purchas ed little or no refuge seed from the registrant, licensee, or affiliated company.

20] The registrant will contract with thir d parties to perform on-farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all first-time on-farm assessments as well as secondyear on-farm assessments of those grower s found out of compliance in a first-time

assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and leve l of refuge compliance for the product.

22] The registrant will follow up with grower s who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

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

198additional refuge assistance in formation for a minimum of two years by the registrant, seed supplier, or third pa rty assessor, after completing the assessment process;

ii. The registrant will conduct follow-up check s on growers found to be significantly out of compliance within three year s after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a fi ve-year period will be denied access to the

Bt corn product in the subsequent year.

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

d. Insect Resistance Monitoring and Remedial Action Plan

The Agency is imposing the following conditions for the mCry3A toxi n expressed in this product: The registrant must monitor for mCry3A resistance and/or trends in increased tolerance for corn rootworm. Sampling should be focused in those ar eas in which there is the highest risk of resistance development.

1] The resistance monitoring plan must include: baseline sensitivity data, sampling (number of locations, samples per locations), sampling methodology and life-stage sampled, bioassay methodology, standardization proc edures (including QA/QC provisions), detection technique and sensitivity, the statistical analysis of the probability of detecting resistance, and an interim description of rootworm damage guidelines.

2] The registrant must work to develop a di agnostic assay for corn rootworm resistance monitoring to detect potentially re sistant individuals. As part of this effort, the registrant must investigate the feasibility of using the Sublethal Seedling Assay IX as a diagnostic assay. A report on this requirement must be submitted to the Agency within six (6) months from the date of the amended registration.

3] The registrant must submit revised corn rootworm damage guidelines (to characterize unexpected pest damage). Th e revised guidelines must take into consideration the

comments and recommendations from EPA’s June 30, 2010, review of the rootworm resistance monitoring program for (insert toxin) . A report on this requirement must be submitted to the Agency within six (6) months from the date of the amended registration.

4] The registrant must follow- up on grower, extension specialis t or consultant reports of unexpected damage or control failures for corn rootworm.

5] The registrant must provide EPA with an annual resistance mon itoring report by August 31st of each year, reporting on populati ons collected the previous year.

IX Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and B.D. Siegfried. 2008. Validation of a novel resist ance monitoring technique for corn rootworm (Coleoptera: Chrysomelidae) and event DAS- 59122-7 maize. J. Appl. Entomol. 132:177-188)

199e. Remedial Action Plans

The following program summary describes, in order of events, the steps that must be taken to implement a remedial action plan if resistance to target pests is confirmed (this general process has been implemented for other lepidopteron and CRW Bt corn products).

1. Definition of Suspected Resistance: Resistance will be suspected if investigations of unexpected damage reports show that:

a. implicated maize plant roots were expre ssing the mCry3A protei n at the expected level;

b. alternative causes of dama ge or lodging, such as non-t arget pest insect species, weather, physical damage, larval moveme nt from alternate hosts, planting errors,

and other reasonable causes for the observations, have been ruled out;

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

If resistance is “suspected”, the registrants will instruct affected growers to use alternate pest control measures such as adulticide treatment, crop rotation the following year, or use of soil or seed insecticides the following year. These meas ures are intended to re duce the possibility of potentially resistant insects contributi ng to the following year’s pest population.

2. Confirmation of Resistance : Resistance will be confirmed if all of the following criteria are met by progeny from the target pest species sampled from the area of “suspected resistance”

a. the proportion of larvae that can feed and survive on mCry3A roots from neonate to adult is significantly higher than the baseline proportion (currently being established);

b. the LC 50 of the test population exceeds the upper limit of the 95% confidence

interval for the LC 50 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 ong oing baseline monitoring program;

c. the ability to survive is heritable;

d. mCry3A plant assays determine that da mage caused by surviving insects would exceed economic thresholds;

e. the identified frequency of field resistance could lead to widespread product failure if subsequent collections in the affected field area(s) demonstr ated 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 agen ts will be notified about confirmed resistance;

200c. 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 acti on plan will be devised according to the

characteristics of the resistance event and local agronomic needs. [The details of such a plan should be approved by EPA and all appropriate stakeholders.]

f. Annual Reporting Requirements

1] Annual Sales: reported and summed by state (county level data available by request), January 31st each year;

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

the number of such units that were sold to persons who have signed grower agreements, January 31st each year;

3] Grower Education: substant ive changes to education progr am completed previous year, January 31st each year;

4] Compliance Assurance Plan: Compliance A ssurance Program activities and results, January 31st each year;

5] Compliance: to include annua l survey results and plans fo r 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.

201Date Registered Date Expired Registrant Registration # Active Ingredients

Syngenta 67979-8 Bt Corn Event MIR 604 +

Bt 11 with modified Cry3A + Cry1Ab (Agrisure CB/RW) 24-Jan-07 30-Sep-15

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

2] The subject registration will be limited to mCry3A corn, modified Cry3A protein and the genetic material necessary for its production (v ia elements of pZM26) in Event MIR604

corn SYN-IR604-8.

3] Submit/cite all data required for registrati on of your product under FIFRA § 3(c)(5) when the Agency requires registrants of si milar products to submit such data.

4] The subject plant-incorporat ed protectant may be combin ed through conventional breeding with other registered plant-incorporated prot ectants that are simila rly approved for use in combination, through conventional breeding, with other plant-incorpor ated protectants to produce inbred corn lines and hybrid corn va rieties with combined pesticidal traits.

5] Three (3) year full-scale fiel d or semi-field studies for eval uation 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 sample s per plot based on recommendations of the August, 2002 SAP and subsequent relevant research on appropriate study design). A protocol is due within 90 da ys of the date of registra tion. Should the registration expiration date be extended, a final report is due January 31, 2011.

6] Submit/cite all data, determined by the Agency to be acceptable, required to support the individual plant-incorporated protectant s in Event MIR 604 with modified Cry3A (Agrisure RW) corn within the timeframes required by the terms and conditions of EPA Registration Numb ers 67979-5 and 67979-1.

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

a. Refuge Requirements

These refuge requirements do not apply to seed pr opagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

1] Grower agreements (also known as stewar dship agreements) will specify that growers

202must adhere to the refuge requirements as described in the grower guide/product use guide and/or in supplements to th e grower guide/product use guide.

2] Specifically, growers must pl ant a structured refuge of at least 20% non-corn rootworm protected Bt corn that may be treated with inse cticides 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 adj acent (e.g., across the road ) to mCry3A MIR604

fields.

5] When planting the refuge in strips across the field, refuges mu st be at least 4 consecutive

rows wide.

6] Insecticide treatments for cont rol of corn rootworm larvae ma y 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 re fuge 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 co rn, then the MIR604 field may be planted on

either continuous or in a field th at is in a crop rotation system.

9] Refuge requirements do not appl y 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 co ntract, license agreement, or similar legal

document.

2] The grower agreement and/or specific stew ardship documents referenced in the grower agreement must clearly set forth the terms of the current IRM program. By signing the grower agreement, a grower must be contractually bound to comply with the requirements of the IRM program.

3] The registrant must continue to implemen t a system (equivalent to what is already approved for Bt 11 field corn, EPA Reg. No. 67979-1) th at 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.

2034] If Syngenta wishes to ch ange any part of the grower agreement or any specific stewardship documents referenced in the grow er agreement that woul d affect either the content of the IRM program or the legal enforceability of th e provisions of the agreement relating to the IRM program, thirty days pr ior to implementing a proposed change, the registrant must submit to EPA the text of such changes to ensure that it is consistent with

the terms and conditions of the amendment.

5] The registrant must continue to implemen t a system (equivalent to what is already approved for Bt 11, EPA Reg. No. 67979-1) that is r easonably likely to assure that persons purchasing the Bt corn sign grower agreement(s).

6] The registrant shall maintain records of all Bt corn grower agreements for a period of three years from December 31st of the year in which the agreement was signed.

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

Bt MIR604 corn seeds sold or shipped and not re turned, 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 cove ring the prior August through July.

8] Annually, the registrant shall submit annual re ports 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 progr am, including the education program on or before January 31 st each year.

9] The registrant must allow a review of the grower agreements and grower agreement records by EPA or by a State pesticide regu latory agency if the State agency can

demonstrate that confidential business information, including names, personal information, and grower license number, will be protected.

c. IRM Education and IRM Compliance Monitoring Programs

1] Syngenta must maintain and implement a comprehensive, ongoing IRM education program designed to convey to Bt MIR604 corn users the impor tance of complying with the IRM program. The program shall include information encouraging Bt MIR604 corn users to pursue optional elements of the IR M program relating to refuge configuration and proximity to Bt MIR604 corn fields. The education program shall involve the use of multiple media, e.g. face-to-face meetings, mailing written materials, EPA reviewed language on IRM requirements on the bag or bag tag, and electronic communications such as by Internet, radio, or television comm ercials. Copies of the materials will be provided to EPA for its reco rds. The program shall invol ve 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

204take into account the information collected through the compliance survey required under paragraph 6] and from other sources. The changes shall address aspects of grower compliance that are not sufficiently high.

3] Annually, the registrant must provide a repo rt to EPA summarizing the activities carried out under the education program for the prior year and any substantive changes to its grower education activities as part of the overall IRM compliance assurance program report. The required features of the compliance assurance program are described in paragraphs 4-22 below.

4] The registrant must continue to implement an ongoing IRM compliance assurance program designed to evaluate the extent to which growers purchasing its MIR604 Bt corn product are complying with the IRM program and that takes such actions as are reasonably needed to assure that growers w ho 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

Bt 11, EPA Registration Number 67979-1. Other required featur es of the program are described in paragraphs 5 - 22 below.

5] The registrant must conti nue to implement and publicize a "phased compliance approach," i.e., a guidance document that indicates how th e registrant will a ddress instances of noncompliance with the terms of the IRM program and general criteria for choosing among options for responding to any non-complia nt growers. The op tions shall include withdrawal of the right to purchase MIR604 Bt corn for an individua l 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 sha ll include an annual survey conducted by an independent third party of a statistically representative sample of growers of Bt corn products who plant th e vast majority of all corn in th e U.S. and in ar eas 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 mo re acres of corn in corn-cotton areas. The survey shall measur e the degree of compliance with the IRM program by growers in different regions of th e country and consider the potential impact of non-response. The sample size and geogr aphical resolution may be adjusted annually, based upon input from the independent marketing research firm and academic scientists, to allow analysis of compliance behavior with in regions or between regions. The sample size must provide a reasonable sensitivit y for comparing results across the U.S.

i. A third party is classified as a party ot her than the registrant, the grower, or anyone else with a direct interest in IRM compliance for Bt corn.

