docker: production image + Gitea Actions for monthly refresh
Image rebuild (skip scrape) / build (push) Failing after 1h37m12s
Image rebuild (skip scrape) / build (push) Failing after 1h37m12s
Dockerfile: self-contained image with corpus + Chroma + BM25 baked in. Drawbar's compose pulls + runs without volume mounts. Built from sources.json (labels schema), PRODUCT_NAME=crop_chem by default, HYBRID_SEARCH=true (always-on for production quality). RERANK_URL + OLLAMA_URL get set at compose time. .gitea/workflows/refresh.yml: monthly cron (1st @ 06:00 UTC) does full scrape → reindex → image push. Scrapes Bayer (~30 min) + EPA PPLS row-crop filtered (~7h). Skips reindex+push if no corpus diff. Tags pushed: :latest, :<sha12>, :corpus-<YYYY.MM.DD>. .gitea/workflows/image-only.yml: on-demand or auto on code-only pushes to main (paths: docs_mcp/, rag/, scrape/, requirements.txt, Dockerfile, sources.json). Reindexes from committed corpus, builds image, pushes. ~10 min vs ~9h full refresh. .gitignore: corpus/ now COMMITTED (4,159 labels, 265 MB of .md + sidecars). Lets image-only.yml rebuild indexes without re-scraping. chroma/ + bm25/ still gitignored (regenerable binary indexes). .dockerignore: drops venv, eval results, PLAN/README/CLAUDE.md, deploy/, .git/ — keeps the image lean. corpus + chroma + bm25 explicitly NOT in dockerignore (those go INTO the image). Co-Authored-By: Claude Opus 4.7 (1M context) <noreply@anthropic.com>
This commit is contained in:
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# MON 89034 X TC1507 SEED BLEND
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- EPA Reg No: **524-612**
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- Registrant: BAYER CROPSCIENCE, LLC
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- Signal word: Caution
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- Active ingredients: Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (plasmid insert PHI8999) in corn (0.0012%); Bacillus thuringiensis Cry1A.105 protein and genetic material necessary (vector PV-ZMIR245) for its production in corn (0.0026%); Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary (vector PV-ZMIR245) for its production in corn (0.0053%)
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- Label accepted: 2018-11-07
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- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00612-20181107.pdf
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---
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
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Washington, D.C. 20460
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OFFICE OF CHEMICAL SAFETY
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AND POLLUTION PREVENTION
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November 7, 2018
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David J. Chi
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Regulatory Affairs Manager
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Monsanto Company
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800 North Lindbergh Blvd.
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St. Louis, MO 63137
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Subject: Amendment to update the label, compliance terms, and extend the expiration date of MON
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89034 x TC1507 Seed Blend
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EPA Registration Number: 524-612
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Submission Date: 5/23/2018
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OPP Decision Number: 542180
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Dear Mr. Chi:
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The amendment referenced above, submitted in connection with registration under Section
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3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), is acceptable provided that
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you comply with the updated terms and conditions as described in this letter.
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1. The subject registration will automatically expire at midnight on November 30, 2030.
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2. The subject registration will be limited to a field corn seed blend of up to 95% Bacillus thuringiensis
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Cry1A.105 and Cry2Ab2 proteins and the genetic material (vector PV-ZMIR245) necessary for their
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production in corn event MON 89034 (OECD Unique Identifier: MON-89Ø34-3) and Bacillus
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thuringiensis Cry1F protein and the genetic material (vector PHP8999) necessary for its production in
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corn event TC1507 (OECD Unique Identifier: DAS-Ø15Ø7-1) field corn seed and a minimum of 5%
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non-Bt corn seed that when planted creates an interspersed refuge within the field.
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3. Submit/cite all data required for registration of your product under FIFRA section 3(c)(5) when the
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Environmental Protection Agency (EPA) requires registrants of similar products to submit such data.
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4. This plant-incorporated protectant (PIP) may be combined through conventional breeding with other
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registered plant-incorporated protectants that are similarly approved for use in combination, through
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conventional breeding, with other registered plant-incorporated protectants to produce inbred corn lines
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and hybrid corn varieties with combined pesticidal traits.
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5. Monsanto Company (hereafter referred to as Monsanto) must commit to do the following Insect
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Resistance Management (IRM) Program, consisting of the following elements:
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Requirements relating to a refuge assurance program for ensuring the correct refuge blend
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percentage.
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Page 2 of 13
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EPA Reg. No. 524‐612
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OPP Decision No. 542180
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Requirements relating to creation of a lepidopteran refuge (consisting of corn that does not
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contain any Bt trait for lepidopteran control) in cotton growing regions in conjunction with the
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planting of any acreage of MON 89034 x TC1507 Seed Blend corn;
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Requirements for Monsanto to prepare and require MON 89034 x TC1507 Seed Blend corn users
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to sign grower agreements that impose binding contractual oblig ations on growers to comply
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with the refuge requirements.
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Requirements for Monsanto to develop, implement, and report to EPA on programs to
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educate growers about IRM requirements.
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Requirements for Monsanto to develop, implement, and report to EPA on programs to
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evaluate and promote growers’ compliance with IRM requirements.
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Requirements for Monsanto to develop, implement, and report to EPA on monitoring programs
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to evaluate whether there are statistically significant and biologically relevant changes in
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susceptibility to the Cry1A.105, Cry1F, or Cry2Ab2 proteins in the target insects.
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Requirements for Monsanto to develop, and if triggered, to implement a remedial action plan
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that would contain measures Monsanto would take in the event that any field-relevant insect
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resistance to Cry1A.105, Cry1F, or Cry2Ab2 was detected, as well as to report on activity
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under the plan to EPA.
