### Table of Contents for: Plant-Incorporated Protectants (PIP’s) Terms and Conditions

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

a. Reg. # 67979-1 Bt Corn Event BT11 with Cry 1Ab (Field Corn)

b. Reg. # 65268-1 Bt Corn Event BT11 with Cry 1Ab (Sweet Corn

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

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

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

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

g. Reg. # 29964-7 1507 (POCry1F) x MON 810 (POCry1Ab)


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

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

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

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

d. Reg. # 524-552 Bt Corn Event MON 88017 + MON 810 with Cry 1Ab + Cry 3Bb


### III. Cry 34Ab1 and Cry35Ab1 BRAD Re gistered Products (pp.113-193)

a. Reg. # 68467-5 Bt Corn Event DAS-591227-7 with Cry34Ab1 + Cry35Ab1


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



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


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



### e. Reg. # 29964-8 1507 (PO Cry1F) x DAS-591227-7 (Cry34Ab1 + Cry35Ab1) x MON 810 (Cry 1Ab)


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


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

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


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


### V. MON89034 BRAD Registered Products (pp.214-242)

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

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


### VI. OAM BRAD Registered Pr oducts (pp.243-258)

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

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

corn1 Registrant Registration # Active Ingredients Date Registered Date Expired

Syngenta 67979-1 Bt corn Event Bt11 with Cry1Ab ( field corn – AgriSure CB) Feb-98 30-Sep-10

Expiration Date:

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

Data:

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

1. The Agency is requiring Syngenta Seeds, Inc. to submit an analytical method for the detection of Cry1Ab protein in corn grain and a thorough characterization of the antisera used in the method(s). The method must be validated by an independent laboratory validation. Both the method and the validation must be submitted to EPA by June 1, 2002.

2. Data for Bt 11 Cry1Ab protein which compares the am ino acid sequence of the Cry1Ab protein expressed in field corn with know n toxins and allergens must be submitted to the Agency for evaluation. For allergens, these data must also include a stepwise 8 amino acid analysis of the subject protein against available allergen sequence databases. These additional data are required to augment the health effects database for Cr y1Ab expressed in corn. These data must be submitted on or before March 15, 2003.

3. The Agency is requiring prot ein expression data in terms of dry weight, as the amount of protein present in the given tissu e. Tissues for which expression data must be provided include: leaf, root, pollen, seed, and whole plant. In addition, data for each of these tissues should be provided for young plants in rapid growth, during flowering, and ma ture plants before harvest when that part of the plan t is present. Data are du e on or before March 15, 2003.

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

of

Bt corn cultivation. EPA requires Syngenta or S yngenta in cooperation with other registrants to submit test protocols before the studies ar e actually conducted. In general, the Agency anticipates that soils would be sampled from fields where Bt corn has been grown continuously for at least 3 years compared with fields where no Bt crop has been grown. These paired fields

would include several locations throughout the corn growing area of the US representing different soil and climatic variations. The Agen cy anticipates that samples would need to be taken 2 or 3 times during the grow ing season. The regist rant is required to submit a protocol on or before March 15, 2002. An in terim report is due 12 months afte r the protocol is approved and a final report is due 24 months afte r the final protocol is approved.

5. EPA is requiring confirmatory field data for possible impacts on non-target insects. Either2 existing studies must be submitted or the registrants must submit a protocol for field survey studies on or before March 15, 2002 with an interim report submitted 12 months after approval of the protocol and a final report submitted 36 months after approval of the protocol.

6. Based upon research recently published in th e Proceedings of the National Academy of Sciences and upon the response of the Agri cultural Biotechnology St ewardship Technical

Committee to the December 1999 Bt corn Data Call-in Notice, EPA has concluded that the weight of scientific data indicate that Bt corn poses no unreasonable adverse impact on monarch butterfly populations. However, it has been identif ied in one of these papers, (Stanley-Horne, et al, 2001) that the published data only cover acute exposure and longer term exposure to Bt corn pollen should be considered. EPA is aware that studies are underway to assess the potential for longer-term exposure to Bt corn pollen to adversely impact monarch populations. Syngenta must report the results of thes e studies to EPA as soon as the results ar e available public ly or Syngenta must provide valid scientific studies to addr ess this issue by January 31, 2003. The report must be able to be made available to the pub lic at the time it is submitted to EPA.

7. Submitted avian toxicity data on Cry1Ab Bt corn was scientifica lly sound and no treatment mortality or behavior change wa s observed between the dosed and control replicates. However, these data from repeated expos ure(s) to higher doses of Bt corn are needed to make a hazard assessment. A supplemental study is required. The study must be of a ppropriate duration to represent the start and growing periods of the test species such as six weeks in meat-type

chickens. Balanced diets should be formulat ed according to the National Research Council guidelines (“Nutrient Requirement s of Poultry,” Ninth Revised Ed ition, 1994) with the energy requirements of the test species being met by the in clusion of corn in the diet to assess hazards from chronic exposure of wild or domesticated fowl. A protocol for poultry studies must be submitted on or before March 15, 2002 with a fina l report submitted 18 months after approval of the protocol.

8. Studies are required to evaluate the impacts of north-south movement of Helicoverpa zea from corn-growing regions to cotton-growing regions on the resistance management of corn earworm, including field studies, as need ed, to determine the adequacy of the current resistance management program. Either exis ting studies must be submitted or a protocol for field studies must be submitted on or before March 15, 2002 with an interim report submitted 12 months after approval of the protocol and a final report submit ted 24 months after approval of the protocol.

9. Research on the impacts of insecticidal sprays on the effectiveness of th e refuge are required. Syngenta must submit either a copy of the NC- 205 protocol or a protocol of its own to the Agency by March 15, 2002. An interim report is due in 12 months after submitting the NC-205 protocol or approval of the regi strant’s protocol and a final re port is due 24 months after submitting the NC-205 protocol or appr oval of the registrant’s protocol.

10. The subject plant-incorporated protectant may be combined 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.3 Insect Resistance Management:

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

1] Requirements relating to creation of a non- Bt corn and/or non-lepidopter an 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” which impose binding contractual obligations 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 insects;

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

7] Submit annual reports on units 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.

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 insectic ides 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.4 · 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-lepidopteran re sistant 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 resi stant Bt corn that may be tr eated with ins ecticides 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-lepidopteran 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).5 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 whic h 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 whic h 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 nu mber 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 shall6 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 expa nd 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 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 sha ll include an annual survey conducted by an independent third party of a sta tistically 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 IR M 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.

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 gr ower feedback on the usefulness of specific7 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 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 w ith 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.

d. Insect Resistance Monitoring

The Agency is imposing the following conditions for this product:

The registrant will monitor for resistance to its lepidopteran-resi stant Bt corn. The monitoring program shall consist of two a pproaches: (1) focused population sampling and laboratory testing;8 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 ar e planted on a high proportion of the corn 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 popula tion response to lepidopte ran resistant Bt corn and/or changes in resistance alle le 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 importa nce and for the adoption levels of lepidopteran-resistant Bt corn. The Agency shall be consulted prior to the implementation of such modifications.

The registrant will report to the Agency before August 31 each year the results of the population sampling and bioassay monitoring program.

Any incidence of unusually low sensitivity to the Bt protein in bioassays shall be investigated as soon as possible to understand 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 met hods that are representative of exposure to Bt9 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 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 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 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 confirme d to be lepidopteran-active Bt corn;

• the seed used had the proper percenta ge of corn expres sing Bt protein;

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

• it has been ruled out th at species not susceptible to the protein could be responsible for10 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 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 mont h 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 bi oassays using diagnostic concen trations 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:11 • 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 ex tent 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.

If these conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA section 6(e). Your release for shipment of Bt11 field corn constitutes acceptance of these conditions.12 Registrant Registration # Active Ingredients Date Registered Date Expired

Syngenta 65268-1 Bt corn Event Bt11 with Cry1Ab ( sweet corn - Attribute--no refugia for sweet corn) Feb-98 30-Sep-10

Expiration Date:

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

Data:

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

1. The Agency is requiring Syngenta Seeds, Inc. to submit an analytical method for the detection of Cry1Ab protein in corn grain and a thorough characterization of the antisera used in the method(s). The method must be validated by an independent laboratory. Both the method and the validation must be submitted to EPA by June 1, 2002.

2. Data comparing the amino acid sequence of the Bt 11 Cry1Ab protein expr essed in sweet corn with known toxins and allergens mu st be submitted to the Agency for evaluation. For allergens, these data must also include a stepwise 8 ami no acid analysis of the subject protein against available allergen sequence databases. These a dditional data are required to augment the health effects database for Cry1Ab expressed in corn. These data must be submitted on or before March 15, 2003.

3. The Agency is requiring prot ein expression data in terms of dry weight, as the amount of protein present in the given tissue. Tissues for which expression da ta must be provided include: leaf, root, pollen, seed, and whole plant. In addition, data for each of these tissues should be provided for young plants in rapid growth, during flowering, and ma ture plants before harvest when that part of the plan t is present. Data are du e on or before March 15, 2003.

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

of

Bt corn cultivation. EPA requires Syngenta or S yngenta in cooperation with other registrants to submit test protocols before the studies ar e actually conducted. In general, the Agency anticipates that soils would be sampled from fields where Bt corn has been grown continuously for at least 3 years compared with fields where no Bt crop has been grown. These paired fields

would include several locations throughout the corn growing area of the US representing different soil and climatic variations. The Agen cy anticipates that samples would need to be taken 2 or 3 times during the grow ing season. The regist rant is required to submit a protocol on or before March 15, 2002. An in terim report is due 12 months afte r the protocol is approved and a final report is due 24 months afte r the final protocol is approved.

5. Based upon research recently published in th e Proceedings of the National Academy of13 Sciences and upon the response of the Agri cultural Biotechnology St ewardship Technical

Committee to the December 1999 Bt corn Data Call-in Notice, EPA has concluded that the weight of scientific data indicate that Bt corn poses no unreasonable adverse impact on monarch butterfly populations. However, it has been identif ied in one of these papers, (Stanley-Horne, et al, 2001) that the published data only cover acute exposure and longer term exposure to Bt corn pollen should be considered. EPA is aware that studies are underway to assess the potential for longer-term exposure to Bt corn pollen to adversely impact monarch populations. Syngenta must report the results of thes e studies to EPA as soon as the results ar e available public ly or Syngenta must provide valid scientific studies to addr ess this issue by January 31, 2003. The report must be able to be made available to the pub lic at the time it is submitted to EPA.

6. Submitted avian toxicity data on Cry1Ab Bt corn was scientifica lly sound and no treatment mortality or behavior change was observed betw een the dosed and control replicates. However, data from repeated exposure(s) to higher doses of Bt corn are needed to make a hazard assessment. A supplemental study is required. The study must be of a ppropriate duration to represent the starter and growing periods of the test specie s such as six weeks in meat-type

chickens. Balanced diets should be formulat ed according to the National Research Council guidelines (“Nutrient Requirement s of Poultry,” Ninth Revised Ed ition, 1994) with the energy requirements of the test species being met by the in clusion of corn in the diet to assess hazards from chronic exposure of wild or domesticated fowl. A protocol for poultry studies must be submitted on or before March 15, 2002 with a fina l report submitted 18 months after approval of

the protocol.

7. The subject plant-incorporated protectant may be combined through conventional breeding with other registered plant-incorporated 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.

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” which impose binding contractua l obligations on the grower to comply with the refuge requirements;

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

3] 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 “remedial action pl an” which contains measures the registrants14 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.

3] The registrant must maintain a system whic h 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 changes15 to ensure that it is consistent with th e terms and conditions of the amendment.

5] The registrant must maintain a system whic h 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 nu mber 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 expa nd 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 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.16 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 in clude an annual survey of all Bt sweet corn customers who purchase 5 or more bags of Bt11 sw eet corn. The survey shall measure the degree of compliance with the IRM progr am, identify 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.

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 gr ower 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 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 train its representatives w ho make on-farm visits w ith 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 results17 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.

d. Insect Resistance Monitoring

The Agency is imposing the following conditions for this product:

The registrant will monitor for resistance to its lepidopteran-resi stant 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.

(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 the18 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 allele frequency in response to the use of Bt corn and, as far as possible, should be consistent 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 importa nce and for the adoption levels of lepidopteran-resistant Bt corn. The Agency shall be consulted prior to the implementation of such modifications.

The registrant will report to the Agency before August 31 each year the results of the population sampling and bioassay monitoring program.

Any incidence of unusually low sensitivity to the Bt protein in bioassays shall be investigated as soon as possible to understand 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 met hods 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);19 • 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 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 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

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

• the corn in question has been confirme d to be lepidopteran-active Bt corn;

• the seed used had the proper percenta ge of corn expres sing Bt protein;

• the relevant plant tissues are expressing 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 fields before responsive measures are

undertaken.

If resistance is suspected, the registrant will instruct growers to do the following:20 • Use alternative control measures in the Bt corn fields in the affected region to control the target pest during the immediate growing season.

• Destroy Bt corn crop residues in the affected region within one mont h 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 bi oassays using diagnostic concen trations 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 ex tent and impact of resistance;

• If appropriate (depending on the resistant pest species, the extent of resistance, the timing21 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.

If these conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA section 6(e). Your releas e for shipment of bt11 sweet corn constitutes acceptance of these conditions.22 Registrant Registration # Active Ingredients Date Registered Date Expired

Monsanto 524-489 Bt corn Event MON810 Cry1Ab (YieldGard) Dec-96 30-Sep-10

Expiration Date:

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

Data:

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

1. The Agency is requiring Monsanto to subm it an analytical method for the detection of Cry1Ab protein in corn grain an d a thorough characterization of the antisera used in the method(s). The method must be validated by an independent laboratory validation. Both the method and the validation must be submitted to EPA by June 1, 2002.

2. Amino acid sequence data submitted indicate that there are no similarities between Cry1Ab protein and any known toxins or allergens. Howe ver, since the initial registration, the value of comparing the amino acid sequence to known toxi ns and allergens has been highlighted and therefore a stepwise 8 amino acid analysis of the subject protein against newly available known allergen sequence databases is required. In ad dition, a processing and/or heat stability study must also be conducted. These additional data are required to augment the health effects database for Cry1Ab corn by March 15, 2003.

3. The Agency is requiring prot ein expression data in terms of dry weight, as the amount of protein present in the given tissu e. Tissues for which expression data must be provided include: leaf, root, pollen, seed, and whole plant. In addition, data for each of these tissues should be provided for young plants in rapid growth, during flowering, and ma ture plants before harvest when that part of the plan t is present. Data are du e on or before March 15, 2003.

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

of

Bt corn cultivation. EPA requires Monsanto or Monsanto in cooperation with other registrants to submit test protocols before the studies ar e actually conducted. In general, the Agency anticipates that soils would be sampled from fields where Bt corn has been grown continuously for at least 3 years compared with fields where no Bt crop has been grown. These paired fields

would include several locations throughout the corn growing area of the US representing different soil and climatic variations. The Agen cy anticipates that samples would need to be taken 2 or 3 times during the growing season. Mons anto is required to s ubmit a protocol on or before March 15, 2002. An interim report is due 12 months after the protoc ol is approved and a final report is due 24 months after the final protocol is approved.

5. EPA is requiring confirmatory field data for possible impacts on non-target insects. Either23 existing studies must be submitted or the registrants must submit a protocol for field survey studies on or before March 15, 2002 with an interim report submitted 12 months after approval of the protocol and a final report submitted 36 months after approval of the protocol.

6. Based upon research recently published in th e Proceedings of the National Academy of Sciences and upon the response of the Agri cultural Biotechnology St ewardship Technical

Committee to the December 1999 Bt corn Data Call-in Notice, EPA has concluded that the weight of scientific data indicate that Bt corn poses no unreasonable adverse impact on monarch butterfly populations. However, it has been identif ied in one of these papers, (Stanley-Horne, et al, 2001) that the published data only cover acute exposure and longer term exposure to Bt corn pollen should be considered. EPA is aware that studies are underway to assess the potential for longer-term exposure to Bt corn pollen to adversely impact monarch populations. Monsanto must report the results of these studies to EPA as soon as the results are available publicly or Monsanto must provide valid scie ntific studies to address this issue by January 31, 2003. The report must be able to be made available to th e public at the time it is submitted to EPA.

7. Submitted avian toxicity data on Cry1Ab Bt corn was scientifica lly sound and no treatment mortality or behavior change wa s observed between the dosed and control replicates. However, data from repeated exposure(s) to higher doses of Bt corn are needed to make a hazard assessment. A supplemental study is required. The study must be of a ppropriate duration to represent the start and growing periods of the test species such as six weeks in meat-type

chickens. Balanced diets should be formulat ed according to the National Research Council guidelines (“Nutrient Requirement s of Poultry,” Ninth Revised Ed ition, 1994) with the energy requirements of the test species being met by the in clusion of corn in the diet to assess hazards from chronic exposure of wild or domesticated fowl. A protocol for poultry studies must be submitted on or before March 15, 2002 with a fina l report submitted 18 months after approval of the protocol.

8. Studies are required to evaluate the imp acts of north-south m ovement of Helicoverpa zea from corn-growing regions to cotton-growing regions on the resistance management of corn earworm, including field studies, as need ed, to determine the adequacy of the current resistance management program. Either exis ting studies must be submitted or a protocol for field studies must be submitted on or before March 15, 2002 with an interim report submitted 12 months after approval of the protocol and a final report submit ted 24 months after approval of the protocol.

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

Monsanto must submit either a copy of the NC-205 protocol or a protocol of its own to the Agency by March 15, 2002. An interim report is due in 12 months after submitting the NC-205 protocol or approval of the regi strant’s protocol and a final re port is due 24 months after submitting the NC-205 protocol or appr oval of the registrant’s protocol.

10. The subject plant-incorporated protectant may be combined 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.24 Insect Resistance Management:

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

1] Requirements relating to creation of a non- Bt corn and/or non-lepidopter an 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” which impose binding contractual obligations 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 insects;

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

7] Submit annual reports on units 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.

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 insectic ides 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.25 · 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-lepidopteran re sistant 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 resi stant Bt corn that may be tr eated with ins ecticides 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 thre sholds 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-lepidopteran 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).26 b. Grower Agreements

1] Persons purchasing the Bt corn product must sign a grower agreement. The term “grower agreement” refers to any grower purchase contract , license agreement, or similar legal document.

2] The grower agreement and/or specific 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 whic h 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 whic h 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 nu mber 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 the27 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 expa nd 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 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 sha ll include an annual survey conducted by an independent third party of a sta tistically 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 IR M 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.

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.28 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.

11] The registrant shall conduct an annual on-farm assessment program. The registrant shall train its representatives who make on-farm visits w ith 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.

d. Insect Resistance Monitoring

The Agency is imposing the following conditions for this product:

The registrant will monitor for resistance to its lepidopteran-resi stant Bt corn. The monitoring29 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; 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 hi gh proportion of the corn 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 popula tion response to lepidopte ran resistant Bt corn and/or changes in resistance alle le 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 importa nce and for the adoption levels of lepidopteran-resistant Bt corn. The Agency shall be consulted prior to the implementation of such modifications.

The registrant will report to the Agency before August 31 each year the results of the population sampling and bioassay monitoring program.

Any incidence of unusually low sensitivity to the Bt protein in bioassays shall be investigated as soon as possible to understand 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 the30 diagnostic concentration will be tested using met hods 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 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 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 confirme d to be lepidopteran-active Bt corn;

• the seed used had the proper percenta ge of corn expres sing Bt protein;

• the relevant plant tissues are expressing the expected level of Bt protein; and31 • 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 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 mont h 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 bi oassays using diagnostic concen trations 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 Field32 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 ex tent 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.

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.33 Registrant Registration # Active Ingredients Date Registered Date Expired

Dow/Mycogen 68467-2 Bt corn Event TC1507 with plant optimized (PO) Cry1F (Her culex 1) May-01 30-Sep-10

Expiration Date:

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

Data:

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

1. The Agency is requiring Mycogen to submit an analytical method for the detection of Cry1F protein in corn grain and a thorough characteriza tion of the antisera used in the method(s). The method must be validated by an independent laboratory validation. Both the method and the validation must be submitted to EPA by June 1, 2002.

2. The Agency is requiring testing of Cry1F pr otein levels in soil under a range of conditions typical of Bt corn cultivation. EPA requires Mycogen or Mycoge n in cooperation with other registrants to submit test protocols before the studies are actually conduc ted. In general, the Agency anticipates that soils would be sampled from fields where Bt corn has been grown continuously for at least 3 years compared with fields where no Bt crop has been grown. These paired fields would include several locations throughout the corn grow ing area of the US representing different soil and climatic variations. The Agency anticipates that samples would need to be taken 2 or 3 times during the growing season. Mycogen is required to submit a protocol on or before March 15, 2002. Due dates for any interim reports will be determined at the time the protocol is approved. The final data for Cry1F will be submitted no later than March 15, 2008, but may be due earlier depe nding upon the final approved protocol.

3. EPA is requiring confirmatory field data for possible impacts on non-target insects. Either existing studies must be submitted or the registrants must submit a protocol for field survey studies on or before March 15, 2002 with an interim report submitted 12 months after approval of the protocol and a final report submitted 36 months after approval of the protocol.

4. Submitted avian toxicity data on Cry1F Bt corn was scientifically sound and no treatment mortality or behavior change was observed betw een the dosed and control replicates. However, data from repeated exposure(s) to higher doses of Bt corn are needed to make a hazard assessment. A supplemental study is required. The study must be of a ppropriate duration to represent the start and growing periods of the test species such as six weeks in meat-type

chickens. Balanced diets should be formulat ed according to the National Research Council guidelines (“Nutrient Requirement s of Poultry,” Ninth Revised Ed ition, 1994) with the energy requirements of the test species being met by the in clusion of corn in the diet to assess hazards from chronic exposure of wild or domesticated fowl. A protocol for poultry studies must be submitted on or before March 15, 2002 with a fina l report submitted 18 months after approval of the protocol.34 5. Studies are required to evaluate the imp acts of north-south m ovement of Helicoverpa zea from corn-growing regions to cotton-growing regions on the resistance management of corn earworm, including field studies, as need ed, to determine the adequacy of the current resistance management program. Either exis ting studies must be submitted or a protocol for field studies must be submitted on or before March 15, 2002 with an interim report submitted 12 months after approval of the protocol and a final report submit ted 24 months after approval of the protocol.

6. Research on the impacts of insecticidal sprays on the effectiveness of th e refuge are required. Mycogen must submit either a copy of the NC-205 protocol or a protocol of its own to the Agency by March 15, 2002. An interim report is due in 12 months after submitting the NC-205 protocol or approval of the regi strant’s protocol and a final re port is due 24 months after submitting the NC-205 protocol or appr oval of the registrant’s protocol.

Insect Resistance Management:

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

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

1] Requirements relating to creation of a non- Bt corn and/or non-lepidopter an 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” which impose binding contractual obligations 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;

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

7] Submit annual reports on units 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.35 1) Corn-Belt Refuge Requirements

Field corn grown outside cotton- growing areas (e.g., the Corn Belt), grower agreements (also known as stewardship agreements) will specify that growers must adhere to the refuge requirements as described in 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 insectic ides 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-lepi dopteran 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 resi stant Bt corn that may be tr eated with ins ecticides 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).36 Instructions to growers w ill 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, 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 whic h 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 whic h 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 nu mber 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 re gulatory agency if the State agency can demonstrate that37 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 expa nd 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 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 sha ll include an annual survey conducted by an independent third party of a sta tistically representative sample of growers of Bt corn borer38 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 IR M 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.

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 gr ower 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.

11] The registrant shall conduct an annual on-farm assessment program. The registrant shall train its representatives who make on-farm visits w ith 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, grower39 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.

d. Insect Resistance Monitoring

The Agency is imposing the following conditions for this product:

The registrant will monitor for resistance to its lepidopteran-resi stant 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.

(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 ar e planted on a high proportion of the corn 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 popula tion response to lepidopte ran resistant Bt corn and/or changes in resistance alle le 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 importa nce and for the adoption levels of lepidopteran-resistant Bt corn. The Agency shall be consulted prior to the implementation of such modifications.40 The registrant will report to the Agency before August 31 each year the results of the population sampling and bioassay monitoring program.

Any incidence of unusually low sensitivity to the Bt protein in bioassays shall be investigated as soon as possible to understand 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 met hods 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 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 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.41 If reports of unexpected levels of damage lead to the suspicion of resistance in any of the key target pests (ECB, SWCB, and CEW), the 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 confirme d to be lepidopteran-active Bt corn;

• the seed used had the proper percenta ge of corn expres sing Bt protein;

• the relevant plant tissues are expressing 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 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 mont h 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:42 • 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 bi oassays using diagnostic concen trations 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 ex tent 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; and43 • 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 rel ease for shipment of Cry1F corn constitutes acceptance of these conditions.44 Registrant Registration # Active Ingredients Date Registered Date Expired

Pioneer/Dupont 29964-3 Bt corn Event TC1507 with POCry1F (Herculex 1) May-01 30-Sep-10

Expiration Date:

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

Data:

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

1. The Agency is requiring Pioneer to submit an analytical method for the detection of Cry1F protein in corn grain and a thorough characteriza tion of the antisera used in the method(s). The method must be validated by an independent laboratory validation. Both the method and the validation must be submitted to EPA by June 1, 2002.

2. The Agency is requiring testing of Cry1F pr otein levels in soil under a range of conditions typical of Bt corn cultivation. EPA requires Pioneer or Pioneer in cooperation with other registrants to submit test protocols before the studies are actually conduc ted. In general, the Agency anticipates that soils would be sampled from fields where Bt corn has been grown continuously for at least 3 years compared with fields where no Bt crop has been grown. These paired fields would include several locations throughout the corn grow ing area of the US representing different soil and climatic variations. The Agency anticipates that samples would

need to be taken 2 or 3 times during the growing season. Pioneer is required to submit a protocol on or before March 15, 2002. Due dates for any inte rim reports will be determined at the time the protocol is approved. The final data for Cry1F will be submitted no later than March 15, 2008, but may be due earlier dependi ng upon the final approved protocol.

3. EPA is requiring confirmatory field data for possible impacts on non-target insects. Either existing studies must be submitted or the registrants must submit a protocol for field survey studies on or before March 15, 2002 with an interim report submitted 12 months after approval of the protocol and a final report submitted 36 months after approval of the protocol.

4. Submitted avian toxicity data on Cry1F Bt corn was scientifically sound and no treatment mortality or behavior change was observed betw een the dosed and control replicates. However, data from repeated exposure(s) to higher doses of Bt corn are needed to make a hazard assessment. A supplemental study is required. The study must be of a ppropriate duration to represent the start and growing periods of the test species such as six weeks in meat-type

chickens. Balanced diets should be formulat ed according to the National Research Council guidelines (“Nutrient Requirement s of Poultry,” Ninth Revised Ed ition, 1994) with the energy requirements of the test species being met by the in clusion of corn in the diet to assess hazards45 from chronic exposure of wild or domesticated fowl. A protocol for poultry studies must be submitted on or before March 15, 2002 with a fina l report submitted 18 months after approval of the protocol.

5. Studies are required to evaluate the imp acts of north-south m ovement of Helicoverpa zea from corn-growing regions to cotton-growing regions on the resistance management of corn earworm, including field studies, as need ed, to determine the adequacy of the current resistance management program. Either exis ting studies must be submitted or a protocol for field studies must be submitted on or before March 15, 2002 with an interim report submitted 12 months after approval of the protocol and a final report submit ted 24 months after approval of the protocol.

6. Research on the impacts of insecticidal sprays on the effectiveness of th e refuge are required. Pioneer must submit either a copy of the NC-205 prot ocol or a protocol of its own to the Agency by March 15, 2002. An interim report is due in 12 months after submitting the NC-205 protocol or approval of the registrant’s protocol and a final report is due 24 months after submitting the NC-205 protocol or approval of the registrant’s protocol.