7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potential bi ological significance of any implementation

205deviations.

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

educational tools and initiatives.

9] The registrant shall provide a final writte n summary of the results of the prior year's survey (together with a de scription of the regions, the methodology used, and the supporting data) to EPA by January 31 of each year. The registrant shall confer with

other Bt corn registrants and EPA on the design and content of the survey prior to its implementation.

10] Annually, the registrant sh all 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 su fficiently high. The regi strant must confer with the Agency prior to adopting any changes to a pr eviously approved CAP.

11] The registrant shall conduct an annual on-fa rm 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 co mpliance with the IRM program, the registrant shall take appropriate action, consistent with its "p hased 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 w ho 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 sp ecifically identified as not being in compliance during the previous year, the registrant shall visit with the grower and evaluate whether th at the grower is in complia nce with the IRM program for the current year.

14] Annually, Syngenta shall provide a report to EPA summarizing the activities carried out under their compliance assurance program for the prior year and the plans for the compliance assurance program during the current year. The report will include information regarding grower interactions (including, but not limited to, on-farm visits, verified tips and complaints, grower meetings and letters), the extent of non-compliance,

corrective measures to address the non-co mpliance, and any follow-up actions taken.

15] The registrant and the seed corn dealers fo r the registrant must allow a review of the compliance records by EPA or by a State pesticid e regulatory agency if the State agency

can demonstrate that confid ential business information, including the names, personal information, and grower license number of the growers will be protected.

20616] The registrant shall revi se and expand its existing Comp liance Assurance Program to include the following elements. The registra nt must prepare and submit by January 31, 2011, a written description of its revised Compliance Assura nce Program. The registrant may coordinate with other registrants in designing and implementing its Compliance Assurance Program.

17] The registrant will enhan ce the refuge education progra m throughout the seed delivery

channel:

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of correct refuge implementation and potenti al consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the ne xt three growing seasons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

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

risks for resistance:

i. Use Bt corn adoption, pest pressure information, a nd other available information to identify regions where the risk of resistance is greatest;

ii. Focus approximately two-thirds of on-fa rm assessments on these regions, with the remaining assessments conducted across othe r regions where the product is used.

19] The registrant will use its available Bt sales records and other information to refine grower lists for on-farm assessments of th eir compliance with re fuge requirement:

i. Identify for potential on-farm assessment gr owers whose sales information indicates they have purchased the Bt corn product but may have purchas ed little or no refuge seed from the registrant, licensee, or affiliated company.

20] The registrant will contract with thir d parties to perform on-farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all first-time on-farm assessments as well as secondyear on-farm assessments of those grower s found out of compliance in a first-time

assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and leve l of refuge compliance for the product.

22] The registrant will follow up with grower s who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

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

207additional refuge assistance in formation for a minimum of two years by the registrant, seed supplier, or third pa rty assessor, after completing the assessment process;

ii. The registrant will conduct follow-up check s on growers found to be significantly out of compliance within three year s after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a fi ve-year period will be denied access to the

Bt corn product in the subsequent year.

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

d. Insect Resistance Monitoring and Remedial Action Pl an (mCry3A – Corn Rootworm)

The Agency is imposing the following conditions for the mCry3A toxin expressed in this product: The registrant must monitor for mCry3A resistance and/or trends in increased tolerance for corn rootworm. Sampling should be focused in those ar eas in which there is the highest risk of resistance development.

1] The resistance monitoring plan must include: baseline sensitivity data, sampling (number of locations, samples per locations), sampling methodology and life-stage sampled, bioassay methodology, standardization proc edures (including QA/QC provisions), detection technique and sensitivity, the statistical analysis of the probability of detecting resistance, and an interim description of rootworm damage guidelines.

2] The registrant must work to develop a di agnostic assay for corn rootworm resistance monitoring to detect potentially re sistant individuals. As part of this effort, the registrant must investigate the feasibility of using the Sublethal Seedling Assay X as a diagnostic assay. A report on this requirement must be submitted to the Agency within six (6) months from the date of the amended registration.

3] The registrant must submit revised corn rootworm damage guidelines (to characterize unexpected pest damage). Th e revised guidelines must take into consideration the

comments and recommendations from EPA’s June 30, 2010, review of the rootworm resistance monitoring program for mCry3A . A report on this requirement must be submitted to the Agency within six (6) months from the date of the amended registration.

4] The registrant must follow- up on grower, extension specialis t or consultant reports of unexpected damage or control failures for corn rootworm.

5] The registrant must provide EPA with an annual resistance mon itoring report by August

X Nowatzki, T., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer, and B.D. Siegfried. 2008. Validation of a novel resist ance monitoring technique for corn rootworm (Coleoptera: Chrysomelidae) and event DAS- 59122-7 maize. J. Appl. Entomol. 132:177-188)

20831st of each year, reporting on populati ons collected the previous year.

e. Remedial Action Plans

The following program summary describes, in orde r of events, the steps th at 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 suspect ed if investigations of unexpected damage reports show that:

d. implicated maize plant root s were expressing the mCry3A pr otein at the expected level;

a. alternative causes of dama ge or lodging, such as non-tar get pest insect species, weather, physical damage, larval moveme nt from alternate hosts, planting errors,

and other reasonable causes for the observations, have been ruled out;

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

If resistance is “suspected”, the registrants will instruct affected growers to use alternate pest control measures such as adulticide treatment, crop rotation the following year, or use of soil or seed insecticides the following year. These meas ures are intended to re duce the possibility of potentially resistant insects contributi ng to the following year’s pest population.

2. Confirmation of Resistance : Resistance will be confirmed if all of the following criteria are met by progeny from the target pest species sampled from the area of “suspected resistance”:

a. the proportion of larvae that can feed and survive on mCry3A roots from neonate to adult is significantly higher than the baseline proportion (currently being established);

b. the LC 50 of the test population exceeds the upper limit of the 95% confidence

interval for the LC 50 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 ong oing baseline monitoring program;

c. the ability to survive is heritable;

d. mCry3A plant assays determine that da mage caused by surviving insects would exceed economic thresholds;

e. the identified frequency of field resistance could lead to widespread product failure if subsequent collections in the affected field area(s) demonstr ated 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 agen ts 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;

209e. a long-term resistance management acti on plan will be devised according to the

characteristics of the resistance event and local agronomic needs. [The details of such a plan should be approved by EPA and all appropriate stakeholders.]

f. Insect Resistance Monito ring (Cry1Ab – Corn Borer)

The Agency is imposing the following conditions for this product:

The registrant will monitor for resistance to its lepidopteran-resistant Bt corn. The monitoring program shall consist of two a pproaches: (1) focused population sampling and laboratory testing; and (2) investigation of reports of less-than ex pected control of labeled insects. Should fieldrelevant resistance be confirmed, an appropri ate 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 th e target pests will be focused

in areas identified as those with the highest risk of re sistance development (e.g., where lepidopteran-active Bt hybrids are planted on a high proportion of the co rn acres, and where the insect species are regarded as key pests of corn). Bioassay met hods must be appropriate for the goal of detecting field-relevant shifts in population response to lepidopteran resistant Bt corn and/or changes in resist ance allele frequency in response to the use of Bt corn and, as far as possible, should be consistent ac ross sampling years to enable co mparisons with historical data.

The number of populations to be collected shall reflect the regional im portance of the insect species as a pest, and specific collection region s will be identified for each pest. For ECB, a minimum of 12 populations across the sampling re gion 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 allele s before they become common enough to cause measurable field damage, each population collectio n 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 in sect populations or genomes due to factors such as natural fluctuations in pest density, environmental conditions, and area-wid e pest suppression.

The sampling program and geographic range of co llections may be modi fied 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 sh all be investigated as soon as possible to understand a ny field relevance of such a fi nding. Such investigations shall

210proceed in a stepwise manner until the field relevance can be either confirmed or refuted, and

results of these shall be reported to the Ag ency annually before A ugust 31. The investigative steps will include:

1. Re-test progeny of the co llected population to dete rmine whether the unusual bioassay response is reproducible and he ritable. If it is not reproducible and heritable, no furthe r action is required.

2. If the unusual response is reproducible and heritable, progeny of insects that survive the diagnostic concentrat ion will be tested using met hods 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 freq uency in the original population;

• determining whether the resistance-allel e 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 th e site where the resistance allele(s) was originally collected.

Should field-relevant resist ance 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 lepido pteran pests listed on the pesticide label. The registrant will instruct its custom ers to contact them if such inci dents occur. The registrant will investigate all legitimate reports submitted to the company or the company's representatives.

If reports of unexpected leve ls of damage lead to the suspicion of resistance in any of the key target pests (ECB, SW CB, and CEW), the registrant will implement the actions described below, based on the following definitions of suspected resistance and confirmed resistance.

Suspected resistance

211EPA defines suspected resistance to mean field reports of unexpected levels of insect feeding damage for which:

• the corn in question has been c onfirmed to be lepidopteran-active Bt corn;

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

• the relevant plant tissues are ex pressing the expected level of Bt protein; and

• it has been ruled out th at species not susceptible to the protein could be responsible for the damage, that no climatic or cultural reas ons could be responsible for the damage, and

that that there could be no othe r reasonable causes for the damage.

The Agency does not interpret suspected resistance to mean grower report s of possible control failures or suspicious results fr om annual insect monitoring assa ys, 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 fiel ds 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 pr actices to minimize the possibility of resistant insects over-wintering and contribu ting to the next season's target pest population.

Additionally, if possible, and prior to the app lication of alternative control measures or destruction of crop residue, the re gistrant will collect samples of the insect population in the affected fields for laboratory rearing and testin g. Such rearing and testing shall be conducted as expeditiously as practical.

Confirmed resistance

EPA defines confirmed resistance to mean, in the case of field re ports of unexpected levels of damage from the key target pests, th at all the following criteria are met:

• There is > 30% insect survival and commensurate ins ect 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 th ere may be a resistance allele frequency of ≥ 0.1 in the sampled population.

212• In standardized labora tory bioassays, the LC 50 exceeds the upper limit of the 95%

confidence interval of the LC 50 for susceptible populations su rveyed 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 wi ll be notified about confirmed resistance within 30 days;

• Monitoring will be increased in the affected ar ea 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 availab ility of suitable alternative control measures), alternative control measur es will be employed to reduce or control target pest populations in th e affected area. Alternative control measures may include advising customers and extensi on agents in the affected area to incorporate crop residues into the soil following harvest to minimi ze 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, consulta nts, extension agents , seed distributors, university cooperators and state/ federal authorities as approp riate) in the region of the resistance situation and approved action plan; and

• In subsequent growing seasons, maintain sa les 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 resistan ce management plan is in place to mitigate the resistance.