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Requirements for Monsanto to maintain, and provide the Agency upon request, the number
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of units sold by state and county, IRM grower agreement results, and substantive changes to
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educational programs. Monsanto is required to submit reports within three months of the
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Agency’s request.
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Bag Tag Requirements for MON 89034 x TC1507 Seed Blend corn. Seed bags and/or bag tags
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for corn hybrids that contain plant- incorporated protectants produced in MON 89034 x
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TC1507 Seed Blend corn must display the registration number and active ingredients, and
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stipulate that growers read the Monsanto Stewardship Guide (or equivalent guidance) prior to
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planting these hybrids. The refuge size requirement must be displayed on the bag or bag tag in
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both text and graphic format.
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a. Refuge Requirements for MON 89034 x TC1507 Seed Blend Corn
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The following information must be included on the product bag o r bag-tag as sold per respective region and in
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the Grower Guide:
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Corn Belt/Non-Cotton Growing Areas
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MON 89034 x TC1507 Seed Blend contains a Lepidopteran refuge that is “in the bag” and is automatically
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implemented when the grower plants the product. No additional refuge is required when planting this product.
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Foliar insecticide treatments for control of European corn borer, corn earworm, southwestern corn borer, fall
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armyworm, black cutworm, western bean cutworm, lesser corn stalk borer, southern corn stalk borer, stalk borer
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and sugarcane borer may be applied only if economic thresholds are reached for one or more of these target
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Page 3 of 13
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EPA Reg. No. 524‐612
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OPP Decision No. 542180
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pests. Foliar insecticide treatments are also permitted for control of corn rootworm adults if economic
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thresholds are reached. Economic thresholds will be determined using methods recommended by local or
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regional professionals (e.g., Extension Service agents, crop consultants).
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Cotton-Growing Region Refuge Requirements
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These refuge requirements do not apply to seed increase/propagation of inbred and hybrid seed corn up to a
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total of 20,000 acres per county and up to a combined United States (U.S.) total of 250,000 acres per plant-
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incorporated protectant (PIP) active ingredient per registrant per year. Grower agreements (also known as
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stewardship agreements) will specify that growers must adhere to the refuge requirements as described in the
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grower guide/product use guide and/or in supplements to the grower guide/product use guide.
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In the cotton-growing area where corn earworm is a significant pest:
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A 20% refuge must be planted with non-Bt corn hybrids.
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MON 89034 x TC1507 Seed Blend and the 20% non-Bt refuge should be sown on the same day, or with
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the shortest window possible between planting dates.
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External refuges may be planted as an in-field or adjacent (e.g., across the road) refuge or planted as a
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separate block within 1/2 mile of the MON 89034 x TC1507 Seed Blend field.
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In field refuge options include blocks, perimeter strips (i.e., along the edges or headlands), or in-field
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strips.
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When planting the refuge in strips across the field, refuges must be at least four (4) rows wide.
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Foliar insecticide treatments for control of European corn borer, corn earworm, southwestern corn borer,
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fall armyworm, black cutworm, western bean cutworm, lesser corn stalk borer, southern corn stalk
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borer, stalk borer and sugarcane borer may be applied only if economic thresholds are reached for one or
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more of these target pests. Economic thresholds will be determined using methods recommended by
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local or regional professionals (e.g., Extension Service agents, crop consultants). Microbial Bt
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insecticides must not be applied to non-Bt corn refuge plants.
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Cotton-growing areas include the following states: Alabama, Arkansas, Georgia, Florida, Louisiana,
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North Carolina, Mississippi, South Carolina, Oklahoma (only counties of Beckham, Caddo, Comanche,
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Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, and Washita), Tennessee (only the counties of
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Carroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Haywood, Lake,
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Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), Texas (except the counties of
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Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, Moore, Ochiltree, Roberts, and Sherman),
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Virginia (only the counties of Dinwiddie, Franklin City, Greensville, Isle of Wight, Northampton,
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Southampton, Suffolk City, Surrey, and Sussex) and Missouri (on
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ly the counties of Dunklin, New
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Madrid, Pemiscot, Scott, and Stoddard). All other states and counties are considered to be in the corn-
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growing area where no structured refuge is required.
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b. Grower Agreements for MON 89034 x TC1507 Seed Blend Corn
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1. Persons purchasing MON 89034 x TC1507 Seed Blend corn must sign a grower agreement. The term
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grower agreement refers to any grower purchase contract, license agreement, or similar legal document.
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Page 4 of 13
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EPA Reg. No. 524‐612
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OPP Decision No. 542180
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2. The grower agreement and/or specific stewardship documents referenced in the grower agreement must
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clearly set forth the terms of the current IRM program. By signing the grower agreement, a grower must be
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contractually bound to comply with the requirements of the IRM program.
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3. Monsanto must continue to integrate this registration into the current system used for its other Bt corn
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plant- incorporated protectants, which is reasonably likely to assure that persons purchasing MON 89034 x
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TC1507 Seed Blend corn will affirm annually that they are contractually bound to comply with the
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requirements of the IRM program.
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4. Monsanto must continue to use its current grower agreement for MON 89034 x TC1507 Seed Blend corn.
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If Monsanto wishes to change any part of the grower agreement or any specific stewardship documents
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referenced in the grower agreement that would affect either the content of the IRM program or the legal
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enforceability of the provisions of the agreement relating to the IRM program, then thirty (30) days prior to
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implementing a proposed change, Monsanto must submit to EPA the text of such changes to ensure that it
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is consistent with the terms and conditions of this amended registration.
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5. Monsanto shall maintain records of all MON 89034 x TC1507 Seed Blend corn grower agreements for a
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period of three (3) years from December 31st of the year in which the agreement was signed.
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6. Monsanto shall make available to the Agency upon request records of the number of units of MON 89034
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x TC1507 Seed Blend corn seed sold or shipped and not returned, and the number of such units that were
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sold to persons who have signed grower agreements for the previous growing season. Monsanto is required
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to submit reports within three months of the Agency’s request.