Insect Resistance Management:

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

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

1] Requirements relating to creation of a non- Bt corn and/or non-lepidopter an 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” which impose binding contractual obligations 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;

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

7] Submit annual reports on units 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.46 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.

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 insectic ides 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 thre sholds 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-lepi dopteran 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 resi stant Bt corn that may be tr eated with ins ecticides 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.47 · 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-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, 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 whic h 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 whic h is reasonably likely to assure that persons purchasing the Bt corn sign grower agreement(s).

6] The registrant shall maintain records of all Bt corn grower agreements for a period of three years from December 31 of the year in which the agreement was signed.48 7] The registrant shall 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 nu mber 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 expa nd 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 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 a49 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 sha ll include an annual survey conducted by an independent third party of a sta tistically 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 IR M 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.

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 gr ower 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.

11] The registrant shall conduct an annual on-farm assessment program. The registrant shall train its representatives who make on-farm visits w ith 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.”50 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.

d. Insect Resistance Monitoring

The Agency is imposing the following conditions for this product:

The registrant will monitor for resistance to its lepidopteran-resi stant 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.

(5) Focused Population Sampling

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

nubilalis (European corn borer; ECB), Diatraea grandiosella (Southwestern corn borer; S WCB), and Helicoverpa zea (corn earworm; CE W). Sampling 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 ar e planted on a high proportion of the corn 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 popula tion response to lepidopte ran resistant Bt corn and/or changes in resistance alle le 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 population51 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 importa nce and for the adoption levels of lepidopteran-resistant Bt corn. The Agency shall be consulted prior to the implementation of such modifications.

The registrant will report to the Agency before August 31 each year the results of the population sampling and bioassay monitoring program.

Any incidence of unusually low sensitivity to the Bt protein in bioassays shall be investigated as soon as possible to understand 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 met hods 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 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 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 Target52 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 confirme d to be lepidopteran-active Bt corn;

• the seed used had the proper percenta ge of corn expres sing Bt protein;

• the relevant plant tissues are expressing 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 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 mont h 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.53 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 bi oassays using diagnostic concen trations 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 resistan ce 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 ex tent 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.54 The registrant will consult with appropriate stakeholders in the development of the action plan, and the details of such a plan shall be approved by EPA prior to implementation;

• Notify affected parties (e.g. growers, 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.

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.55 Registrant Registration # Active Ingredients Date Registered Date Expired

Dow Agrosciences 68467-4 Bt corn Event DAS-06275-8 with MOCry1F (Mycogen Brand Bt Cry1F Event DAS-06274-8 corn) 27-May-05 30-Sep10

Expiration Date:

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

Data:

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

1. The Agency is requiring Mycogen to submit an analytical method for the detection of Cry1F protein in corn grain and a thorough characteriza tion of the antisera used in the method(s). The method must be validated by an independent laboratory validation. Both the method and the validation must be submitted to EPA by June 1, 2002.

2. The Agency is requiring testing of Cry1F pr otein levels in soil under a range of conditions typical of Bt corn cultivation. EPA requires Mycogen or Mycoge n in cooperation with other registrants to submit test protocols before the studies are actually conduc ted. In general, the Agency anticipates that soils would be sampled from fields where Bt corn has been grown continuously for at least 3 years compared with fields where no Bt crop has been grown. These paired fields would include several locations throughout the corn grow ing area of the US representing different soil and climatic variations. The Agency anticipates that samples would need to be taken 2 or 3 times during the growing season. Mycogen is required to submit a protocol on or before March 15, 2002. Due dates for any interim reports will be determined at the time the protocol is approved. The final data for Cry1F will be submitted no later than March 15, 2008, but may be due earlier depe nding upon the final approved protocol.

3. EPA is requiring confirmatory field data for possible impacts on non-target insects. Either existing studies must be submitted or the registrants must submit a protocol for field survey studies on or before March 15, 2002 with an interim report submitted 12 months after approval of the protocol and a final report submitted 36 months after approval of the protocol.

4. Submitted avian toxicity data on Cry1F Bt corn was scientifically sound and no treatment mortality or behavior change was observed betw een the dosed and control replicates. However, data from repeated exposure(s) to higher doses of Bt corn are needed to make a hazard assessment. A supplemental study is required. The study must be of a ppropriate duration to represent the start and growing periods of the test species such as six weeks in meat-type

chickens. Balanced diets should be formulat ed according to the National Research Council guidelines (“Nutrient Requirement s of Poultry,” Ninth Revised Ed ition, 1994) with the energy requirements of the test species being met by the in clusion of corn in the diet to assess hazards from chronic exposure of wild or domesticated fowl. A protocol for poultry studies must be submitted on or before March 15, 2002 with a fina l report submitted 18 months after approval of56 the protocol.

5. Studies are required to evaluate the imp acts of north-south m ovement of Helicoverpa zea from corn-growing regions to cotton-growing regions on the resistance management of corn earworm, including field studies, as need ed, to determine the adequacy of the current resistance management program. Either exis ting studies must be submitted or a protocol for field studies must be submitted on or before March 15, 2002 with an interim report submitted 12 months after approval of the protocol and a final report submit ted 24 months after approval of the protocol.

6. Research on the impacts of insecticidal sprays on the effectiveness of th e refuge are required. Mycogen must submit either a copy of the NC-205 protocol or a protocol of its own to the Agency by March 15, 2002. An interim report is due in 12 months after submitting the NC-205 protocol or approval of the regi strant’s protocol and a final re port is due 24 months after submitting the NC-205 protocol or appr oval of the registrant’s protocol.

Insect Resistance Management:

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

1] Requirements relating to creation of a non- Bt corn and/or non-lepidopter an 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” which impose binding contractual obligations 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 insects;

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

7] Submit annual reports on units 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.57 1) Corn-Belt Refuge Requirements

Field corn grown outside cotton- growing areas (e.g., the Corn Belt), grower agreements (also known as stewardship agreements) will specify that growers must adhere to the refuge requirements as described in 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 insectic ides 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-lepidopteran re sistant 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 resi stant Bt corn that may be tr eated with ins ecticides 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 by58 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-lepidopteran 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 whic h 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 whic h 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 nu mber 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 records59 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 expa nd 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 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 sha ll include an annual survey conducted by an60 independent third party of a sta tistically 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 IR M 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.

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 gr ower 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.

11] The registrant shall conduct an annual on-farm assessment program. The registrant shall train its representatives who make on-farm visits w ith 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 grower61 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.

d. Insect Resistance Monitoring

The Agency is imposing the following conditions for this product:

The registrant will monitor for resistance to its lepidopteran-resi stant 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.

(6) Focused Population Sampling

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

nubilalis (European corn borer; ECB), Diatraea grandiosella (Southwestern corn borer; S WCB), and Helicoverpa zea (corn earworm; CE W). Sampling 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 hi gh proportion of the corn 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 popula tion response to lepidopte ran resistant Bt corn and/or changes in resistance alle le 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 importa nce and for the adoption levels of lepidopteran-resistant Bt corn. The Agency shall be consulted prior to the implementation of such modifications.62 The registrant will report to the Agency before August 31 each year the results of the population sampling and bioassay monitoring program.

Any incidence of unusually low sensitivity to the Bt protein in bioassays shall be investigated as soon as possible to understand 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 met hods 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 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 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.63 If reports of unexpected levels of damage lead to the suspicion of resistance in any of the key target pests (ECB, SWCB, and CEW), the 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 confirme d to be lepidopteran-active Bt corn;

• the seed used had the proper percenta ge of corn expres sing Bt protein;

• the relevant plant tissues are expressing 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 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 mont h 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 corn64 hybrids under field conditions (ECB and SWCB only).

• In standardized laboratory bi oassays using diagnostic concen trations 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 resistan ce 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 ex tent 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 resistance65 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.66 Registrant Registration # Active Ingredients Date Registered Date Expired

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

2010 30-Sep-10

1. The subject registration will auto matically expire September 30, 2010.

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

Study Type Required Data Due Date

Insect Resistance Management - Grower Agreement A copy of the grower agreement, as sociated stewardship documents, and written description of a system, which assures that growers will sign grower agreements and persons purchasing 1507xMON810 corn will annually affirm that they are cont ractually bound to comply with the requirements of the insect resistan ce management (IRM) program, must

be submitted. Within 90 days of

the date of registration

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

follows.

The required IRM program for 1507xMON810 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;

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

• Requirements regarding programs to edu cate growers about IRM requirements;67 • Requirements regarding programs to evaluate and promote growers’ compliance with IRM requirements;

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

• Requirements regarding a remedial action pla n, which 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

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.

• 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.68 • 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).

b) Grower Agreements

1. Persons purchasing the Bt corn product must sign a grower agreement. The term “grower agreement” refers to any grower purchase contract, license agreement, or similar legal

document.

2. The grower agreement and/or specific stewardship documents referenced in the grower agreement must clearly set forth the terms of the current IRM program. By signing the grower agreement, a grower must be contractually bound to comply with the requirements of the IRM program.

3. Pioneer must maintain a system which is reasonably likely to assure that persons purchasing the Bt corn product will affirm annually that they are 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 days69 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 agreem ent 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

convey 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 re quirements 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 take into account the information collected through the compliance survey required under70 paragraph 6 and from other sources. The regist rant shall identify deficiencies in grower compliance and revise the education pr ogram 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

be denied sales of 1507xMON810 corn the next year. Simila rly, seed dealers who are not fulfilling their obligations to inform/educate gr owers of their IRM obligations will lose their opportunity to sell 1507xMON810 corn.

6. Pioneer must maintain an IRM compliance assurance program (CAP) which shall include an annual survey conducted by an independent third party of a statistically representative sample of growers of Bt corn borer protected products 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 reasonable71 sensitivity for comparing results across the U.S.

7. The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potential 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 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 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.72 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.

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 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; 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.73 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.

2. 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 withthe 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 registrant74 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

• 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 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 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:75 • 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

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 ex tent 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) in76 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 sold 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.77 Registrant Registration # Active Ingredients Date Registered Date Expired

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

MON 863

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

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

2) The subject registration will be limited to Bacillus thuringiensis Cry3Bb1 Protein and the Genetic Material Necessary for its Producti on (Vector ZMIR13L) in Event MON863 Corn

use in field corn.

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

4) Submit production information for this produc t to Mr. Owen Beeder of Office of Pesticide Programs, Registration Division (m ail code 7505C) for the fiscal year in which this product is conditionally registered, in accordance with FIFRA § 29. The fiscal y ear begins October 1 and ends September 30. Production information will be submitted to the Agency no later than December 15, following the end of the preceding fiscal year.

5) Submit independent laborat ory method validation (under OPPTS Guidelines 860.1340) to complete the database for Cry3Bb1 corn within 12 months of the date of registration. Provide to the EPA laboratory (Ft. Meade, MD) methodology and/or reagents necessary for validation of a Cry3Bb1 analy tical method once requested by EPA’s Ft. Meade laboratory.

The extraction and detection method as desc ribed for Cry3Bb1 protein appears to be adequate for analysis of Cry3Bb1 protein in corn grain. However, this method must be validated by both an independent laboratory and the EPA Biological and Economic Analysis Division laboratory before it can be considered a valid method. In addition, to assure that grain handlers have a test met hod in place prior to harvest, Monsanto must make available Cry3Bb1 strip tests to grain handl ers and demonstrate to the Agency this provision prior to September 2003. EPA understands that these are 'qua litative' test kits and that Monsanto is in discussions with USDA/GIPSA about providin g methodology and reagents for their use in developing a validated 'quantitative' method for MON 863 and that this transfer of materials will take place once registration occurs. Data requirement satisf ied. Validation by EPA’s Biological and Economic Analysis Division Laboratory pending.

6) Submit expression data in terms of dry weight , as the amount of protein present in the given tissue. Tissues for which expression data must be provided include: leaf , root, pollen, seed, and whole plant. In addition, data for each of these tissues should be provided for young plants in rapid growth, during fl owering, and mature plants before harvest when that part of the plant is present. Data ob tained for roots should also in clude typical times when corn rootworm would be feeding. Data requirement satisfied.

7) Submit field degradation studies evaluating accumulation and persistence of Cry3Bb1 in several different soils in various strata. Repres entative fields must ha ve been planted with

MON863 and include both conven tional tillage and no-till sa mples and be harvested under78 typical agronomic conditions. Sampling must con tinue until the limit of detection is reached. Studies should include soils with high levels of a variety of clays. Both ELISA and insect bioassays need to be conducted and compared to determine if Cry3Bb1 is accumulating or persisting in soil samples. Data requirement satisfied provided three (3) year YieldGard Plus (EPA Reg. No. 524-545) fate data submitted and found acceptable.

8) Submit laboratory toxicity tests with Orius insi diosus (minute pirate bu g), and carabid (ground beetle), within 24 months of th e date of registration, provided the registration is amended to extend the registration date. Data submitted and under review. Protocols are due within 120 days of the date of registration. We note th at further investigati on of the biology and life cycle of the red milkweed beetle demonstrates that there will be li ttle or no exposure of larvae under natural conditions. Although adults may be exposed to Bt corn pollen while feeding on milkweed leaves, Bt is typically less toxic to adults than larvae. There is also no protocol for rearing red milkweed beetles in the laboratory and the development of such a laboratory assay would be difficu lt due to the red milkweed b eetle’s long development time. Therefore, on October 1, 2003, the Agency granted Monsanto’s request and the waived requirement for conducting a red milkweed beetle study set forth in the notice of registration.

9) Full-scale field or semi-field studies with ap propriate end points and statistical power must be conducted. Submit intermediate and multi-year non-target organism field studies with statistical power. You must submit final result s to field studies previously summarized in MRID No.456530-03 (The carabid and nematode data are of particular interest.) and annual reports each year of this registration every April 30 th

. Data submitted and under review.

10) Submit a six week broiler dietary study with 60% - 70% MON 863 corn in the diet that is of appropriate duration to re present the start and growing period s of the test species. Balanced diets should be formulated according to the National Research Council guidelines (““Nutrient Requirements of Poultry,”” Nint h Revised Edition, 1994) with the energy requirements of the test species being met by th e inclusion of corn in the diet to assess hazards from chronic exposure of wild or domesticated fowl. A protocol for poultry studies must be submitted within 90 days of the date of registration with a final report submitted 18 months after approva l of the protocol. Data submitted and under review.

11) Submit the following insect resistance manage ment/pest biology data. Pr otocols and data sets identified in Monsanto’’s 12/13/2002 letter must be submitted within 90 days of the date of registration. A progress report must be subm itted by January 31, 2004. The final reports must be submitted by January 31, 2006. Data requirement satisfied.

- Research regarding adult and larval movement and dispersal, mating habits, ovipositional patterns, number of times a fe male can mate and fecundity.

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

MCRW

- Research regarding the mechanism of potential resistance of CRW to MON 863 is necessary to develop an appropriate long-term IRM strategy. Monsanto must attempt to develop resistant CRW colonies to aid in determining selection intensity.

- Research regarding the eff ect of WCRW ovipositing in soybe an prior to overwintering and extended diapause in NCRW on an IRM strategy needs further investigation.79 - Detailed summaries of the four data-sets id entified in Monsanto’’s December 13, 2002 letter should be submitted to the Agency to support thei r conclusion that the initial resistance allele frequency is? 0.01.

- Baseline susceptibility studies currently un derway should be continued for WCRW and initiated for NCRW and monitoring technique s such as discriminating dose concentration assays need to be thoroughly investigated for th eir feasibility as resistance monitoring tools.

12) BPPD strongly urges Monsanto to submit da ta and information cited in the benefits assessment to help measure the impacts and pote ntial benefits of the use of MON 863 corn on a wide scale. [Note that th is is not a required term or condition of the registration.] No information submitted, but not required.

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

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

1] Requirements relating to crea tion of a non-Cry3Bb1 Bt corn re fuge in conjunc tion with the planting of any acreage of commercial Cry3Bb1 Bt corn;

2] Requirements for the registrants to prepare and require Cry3Bb1 Bt corn users to sign ““grower agreements”” which impose binding contractual obligations on the grower to comply with the refuge requirements;

3] Requirements for the registrants to develop, implement, and report to EPA on programs to educate growers about IRM requirements;

4] Requirements for the registrants to develop, implement, and report to EPA on programs to evaluate and promote growers’’ complian ce with IRM requirements (the Cry3Bb1 Compliance Assurance Program (CAP) must inte grate with the CAP already approved for MON810, EPA Registration Number 524-489);

5] Requirements for the registrants to develo p, implement, and report to EPA on monitoring programs to evaluate whether there are statis tically significant and biologically relevant changes in target insect susceptibility to Cry3Bb1 protein in th e target insects;

6] Requirements for the registrant s to develop, and if triggered, to implemen t a ““remedial action plan”” which would contain measures the registra nts would take in the event that any insect

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

7] Submit annual reports on units so ld by state (units sold by count y level will be made available to the Agency upon request), IRM grower ag reements results, compliance and assurance program including the educational program on or before January 31st each year.

a. Refuge Requirements

Grower agreements (also known as stewardship agreements) will specify that growers must adhere to the refuge requirements as describe d in the grower guide/product use guide and/or in supplements to the grower guide/product use guide.

- Specifically, growers must plan t a structured refuge of at l east 20% non-Cry3Bb1 Bt corn that may be treated with insecticides as needed to control corn rootworm larvae. Growers will not be permitted to apply CRW labeled insecticides to the refuge for control of insect pests while adult corn rootworm are present unless the Cr y3Bb1 field is treated in a similar manner.

- Refuge planting options include: refuge acres should be planted as blocks adjacent to MON 863 corn fields or as in-field strips.80 - External refuges must be plante d adjacent to Cry3Bb1 MON 863 fields.

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

wide.

- Insecticide treatments for contro l of corn rootworm larvae may be applied. Instructions to growers will specify that insecticides labeled fo r control of corn root worm adults cannot be applied while adults are present in the refuge unless the Cry3Bb1 field is treated in a similar

manner.
b. Grower Agreements

1] Persons purchasing the Bt corn product must sign a grower agreement. The term ““grower agreement”” refers to any grower purchase 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 contract ually bound to comply with the requirements of the IRM program.

3] The registrant must develop a system (equi valent to what is al ready approved for MON 810, EPA Reg. No. 524-489) which is re asonably likely to assure that persons purchasing the Bt corn product will affirm annually that they are contractually bound to comply with the requirements of the IRM program. The proposed system will be submitt ed 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 specific stewardship documents referenced in the grower agreement. If Monsanto wishes to change any part of the grower agreement or any specific stewardship documents referenced in the grower agreement that would affect either the content of the IRM program or the legal enforceability of the provisions of the agreement relating to the IRM program, thirty days prior to implemen ting a proposed change, the registrant must submit to EPA the text of such changes to ensure that it is consistent with

the terms and conditions of the amendment.

5] The registrant must establish a system (equi valent to what is alr eady approved for MON 810, EPA Reg. No. 524-489) which is re asonably likely to assure that persons purchasing the Bt corn sign grower agreement(s), and must pr ovide within 90 days from the date of the registration a written desc ription of that system.

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

7] Beginning on January 31, 2004 and annually thereaft er, the registrant shall provide EPA with a report showing the number of units of its Bt MON863 corn seeds sold or shipped and not returned, and the number of such units that were sold to pe rsons 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.81 c. IRM Education and IRM Co mpliance Monitoring Programs

1] Monsanto must design and implement a comprehensive, ongoing IRM education program designed to convey to Bt MON863 corn users the importance of complying with the IRM program. The program shall include informa tion encouraging Bt MON863 corn users to pursue optional elements of the IRM program re lating to refuge configuration and proximity to Bt MON863 corn fields. The education progr am shall involve the us e of multiple media,e.g. face-toface meetings, mailing written materials, EPA reviewed language on IR M requirements on the bag or bag tag, and electronic communications such as by Internet, radio, or television commercials. Copies of the materials will be provided to EPA for its records. The program shall involve at least one written communication annually to each Bt MON863 corn user separate from the grower technical guide. Th e communication shall inform the user of the current IRM requirements. Monsanto shall coordinate its education programs with educational efforts of other registrants and ot her organizations, such as the National Corn Growers Association and 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] Beginning January 31, 2004 and 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 registrant must e ither submit a separate report or contribute to the report from the industry working group (ABSTC).

4] The registrant must design and implement an ongoing IRM compliance assurance program designed to evaluate the extent to which growers purchasing it s MON863 Bt corn product are complying with the IRM program and that take s 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 MON863 Bt corn product. The registrant shall coordinate with other Bt corn registrants in designing and implementing its compliance assurance program and integrate the Cry3Bb1 CAP with the CAP 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] - 15] 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 program and general criteria for choosing among options for responding to any non-compliant grow ers. The options shall include withdrawal of the right to purchase MON863 Bt corn for an individual grower or for all growers in a specific region. An individual grower found to be significantly out of compliance two years in a row would be denied sales of the product the next year. Similarl y, seed dealers who are not fulfilling their obligations to inform/educat e growers of their IRM obligations will lose their opportunity to sell MON863 Bt corn.

6] The IRM compliance assurance program sha ll include an annual survey conducted by an independent third party of a statistically re presentative sample of growers of Bt corn82 protected products who plant the va st majority of all corn in th e 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 w ho plant 100 or more acres of corn in corncotton areas.. The survey shall measure the degr ee of compliance with the IRM program by growers in different regions of the country and consider the potential im pact of non-response. The sample size and geographical resolution may be adjusted annually, based upon input from the independent marketing research firm and academic scientists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasonable sensitivity for comparing results across the U.S.

7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potenti al 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 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 su rvey prior 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] through 8] and fr om 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 conduct an annual on-farm assessment program. The registrant shall train its representatives who make on-farm visits with growers of their Bt corn products to perform assessments of compliance with IRM requiremen ts. 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 th ese visits result in the identifica tion 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 ou t 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 it’s ““phased compliance approach.””

13] If a grower, who purchases MON863 Bt corn fo r planting, was specifically identified as not being in compliance during the previous year, th e registrant shall visit with the grower and evaluate whether that the grower is in compliance with the IRM program for the current year.

14] Beginning January 31, 2004 and annually thereafter, Monsanto shall provide a report to EPA summarizing the activities carried out under thei r 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 inte ractions (including, but not limited to, on-farm visits, verified tips and complaints, growermeetings and letters), the extent of noncompliance, corrective measures to address the non-compliance, and any follow-up actions

taken.83 15] The registrant and the seed corn dealers 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.

d. Insect Resistance Monitoring

The Agency is imposing the following conditions for this product: 1) The registrants will monitor for resistance a nd/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. You must submit a pr otocol within 90 days of the date of registration.

2) The registrant shall provide to EPA a description of its resi stance monitoring plan by January 31, 2004. The description shall include: sampling (number of locations and samples per locations), sampling methodol ogy, bioassay methodology, standardization procedures, detection technique and sensitivit y, and the statistical analysis of the probability of detecting

resistance.

3) The registrant must follow up on grower, extension spec ialist or consultant reports of less than expected results or control failures for the corn rootworm. The registrant will instruct its customers (growers and seed distributors) to contact them (e.g., via a toll-free customer service number) if incidents of une xpected levels of damage occurs from these target pests. The registrant will investigate all damage reports submitted to the company or the company’s representatives. See Remedial Action Plans section below.

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

e. Remedial Action Plans

A Remedial Action Plan covering both suspected and confirmed resistance for corn rootworm must be submitted by 1/31/2004. If resistance is confirmed, all MON863 acres (including

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

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

Annual Reports:

The registrant will provide annua l reports to EPA by January 31 st each year based on the following table.

Report Description

Annual Sales Reported by state

Grower Agreement N umber of units of Bt corn seeds shipped or sold and not returned, and the number of such units that were sold to persons84 who have signed grower agreements

Grower

Education Significant changes in grower education plan

Compliance

Assurance

Plan Compliance Assurance Program activities and results

Compliance Annual survey results and plans for the next year

Additionally, at least 30 days before any changes related to IRM are expected to be imposed (e.g. grower agreement); a report of such changes mu st be submitted to EPA. Results of insect resistance monitoring and investigations of damage reports must be submitted by April 30 th each

year.85 Registrant Registration # Active Ingredients Date Registered Date Expired

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

YieldGard Plus

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

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

2) The subject registration will be limited to the use of a) Bacillus thur ingiensis Cry3Bb1 Protein and the Genetic Material Necessary for its Production (Vector ZMIR 13L) in MON 863 corn and b) Bacillus thuringiensis Cry1Ab1 Protein and the Genetic Material Necessary for its

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

MON 810 and MON 863 corn.

3) Monsanto must submit/cite all data required for registration of their product under FIFRA§ 3(c) (5) when the Agency requires registrant s of similar products to submit such data.

4) Monsanto must submit production information for this product to th e Office of Pesticide Programs for the fiscal year in which this product is conditionally regist ered, in accordance with FIFRA § 29. The fiscal year begins October 1 and ends September 30. Production information will be submitted to the Agency no later than December 15, following the end of the preceding fiscal year.

5) Monsanto must submit all data required to support the individual plant-incorporated protectants in YieldGard® Corn Borer (M ON 810) and YieldGard® Rootworm (MON 863) corn, EPA Registration Nos. 524-489 & 524-528.

6) Monsanto must submit small and large-scale field studies conducted with YieldGard® Plus Corn with appropriate end poi nts and statistical power to verify there are no adverse ecological effects to non-target invertebrate populations. M onsanto must submit annual reports each year of this registration ev ery April 30th, beginning in 2005, provided the registration expiration date is extended.

7) Monsanto must submit field degradation studi es evaluating accumulation and persistence of Cry1Ab and Cry3Bb1 from YieldGard® Plus Corn in several different soils in various strata. Representative fields must have been planted with YieldGard® Plus Corn for at least three consecutive years and include bo th conventional tillage and no-till samples and be harvested under typical agronomic conditions. Sampling must begin after three consecutive years of YieldGard® Plus Corn planting and continue until the limit of detection is reached. Studies should include soils with high levels of a variet y of clays. Both ELISA and insect bioassays need to be conducted and compared to de termine if Cry1Ab and Cry3Bb1 are accumulating or persisting in soil samples. A protocol is due within 120 days of th e date of registration. Planting of YieldGard® Plus Corn for the study must begin in 2004, with sampling beginning after the 2006 growi ng season. Provided, the registra tion and tolerance exemption are amended to extend the expiration date s, a final report is due November 15, 2007.86 8) 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 conventional breeding, with other plant-incorporat ed protectants to produce inbred corn lines and hybrid corn va rieties with combined pesticidal traits.

9) Monsanto must do the following In sect Resistance Management Program:

The required IRM program for YieldGard Plus ® Bt corn has the following elements:

1] Requirements relating to cr eation of either common or se parate refuges for Cry3Bb1 and Cry1Ab in conjunction with the planting of a ny acreage of commercial YieldGard Plus® Bt

corn;
2] Requirements for the registrant to prepare and require YieldGar d Plus® Bt corn users to sign ““grower agreements”” which impose binding contractual obligations on the grower to comply with the refuge requirements;

3] Requirements for the registrant to develop, implement, and report to EPA on programs to educate growers about IRM requirements;

4] Requirements for the registrant to develop, implement, and report to EPA on programs to evaluate and promote growers’’ compliance wi th IRM requirements (the YieldGard Plus® Compliance Assurance Program (CAP) must in tegrate with the Cry1 and Cry3Bb1 Caps);

5] Requirements for the registrant to develop, implement, and report to EPA on monitoring programs to evaluate whether there are statis tically significant and biologically relevant changes in target insect suscep tibility to Cry3Bb1 or Cry1Ab protei ns in the target insects;

6] Requirements for the registrant to develop, a nd if triggered, to implement a ““remedial action plan”” which would contain measures the registra nts would take in the event that any insect

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

7] Submit annual reports on units so ld by state (units sold by count y level will be made available to the Agency upon request), IRM grower ag reements results, compliance and assurance program including the educational program on or before January 31st each year.

a. Refuge Requirements

These refuge requirements do not apply to seed 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.