A report on results of resistan ce monitoring and investigations of damage reports must be submitted to the Agency annually by August 31 st each year for the duration of the conditional registration.

213If these conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA section 6(e). Your re lease for shipment of Cry1Ab corn constitutes acceptance of these conditions.

g. Annual Reporting Requirements

1] Annual Sales: reported and summed by state (county level da ta 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: substant ive changes to education program completed previous year, January 31st each year;

4] Compliance Assurance Plan: Compliance A ssurance Program activities and results, January 31st each year;

5] Compliance: to include annual survey resu lts and plans for the next year; full report January 31st each year;

6] Insect Resistance Monitori ng Results: results of monito ring and investigations of damage reports, August 31st each year.

214

### V. MON89034 BRAD Regist ered Products

Date Registered Date Expired Registrant Registration # Active Ingredients

Monsanto 524-575 Bt corn Event MON 89034 with Cry1A.105 + CryAb2 10-Jun-08 30-Sep-22

1) The subject registration will automatical ly expire on midnight September 30, 2022.

2) The subject registration will be limited to MON 89034 in field or sweet corn. Further, MON 89034 sweet corn may only be sold direc tly to processors or through commercial dealers to large growers. M ON 89034 sweet corn must not be sold to small roadside or home growers.

3) Submit/cite all data required for registrati on of your product under FI FRA § 3(c)(5) when the Agency requires registrants of si milar products to submit such data.

4) This plant-incorporated protectant may be combined through conventional breeding with other registered plant-incor porated protectants that are similarly approved for use in combination, through conventional breeding, w ith other registered plant-incorporated protectants to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits.

5) Submit the following Insect Resistance Manage ment Resistance Monitoring data in the

time frames listed:

6) The Insect Resistance Management (IRM) terms and conditions for this product are as

follows.

The required IRM program for MON 89034 must have the following elements:

• Requirements relating to creation of a non- Bt corn and/or non-le pidopteran resistant Bt corn refuge in conjunction with the plan ting of any acreage of MON 89034 field corn;

• Requirements for Monsanto to prepare a nd require MON 89034 users to sign “grower agreements,” that impose binding contractual ob ligations on the grower to comply with the refuge requirements;

• Requirements regarding programs to edu cate 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 rele vant changes in targ et insect susceptibi lity to Cry1A.105 and Cry2Ab2 proteins in the target insects;

215• Requirements regarding a “remedial action pl an,” that contains measures Monsanto would take in the event that any field relevant insect resistance was detected as well as to report on activity under the plan to EPA;

• Submit annual reports on units sold by state ( units sold by county level will be made available to the Agency upon request), IR M grower agreement results, and the compliance assurance program including the ed ucation program on or before January 31 st
each year, beginning in 2010.

a) Refuge Requirem ents for MON 89034 Field Corn

These refuge requirements do not apply to seed increase/propagatio n of inbred and hybrid seed corn up to a total of 20,000 acres per county and up to a combin ed United States (U.S.) total of 250,000 acres per plant-incorporated protectant (PIP) active ingredie nt 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 co tton-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 stru ctured refuge of at least 5% non- Bt corn and/or non-lepidopteran resistant Bt corn that may be treated w ith insecticides, as detailed below, to control lepidopteran stalk-boring and other pests.

• Refuge planting options include: separate fi elds, blocks within fields (e.g., along the edges or headlands), perimeter st rips, and strips across the field.

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

• When planting the refuge as strips across the fi eld 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 me thods 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-lepidopt eran resistant Bt corn refuges.

2) Cotton-Growing Area Refuge Requirements

For MON 89034 field corn grown in cotto n-growing areas, grower agreements (also known as stewardship agreements) will specify that grow ers must adhere to the refuge requirements as

216described in the grower guide/product use guide and/or in supplements to the grower guide/ product use guide.

• Specifically, growers in these areas must plan t 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 lepidopt eran stalk-boring and other pests.

• Refuge planting options include: separate fiel ds, blocks within fields (e.g., along the edges or headlands), perimeter st rips, and strips across the field.

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

• When planting the refuge as strips across the fi eld 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 me thods 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-lepidopt eran resistant Bt corn refuges.

• Cotton-growing areas include the following stat es: Alabama, Arkansas, Georgia, Florida, Louisiana, North Carolina, Mi ssissippi, South Carolina, Okla homa (only the counties of Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, Washita), Tennessee (only the counties of Ca rroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Hayw ood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), Texa s (except the counties of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, Moor e, 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 sw eet corn. Growers must adhere to the following types of crop destruction requirements as descri bed 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 resi stant insects.

217c) 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 stewar dship 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 a ssure that persons pur chasing 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 wo uld affect either the content of the IRM program or the legal enforceability of the prov isions 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 purchas ing 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 y ear in which the agreement was signed.

7) Beginning on January 31, 2010, and annually ther eafter, 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 th at were sold to persons who have signed grower agreements. The repor t 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 registrati on 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 na mes, 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 comp rehensive, ongoing IRM education program designed to convey to MON 89034 users the importance of complying with the IRM program. The program shall include in formation encouraging MON 89034 users to

218pursue optional elements of the IRM progr am 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 writ ten materials, EPA-re viewed language on IRM requirements on the bag or bag tag, a nd electronic communications such as by Internet, radio, or television co mmercials. Copies of the ma terials will be provided to EPA for its records. The program shall i nvolve at least one written communication annually to each MON 89034 user separate fr om the grower technical guide. The communication shall inform the user of the current IRM requirements. Monsanto shall coordinate its education programs with educa tional 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 th rough 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 fo r the prior year. Annually thereafter, Monsanto must provide EPA any substantive ch anges to its grower education activities as part of the overall IRM compliance assuranc e 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 whic h growers purchasing MON 89034 are complying with the IRM program and that takes such acti ons 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 sh all 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 para graphs 5 – 15 below.

5) Monsanto must establish and publicize a “pha sed compliance approach,” i.e., a guidance document that indicates how they will addr ess instances of non-compliance with the terms of the IRM program and general cr iteria for choosing among options for responding to any non-compliant growers. While recognizing th at for reasons of difference in business practices there are needs for flexibility between different companies, Monsanto must use a consiste nt 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 y ears in a row would be denied sales of Monsanto corn PIP produc ts 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 a ssurance program shall include an annual survey, conducted by an independent third part y, of a statistically representative sample

219of growers of MON 89034 fiel d corn who plant the vast majority of all corn in the

United States and in areas in which the select ion 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 differe nt regions of the country and consider the pot ential impact of non-respon se. The sample size and geographical resolution may be adjusted a nnually, based upon input from independent marketing research firms and academic scientists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasonable sensitivity for comparing results across the United States.

i. A third party is classified as a party ot her than the registrant, the grower, or anyone else with a direct interest in IRM compliance for Bt corn.

6b) MON 89034 Sweet Corn: The IRM complianc e 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 m easure 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 provi de an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potential bi ological significance of any implementation

deviations.

8) The survey shall be designed to obtain grow er feedback on the us efulness of specific

educational tools and initiatives.

9a) MON 89034 Field Corn: Monsanto shall provi de a final written summary of the results of the prior year’s survey (together with a description of the re gions, the methodology used, and the supporting data) to EPA by January 31 st of each year, beginning in 2010.

Monsanto shall confer with other registrants and EPA on th e 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 31 st 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 ex pand 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 s ources. The changes shall address aspects of grower compliance that are not sufficiently high. Monsanto must confer with the Agency prio r to adopting any changes.

22011) 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 requirem ents. 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 legiti mate “tips and complaints” that its growers are not in compliance with the IRM program. Whenever an investigation results in the identification of a grower w ho 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 pl anting, was specifically identified as not being in compliance during the previous year, Monsanto shal l 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 comp liance assurance program for the prior year and the plans for the comp liance assurance program during the current year. The report will include information rega rding grower interactions (including, but not limited to, on-farm visits, verified tips a nd complaints, grower meetings and letters), the extent of non-compliance, corrective m easures to address the non-compliance, and any follow-up actions taken. Monsanto may el ect to coordinate in formation with other registrants and report collectively the results of compliance assurance programs.

15) Monsanto and the seed corn dealers for Mo nsanto must allow a review of the compliance records by EPA or by a State pesticide regu latory agency if the State agency can demonstrate that confidential business information, including the names, personal information, and grower license number of the growers will be protected. 16) The registrant shall revi se and expand its existing Comp liance Assurance Program to include the following elements. The registra nt must prepare and submit by January 31, 2011, a written description of its revised Compliance Assura nce Program. The registrant may coordinate with other registrants in designing and implementing its Compliance Assurance Program.

17) The registrant will enhan ce the refuge education progra m throughout the seed delivery

channel:

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of correct refuge implementation and potenti al consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the ne xt three growing seasons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

22118) The registrant will focus the majority of on-farm assessments on regions with the greatest

risks for resistance:

i. Use Bt corn adoption, pest pressure information, a nd other available information to identify regions where the risk of resistance is greatest;

ii. Focus approximately two-thirds of on-fa rm assessments on these regions, with the remaining assessments conducted across othe r regions where the product is used.

19) The registrant will use its available Bt sales records and other information to refine grower lists for on-farm assessments of th eir compliance with re fuge requirement:

i. Identify for potential on-farm assessment gr owers whose sales information indicates they have purchased the Bt corn product but may have purchas ed little or no refuge seed from the registrant, licensee, or affiliated company.

20] The registrant will contract with thir d parties to perform on-farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all first-time on-farm assessments as well as secondyear on-farm assessments of those grower s found out of compliance in a first-time

assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and leve l of refuge compliance for the product.

22] The registrant will follow up with grower s who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

i. All growers found to be significantly out of co mpliance in a prior year will annually be sent additional refuge assistance in formation for a minimum of two years by the registrant, seed supplier, or third pa rty assessor, after completing the assessment process;

ii. The registrant will conduct follow-up check s on growers found to be significantly out of compliance within three year s after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a fi ve-year period will be denied access to the

Bt corn product in the subsequent year.

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

e) Insect Resistance Monitoring and Remedial Action Plan for MON 89034

The Agency is imposing the followi ng conditions for the Cry1A.105 and Cry2Ab2 toxins expressed in MON 89034:

222Monsanto will monitor for resistance to Cry1A.105 and Cry2Ab2 expressed in MON 89034.

