crop-chem-docs/corpus/epa_ppls/524-545.md

MON 863 X MON 810

• EPA Reg No: 524-545
• Registrant: BAYER CROPSCIENCE, LLC
• Signal word: Caution
• Active ingredients: Bacillus thuringiensis Cry3B1 protein and the genetic material necessary for its production (Vector ZMIR 13L) in corn (0.016%); Bacillus thuringiensis Cry1Ab protein and the genetic material (PV-ZMBK07) necessary for its production in corn event MON-00810-6; % dry weight (0.005%)
• Label accepted: 2009-03-19
• Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00545-20090319.pdf

---

. 3/ I'q, / UJO'1 UNITED C:rES ENVIR9NMEN.TAL PROTECTION AC _ JCY Ms. Margaret Wideman Regulatory Affairs Manager Monsanto Company 800 North Lindbergh Blvd St. Louis, MO 63167 Dear Ms. Wideman: MAR 1 S20m Subject: Your September 4, 2008 Amendment Request to Amend the Insect Resistance Management Terms and Conditions for MON 863 x MON 810 EPA Registration No. 524-545 The amendment referred to above, submitted in connection with registration under section 3 (c)(7)(A)of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, are acceptable subject to the following comments. Insect Resistance Management: The listed IRM terms and conditions are being modified as follows.

1. Under 8a. Refuge Requirements, the following statement is added "These refuge requirements do not apply to seed propagation of inbred and hybrid corn seed corn up to a total of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient per registrant per year." ,2) Under 8d. Insect Resistance Monitoring and 8e. Remedial Action Plans, the CrylAb-related portions (European corn beirer, Southwestern corn borer, and corn earworm; MON 810; 524-489) are removed and replaced by 8f. below. Further the 8d and 8e headings are modified to read as 8d. Cry3Bbl Insect Resistance Monitoring and 8e. Cry3Bbl Remedial Action Plans. 8f. Cryl Ab Insect Resistance Monitoring The Agency is imposing the following cOnditions for this product: The'registrant will monitor for resistance to its lepidopteran-resistant Bt com. The monitoring program shall consist of two approaches: (1) focused population sampling and lboratory testing; and (2).investigation of reports ofless-than expected control oflabeled insects. Should field­ relevant resistance be confimied, an appropriate resistance management action plan will be . SVM ~ii:·~ilf..······I·········'···········I··=~~~~~E·l··················1·····················1·····················1······················ :;:E B::t:i1 ... · ..................... : ..................... · ..................................................................................... . EPA Form 1320-1 A '(1/90) , Printed on Recycled Paper OFFICIAL FILE COpy .. U,S, Government Printing Omce: 2005 ~ (mac)

( (1) Focused Population Sampling The registrant shall annually sample and bioassay populations of the key target pests Ostrinia nubilalis (European corn borer; ECB), Diatraea grandiosella (Southwestern corn borer; S WCB), and Helicoverpa zea (corn earworm; CEW). Sampling for the target pests will be focused in areas identified as those with the highest risk of resistance development (e.g., where lepidopteran-active Bt hybrids are planted on a high proportion of the corn acres, and where the insect species are regarded as key pests of corn). Bioassay methods must be appropriate for the goal of detecting field-relevant shifts in population response to lepidopteran resistant Bt corn and/or changes in resistance allele frequency in response to the use ofBt corn and, as far as possible, should be consistent across sampling years to enable comparisons with historical data. The number of populations to be collected shall reflect the regional importance of the insect species as a pest, and specific collection regions will be identified for each pest. For ECB, a minimum of 12 populations across the sampling region will be targeted for collection at each annual sampling. For SWCB, the target will be a minimum of six populations. For CEW, the target will be a minimum of 10 populations. Pest populations should be collected from multiple corn'-growing states reflective of different geographies and agronomic conditions. To obtain sufficient sensitivity to detect resistance alleles before they become common enough to cause measurable field damage, each population collection shall attempt to target 400 insect genomes (egg masses, larvae, mated females, and/or mixed-sex adults), but a successful population collection will contain a minimum of 100 genomes. It is recognized that it may not be possible to collect the target number of insect populations or genomes due to factors such as natural fluctuations in pest density, environmental conditions, and area-wide pest suppression. The sampling program and geographic range of collections may be modified as appropriate based on changes in pest importance and for the adoption levels oflepidopteran-resistant Bt corn. The Agency shall be consulted prior to the implementation of such modifications. The registrant will report to the Agency before August 31 each year the results of the population sampling and bioassay monitoring program. Any incidence of unusually low sensitivity to the Bt protein in bioassays shall be investigated as soon as possible to understand any field relevance of such a finding. Such investigations shall . proceed in a stepwise manner until the field relevance can be either confirmed or refuted, and results of these shall be reported to the Agency annually before August 31. The investigative steps will include:

1. Re-test progeny of the collected population to determine whether the unusual bioassay response is reproducible and heritable. If it is not reproducible and heritable, no further action is required.
2. If the unusual response is reproducible and heritable, progeny of insects that 2

( survive the diagnostic concentration will be tested using methods that are representative of exposure to Bt com 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. Ifinsects survive steps 1 and 2, resistance is confirmed, and further steps will be taken to evaluate the resistance. These steps may include: • determining the nature of the resistance (i.e., recessive or dominant, and the level of functional dominance); • estimating the resistance-allele frequency in the original population; • detennining 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; • detennining the geographic distribution of the resistance allele by analyzing field collections in subsequent years from sites surrounding the site where the resistance allele(s) was originally collected. Should field-relevant resistance be confirmed, and the resistance appears to be increasing or spreading, the registrant will consult with the Agency to develop and implement a case-specific resistance management action plan. (2) Investigation of Reports of Unexpected Levels of Damage by the Target Pests: The registrant will follow up on grower; extension specialist or consultant reports of unexpected levels of damage by the lepidopteran pests listed on the pesticide label. The registrant will instruct its customers to contact them if such incidents occur. The registrant will investigate all legitimate reports submitted to the company or the company's representatives. If reports of unexpected levels of damage lead to the suspicion of resistance in any of the key target pests (ECB, SWCB, and CEW), the registrant will implement the actions described below, based on the following definitions of suspected resistance and confirmed resistance. Suspected resistance EP A defines suspected resistance to mean field reports of unexpected levels of 3 3 ./" I~

insect feeding damage for which: • the com in question has been confinned to be lepidopteran-active Bt com; • the seed used had the proper percentage of com expressing Bt protein; • the relevant planttissues are expressing the expected level of Bt protein; and • it has been ruled out that species not susceptible to the protein could be responsible for the damage, that no climatic or cultural reasons could be . responsible for the damage, and that that there could be no other reasonable causes for the damage. The Agency does not interpret suspected resistance to mean grower reports of possible control failures or suspicious results from annual insect monitoring assays, nor does the Agency intend that extensive field studies and testing be undertaken to confinn scientifically the presence of insects resistant to Bt com 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 com fields in the affected region to control the target pest during the immediate growing season. • Destroy Bt com 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 ov~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, the registrant will collect samples of the insect population in the affected fields for laboratory rearing and testing. Such rearing and testing shall be conducted as expeditiously as practical. Confirmed resistance EPA defines confirmed resistance to mean, in the case of field reports of unexpected levels of damage from the key target pests, that all the following criteria are met: • There is >30% insect survival and commensurate insect feeding in a bioassay, initiated with neonate larvae, that uses methods that are representative of exposure to Bt com hybrids under field conditions (ECB and SWCB oniy). 4 ~ I)