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

For 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 hybri ds 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 YieldGard Plus acres and refuge acres). It can be planted as a block adjacent to the YieldGard Pl us field, perimeter strips, or in-field strips. If perimeter strips are implemented, the strips must be at least 4 consecutive rows wide. If strips within the87 YieldGard Plus field are implemented, then at least 4 consecutive rows should be planted. The common refuge can be treated with a soil-applied or seed-applied insecticide to control

rootworm larvae and other soil pests. The refuge can also be treated with a non-Bt foliar

insecticide for control of late season pests if pest pressure reaches an economic threshold for damage; however, if rootworm adults are presen t at the time of foliar applications then the

YieldGard Plus field must be treated in a similar manner.

The second option is planting separate refuge ar eas for corn borers and corn rootworms. The corn borer refuge must be planted with a non-B t/lepidopteran-protected hybrid, must represent at least 20% of the grower’s corn acres (i.e. sum of YieldGard Plus acres and corn borer refuge acres), and must be planted within 1⁄2 mile of th e YieldGard Plus field. The corn borer refuge can be treated with a soil-applied or seed-applied insecticide for corn rootworm larval control, or a non- Bt foliar-applied insecticide for corn borer control if pest pressu re reaches an economic threshold for damage. The corn rootworm refuge must be planted with a non-Bt/corn rootwormprotected hybrid, but can be planted with Bt co rn hybrids that control corn borers. The corn rootworm refuge must represent at least 20% of the grower’s co rn acres (i.e. sum of YieldGard

Plus acres and corn rootworm re fuge acres) and can be planted as an adjacent block, perimeterstrips, or infield strips. The corn rootworm refuge can be treated with a soil-applied or seed-applied

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

non-Bt foliar insecticide for control of late season pests; however, if rootworm adults are present at the time of foliar applications then the Yiel dGard Plus field must be treated in a similar manner. Growers who fail to comply with the IRM requirements risk losing access to the product.

Cotton Growing Area Refuge Requirements

For YieldGard Plus corn grown in cotton-growi ng areas the common refuge and separate refuge options are also available, however, the refuge area is larger. Cotton-growing areas include the following states: Alabama, Arkansas, Florida, Geor gia, Louisiana, North Carolina, Mississippi, South Carolina, Oklahoma (only the counties of Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, and Washit a), Tennessee (only th e counties of Carroll, Chester, Crockett, Dyer, Fayette, Frank lin, Gibson, Hardeman, Hardin, Haywood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, a nd Tipton), 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 Cit y, Surrey, and Sussex), and Missouri (only the counties of Dunkin, New Madrid, Pemiscot, Scott, and Stoddard).

The first option is planting a common refuge fo r both corn borers and corn rootworms. The common refuge must be planted with corn hybri ds 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. sum of YieldGard Plus acres and refuge acres). It can be planted as a block adjacent to the YieldGard Pl us field, perimeter strips, or in-field strips. If perimeter strips are implemented, the strips must be at least 4 consecutive rows wide. If strips within the YieldGard Plus field are implemented, then at least 4 consecutive rows should be planted. The common refuge can be treated with a soil-applied or seed-applied insecticide to control

rootworm larvae and other soil pests. The refuge can also be treated with a non-Bt foliar

insecticide for control of late season pests if pest pressure reaches an economic threshold for88 damage; however, if rootworm adults are presen t at the time of foliar applications then the

YieldGard Plus field must be treated in a similar manner.

The second option is planting separate refuge ar eas for corn borers and corn rootworms. The corn borer refuge must be planted with a non-B t/lepidopteran-protected hybrid, must represent at least 50% of the grower’s corn acres (i.e. sum of YieldGard Plus acres and corn borer refuge acres), and must be planted within 1⁄2 mile of th e YieldGard Plus field. The corn borer refuge can be treated with a soil-applied or seed-applied insecticide for corn rootworm larval control, or a non- Bt foliar-applied insecticide for corn borer control if pest pressure reaches an economic threshold for damage. The corn rootworm refuge must be planted with a non-Bt corn/rootwormprotected hybrid, but can be planted with Bt co rn hybrids that control corn borers. The corn rootworm refuge must represent at least 20% of the grower’s co rn acres (i.e. sum of YieldGard

Plus acres and corn rootworm ref uge acres) and be planted as an adjacent block, perimeter strips, or in-field strips. The corn rootworm refuge can be treated with a soil-applied or seed-applied

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

non-Bt foliar insecticide for control of late season pests; however, if rootworm adults are present at the time of foliar applications then the Yiel dGard Plus field must be treated in a similar manner. Growers who fail to comply with the IRM requirements risk losing access to the product.

b. Grower Agreements

1] Persons purchasing the Bt corn product must sign a grower agreement. The term ““grower agreement”” refers to any grower purchase 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 contract ually bound to comply with the requirements of the IRM program.

3] The registrant must develop a system (equi valent to what is al ready approved for MON 810, EPA Reg. No. 524-489) which is re asonably likely to assure that persons purchasing the Bt corn product will affirm annually that they are contractually bound to comply with the requirements of the IRM program. The proposed system will be submitt ed 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 specific stewardship documents referenced in the grower agreement. If Monsanto wishes to change any part of the grower agreement or any specific stewardship documents referenced in the grower agreement that would affect either the content of the IRM program or the legal enforceability of the provisions of the agreement relating to the IRM program, thirty days prior to implemen ting a proposed change, the registrant must submit to EPA the text of such changes to ensure that it is consistent with

the terms and conditions of the amendment.

5] The registrant must establish a system (equi valent to what is alr eady approved for MON 810, EPA Reg. No. 524-489) which is re asonably likely to assure that persons purchasing the Bt corn sign grower agreement(s), and must pr ovide within 90 days from the date of the registration a written desc ription of that system.

6] The registrant shall maintain records of all Bt corn grower agreements for a period of three years from December 31st of the year in which the agreement was signed.89 7] Beginning on January 31, 2005 and annually thereaft er, the registrant shall provide EPA with a report showing the number of units of its Yiel dGard Plus® corn seeds sold or shipped and not returned, and the number of such units that were sold to persons who have signed grower agreements. The report shall cover the time frame of the twelve-month period covering the prior August through July.

8] The registrant must allow a review of the grower agreements and grower agreement records by EPA or by a State pesticide regulatory agency if the State agency can demonstrate that confidential business information, including name s, personal information, and grower license number, will be protected.

c. IRM Education and IRM Co mpliance Monitoring Programs

1] Monsanto must design and implement a comprehensive, ongoing IRM education program designed to convey to YieldGard Plus corn us ers the importance of complying with the IRM program. The program shall include information encouraging YieldGard Plus corn users to pursue optional elements of the IRM program re lating to refuge configuration and proximity

to YieldGard Plus corn fields. The educati on 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 wr itten communication annually to each YieldGard Plus corn user separate from the grower t echnical guide. The communication shall inform the user of the current IRM require ments. Monsanto shall coordina te its education programs with educational efforts of other registrants and ot her organizations, such as the National Corn Grower Association and 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] Beginning January 31, 2005 and 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 registrant must e ither submit a separate report or contribute to the report from the industry working group (ABSTC).

4] The registrant must design and implement an ongoing IRM compliance assurance program designed to evaluate the extent to which grow ers purchasing its YieldGard® Plus Bt corn product are complying with the IRM program and that takes such actions as are reasonably needed to assure that grower s who have not complied with th e program either do so in the

future or lose their access to the YieldGard® Plus Bt corn product. Monsanto shall ensure that the YieldGard® Plus compliance assurance program (CAP) will be consistent with and integrated with the Caps for MON 863 and MON 810, EPA Registration Nos. 524-489 and 524-528. The registrant must prepare and submit w ithin 90 days of the date of registration a written description of their compliance assu rance program including a summary of the program to be implemented in the 2004 growi ng season. Other required features of the program are described in pa ragraphs 5] - 15] 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 non-90 compliance with the terms of the IRM program and general criteria for choosing among options for responding to any non-compliant grow ers. The options shall include withdrawal of the right to purchase YieldGar d Plus corn for an individual gr ower 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. Similarl y, seed dealers who are not fulfilling their obligations to inform/educat e growers of their IRM obligations will lose their opportunity to sell YieldGard Plus corn.

6] The IRM compliance assurance program sha ll include an annual survey conducted by an independent third party of a statistically re presentative sample of growers of Bt corn protected products who plant the va st majority of all corn in th e 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 w ho plant 100 or more acres of corn in corncotton areas.. The survey shall measure the degr ee of compliance with the IRM program by growers in different regions of the country and consider the potential im pact of non-response. The sample size and geographical resolution may be adjusted annually, based upon input from the independent marketing research firm and academic scientists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasonable sensitivity for comparing results across the U.S.

7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potenti al 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 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 ot her registrants and EPA on the design and content of the su rvey prior 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] through 8] and fr om 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 changes.

11] The registrant shall conduct an annual on-farm assessment program. The registrant shall train its representatives who make on-farm visits with growers of their Bt corn products to perform assessments of compliance with IRM requirem ents. 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 th ese visits result in the identifica tion 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 ou t 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 it’s ““phased compliance approach.””91 13] If a grower, who purchases YieldGard Plus co rn for planting, was specif ically identified as not being in compliance during the previous year , the registrant shall visit with the grower and evaluate whether that the grower is in compliance with the IRM program for the current

year.
14] Beginning January 31, 2005 and annually thereafter, Monsanto shall provide a report to EPA summarizing the activities carried out under thei r 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 inte ractions (including, but not limited to, on-farm visits, verified tips and complaints, growermeetings and letters), the extent of noncompliance, corrective measures to address the non-compliance, and any follow-up actions

taken.

15] The registrant and the seed corn dealers 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.

d. Cry3Bb1 Insect Resistance Monitoring

The Agency is imposing the following conditions for this product:

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

should be focused in those areas in which there is the highest risk of resistance development. Monitoring must be carried out under the same protocols used for the individual trait product MON 863, EPA Registration No. 524-528.

2) The registrant shall provide to EPA a description of its resi stance monitoring plan by January 31, 2005. The description shall include: sampling (number of locations and samples per locations), sampling methodol ogy, bioassay methodology, standardization procedures, detection technique and sensitivit y, and the statistical analysis of the probability of detecting

resistance.

3) The registrant must follow up on grower, extension spec ialist or consultant reports of less than expected results or control failures for all pest s listed on the label an d/or grower guide. The registrant will instruct its customers (growers and seed distributors) to contact them (e.g., via a toll-free customer service number) if incidents of unexpected levels of damage occurs from these target pests. The regi strant will investigate all da mage reports submitted to the company or the company’s representatives. See Remedial Action Plans section below.

4) A report on results of resistance monitoring and investigations of damage reports must be submitted to the Agency annually by August 31 st each year for the duration of the conditional registration, beginning in 2005.

e. Cry 3Bb1 Remedi al Action Plans

A Remedial Action Plan covering both suspected and confirmed resistance must be submitted by 1/31/2005. If resistance is confirmed, all acres (Yie ldGard Plus and refuges) should be treated with insecticides targeted at CRW adults as well as larvae.

Annual Reports:

The registrant will provide annua l reports to EPA by January 31 st each year based on the following table.92 Report Description

Annual Sales Reported by state

Grower Agreement N umber of units of Bt corn seeds shipped or sold and not returned, and the number of such un its that were sold to persons who have signed grower agreements

Grower

Education Significant changes in grower education plan

Compliance

Assurance

Plan Compliance Assurance Program activities and results

Compliance Annual survey results and plans for the next year

Additionally, at least 30 days before any changes related to IRM are expected to be imposed (e.g. grower agreement); a report of such changes mu st be submitted to EPA. Results of insect resistance monitoring and investigations of damage reports must be submitted by April 30 th each

year.

f. Cry1Ab Insect Resistance Monitoring

The Agency is imposing the following conditions for this product:

The registrant will monitor for resistance to its lepidopteran-resi stant 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) 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 focused93 in areas identified as those with the highest risk of re sistance development (e.g., where lepidopteran-active Bt hybrids ar e planted on a high proportion of the corn 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 popula tion response to lepidopte ran resistant Bt corn and/or changes in resistance alle le 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 importa nce and for the adoption levels of lepidopteran-resistant Bt corn. The Agency shall be consulted prior to the implementation of such modifications.

The registrant will report to the Agency before August 31 each year the results of the population sampling and bioassay monitoring program.

Any incidence of unusually low sensitivity to the Bt protein in bioassays shall be investigated as soon as possible to understand 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 collect ed population to determine wh ether 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 repr oducible and heritable, progeny of insects that survive the diagnostic concentration will be tested using met hods that are representative of exposure to Bt corn hybrids under field conditi ons. If progeny do not survive to adulthood, 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);94 • 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 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 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 grower, extension specialist or consultant reports of unexpected levels of damage by the lepidopteran pests listed on the pesticide label. The registrant will

instruct its customers to contact them if such in cidents occur. The registrant 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 registrant will implemen t 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 unexpe cted levels of insect feeding damage for which:

• the corn in question has been confirme d to be lepidopteran-active Bt corn;

• the seed used had the proper percenta ge of corn expres sing Bt protein;

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

• it has been ruled out that speci es not susceptible to the prot ein 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 ins ect 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 pr oduction fields before responsive measures are

undertaken.95 If resistance is suspected, the registrant will instruct growers to do the following:

• Use alternative control measures in the Bt corn fields in the affected region to control the target pest during the immediate growing season.

• Destroy Bt corn crop residues in the affected region within one month after harvest with a technique appropriate for local production practices to mi nimize the possibility of

resistant insects over-winteri ng and contributing to the next season's target pest population.

Additionally, if possible, and pr ior to the application of alte rnative control measures or destruction of crop residue, the registrant will collect samples of the insect population in the affected fields for laboratory re aring and testing. Such rearing a nd 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 bi oassays using diagnostic concen trations 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 ex tent and impact of resistance;96 • If appropriate (depending on the resistant pest species, the extent of resistance, the timing of resistance, and the nature of resistance, and the 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.

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.97 Registrant Registration # Active Ingredients Date Registered Date Expired

Monsanto 524-551 Bt corn Event MON 88017 with Cry3Bb1 (YieldGard VT RW) 13-Dec-05 30-Sep-10

MON 88017

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

2) The subject registration will be limited to Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its producti on (Vector 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) Submit all data required to support the individual plant-incorporated pr otectant in Event MON863 (YieldGard Rootworm), 524-528. In the event that the Agency concludes MON 863 (YieldGard Rootworm) studies do not sufficiently demonstrate a lack of significant adverse effects, additional data with MON 88017 corn must be submitted. This data may include a) laboratory toxicity testing with Orius insidiosus (minute pirate bug), b) laboratory toxicity testing with a carabid (g round beetle), c) long range effects te sting on invertebrate populations in the field, and d) long range soil persistence testing.

5) You must commit to do the following Insect Resistance Management Program:

a. Refuge Requirements

1. Grower agreements (also known as 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 plan t a structured 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. 3. 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 ins ecticides 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 Agreements98 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 develop a system (equi valent to what is al ready approved for MON 810, EPA Reg. No. 524-489) which is re asonably likely to assure that persons purchasing the Bt corn product will affirm annually that they are contractually bound to comply with the requirements of the IRM program. The proposed system will be submitt ed 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 specific stewardship documents referenced in the grower agreement. If Monsanto wishes to change any part of th e 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 implemen ting a proposed change, the registrant must submit to EPA the text of such changes to ensure that it is consistent with

the terms and conditions of the amendment. 5] The registrant must establish a system (equi valent to what is alr eady approved for MON 810, EPA Reg. No. 524-489) which is re asonably likely to assure that persons purchasing the Bt corn sign grower agreement(s), and must pr ovide within 90 days from the date of the registration a written desc ription of that system. 6] The registrant shall maintain records of all Bt corn grower agreemen ts for a period of three years from December 31st of the year in which the agreement was signed. 7] Beginning on January 31, 2007 and annually thereaft er, the registrant shall provide EPA with a report showing the number of units of its Bt MON 88017 corn seeds sold or shipped and not returned, and the number of such units that were sold to persons who have signed grower agreements. The report shall cover the time frame of the twelve-month period covering the prior August through July. 8] The registrant must allow a review of the grower agreements and grower agreement records by EPA or by a State pesticide regulatory agency if the State agency can demonstrate that confidential business information, including 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 Bt MON 88017 corn users the importance of complying with the IRM program. The program shall include informati on 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 wr itten communication annually to each Bt MON99 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] On January 31, 2007, the registrant must pr ovide a report to EPA su mmarizing the activities

carried out under the education program for the prior year. Annua lly thereafter, the registrant must provide EPA any substantive changes to its grower educatio n activities as part of the overall IRM compliance assurance program report. The required features of the compliance assurance program are described in paragraphs 4]-15] below. 4] The registrant must design and implement an ongoing IRM compliance assurance program designed to evaluate the extent to which growers purchasing its MON 88017 Bt corn product are complying with the IRM program and that 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 co rn product. The registrant shal l 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] - 15] below. 5] The registrant must establish and publicize a “phased compliance approach,” i.e., a guidance document that indicates how the registrant will address instances of non-compliance with the terms of the IRM program and general criteria for choosing among options for responding to any non-compliant growers. The options shall 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. 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. 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.100 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] through 8] and fr om 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 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] Beginning January 31, 2007 and annually thereafter, Monsanto shall provide a report to EPA summarizing the activities carried out under thei r 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 inte ractions (including, but not limited to, on-farm visits, verified tips and complaints, growermeetings and letters), the extent of noncompliance, corrective measures to address the non-compliance, and any follow-up actions

taken. 15] The registrant and the seed corn dealers 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.

9d. Insect Resistance Monitoring

The Agency is imposing the following conditions for 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 registrant must provide EPA its resist ance monitoring plan for approval. A revised monitoring plan must be submitted to the Agency with 3 months of the date of registration consisting of a descri ption of the steps to be take n to establish corn rootworm baseline sensitivity and damage guidelines. A detailed resistance monitoring plan must be submitted to the Agency for review by January 31, 2008. This plan must include: baseline101 sensitivity data, sampling (number of locations, samples per locations), sampling methodology and life-stage sampled, bioassay methodology, standardization procedures (including QA/QC provisions), de tection technique and sensitivity, the statistical analysis of the probability of detecting resistance, a nd an interim description of rootworm damage guidelines.

2. The registrant must develop and validate an appropriate discriminating or diagnostic dose assay by January 31, 2010.

3. You must finalize rootworm damage guide lines and submit these to BPPD by January 31, 2010.

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 beginning with 2007, reporting on populations collected the previous year.

e. 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 and summed by st ate (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.102 Registrant Registration # Active Ingredients Date Registered Date Expired

Monsanto 524-552 Bt corn Event MON 88017 + MON 810 with Cry1Ab + Cry3Bb (YieldGard VT Plus) 13-Dec-05 30-Sep10

MON 88017 x MON 810

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

2) The subject registration will be limited to Cry3Bb1 [ Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (Vector ZMIR 39) in MON 88017 corn (OECD Unique Identifier: MON-88Ø17-3)] X Cr y1Ab [Bacillus thuri ngiensis Cry1Ab deltaendotoxin and the genetic material necessary for its production in corn] corn for use in field corn.

3) Submit/cite all data required for 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 all data required to support the individu al plant-incorporated protectants in MON 810 (YieldGard), Event MON863 (YieldGard Root worm), MON 88017 corn; EPA Registration Nos. 524-489, 524-528. In the event that the Agency concludes MON 863 (YieldGard Rootworm) studies do not sufficiently demonstrate a lack of significant adverse effects, additional data with

MON 88017 x MON 810 corn must be submitted. This data may include a) laboratory toxicity testing with Orius insidiosus (minute pirate bug), b) laboratory toxicity testing with a carabid (ground beetle), c) long range eff ects testing on inverteb rate populations in the field, and d) long range soil persistence testing.

5) Submit expression level data regarding Cr y1Ab protein levels in MON 810 and MON 88017 x MON 810 young root and forage root within 12 months of the date of registration.

6) The subject plant-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.

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.

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.103 Corn Belt / Non-Cotton Growi ng Region Refuge Requirements

For 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 hybri ds 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] acre s and refuge acres). It can be planted as a block adjacent to the [MON 88017 x MON 810] field, perimeter strips, or in-field strips. If perimeter strips are 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 can be treated with a soil -applied or seed-applied

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

non-Bt foliar insecticide for control of late seas on 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 ar eas for corn borers and corn rootworms. The corn borer refuge must be planted with a non-B t/lepidopteran-protected hybrid, must represent at least 20% of the grower’s corn acres (i.e. sum of [MON 88017 x MON 810] acres and corn borer refuge acres), and must be planted within 1⁄2 mile of the [MON 88017 x MON 810] field. The corn borer refuge can be treated with a soil-appl ied or seed-applied insecticide for corn rootworm larval control or a non-Bt foliar-app lied insecticide for corn borer c ontrol if pest pressure reaches an economic threshold for damage. The corn r ootworm refuge must be planted with a nonBt/corn rootworm-protected hybrid, but can be planted with Bt co rn hybrids that control corn borers. The corn rootworm refuge must represent at least 20% of the grower’s corn acres (i.e. sum of [MON 88017 x MON 810] acres and corn rootworm refuge acres) and can be planted as an adjacent block, perimeter strips, or in-field st rips. The corn rootworm refuge can be treated with a soil-applied or seed-applied insecticide to control rootworm larv ae and other soil pests. The refuge can also be treated with a non-Bt foliar ins ecticide for control of late season pests; however, if rootworm adults are present at th e time of foliar applications then the [MON 88017 x MON 810] field must be treated in a similar manner. Growers w ho 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).104 The first option is planting a common refuge fo r both corn borers and corn rootworms. The common refuge must be planted with corn hybri ds 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. sum of [MON 88017 x MON 810] acres and refuge acres). It can be planted as a block adjacent to the [MON 88017 x MON 810] field, perimeter strips, or in-field strips. If perimeter strips are 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 can be treated with a soil -applied or seed-applied

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

non-Bt foliar insecticide for control of late seas on 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 ar eas for corn borers and corn rootworms. The corn borer refuge must be planted with a non-B t/lepidopteran-protected hybrid, must represent at least 50% of the grower’s corn acres (i.e. sum of [MON 88017 x MON 810] acres and corn borer refuge acres), and must be planted within 1⁄2 mile of the [MON 88017 x MON 810] field. The corn borer refuge can be treated with a soil-appl ied or seed-applied insecticide for corn rootworm larval control or a non-Bt foliar-app lied insecticide for corn borer c ontrol if pest pressure reaches an economic threshold for damage. The corn root worm refuge must be planted with a non-Bt corn/rootworm-protected hybrid, but can be plante d with Bt corn hybrid s that control corn borers. The corn rootworm refuge must represent at least 20% of the grower’s corn acres (i.e. sum of [MON 88017 x MON 810] acres and corn rootworm refuge ac res) and be planted as an adjacent block, perimeter strips, or in-field strips . The corn rootworm ref uge can be treated with a soil-applied or seed-applied insecticide to cont rol rootworm larvae and other soil pests. The refuge can also be treated with a non-Bt foliar insecticide for control of late season pests; however, if rootworm adults are present at th e time of foliar applications then the [MON 88017 x MON 810] field must be treated in a similar manner. Growers w ho 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 al ready approved for MON 810, EPA Reg. No. 524-489) which is reasonably likely to assure that persons purchasing the Bt corn product will affirm annually that they are 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 the105 content of the IRM program or the legal enfo rceability 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 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) which is reasonably likely to assure that persons purchasing the Bt corn sign grower agreement(s), and must provide within 90 days from the date of the registration a written description of that system. 6] The registrant shall maintain records of all Bt corn grower agreements for a period of three years from December 31st of the year in which the agreement was signed. 7] Beginning on January 31, 2007 and annually thereaft er, the registrant shall provide EPA with a report showing the number of units of its [MON 88017 x MON 810] corn seeds sold or shipped and not returned, and the number of such units th at 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 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 requi rements 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 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] On January 31, 2007, the registrant must pr ovide a report to EPA su mmarizing the activities

carried out under the education program for the prior year. Annua lly thereafter, the registrant must provide EPA any substantive changes to its grower educatio n activities as part of the overall IRM compliance assurance program report. The required features of the compliance assurance program are described in paragraphs 4]-15] below. 4] The registrant must design and implement an ongoing IRM compliance assurance program designed to evaluate the extent to whic h growers purchasing its [MON 88017 x MON 810] Bt corn product are complying with the IRM program and that takes such actions as are106 reasonably needed to assure that growers who have not complied with the program either do

so in the future or lose their access to the [MON 88017 x MON 810] Bt corn product. The registrant shall coordinate with other Bt co rn registrants in designing and implementing its compliance assurance program and integrat e the Cry3Bb1 CAP with the CAP already approved for MON810, EPA Registration Number 524-489. The registrant must prepare and submit within 90 days of the 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 ar e described in paragraphs 5] - 15] below. 5] The registrant must establish and publicize a “phased compliance approach,” i.e., a guidance document that indicates how the registrant will address instances of non-compliance with the terms of the IRM program and general criteria for choosing among options for responding to any non-compliant growers. The options shall 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 poten tial 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. 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] through 8] and fr om 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.107 12] The registrant shall carry out a program for investigating legitimate “tips and complaints” that its growers are not in compliance with the IRM program. Whenever an investigation

results in the identification of a grower who is not in compliance with the IRM program, the registrant shall take 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] Beginning January 31, 2007 and annually thereafter, Monsanto shall provide a report to EPA summarizing the activities carried out under thei r 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 inte ractions (including, but not limited to, on-farm visits, verified tips and complaints, growermeetings and letters), the extent of noncompliance, corrective measures to address the non-compliance, and any follow-up actions

taken. 15] The registrant and the seed corn dealers 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.

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) For the Cry3Bb1 portion of th e product, the registrant must provide EPA its resistance monitoring plan for approval. A revised monito ring plan must be submitted to the Agency with 3 months of the date of registration consistin g of a description of th e steps to be taken to establish corn rootworm baseline sensitivity a nd damage guidelines. A detailed resistance monitoring plan must be submitted to the Ag ency for review by January 31, 2008. This plan must include: baseline sensitivity data, sampling (number of locations, samples per locations), sampling methodology and lif e-stage sampled, bioassay methodology, standardization procedures (including QA/ QC provisions), detection technique and sensitivity, the statistical analysis of the probability of detecting resistance, and an interim description of rootworm damage guidelines.

3) For the Cry3Bb1 portion of the product, the registrant must deve lop and validate an appropriate discriminating or dia gnostic dose assay by January 31, 2010.

4) For the Cry3Bb1 portion of the product, the registrant must fina lize rootworm damage guidelines and submit these to BPPD by January 31, 2010.

5) The registrant must follow- up on grower, extension specialis t or consultant reports of unexpected damage or control failures for corn rootworm.108 6) The registrant must provide EPA with an annual resistance monitoring report by August 31 st
of each year beginning with 2007, reporting on populations collected the previous year.

e. Cry3Bb1 Remedial Action Plans

Once a remedial action plan is approved for MON 863, it also must be used for corn rootworm suspected and confirmed 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-resi stant 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.

(8) Focused Population Sampling

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

nubilalis (European corn borer; ECB), Diatraea grandiosella (Southwestern corn borer; S WCB), and Helicoverpa zea (corn earworm; CEW). Sampling for 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 ar e planted on a high proportion of the corn 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 popula tion response to lepidopte ran resistant Bt corn and/or changes in resistance alle le 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 importa nce and for the adoption levels of lepidopteran-resistant Bt corn. The Agency shall be consulted prior to the implementation of such modifications.109 The registrant will report to the Agency before August 31 each year the results of the population sampling and bioassay monitoring program.