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7. Monsanto must allow a review of the grower agreements and grower agreement records by EPA or by a
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State pesticide regulatory agency if the State agency can demonstrate that confidential business
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information, including names, personal information, and grower license numbers of the growers, will be
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protected.
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c. IRM Education and IRM Compliance Monitoring Program for MON 89034 x TC1507 Seed
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Blend Corn in EPA-designated Cotton Counties
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1. Monsanto must implement and enhance (as set forth in paragraph 17 of this section) a comprehensive,
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ongoing IRM education program designed to convey to MON 89034 x TC1507 Seed Blend corn users the
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importance of complying with the IRM program, as well as seed blend product performance expectations
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and guidance to growers on actions to take when unexpected damage occurs. The program shall include
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information encouraging MON 89034 x TC1507 Seed Blend corn users to pursue optional elements of the
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IRM program relating to refuge configuration and proximity to MON 89034 x TC1507 Seed Blend corn
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fields. The education program shall involve the use of multiple media, e.g. face-to-face meetings, mailing
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written materials, EPA-reviewed language on IRM requirements on the bag or bag tag, and electronic
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communications such as by internet, radio, or television commercials. The program shall involve at least
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one written communication annually to each MON 89034 x TC1507 Seed Blend corn user separate from
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the grower technical guide. The communication shall inform the user of the current IRM requirements and
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specifically the need to plant a lepidopteran refuge in cotton growing regions. Monsanto shall coordinate
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its education program with the educational efforts of other registrants and other organizations, such as the
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National Corn Growers Association and state extension programs.
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2. Monsanto shall revise, and expand as necessary, its education program to take into account the information
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Page 5 of 13
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EPA Reg. No. 524‐612
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OPP Decision No. 542180
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collected through the compliance survey, required under paragraphs 6–9 of this section, and from other
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sources. The changes shall address aspects of grower compliance that are not sufficiently high.
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3. Upon EPA request, Monsanto shall provide copies of grower education materials and information on
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grower education activities including any substantive changes to these materials and activities conducted
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either individually or as part of the industry working group Agricultural Biotechnology Stewardship
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Technical Committee (ABSTC). Monsanto is required to submit reports within three months of the
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Agency’s request. The required features of the compliance assurance program are described in paragraphs
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4–22 of this section.
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4. Monsanto must implement and improve an ongoing IRM compliance assurance program designed to
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evaluate the extent to which growers purchasing MON 89034 x TC1507 Seed Blend corn are compliant
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with the requirement of a 20% refuge for lepidopteran pests in cotton growing areas, and that takes such
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actions as are reasonably needed to assure that growers who have not complied with the program either do
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so in the future or lose their access to Monsanto’s Bt corn products. Monsanto shall coordinate with other
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Bt corn registrants in improving its compliance assurance program and integrate this registration into the
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current compliance assurance program used for its other Bt corn plant-incorporated protectants. Other
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required features of the program are described in paragraphs 5–22 of this section.
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5. Monsanto must maintain and publicize a phased compliance approach (i.e., a guidance document that
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indicates how it will address instances of non-compliance with the terms of the IRM program and general
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criteria for choosing among options for responding to any non-compliant growers after the first year of
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non-compliance). While recognizing that for reasons of difference in business practices there are needs for
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flexibility between different companies, Monsanto must use a consistent set of standards for responding to
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non-compliance. An individual grower found to be significantly out of compliance two (2) years in a row
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would be denied access the next year to Monsanto’s Bt corn products for which the grower is required to
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plant a separate structured refuge. Similarly, seed dealers who are not fulfilling their obligations to
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inform/educate growers of their IRM obligations will lose their opportunity to sell Bt corn.
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6. The IRM compliance assurance program shall include an annual survey, conducted by an independent third
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party, of a statistically representative sample of growers MON 89034 x TC1507 Seed Blend corn. The
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survey shall be conducted in odd-numbered years beginning in 2019 and shall include growers who plant
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100 or more acres of corn in the Southern U.S. corn-cotton areas. Monsanto may collaborate with other
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registrants of Bt corn [for example, through the industry working group the Agricultural Biotechnology
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Stewardship Technical Committee (ABSTC)] to conduct the survey.
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In the U.S. Corn Belt, no anonymous grower survey is required for MON 89034 x TC1507 Seed Blend
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corn if Monsanto can demonstrate that the industry-wide adoption of integrated refuge products (i.e.,
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refuge seed blends) is equal to or greater than 70% of Bt corn acres in the Corn Belt. If industry- wide
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adoption of integrated refuge products (i.e., refuge seed blends) falls below 70% of Bt corn acres in the
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Corn Belt, an anonymous grower survey shall also be conducted in this region during the next growing
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season using a statistically representative sample of growers who plant 200 or more acres of corn, and
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grower surveys shall be continued every odd-numbered year until the industry-wide adoption of integrated
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refuge products (i.e., refuge seed blends) is again equal to or greater than 70% of Bt corn acres in this
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region. Monsanto may collaborate with other registrants of Bt corn (for example, through the industry
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working group the ABSTC) to compile the integrated refuge adoption data and to conduct the surveys.
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Alternatively, if Monsanto is not a participant of an industry working group (e.g., the ABSTC) and
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Monsanto’s sales of integrated refuge products are equal to or greater than 70% of Monsanto’s total Bt corn
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Page 6 of 13
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EPA Reg. No. 524‐612
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OPP Decision No. 542180
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sales in the prior year, then no anonymous grower survey is required in the U.S. Corn Belt. If Monsanto’s
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sales of integrated refuge products fall below 70% of Monsanto’s total Bt corn sales, an anonymous grower
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survey shall also be conducted in this region during the next growing season using a statistically
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representative sample of growers who plant 200 or more acres of corn, and grower surveys shall be
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continued every odd-numbered year until sales of integrated refuge products (i.e., refuge seed blends) are
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again equal to or greater than 70% of Monsanto’s total Bt corn sales in this region.