( • In standardized laboratory bioassays using diagnostic concentrations of the Bt protein suited to the target pest in question, the pest exhibits resistance that has a genetic basis and the level of survivorship indicates that there may be a resistance allele frequency of:::: 0.1 in the sampled population. . • In standardized laboratory bioassays, the LCso exceeds the upper limit of the 95% confidence interval of the LCso for susceptible populations surveyed both in the original baselines developed for this pest species and in previous years of field monitoring. (3) Response to Confirmed Resistance in a Key Target Pest as the Cause of Unexpected Levels of Damage in the Field When field resistance is confirmed (as defined above), the following steps will be taken by the registrant: • EPA will receive notificatioJ;l within 30 days of resistance confinnation; • Affected customers and extension agents will be notified about confinned resistance within 30 days; • Monitoring will be increased in the affected area and local target pest populations will be sampled annually to detennine the extent and impact of resistance; • If appropriate (depending on the resistant pest species, the extent of resistance, the timing of resistance, and the nature of resistance, and the availability of suitable alternative control measures), alternative control measures will be employed to reduce or control target pest populations in the affected area. Alternative control measures may include advising customers and extension agents in the affected area to incorporate crop residues into the soil following harvest to minimize the possibility of over-wintering insects, and/or applications of chemical insecticides; • Unless otherwise agreed with EPA, stop sale and distribution of the relevant lepidopteran-active Bt com hybrids in the affected area immediately until an effective local mitigation plan approved by EPA has been implemerited; • The registrant will develop a case-specific resistance management action plan within 90 days according to the characteristics of the resistance event and . local agronomic needs. The registrant will consult with appropriate stakeholders in the development of the action plan, and the details of such a plan shall be approved by EPA prior to implementation; • Notify affected parties (e.g. growers, consultants, extension agents, seed distributors, university cooperators and state/federal authorities as appropriate) in the region of the resistance situation and approved action plan; and 5

( • In subsequent growing seasons, maintain sales suspension and alternative r€?sistance management strategies in the affected region(s) for the Bt com hybrids that are affected by the resistant population until an EP A -approved local resistance management plan is in place to mitigate the resistance. A report on results of resistance monitoring and investigations of damage reports. must be submitted to the Agency annually by August 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 Cry lAb com constitutes acceptance of these conditions. A stamped copy of the FIFRA label is enclosed for your records. Sincerely, cf!:!du~ef Microbial Pesticides Branch Biopesticides and Pollution Prevention Division (7511P) 6 b ./" 13

( MON 863 x MON 810 Rootworm-and Corn Borer-Protected Corn Seed (OECD Unique Identifier: MON-00863-5 x MON-00810-6) This product is effective in controlling com leaf, stalk and ear damage caused by corn borers and root feeding damage caused by com rootworm larvae. Active Ingredient: Bacillus thuringiensis Cry3Bbl protein and the genetic material necessary for its production (Vector ZMIR13L) in MON 863 com (OECD Unique Identifier: MON-00863-5) ............ . ... .... .... ..................... ........ ........................ ............................ .. 0.003 - 0.0160/0 Bacillus thuringiensis CrylAb delta-endotoxin and the genetic material necessary for its production (Vector PV-ZMCTOl) in event MON 810 .com (OECD Unique Identifier: MON-00810-6): ........................................................................ 0.002 - 0.005% Other Ingredients: Substance produced by a marker gene and the genetic material necessary for its production (Vector ZMIR13L) in event MON 863 com (OECD Unique Identifier: MON-00863-5) ......................................................................................... 0.00005 - 0.0001 % Percentage (wt/wt) on a dry weight basis for whole plant (forage). CAUTION KEEP OUT OF REACH OF CHILDREN NET CONTENTS ___ _ EPA Registration No. 524-545 EPA Establishment No. 524-MO-002 Monsanto Company 800 North Lindbergh Blvd. St. Louis, MO 63198 13

( . DIRECTIONS FOR USE It is a violation of Federal law to use this product in any manner inconsistent with this labeling~ The following information regarding commercial production must be included in the MON 863 x MON 810 Technology Use Guide (IRM Guide). MON 863 x MON 810 protects com crops from leaf, stalk, and ear damage caused by com borers and root damage caused by com rootworm larvae. In order to minimize the risk of these pests developing resistance to MON 863 x MON 810 com, an insect resistance management plan must be implemented which includes planting of a structured refuge. This plant-incorporated protectant may be combined through conventional breeding with other registered plant-incorporatedprotectants that are similarly approved for use in combination, through conventional breeding, with other plant-incorporated protectants to produce inbred com lines and hybrid com varieties with combined pesticidal traits. INSECT RESISTANCE MANAGEMENT Corn Belt / Noncotton Growing Region Refuge Requirements For MON 863 x MON 810 com groWn in noncotton growing regions of the United States, two options for deployment of the refuge are available to growers. The first option is planting a common refuge for both com borers and com rootworms. The common refuge must be planted with com hybrids that do not contain Bacillus thuringiensis (B.t.) technologies for the control of com borers or com rootworms. The refuge area must represent at least 20% of the grower's com acres (i.e., sum ofMON 863 x MON 810 acres and refuge acres; refuge area must contain 20 acres of com for every 80 acres ofMON 863 x MON 810 com planted). It can be planted as a block within or adjacent (e.g., across the road) to the MON 863 x MON 810 field, perimeter strips (i.e. strips around the field), or in­ field strips. Ifperimeter or in-field strips are implemented, the strips must be at least 4 consecutive rows wide. The common refuge' can be treated with an insecticide to control rootworm larvae and other soil pests. The refuge can also be treated with a non-B.t. foliar insecticide for control of late season pests if pest pressure reaches an economic threshold for damage; however, if rootworm adults are present at the time of foliar applications then the MON 863 x MON 810 field (acres) must be treated in a similar manner. Economic thresholds will be determined using methods recommended by local or regional professionals (e.g., Extension Service agents, crop consultants, etc.). A schematic of one common refuge deployment option is shown below:

( Common Refuge MON863xMON 810 Corn (80 ac) ( [ Refuge: J Non-B.t. Corn (20 ac) The second option is planting separate refuge areas (e.g., two refuge areas, a double refuge, paired refuge areas) for com borers and com rootworms. The com borer refuge must be planted with com that is not a lepidoteran-protected B.t. hybrid, must represent at least 20% of the grower's com acres, and must be planted within Y2 mile of the MON 863 x MON 810 field. The com borer refuge can be treated with an insecticide for com rootworm larval control, or a non-B.t. foliar-applied insecticide for com borer control if pest pressure reaches an economic threshold for damage. The com rootworm refuge must be planted with com that is not a com rootworm-protected B.t. hybrid, but can be planted with B.t. hybrids that control com borers. The com rootworm refuge must represent at least 20% of the grower's com acres (i.e., corn rootwoim refuge must contain 20 acres of corn for every 80 acres of MON 863 x MON 810 corn planted) and can be planted as a block within or adjacent to the MON 863 x MON 810 field, strips around the field; or in-field strips. The com rootworm refuge can be treated with an insecticide to control rootworm larvae and other soil pests. The refuge can also be treated with a non-B.t. foliar insecticide for control of late season pests; however, if corn rootworm adults are present at the time of foliar applications then the MON 863 x MON 810 field must be treated in a similar manner. A schematic of one separate refuge option with the com rootworm refuge planted as a block within the field and the corn borer refuge planted within a Y2 mile of the MON 863 x MON 810 field is shown below:

/"' ( ( Separate-Refuge Option {Two-Refuge Option, Double-Refuge Option, Paired-Refuge Option} MON 863 xMON 810 Corn (80 ac) r Refuge: Corn borer protected corn (20 ac) ..... ::SYz mile ,.- J Refuge: Non-B.t. Corn '- (25 ac) Corn/Cotton Growing Area (Cotton Growing Area) Refuge Requirements For MON 863 x MON 810 com grown in cotton growing areas of the U.S. the common refuge and separate refuge options (e.g., two-refuge options, double-refuge options, paired­ refuge options) are also available, however, the refuge area is larger. Cotton growing areas include the following states: Alabama, Arkansas, Florida, Georgia, Louisiana, North Carolina, Mississippi, South Carolina, Oklahoma (only the counties of Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, and Washita), Tennessee (only the counties of Carroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Haywood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), Texas (except the counties of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, Moore, Ochiltree, Roberts, and Sherman) Virginia (only the counties of Dinwiddie, Franklin City, Greensville, Isle of Wight, Northampton, Southampton, Suffolk City, Surrey, and Sussex), and Missouri (only the counties of Dunkin, New Madrid, Pemiscot, Scott, and Stoddard). The first option is planting a common refuge for both com borers and com rootworms. The common refuge must be planted with com hybrids that do not contain B.t. technologies for the control of com rootworms or com borers. The refuge area must represent at least 50% of the grower's com acres (i.e., refuge must contain 50 acres ofnon-B.t. com for every 50 acres ofMON 863 x MON 810 com planted). It can be planted as a block within or adjacent to the MON 863 x MON 810 field, strips around the field, or in-field strips. Ifperimeter or in-field strips are implemented, the strips must be at least 4 consecutive rows wide. The common refuge can be treated with an insecticide to control rootworm larvae and other soil pests. The refuge can also be treated with a non-B. t. foliar insecticide for control of late season pests if pest pressure reaches an economic threshold for damage; however, if rootworm adults are present at the time of foliar applications thenthe MON 863 x MON 810 field must be treated in a similar manner. A schematic of one common refuge deployment option is shown below: (u / 13