Any incidence of unusually low sensitivity to the Bt protein in bioassays shall be investigated as soon as possible to understand 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 met hods 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 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 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.110 If reports of unexpected levels of damage lead to the suspicion of resistance in any of the key target pests (ECB, SWCB, and CEW), the 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 confirme d to be lepidopteran-active Bt corn;

• the seed used had the proper percenta ge of corn expres sing Bt protein;

• the relevant plant tissues are expressing 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 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 mont h 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:111 • 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 bi oassays using diagnostic concen trations 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 ex tent 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; and112 • 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.113 Registrant Registration # Active Ingredients Date Registered Date Expired

Dow AgroSciences 68467-5 Bt corn Event DAS-591227- 7 with Cry 34Ab1 + Cry35Ab1 (Herculex RW) 31-Aug-05 30-Sep-10



### Terms and Conditions of the Registration

1) The subject registrations will automatical ly expire on midnight September 30, 2010. Based on the Agency’s review of the data submitted and cite d in support of this application, the Agency anticipates at this me that an expiration date five years from the initial date of registration for this product would be appropriate.

2) The subject registrations will be limited to B acillus thuringiensi s Cry34Ab1 and Cry35Ab1 proteins and the genetic materi al necessary for their production (plasmid insert PHP17662) in

Event DAS-59122-7 corn 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) Provide to the EPA laboratory (Ft. Meade, MD) methodology and/or reagents necessary for validation of a Cry34/35Ab1 analytical method with in 6 months of the date of registration.

5) Submit field degradation st udies evaluating accumulation a nd persistence of Cry34/35Ab1 in several different soils in various strata. Repr esentative fields must ha ve been planted with Cry34/35Ab1 corn and include both conventional tillage and no-till samp les and be harvested under typical agronomic conditions. Sampling must continue until the limit of detection is reached. Studies should include soils with high le vels of a variety of clays. Both ELISA and insect bioassays need to be conducted an d compared to determine if Cry34/35Ab1 is accumulating or persisting in soil samples. A prot ocol is due within 90 days of the date of registration. A final report regarding data from fields that have had three continuous years of

cultivation of Event DAS-59122-7 corn is due by January 31, 2010.

6) Submit laboratory toxicity tests with Orius insidiosus (minute pirate bug), carabid (ground beetle), within 24 months of th e date of registration. Protocols are due within 120 days of the date of registration.

7) Additional 3 year full-scale field or semi-field studies fo r evaluation of Cry34/35Ab1 Event

DAS-59122-7 corn exposure on non-target invertebrates must be conducted. Full-scale field experiments must be appropriate ly designed to provide a measur e of ecological impacts (larger fields, more replicates, more samples per pl ot based on recommendations of the August, 2002 SAP). The previously submitted two-year field study is not sufficient to determine if Cry34/35Ab1 corn will have long term impact on non- target invertebrates. A protocol is due within 90 days of the date of registra tion. A final report is due September 30, 2009.

8) The following insect resistance management data are recommended.114 Additional research on corn rootworm pest bi ology and ecology, genetics and mechanisms of resistance, functional dominance, fitness costs, cross-resistance potenti al, dose (including the role of density-dependence), and mode of action are recommended to evaluate the sustainability of the insect resistance management durability plan and confirm the assumptions made in the simulation models. Research reports should be provided to the Agency once the research is completed and at least nine months prior to the expiration of this registration.

Should you wish to amend the re fuge treatment option to allow independent treatment of the refuge for pests other than corn rootworms, da ta would be required regarding the impact of independent treatment of the ref uge for other pests (not corn r ootworm, e.g., corn borers, spider mites) on corn rootworm resistance management.

9) You must commit to do the following Insect Resistance Management Program which has the following elements:

a) Requirements relating to creation of a non-(cor n rootworm-protected PIP) corn refuge in conjunction with the planting of a ny acreage of comm ercial Cry34/35Ab1 Bt corn;

b) Requirements for the registrant s to prepare and require Cry34/35Ab1 Bt corn users to sign “grower agreements” which impose binding contract ual obligations on th e grower to comply with the refuge requirements;

c) Requirements for the registrants to develop, implement, and report to EPA on programs to educate growers about IRM requirements;

d) Requirements for the registrants to develop, implement, and report to EPA on programs to evaluate and promote grower s’ compliance with IRM re quirements (the Cry34/35Ab1 Compliance Assurance Program (CAP) mu st integrate with the Cry1 Caps);

e) Requirements for the registrants to develop, implement, and report to EPA on monitoring programs to evaluate whether ther e are statistically significant a nd biologically relevant changes in target insect susceptibility to Cry34/ 35Ab1 proteins in the target insects;

f) Requirements for the re gistrants to develop, a nd if triggered, to implement a “remedial action plan” which would contain measures the registra nts 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 so ld by state (units sold by count y level will be made available to the Agency upon request), IRM grower agre ements results, compliance assurance program including the education progr am, and resistance monitoring on or before January 31 st each year beginning in 2007.

9a. Refuge Requirements

Grower agreements (also known as stewardship agreements) will specify that growers must adhere to the refuge requirements as described in the grower guide/produ ct use guide and/or in115 supplements to the grower guide/product use guide.

1. Refuge size . The use of Cry34/35 corn from event DAS 59122-7 requires an accompanying 20% refuge

2. Refuge location. The rootworm refuge is required to be planted within or adjacent (e.g. across the road) to the Cry34/35 corn field.

3. Refuge management options. The rootworm refuge may be managed in such a way that there is little or no yield loss to rootworms, but mu st 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 m easuring at least four (4) crop rows wide.

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

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

• If the refuge is planted in continuous cor n, the Cry34/35 field may be planted on either continuous or rotated land (option encouraged where WCRW rotation -resistant biotype may be present).

• Application of soil insecticide is permitted in the refuge.

• Seed treatment is permitted in the refuge, eith er 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 onl y be treated with CRW-labeled insecticide on the refuge acres without trea ting the Cry34/35 acres if treatment occurs when adult corn rootworms are not present. Pests on the Cry34 /35 acres can be treate d as needed without having to treat the refuge.

• The rootworm refuge can be planted to any corn hybrid that does not express PIPs for rootworm control (e.g. lepidop teran-protected Bt corn, he rbicide-tolerant corn, or conventional corn).

• The refuge and Cry34/35 corn should be sown on the same date, or with the shortest window possible between planting dates, to ensure th at corn root development is similar among

varieties.

• Growers are encouraged to plant the rootworm re fuge 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 re fuge would be impractical.116 9b. Grower Agreements

1] Persons purchasing the Bt corn product must sign a grower agreement. The term “grower agreement” refers to any grower purchase contract , license agreement, or similar legal document.

2] The grower agreement and/or specific 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 (equivalent to what is already approved for Cry1F Bt corn) which is reasonably likely to assure that pers ons purchasing the Bt corn product will affirm annually that they are co ntractually bound to comply with th e requirements of the IRM program. The proposed system will be submitted to EPA by January 31, 2006.

4] The registrant must use grower agreements and submit to EPA by January 31, 2006 a copy of that agreement and any specific stewardship docume nts referenced in the grower agreement. If either registrant wishes to cha nge any part of the gr ower agreement or any specific stewardship documents referenced in the grower agreement th at would 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 pro posed change, the registrant must submit to EPA the text of such changes to ensure that it is consistent with the terms and conditions of the

amendment.

5] The registrant must establish a system (equiva lent to what is alrea dy approved for Cry1F Bt Corn) which is reasonably likely to assure that persons purchasing the Bt corn sign grower agreement(s), and must provide by January 31, 2006 a written descrip tion of that system.

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

7] Beginning on January 31, 2007 and annually thereaft er, the registrant shall provide EPA with a report showing the number of units of its Cr y34/35Ab1 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 fram e 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.

9c. IRM Education and IRM Co mpliance Monitoring Programs

1] The registrants must implement a compre hensive, 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 configurat ion and proximity to Bt117 Cry34/35Ab1 corn fields. The education program shall involve the use of multiple media, e.g. face-to-face meetings, mailing written materials, EPA review ed language on IRM requirements on the bag or bag tag, and electronic communicatio ns such as by Internet, radio, or television commercials. Copies of the materi als will be provided to EPA for its records for the first year of commercialization (2006 growi ng season) by January 31, 2007. Th e 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 or ganizations, such as the Nationa l Corn Grower Association and state extension programs.

2] Annually, the registrant shall revise, and expa nd as necessary, its education program to take into account the information collected through the compliance survey required under paragraph 6] and from other sources. Th e changes shall address aspects of grower compliance that are not sufficiently high.

3] Beginning January 31, 2008 and annually thereaf ter, the registrant must provide EPA any substantive changes to its grower education act ivities as part of the overall IRM compliance assurance program report. The required featur es of the compliance assurance program are described in paragraphs 4]-15] below.

4] The registrant must design and implement an ongoing IRM compliance assurance program designed to evaluate the extent to which growers purchas ing its Cry34/35Ab1 Bt corn product are complying with the IRM program and that takes such actions as are reasonably needed to assure that growers who have not complied with the program either do so in the future or lose their access to the Cry34/35Ab1 Bt corn product. The registrant shall coordinate with other Bt corn registrants in designing and implementing its compliance assurance program and integrate the Cry34/35Ab1 CAP with the Cry1 Caps. The re gistrant must prepare and submit by January 31, 2006 a written description of their compliance assurance progr am including a summary of the program implemented in the 2006 growing season. Other required features of the program are described in paragraphs 5] - 15] below.

5] The registrant must establish and publicize a “phased compliance approach,” i.e., a guidance document that indicates how the registrant 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. The opt ions shall include withdrawal of the right to purchase Cry34/35Ab1 Bt corn for an individual grower or for all growers in a specific region. An individual grower found to be significantly out of compliance two years in a row would be denied sales of the product the next year. Simi larly, seed dealers who are not fulfilling their obligations to inform/educate growers of their IR M obligations will lose their opportunity to sell Cry34/35Ab1 Bt corn.

6] The IRM compliance assurance program sha ll include an annual survey conducted by an independent third party of a statistica lly representative sample of Cry34/35Ab1 Bt corn growers who plant the vast majority of all corn in the U.S. and in areas in which the selection intensity is greatest The survey shall consider only those grow ers 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 di fferent regions of the118 country and consider the potential impact of no n-response. The sample size and geographical resolution may be adjusted annually, based upon input from the independ ent marketing research firm and academic scientists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasona ble sensitivity for comp aring results across the

U.S.

7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potenti al 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 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 31 of each year, beginning with 2007. The registrant shall confer with EPA on the design and content of the surv ey prior to its implementation.

10] Annually, the registrant sh all revise, and expand as nece ssary, its compliance assurance program to take into account the information co llected through the comp liance 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 registrant must confer with the Agency prior to adopting any significant 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 Cry34/35Ab1 Bt corn growers to perform assessments of compliance with IRM requirement s. 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 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 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 Cry34/35Ab1 Bt corn for planting, was spec ifically identified as not being in compliance during the previous year, the registrant shall visit with the grower and evaluate whether that the grower is in compliance with the IRM program for the current year.

14] Beginning January 31, 2007 and a nnually thereafter, The registra nts shall provide a report to EPA summarizing the activities carried out under their compliance assurance program for the prior year including changes to the grower education program, and the plans for the compliance assurance program during the current year. The re port will include information regarding grower interactions (including, but not limited to, third-party gr ower survey, on-farm visitation program, verified tips and complaints, educatio n programs (e.g., grower meetings and letters), the extent of non-compliance, corrective meas ures to address the non-compliance (phased-119 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 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.

9d. Insect Resistance Monitoring

The Agency is imposing the following conditions for 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 registrants must provide EPA its resi stance monitoring plan for approval. A preliminary plan must be submitted to th e Agency by January 31, 2006 consisting of a description of the steps to be taken to esta blish corn rootworm baseline sensitivity and damage guidelines. A detailed resistance monitoring plan must be submitted to the Agency for review by January 31, 2008. This plan must include: baseline sensitivity data, sampling (number of locations, samp les per locations), sampling methodology and life-stage sampled, bioassay methodology, stan dardization 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 registrants must develop and validate an appropriate discrimi nating or diagnostic dose assay by January 31, 2010. Further you must provide BPPD with a detailed explanation and validation (steps for) of the “high-throughput diagnostic screen” if it is to be considered an acceptable diagnostic dose assay.

3. You must finalize rootworm damage guide lines and submit these to BPPD by January 31, 2010.

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 mon itoring report by January

31 st of each year beginning with 2008, repor ting on populations collected the previous

year.

9e. Remedial Action Plans

The remedial action plan is designed as a tiered approach for mitigating WCRW, NCRW, and MCRW resistance development to 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 registrants120 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 unexpected damage reports show that:

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

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

c. alternative causes of damage or lodging, such as non-target 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 met by progeny from the target pest species sampled from the area of “suspected resistance”:

a. the proportion of larvae that can feed and survive on Cry34/35Ab1 roots from neonate to adult is significantly higher than the 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.

10) Annual Reports:

The registrant must provide annual reports to EPA on its Cry34/35Ab1 PIP expressed in corn based on the following table.121 Report Description Due Date

Annual Sales Units sold by st ate (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 ch anges 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

Proposed Compliance Plan Written description of Compliance Assurance Program January 31, 2006

Compliance Assurance Program Compliance Assurance Program Activitiesand Results: third-party grower survey, onfarm visitation program, phased-compliance report, tips and comp laints, and grower education programs January 31 st each year starting in 2007

Insect Resistance Monitoring Plan Description of the steps to be taken to establish corn rootworm baseline sensitivity and damage guidelines January 31, 2006

Insect Resistance Monitoring Plan Submission of plan. Description of the program including baseline sensitivity, sampling (number of locations and samples per locations), sampling methodology, bioassay methodology, standardization procedures, detection technique, sensitivity, and the statistical analysis of the probability of detecting resistan ce, and an interim description of rootworm damage guidelines January 31, 2008

Insect Resistance Monitoring Submission of rootworm damage guidelines January 31, 2010

Insect Resistance Monitoring Development of diagnostic dose assay/high through-put screen January 31, 2008122 Report Description Due Date

Insect Resistance Monitoring Annual report of the insect resistance monitoring program. Results of monitoring and investigations of damage reports August 31st each year beginning in 2008

Additional reports are due as desc ribed in the following table:

IRM Grower Agreements Proposed system to assure growers sign grower agreements January 31, 2006

IRM Affirmation

Plan System to assure annual affirmation by growers of their IRM obligations January 31, 2006

Changes to Grower Agreement and/or

IRM documents Current grower agreement(s) and any specific stewardship documents At least 30 days before any changes related to IRM are expected to be imposed.

Grower Agreement Submission of grower agreement and any specific stewardship documents referenced in the grower agreement January 31, 2006123 Registrant Registration # Active Ingredients Date Registered Date Expired

Pioneer/Dupont 29964-4 Bt corn Event DAS-591227- 7 with Cry 34Ab1 + Cry35Ab1 (Herculex RW) 31-Aug-05 30-Sep-10



### Terms and Conditions of the Registration

1) The subject registrations will automatical ly expire on midnight September 30, 2010. Based on the Agency’s review of the data submitted and cite d in support of this application, the Agency anticipates at this time that an expiration date five years from the initial date of registration for this product would be appropriate.

2) The subject registrations will be limited to B acillus thuringiensi s Cry34Ab1 and Cry35Ab1 proteins and the genetic materi al necessary for their production (plasmid insert PHP17662) in

Event DAS-59122-7 corn 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) Provide to the EPA laboratory (Ft. Meade, MD) methodology and/or reagents necessary for validation of a Cry34/35Ab1 analytical method with in 6 months of the date of registration.

5) Submit field degradation st udies evaluating accumulation a nd persistence of Cry34/35Ab1 in several different soils in various strata. Repr esentative fields must ha ve been planted with Cry34/35Ab1 corn and include both conventional tillage and no-till samp les and be harvested under typical agronomic conditions. Sampling must continue until the limit of detection is reached. Studies should include soils with high le vels of a variety of clays. Both ELISA and insect bioassays need to be conducted an d compared to determine if Cry34/35Ab1 is accumulating or persisting in soil samples. A prot ocol is due within 90 days of the date of registration. A final report regarding data from fields that have had three continuous years of

cultivation of Event DAS-59122-7 corn is due by January 31, 2010.

6) Submit laboratory toxicity tests with Orius insidiosus (minute pirate bug), carabid (ground beetle), within 24 months of th e date of registration. Protocols are due within 120 days of the date of registration.

7) Additional 3 year full-scale field or semi-field studies fo r evaluation of Cry34/35Ab1 Event

DAS-59122-7 corn exposure on non-target invertebrates must be conducted. Full-scale field experiments must be appropriate ly designed to provide a measur e of ecological impacts (larger fields, more replicates, more samples per pl ot based on recommendations of the August, 2002 SAP). The previously submitted two-year field study is not sufficient to determine if Cry34/35Ab1 corn will have long term impact on non- target invertebrates. A protocol is due within 90 days of the date of registra tion. A final report is due September 30, 2009.

8) The following insect resistance management data are recommended.124 Additional research on corn rootworm pest bi ology and ecology, genetics and mechanisms of resistance, functional dominance, fitness costs, cross-resistance potenti al, dose (including the role of density-dependence), and mode of action are recommended to evaluate the sustainability of the insect resistance management durability plan and confirm the assumptions made in the simulation models. Research reports should be provided to the Agency once the research is completed and at least nine months prior to the expiration of this registration.

Should you wish to amend the re fuge treatment option to allow independent treatment of the refuge for pests other than corn rootworms, da ta would be required regarding the impact of independent treatment of the ref uge for other pests (not corn r ootworm, e.g., corn borers, spider mites) on corn rootworm resistance management.

9) You must commit to do the following Insect Resistance Management Program which has the following elements:

a) Requirements relating to creation of a non-(cor n rootworm-protected PIP) corn refuge in conjunction with the planting of a ny acreage of comm ercial Cry34/35Ab1 Bt corn;

b) Requirements for the registrant s to prepare and require Cry34/35Ab1 Bt corn users to sign “grower agreements” which impose binding contract ual obligations on th e grower to comply with the refuge requirements;

c) Requirements for the registrants to develop, implement, and report to EPA on programs to educate growers about IRM requirements;

d) Requirements for the registrants to develop, implement, and report to EPA on programs to evaluate and promote grower s’ compliance with IRM re quirements (the Cry34/35Ab1 Compliance Assurance Program (CAP) mu st integrate with the Cry1 Caps);

e) Requirements for the registrants to develop, implement, and report to EPA on monitoring programs to evaluate whether ther e are statistically significant a nd biologically relevant changes in target insect susceptibility to Cry34/ 35Ab1 proteins in the target insects;

f) Requirements for the re gistrants to develop, a nd if triggered, to implement a “remedial action plan” which would contain measures the registra nts 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 so ld by state (units sold by count y level will be made available to the Agency upon request), IRM grower agre ements results, compliance assurance program including the education progr am, and resistance monitoring on or before January 31 st each year beginning in 2007.

9a. Refuge Requirements

Grower agreements (also known as stewardship agreements) will specify that growers must125 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.

1. Refuge size . The use of Cry34/35 corn from event DAS 59122-7 requires an accompanying 20% refuge

2. Refuge location. The rootworm refuge is required to be planted within or adjacent (e.g. across the road) to the Cry34/35 corn field.

3. Refuge management options. The rootworm refuge may be managed in such a way that there is little or no yield loss to rootworms, but mu st 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 m easuring at least four (4) crop rows wide.

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

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

• If the refuge is planted in continuous cor n, the Cry34/35 field may be planted on either continuous or rotated land (option encouraged where WCRW rotation -resistant biotype may be present).

• Application of soil insecticide is permitted in the refuge.

• Seed treatment is permitted in the refuge, eith er 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 onl y be treated with CRW-labeled insecticide on the refuge acres without trea ting the Cry34/35 acres if treatment occurs when adult corn rootworms are not present. Pests on the Cry34 /35 acres can be treate d as needed without having to treat the refuge.

• The rootworm refuge can be planted to any corn hybrid that does not express PIPs for rootworm control (e.g. lepidop teran-protected Bt corn, he rbicide-tolerant corn, or conventional corn).

• The refuge and Cry34/35 corn should be sown on the same date, or with the shortest window possible between planting dates, to ensure th at corn root development is similar among

varieties.

• Growers are encouraged to plant the rootworm re fuge 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 once126 and for growers who grow continuous corn. However, for those growers who need to employ crop rotation, a fixed re fuge would be impractical.

9b. Grower Agreements

1] Persons purchasing the Bt corn product must sign a grower agreement. The term “grower agreement” refers to any grower purchase contract , license agreement, or similar legal document.

2] The grower agreement and/or specific 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 (equivalent to what is already approved for Cry1F Bt corn) which is reasonably likely to assure that pers ons purchasing the Bt corn product will affirm annually that they are co ntractually bound to comply with th e requirements of the IRM program. The proposed system will be submitted to EPA by January 31, 2006.

4] The registrant must use grower agreements and submit to EPA by January 31, 2006 a copy of that agreement and any specific stewardship docume nts referenced in the grower agreement. If either registrant wishes to cha nge any part of the gr ower 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 prov isions of the agreement relating to the IRM program, thirty days prior to implementing a pro posed change, the registrant must submit to EPA the text of such changes to ensure that it is consistent with the terms and conditions of the

amendment.

5] The registrant must establish a system (equiva lent to what is alrea dy approved for Cry1F Bt Corn) which is reasonably likely to assure that persons purchasing the Bt corn sign grower agreement(s), and must provide by January 31, 2006 a written descrip tion of that system.

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

7] Beginning on January 31, 2007 and annually thereaft er, the registrant shall provide EPA with a report showing the number of units of its Cr y34/35Ab1 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 fram e 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.

9c. IRM Education and IRM Co mpliance Monitoring Programs

1] The registrants must implement a compre hensive, ongoing IRM education program designed127 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 configurat ion and proximity to Bt Cry34/35Ab1 corn fields. The education program shall involve the use of multiple media, e.g. face-to-face meetings, mailing written materials, EPA review ed language on IRM requirements on the bag or bag tag, and electronic communicatio ns such as by Internet, radio, or television commercials. Copies of the materi als will be provided to EPA for its records for the first year of commercialization (2006 growi ng season) by January 31, 2007. Th e 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 or ganizations, such as the Nationa l Corn Grower Association and state extension programs.

2] Annually, the registrant shall revise, and expa nd as necessary, its education program to take into account the information collected through the compliance survey required under paragraph 6] and from other sources. Th e changes shall address aspects of grower compliance that are not sufficiently high.

3] Beginning January 31, 2008 and annually thereaf ter, the registrant must provide EPA any substantive changes to its grower education act ivities as part of the overall IRM compliance assurance program report. The required featur es of the compliance assurance program are described in paragraphs 4]-15] below.

4] The registrant must design and implement an ongoing IRM compliance assurance program designed to evaluate the extent to which growers purchas ing its Cry34/35Ab1 Bt corn product are complying with the IRM program and that takes such actions as are reasonably needed to assure that growers who have not complied with the program either do so in the future or lose their access to the Cry34/35Ab1 Bt corn product. The registrant shall coordinate with other Bt corn registrants in designing and implementing its compliance assurance program and integrate the Cry34/35Ab1 CAP with the Cry1 Caps. The re gistrant must prepare and submit by January 31, 2006 a written description of their compliance assurance progr am including a summary of the program implemented in the 2006 growing season. Other required features of the program are described in paragraphs 5] - 15] below.

5] The registrant must establish and publicize a “phased compliance approach,” i.e., a guidance document that indicates how the registrant 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. The opt ions shall include withdrawal of the right to purchase Cry34/35Ab1 Bt corn for an individual grower or for all growers in a specific region. An individual grower found to be significantly out of compliance two years in a row would be denied sales of the product the next year. Simi larly, seed dealers who are not fulfilling their obligations to inform/educate growers of their IR M obligations will lose their opportunity to sell Cry34/35Ab1 Bt corn.

6] The IRM compliance assurance program sha ll include an annual survey conducted by an independent third party of a statistica lly representative sample of Cry34/35Ab1 Bt corn growers who plant the vast majority of all corn in the U.S. and in areas in which the selection intensity is128 greatest The survey shall consider only those grow ers 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 di fferent regions of the country and consider the potential impact of no n-response. The sample size and geographical resolution may be adjusted annually, based upon input from the independ ent marketing research firm and academic scientists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasona ble sensitivity for comp aring results across the

U.S.

7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An analysis of the survey results must include the reasons, extent, and potenti al 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 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 31 of each year, beginning with 2007. The registrant shall confer with EPA on the design and content of the surv ey prior to its implementation.

10] Annually, the registrant sh all revise, and expand as nece ssary, its compliance assurance program to take into account the information co llected through the comp liance 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 registrant must confer with the Agency prior to adopting any significant 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 Cry34/35Ab1 Bt corn growers to perform assessments of compliance with IRM requirement s. 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 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 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 Cry34/35Ab1 Bt corn for planting, was spec ifically identified as not being in compliance during the previous year, the registrant shall visit with the grower and evaluate whether that the grower is in compliance with the IRM program for the current year.

14] Beginning January 31, 2007 and a nnually thereafter, The registra nts shall provide a report to EPA summarizing the activities carried out under their compliance assurance program for the prior year including changes to the grower education program, and the plans for the compliance assurance program during the current year. The re port will include information regarding grower129 interactions (including, but not limited to, third-party gr ower survey, on-farm visitation program, verified tips and complaints, educatio n programs (e.g., grower meetings and letters), the extent of non-compliance, corrective meas ures to address the non-compliance (phasedcompliance 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 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.

9d. Insect Resistance Monitoring

The Agency is imposing the following conditions for 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.

6. The registrants must provide EPA its resi stance monitoring plan for approval. A preliminary plan must be submitted to th e Agency by January 31, 2006 consisting of a description of the steps to be taken to esta blish corn rootworm baseline sensitivity and damage guidelines. A detailed resistance monitoring plan must be submitted to the Agency for review by January 31, 2008. This plan must include: baseline sensitivity data, sampling (number of locations, samp les per locations), sampling methodology and life-stage sampled, bioassay methodology, stan dardization 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.

7. The registrants must develop and validate an appropriate discrimi nating or diagnostic dose assay by January 31, 2010. Further you must provide BPPD with a detailed explanation and validation (steps for) of the “high-throughput diagnostic screen” if it is to be considered an acceptable diagnostic dose assay.

8. You must finalize rootworm damage guide lines and submit these to BPPD by January 31, 2010.

9. The registrants must follow-up on grower, exte nsion specialist or consultant reports of unexpected damage or control failures for corn rootworm.

10. The registrants must provide EPA with an annual resistance mon itoring report by January

31 st of each year beginning with 2008, repor ting on populations collected the previous

year.

9e. Remedial Action Plans

The remedial action plan is designed as a tiered approach for mitigating WCRW, NCRW, and MCRW resistance development to th e Cry34/35Ab1 protein. The following program summary describes, in order of events, the step s that must be taken to implement a remedial130 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 unexpected damage reports show that:

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

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

g. alternative causes of damage or lodging, such as non-target 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.