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A third party is classified as a party other than the registrant, the grower, or anyone else with a
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direct interest in IRM compliance for Bt corn.
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7. The survey shall be designed to provide an understanding of any difficulties growers encounter in
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implementing IRM requirements. An analysis of survey results must include the reasons, extent, and
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potential biological significance of any implementation deviations.
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8. The survey shall be designed to obtain grower feedback on the usefulness of specific educational tools and
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initiatives.
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9. In years in which the survey is conducted, Monsanto shall provide a final written summary of the results of
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the survey (together with a description of the regions, the methodology used, and the supporting data) to
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||||
EPA on or before January 31st of the following year. Monsanto shall confer with other registrants and EPA
|
||||
on the design and content of the survey prior to its implementation.
|
||||
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10. Monsanto shall revise, and expand as necessary, its compliance assurance program to take into account the
|
||||
information collected through the compliance survey, required under paragraphs 6–9 of this section, and
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from other sources. The changes shall address aspects of grower compliance that are not sufficiently high.
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Monsanto must confer with EPA prior to adopting any changes.
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||||
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11. Monsanto shall conduct and enhance an annual on-farm assessment program. Monsanto shall train its
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||||
representatives who make on-farm visits with MON 89034 x TC1507 Seed Blend corn growers to perform
|
||||
assessments of compliance with IRM requirements. There is no minimum corn acreage size for this
|
||||
program. Therefore, growers will be selected for this program from across all farm sizes. In the event that
|
||||
any of these visits result in the identification of a grower who is not in compliance with the IRM program,
|
||||
Monsanto shall take appropriate action, consistent with its phased compliance approach, to promote
|
||||
compliance.
|
||||
|
||||
12. Monsanto shall implement a program for investigating legitimate tips and complaints that MON 89034 x
|
||||
TC1507 Seed Blend corn growers are not in compliance with the IRM program. Whenever an investigation
|
||||
results in the identification of a grower who is not in compliance with the IRM program, Monsanto shall
|
||||
take appropriate action, consistent with its phased compliance approach.
|
||||
|
||||
13. If a grower, who purchases MON 89034 x TC1507 Seed Blend corn for planting, was specifically
|
||||
identified as not being in compliance during the previous year, Monsanto shall visit with the grower and
|
||||
evaluate whether the grower is in compliance with the IRM program for the current year.
|
||||
|
||||
14. Annually, by January 31st each year, Monsanto must provide a report to EPA summarizing the MON
|
||||
89034 x TC1507 Seed Blend compliance assurance program activities and results for the prior year and
|
||||
plans for the MON 89034 x TC1507 Seed Blend compliance assurance program for the current year.
|
||||
Within one month of submitting this report to EPA, the registrant shall meet with EPA to discuss its
|
||||
findings. The report must inform EPA of the number of growers deemed ineligible to purchase Bt corn
|
||||
|
||||
Page 7 of 13
|
||||
EPA Reg. No. 524‐612
|
||||
OPP Decision No. 542180
|
||||
seed on the basis of continued non-compliance with the insect resistance management refuge requirements.
|
||||
Monsanto may elect to coordinate information with other registrants and report collectively the results of
|
||||
compliance assurance programs.
|
||||
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||||
15. Monsanto and the seed corn dealers for Monsanto must allow a review of the compliance records by EPA
|
||||
or by a State pesticide regulatory agency if the State agency can demonstrate that confidential business
|
||||
information, including the names, personal information, and grower license numbers of the growers, will
|
||||
be protected.
|
||||
|
||||
16. Monsanto shall revise and expand its existing Compliance Assurance Program to include the following
|
||||
elements. The registrant may coordinate with other registrants in designing and implementing its
|
||||
Compliance Assurance Program.
|
||||
|
||||
17. Monsanto will enhance the refuge education program throughout the seed delivery channel:
|
||||
|
||||
Ensure sales representatives, licensees, seed dealers, and growers recognize the importance of
|
||||
correct refuge implementation and potential consequences of failure to plant the required refuge.
|
||||
|
||||
Implement a “bag tag” that will be attached to all bags of MON 89034 x TC1507 Seed Blend
|
||||
seed sold and delivered. The purpose of this bag tag is to remind growers that MON 89034 x
|
||||
TC1507 Seed Blend products require a separate 20% lepidopteran refuge in cotton growing
|
||||
areas. The PIP product label accepted by EPA must include how this information will be
|
||||
conveyed to growers via text and graphics.
|
||||
|
||||
18. Monsanto will focus the majority of on-farm assessments on regions with the greatest risks for resistance:
|
||||
|
||||
Use Bt corn adoption, pest pressure information, and other available information to identify
|
||||
regions where the risk of resistance is greatest;
|
||||
|
||||
Focus approximately two-thirds of on-farm assessments on these regions, with the remaining
|
||||
assessments conducted across other regions where MON 89034 x TC1507 Seed Blend is used.
|
||||
|
||||
19. Monsanto will use its available MON 89034 x TC1507 Seed Blend sales records and other information to
|
||||
refine grower lists for on-farm assessments of their compliance with refuge requirements:
|
||||
|
||||
Identify for potential on-farm assessment growers whose sales information indicates they have
|
||||
purchased MON 89034 x TC1507 Seed Blend corn product but may have purchased little or no
|
||||
refuge seed from the registrant, licensee, or affiliated company.