Common Refuge MON 863 x MOl' Refuge: 810 Corn (50 ac) . Non-B.t. Corn (50 ac) The second option is planting separate refuge areas (e.g., two refuge areas, double refuge areas, paired refuge areas) for com borers and comrootworms. The com borer refuge must be planted with com that is not a lepidopteran-protected B.t. hybrid, must represent at least 50% of the grower's com acres (i.e., must contain 50 acres of com for every 50 acres of lepidopteran-protected com planted), and must be planted within 12 mile of the MON 863 x MON 810 field. The com borer refuge can be treated with an insecticide for com rootworm larval control, or a non-B.t. foliar-applied insecticide for com borer control If pest pressure reaches an economic threshold for damage. Economic thresholds will be determined using methods recommended by local or regional professionals (e.g., Extension Service agents, crop consultants, etc.). The com rootworm refuge must be planted with com that is not a rootw6rm-protected B. t. hybrid, but can be planted with B.t. hybrids that control com borers. The com rootworm refuge must represent at least 20% of the grower's com acres (i.e., com rootworm refuge must contain 20 acres of com for every 80 acres of MON 863 x MON 810 com planted) and· be planted as a block within or adjacent to the MON 863 x MON 810 field, strips around the field, or in-field strips. The com rootworm refuge can be treated with an insecticide to control rootworm larvae and other soil pests. The refuge can also be treated with a non-B.t. foliar insecticide for control of late season pests; however, if rootworm adults are present at the time of foliar applications then the MON 863 x MON 810 field must be treated in a similar manner. Schematics for two separate-refuge options with the com rootworm refuge planted as a block within the MON 863 x MON 810 field and the com borer refuge planted as a block within a 12 mile of the MON 863 xMON 810 field are shown below: 1\ /"" I,)

( Separate-Refuge Option {Two-Refuge Option, Double-Refuge Option; Paired-Refuge Option} MON863xMON 810 Corn (80 ac) [ , Corn borer protected corn (20 ac)

MON863xMON 810 Corn (80 ac) ..... [ Corn borer protected corn (20 ac) ~Y2 mile --'"

• or - . ~Y2 mile .. ~ Non-B.t. Corn (100 ac) MON863 Corn (80 ac) [ Non-B.L corn' (20 ac) --'" Grower agreements will specify that growers must adhere to the refuge requirements that will be described in the Technology Use Guide (IRM Guide) for MON 863 x MON 810 com or other applicable product use documents. Growers who fail to comply with the IRM requirements risk losing access to the product. These refuge requirements do not apply to seed propagation of inbred and hybrid com seed up to total qf 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.

( ( CORN INSECTS CONTROLLED OR SUPPRESSED Field com has been genetically transformed to produce the B.t. CrylAb and Cry3Bbl proteins for the control or suppression of the following lepidopteran and coleopteran insects, respectively: European com borer (Ostrinia nubilalis)· Southwestern com borer (Diatraea grandiosella) Southern cornstalk borer (Diatraea crambidoides) Sugarcane cornstalk borer (Diatraea saccharalis) Com earworm (Helicoverpa zea) Fall armyworm (SpodopteraJrugiperda) Stalk borer (Papaipema nebris) Western com rootworm (Diabrotica virgifera virgifera) Northern com rootworm (Diabrotica barberi) . Mexican com rootworm (Diabrotica virgifera zeae) MON 863 x MON 810 is a product of Monsanto's research program offering unique genetic characteristics for specific grower needs and may be protected by one or more of the following U.S. Patents: 5,023,179,5,110,732,5,352,605,5,424,412, 5,484,956, 5,859,347, 5,593,874,6,063,597,6,174,724,6,331,665" 6,501,009, 7,064248 and 7,231,056.