The monitoring program shall consist of two approaches: (1) focuse d population sampling and laboratory testing and (2) investigation of re ports of less-than expect ed control of labeled

insects. Should field relevant resistance be confirmed, an appr opriate resistance management action plan will be implemented.

(1) Focused Population Sampling

Monsanto will develop and ensure the impl ementation of a plan for resistance monitoring for Spodoptera frugiperda (fall armyworm or FAW) in counti es 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 shou ld 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 propose d resistance monitoring plan for EPA’s approval prior to implementation. This proposed FAW monitoring pl an must be submitted to EPA by January 31 st
of the year following that in which M ON 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 pr oposed plan will remain in place until an EPA approved plan can be implemented.

Monsanto shall annually sample a nd 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 resist ance development (e.g., where lepidopteran-active Bt hybrids are planted on a high proportion of the co rn acres, and where the insect species are regarded as ke y pests of corn). Bioassay met hods must be appropriate for the goal of detecting field-relevant shifts in population response to MON 89034 and/or changes in

resistance-allele fr equency in response to the use of M ON 89034 and, as far as possible, should be consistent across sampling years to enable comp arisons with historical data. Each protein in MON 89034 must be tested separately, rather th an a mixture of the two proteins, because resistance to one protei n could be masked by the activity of the other.

The number of populations to be collecte d 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 re gion 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. Pe st populations should be collected from multiple corn-growing states reflective of different ge ographies and agronomic conditions. To obtain sufficient sensitivity to detect resistance allele s before they become common enough to cause measurable field damage, each population collectio n 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, environmenta l conditions, and area-w ide pest suppression.

223The sampling program and geographic range of collections may be m odified 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 31 st of each year, beginning in 2010, the results of the population sampling and bioassay monitoring program.

Any incidence of unusually low sens itivity to the Cry1A.105 a nd 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 st epwise manner until the fiel d relevance can be either confirmed or refuted, an d results of these shall be reported to the Agen cy annually before August

31 st , beginning in 2010. The invest igative steps will include:

1. Re-test progeny of the collect ed population to determine wh ether the unusual bioassay response is reproducible and heri table. If it is not reproduc ible and heritable, no further action is required.

2. If the unusual response is reproducible and heri table, 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 releva nt 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 freq uency in the original population;

• determining whether the resistance-allele frequency is increasi ng 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 th e 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 confir med, and the resistance appears to be increasing or spreading, Monsanto will consult with the Agen cy to develop and implement a case-specific resistance management action plan.

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

224Monsanto 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 l ead to the suspicion of resistance in any of the key target pests (ECB, SWCB, CEW, and FAW), M onsanto 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 unexpect ed levels of insect feeding damage for which:

• the corn in question has been c onfirmed to be lepidopteran-active Bt corn;

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

• the relevant plant tissues are ex pressing 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 clim atic or cultural reasons could be responsible for the damage, and that ther e could be no other re asonable 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 monito ring assays, nor does the Agency

intend that extensive field studies and testing be undertaken to conf irm scientifically the presence

of insects resistant to MON 89034 in commercial production fiel ds before responsive measures

are undertaken.

If resistance is suspected, Monsanto will instruct grow ers 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 fo r local production practices to minimize the possibility of resistant insects ove r-wintering and contributing to the next season’s target pest population.

Additionally, if possible, and prior to the application of alternative control measures or destruction of crop residue, Monsanto will coll ect 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

225EPA defines confirmed resistance to mean, in the case of fiel d 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 us ing diagnostic concentrations of the Bt protein suited to the target pest in questi on, the pest exhibits re sistance that has a genetic basis and the level of survivor ship indicates that there may be a resistance-allele frequency of ≥ 0.1 in the sampled population.

• In standardized laboratory bioassays, the LC 50 exceeds the upper limit of the 95%

confidence interval of the LC 50 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 K ey 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 affect ed area and local target pest populations will be sampled annually to determine th e extent and impact of resistance;

• If appropriate (depending on the resistant pe st species, the extent of resistance, the timing of resistance, and the nature of resistance, and th e availability of suitable alternative control measures), alternativ e 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 in sects, 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 resist ance management action plan within 90 days according to the charac teristics 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

226implementation;

• Notify affected parties (e.g., growers, consultants, extension agents, seed distributors, university coopera tors and state/federal auth orities as a ppropriate) in the region of the resistance situat ion 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 un til an EPA-approved local resistance management plan is in place to mitigate the resistance.

A report on results of resistance monitori ng and investigations of damage reports must be submitted to the Agency annually by August 31 st each year, beginning in 2010, for the duration of the conditional registration.

f) Annual Reporting Requirements for MON 89034

1) Annual Sales: reported and summed by state (county level data available by request), January 31 st 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 pe rsons who have signed grower agreements, January 31 st each year, beginning in 2010.

3) Grower Education: substantive changes to education program completed previous year, January 31 st each year, beginning in 2010.

4) Compliance Assurance Plan: Compliance Assurance Program activities and results, January 31 st each year, beginning in 2010.

5) Compliance Survey Results: to include annual su rvey results and plans for the next year; full report January 31 st each year, beginning in 2010.

6) Insect Resistance Monitoring Results: results of monitoring and investigations of damage reports, August 31 st each year, beginning in 2010.

227Registrant Registration # Active Ingredients Date Registered Date Expired

Monsanto 524-576 Bt corn Event MON 89034 + MON 88017 with Cry1A.105 + Cry2Ab2 + Cry 3Bb1 10-Jun-08 30-Sep-15

1) The subject registration will automatical ly expire on midnight September 30, 2015.

2) The subject registration will be limited to MON 89034 x MON 88017 in field or sweet corn. Further, MON 89034 x MON 88017 sweet corn may only be sold directly to processors or through commercial dealers to large growers. MON 89034 x MON 88017

sweet corn must not be sold to small roadside or home growers.

3) Submit/cite all data required for registrati on of your product under FI FRA § 3(c)(5) when the Agency requires registrants of si milar products to submit such data.

4) This plant-incorporated protectant may be combined through conventional breeding with other registered plant-incor porated protectants that are similarly approved for use in combination, through conventional breeding, w ith other registered plant-incorporated protectants to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits.

5) Submit or cite all data required to support the individual plant-incorpor ated 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 e ffects, 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 t oxicity testing with a carabid (ground beetle), c) long range effects testing on invert ebrate populations in th e field, and d) long range soil persistence testing.

6) Submit the following Insect Resistance Manage ment Resistance Monitoring data in the

time frames listed:

7) The Insect Resistance Management (IRM) te rms and conditions for this product are as

follows.

The required IRM program for MON 89034 x MON 88017 must have the following

elements:

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

Bt corn refuge in conjunction with the planting of any acreage of MON 89034 x MON 88017 field corn;

• Requirements for Monsanto to prepar e and require MON 89034 x MON 88017 users to sign “grower agreements,” that impos e binding contractual obligations on the

228grower to comply with the refuge requirements;

• Requirements regarding programs to edu cate growers about IRM requirements;

• Requirements regarding programs to eval uate and promote growers’ compliance with IRM requirements;

• Requirements regarding programs to eval uate whether there are statistically significant and biologi cally relevant changes in targ et insect susceptibility to Cry1A.105, Cry2Ab2, and Cry3Bb1 protei ns in the target insects;

• Requirements regarding a “remedial action pl an,” that contains measures Monsanto would take in the event that any field relevant insect resistance was detected as well as to report on activity under the plan to EPA;

• Submit annual reports on units sold by state (units sold by county level will be made available to the Agency upon request), IR M grower agreement results, and the compliance assurance program including the education program on or before January 31 st 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/propagatio n of inbred and hybrid seed corn up to a total of 20,000 acres per county and up to a combin ed United States (U.S.) total of 250,000 acres per plant-incorporated protectant (PIP) active ingredie nt per registrant per year. Furthermore, these refuge requirements do not apply to commercial hybrid sweet corn.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

1) Corn-Belt Refuge Requirements

For MON 89034 x MON 88017 field corn grown outside cotton-growing areas (e.g., the Corn Belt), grower agreements (also known as st ewardship agreements) w ill specify that growers must adhere to the refuge requirements as de scribed in the grower guide/product use guide and/or in supplements to the grower guide/produ ct use guide. Two options for the deployment of the refuge are available to growers.

The first option is planting a common refu ge 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 repres ent at least 20% of the grower’s corn acres (i.e. sum of MON 89034 x MON 88017 acres and refuge ac res). 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 impl emented, the strips must be at least 4 consecutive rows wide. The common refuge may be treated w ith a soil-applied or seed-applied insecticide to control rootworm larvae and other soil pests. The refuge may also be treated with a non- Bt foliar

229insecticide 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, th en the MON 89034 x MON

88017 field must be treated in a similar manner.

The second option is planting separate ref uge 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-f ield strips. If perimeter or in -field strips are implemented, the strips must be at least 4 consecutive rows wide. The corn borer refuge may be treated with a soil-applied or seed-applied insecticide for corn rootworm larval control or a non- Btfoliarapplied insecticide for corn borer control if pest pressure reaches an economic threshold for damage (determined using methods recommended by local or regional profe ssionals). The corn rootworm refuge must be planted with a non- Bt /corn rootworm-protect ed hybrid but may be planted with Bt corn hybrids that control corn borers. The corn rootworm refuge must represent at least 20% of the grower’s corn acres (i .e. sum of MON 89034 x MON 88017 acres and corn rootworm refuge acres) and must be planted as an adjacent block, perimeter strips, or in-field strips. If perimeter or in-field strips are impl emented, the strips must be at least 4 consecutive rows wide. The corn rootworm refuge may be treated with a soil-applied or seed- applied

insecticide to control rootworm la rvae and other soil pests. The re fuge may also be treated with

a non- Bt foliar insecticide for control of late seas on pests; however, if rootworm adults are present at the time of folia r applications, then the MON 89034 x MON 88017 field must be

treated in a similar manner.

Growers who fail to comply with the IR M 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, Mi ssissippi, South Carolina, Ok lahoma (only the counties of Beckham, Caddo, Comanche, Cust er, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, Washita), Tennessee (only the counties of Carroll, Chester, Crockett, Dyer, Faye tte, Franklin, Gibson, Hardeman, Hardin, Haywood, Lake, Lauderdale, Li ncoln, Madison, Obion, Rutherford, Shelby, and Tipton), Texas (except the counties of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, Moore, Ochiltree, Robe rts, and Sherman), Virginia (only the counties of Dinwiddie, Franklin City, Greensville, Isle of Wight, Northampton, Southampton, Suffolk City, Surrey, Sussex), and Missouri (only the counties of Dunkin, New Madrid, Pemiscot, Scott, and Stoddard).