2. Confirmation of Resistance : Resistance will be confirmed if all of the following criteria are met by progeny from the target pest species sampled from the area of “suspected resistance”:

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

10) Annual Reports:

The registrant must provide annual reports to EPA on its Cry34/35Ab1 PIP expressed in corn based on the following table.131 Report Description Due Date

Annual Sales Units sold by st ate (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 ch anges 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

Proposed Compliance Plan Written description of Compliance Assurance Program January 31, 2006

Compliance Assurance Program Compliance Assurance Program Activitiesand Results: third-party grower survey, onfarm visitation program, phased-compliance report, tips and comp laints, and grower education programs January 31 st each year starting in 2007

Insect Resistance Monitoring Plan Description of the steps to be taken to establish corn rootworm baseline sensitivity and damage guidelines January 31, 2006

Insect Resistance Monitoring Plan Submission of plan. Description of the program including baseline sensitivity, sampling (number of locations and samples per locations), sampling methodology, bioassay methodology, standardization procedures, detection technique, sensitivity, and the statistical analysis of the probability of detecting resistan ce, and an interim description of rootworm damage guidelines January 31, 2008

Insect Resistance Monitoring Submission of rootworm damage guidelines January 31, 2010

Insect Resistance Monitoring Development of diagnostic dose assay/high through-put screen January 31, 2008132 Report Description Due Date

Insect Resistance Monitoring Annual report of the insect resistance monitoring program. Results of monitoring and investigations of damage reports August 31st each year beginning in 2008

Additional reports are due as desc ribed in the following table:

IRM Grower Agreements Proposed system to assure growers sign grower agreements January 31, 2006

IRM Affirmation

Plan System to assure annual affirmation by growers of their IRM obligations January 31, 2006

Changes to Grower Agreement and/or

IRM documents Current grower agreement(s) and any specific stewardship documents At least 30 days before any changes related to IRM are expected to be imposed.

Grower Agreement Submission of grower agreement and any specific stewardship documents referenced in the grower agreement January 31, 2006133 Registrant Registration # Active Ingredients Date Registered Date Expired

Dow AgroSciences 68467-6 Bt corn Events DAS 59122- 7 + TC1507 with Cry 34Ab1 + Cry35Ab1 + PO Cry1F (Herculex Xtra) (PDF) 27-Oct-05 30-Sep-10



### Terms and Conditions of the Registration

1. The subject registrations will automatic ally expire on midnight September 30, 2010.

2. The subject registration will be limited to Cry1F [Bacillus thuringiensis Cry1F protein and the genetic material necessary for its pr oduction (plasmid insert PHI8999) in Event TC1507 corn] X Cry34/35Ab1 [Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for th eir production (plasmid insert PHP17662) in Event DAS-59122-7 corn] corn for use in field corn.

3. Submit/cite all data required for registration of this produc t under FIFRA § 3(c)(5) when the Agency requires registrants of si milar products to submit such data.

4. Submit all data required to support the individua l plant-incorporated protectants in Event TC1507 (Herculex I) and Event DAS-59122-7 (Her culex Rootworm) corn. In the event that the Agency concludes Cry34/35A b1 (Herculex Rootworm) studies do not sufficiently demonstrate a lack of long rang e adverse effects, a dditional data with Herculex? XTRA corn must be submitted. This data may include

a. laboratory toxicity testing with Or ius insidiosus (minute pirate bug),

b. laboratory toxicity testing with a carabid (ground beetle),

c. long range effects testing on inverteb rate populations in the field, and

d. long range soil persistence testing.

5. You must commit to do the following In sect Resistance Management Program:

The required IRM program for Cry1FxCry34/ 35Ab1 corn has the following elements:

1. Requirements relating to creation of a refuge for both the Cry1F and Cry34/35Ab1 components that meets the requirements of the individual traits. The refuge for both traits may be combined by planting non -Bt corn as the refuge, or th e 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 le pidopteran-resist ant Bt corn may be planted in the corn rootworm refuge for the Cry34/35Ab1 component.

2. Requirements for the registrants to prepare and require Bt corn users to sign grower agreements which impose bindi ng contractual obligations on the grower to comply with the refuge requirements;

3. Requirements for the registrants to deve lop, implement, and report to EPA on programs to educate growers about IRM requirements;

4. Requirements for the registrants to deve lop, implement, and report to EPA on programs to evaluate and promote growers= compliance with IRM requirements (the Cry1F x Cry34/35Ab1 Compliance Assurance Program (CAP) must integrate with the Cry1 and Cry34/35Ab1 Caps);134 5. Requirements for the registrants to deve lop, implement, and report to EPA on programs to evaluate whether there are st atistically significant and biologically relevant changes in target insect suscep tibility to Cry1F and Cry34/35Ab1 proteins in the target insects;

6. Requirements for the registrant s to develop, and if triggere d, to implement a remedial action plan which would contain measures the registrants would take in the event that any insect resistance was detected as well as to report on activity under the plan to EPA;

7. Submit annual reports on units sold by state (units sold by county level will be made available to the Agency upon request), IR M grower agreements results, compliance assurance program including the education pr ogram, on or before January 31st each year, and for resistance monitoring, on or before April 30th each year for Cry1F and on or before August 31st each for Cry34/35Ab1, beginning in 2007.

5a. Refuge Requirements

The use of Cry1F x Cry34/35Ab1 corn 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-re sistant 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 plante d 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.

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 Cry34/35A b1 corn requires an accompanying 20% refuge consisting of non-Bt corn or non-lepidopteran resistant Bt corn.

2. Refuge size, (Corn/Cotton-growing areas ). * The use Cry1F x Cry34/35Ab1 corn requires an accompanying 50% refuge consis ting of non-Bt corn or non-lepidopteran

resistant Bt corn.135 3. Refuge location.

 The lepidopteran refuge can be planted in a se parate field not more than 1⁄2 mile of the Cry1F x Cry34/35Ab1 field.

 The lepidopteran refuge can be planted within the Cry1F x Cry34/35Ab1 field as blocks (e.g. along the edges or headlands)

 The lepidopteran refuge can be planted within the Cry1F x Cry34/35Ab1 field as strips across the field at least f our 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 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.

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 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 rootworm refuge can be managed in such a way that there is little or no yield loss to rootwo rms, 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 (option encouraged where

WCRW rotation-resistant bi otype may be present).136  Application of soil insecticide is permitted in the rootworm refuge.

 Seed treatment is permitted in the rootworm refuge, either at a rate for rootworm protection or at a rate for 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 pe sticide without activity against adult corn rootworms is used. Pests on the Cry1F x Cr y34/35Ab1 acres can be treated as needed without having to treat the rootworm refuge.

 The rootworm refuge can be planted to any corn hybrid that does not express PIPs for rootworm control (e.g. lepidopteran-protecte d Bt corn, herbicide- tolerant 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 wi ndow possible between planting dates, to ensure that corn root development is similar among varieties.

 Growers are encouraged to plant the rootworm refuge in the same location each year,

as it allows the rootworm population to remain high and th e durability of the trait is extended. This option may be preferable to growers who wish to only think of their refuge design once and for growers who grow continuous corn. However, for those growers who need to employ crop rotation, a fixed refuge would be impractical.

C. For the combined refuge option (i.e. the lepidopteran refuge combined with the rootworm refuge by planting non-Bt corn), the refuge must be planted and managed such that it is consistent with the requirem ents of the two individual traits, as follows

1. Refuge size shall be 20% in corn-growi ng 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 planted as a single block or as a series of strips measuring at least four (4) rows wide (six rows preferred).

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

 If the combined refuge is planted on rotated ground, then th e Cry1F x Cry34/35Ab1 corn must also be planted on rotated ground.

 If the combined refuge is planted on continuous corn, the Cry1F x Cry34/35Ab1 field may be planted on either continuous or rotated land (option encouraged where

WCRW rotation-resistant bi otype may be present).

 Application of soil insecticide for corn root worm control is permitted in the combined refuge.

 Seed treatment is permitted in the combined refuge, either at a rate for rootworm protection or at a rate for c ontrolling secondary soil pests.137  If aerial insecticides are applied to the co mbined 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 ref uge for control of European corn borer, corn earworm, southwestern corn borer, fa ll 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 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. Ex tension Service Agents, crop consultants). These pests

can be treated with CRW-labeled insecticid e on the combined refuge acres without treating the Cry1F x Cry34/35Ab1 acres only if treatment occurs when adults corn rootworms are not present. Microbial Bt insecticides must not be applied to the common refuges.

 Pests other than adult corn rootworms can be treated with CRW-labeled insecticide on the combined refuge acres without tr eating the Cry1F x Cry34/35Ab1 acres only if

treatment occurs when adults corn rootwo rms are not present. Pests on the Cry1F x Cry34/35Ab1 acres can be treated as needed without having to treat the refuge.

 The combined refuge can be planted to any corn hybrid that does not express PIPs for lepidopteran or rootworm control (i.e. herbic ide tolerant corn or conventional corn).

 The combined refuge and Cry1F x Cry34/35Ab1 corn should be sown on the same day, or with the shortest wi ndow possible between planting dates, to ensure that corn root development is similar among varieties.

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

5b. Grower Agreements

4. Persons purchasing the Bt corn product mu st sign a grower agreement. The term "grower agreement" refers to any grower purchase contract, license agreement, or similar legal document.

5. The grower agreement and/or specific st ewardship documents referenced in the grower agreement must clearly set forth the terms of the current IRM program. By signing the grower agreement, a grower mu st be contractually bound to comply with the requirements of the IRM program.

6. The registrant must develop a system (equi valent to what is already approved for Cry1F Bt corn) which is reasonably likely to assure that persons purchasing the Bt corn product will affirm annually that they are contractually bound to comply with the requirements of the IRM program. The proposed system will be submitted to EPA by January 31, 2006.

7. The registrant must use grower agreem ents and submit to EPA by January 31, 2006 a copy of that agreement and any specific st ewardship documents referenced in the grower agreement. If the registrants wish to change any part of the grower agreement or any specific stewardship documents refere nced in the grower agreement that would affect either the content of the IRM program or the legal enforceability of the provisions of the ag reement relating to the IRM program, thirty days prior to implementing a proposed change, the registrant must submit to EPA the text of such138 changes to ensure that it is consistent with the terms and conditions of the

amendment.

8. The registrant must establish a system (e quivalent to what is already approved for Cry1F Bt Corn) which is reasonably likely to assure that persons purchasing the Bt corn sign grower agreement(s), and must provide by January 31, 2006 a written description of that system.

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

10. Beginning on January 31, 2007 and annually th ereafter, the registrant shall provide EPA with a report showing the number of units of its Cry1F x Cry34/35Ab1 corn seeds sold or shipped and not returned, and the number of su ch units that were sold to persons who have signed grower agreements . The report shall cover the time frame of the twelve-month period covering the prior August through July.

11. The registrant must allow a review of the grower agreem ents and grower agreement records by EPA or by a State pesticide regulatory agency if the State agency can demonstrate that confidential business information, including names, personal information, and grower license number, will be protected.

5c. IRM Education and IRM Compliance Monitoring Programs

12. The registrants must implement a compre hensive, 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 el ements of the IRM program relating to refuge configuration and proximity to Bt Cry1F x Cry34/35Ab1 corn fields. The education program shall involve the use of multiple media, e.g. face-to-face meetings, mailing written materials, EPA reviewed language on IRM requirements on the bag or bag tag, and electronic communications su ch 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 writte n 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 educati on programs with educational efforts of other registrants and other organizations, such as the National Corn Grow er Association and state extension programs.

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

to take into account the information colle cted through the complia nce survey required under paragraph 6] and from other sources. The changes shall address aspects of grower compliance that ar e not sufficiently high.

14. Beginning January 31, 2008 and annually thereaf ter, the registrant must provide EPA any substantive changes to its grower educat ion activities as part of the overall IRM compliance assurance program report. The required features of the compliance assurance program are described in paragraphs 4]-15] below.

15. The registrant must design and 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 takes139 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 implementi ng its compliance assurance program and integrate the Cry1F x Cry34/35Ab1 CAP with the Cry1 Caps. The registrant must prepare and submit by January 31, 2006 a wr itten description of their compliance assurance program including a summary of the program implemented in the 2006 growing season. Other required features of the program are described in paragraphs 5] - 15] below.

16. The registrant must establish and 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 program and general criteria for choosing among options for responding to any non-co mpliant growers. The options shall include withdrawal of the right to pur chase Cry1F x Cry34/35Ab1Bt corn for an individual grower or for all growers in a specific region. An individual grower found to be significantly out of compliance two y ears 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 oblig ations will lose their opportunity to sell Cry1F x Cry34/35Ab1Bt corn.

17. The IRM compliance assurance program sha ll include an annual survey conducted by an independent third party of a statisti cally representative sample of Cry1F x Cry34/35Ab1Bt corn growers who pl ant 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 ar eas. The survey shall measure the degree of compliance with th e IRM program by growers in diffe rent regions of the country and consider the potential impact of non -response. The sample size and geographical resolution may be adjusted annually, based upon input from the independent marketing research firm and academic scie ntists, to allow analysis of compliance behavior within regions or between re gions. The sample si ze must provide a reasonable sensitivity for comparing results across the U.S.

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

19. The survey shall be designed to obtain grow er feedback on the usefulness of specific

educational tools and initiatives.

20. The registrant shall provide a written summary of the results of the prior year's survey (together with a description of the regi ons, the methodology us ed, and the supporting data) to EPA by January 31 of each year, beginning with 2007. The registrant shall confer with EPA on the design and content of the survey prior to its implementation.

21. Annually, the registrant shall revise, and expand as necessary, its compliance assurance program to take into account the information collected through the compliance survey required under paragraphs 6] through 8] and from other sources. The changes shall address aspects of grower compliance that are not sufficiently high. The registrant must confer with the Agency prior to adopting any significant changes.

22. The registrant shall conduct an annual on- farm assessment program. The registrant shall train its representatives who make on-farm visits with Cry1F x Cry34/35Ab1Bt140 corn growers to perform assessments of co mpliance with IRM requirements. There is no minimum corn acreage size for this progra m. Therefore, growers will be selected for this program from across all farm sizes. In the event that any of these visits result in the identification of a grower who is not in compliance with the IRM program, the registrant shall take appropriate action, consistent with its "phased compliance approach," to promote compliance.

23. The registrant shall carry out a program for investigating legitimate “tips and complaints” that its growers are not in compliance with the IRM program. Whenever an investigation results in the identification of a grower who is not in compliance with the IRM program, the registrant shall take appropriate action, consistent with its “phased compliance approach.”

24. If a grower, who purchases Cry1F x Cry34/35Ab1Bt corn for planting, was specifically identified as not being in compliance during the previous year, the registrant shall visit with the grower and evaluate whether that the grower is in compliance with the IRM program for the current year.

25. Beginning January 31, 2007 and annually thereaf ter, the registrant s shall provide a report to EPA summarizing the activitie s carried out under their compliance assurance program for the prior year incl uding changes to the grower education program, and the plans for the compliance a ssurance program during the current year. The report will include inform ation regarding grower inte ractions (including, but not limited to, third-party grower survey, on-farm visitation program, verified tips and complaints, education programs (e.g., grower meetings and letters), the extent of noncompliance, corrective measures to addr ess the non-compliance (phased-compliance program), and any follow-up actions taken.

26. The registrant and the seed corn dealers for the registrant must allow a review of the compliance records by EPA or by a State 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.

5d. Insect Resistance Monitoring

The Agency is imposing the following conditions for 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 31st of each year beginning with 2008, reporting on populations colle cted the previous year.

Cry1 F

27. The registrants will monitor for resistance and/or trends in increased tolerance for Ostrinia nubilalis (European corn borer), Diatraea grandiosella (Southwestern corn borer), and/or Helicoverpa zea (corn earworm ). Sampling should be focused in those areas in which there is the highest risk of resistance development. The ABSTC has identified four regions for its co mpliance and monitoring programs.141 28. The registrant shall provide to EPA a descri ption of its Cry1F resistance monitoring plan by January 31, 2006. The description shall include: sampling (number of locations and samples per locations), sampling methodology, bioassay methodology, standardization procedures, detection technique and sens itivity, and the statistical analysis of the probability of detecting resistance.

29. 3) The registrant must follow up on grower, extension specialist or consultant reports of less than expected results or control failures for the target lepidopteran pests

Ostrinia nubilalis (ECB), Diatraea grandiosella (SWCB), Helicoverpa zea (CEW/CBW), Spodoptera frugiperda (FAW), Agrotis ipsilon (BCW), and Richia

albicosta (WBCW), Sugar cane borer Diatraea saccharalis ; southern corn stalk borer, Diatraea

crambidoides ; lesser corn stalk borer, Elasmopalpus lignosellus . The registrant will instruct its customers (growers and seed di stributors) to contact them (e.g., via a toll free customer service number) if incidents of unexpected levels of damage occurs from these target pests. The registrant will investigate all damage reports submitted to the company or the company=s representati ves. 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 registrant must provide EPA its resi stance monitoring plan for approval. A preliminary plan must be submitted to the Agency by January 31, 2006 consisting of a description of the steps to be taken to es tablish corn rootworm baseline sensitivity and damage guidelines. A detailed resistan ce monitoring plan must be submitted to the Agency for review by January 31, 2008. This plan must include: baseline sensitivity data, sampling (number of locations, samples per locations), sampling methodology and life-stage sampled, bi oassay methodology, standardization procedures (including QA/QC provisions), detection technique and sensitivity, the statistical analysis of the probability of detecting resistance, and an interim description of rootworm damage guidelines.

2. The registrant must develop and validate an appropriate discrimi nating or diagnostic dose assay by January 31, 2010. Further the re gistrant must provi de BPPD with a detailed explanation and validation (steps for) of the "high-throughput diagnostic

screen" if it is to be considered an acceptabl e diagnostic dose assay.

3. The registrant must finalize rootworm damage guidelines and submit these to BPPD by January 31, 2010 should the registration be extended.

4. The registrant must follow-up on grower, exte nsion specialist or c onsultant reports of unexpected damage or control failures for corn rootworm.142 5e. Remedial Action Plans

Cry1F

A Remedial Action Plan covering both suspec ted and confirmed resistance for European corn borer, corn earworm, and southwestern co rn 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)

XXX. Definitions

Suspected resistance

EPA defines "suspected" resist ance to mean, in the case of reported product failure, that: the corn in question has b een confirmed to be Bt corn

 the seed used had the proper percentage of corn expressi ng Bt protein;

 the relevant plant tissues are expressing the expected level of Bt protein; and it has been ruled out that species not susceptible to the protein could be responsible for the damage, that no climatic or cultural reasons could be res ponsible for the damage, and

that other reasonable causes for the observe d product failure have been ruled out. The Agency does not interpret "suspected resist ance" to mean grower reports of possible control failures, nor does the Agency intend th at extensive field st udies and testing to confirm scientifically insect resistance be completed before responsive measures are

undertaken.

If resistance is “suspected,” the registrant must instruct growers to do the following:

 Use alternate control measures to control the pest suspected of resistance to Bt corn in the affected region.

 Destroy crop residues in the affected regi on immediately after harv est (i.e. within one month) with a technique a ppropriate for local production practices to minimize the possibility of resistant ins ects 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 co rn in the remedial action zone (may be less than a single county, single county, or multiple counties) where the resistance has been shown until an effective local mitigation plan approved by EPA has been implemented.143 A resistance event becomes confirmed if the progeny of the sampled ECB, CEW, or SWCB population would exhib it all of the following characteristics in bioassays

initiated with neonates:

5. If there is > 30% survival and > 25% leaf area damage d in a 5-day bioassay using Cry1Ab-positive or Cry1F-positive leaf tissu e under controlled laboratory conditions.

6. If standardized laboratory bioassays usi ng diagnostic doses for ECB (Marçon et al. 2000), SWCB (Trisyono and Chippendale 1999), or CEW/CBW (USDA/ARS/SIMRU, unpublished) demonstrat e resistance has a genetic basis and survivorship in excess of 1% (g ene frequency of population ?0.1).

7. If an LC50 in a standard Cry1Ab or Cry1F diet bioassay exceeds the upper limit of

the 95% confidence interval of the standa rd unselected laborat ory population LC50 for susceptible ECB, SWCB, or CEW popul ations, as established by the ongoing baseline monitoring program.

Remedial Action

The registrant assumes responsibility for the implementation of resistance mitigation actions undertaken in response to the 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:

8. Notify customers and extension agents in the affected area,

9. Require to customers and extension agents in the affected area the use of alternative

control measures to reduce or contro l the local target pest population,

10. 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.

11. Immediately stop sale and distri bution of Bt corn in the re medial 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:

12. Notify the Agency of the immediate mitiga tion measures that were implemented,

13. Submit to the Agency a proposed long-term resistance management action plan for the affected area,

14. Submit to the Agency a proposed long-term resistance management action plan for the affected area,144 15. Implement an action plan that is approved by EPA and that consists of some or all the following elements, as warranted:

a. Informing customers and extension agents in the affected area of pest resistance,

b. Increasing monitoring in the affected area, and ensuring that local target pest populations are sampled on an annual basis,

c. Recommending alternative measures to reduce or control target pe st populations in the affected area,

d. Implementing intensified local IRM measures in the affected area based on the latest research results. The implementation of su ch measures will be coordinated by the Agency with other registrants; and

e. 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:

16. Maintenance of the sales susp ension of all Bt corn hybrid s (with the same protein or similar Bt proteins as the Bt corn hybrids with the resistan t population) in the affected region would remain in place until an EPA- approved local resistance management plan is in place to mitigate resist ance in the affected region(s).

17. The development and recommendation of alternative resistance management strategies for controlling the resistant pest(s) on corn in the affected region.

18. Notification of all relevant personnel (e.g., growers, consultants, extension agents, seed distributors, processors, university c ooperators, and state/fede ral 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.

8. Definition of Suspected Resistance: Resistan ce will be suspected if investigations of unexpected damage reports show that:

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

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

b. alternative causes of damage or lodging, su ch as non-target pest insect species, weather, physical damage, larval movement from alternate hosts, planting errors, and

other reasonable causes for the obs ervations, have been ruled out;

c. the level of damage exceeds guidelines for expected damage.145 If resistance is "suspected", the registrant will instruct affected growers to use alternate pest control measures such as adulticide treatment, crop rotation the following year,

or use of soil or seed insecticides the fo llowing year. These measures are intended to reduce the possibility of pot entially resistant insects contributing to the following year's pest population.

9. Confirmation of Resistance: Resistance will be confirmed if all of the following criteria are met by progeny from the target pest species sampled from the area of "suspected resistance":

. the proportion of larvae that can feed and surviv e on Cry34/35Ab1 roots from neonate to adult is significantly higher th an the baseline propor tion (currently being established);

a. the LC50 of the test population exceeds the upper limit of the 95% confidence

interval for the LC50 of a standard unsel ected population, and/or survival in the diagnostic assay is significan tly greater than that of a standard unselected population, as established by the ongoing baseline monitoring program;

b. the ability to survive is heritable;

c. Cry34/35Ab1 plant assays determine that damage caused by surviving insects would exceed economic thresholds;

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

results.

10. Response to Confirmed Resistance: When resistance is "confirmed", the following steps will be taken:

. EPA will receive notification within 30 days of confirming resistance;

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

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

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

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

characteristics of the resistance event and local agronomic needs.146 Registrant Registration # Active Ingredients Date Registered Date Expired

Pioneer/Dupont

29964-5 Bt corn Events DAS 59122- 7 + TC1507 with Cry 34Ab1 + Cry35Ab1 + PO Cry1F (Herculex Xtra) (PDF) 27-Oct-05 30-Sep-10



### Terms and Conditions of the Registration

6. The subject registrations will automatic ally expire on midnight September 30, 2010.

7. The subject registration will be limited to Cry1F [Bacillus thuringiensis Cry1F protein and the genetic material necessary for its pr oduction (plasmid insert PHI8999) in Event TC1507 corn] X Cry34/35Ab1 [Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for th eir production (plasmid insert PHP17662) in Event DAS-59122-7 corn] corn for use in field corn.

8. Submit/cite all data required for registration of this produc t under FIFRA § 3(c)(5) when the Agency requires registrants of si milar products to submit such data.

9. Submit all data required to support the individua l plant-incorporated protectants in Event TC1507 (Herculex I) and Event DAS-59122-7 (Her culex Rootworm) corn. In the event that the Agency concludes Cry34/35A b1 (Herculex Rootworm) studies do not sufficiently demonstrate a lack of long rang e adverse effects, a dditional data with Herculex? XTRA corn must be submitted. This data may include

a. laboratory toxicity testing with Or ius insidiosus (minute pirate bug),

b. laboratory toxicity testing with a carabid (ground beetle),

c. long range effects testing on inverteb rate populations in the field, and

d. long range soil persistence testing.

10. 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 creation of a refuge for both the Cry1F and Cry34/35Ab1 components that meets the requ irements of the individual traits. The refuge for both traits may be combin ed by planting non-Bt corn as the refuge, or the refuge for each trait may be plante d separately. In the latter case, corn rootworm-resistant Bt corn may be plante d in the lepidopter an refuge for the Cry1F component and lepidopte ran-resistant Bt corn may be planted in the corn rootworm refuge for the Cry34/35Ab1 component.

b. Requirements for the registrants to prepar e and require Bt corn users to sign grower agreements which impose binding c ontractual obligations on the grower to comply with the refuge requirements;

c. Requirements for the registrants to de velop, implement, and report to EPA on programs to educate growers about IRM requirements;147 d. 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 Cry1F x Cry34/35Ab1 Compliance Assu rance Program (CAP) must integrate with the Cry1 and Cry34/35Ab1 Caps);

e. Requirements for the registrants to de velop, implement, and report to EPA on programs to evaluate whether there are st atistically significa nt and biologically relevant changes in target insect su sceptibility to Cry1 F 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 which would contain measures the registra nts would take in the event that any insect resistance was dete cted 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 request ), IRM grower agreements results, compliance assurance program including th e education program, on or before January 31st each year, and for resist ance monitoring, on or before April 30th each year for Cry1F and on or before August 31st each for Cry34/35Ab1, beginning in 2007.

5a. Refuge Requirements

The use of Cry1F x Cry34/35Ab1 corn 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-re sistant 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 plante d 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.

A. Lepidopteran refuge for the Cry1F component.148 1. Refuge size, Corn-Growing Areas (= corn belt and other non corn/cotton-growing regions). The use of Cry1F x Cry34/35A b1 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 consis ting of non-Bt corn or non-lepidopteran

resistant Bt corn.

3. Refuge location.

 The lepidopteran refuge can be planted in a separate field not more than 1⁄2 mile of the Cry1F x Cry34/35Ab1 field.

 The lepidopteran refuge can be planted within the Cry1F x Cry34/35Ab1 field as blocks (e.g. along the edges or headlands)

 The lepidopteran refuge can be planted within the Cry1F x Cry34/35Ab1 field as strips across the field at least f our 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 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.

1. Refuge size. The use of Cry1F x Cry34/35A b1 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 re quired to be planted within or adjacent (e.g. across the road) to the Cry1F x Cry34/35Ab1 corn field.149 3. Refuge management options. The rootworm refuge can be managed in such a way that there is little or no yield loss to rootwo rms, 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 (option 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 pe sticide without activity against adult corn rootworms is used. Pests on the Cry1F x Cr y34/35Ab1 acres can be treated as needed without having to treat the rootworm refuge.

 The rootworm refuge can be planted to any corn hybrid that does not express PIPs for rootworm control (e.g. lepidopteran-protecte d Bt corn, herbicide- tolerant 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 wi ndow possible between planting dates, to ensure that corn root development is similar among varieties.

 Growers are encouraged to plant the rootworm refuge in the same location each year,

as it allows the rootworm population to remain high and th e durability of the trait is extended. This option may be preferable to growers who wish to only think of their refuge design once and for growers who grow continuous corn. However, for those growers who need to employ crop rotation, a fixed refuge would be impractical.

C. For the combined refuge option (i.e. the lepidopteran refuge combined with the rootworm refuge by planting non-Bt corn), the refuge must be planted and managed such that it is consistent with the requirem ents of the two individual traits, as follows

1. Refuge size shall be 20% in corn-growi ng 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 mu st be planted as a single bloc k or as a series of strips measuring at least four (4) rows wide (six rows preferred).