|
||||
|
||||
20. Monsanto will contract with third parties to perform on-farm assessments of compliance with refuge
|
||||
requirements:
|
||||
|
||||
The third-party assessors will conduct all first-time on-farm assessments as well as second-year
|
||||
on-farm assessments of those growers found out of compliance in a first- time assessment.
|
||||
|
||||
21. Monsanto will annually refine the on-farm assessment program for the MON 89034 x TC1507 Seed Blend
|
||||
corn product to reflect the adoption rate and level of refuge compliance for the product.
|
||||
|
||||
Page 8 of 13
|
||||
EPA Reg. No. 524‐612
|
||||
OPP Decision No. 542180
|
||||
22. Monsanto will follow up with growers who have been found significantly out of compliance under the on-
|
||||
farm assessment program and are found to be back in compliance the following year:
|
||||
|
||||
All growers found to be significantly out of compliance in a prior year will annually be sent
|
||||
additional refuge assistance information for a minimum of two years by Monsanto, seed
|
||||
supplier, or third-party assessor, after completing the assessment process;
|
||||
|
||||
Monsanto will conduct follow-up checks on growers found to be significantly out of compliance
|
||||
within three years after they are found to be back in compliance;
|
||||
|
||||
A grower found with a second incident of significant non-compliance with refuge requirements
|
||||
for the Bt corn product within a five-year period will be denied access to Monsanto’s Bt corn
|
||||
products the next year. Similarly, seed dealers who are not fulfilling their obligations to
|
||||
inform/educate growers of their IRM obligations will lose their opportunity to sell Bt corn.
|
||||
|
||||
d. Insect Resistance Monitoring and Mitigation Plan for MON 89034 x TC1507 Seed Blend Corn
|
||||
|
||||
1. EPA is imposing the following conditions for the Cry1A.105, Cry1F, and Cry2Ab2 toxins expressed
|
||||
in MON 89034 x TC1507 Seed Blend
|
||||
|
||||
Monsanto will monitor for resistance to Cry1A.105, Cry1F, or Cry2Ab2 expressed in MON 89034 x TC1507
|
||||
Seed Blend corn. The monitoring program shall consist of two approaches: (1) focused population sampling
|
||||
and laboratory testing; and (2) investigation of reports of less-than expected control of labeled insects.
|
||||
Should field-relevant resistance be confirmed, an appropriate resistance management action plan will be
|
||||
implemented.
|
||||
|
||||
Focused Population Sampling
|
||||
|
||||
Monsanto shall annually sample and bioassay populations of the key target pests: Ostrinia nubilalis
|
||||
(European corn borer; ECB), Diatraea grandiosella (southwestern corn borer; SWCB), and Helicoverpa zea
|
||||
(corn earworm; CEW). Sampling for the target pests will be focused in areas identified as those with the
|
||||
highest risk of resistance development (e.g., where lepidopteran active Bt hybrids are planted on a high
|
||||
proportion of the corn acres, and where the insect species are regarded as key pests of corn). Bioassay
|
||||
methods must be appropriate for the goal of detecting field-relevant shifts in population response to MON
|
||||
89034 x TC1507 Seed Blend corn and/or changes in resistance allele frequency in response to the use of
|
||||
MON 89034 x TC1507 Seed Blend 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 twelve (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 (6) populations. For CEW, the target will be a minimum of ten (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
|
||||
|
||||
Page 9 of 13
|
||||
EPA Reg. No. 524‐612
|
||||
OPP Decision No. 542180
|
||||
population collection will contain a minimum of 100 genomes. It is recognized that it may not be possible to
|
||||
collect the target number of insect populations or genomes due to factors such as natural fluctuations in pest
|
||||
density, environmental conditions, and area-wide pest suppression.
|
||||
|
||||
The sampling program and geographic range of collections may be modified as appropriate based on changes
|
||||
in pest importance and for the adoption levels of MON 89034 x TC1507 Seed Blend corn. EPA shall be
|
||||
consulted prior to the implementation of such modifications.
|
||||
|
||||
Monsanto will report to EPA, on or before August 31st of each year, the results of the population sampling
|
||||
and bioassay monitoring program.
|
||||
|
||||
Any incidence of unusually low sensitivity to the Cry1A.105, Cry1F, or Cry2Ab2 proteins in bioassays shall
|
||||
be investigated as soon as possible to understand any field relevance of such a finding. Such investigations
|
||||
shall proceed in a stepwise manner until the field relevance can be either confirmed or refuted, and results of
|
||||
these shall be reported to EPA annually on or before August 31st. The investigative steps will include the
|
||||
following:
|
||||
|
||||
i. Re-test progeny of the collected population to determine whether the unusual bioassay
|
||||
response is reproducible and heritable. If it is not reproducible and heritable, no further action
|
||||
is required.
|
||||
|
||||
ii. If the unusual response is reproducible and heritable, progeny of insects that survive the
|
||||
diagnostic concentration will be tested using methods that are representative of exposure to
|
||||
MON 89034 x TC1507 Seed Blend corn under field conditions. If progeny do not survive to
|
||||
adulthood, any suspected resistance is not field relevant and no further action is required.
|
||||
|
||||
iii. If insects survive steps 1 and 2, resistance is confirmed, and further steps will be taken to
|
||||
evaluate the resistance. These steps may include the following:
|
||||
a. Determining the nature of the resistance (i.e., recessive or dominant, and the level of
|
||||
functional dominance);
|
||||
b. Estimating the resistance allele frequency in the original population;
|
||||
c. 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;
|
||||
d. Determining the geographic distribution of the resistance allele by analyzing field
|
||||
collections in subsequent years from sites surrounding the site where the resistance
|
||||
allele(s) was originally collected.
|
||||
|
||||
Should field-relevant resistance be confirmed, and the resistan
|
||||
ce appears to be increasing or spreading,
|
||||
Monsanto will consult with EPA to develop and implement a case-specific resistance management action
|
||||
plan.