Two options for the deployment of the refuge are available to growers.

230The first option is planting a common refu ge 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 repres ent at least 20% of the grower’s corn acres (i.e. sum of MON 89034 x MON 88017 acres and refuge acr es). 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 impl emented, the strips must be at least 4 consecutive rows wide. The common refuge may be treated w ith a soil-applied or seed-applied insecticide to control rootworm larvae and other soil pests. The refuge may also be treated with a non- Bt foliar

insecticide for control of late season pests if pest pressure reaches an economic threshold for damage (determined using methods recommended by local or regional professionals); however, if rootworm adults are present at the time of foliar applications, th en the MON 89034 x MON

88017 field must be treated in a similar manner.

The second option is planting separate ref uge 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 fiel ds (e.g., along the edges or headlands), perimeter strips, or in-f ield strips. If perimeter or in -field strips are implemented, the strips must be at least 4 consecutive rows wide. The corn borer refuge may be treated with a soil- applied or seed-applied insecticide for corn rootworm larval control or a non- Btfoliarapplied insecticide for corn bore r control if pest pressure re aches an economic threshold for damage (determined using methods recommended by local or regional profe ssionals). The corn rootworm refuge must be planted with a non- Bt /corn rootworm-protect ed hybrid but may be planted with Bt corn hybrids that control corn borers. The corn rootworm refuge must represent at least 20% of the grower’s corn acres (i .e. sum of MON 89034 x MON 88017 acres and corn rootworm refuge acres) and must be planted as an adjacent block, perimeter strips, or in-field strips. If perimeter or in-field strips are impl emented, the strips must be at least 4 consecutive rows wide. The corn rootworm refuge may be treated with a soil-applied or seed-applied

insecticide to control rootworm la rvae and other soil pests. The re fuge may also be treated with

a non- Bt foliar insecticide for control of late seas on pests; however, if rootworm adults are present at the time of foliar appl ications then the MON 89034 x M ON 88017 field must be

treated in a similar manner.

Growers who fail to comply with the IR M requirements risk losing access to Monsanto corn PIP products.

b) Post-Harvest Requirements fo r MON 89034 x MON 88017 Sweet Corn

Sweet corn is harvested long befo re 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 sw eet corn. Growers must adhere to the following types of crop destruction requirements as descri bed in the grower guide/product use guide and/or in supplements to the grower guide/product use guide.

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

231• The allowed crop destruction methods are: rotary mowing, disc ing, or plow down. Crop destruction methods should destr oy 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 purch ase contract, license agreement, or similar legal document.

2) The grower agreement and/or speci fic stewardship documents re ferenced 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 ar e 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 wo uld affect either the content of the IRM program or the legal enforceability of the prov isions 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 purch asing 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 31s t of the year in which the agreement was signed.

7) Beginning on January 31, 2010, and annually thereafter, Mons anto shall provide EPA with a report showing the number of un its 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 th rough July. Note: The first report shall contain the specified information from th e 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 pestic ide regulatory agency if the State agency can demonstrate

232that confidential business information, in cluding 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 progr am shall include information encouraging MON 89034 x MON 88017 users to pursue opti onal elements of the IRM program relating to refuge configuration and proxi mity 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 comm unications such as by Inte rnet, radio, or television commercials. Copies of the materials will be provided to EPA fo r its records. The program shall involve at least one writte n communication annually to each MON 89034 x MON 88017 user separate from the grower technical guide. Th e communication shall inform the user of the current IRM require ments. Monsanto shall coordinate its education programs with educational efforts of other registrants a nd other organizations,

such as the National Corn Growers Asso ciation 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 complia nce survey required under paragraphs 6a or 6b and from other sources. The changes shal l 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 educati on program for the prior y ear. Annually thereafter, Monsanto must provide EPA any substantive ch anges to its grower e ducation activities as part of the overall IRM compliance assuranc e 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 wh ich growers purchasin g MON 89034 x MON 88017 are complying with the IRM program and th at 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 featur es of the program are described in paragraphs 5 – 15 below.

5) Monsanto must establish and publicize a “pha sed compliance approach,” i.e., a guidance document that indicates how they will addr ess instances of non-compliance with the terms of the IRM program and general cr iteria 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

233companies, Monsanto must use a consiste nt set of standards for responding to noncompliance. The options shall include wit hdrawal 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 produc ts 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, c onducted by an independent thir d 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 comp liance with the IRM program by growers in different regions of the count ry and consider th e potential impact of non-response. The sample size and geographical resolution may be adjusted annually, based upon input from independent marketing research firms and ac ademic scientists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasonable sensitivity for comparing results across the United States.

i. A third party is classified as a party ot her than the registrant, the grower, or anyone else with a direct interest in IRM compliance for Bt corn.

6b) MON 89034 x MON 88017 Sweet Corn: The IR M 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 co rn acres covered by the responses), and consider the potential impact of non-re sponse. An independe nt 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 provi de an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potential bi ological significance of any implementation

deviations.

8) The survey shall be designed to obtain gr ower feedback on the usefulness of specific

educational tools and initiatives.

9a) MON 89034 x MON 88017 Field Corn: Monsanto shall provide a fi nal written summary of the results of the prior year’s survey (t ogether with a description of the regions, the methodology used, and the supporting data) to EPA by January 31 st of each year, beginning in 2010. Monsanto shall confer w ith other registrants and EPA on the design and content of the survey prior to its implementation.

2349b) MON 89034 x MON 88017 Sweet Corn: Monsan to shall provide a written summary of the results of the prior yea r’s survey (together with a description of the methodology used and the supporting data) to EPA by January 31 st 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 ex pand as necessary, its compliance assurance program to take into account the information collected through th e 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 prio r to adopting any changes.

11) Monsanto shall conduct an annual on-farm assessment program. Monsanto shall train its representatives who make on-farm vi sits 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 a ny of these visits result in the identification of a grower who is not in compliance with the IRM program, M onsanto shall take appropriate action, consistent with its “ phased compliance approach,” to promote compliance.

12) Monsanto shall carry out a program for i nvestigating 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 appropria te 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 th e 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 in formation regarding grower interactions (including, but not limited t o, on-farm visits, verified tips and complaints, grower meetings and letters), the exte nt of non- compliance, Correct ive 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 pe sticide regulatory agency if the State agency can demonstrate that confidential business information, including the names, personal information, and grower license num ber of the growers will be protected.

23516] The registrant shall revi se and expand its existing Comp liance Assurance Program to include the following elements. The registra nt must prepare and submit by January 31, 2011, a written description of its revi sed Compliance Assurance Program. The registrant may coordinate with other registrants in designing and implementing its Compliance Assurance Program.

17] The registrant will enhan ce the refuge education progra m throughout the seed delivery

channel:

i. Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of correct refuge implementation and potenti al consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the next three grow ing seasons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

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

risks for resistance:

i. Use Bt corn adoption, pest pressure information, a nd other available information to identify regions where the risk of resistance is greatest;

ii. Focus approximately two-thirds of on-fa rm assessments on these regions, with the remaining assessments conducted across othe r regions where the product is used.

19] The registrant will use its available Bt sales records and other information to refine grower lists for on-farm assessments of th eir compliance with re fuge requirement:

i. Identify for potential on-farm assessment gr owers whose sales information indicates they have purchased the Bt corn product but may have purchas ed little or no refuge seed from the registrant, licensee, or affiliated company.

20] The registrant will contract with thir d parties to perform on-farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all first-time on-farm assessments as well as secondyear on-farm assessments of those grower s found out of complianc e in a first-time

assessment

21] The registrant will annually refine the on-farm assessment program for the Bt corn product to reflect the adoption rate and leve l of refuge compliance for the product.

22] The registrant will follow up with grower s who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

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

236additional refuge assistance information for a minimum of two years by the registrant, seed supplier, or third pa rty assessor, after completing the assessment process;

ii. The registrant will conduct follow-up check s on growers found to be significantly out of compliance within three year s after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a five-year period will be denied access to

the Bt corn product in the subsequent year.

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

e) Insect Resistance Monitoring and Re medial Action Plan s for MON 89034 x MON

88017

(1) The Agency is imposing the following c onditions for the Cry1A.105 and Cry2Ab2 toxins expressed in MON 89034:

Monsanto will monitor for resistan ce 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 tes ting and (2) investigation of reports of lessthan expected control of labeled insects. Sh ould field relevant resistance be confirmed, an appropriate resistance management action plan will be implemented.

(a) Focused Population Sampling

Monsanto will develop and ensure the impl ementation of a plan for resistance monitoring for Spodoptera frugiperda (fall armyworm or FAW) in coun ties 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 shou ld 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 propose d resistance monitoring plan for EPA’s approval prior to implementation. This proposed FAW monitoring pl an must be submitted to EPA by January 31 st
of the year following that in which M ON 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 pr oposed plan will remain in place until an EPA approved plan can be implemented.

Monsanto shall annually sample a nd 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 resist ance development (e.g., where lepidopteran-active Bt hybrids are planted on a high proportion of the co rn acres, and where the insect species are regarded as ke y pests of corn). Bioassay met hods 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 frequenc y in response to the use of MON 89034 x MON

23788017 and, as far as possible, shoul d be consistent across sampling years to enable comparisons with historical data. Each prot ein in MON 89034 must be tested se parately, 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 collecte d 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 regi on 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. Pe st populations should be collected from multiple corn-growing states reflective of different ge ographies and agronomic conditions. To obtain sufficient sensitivity to detect resistance allele s before they become common enough to cause measurable field damage, each population collectio n 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, environmenta l conditions, and area-w ide pest suppression.

The sampling program and geographic range of collections may be m odified 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 31 st of each year, beginning in 2010, the results of the population sampling and bioassay monitoring program.

Any incidence of unusually low sens itivity to the Cry1A.105 a nd 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 31 st , beginning in 2010. The inves tigative steps will include:

1. Re-test progeny of the collect ed population to determine wh ether the unusual bioassay response is reproducible and heri table. If it is not reproduc ible and heritable, no further action is required.

2. If the unusual response is reproducible and heri table, 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 freq uency in the original population;

238• determining whether the resistance-allele frequency is increasi ng 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 site s surrounding the site where the resistance allele(s) was originally collected.

Should field relevant resistance be confir med, and the resistance appears to be increasing or spreading, Monsanto will consult with the Agen cy to develop and implement a case-specific resistance management action plan.

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

Monsanto will follow up on grower, extension specialist or consultant reports of unexpected levels of damage by the lepidopteran pests listed on the pesticide label. Monsanto will instruct

its customers to contact them if such incidents occur. Monsanto will investigate all legitimate reports submitted to the company or the company's representatives.