 Seed mixtures of Cry1F x Cry34/35Ab1 and refuge corn are not permitted.150  If the combined refuge is planted on ro tated 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 eith er continuous or rotated la nd (option encouraged where

WCRW rotation-resistant bi otype may be present).

 Application of soil insecticide for corn rootworm control is permitted in the combined refuge.

 Seed treatment is permitted in the combined refuge, either at a rate for rootworm protection or at a rate for c ontrolling secondary soil pests.

 If aerial insecticides are applied to the co mbined 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 ref uge for control of European corn borer, corn earworm, southwestern corn borer, fa ll 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 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. Ex tension Service Agents, crop consultants). These pests

can be treated with CRW-labeled insecticid e on the combined refuge acres without treating the Cry1F x Cry34/35Ab1 acres only if treatment occurs when adults corn rootworms are not present. Microbial Bt insecticides must not be applied to the common refuges.

 Pests other than adult corn rootworms can be treated with CRW-labeled insecticide on the combined refuge acres without tr eating the Cry1F x Cry34/35Ab1 acres only if

treatment occurs when adults corn rootwo rms are not present. Pests on the Cry1F x Cry34/35Ab1 acres can be treated as needed without having to treat the refuge.

 The combined refuge can be planted to a ny corn hybrid that does not express PIPs for lepidopteran or rootworm control (i.e. herbicide tolerant co rn or conventional corn).

 The combined refuge and Cry1F x Cry34/35Ab1 corn should be sown on the same day, or with the shortest wi ndow possible between planting dates, to ensure that corn root development is similar among varieties.

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

5b. Grower Agreements

4. Persons purchasing the Bt corn product mu st sign a grower agreement. The term "grower agreement" refers to any grower purchase contract, license agreement, or similar legal document.

5. The grower agreement and/or specific st ewardship documents referenced in the grower agreement must clearly set forth the terms of the current IRM program. By signing the grower agreement, a grower mu st be contractually bound to comply with the requirements of the IRM program.151 6. The registrant must develop a system (equi valent to what is already approved for Cry1F Bt corn) which is reasonably likely to assure that persons purchasing the Bt corn product will affirm annually that they are contractually bound to comply with the requirements of the IRM program. The proposed system will be submitted to EPA by January 31, 2006.

7. The registrant must use grower agreem ents and submit to EPA by January 31, 2006 a copy of that agreement and any specific stewardship documents referenced in the grower agreement. If the registrants wish to change any part of the grower agreement or any specific stewardship documents refere nced in the grower agreement that would affect either the content of the IRM program or the legal enforceability of the provisions of the ag reement relating to the IRM program, thirty days prior to implementing a proposed change, the registrant must submit to EPA the text of such changes to ensure that it is consistent with the terms and conditions of the

amendment.

8. The registrant must establish a system (e quivalent to what is already approved for Cry1F Bt Corn) which is reasonably likely to assure that persons purchasing the Bt corn sign grower agreement(s), and must provide by January 31, 2006 a written description of that system.

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

10. Beginning on January 31, 2007 and annually th ereafter, the registrant shall provide EPA with a report showing the number of units of its Cry1F x Cry34/35Ab1 corn seeds sold or shipped and not returned, and the number of su ch units that were sold to persons who have signed grower agreements . The report shall cover the time frame of the twelve-month period covering the prior August through July.

11. The registrant must allow a review of the grower agreem ents and grower agreement records by EPA or by a State pesticide regulatory agency if the State agency can demonstrate that confidential business information, including names, personal information, and grower license number, will be protected.

5c. IRM Education and IRM Compliance Monitoring Programs

12. The registrants must implement a compre hensive, 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 el ements of the IRM program relating to refuge configuration and proximity to Bt Cry1F x Cry34/35Ab1 corn fields. The education program shall involve the use of multiple media, e.g. face-to-face meetings, mailing written materials, EPA reviewed language on IRM requirements on the bag or bag tag, and electronic communications su ch 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 writte n 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 registrants152 shall coordinate their educati on programs with educational efforts of other registrants and other organizations, such as the National Corn Grow er Association and state extension programs.

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

to take into account the information colle cted through the complia nce survey required under paragraph 6] and from other sources. The changes shall address aspects of grower compliance that ar e not sufficiently high.

14. Beginning January 31, 2008 and annually thereaf ter, the registrant must provide EPA any substantive changes to its grower educat ion activities as part of the overall IRM compliance assurance program report. The required features of the compliance assurance program are described in paragraphs 4]-15] below.

15. The registrant must design and 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 implementi ng its compliance assurance program and integrate the Cry1F x Cry34/35Ab1 CAP with the Cry1 Caps. The registrant must prepare and submit by January 31, 2006 a wr itten description of their compliance assurance program including a summary of the program implemented in the 2006 growing season. Other required features of the program are described in paragraphs 5] - 15] below.

16. The registrant must establish and 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 program and general criteria for choosing among options for responding to any non-co mpliant growers. The options shall include withdrawal of the right to pur chase Cry1F x Cry34/35Ab1Bt corn for an individual grower or for all growers in a specific region. An individual grower found to be significantly out of compliance two y ears 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 oblig ations will lose their opportunity to sell Cry1F x Cry34/35Ab1Bt corn.

17. The IRM compliance assurance program sha ll include an annual survey conducted by an independent third party of a statisti cally representative sample of Cry1F x Cry34/35Ab1Bt corn growers who pl ant 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 ar eas. The survey shall measure the degree of compliance with th e IRM program by growers in diffe rent regions of the country and consider the potential impact of non -response. The sample size and geographical resolution may be adjusted annually, based upon input from the independent marketing research firm and academic scie ntists, to allow analysis of compliance153 behavior within regions or between re gions. The sample si ze must provide a reasonable sensitivity for comparing results across the U.S.

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

19. The survey shall be designed to obtain grow er feedback on the usefulness of specific

educational tools and initiatives.

20. 7The registrant shall provide a written su mmary of the results of the prior year's survey (together with a description of the regions, the methodology used, and the supporting data) to EPA by January 31 of each year, beginning with 2007. The registrant shall confer with EPA on the design and content of the survey prior to its implementation.

21. Annually, the registrant shall revise, and expand as necessary, its compliance assurance program to take into account the information collected through the compliance survey required under paragraphs 6] through 8] and from other sources. The changes shall address aspects of grower compliance that are not sufficiently high. The registrant must confer with the Agency prior to adopting any significant changes.

22. The registrant shall conduct an annual on- farm assessment program. The registrant shall train its representatives who make on-farm visits with Cry1F x Cry34/35Ab1Bt corn growers to perform assessments of co mpliance with IRM requirements. There is no minimum corn acreage size for this progra m. Therefore, growers will be selected for this program from across all farm sizes. In the event that any of these visits result in the identification of a grower who is not in compliance with the IRM program, the registrant shall take appropriate action, consistent with its "phased compliance approach," to promote compliance.

23. The registrant shall carry out a program for investigating legitimate “tips and complaints” that its growers are not in compliance with the IRM program. Whenever an investigation results in the identification of a grower who is not in compliance with the IRM program, the registrant shall take appropriate action, consistent with its “phased compliance approach.”

24. If a grower, who purchases Cry1F x Cry34/35Ab1Bt corn for planting, was specifically identified as not being in compliance during the previous year, the registrant shall visit with the grower and evaluate whether that the grower is in compliance with the IRM program for the current year.

25. Beginning January 31, 2007 and annually thereaf ter, the registrant s shall provide a report to EPA summarizing the activitie s carried out under their compliance assurance program for the prior year incl uding changes to the grower education program, and the plans for the compliance a ssurance program during the current year. The report will include inform ation regarding grower inte ractions (including, but not limited to, third-party grower survey, on-farm visitation program, verified tips and complaints, education programs (e.g., grower meetings and letters), the extent of noncompliance, corrective measures to addr ess the non-compliance (phased-compliance program), and any follow-up actions taken.

26. The registrant and the seed corn dealers for the registrant must allow a review of the compliance records by EPA or by a State 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.154 5d. Insect Resistance Monitoring

The Agency is imposing the following conditions for 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 31st of each year beginning with 2008, reporting on populations colle cted the previous year.

Cry1 F

27. The registrants will monitor for resistance and/or trends in increased tolerance for Ostrinia nubilalis (European corn borer), Diatraea grandiosella (Southwestern corn borer), and/or Helicoverpa zea (corn earworm ). Sampling should be focused in those areas in which there is the highest risk of resistance development. The ABSTC has identified four regions for its co mpliance and monitoring programs.

28. The registrant shall provide to EPA a descri ption of its Cry1F resistance monitoring plan by January 31, 2006. The description shall include: sampling (number of locations and samples per locations), sampling methodology, bioassay methodology, standardization procedures, detection technique and sens itivity, and the statistical analysis of the probability of detecting resistance.

29. 3) The registrant must follow up on grower, extension specialist or consultant reports of less than expected results or control failures for the target lepidopteran pests

Ostrinia nubilalis (ECB), Diatraea grandiosella (SWCB), Helicoverpa zea (CEW/CBW), Spodoptera frugiperda (FAW), Agrotis ipsilon (BCW), and Richia

albicosta (WBCW), Sugar cane borer Diatraea saccharalis ; southern corn stalk borer, Diatraea

crambidoides ; lesser corn stalk borer, Elasmopalpus lignosellus . The registrant will instruct its customers (growers and seed di stributors) to contact them (e.g., via a toll free customer service number) if incidents of unexpected levels of damage occurs from these target pests. The registrant will investigate all damage reports submitted to the company or the company=s representati ves. 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 registrant must provide EPA its resi stance monitoring plan for approval. A preliminary plan must be submitted to the Agency by January 31, 2006 consisting of a description of the steps to be taken to es tablish corn rootworm baseline sensitivity and damage guidelines. A detailed resistan ce monitoring plan must be submitted to the Agency for review by January 31, 2008. This plan must include: baseline sensitivity data, sampling (number of locations, samples per locations), sampling155 methodology and life-stage sampled, bi oassay methodology, standardization procedures (including QA/QC provisions), detection technique and sensitivity, the statistical analysis of the probability of detecting resistance, and an interim description of rootworm damage guidelines.

2. The registrant must develop and validate an appropriate discrimi nating or diagnostic dose assay by January 31, 2010. Further the re gistrant must provi de BPPD with a detailed explanation and validation (steps for) of the "high-throughput diagnostic

screen" if it is to be considered an acceptabl e diagnostic dose assay.

3. The registrant must finalize rootworm damage guidelines and submit these to BPPD by January 31, 2010 should the registration be extended.

4. The registrant must follow-up on grower, exte nsion specialist or c onsultant reports of unexpected damage or control 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 co rn 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)

XXX. Definitions

Suspected resistance

EPA defines "suspected" resist ance to mean, in the case of reported product failure, that: the corn in question has b een confirmed to be Bt corn

 the seed used had the proper percentage of corn expressi ng Bt protein;

 the relevant plant tissues are expressing the expected level of Bt protein; and it has been ruled out that species not susceptible to the protein could be responsible for the damage, that no climatic or cultural reasons could be res ponsible for the damage, and

that other reasonable causes for the observe d product failure have been ruled out. The Agency does not interpret "suspected resist ance" to mean grower reports of possible control failures, nor does the Agency intend th at extensive field st udies and testing to confirm scientifically insect resistance be completed before responsive measures are

undertaken.156 If resistance is “suspected,” the registrant must instruct growers to do the following:

 Use alternate control measures to control the pest suspected of resistance to Bt corn in the affected region.

 Destroy crop residues in the affected regi on immediately after harv est (i.e. within one month) with a technique a ppropriate for local production practices to minimize the possibility of resistant ins ects 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 co rn 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:

5. If there is > 30% survival and > 25% leaf area damage d in a 5-day bioassay using Cry1Ab-positive or Cry1F-positive leaf tissu e under controlled laboratory conditions.

6. If standardized laboratory bioassays usi ng diagnostic doses for ECB (Marçon et al. 2000), SWCB (Trisyono and Chippendale 1999), or CEW/CBW (USDA/ARS/SIMRU, unpublished) demonstrat e resistance has a genetic basis and survivorship in excess of 1% (g ene frequency of population ?0.1).

7. If an LC50 in a standard Cry1Ab or Cry1F diet bioassay exceeds the upper limit of

the 95% confidence interval of the standa rd unselected laborat ory population LC50 for susceptible ECB, SWCB, or CEW popul ations, as established by the ongoing baseline monitoring program.

XXXI. Remedial Action

The registrant assumes respons ibility for the implementati on 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:

0. Notify customers and extension agents in the affected area,157 1. Require to customers and extension agents in the affected area the use of alternative

control measures to reduce or contro l the local target pest population,

2. 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.

3. Immediately stop sale and distri bution of Bt corn in the re medial 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:

4. Notify the Agency of the immediate mitiga tion measures that were implemented,

5. Submit to the Agency a proposed long-term resistance management action plan for the affected area,

6. Submit to the Agency a proposed long-term resistance management action plan for the affected area,

7. Implement an action plan that is approved by EPA and that consists of some or all the following elements, as warranted:

a. Informing customers and extension agents in the affected area of pest resistance,

b. Increasing monitoring in the affected area, and ensuring that local target pest populations are sampled on an annual basis,

c. Recommending alternative measures to reduce or control target pe st populations in the affected area,

d. Implementing intensified local IRM measures in the affected area based on the latest research results. The implementation of su ch measures will be coordinated by the Agency with other registrants; and

e. 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:

8. Maintenance of the sales susp ension of all Bt corn hybrid s (with the same protein or similar Bt proteins as the Bt corn hybrids with the resistan t population) in the affected region would remain in place until an EPA- approved local resistance management plan is in place to mitigate resist ance in the affected region(s).

9. The development and recommendation of alternative resistance management strategies for controlling the resistant pest(s) on corn in the affected region.

10. Notification of all relevant personnel (e.g., growers, consultants, extension agents, seed distributors, processors, university c ooperators, and state/fede ral authorities) in the affected region of the resistance situation.

Cry34/35Ab1158 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.

8. Definition of Suspected Resistance: Resistan ce will be suspected if investigations of unexpected damage reports show that:

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

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

b. alternative causes of damage or lodging, su ch as non-target pest insect species, weather, physical damage, larval movement from alternate hosts, planting errors, and

other reasonable causes for the obs ervations, have been ruled out;

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

If resistance is "suspected", the registrant will instruct affected growers to use alternate pest control measures such as adulticide treatment, crop rotation the following year,

or use of soil or seed insecticides the fo llowing year. These measures are intended to reduce the possibility of pot entially resistant insects contributing to the following year's pest population.

9. Confirmation of Resistance: Resistance will be confirmed if all of the following criteria are met by progeny from the target pest species sampled from the area of "suspected resistance":

. the proportion of larvae that can feed and surviv e on Cry34/35Ab1 roots from neonate to adult is significantly higher th an the baseline propor tion (currently being established);

a. the LC50 of the test population exceeds the upper limit of the 95% confidence

interval for the LC50 of a standard unsel ected population, and/or survival in the diagnostic assay is significan tly greater than that of a standard unselected population, as established by the ongoing baseline monitoring program;

b. the ability to survive is heritable;

c. Cry34/35Ab1 plant assays determine that damage caused by surviving insects would exceed economic thresholds;

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

results.

10. Response to Confirmed Resistance: When resistance is "confirmed", the following steps will be taken:159 . EPA will receive notification within 30 days of confirming resistance;

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

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

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

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

characteristics of the resistance event and local agronomic needs.160 Registrant Registration # Active Ingredients Date Registered Date Expired

Pioneer/Dupont 29964-8 1507 (PO Cry1F) x 59122 (PO Cry34Ab1 + Cry35Ab1) x MON810 (PO Cry1Ab) 24-Feb-10 31-Oct-10



### Terms and Conditions of the Registration

1. The subject registration will auto matically expire October 31, 2010.

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 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 required to support the PI P registrations of the indivi dual 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, within the time frames required by the terms a nd conditions of EPA Registration Numbers 29964-3, 29964-4, 524-489 and 29964-5, respectively.

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

Study Type Required Data Due Date

Insect Resistance Management - Grower Agreement A copy of the grower agreement, as sociated stewardship documents, and written description of a system, wh ich assure that growers will sign grower agreements and persons purchasing 1507x59122xMON810 corn will annually affirm that they are contractually bound to comply with the requirements of the insect resistan ce management (IRM) program, must

be submitted. Within 90 days of

the date of registration

6. The insect resistance management terms and conditions for 1507x59122xMON810 corn

are as follows.

The required IRM program for 1507x59122xMON 810 corn must have the following

elements:161 • Requirements relating to creation of a refuge for the Cry1F , Cry1Ab and Cry34/35Ab1 components that meets the requirements of the individual traits. The refuge for all three traits may be combined by planting non- Bt corn as the refuge, or the refuge for each trait may be planted separately. In the latter case, corn rootworm-resistant Bt corn may be planted in the lepidopteran refuge fo r the Cry1F and Cry1Ab component(s) and lepidopteran-resistant Bt corn may be planted in the corn rootworm refuge for the Cry34/35Ab1 component;

• Requirements for the regist rants to prepare and require Bt corn users to sign grower agreements which impose bindi ng contractual obligations on the grower to comply with the refuge requirements;

• Requirements for the registrants to devel op, implement, and report to EPA on programs to educate growers about IRM requirements;

• Requirements for the registrants to devel op, implement, and report to EPA on programs to evaluate and promote growers complia nce 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 devel op, implement, and report to EPA on programs to evaluate whether there are statistically sign ificant and biologically relevant changes in target insect susceptibility to Cry1F, Cr y1Ab and Cry34/35Ab1 proteins in the target insects;

• Requirements for the registrants to devel op, and if triggered, to implement a remedial action plan, which would contain measures the registrants would take in the event that any insect resistance was detected as well as to report on activity unde r the plan to EPA;

• Submit annual reports on units sold by stat e (units sold by county level will be made available to the Agency upon request), IRM gr ower 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.

I. Refuge Requirements

The use of 1507x59122xMON810 corn (Cry1F x Cry34/35Ab1 x Cry1Ab) corn requires accompanying corn refuge(s) for the Cry1F, Cry1Ab and Cry34/35Ab1 components that meets the requirements of the individual traits, described below. The refuge(s) for all three traits may be combined by planting non- Bt corn as the refuge (see C. below), or the refuges for the lepidopteran resistant traits and the corn rootworm -resistant traits may be planted separately (see A. and B. below). For the separate refuges, corn rootworm-resistant Bt corn (e.g., Herculex RW) may be planted in the lepidopteran refuge for the Cry1F and Cry1Ab compon ent and lepidopteran-resistant Bt corn162 (e.g., Herculex I or YieldGard) may be planted in the corn rootworm re fuge for the Cry34/35Ab1 component. Depending on cropping practices, pest problems, and pest management options employed on any given farm, growers may need to choose different refuge arrangements for different fields. Possible options include: tw o refuge blocks (one for rootworm, one for Lepidoptera) can be planted with in one field, or strips can be used for either refuge. Alternatively, a block of Herculex RW corn can serve as an in-f ield lepidopteran refuge for one field planted to Cry1F x Cry34/35Ab1 x Cry1Ab and an external lepidopteran refuge for separate fields planted to Cry1F x Cry34/35Ab1x Cry1Ab, wh ile the rootworm refuge is planted as

Herculex I corn or YieldGard in an external ad jacent field. In all opti ons, size and management of each individual refuge must be followe d 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.

A. Lepidopteran refuge for the Cry1F and Cry1Ab component.

1. Refuge size, Corn-Growing Areas (i.e., cornbelt and other non corn/cotton-growing regions). The use of 1507x59122xMON810 corn requires an accompanying 20% refuge consisting of non-Bt corn or non-lepidopteran resistant Bt corn.

2. Refuge size, Corn/Cotton-growing areas*. The use of 1507x59122xMON810 corn requires an accompanying 50% refuge consisting of non- Bt corn or non-lepidopteran

resistant Bt corn.

3. Refuge location.

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

of the 1507x59122xMON810 field

ii. The lepidopteran refuge can be planted within the 1507x59122xMON810 field as blocks (e.g. along the edges or headlands)

iii. The lepidopteran refuge can be planted within the 1507x59122xMON810 field as strips across the field at least four rows wide (six preferred).

4. Refuge management. Insecticide treatments for control of 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.

* 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,163 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.

i. The in-field rootworm refuge options ma y be planted as a single block or as a series of strips measuring at least four (4) crop rows wide.

ii. Seed mixtures of 1507x59122xMON810 and rootworm refuge corn are not permitted.

iii. If the rootworm refuge is planted on rotated ground, then 1507x59122xMON810 corn must also be planted on rotated ground.

iv. If the rootworm refuge is plante d in continuous corn, the 1507x59122xMON810 field may be planted on either conti nuous or rotated land (option encouraged where WCRW rotation-resistant biotype may be present).

v. Application of soil insecticide is permitted in the rootworm refuge.

vi. Seed treatment is permitted in the rootworm refuge, either at a rate for rootworm protection or at a rate fo r controlling secondary soil pests.

vii. If aerial insecticides are applied to the rootworm refuge for control of CRW adults, the same treatment must also be applied in the same time-frame to

1507x59122xMON810 corn.

viii. Pests other than adult corn rootworms can be treated on the rootworm refuge acres without treating the 1507x59122xMON810 acr es only if treatment occurs when adult corn rootworms are not pres ent or if a pestic ide without activity against adult corn rootworms is used. Pests on the 1507x59122xMON810 acres

can be treated as needed without ha ving to treat the rootworm refuge.

ix. The rootworm refuge can be planted to any corn hybrid that does not express

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

x. The rootworm refuge and 1507x59122xMON810 corn should be sown on the same day, or with the shortest window possible between pl anting dates, to ensure that corn root developm ent is similar among varieties.

xi. 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.164 C. For the combined refuge option (i.e. the lepidopteran refuge combined with the rootworm refuge by planting non -Bt corn), the refuge must be planted and managed such that it is consistent with the requirements of the two individual traits, as follows:

1. Refuge size shall be 20% in corn-growing areas and 50% in cotton-growing areas (see list labeled with “*” under A).

2. Refuge location. The combined refuge is required to be planted within or adjacent (e.g. across the road) to th e 1507x59122xMON810 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 1507x59122xMON810 and refuge corn are not permitted.

iii. If the combined refuge is pl anted on rotated ground, then the 1507x59122xMON810 corn must also be planted on rotated ground.

iv. If the combined refuge is planted on continuous corn, the 1507x59122xMON810 field may be planted on either continuous or rotated land (option encouraged where WCRW rotation-resistant biotype may be present).

v. Application of soil insecticide for corn rootworm control is permitted in the combined refuge.

vi. Seed treatment is permitted in the co mbined refuge, either at a rate for rootworm protection or at a rate fo r controlling secondary soil pests.

vii. If aerial insecticides are applied to the combined refuge for control of CRW adults, the same treatment must also be applied in the same timeframe to

1507x59122xMON810 corn.

viii. Insecticide treatments in the combined refuge for control of European corn borer, corn earworm, southwestern corn borer, fall armyworm, black cutworm, western bean cutworm, sugarcane borer, lesser corn stalk borer, or southern corn stalk borer may be applied only if economic thresholds are reached for one or more of these target pests. Economic thresholds will be determined using methods recommended by local or regional profession als (e.g. Extension Service Agents, crop consultants). Th ese pests can be treated with CRWlabeled insecticide on the combined refuge acres wi thout treating the 1507x59122xMON810 acres only if treatment occurs when adult corn rootworms are not present. Microbial Bt insecticides must not be applied to the common refuges.

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

insecticide on the combined ref uge acres without treating the 1507x59122xMON810 acres only if treatment occurs when adult corn165 rootworms are not present. Pest s on the 1507x59122xMON810 acres can be

treated as needed without having to treat the refuge.

x. The combined refuge can be planted to any corn hybrid th at does not express PIPs for lepidopteran or rootworm cont rol (i.e. herbicide tolerant corn or conventional corn).

xi. The combined refuge and 1507x59122xMON810 corn should be sown on the same day, or with the shortest window possible between planting dates, to ensure that corn root developm ent is similar among varieties.

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

II. Grower Agreement

A. Persons purchasing 1507x59122xMON810 corn must sign a grower agreement. The term “grower agreement” refers to any grow er purchase contract, license agreement, or similar legal document.

B. The grower agreement and/or specific stewardship documents referenced in the grower agreement must clearly set forth the terms of the current IRM program. By signing the grower agreement, a grower must be contractually bound to comply with the requirements of the IRM program.

C. Pioneer must implement a system equivalent to what is already a pproved 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 descrip tion 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 enforceability 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 1507, 59122 and MON810), which is re asonably likely to assure that persons purchasing 1507x59122xMON810 corn sign grower agreement(s). A description of the system must be submitted to EPA within 90 days from the date of registration.

F. Pioneer shall maintain records of all 1507x59122xMON810 corn grower agreements for166 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 units of 1507x59122xMON 810 corn seed sold or shipped and not returned, and the number of such units th at were sold to persons who have signed grower agreements. The report shall cover the time frame of a twelve-month period. Note: The first report shall contain the specifi ed information from the time frame starting with the date of registration and extending through the 2010 growing season.

H. Pioneer must allow a review of the grower agreements and grower agreement records by EPA or by a State pesticide regulatory agency if the State agency can demonstrate that confidential business information, including na mes, personal information, and grower license number, will be protected.

III. IRM Education and IRM Compliance Monitoring Program

A. Pioneer must maintain a comprehensive, ongoing IRM education program designed to convey to 1507x59122xMON810 corn users the im portance of complying with the IRM program for all Bt corn products contai ning the Cry1F, Cry1Ab and Cry34/45Ab1events. The program shall include information encouraging 1507x59122xMON810 corn users to pursue optional elements of the IRM program relating to refuge configuration and proximity to 1507x59122xMON810 corn fields. Th e education program shall involve the use of multiple media (e.g. face-to-face me etings, mailing written materials, EPAreviewed language on IRM requirements 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 their records. The pr ogram shall involve at least one written communication annually to each 1507x59122xMON810 corn user separate from the grower technical guide. The communication shall inform the user of the current IRM requirements. Pioneer sh all coordinate its education program with the educational efforts of other registrants a nd other organizations, such as the National Corn Growers Association and state extension programs.

B. Annually, Pioneer shall revise, and expand as necessary, its education program to take

into account the information collected th rough the compliance survey required under paragraph F and from other sources. The regi strant shall identify deficiencies in grower compliance and revise the education pr ogram to address those deficiencies.

C. 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 Stewards hip Technical Committee (ABSTC).

D. 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 growers purchasing 1507x59122xMON810 corn are167 complying with the IRM program, and that take s 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. Pion eer shall coordinate with other Bt corn registrants in designing and implementing its compliance assurance program and integrate this registration into the current compliance assurance program used for their other Bt corn PIPs. Pioneer must prepare and submit within 90 days of the date of registration a written description of the compliance assurance program. Other required features of the program are describe d in paragraphs E through O below.

E. 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

1507x59122xMON810 corn for an indivi dual grower or for all growers in a specific region. An individual grower found to be significantly out of compliance two years in a

row would be denied sales of 1507x59122xMON810 co rn the next year. Similarly, seed dealers who are not fulfilling their obligati ons to inform/educate growers of their IRM obligations will lose their opportunity to sell 1507x59122xMON810 corn.

F. The IRM compliance assurance program shall include an annual survey, conducted by an independent third party, of a statistically representative sample of growers of 1507x59122xMON810 corn who plant the vast majority of all corn in the United States and in areas in which the selection intensity is the greatest. The survey shall consider only those growers who plant 200 or more acres of corn in the Corn-Belt or who plant 100 or more acres of corn in corn-cotton gr owing 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.