|
||||
|
||||
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
|
||||
|
||||
Page 10 of 13
|
||||
EPA Reg. No. 524‐612
|
||||
OPP Decision No. 542180
|
||||
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), Monsanto will implement the actions described below, based on the following
|
||||
definitions of suspected resistance and confirmed resistance.
|
||||
|
||||
Suspected Resistance
|
||||
|
||||
EPA defines suspected resistance to mean field reports of unexpected levels of insect-feeding damage for
|
||||
which:
|
||||
The corn in question has been confirmed to be lepidopteran-active Bt corn;
|
||||
|
||||
The seed used had the proper percentage of corn expressing Bt protein;
|
||||
|
||||
The relevant plant tissues are expressing the expected level of Bt protein; and
|
||||
|
||||
It has been ruled out that species not susceptible to the protein could be responsible for the damage,
|
||||
that no climatic or cultural reasons could be responsible for the damage, and
|
||||
|
||||
That there could be no other reasonable causes for the damage.
|
||||
|
||||
EPA does not interpret suspected resistance to mean grower reports of possible control failures or suspicious
|
||||
results from annual insect monitoring assays, nor does EPA intend that extensive field studies and testing be
|
||||
undertaken to confirm scientifically the presence of insects resistant to MON 89034 x TC1507 Seed Blend
|
||||
corn in commercial production fields before responsive measures are undertaken.
|
||||
|
||||
If resistance is suspected, Monsanto will instruct growers to do the following:
|
||||
|
||||
Use alternative control measures in MON 89034 x TC1507 Seed Blend corn fields in the affected
|
||||
region to control the target pest during the immediate growing season.
|
||||
|
||||
Destroy MON 89034 x TC1507 Seed Blend corn crop residues in the affected region within one (1)
|
||||
month after harvest with a technique appropriate for local production practices to minimize the
|
||||
possibility of resistant insects over- wintering and contributing to the next season's target pest
|
||||
population.
|
||||
|
||||
Additionally, if possible, and prior to the application of alternative control measures or destruction of crop
|
||||
residues, Monsanto will collect samples of the insect population in the affected fields for laboratory rearing
|
||||
and testing. Such rearing and testing shall be conducted as expeditiously as practical.
|
||||
|
||||
Confirmed Resistance
|
||||
|
||||
EPA defines confirmed resistance to mean, in the case of field reports of unexpected levels of damage from
|
||||
the key target pests, that all the following criteria are met:
|
||||
|
||||
There is >30% insect survival and commensurate insect feeding in a bioassay, initiated with
|
||||
neonate larvae, that uses methods that are representative of exposure to Bt corn hybrids under field
|
||||
conditions (ECB and SWCB only).
|
||||
|
||||
Page 11 of 13
|
||||
EPA Reg. No. 524‐612
|
||||
OPP Decision No. 542180
|
||||
|
||||
In standardized laboratory bioassays using diagnostic concentrations of the Bt protein suited to the
|
||||
target pest in question, the pest exhibits resistance that has a genetic basis and the level of survivorship
|
||||
indicates that there may be a resistance allele frequency of ≥ 0.1 in the sampled population.
|
||||
|
||||
In standardized laboratory bioassays, the LC50 exceeds the upper limit of the 95% confidence interval
|
||||
of the LC50 for susceptible populations surveyed both in the original baselines developed for this pest
|
||||
species and in previous years of field monitoring.
|
||||
|
||||
Response to Confirmed Resistance in a Key Target Pest as the Cause of Unexpected Levels
|
||||
of Damage in the Field
|
||||
|
||||
When field resistance is confirmed (as defined above), the following steps will be taken by Monsanto:
|
||||
|
||||
EPA will receive notification within 30 days of resistance confirmation;
|
||||
|
||||
Affected customers and extension agents will be notified about confirmed resistance within 30 days;
|
||||
|
||||
Monitoring will be increased in the affected area and local target pest populations will be
|
||||
sampled annually to determine the extent and impact of resistance;
|
||||
|
||||
If appropriate (depending on the resistant pest species, the extent of resistance, the timing of
|
||||
resistance, and the nature of resistance, and the availability of suitable alternative control measures),
|
||||
alternative control measures will be employed to reduce or control target pest populations in the
|
||||
affected area. Alternative control measures may include advising customers and extension agents in
|
||||
the affected area to incorporate crop residues into the soil following harvest to minimize the
|
||||
possibility of over-wintering insects, and/or applications of chemical insecticides;
|
||||
|
||||
Unless otherwise agreed with EPA, stop sale and distribution of the relevant lepidopteran-active Bt
|
||||
corn hybrids in the affected area immediately until an effective local mitigation plan, approved by
|
||||
EPA, has been implemented;
|
||||
|
||||
Monsanto will develop a case-specific resistance management action plan within 90 days according
|
||||
to the characteristics of the resistance event and local agronomic needs. Monsanto will consult with
|
||||
appropriate stakeholders in the development of the action plan, and the details of such a plan shall be
|
||||
approved by EPA prior to implementation;
|
||||
|
||||
Monsanto will notify affected parties (e.g., growers, consultants, extension agents, seed
|
||||
distributors, university cooperators, and state/federal authorities as appropriate) in the region of
|
||||
the resistance situation and approved action plan; and
|
||||
|
||||
In subsequent growing seasons, maintain sales suspension and alternative resistance management
|
||||
strategies in the affected region(s) for the Bt corn hybrids that are affected by the resistant
|
||||
population until an EPA-approved local resistance management plan is in place to mitigate the
|
||||
resistance.
|
||||
|
||||
A report on results of resistance monitoring and investigations of damage reports must be submitted to EPA,
|
||||
on or before August 31st of each year, for the duration of the registration.