If reports of unexpected levels of damage l ead to the suspicion of resistance in any of the key target pests (ECB, SWCB, CEW, and FAW), M onsanto 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 unexpect ed levels of insect feeding damage for which:

• the corn in question has been c onfirmed to be lepidopteran-active Bt corn;

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

• the relevant plant tissues are ex pressing 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 clim atic or cultural reasons could be responsible for the damage, and that ther e could be no other re asonable 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 monito ring assays, nor does the Agency

intend that extensive field studies and testin g 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 grow ers to do the following:

239• 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 880 17 crop residues in the affected region within

one month after harvest with a tech nique appropriate for local production practices to minimize the possibility of resistant insects over-wintering and contributing to the next s eason’s target pest population.

Additionally, if possible, and prior to the application of alternative control measures or destruction of crop residue, Monsanto will coll ect 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 fiel d 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 us ing diagnostic concentrations of the Bt protein suited to the target pest in questi on, the pest exhibits re sistance that has a genetic basis and the level of survivor ship indicates that there may be a resistance-allele frequency of ≥ 0.1 in the sampled population.

• In standardized laboratory bioassays, the LC 50 exceeds the upper limit of the 95%

confidence interval of the LC 50 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 agen ts 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 th e extent and impact of resistance;

• If appropriate (depending on the resistant pe st species, the extent of resistance, the

240timing 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. Altern ative 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 insect s, 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 characteristic s of the resistance event and local agronomic needs. Monsanto will consult with appropriate stakeholders in the development of the action plan, and the de tails of such a plan shall be approved by EPA prior to implementation;

• Notify affected parties (e.g., growers, consultants, extension agents, seed distributors, university coope rators and state/federal authorities as appropriate) in the region of the resistance situati on and approved action plan; and

• In subsequent growing seasons, main tain 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 monitori ng and investigations of damage reports must be submitted to the Agency annually by August 31 st each year, beginning in 2010, for the duration of the conditional registration.

(2) The Agency is imposing the following co nditions for the Cry3Bb1 toxin expressed in

MON 88017:

i) Monsanto must monitor for Cry3Bb1 resi stance 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 resist ance development.

ii) Monsanto must develop and validate an appropriate discriminating or diagnostic dose assay by January 31, 2010.

iii) Monsanto must finalize rootworm da mage guidelines and submit these to EPA by January 31, 2010.

iv) Monsanto must follow-up on grower, exte nsion specialist or consultant reports of unexpected damage or contro l failures for corn rootworm.

241v) Monsanto must provide EPA with an annua l resistance monitoring report by August 31 st
each year, beginning with 2010, reporting on pop ulations collected the previous year.

vi) The current remedial action plan approved for MON 863 must be used for corn rootworm suspected and confirmed re sistance in MON 89034 x MON 88017. If corn rootworm resistance is confirmed, all acres of MON 89034 x MON 88017 a nd refuges must be treated with insecticides targeted at co rn rootworm adults as well as larvae.

f) Annual Reporting Requirements for Mon 89034 x MON 88017

1) Annual Sales: reported and summed by state (county level data available by request), January 31 st 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 31 st each year, beginning in 2010;

3) Grower Education: substantive changes to education program completed previous year, January 31 st each year, beginning in 2010;

4) Compliance Assurance Plan: Compliance Assurance Program activities and results, January 31 st each year, beginning in 2010;

5) Compliance Survey Results: to include annual su rvey results and plans for the next year; full report January 31 st each year, beginning in 2010;

6) Insect Resistance Monitoring Results: results of monitoring and inves tigations of damage reports, August 31 st each year, beginning in 2010.

242VI. 

### OAM BRAD Registered Products

Registrant Registration # Active Ingredients Date Registered Date Expired

Pioneer/Dupont 29964-6 Optimum AcreMax 1 (OAM 1) Seed Blend of Herculex

Xtra + Herculex I 30-Apr-10 30-Sep-12

1] The subject registration will automa tically expire on midnight September 30, 2012.

2] The subject registration will be limited to a seed mix of TC1507 (Cry1F) xDAS-59122-7 (Cry34Ab1/Cry35Ab1) corn seed blended with not less than 10% TC1507 (Cry1F) corn seed.

3] Submit/cite all data required for registration of your product under FIFRA § 3(c)(5) when the Agency requires registrants of si milar 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 register ed plant-incorporated protectants to produce inbred corn lines and hybrid corn varie ties with combined pesticidal traits.

5] In light of recently published laboratory st udies showing reduced growth in shredding caddis flies exposed to anti-lepidopteran Cry1A protei n corn litter (Rosi-Marshall, et al. 2007), additional aquatic invertebrate da ta are required. A 7 to 14 day Daphnia magna study as per the 885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, representing the functional group of a leaf shre dder in headwater streams must be submitted by January 31, 2012.

6] Submit the following data in the timeframes listed:

Study Type Required Data Due Date

Insect Resistance Management Pioneer must provide the Agency with a copy of the grower agreement, associated stewardship documents, and written description of a system, which assures that growers will sign grower agreements and persons purchasing OAM1 corn will annually affirm that they are contractually bound to comply with requirements of the insect resistance management (IRM) program. 90 days from

the date of registration

Insect Resistance Management Pioneer must implement an enhanced resistance monitoring plan for OAM1. Pioneer must provide the Agency with a baseline (benchmark) study that shows the susceptibility of western corn rootworm populations (WCRW) in the Sublethal S eedling Assay prior to the large-scale introduction of OAM1. Although northern corn rootworm (NCRW) is di fficult to rear, Pioneer must 12/1/2010 for

WCRW

12/1/11 for

NCRW

243attempt to obtain benchmark susceptibility data using the Sublethal Seedling Assa y for NCRW as well.

Insect Resistance Management Pioneer must submit a detailed OAM1-specific resistance monitoring and remedial action plan, including an analysis to determine the expected field performance criteria for OAM1 products so that unexpected damage

can be benchmarked. Pioneer will update the plan by 12/1/2012, if needed, based on continued field evaluation of OAM1 performance. 12/1/2010

6] Pioneer must commit to implement the following Insect Resistance Management Program:

The required IRM program for OAM1 corn must have the following elements:

Requirements relating to creation of a lepidopteran refuge (cons isting of corn that does not contain any Bt trait for lepidopteran contro l) in conjunction with the planting of any acreage of OAM1 corn;

Requirements for Pioneer to prepare and require OAM1 users to sign “grower agreements,” that impose binding contractual obligatio n on the grower to comply with the refuge requirements;

Requirements regarding programs to edu cate growers about IRM requirements;

Requirements regarding programs to evaluate and promote growers’ compliance with IRM requirements;

Requirements regarding programs to evaluate wh ether there are statistically significant and biologically relevant changes in target insect susceptibility to Cry1F and Cry34Ab1/Cry35Ab1 proteins in the target insects;

Requirements regarding a “remedial action plan,” that contains measures Pioneer would take in the event that any field-relevant insect resistan ce was detected as well as to report on activity under the plan to EPA;

Annual reports on units sold by stat e (units sold by county level wi ll be made available to the Agency upon request), IRM grower agreements re sults, and the complia nce assurance program including the educational program on or before January 31 st 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 co rn hybrids that do not contain Bt technologies fo r the control of corn borers. Refuge options ar e based on the planting of OAM1 in cotton or non-cotton growing regions and insect pressure present in those lo cations. 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 acr es of OAM1) or 20% in non-cotton growing

244regions ( 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 op tions 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 Al abama, Arkansas, Georgia, Florid a, Louisiana, North Carolina, Mississippi, South Carolina, Oklahoma(only the counties of Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, T illman, Washita), Tennessee (only the counties of Carroll, Chester, Crockett, Dyer, Fayett e, Franklin, Gibson, Hardeman, Hardin, Haywood, Lake, Lauderdale, Lincoln, Madison, Obion, Ruth erford, Shelby, and Tipt on), Texas (except the counties of Carson, Dallam, Hansford, Hartle y, 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 ro ws 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 exce eds economic thresholds. Economic thresholds will be determined using methods recommende d by local or regional professionals (e.g., Extension Service agents, crop consultants).

These refuge requirements do not apply to seed pr opagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

When on-farm assessments identify non-compliance with refuge requirements for one or more Bt corn products, additional educational material and assistance are provided by the registrant to help these growers meet the refuge re quirements across their farming operations.

b) Grower Agreement for OAM1 Corn

1. Persons purchasing OAM1 corn must sign a grower agreement. The term “grower agreement” refers to any grower purchase contract, license agreement, or similar legal document.

2. The grower agreement and/or specific st ewardship documents referenced in the grower agreement must clea rly 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 equiva lent 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 re quirements of the IRM program. A description of the system must be submitte d 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 regist ration, a copy of that agreement and any specific

245stewardship documents referenced in the grower agreement. If Pioneer wishes to change any part of the grower agreemen t 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 pr ior 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 31 st of the year in which the agreement was signed.

6. Beginning on January 31, 2011, and annually thereafter, Pioneer shall provide EPA with a report on the number of units of OAM1 corn seed shipped and not returned, and the number of su ch 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 cont ain the specified information from the time frame starting with the date of re gistration 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 regu latory 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 pr ogram 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 fo r their records. The program shall

involve at least one written communicat ion annually to each OAM1 corn user separate from the grower technical gui de. The communication shall inform the user of the current IRM requirements and specifically the need to plant a lepidopteran refuge. Pioneer shall coor dinate its education program with the educational efforts of other registrant s and other organizations, such as the

National Corn Growers Associati on and state extension programs.

2. Pioneer must design and immediately implemen t a “bag tag” that will be attached to all bags of OAM1 seed sold and delivered for the 2011 growing season and annually thereafter. The purpose of this bag tag is to remind growers that OAM1 products require a separate 20% lepi dopteran refuge, and a 50% refuge requirement in cotton-growing areas.

3. Pioneer must conduct targeted, on-farm compliance assessments for growers who purchase OAM1 seed to ensure growers are compliant with the requirement of a

24620% refuge for lepidopteran pests. For the 2010 growing season, Pioneer must

conduct at least 500 on-farm assessmen ts or roughly half the number of

assessments that Pioneer will contri bute to the 2010 Agricultural Biotechnology Stewardship Technical Committee (ABS TC) compliance assurance program

assessment for corn borer and stacked products. Beginning in 2011 and annually thereafter, Pioneer will cont ract with an independent third party to conduct these compliance assessments and target twice the number of on-farm assessments for OAM1 as Pioneer conducts for corn borer and stacked products on an annual

basis. The table below reflects the rela tive number of on-farm assessments for

OAM1 based on Pioneer’s contribution to the ABSTC compliance assurance program report and is subject to ch ange with time as appropriate.

i. A third party is classified as a part y other than the registrant, the grower, or anyone else with a direct in terest in IRM compliance for Bt corn.