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

deviations.

H. The survey shall be designed to obtain grow er feedback on the us efulness of specific

educational tools and initiatives.

I. 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 confer168 with other registrants and EPA on the design and content of the survey prior to its implementation.

J. Annually, Pioneer shall revise, and expand as necessary, its compliance assurance program to take into account the information collected through the compliance survey (required under paragraphs F th rough H) and from other sour ces. The registrant shall identify deficiencies in grower compliance and revise the education program to address

those deficiencies. Pioneer must confer with the Agency prior to adopting any changes.

K. Pioneer shall conduct an annual on-farm asse ssment program. Pioneer shall train its representatives who make on-farm visi ts with growers of 1507x59122xMON810 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.

L. 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.”

M. If a grower, who purchases 1507x59122xMON810 co rn for planting, was specifically identified as not being in compliance during th e previous year, Pioneer shall visit with the grower and evaluate whether th at grower is in compliance with the IRM program for the

current year.

N. Beginning January 31, 2011, and annually thereafte r, Pioneer shall provide a report to EPA summarizing the activitie s 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 report collectively the results of compliance

assurance programs.

O. 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.

IV. Insect Resistance Monitori ng and Remedial Action Plans

A. Lepidopteran Resistance Monitoring. The Agen cy is imposing the following conditions for the Cry1Ab and Cry1F toxins expressed in 1507x59122xMON810 corn:169 Pioneer will monitor for resistance to Cry1Ab and Cry1F toxins expressed in 1507x59122xMON810 corn. The monitoring program 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

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 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 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.

Any 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 and170 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 below, based on the following definitions of suspected resistance and confirmed

resistance.

3. Suspected resistance

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

i. The corn in question has been confirmed to be lepidopteran-active Bt corn;171 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 r easonable 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).

ii. 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 field172 monitoring.

5. Response to Confirmed Resist ance 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 hybrid s in the affected 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 alternative 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 increas ed tolerance for corn rootworm using the existing corn rootworm monitoring program developed for previously173 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).174 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, such 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”:

• 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 a ffected 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 confirmed175 resistance;

• affected customers and extension agents wi ll 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 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.

V. Annual Reporting Requirements

1) Annual Sales: reported and summed by state (county level data available by request) January 31st each year, beginning in 2011;

2) Grower Agreements: number of units of 1507x59122xMON810 corn seed shipped or sold and not returned, and the number of such units that were sold to persons who have signed grower agreements, January 31st each year, beginning in 2011;

3) Grower Education: substantive changes to education program completed previous year, January 31st each year, beginning in 2011;

4) Compliance Assurance Program: 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 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.176 Registrant Registration # Active Ingredients Date Registered Date Expired

Pioneer/Dupont 29964-9 59122 (PO Cry34Ab1 + Cry35Ab1) x MON810 (PO Cry1Ab) 24-Feb-10 31-Oct-10



### Terms and Conditions of the Registration

1. The subject registration will auto matically expire October 31, 2010.

2. The subject registration will be limited to Bacillus thuringiensis Cry34Ab1 protein and the genetic material (PHP17662) necessary for its production in corn event 59122 (OECD Unique Identifier DAS-59122-7) x Bacillus thuringiensis Cry35Ab1 protein and the genetic material (PHP17662) necessary 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. You must submit the following data and/or information in the time frames listed:

Study Type Required Data Due Date

Insect Resistance Management -

Grower Agreement A copy of the grower agreement, as sociated stewardship documents, and written description of a system, wh ich assure that growers will sign grower agreements and persons purchasing 59122xMON810 corn will annually affirm that they are cont ractually bound to comply with the requirements of the insect resistan ce management (IRM) program, must

be submitted. Within 90 days of the date of registration

6. The insect resistance management terms and conditions for 59122xMON810 corn are as

follows:

The required IRM program 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 the individual traits. The refuge for both traits may be combined by planting non- Bt corn as the refuge, or the refuge for each177 trait may be planted separately. In the latter case, corn rootworm-resistant Bt corn may be planted in the lepidopteran refuge for the Cry1Ab component and lepidopteranresistant Bt corn may be planted in the corn rootworm refuge for the Cry34/35Ab1

component;

• Requirements for the registra nts to prepare and require Bt corn users to sign grower agreements which impose bindi ng contractual obligations on the grower to comply with the refuge requirements;

• Requirements for the registrants to devel op, implement, and report to EPA on programs to educate growers about IRM requirements;

• Requirements for the registrants to devel op, implement, and report to EPA on programs to evaluate and promote growers compliance with IRM requirements (the 59122xMON810 Compliance Assurance Program (C AP) must integrate with the CAPS for the individually registered and comb ination products expressing Cry34/35Ab1 and Cry1Ab);

• Requirements for the registrants to devel op, implement, and report to EPA on programs

to evaluate whether there ar e statistically significant and biologically relevant changes in target insect susceptibility 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, which would contai n measures the registrants w ould take in the event that any insect resistance was detected as well as to report on activity unde r 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 gr ower 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 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 of178 Herculex RW corn can serve as an in-field lepidopteran refuge for one field planted to Cry34/35Ab1 x Cry1Ab and an external lepidopteran refuge for separate fields planted to Cry34/35Ab1x Cry1Ab, while the rootworm refuge is planted as YieldGard in an external adjacent field. In all options, size and manageme nt of each individual re fuge 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.

A. Lepidopteran refuge for the Cry1Ab component.

1. Refuge size, Corn-Growing Areas (i.e., cornbelt and other non corn/cotton-growing regions). The use of 59122xMON810 corn requires an accompanying 20% refuge consisting of non-Bt corn or non-lepidopteran resistant Bt corn.

2. Refuge size, Corn/Cotton-Growing areas *. 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 armyworm, 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, 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).179 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).

x. 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 each180 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 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 Serv ice Agents, crop consultants). These pests can be treated with CRW-labeled in secticide on the combined refuge acres without treating the 59122xMON8 10 acres only if treatment occurs when adult181 corn rootworms are not present. Microbial Bt insecticides must not be applied to the common refuges.

ix. Pests other than adult corn rootworm s can be treated with CRW-labeled insecticide on the combined refuge acres without treating the 59122xMON810 acres only if treatment occurs when adult corn rootworms are not present. Pests

on the 59122xMON810 acres can be treated as needed without havi ng 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 th e previously registered events 59122 and MON810, which is reasonably likely to assure that persons purchasing 59122xMON810 corn will affirm annually that they ar e 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 enforceability 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 for182 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

P. 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.

Q. 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.

R. 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 must183 either submit a separate report or contribut e to the report from the industry working group, Agricultural Biotechnology Stewards hip Technical Committee (ABSTC).

S. 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.

T. 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.

U. The IRM compliance assurance program shall include an annual survey, conducted by an independent third party, of a statistically representative sample of growers of 59122xMON810 corn who plant the vast majority of all corn in the United States and in areas in which the selection intensity is the 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.

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

deviations.184 W. The survey shall be designed to obtain grow er feedback on the us efulness of specific

educational tools and initiatives.

X. 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.

Y. Annually, Pioneer shall revise, and expand as necessary, its compliance assurance program to take into account the information collected through the compliance survey (required under paragraphs F. through H.) and from other sources. The registrant shall identify deficiencies in grower compliance and revise the education program to address

those deficiencies. Pioneer must confer with the Agency prior to adopting any changes.

Z. Pioneer shall conduct an annual on-farm 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.

AA. Pioneer shall carry out a progr am 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, Pioneer shall take appropriate action, consis tent with its “phased compliance approach.”

BB. If a grower, who purchases 59122xMON810 corn for planting, was specifically identified as not being in compliance during th e previous year, Pioneer shall visit with the grower and evaluate whether th at grower is in compliance with the IRM program for the

current year.

CC. Beginning January 31, 2011, and annually therea fter, Pioneer shall provide a report to EPA summarizing the activitie s 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.

DD. 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.185 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 and agronomic conditions. To obtain sufficient sensitivity to detect resistance alleles before they become common enough to cause measurable field damage, each population collection shall attempt to target 400 insect genomes (egg masses, 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.

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.186 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.

iii. 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.187 3. Suspected resistance

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

i. the corn in question has been 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.

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 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).188 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

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

i. EPA will receive notification within 30 days of resistance confirmation;

ii. Affected customers and extension 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 authorities189 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 increas ed 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 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 to190 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 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 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 affect ed 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.191 V. Annual Reporting Requirements

1. Annual Sales: reported and summed by state (county level data available by request) January 31st each year, beginning in 2011;

2. Grower Agreements: number of units of 59122xMON810 corn seed shipped or sold and not returned, and the number of such 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 plans 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 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.192 Registrant Registration # Active Ingredients Date Registered Date Expired

Syngenta 67979-5 Bt Corn Event MIR 604 with modified Cry3A (Agrisure RW) 3-Oct-06 30-Sep-10



### Terms and Conditions of the Registration

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

2) The subject registration will be limited to mCry3A corn, modified Cry3A protein and the genetic material necessary for its production (via elements of pZM26) in Event MIR604 corn

SYN-IR604-8.

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

4) Provide to the EPA laboratory (Ft. Meade, MD) methodology and/or reagents necessary for validation of a mCry3A analytic al method within 6 months from the date that the Agency requests them.

5) Submit field degradation studies evaluatin g accumulation and persistence of mCry3A in

several different soils in various strata. Representative fields must have been planted with mCry3A corn and include both conventional till age and no-till samples and be harvested under typical agronomic conditions. Samp ling must continue until the limit of detection is reached. Studies should include soils with high levels of a variety of clays. Both ELISA and insect bioassays need to be conducted and compared to determine if mCry3A is accumulating or persisting in soil samples. A protocol is due with in 90 days of the date of registration. Should the registration expiration date be ex tended, a final report regarding da ta from fields that have had three continuous years of cultivation of Ev ent MIR604 corn is due by January 31, 2011.

6) Three (3) year full-scale field or semi-field studies for evaluation of mCry3A Event MIR604 corn exposure on non-target invertebrates must be conducted. Full-scale fi eld experiments must be appropriately designed to provide a measur e of ecological impacts (larger fields, more replicates, more samples per plot based on recommendations of the August, 2002 SAP and subsequent relevant research on ap propriate study design). A prot ocol is due within 90 days of the date of registration. Should th e registration expiration date be extended, a fina l report is due January 31, 2011.

7) Submit the following data to augment the mCry3A amino acid sequence analysis to known toxins and allergens within six months of the date of registration: specif ication of which version of NCBI database was utilized; descriptions of para meters utilized; and dates accessed for the

BLAST search.

8) Submit the following insect resistan t management data by January 31, 2010.

a)Initiate establishment of CRW strains that are resistant to mCry3A and investigate the nature,193 inheritance, and fitness costs of specific mechanisms of resistance to the mCry3A protei n expressed in MIR604 maize.

b) Study the behavioral deterrence (avoi dance) mechanism further and submit appropriate

results.

c) Continue studies on the biological impact of adults surviving on MIR604 maize and submit

these results.

9) You must commit to do the following Insect Resistance Management Program:

a. Refuge Requirements

These refuge requirements do not apply to seed increase/propagation of inbred and hybrid seed

corn.

1] Grower agreements (also known as stewardshi p 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.

2] Specifically, growers must pl ant a structured refuge of at least 20% non-corn rootworm protected Bt corn that may be treated with ins ecticides 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 stri ps, or as in-field strips.

4] External refuges must be planted adjacent (e .g., across the road) to mCry3A MIR604 fields.

5] When planting the refuge in st rips across the field, refuges must be at least 4 consecutive rows

wide.

6] Insecticide treatments for control of corn r ootworm larvae may be a pplied. Instructions to growers will specify that insect icides labeled for control of co rn rootworm adults cannot be applied while adults are present in the refuge unless the mCry3A field is treated in a similar

manner.

7] If the refuge is planted in a field that is in a crop rotation system, then MIR604 must also be planted in a field that is in a crop rotation system.

8] If the refuge is planted on continuous corn, then the MIR604 field may be planted on either

continuous or in a field that is in a crop rotation system.

b. Grower Agreements

1] Persons purchasing the Bt corn product must sign a grower agreement. The term "grower194 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 (equiva lent to what is alread y approved for Bt11 field corn, EPA Reg. No. 67979-1) which is reasonably likel y to assure that pers ons purchasing the Bt corn product will affirm annually that they are contractually bound to comply with the requirements of the IRM program. The proposed system will be submitted to EPA within 90 days from the date of registration.

4] The registrant must use grower agreements 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 Syngenta wishes to chan ge 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 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 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 already approved for Bt11, EPA Reg. No. 67979-1) which is reasonably likely to a ssure 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 agreemen ts for a period of three years from December 31st of the year in which the agreement was signed.

7] Beginning on January 31, 2008 and annually thereaft er, the registrant shall provide EPA with a report showing the number of units of its Bt MIR604 corn seeds sold or shipped and not returned, and the number of such units that were sold to pe rsons who have signed grower agreements. The report shall cover the time frame of the twelve-month period covering the prior August through July.

8] Beginning in January 31, 2008, and annually th ereafter, the registrant shall submit annual reports on units sold by State (units sold by coun ty level will be made available to the Agency upon request), IRM grower agreement results, a nd the compliance assurance program, 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 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] Syngenta must design and implement a comprehensive, ongoing IRM education program195 designed to convey to Bt MIR6 04 corn users the importance of complying with the IRM program. The program shall include information encouraging Bt MIR604 corn users to pursue optional elements of the IRM program relating to refuge configuratio n and proximity to Bt

MIR604 corn fields. The educati on program shall involve the use of multiple media, e.g. face-toface meetings, mailing written materials, EPA reviewed language on IR M requirements on the bag or bag tag, and electronic communications such as by Internet, radio, or television commercials. Copies of the materials will be provided to EPA for its records. The program shall

involve at least one written comm unication annually to each Bt MI R604 corn user separate from the grower technical guide. The communication shall inform the user of the current IRM requirements. Syngenta shall coordinate its educa tion programs with educational efforts of other registrants and other organizations, such as th e National Corn Growers Association and state extension programs.

2] Annually, the registrant shall revise, and expa nd as necessary, its education program to take into account the information collected through the compliance survey required under paragraph 6] and from other sources. The changes shall a ddress aspects of grower compliance that are not sufficiently high.

3] On January 31, 2008, the registrant must pr ovide a report to EPA su mmarizing the activities carried out under the education program for the pr ior year. Annually therea fter, the registrant must provide EPA any substantive changes to its grower education activ ities as part of the overall IRM compliance assurance program repor t. The required features of the compliance assurance program are described in paragraphs 4]-15] below.

4] The registrant must design and implement an ongoing IRM compliance assurance program designed to evaluate the extent to which growers purchasing its MIR604 Bt corn product are complying with the IRM program and that takes su ch actions as are reasonably needed to assure that growers who have not complied with the progr am either do so in the future or lose their access to the MIR604 Bt corn product. The regist rant shall coordinate with other Bt corn registrants in designing and implementing its compliance assurance program and integrate the mCry3A CAP with the CAP already approved for Bt11, EPA Registra tion Number 67979-1. The registrant must prepare and submit within 90 days of the date of registra tion a written description of their compliance assurance pr ogram. Other required features of the program are described in paragraphs 5] - 15] below.

5] The registrant must establis h and publicize a "phase d 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. The options shall include withdrawal of the right to pur chase MIR604 Bt corn for an individual grower or for all growers in a specific region. An individual grower found to be significantly out of compliance two y ears 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 sta tistically representative sample of growers of Bt corn products who plant the vast majority of all corn in the U.S. and in areas in which the selection intensity is196 greatest The survey shall consider only those gr owers who plant 200 or mo re acres of corn in the Corn-Belt and who plant 100 or more acres of corn in corn-c otton areas.. The survey shall measure the degree of compliance with the IRM program by growers in di fferent regions of the country and consider the potential impact of no n-response. The sample size and geographical resolution may be adjusted annually, based upon input from the independ ent marketing research firm and academic scientists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasona ble sensitivity for comp aring results across the

U.S.

7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An an alysis of the survey re sults 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 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, beginning with 2008. The registrant shall c onfer with other Bt corn registrants and EPA on the design and conten t 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 co llected through the comp liance survey required under paragraphs 6] through 8] and from other sources. The changes shall address aspects of grower compliance that are not sufficiently high. The registrant must confer with the Agency prior to adopting any changes to a previously approved CAP.

11] The registrant shall conduct an annual on-farm assessment program. The registrant shall train its representatives who make on-fa rm visits with growers of thei r 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 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 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 MIR604 Bt corn for planting, was specifically identified as not being in compliance during the previous year, th e registrant shall visit with the grower and evaluate whether that the grower is in compliance with the IR M program for the current year.

14] Beginning January 31, 2008 and annually thereafte r, Syngenta shall provide a report to EPA summarizing the activities carried out under thei r 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 grow er interactions (including, but not limited to, on-farm visits,197 verified tips and complaints, grower meetings and letters), the extent of non-compliance,

corrective measures to address the non-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 confidential business information, including the names, personal information, and grower license number of the growers will be protected.

d. Insect Resistance Monitoring

The Agency is imposing the following conditions for this product: The registrant must monitor for mCry3A resistance and/or trends in increased tolerance for corn rootworm. Sampling should be focused in those ar eas in which there is the highest risk of resistance development.

1] The registrant must provide EPA its resi stance monitoring plan for approval. A revised monitoring plan must be submitted to the Agency with 3 months of the date of registration consisting of a description of the steps to be take n to establish corn rootwo rm baseline sensitivity and damage guidelines. A detailed resistance monitoring plan must be submitted to the Agency for review by January 31, 2008. This plan must include: baseline sensitivity data, sampling (number of locations, samples per locations), sampling methodology and life-stage sampled, bioassay methodology, standardization procedur es (including QA/QC pr ovisions), detection technique and sensitivity, the statistical analysis of the probability of det ecting resistance, and an interim description of root worm damage guidelines.

2] The registrant must develop and validate an appropriate discriminating or diagnostic dose assay by January 31, 2010.

3] You must finalize rootworm damage guidelin es and submit these to BPPD by January 31,

2010.

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 31st of each year beginning with 2008, reporting on populations 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 lepi dopteron and CRW Bt corn products).

1. Definition of Suspected Resistance: Resistance will be suspect ed if investigations of unexpected damage reports show that: i. implicated maize plant roots were expr essing the mCry3A protein at the expected level;198 j. alternative causes of da mage or lodging, such as non-t arget pest insect species, weather, physical damage, larval movement from alternate hosts, planting errors, and

other reasonable causes for the obs ervations, have been ruled out; k. the level of damage exceeds guidelines for expected damage.

If resistance is “suspected”, the registrants wi ll instruct affected gr owers to use alternate pest control measures such as adulticide tr eatment, crop rotation the following year, or use of soil or seed insecticides the following year. These measures are intended to reduce the possibility of potentially resistant insect s contributing to the fo llowing year’s pest population.

2. Confirmation of Resistance : Resistance will be confirmed if all of the following criteria are met by progeny from the target pest species sampled from the area of “suspected resistance” k.the proportion of larvae that can feed a nd survive on mCry3A roots from neonate to adult is significantly higher than the baseli ne proportion (currently being established);

l.the LC 50 of the test population exceeds the upper limit of the 95% confidence

interval for the LC 50 of a standard unselected populat ion and/or survival in the diagnostic assay is significan tly greater than that of a standard unselected population, as established by the ongoing baseline monitoring program; m.the ability to survive is heritable; n.mCry3A plant assays determine that da mage caused by surviving insects would exceed economic thresholds; o.the identified frequency of field resistance could lead to widespread product failure if subsequent collections in the affected field area(s) demonstrated similar bioassay

results.

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

a. EPA will receive notification within 30 days of resistance confirmation; b.affected customers and extension 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;

e. a long-term resistance management acti on plan will be devised according to the

characteristics of the resistan ce 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 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 31st199 each year;

3) Grower Education: substantive changes to education program comp leted previous year, January 31st each year;

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

5) Compliance: to include annual survey results and plans for the next year; full report January 31st each year;

6) Insect Resistance Monitoring Results: results of monitoring and inves tigations of damage reports, August 31st each year, beginning in 2008.200 Registrant Registration # Active Ingredients Date Registered Date Expired

Syngenta 67979-8 Bt Corn Event MIR 604 + Bt11 with modified Cry3A + Cry1Ab (Agrisure CB/RW) 24-Jan-07 30-Sep-10



### Terms and Conditions of the Registration

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

2) The subject registration will be limited to mCry3A corn, modified Cry3A protein and the genetic material necessary for its production (via elements of pZM26) in Event MIR604 corn

SYN-IR604-8.

3) Submit/cite all data required for 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 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.

5) Provide to the EPA laboratory (Ft. Meade, MD) methodology and/or reagents necessary for validation of a mCry3A analytic al method within 6 months from the date that the Agency requests them.

6) Submit field degradation studies evaluatin g accumulation and persistence of mCry3A in

several different soils in various strata. Representative fields must have been planted with mCry3A corn and include both conventional till age and no-till samples and be harvested under typical agronomic conditions. Samp ling must continue until the limit of detection is reached. Studies should include soils with high levels of a variety of clays. Both ELISA and insect bioassays need to be conducted and compared to determine if mCry3A is accumulating or persisting in soil samples. A protocol is due with in 90 days of the date of registration. Should the registration expiration date be ex tended, a final report regarding da ta from fields that have had three continuous years of cultivation of Ev ent MIR604 corn is due by January 31, 2011.

7) Three (3) year full-scale field or semi-field studies for evaluation of mCry3A Event MIR604 corn exposure on non-target invertebrates must be conducted. Full-scale fi eld experiments must be appropriately designed to provide a measur e of ecological impacts (larger fields, more replicates, more samples per plot based on recommendations of the August, 2002 SAP and subsequent relevant research on ap propriate study design). A prot ocol is due within 90 days of the date of registration. Should th e registration expiration date be extended, a fina l report is due January 31, 2011.201 8) Submit the following data to augment the mCry3A amino acid sequence analysis to known toxins and allergens within six months of the date of registration: specif ication of which version of NCBI database was utilized; descriptions of para meters utilized; and dates accessed for the

BLAST search.

9) Submit the following insect resistan t management data by January 31, 2010.

a)Initiate establishment of CRW strains that are resistant to mCry3A and investigate the nature, inheritance, and fitness costs of specific mechanisms of resistance to the mCry3A protei n expressed in MIR604 maize.

b) Study the behavioral deterrence (avoi dance) mechanism further and submit appropriate

results.

c) Continue studies on the biological impact of adults surviving on MIR604 maize and submit

these results.

9) You must commit to do the following Insect Resistance Management Program:

b. Refuge Requirements

These refuge requirements do not apply to seed increase/propagation of inbred and hybrid seed

corn.

1] Grower agreements (also known as stewardshi p 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.

2] Specifically, growers must pl ant a structured refuge of at least 20% non-corn rootworm protected Bt corn that may be treated with ins ecticides 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 stri ps, or as in-field strips.

4] External refuges must be planted adjacent (e .g., across the road) to mCry3A MIR604 fields.

5] When planting the refuge in st rips across the field, refuges must be at least 4 consecutive rows

wide.

6] Insecticide treatments for control of corn r ootworm larvae may be a pplied. Instructions to growers will specify that insect icides labeled for control of co rn rootworm adults cannot be applied while adults are present in the refuge unless the mCry3A field is treated in a similar

manner.

7] If the refuge is planted in a field that is in a crop rotation system, then MIR604 must also be202 planted in a field that is in a crop rotation system.

8] If the refuge is planted on continuous corn, then the MIR604 field may be planted on either

continuous or in a field that is in a crop rotation system.

9] Refuge requirements do not appl y to seed propagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per c ounty and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year.

b. Grower Agreements

1] Persons purchasing the Bt corn product must sign a grower agreement. The term "grower agreement" refers to any grower purchase contract , license agreement, or similar legal document.

2] The grower agreement and/or specific 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 (equiva lent to what is alread y approved for Bt11 field corn, EPA Reg. No. 67979-1) which is reasonably likel y to assure that pers ons purchasing the Bt corn product will affirm annually that they are contractually bound to comply with the requirements of the IRM program. The proposed system will be submitted to EPA within 90 days from the date of registration.

4] The registrant must use grower agreements 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 Syngenta wishes to chan ge 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 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 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 already approved for Bt11, EPA Reg. No. 67979-1) which is reasonably likely to a ssure 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 agreemen ts for a period of three years from December 31st of the year in which the agreement was signed.

7] Beginning on January 31, 2008 and annually thereaft er, the registrant shall provide EPA with a report showing the number of units of its Bt MIR604 corn seeds sold or shipped and not returned, and the number of such units that were sold to pe rsons who have signed grower agreements. The report shall cover the time frame of the twelve-month period covering the prior August through July.

8] Beginning in January 31, 2008, and annually th ereafter, the registrant shall submit annual203 reports on units sold by State (units sold by coun ty level will be made available to the Agency upon request), IRM grower agreement results, a nd the compliance assurance program, 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 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] Syngenta must design and implement a comprehensive, ongoing IRM education program designed to convey to Bt MIR6 04 corn users the importance of complying with the IRM program. The program shall include information encouraging Bt MIR604 corn users to pursue optional elements of the IRM program relating to refuge configuratio n and proximity to Bt

MIR604 corn fields. The educati on program shall involve the use of multiple media, e.g. face-toface meetings, mailing written materials, EPA reviewed language on IR M requirements on the bag or bag tag, and electronic communications such as by Internet, radio, or television commercials. Copies of the materials will be provided to EPA for its records. The program shall

involve at least one written comm unication annually to each Bt MI R604 corn user separate from the grower technical guide. The communication shall inform the user of the current IRM requirements. Syngenta shall coordinate its educa tion programs with educational efforts of other registrants and other organizations, such as th e National Corn Growers Association and state extension programs.

2] Annually, the registrant shall revise, and expa nd as necessary, its education program to take into account the information collected through the compliance survey required under paragraph 6] and from other sources. The changes shall a ddress aspects of grower compliance that are not sufficiently high.

3] On January 31, 2008, the registrant must pr ovide a report to EPA su mmarizing the activities carried out under the education program for the pr ior year. Annually therea fter, the registrant must provide EPA any substantive changes to its grower education activ ities as part of the overall IRM compliance assurance program repor t. The required features of the compliance assurance program are described in paragraphs 4]-15] below.

4] The registrant must design and implement an ongoing IRM compliance assurance program designed to evaluate the extent to which growers purchasing its MIR604 Bt corn product are complying with the IRM program and that takes su ch actions as are reasonably needed to assure that growers who have not complied with the progr am either do so in the future or lose their access to the MIR604 Bt corn product. The regist rant shall coordinate with other Bt corn registrants in designing and implementing its compliance assurance program and integrate the mCry3A CAP with the CAP already approved for Bt11, EPA Registra tion Number 67979-1. The registrant must prepare and submit within 90 days of the date of registra tion a written description of their compliance assurance pr ogram. Other required features of the program are described in paragraphs 5] - 15] below.

5] The registrant must establis h and publicize a "phase d compliance approach," i.e., a guidance204 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. The options shall include withdrawal of the right to pur chase MIR604 Bt corn for an individual grower or for all growers in a specific region. An individual grower found to be significantly out of compliance two y ears 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 sta tistically representative sample of growers of Bt corn products who plant the vast majority of all corn in the U.S. and in areas in which the selection intensity is greatest The survey shall consider only those gr owers who plant 200 or mo re acres of corn in the Corn-Belt and who plant 100 or more acres of corn in corn-c otton areas.. The survey shall measure the degree of compliance with the IRM program by growers in di fferent regions of the country and consider the potential impact of no n-response. The sample size and geographical resolution may be adjusted annually, based upon input from the independ ent marketing research firm and academic scientists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasona ble sensitivity for comp aring results across the

U.S.