|
||||
|
||||
Page 12 of 13
|
||||
EPA Reg. No. 524‐612
|
||||
OPP Decision No. 542180
|
||||
|
||||
|
||||
e. Refuge Assurance Program for MON 89034 x TC1507 Seed Blend corn
|
||||
|
||||
Monsanto must implement a Blended Seed Refuge Assurance Program designed to ensure MON 89034 x
|
||||
TC1507 Seed Blend corn 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. Standard Operating Procedures for the blending process;
|
||||
|
||||
3. Calibration of blending equipment; and
|
||||
|
||||
4. Records and data retention records for seed blend products.
|
||||
|
||||
Calibration records - Monsanto will retain documentation for a specified period of time on the
|
||||
equipment calibration including the procedure, when it was conducted and the results.
|
||||
|
||||
Blend proportion records (weight and kernel based) - Monsanto will retain documentation for a
|
||||
specified period of time on the kernel per pound data of the components, the calculations to
|
||||
determine the proportions based on weight and the actual weights that are blended together to
|
||||
make up an MON 89034 x TC1507 Seed Blend corn product by seed lot.
|
||||
|
||||
All records must be maintained at the Monsanto blending facility and must be available for the EPA review
|
||||
upon request.
|
||||
|
||||
f. Annual Reporting Requirements for MON 89034 x TC1507 Seed Blend corn
|
||||
|
||||
The following annual reports must be submitted:
|
||||
|
||||
1. Compliance Assurance Plan: Compliance Assurance Program activities, including IRM Grower Survey
|
||||
results and on-farm assessment results for the prior year and plans for the compliance assurance program
|
||||
for the current year, on or before January 31st each year.
|
||||
|
||||
2. Insect Resistance Monitoring Results (Cry1A.105, Cry1F, and Cry2Ab2): results of monitoring and
|
||||
investigations of damage reports, August 31st of each year.
|
||||
|
||||
|
||||
Should you wish to add/retain a reference to your company’s website on your label, then please be aware that
|
||||
the website becomes labeling under FIFRA and is subject to review by the EPA. If the website is false or
|
||||
misleading, the product will be considered to be misbranded and sale or distribution of the product is unlawful
|
||||
under FIFRA section 12(a)(1)(E). 40 CFR § 156.10(a)(5) lists examples of statements the EPA may consider
|
||||
false or misleading. In addition, regardless of whether a website is referenced on your product’s label, claims
|
||||
made on the website may not substantially differ from those claims approved through the registration process.
|
||||
Therefore, should the EPA find or if it is brought to our attention that a website contains false or misleading
|
||||
statements or claims substantially differing from the EPA-approved registration, the website will be referred to
|
||||
the EPA’s Office of Enforcement and Compliance Assurance.
|
||||
|
||||
Page 13 of 13
|
||||
EPA Reg. No. 524‐612
|
||||
OPP Decision No. 542180
|
||||
|
||||
|
||||
Your release for shipment of this product constitutes acceptance of these conditions. If you fail to satisfy these
|
||||
terms and conditions, the EPA will consider appropriate regulatory action including, among other things,
|
||||
cancellation under FIFRA section 6(e).
|
||||
|
||||
A stamped copy of the label is enclosed for your records. A previously approved Confidential Statement of
|
||||
Formula dated November 14, 2013 is on file for this product.
|
||||
|
||||
|
||||
|
||||
S i n c e r e l y ,
|
||||
|
||||
|
||||
A l a n R e ynolds, Team Leader
|
||||
M i c r o b i a l P e s t i c i d e s B r a n c h
|
||||
Biopesticides and Pollution
|
||||
P r e v e n t i o n D i v i s i o n ( 7 5 1 1 P )
|
||||
Office of Pesticide Programs
|
||||
|
||||
|
||||
Enclosure
|
||||
|
||||
Plant-Incorporated Protectant Label
|
||||
|
||||
MON 89034 × TC1507 Seed Blend
|
||||
|
||||
|
||||
Insect-Protected, Herbicide-Tolerant Corn with an Interspersed Refuge
|
||||
(OECD Unique Identifier: MON-89Ø34-3 × DAS-Ø15Ø7-1)
|
||||
|
||||
Active Ingredients:
|
||||
Bacillus thuringiensis Cry1A.105 protein and the genetic material (vector PV-ZMIR245)
|
||||
necessary for its production in corn event MON 89034 (OECD Uniq ue Identifier: MON-
|
||||
89Ø34-3) ........................................................................................................... ≤ 0.0026%*
|
||||
|
||||
Bacillus thuringiensis Cry2Ab2 protein and the genetic material (vector PV-ZMIR245)
|
||||
necessary for its production in corn event MON 89034 (OECD Uniq ue Identifier: MON-
|
||||
89Ø34-3) ........................................................................................................... ≤ 0.0053%*
|
||||
|
||||
Bacillus thuringiensis Cry1F protein and the genetic material (vector PHP8999)
|
||||
necessary for its production in corn event TC1507 (OECD Unique Identifier: DAS-
|
||||
Ø15Ø7-1) .......................................................................................................... ≤ 0.0012%*
|
||||
|
||||
Other Ingredients:
|
||||
The marker protein, Phosphinothricin Acetyltransferase (PAT), a nd the genetic material
|
||||
(vector PHP8999) necessary for its production in corn event TC1507(OECD Unique
|
||||
Identifier: DAS- Ø15Ø7-1) ............................................................................ ≤ 0.00045%*
|
||||
|
||||
*Maximum percent (wt/wt) of dry forage
|
||||
|
||||
MON 89034 × TC1507 Seed Blend contains 95% MON 89034 x TC1507 mixed with at
|
||||
least 5% non-B.t. corn within a single lot of seed.