Number of on-farm assessments conducted by Pioneer

Products Year: 2010 Year: 2011, annually

thereafter

Corn Borer and Stacked

Products 1000 1000

OAM1 500 2000

Total 1500 3000

Pioneer must provide a report to EPA su mmarizing the OAM1 compliance assurance program activities and results for the prio r year and plans for the OAM1 compliance assurance program for the current year, by January 31, 2011, and annually thereafter.

4. Annually, Pioneer shall revise, and expand as necessary, its education program to

take into account the information colle cted through the compliance survey and from other sources. The changes shall address aspects of grower compliance that are not sufficiently high.

5. Beginning January 31, 2011, Pioneer must provide a report to EPA summarizing

the activities it ca rried out under its education pr ogram 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 subm it a separate report or contribute to the report from the industry working group, ABSTC.oh

6. The registrant shall revise and expand its existing Compliance Assurance Program to include the following elements. The registrant must prepare and submit by January 31, 2011, a written description of its revised Compliance Assurance

247Program. The registrant may coordinate w ith other registrants in designing and implementing its Compliance Assurance Program.

7. The registrant will enha nce the refuge education program throughout the seed delivery channel:

i. Ensure sales representatives, licensees , seed dealers, and growers recognize the importance of correct refuge implemen tation and potential consequences of failure to plant the required refuge;

ii. Include the refuge size requirement on all Bt corn seed bags or bag tags. This requirement may be phased in over the next three growing seasons, with 50% implementation in 2012 and full implementation for the 2013 growing season.

8. The registrant will focus the majority of on-farm assessments on regions with the greatest risks for resistance:

i. Use Bt corn adoption, pest pressure informa tion, and other available information to identify regions where the risk of resistance is greatest;

ii. Focus approximately two-th irds of on-farm assessments on these regions, with the remaining assessments conducted across othe r regions where the product is used.

9. The registrant will use its available Bt sales records and other information to refine grower lists for on-farm assessments of th eir compliance with re fuge requirement:

i. Identify for potential on-farm assessment growers whose sales information indicates they have purchased the Bt corn product but may have purchased little or no refuge seed from the registrant, licensee, or affiliated company.

10. The registrant will contract with third parties to perform on-farm assessments of compliance with refuge requirements:

i. The third-party assessors will conduct all first-time on-farm assessments as well as second-year on-farm assessments of thos e growers found out of compliance in a

first-time assessment

11. The registrant will a nnually refine the on-farm a ssessment program for the Bt corn product to reflect the adoption rate and level of refuge compliance for the product.

12. The registrant will follow up with grow ers who have been found significantly out of compliance under the on-farm assessment program and are found to be back in compliance the following year:

i. All growers found to be significantly out of compliance in a prior year will annually be sent additional refuge assistance in formation for a minimum of two years by the registrant, seed supplier, or thir d party assessor, af ter completing the

248assessment process;

ii. The registrant will conduct follow-up ch ecks on growers found to be significantly out of compliance within three years after they are found to be back in compliance;

iii. A grower found with a second incident of significant non-compliance with refuge requirements for the Bt corn product within a five -year period will be denied

access to the Bt corn product in the subsequent year.

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

d) Insect Resistance Monitoring and Remedial Action Plan for OAM1 Corn

The Agency is imposing the following c onditions for this lepidopteran toxin:

The registrant will monitor for resistance to its lepidopteran-resistant Bt corn. The monitoring program shall consist of two a pproaches: (1) focused population sampling and laboratory testing; and (2) investigation of reports of less-than ex pected control of labeled insects. Should fieldrelevant resistance be confirmed, an appropri ate resistance management action plan will be implemented.

(1) Focused Population Sampling

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

nubilalis (European corn borer; ECB), Diatraea grandiosella (Southwestern corn borer; S WCB), and Helicoverpa zea (corn earworm; CE W). Sampling fo r the target pests will be

focused in areas identified as those with the hi ghest risk of resistance development (e.g., where lepidopteran-active Bt hybrids are planted on a high proportion of the co rn acres, and where the insect species are regarded as key pests of corn). Bioassay met hods must be appropriate for the goal of detecting field-relevant shifts in population response to lepidopteran resistant Bt corn and/or changes in resist ance allele frequency in response to the use of Bt corn and, as far as possible, should be consistent ac ross sampling years to enable co mparisons with historical data.

The number of populations to be collected shall reflect the regional im portance of the insect species as a pest, and specific collection region s will be identified for each pest. For ECB, a minimum of 12 populations across the sampling re gion 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 allele s before they become common enough to cause measurable field damage, each population collectio n 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 in sect populations or genomes due to factors such as natural fluctuations in pest density, environmental conditions, and area-wid e pest suppression.

249The sampling program and geographic range of co llections may be modi fied 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 sh all be investigated as soon as possible to understand a ny field relevance of such a fi nding. 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 Ag ency annually before A ugust 31. The investigative steps will include:

1. Re-test progeny of the collected population to determine whether the unusual bioassay response is reproducible and herita ble. If it is not reproducible a nd heritable, no further action is required.

2. If the unusual response is re producible and heritable, proge ny of insects that survive the diagnostic concentration will be tested using me thods that are representative of exposure to Bt corn hybrids under field conditions. If progeny do not survive to ad ulthood, any suspected

resistance is not fiel d relevant and no furthe r 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 freq uency in the original population;

• determining whether the resistance-allele Fr equency 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 th e 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 Ag ency to develop and implement a case-specific resistance management action plan.

(2) Investigation of Reports of Unexpect ed Levels of Damage by the Target

Pests:

The registrant will follow up on gr ower, extension specialist or c onsultant reports of unexpected levels of damage by the lepidopteran pests list ed on the pesticide label. The registrant will

250instruct its customers to contact them if such in cidents occur. The registra nt will investigate all legitimate reports submitted to the comp any 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 registra nt 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 unexpect ed levels of insect feeding damage for which:

• the corn in question has been c onfirmed to be lepidopteran-active Bt corn;

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

• the relevant plant tissues are ex pressing the expected level of Bt protein; and

• it has been ruled out th at species not susceptible to the protein could be responsible for the damage, that no climatic or cultural reas ons could be responsible for the damage, and

that that there could be no othe r reasonable causes for the damage.

The Agency does not interpret suspected resistance to mean grower report s of possible control failures or suspicious results fr om annual insect monitoring assa ys, 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 fiel ds 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 pr actices to minimize the possibility of resistant insects over-wintering and contribu ting to the next season's target pest population.

Additionally, if possible, and prior to the app lication of alternative control measures or destruction of crop residue, the re gistrant will collect samples of the insect population in the affected fields for laboratory rearing and testin g. Such rearing and testing shall be conducted as expeditiously as practical.

Confirmed resistance

EPA defines confirmed resistance to mean, in the case of field re ports of unexpected levels of damage from the key target pests, th at all the following criteria are met:

251• There is > 30% insect survival and commensurate ins ect 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 th ere may be a resistance allele frequency of ≥ 0.1 in the sampled population.

• In standardized labora tory bioassays, the LC 50 exceeds the upper limit of the 95%

confidence interval of the LC 50 for susceptible populations su rveyed both in the original baselines developed for this pest species and in previous years of field monitoring.

(3) Response to Confirmed Resistance in a Ke y 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 wi ll be notified about confirmed resistance within 30 days;

• Monitoring will be increased in the affected ar ea 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 availab ility of suitable alternative control measures), alternative control measur es will be employed to reduce or control target pest populations in th e affected area. Alternative control measures may include advising customers and extensi on agents in the affected area to incorporate crop residues into the soil following harvest to minimi ze 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, consulta nts, extension agents , seed distributors, university cooperators and state/ federal authorities as approp riate) in the region of the resistance situation and approved action plan; and

252• In subsequent growing seasons, maintain sa les 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 resistan ce management plan is in place to mitigate the resistance.

A report on results of resistan ce monitoring and investigations of damage reports must be submitted to the Agency annually by August 31 st each year for the duration of the conditional registration.

The Agency is imposing the following c onditions for this corn rootworm toxin

In addition to the existing two- pronged approach to insect re sistance monitoring (monitoring insect populations using the diet bi oassay and investigations of fiel d 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 mon itoring using the Sublethal Seedling Assay as a complement to the diet bi oassay 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 chan ges in target pest susceptibility that will lead to increased injury potential in west ern and northern corn rootworm feeding on the rootworm component of OAM1 pr oducts. 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 approva l 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 s hould 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, detec tion level, etc.). Pioneer must bioassay a target of 3000 larvae on 59122 plants for each population.

• A description of how monito ring results relate to and are predictive of changes in field efficacy, and change in inju ry potential to DAS-59122-7 constituting product failure and development of a remedial action plan.

3. Pioneer will provide the EPA with an a nnual OAM1 resistance monitoring report by August 31 st of each year beginning with 2011 for western corn rootworm and 2012 for northern corn rootworm, reporting on populat ions collected the previous year. In addition to screening of wide-area corn rootworm populations as outlined above, for the second prong of resistance monitoring Pion eer must investigate grower, extension

253specialist or consultant reports of less-than -expected efficacy or field performance of OAM1 products.

e) Remedial Action Plan for Co rn Rootworm and OAM1 Corn

The remedial action plan is designed as a tie red approach for mitigating western and northern corn rootworm resistance development specificall y due to the commercialization of OAM1 corn. The following program summary describes, in order of events, the steps th at must be taken to implement a remedial action plan if resi stance to target pests is confirmed.

Pioneer will complete a benchmar k study of susceptibi lity 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 ac tion plan by December 1, 2010, so that decision points regarding crop damage and target pest re sistance are established, and a remedial action plan can be initiated when needed. Although northe rn corn rootworm is di fficult 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 th e Sublethal Seedling Assay show that:

• Injury potential of a target pest populati on obtained as part of the annual insect monitoring program has increased to a leve l representative of product failure in field conditions;

• The seeds used in the investigation of this population’s inju ry 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 ad ulticide treatment and/or crop ro tation or use of soil or seedapplied insecticides at rates providing corn rootworm control the following year. These measures are intended to educate growers of th e potential for change in efficacy, reduce the possibility of grower loss from change in e fficacy and reduce potentially resistant insects contributing to the following year's pest population.