7] The survey shall be designed to provide an understanding of any difficulties growers encounter in implementing IRM requirements. An an alysis of the survey re sults 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.

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, beginning with 2008. The registrant shall c onfer with other Bt corn registrants and EPA on the design and conten t 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 co llected through the comp liance survey required under paragraphs 6] through 8] and from other sources. The changes shall address aspects of grower compliance that are not sufficiently high. The registrant must confer with the Agency prior to adopting any changes to a previously approved CAP.

11] The registrant shall conduct an annual on-farm assessment program. The registrant shall train its representatives who make on-fa rm visits with growers of thei r Bt corn products to perform assessments of compliance with IRM requirement s. 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 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"205 that its growers are not in compliance with the IRM program. Whenever an investigation results in the identification of a grower who is not in compliance with the IRM program, the registrant shall take appropriate acti on, consistent with its "pha sed compliance approach."

13] If a grower, who purchases MIR604 Bt corn for planting, was specifically identified as not being in compliance during the previous year, th e registrant shall visit with the grower and evaluate whether that the grower is in compliance with the IR M program for the current year.

14] Beginning January 31, 2008 and annually thereafte r, Syngenta shall provide a report to EPA summarizing the activities carried out under thei r 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 grow er 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 confidential business information, including the names, personal information, and grower license number of the growers will be protected.

d. Insect Resistance Monitoring

The Agency is imposing the following conditions for this product: The registrant must monitor for mCry3A resistance and/or trends in increased tolerance for corn rootworm. Sampling should be focused in those ar eas in which there is the highest risk of resistance development.

1] The registrant must provide EPA its resi stance monitoring plan for approval. A revised monitoring plan must be submitted to the Agency with 3 months of the date of registration consisting of a description of the steps to be take n to establish corn rootwo rm baseline sensitivity and damage guidelines. A detailed resistance monitoring plan must be submitted to the Agency for review by January 31, 2008. This plan must include: baseline sensitivity data, sampling (number of locations, samples per locations), sampling methodology and life-stage sampled, bioassay methodology, standardization procedur es (including QA/QC pr ovisions), detection technique and sensitivity, the statistical analysis of the probability of det ecting resistance, and an interim description of root worm damage guidelines.

2] The registrant must develop and validate an appropriate discriminating or diagnostic dose assay by January 31, 2010.

3] You must finalize rootworm damage guidelin es and submit these to BPPD by January 31,

2010.

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 31st of each year beginning with 2008, reporting on populations collected the previous year.206 e. Remedial Action Plans

The following program summary describes, in 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 lepi dopteron and CRW Bt corn products).

1. Definition of Suspected Resistance: Resistance will be suspect ed if investigations of unexpected damage reports show that: l. implicated maize plant roots were expre ssing the mCry3A protein at the expected level; m. alternative causes of damage or lodging, such as non-target pest insect species, weather, physical damage, larval movement from altern ate hosts, planting errors , and other reasonable

causes for the observations , have been ruled out; n. the level of damage exceeds guidelines for expected damage.

If resistance is “suspected”, the registrants will instruct affected growers to use alternate pest control measures such as adulticide treatment, crop rotation the following year, or use of soil or seed insecticides the following year. These 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”: p.the proportion of larvae that can feed and surv ive on mCry3A roots from neonate to adult is significantly higher than th e baseline proportion (curren tly being established); q.the LC 50 of the test population excee ds the upper limit of the 95% confidence interval for the

LC 50 of a standard unselected population and/or surv ival in the diagnostic assay is significantly greater than that of a standa rd unselected population, as es tablished by the ongoing baseline monitoring program; r.the ability to survive is heritable; s.mCry3A plant assays determine that damage caused by surviving insects would exceed economic thresholds; t.the identified frequency of field resistance could lead to widespread product failure if subsequent collections in the affected field area(s) demonstrated similar bioassay results.

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

will be taken:

f. EPA will receive notification within 30 days of resistance confirmation;

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

h. affected customers and extension agents will be encouraged to employ alternative CRW control measures;

i. sale and distribution of mCry3A maize in the affected area will cease immediately; j. a long-term resistance mana gement action plan will be devised according to the

characteristics of the resistance event and local agronomic needs. [The details of such a plan should be approved by EPA and a ll appropriate stakeholders.]207 f. Cry1Ab Insect Resistance Monitoring

The Agency is imposing the following conditions for this product:

The registrant will monitor for resistance to its lepidopteran-resi stant 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.

(9) Focused Population Sampling

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

nubilalis (European corn borer; ECB), Diatraea grandiosella (Southwestern corn borer; S WCB), and Helicoverpa zea (corn earworm; CEW). Sampling for 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 ar e planted on a high proportion of the corn 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 popula tion response to lepidopte ran resistant Bt corn and/or changes in resistance alle le 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 importa nce and for the adoption levels of lepidopteran-resistant Bt corn. The Agency shall be consulted prior to the implementation of such modifications.

The registrant will report to the Agency before August 31 each year the results of the population sampling and bioassay monitoring program.

Any incidence of unusually low sensitivity to the Bt protein in bioassays shall be investigated as soon as possible to understand 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:208 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 w ill consult with the Agency 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 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

EPA defines suspected resistance to mean field reports of unexpected levels of209 insect feeding damage for which:

• the corn in question has been confirme d to be lepidopteran-active Bt corn;

• the seed used had the proper percenta ge of corn expres sing Bt protein;

• the relevant plant tissues are expressing 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 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 mont h 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 bi oassays using diagnostic concen trations 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.210 • 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 ex tent 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.211 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.

g. Annual Reporting Requirements

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 comp leted previous year, January 31st each year;

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

5) Compliance: to include annual survey results and plans for the next year; full report January 31st each year;

6) Insect Resistance Monitoring Results: results of monitoring and inves tigations of damage reports, August 31st each year, beginning in 2008.212 Registrant Registration # Active Ingredients Date Registered Date Expired

Monsanto 524-575 Bt corn Event MON 89034 with Cry1A.105 + CryAb2 10-Jun-08 30-Sep-10

TERMS AND CONDITIONS OF REGISTRATION

A. Terms and Conditions for MON 89034 as Amended on December 15, 2008:

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

2) The subject registration will be limited to MON 89034 in field or sweet corn. Further, MON 89034 sweet corn may only be sold 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 data in the time frames listed:

OPPTS Guideline/ Study Type Required Data Due Date

Residue Analytical

Method – Plants (OPPTS 860.1340) For event MON 89034 corn, an independent lab validation of the analytical method for the detection of Cry2Ab2 and/or Cry1A.105. Y ou must also agree to provide to the EPA laboratory (Ft. Meade, MD) methodology and/or reagents ne cessary for validation of such analytical method within 6 months from the date that the Agency requests them. 4/1/2009

Aquatic

Invertebrate Acute Toxicity Testing,

Freshwater Daphnids (OPPTS 885.4240) A 7-14 day Daphnia study as per th e 885 Series OPPTS Guidelines needs to be performed. Alternatively, a dietary study of the effects on an aquatic invertebrate, representing the functional group of a leaf shredder in headwater streams, can be performed and submitted in

lieu of the Daphnia study. 9/1/2009 *

Insect Resistance Management – Monsanto must provide addi tional information on crossresistance of Cry1A.105 and Cry1Ac (preferably 7/1/2009 *213 OPPTS Guideline/ Study Type Required Data Due Date

Resistance Monitoring including binding site models and use of resistant colonies) for the target pests and determine how such cross-resistance may impact the durability of MON89034, including any impacts in the southern cottongrowing areas. The Cry1A.105 protein is a chimericprotein consisting of Domains I and II and the Cterminus of Cry1Ac. It is important to address not only

the likelihood of cross-resistance potential of Cry1A.105 and Cry1Ab and, similarly, Cry1A.105 and Cry2Ab2 (which was done by Monsanto) but also that of Cry1A.105 and Cry1Ac.214 OPPTS Guideline/ Study Type Required Data Due Date

Insect Resistance Management –

Resistance Monitoring Baseline susceptibility studi es and/or a discriminating concentration assay are required for the Cry1A.105 protein against European corn borer (ECB),

Southwestern corn borer (SWCB), and corn earworm (CEW) and for the Cry2Ab2 protein against SWCB and

CEW. 7/1/2009 *

for ECB

and CEW

8/31/2010 *

for SWCB

Insect Resistance Management –

Resistance Monitoring To support sweet corn uses , baseline su sceptibility studies must be conducted on fall armyworm (FAW) populations collected from sw eet corn growing areas. Monitoring studies will be conducted on FAW populations collected from sw eet corn distribution areas

in states in which Mons anto MON 89034 and/or MON

89034 x MON 88017 sweet corn plantings exceed 5,000 acres. The collected popul ations of FAW will be monitored for changes in susceptibility to the Cry1A.105 and Cry2Ab2 proteins. 4/1/2010

* Extensions were granted as listed in the above table.

6) The Insect Resistance Management (IRM) terms and conditions for this product are as

follows.

The required IRM program for MON 89034 must have the following elements:

• Requirements relating to creation of a non- Bt corn and/or non-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,” which impose binding contractual obligations 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;

• Requirements regarding a “remedial action pl an,” which contains measures Monsanto would take in the event that any field relevant insect resistance was detected as well as to report on activity under the plan to EPA;215 • Submit annual reports on units sold by state ( units sold by county level will be made available to the Agency upon request), 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 described in the grower guide/product use guide and/or in supplements to the grower guide/ product use guide.216 • 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.217 c) Grower Agreements for MON 89034

1) Persons purchasing MON 89034 must sign a grower agreement. The term “grower agreement” refers to any grower purchase contract, license agreement, or similar legal

document.

2) The grower agreement and/or specific 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 agreemen t 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 to218 pursue 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 Stewards hip 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 party, of a statistically representative sample of219 growers of MON 89034 field corn who plant the vast majority of all corn in the United States and in areas in which the selection intensity is greatest. The survey shall consider only those growers who plant 200 or more acres of corn in the Corn-Belt and who plant 100 or more

acres of corn in corn-cotton areas. The surv ey shall measure the degree of compliance with the IRM program by growers in different region s of the country and c onsider the potential impact of non-response. The sample size and geographical resolu tion may be adjusted annually, based upon input from independent mark eting research firms and academic scientists, to allow analysis of compliance beha vior within regions or between regions. The sample size must provide a reasonable sensitivity for comparing results across the United

States.

6b) MON 89034 Sweet Corn: The IRM 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 meas ure the degree of comp liance with the IRM program, identify the response rate (e.g., th e percent of MON 89034 sweet corn acres covered by the responses), and consider th e 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 (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 with other registrants and EPA on the design and content of the survey prior to its implementation.

9b) MON 89034 Sweet Corn: Monsanto shall provide a written summary of the results of the prior year’s survey (together with a description of the methodology used and the supporting data) to EPA by January 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 informa tion collected through th e compliance survey required under paragraphs 6a th rough 8 and from other sources . The changes shall address aspects of grower compliance that are not suffi ciently high. Monsanto must confer with the Agency prior to adopting any changes.

11) Monsanto shall conduct an annual on-farm assessment program. Monsanto shall train its representatives who make on-farm visits with growers of MON 89034 to perform assessments of compliance with IRM requiremen ts. There is no minimum corn acreage size220 for this program. Therefore, growers will be selected for this program from across all farm sizes. In the event that any of these visits resu lt in the identification of a grower who is not in compliance with the IRM program, Monsanto sha ll take appropriate ac tion, 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, consis tent 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 thereaf ter, 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 a ssurance 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, gr ower meetings and letters), the extent of noncompliance, corrective measures to address the non-compliance, and any follow-up actions taken. Monsanto may elec t to coordinate information with othe r registrants and report collectively the results of co mpliance 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 regulatory agency if the State agency can demonstrate

that confidential busin ess information, including the na mes, personal information, and grower license number of the growers will be protected.

e) Insect Resistance Monitoring and Remedial Action Plan for MON 89034

The Agency is imposing the followi ng conditions for the Cry1A.105 and Cry2Ab2 toxins expressed in MON 89034:

Monsanto will monitor for resistance to Cry1A.105 and Cry2Ab2 expressed in MON 89034.

The monitoring program shall consist of two approaches: (1) 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.

(10) 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 to221 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 re quirement (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 popul ation 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 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. 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. 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 field 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 bioassay222 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 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.

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

Monsanto will follow up on grower, extension specialist or consultant reports of unexpected levels of damage by the lepidopteran pests listed on the pesticide label. Monsanto will instruct

its customers to contact them if such incidents occur. Monsanto will investigate all legitimate reports submitted to the company or the company's representatives.

If reports of unexpected levels of damage 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;223 • 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 r easonable 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

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.224 (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 appropr iate stakeholders in the development of the action plan, and the details of such a plan shall be approved by EPA prior to implementation;

• Notify affected parties (e.g., growers, consultants, extension agents, seed distributors, university 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 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 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.225 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 inves tigations of damage reports, August 31 st each year, beginning in 2010.226 Registrant Registration # Active Ingredients Date Registered Date Expired

Monsanto 524-576 Bt corn Event MON 89034
+ MON 88017 with Cry1A.105 + Cry2Ab2 + Cry 3Bb1 10-Jun-08 30-Sep-10

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

2) The subject registration will be limited to MON 89034 x MON 88017 in field or sweet corn. Further, MON 89034 x MON 88017 sweet corn may only be sold directly to processors or through commercial dealers to large growers. MON 89034 x MON 88017

sweet corn must not be sold to small roadside or home growers.

3) Submit/cite all data required for 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) Submit the following data in the time frames listed:

OPPTS Guideline/ Study Type Required Data Due Date

Residue Analytical

Method – Plants (OPPTS 860.1340) For event MON 89034 x MON 88017 corn, an independent lab validation of the analytical method for the detection of Cry2Ab2 and/or Cry1A.105. You mu st also agree to provide to the EPA laboratory (Ft. Meade, MD) methodology and/or reagents necessary for validation of such analytical method

within 6 months from the da te that the Agency requests

them. 4/1/2009

Aquatic

Invertebrate Acute Toxicity Testing,

Freshwater Daphnids (OPPTS 885.4240) A 7-14 day Daphnia study as per the 885 Series OPPTS Guidelines needs to be perfor med. Alternatively, a dietary study of the effects on an aquati c invertebrate, representing the functional group of a leaf sh redder in headwater streams, can be performed and submitted in lieu of the Daphnia study. 9/1/2009 *227 Insect Resistance Management –

Resistance Monitoring Monsanto must provide additional information on crossresistance of Cry1A.105 and Cry1Ac (preferably including binding site models and use of resistant colonies) for the target pests and determine how such cross-resistance may impact the durability of MON 89034, including any impacts in the southern cotton-growing areas. The Cry1A.105 protein is a chimeric protein consisting of Domains I and II and the C-terminus of Cry1Ac. It is important to address not only the likelihood of cross- resistance potential of Cry1A.105 and Cry1Ab and, similarly, Cry1A.105 and Cry2Ab2 (which was done by Mons anto) but also that of Cry1A.105 and Cry1Ac. 7/1/2009 *

Insect Resistance Management –

Resistance Monitoring Baseline susceptibility studi es and/or a discriminating concentration assay are requi red for the Cry1A.105 protein against European corn borer (E CB), Southwestern corn borer (SWCB), and corn earworm (CEW) and for the Cry2Ab2 protein against SWCB and CEW. 7/1/2009 *

For ECB

and CEW

8/31/2010 *

For SCWB

* Extensions were granted as listed in the table above.

OPPTS Guideline/ Study Type Required Data Due Date

Insect Resistance Management –

Resistance Monitoring To support sweet corn uses, ba seline susceptib ility studies must be conducted on fall armyworm (FAW) populations collected from sweet corn grow ing areas. Monitoring studies will be conducted on FAW popula tions collected from sweet

corn distribution areas in states in which Monsanto MON

89034 and/or MON 89034 x MON 88017 sweet corn plantings exceed 5,000 acres. Th e collected populations of FAW will be monitored for changes in susceptibility to the Cry1A.105 and Cry2Ab2 proteins. 4/1/2010

5) Submit or cite all data required to support the individual plant-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) The Insect Resistance Management (IRM) te rms and conditions for this product are as

follows.228 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,” which impose binding contractual obligations on the grower 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 plan,” which contains measures Monsanto would take in the event that any field relevant insect resistance was detected as well as to report on activity under the plan to EPA;

• Submit annual reports on units sold by state (units sold by county level will be made available to the Agency upon request), 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.

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 represent at least 20% of the229 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 can be treated with a soil-applie d or seed-applied insecticide to control rootworm larvae and other soil pests. The refuge can also be treated with a non- Bt foliar

insecticide for control of late season pests if pest pressure reaches an economic threshold for damage (determined using methods recommended by local or regional professionals); however, if rootworm adults are present at the time of foliar applications, 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 consecuti ve rows wide. The corn borer re fuge can be treated with a soilapplied or seed-applied inse cticide for corn rootworm larval control or a non- Bt foliar-applied

insecticide for corn borer contro l if pest pressure reaches an economic threshold for damage (determined using methods recommended by local or regional professionals). The corn rootworm refuge must be planted with a non- Bt /corn rootworm-protect ed hybrid but can be planted with Bt corn hybrids that control corn borers. The corn rootworm refuge must represent at least 20% of the grower’s corn acres (i .e. sum of MON 89034 x MON 88017 acres and corn rootworm refuge acres) and must be planted as an adjacent block, perimeter strips, or in-field strips. If perimeter or in-field strips are impl emented, the strips must be at least 4 consecutive rows wide. The corn rootworm refuge can be treated with a soil-applied or seed- applied

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

non- Bt foliar insecticide for control of late season pests; however, if rootworm adults are present at the time of foliar applica tions, 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,230 Franklin City, Greensville, Isle of Wight, Northampton, Southampton, Suffolk City, Surrey, Sussex), and Missouri (only the counties of Dunkin, New Madrid, Pemiscot, Scott, and Stoddard).

Two options for the deployment of the refuge are available to growers.

The first option is planting a common 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 represent 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 can be treated with a soil-applie d or seed-applied insecticide to control rootworm larvae and other soil pests. The refuge can also be treated with a non- Bt foliar

insecticide for control of late season pests if pest pressure reaches an economic threshold for damage (determined using methods recommended by local or regional professionals); however, if rootworm adults are present at the time of foliar applications, 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 consecuti ve rows wide. The corn borer re fuge can be treated with a soilapplied or seed-applied inse cticide for corn rootworm larval control or a non- Bt foliar-applied

insecticide for corn borer contro l if pest pressure reaches an economic threshold for damage (determined using methods recommended by local or regional professionals). The corn rootworm refuge must be planted with a non- Bt /corn rootworm-protect ed hybrid but can be planted with Bt corn hybrids that control corn borers. The corn rootworm refuge must represent at least 20% of the grower’s corn acres (i .e. sum of MON 89034 x MON 88017 acres and corn rootworm refuge acres) and must be planted as an adjacent block, perimeter strips, or in-field strips. If perimeter or in-field strips are impl emented, the strips must be at least 4 consecutive rows wide. The corn rootworm refuge can be treated with a soil-applied or seed-applied

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

non- Bt foliar insecticide for control of late season pests; however, if rootworm adults are present at the time of foliar applications then the MON 89034 x MON 88017 field must be treated in

a similar manner.

Growers who fail to comply with the 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 is231 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, 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 agreemen t 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 a nnually thereafter, Monsanto 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 shall232 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 that 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 Stewards hip 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.233 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 companies, 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 MO N 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 academic scientists, to allow analysis of compliance behavior within regions or between regions. The sample size must provide a reasonable sensitivity for comparing results across the United States.

6b) MON 89034 x MON 88017 Sweet Corn: The 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.234 9b) 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 informa tion 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, Monsan to shall provide a report to EPA summarizing the activities carried out under their compliance assurance program for the prior year and the plans for th e 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.235 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 re quirement (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 88017 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 cause236 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;

• 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.237 (b) Investigation of Reports of Unexpected Levels of Damage by the Target Pests:

Monsanto will follow up on grower, extension specialist or consultant reports of unexpected levels of damage by the lepidopteran pests listed on the pesticide label. Monsanto will instruct

its customers to contact them if such incidents occur. Monsanto will investigate all legitimate reports submitted to the company or the company's representatives.

If reports of unexpected levels of damage 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 r easonable 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:

• 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 the238 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 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 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 an239 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 aut horities 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.

v) 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 88017240 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 2010.241 Registrant Registration # Active Ingredients Date Registered Date Expired

Pioneer/Dupont 29964-6 Optimum AcreMax 1 (OAM 1) Seed Blend of Herculex

Xtra + Herculex I 30-Apr-10 30-Sep-10

OAM 1

1) Submit and/or cite all data required for re gistration/ registration review of your product under FIFRA section 3(c)(5) when the Agency requires all registrants of si milar products to submit

such data.

2) The subject registration will automatic ally expire on midnight September 30, 2010.

3) The subject registration will be limited to a seed mix of TC1507 (Cry1F) xDAS-59122-7 (Cry34Ab1/Cry35Ab1) corn seed blended with not less than 10% TC1507 (Cry1F) corn seed.

4) Submit or cite all data required to support the Herculex XTRA and the Herculex I plantincorporated protectant products within the tim eframes required by the terms and conditions of EPA Registration Numbers 29964-3 and 29964-5. 5) The subject registration will be limited to Submit the following data in the timeframes listed:

Study Type Required Data Due Date

Insect Resistance Management Pioneer must provide the Agency with a copy of the grower agreement, associated stewardship documents, and written description of a system, which assures that growers will sign grower agreements and persons purchasing OAM1 corn will annually affirm that they are contractually bound to comply with requirements of the insect resistance management (IRM) program. 90 days from

the date of registration

Insect Resistance Management Pioneer must implement an enhanced resistance monitoring plan for OAM1. Pioneer must provide the Agency with a baseline (benchmark) study that shows the susceptibility of western corn rootworm populations (WCRW) in the Sublethal S eedling Assay prior to the large-scale introduction of OAM1. Although northern corn rootworm (NCRW) is di fficult to rear, Pioneer must attempt to obtain benchmark susceptibility data using the Sublethal Seedling Assa y for NCRW as well. 12/1/2010 for

WCRW

12/1/11 for

NCRW

Insect Resistance Management Pioneer must submit a detailed OAM1-specific resistance monitoring and remedial action plan, including an analysis to determine the expected field performance criteria for OAM1 products so that unexpected damage

can be benchmarked. Pioneer will update the plan by 12/1/2012, if needed, based on continued field evaluation of OAM1 performance. 12/1/2010242 6) Pioneer must commit to do the following In sect Resistance Management Program for

OAM1.

The required IRM program for OAM1 corn must have the following elements:

Requirements relating to creation of a lepidopteran refuge (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 pr epare and require OAM1 users to sign “grower agreements,” which impose binding contractual obligation on the grower to comply with the refuge requirements;

Requirements regarding programs to 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,” which contains measures Pioneer would take in the event that any field-releva nt 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), 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 regions ( i.e., 20 acres of corn that does not contain Bt technology for the control of corn borers for every 80 acres of OAM1). Refuge planting 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,243 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).

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 stewardship 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.244 6. Beginning on January 31, 2011 and annually thereafter, Pioneer shall provide EPA with a report on the number of units of OAM1 corn seed shipped and not returned, and the number of 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 communica tion 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 conduct targeted, on-farm compliance assessments for growers who purchase OAM1 seed to ensure growers are compliant with the requirement of a 20% refuge for lepidopteran pests. For the 2010 growing season, Pioneer must

conduct at least 500 on-farm 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 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.

Number of on-farm assessments conducted by Pioneer

Products Year: 2010 Year: 2011, annually

thereafter245 Corn Borer and Stacked

Products 1000 750-1000

OAM1 500 1500-2000

Total 1500 2250-3000

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, January 31, 2011 and annually thereafter.

3. 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.

4. 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.

d) Insect Resistance Monitoring for OAM1 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 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 enha nced annual resistance monitoring plan. The reports will contain:246 • 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 specialist 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.247 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 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 registra nt 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 treat ment, 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.248 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 30 days of confirmed resistance;

• Affected customers and Extension specia lists will be notified about confirmed resistance;

• Affected customers and Extension specia lists will be encouraged to implement

alternative CRW control measures such as adulticide treatment, crop rotation the following year, or use of soil or seed insecticides the following year;

• Pioneer and EPA will jointly determine the extent of the mitigation needed and determine whether sales should be stoppe d on an appropriate geographic (i.e., county or regional) basis; and

• Pioneer will develop a case-specific resist ance mitigation 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 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 confir med (as defined above), the follo wing steps will he taken by the registrant:

• EPA will receive notification within 30 days of resistance confirmation;249 • Affected customers and extension agents will be notified about confirmed resistance within 30 days;

• Monitoring will be increased in the affected area and local target pest populations will be sampled annually to determine the ex tent 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 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 imme diately until an effectiv e local mitigation plan approved by EPA has been implemented;

• 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 the affected region(s) for the Bt corn hybrids th at 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.250 • Calibration records - Pioneer will retain documentation for a specified period of time on the equipment calibration including the procedure, when it was conducted

and the results.

• Blend proportion records (weight and 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 have signed grower agreements, January 31 st each year, beginning in 2011;

3. Grower Education: substantive cha nges 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.251 Registrant Registration # Active Ingredients Date Registered Date Expired

Pioneer/Dupont 29964-6 Optimum AcreMax RW (OAM RW) Seed Blend of

Herculex RW + Non-Bt corn 30-Apr-10 30-Sep-10

OAM RW

1) Submit and/or cite all data required for re gistration/ registration review of your product under FIFRA section 3(c)(5) when the Agency requires all registrants of si milar products to submit

such data.

2) The subject registration will automatic ally expire on midnight September 30, 2010.

3) Submit or cite all data required to support the Herculex RW plant-in corporated protectant products within the timeframes required by the terms and conditions of EPA Registration

Number 29964-4.

4) The subject registration will be limited to a seed mix of DAS-59122-7 (Cry34Ab1/Cry35Ab1)

corn seed blended with not le ss than 10% non-Bt corn seed.

Because OAMRW controls corn rootworm pests and contains an integrated corn rootworm refuge, no additional refuge is required. When a grower plants a bag of OAMRW, all refuge requirements are fully and automatically met for 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.252 5) Submit the following data in the timeframes listed:

Study Type Required Data Due Date

Insect Resistance Management Pioneer must implement an enhanced resistance monitoring plan for OAMRW. Pioneer must provide the Agency with a baseline (benchmark) study that shows the susceptibility of western corn rootworm populations (WCRW) in the Sublethal S eedling 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

6) Pioneer must commit to do the following In sect Resistance Management Program for

OAMRW.

The required IRM program for OAMRW corn must have the following elements: Requirements regarding programs to evaluate wh ether there are statistically significant and biologically relevant changes in target insect susceptibility to Cry34A b1/Cry35Ab1 proteins in the target insects;

Requirements regarding a “remedial action plan,” which contains measures Pioneer would take in the event that any field-relevant insect 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) 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:253 1. Pioneer must monitor for resistance and or changes in target pest susceptibility that 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 ri sk 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.254 1. Suspected Resistance from Population Monitoring

Definition of Suspected Resistance - Resistance will be suspected if investigations of target pest injury potential to OAMRW maize from 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;255 • 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 registra nt 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 treat ment, 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 30 days of confirmed resistance;

• Affected customers and Extension specia lists will be notified about confirmed resistance;

• Affected customers and Extension specia lists will be encouraged to implement

alternative CRW control measures such as adulticide treatment, crop rotation the following year, or use of soil or seed insecticides the following year;

• Pioneer and EPA will jointly determine the extent of the mitigation needed and determine whether sales should be stoppe d on an appropriate geographic (i.e., county or regional) basis; and

• Pioneer will develop a case-specific resist ance mitigation action plan within 90256 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 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.