2. Confirmed Resistance from Population Monitoring

Definition of Confirmed Resistance - Resistance w ill be confirmed if all of the following criteria are met by progeny from a subsequent rootwo rm 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;

254• 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 th e area suggests that the change is spreading.

3. Suspected Resistance – Invest igation of Field Reports

The registrant will follow up on gr ower, extension specialist or c onsultant 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 inci dents occur. The registra nts 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 th e 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 re sponsible for the damage, and that all other reasonable cau ses based on historical experience for the observed root damage have been ruled out;

• If not due to other reasons, the registrant will conduct a th orough investigation

of the factors known to affect the mani festation 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. Th ese measures are intended to educate growers of the potential for change in efficacy, reduce the possi bility of grower loss from change in efficacy and reduce potentially resistant insects contri buting to the following year's pest population.

Pioneer will collect insects as s oon as possible from the area for laboratory studies to test for resistance by comparing with benchmark suscep tibility data. These studies will be performed following the same laboratory protocols as used for the benchmark determination and monitoring

programs.

4. Confirmed Resistance – Invest igation of Field Reports

• Injury potential of the fi eld-collected rootworm population feeding on plants containing DAS-59122-7 remains at a leve l 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 c onfirms product failure; and

255• Continued monitoring of the area suggests that th e change is spreading.

5. Remedial Action

When resistance is "confirmed", the following steps will be taken:

• The EPA will receive notification within 7 days of confirmed resistance;

• Affected customers and Extension specia lists will be immedi ately notified about confirmed resistance;

• Affected customers and Extension specialists will be strongly encouraged to implement alternative CRW control measures such as adulticide treatment, crop rotation the following year, or use of soil or seed insect icides the following year;

• Within 14 days of notification, Pioneer a nd EPA will jointly determine the extent of the mitigation needed and determine whether sales should be stopped on an appropriate geographic (i.e., c ounty or regional) basis; and

• Pioneer will develop a case-specific resist ance mitigation action plan within 30 days according to the charac teristics of the resistance event and local agronomic needs. Pioneer will consult with appropria te 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 manage ment 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 confirme d (as previously defined), the fo llowing 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 ex tent and impact of resistance;

• If appropriate (depending on the resistant pest species, the extent of re sistance, the timing of resistance, and the nature of resistance, and th e availability of suitable alternative control measures) , alternative control measures will be employed to reduce or control target pest populations in the affected area. Alternative co ntrol 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 immediat ely until an effective local mitigation plan approved by EPA has been implemented;

256• The registrant will develop a case-specific resi stance management action plan within 90 days according to the characteristics of the resistance event and local agronomic needs. The registrant will consult with appropriate stak eholders 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, consu ltants, extension agents, seed distributors, university cooperators and state/ fe deral 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 th e affected region(s) for the Bt corn hybrids that are affected by the resistant population until an EPA-approved local resistance ma nagement plan is in place to mitigate the resistance.

A report on results of resistan ce 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 ap propriate 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 Proced ures 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 ke rnel 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 toge ther 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 31 st 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

257have signed grower agreements, January 31 st each year, beginning in 2011;

3. Grower Education: substantive changes to education program completed previous year, January 31 st each year, beginning in 2011;

4. Compliance Assurance Program: comp liance assurance program activities and results for the prior year and plans for the compliance assurance program for the current year, January 31 st each year, beginning in 2011;

5. Compliance Survey Results: results of annual surveys for the prior year and survey plans for the current year; full report January 31 st each year, beginning in 2011;

6. Insect Resistance Monitoring Resu lts: results of monitoring and investigations of dama ge reports, August 31 st each year, beginning in 2011 for

western corn rootworm and 2012 for northern corn rootworm.

258Registrant Registration # Active Ingredients Date Registered Date Expired

Pioneer/Dupont 29964-6 Optimum AcreMax RW (OAM RW) Seed Blend of

Herculex RW + Non- Bt

corn 30-Apr-10 30-Sep-12

1] The subject registration will automa tically expire on midnight September 30, 2012.

2] The subject registration will be limited to a seed mix of DAS-59122-7 (Cry34Ab1/Cry35Ab1)

corn seed blended with not less than 10% non- Bt corn seed.

3] Submit/cite all data required for registration of your product under FIFRA § 3(c)(5) when the Agency requires registrants of si milar 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 register ed plant-incorporated protectants to produce inbred corn lines and hybrid corn varie ties with combined pesticidal traits.

5] In light of recently published laboratory st udies showing reduced growth in shredding caddis flies exposed to anti-lepidopteran Cry1A protei n corn litter (Rosi-Marshall, et al. 2007), additional aquatic invertebrate da ta are required. A 7 to 14 day Daphnia magna study as per the 885 series OPPTS Guidelines or a dietary study of the effects on an aquatic invertebrate, representing the functional group of a leaf shre dder in headwater streams must be submitted by January 31, 2012.

Because OAMRW controls corn rootworm pests and contains an integrated corn rootworm refuge, no additional refuge is required. When a grower plants a bag of OAMRW, all refuge requirements are fully and automatically met for th is product. Therefore, grower agreements (demonstrating persons purchasing OAMRW co rn will annually affirm that they are contractually bound to comply with requirements of the insect resistance management (IRM) program) and other associated stewardship doc uments are neither necessary nor required.

Targeted on-farm compliance assessments ar e neither necessary nor required for OAMRW because the refuge is automatically imp lemented 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 a ppropriately would be covered by OAM1 grower education, targeted on-farm assessments and stewardship documents.

2596] 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 di fficult 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 re medial action plan, including an analysis to determine the expected field performance criteria for OAMRW products so that unexpected damage can be benchmarked. Pioneer will update the plan by 12/1/2012, if needed, based on continued field evaluation of OAM1 performance. 12/1/2010

7] Pioneer must commit to do the following Insect Resistance Management Program for

OAMRW.

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

- Requirements regarding programs to evaluate whether there are statistically significant and biologically re levant changes in target insect susceptibility to Cry34Ab1/Cry35Ab1 proteins in the target insects;

- Requirements regarding a “remedial actio n plan,” that contains measures

Pioneer would take in the event that an y field-relevant insect resistance was detected as well as to report on activity under the plan to EPA;

Annual reports on units sold by stat e (units sold by county level wi ll be made available to the Agency upon request) on or before January 31 st of each year, beginning in 2011.

a) Insect Resistance Monitoring for OAMRW Corn

In addition to the existing two- pronged approach to insect re sistance monitoring (monitoring insect populations using the diet bi oassay and investigations of fiel d 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-s pecific 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

260that will lead to increased injury potent ial in western and nort hern 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, Miss ouri), Region 3 (Nebraska and Kansas), and Region 4 (Minnesota, South Dakota and Wisconsin).

2. Pioneer must provide the EPA its detail ed 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 s hould 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, detec tion level, etc.). Pioneer must bioassay a target of 3000 larvae on 59122 plants for each population.

• A description of how monito ring results relate to and are predictive of changes in field efficacy, and change in inju ry 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 31 st 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 ro otworm populations as outlined above, for the second prong of resistance monitoring Pioneer must investigate grower, extension specialist or consultant reports of less-than-expected e fficacy or field performance of OAMRW products.

b) Remedial Action Plan for Co rn Rootworm and OAMRW Corn

The remedial action plan is designed as a tie red approach for mitigating western and northern corn rootworm resistance development specific ally 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 re sistance to target pests is confirmed. Pioneer will complete a benchmar k study of susceptibi lity 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 ac tion plan by December 1, 2010, so that decision points regarding crop damage and target pest re sistance are established, and a remedial action plan can be initiated when needed. Although northe rn corn rootworm is di fficult to rear in the laboratory, Pioneer will attempt to complete a benchmark study for susceptibility of northern corn rootworm using the Sublethal Seedling Assay as well.

1. Suspected Resistance from Population Monitoring

261Definition of Suspected Resistance - Resistance will be suspected if investigations of target pest injury potential to OAMRW maize from th e Sublethal Seedling Assay show that:

• Injury potential of a target pest populati on obtained as part of the annual insect monitoring program has increased to a leve l representative of product failure in field conditions;

• The seeds used in the investigation of this population’s inju ry 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 ad ulticide treatment and/or crop ro tation 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 e fficacy and reduce potentially resistant insects contributing to the following year's pest population.

2. Confirmed Resistance from Population Monitoring

Definition of Confirmed Resistance - Resistance w ill be confirmed if all of the following criteria are met by progeny from a subsequent rootwo rm 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 th e area suggests that the change is spreading.

3. Suspected Resistance – Invest igation of Field Reports

The registrant will follow up on gr ower, extension specialist or c onsultant 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 inci dents occur. The registra nts 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 th e 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 re sponsible for the

262damage, and that all other reasonable cau ses based on historical experience for the observed root damage have been ruled out;

• If not due to other reasons, the registrant will conduct a th orough investigation

of the factors known to affect the mani festation 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. Th ese measures are intended to educate growers of the potential for change in efficacy, reduce the possi bility of grower loss from change in efficacy and reduce potentially resistant insects contri buting to the following year's pest population.

Pioneer will collect insects as s oon as possible from the area for laboratory studies to test for resistance by comparing with benchmark suscep tibility data. These studies will be performed following the same laboratory protocols as used for the benchmark determination and monitoring

programs.

4. Confirmed Resistance – Invest igation of Field Reports

• Injury potential of the fi eld-collected rootworm population feeding on plants containing DAS-59122-7 remains at a leve l 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 c onfirms product failure; and

• Continued monitoring of the area suggests that th e change is spreading.

5. Remedial Action

When resistance is "confirmed", the following steps will be taken:

• The EPA will receive notification within 7 days of confirmed resistance;

• Affected customers and Extension specia lists will be immedi ately notified about confirmed resistance;

• Affected customers and Extension specialists will be strongly encouraged to implement alternative CRW control measures such as adulticide treatment, crop rotation the following year, or use of soil or seed insect icides the following year;

• Within 14 days of notification, Pioneer a nd EPA will jointly determine the extent of the mitigation needed and determine whether sales should be stopped on an appropriate geographic (i.e., c ounty or regional) basis; and

• Pioneer will develop a case-specific resist ance mitigation action plan within 30 days according to the charac teristics of the resistance event and local agronomic needs. Pioneer will consult with appropria te stakeholders in the development of the action plan, and the details of such a plan shall be approved by the EPA prior

263264 to implementation. The resistance manage ment 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 Proced ures 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 ke rnel 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 t ogether 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 31 st each year, beginning in 2011;

2. Insect Resistance Monitoring Results: resu lts of monitoring and investigations of damage reports, August 31 st each year, beginning in 2011 for western corn

rootworm and 2012 for northern corn rootworm.