|
||||
|
||||
KEEP OUT OF REACH OF CHILDREN
|
||||
|
||||
CAUTION
|
||||
EPA Registration No. 524-612
|
||||
EPA Establishment No. 524-MO-002
|
||||
|
||||
Monsanto Company
|
||||
800 North Lindbergh Blvd.
|
||||
St. Louis, MO 63167
|
||||
|
||||
|
||||
NET CONTENTS_______
|
||||
|
||||
|
||||
11/07/2018
|
||||
524-612
|
||||
|
||||
DIRECTIONS FOR USE
|
||||
|
||||
It is a violation of Federal law to use this seed in any manner inconsistent with this
|
||||
labeling. Information regarding commercial production must be i ncluded in the
|
||||
Technology Use Guide and/or Insect Resistance Management (IRM) Grower Guide.
|
||||
|
||||
MON 89034 x TC1507 Seed Blend can be used to protect corn plant s from leaf, stalk,
|
||||
and ear damage caused by lepidopteran corn pests listed on this label. To help preserve
|
||||
the effectiveness of B.t. corn technologies, growers planting MON 89034 x TC1507 Seed
|
||||
Blend are required to follow an Insect Resistance Management (IRM) Plan.
|
||||
|
||||
Grower agreements will specify that growers must adhere to the refuge requirements that
|
||||
will be described on the bag or bag-tag for MON 89034 x TC1507 Seed Blend corn or
|
||||
other applicable product use documents.
|
||||
|
||||
Sales of corn hybrids that contain Monsanto’s B.t. corn plant-incorporated protectants
|
||||
must be accompanied by information on planting, production, and insect resistance
|
||||
management. This information may appear on either an IRM Growe r Guide or on the
|
||||
corn seed bag or bag-tag.
|
||||
|
||||
Corn seed bags or bag-tags for products containing MON 89034 x TC1507 Seed Blend
|
||||
must include the refuge requirement.
|
||||
|
||||
INSECT RESISTANCE MANAGEMENT
|
||||
|
||||
Growers are instructed to read information on insect resistance management in the IRM
|
||||
Grower Guide or the bag or bag-tag.
|
||||
|
||||
This product is a seed mixture containing up to 95% MON 89034 × TC1507 and a minimum
|
||||
of 5% non-B.t. seed that when planted creates an interspersed refuge within the field. There
|
||||
are no requirements for a separa te structured refuge for MON 89 034 × TC1507 Seed Blend
|
||||
corn when planted in the U.S. corn growing area, including Alas ka and Hawaii, because the
|
||||
refuge seed is contained within the bag/container.
|
||||
The i n t e rspersed refuge can only be u sed b y planting seed corn specifically generated by
|
||||
qualified seed producers/conditioners licensed by the registran t. The seed producer must
|
||||
ensure a minimum of 5% non -B.t. refuge seed is included with the MON 89034 ×
|
||||
TC1507 in each lot of seed corn.
|
||||
|
||||
The 95/5% MON 89034 x TC1507 Seed Blend product may be planted in cotton growing
|
||||
areas; however, planting the 95/5% MON 89034 x TC1507 Seed Blend in cotton growing
|
||||
areas still requires planting an additional 20% structured refu ge (block, strips, or border)
|
||||
as defined for MON 89034 x TC1507 EPA Registration No. 524-585. The interspersed
|
||||
refuge option for MON 89034 x TC1507 Seed Blend does not alone comply with
|
||||
refuge requirements in cotton growing areas.
|
||||
|
||||
Additional refuge requirements in the cotton-growing area where corn earworm is a
|
||||
significant pest
|
||||
|
||||
In the cotton-growing area, as defined below, MON 89034 × TC150 7 Seed Blend
|
||||
requires the planting of an additional 20% structured refuge (i.e. 20 acres of non-B.t. corn
|
||||
for every 80 acres of MON 89034 × TC1507 Seed Blend planted).
|
||||
The 20% refuge must be planted with corn hybrids that do not co ntain B.t. technologies
|
||||
for the control of lepidopteran pests.
|
||||
The 20% refuge and the MON 89034 × TC1507 Seed Blend should be sown on the same
|
||||
day, or with the shortest window possible between planting date s to ensure that corn root
|
||||
development is similar among varieties. The 20% refuge may be p lanted as an in-field or
|
||||
adjacent (e.g., across the road) refuge or planted as a separat e block that is within
|
||||
1/2 mile of the MON 89034 × TC1507 Seed Blend field. In-field r efuge options include
|
||||
blocks, perimeter strips (i.e., strips around the field), or in -field strips. If perimeter or in-
|
||||
field strips are implemented, the strips must be at least 4 con secutive rows wide. The
|
||||
refuge can be protected from lepidopteran damage by use of non- B.t. insecticides if the
|
||||
population of one or more target pests of MON 89034 × TC1507 Se ed Blend in the
|
||||
refuge exceeds economic thresholds. Insecticide treatments for control of insects listed
|
||||
on this label may be applied only if economic thresholds are re ached for one or more of
|
||||
these target pests. Economic thresholds will be determined using methods recommended
|
||||
by local or regional professionals (e.g., Extension Service age nts, crop consultants).
|
||||
Microbial B.t. insecticides must not be applied to the field containing a see d mix
|
||||
interspersed refuge.
|
||||
The cotton-growing area requiring the additional 20% refuge con sists of the following
|
||||
states: Alabama, Arkansas, Georgia, Florida, Louisiana, North Carolina, Mississippi,
|
||||
South Carolina, Oklahoma (only the counties of Beckham, Caddo, Comanche, Custer,
|
||||
Greer, Harmon, Jackson, Kay, Kiowa, Tillman, and Washita), Tenn essee (only the
|
||||
counties of Carroll, Chester, C rockett, Dyer, Fayette, Franklin , Gibson, Hardeman,
|
||||
Hardin, Haywood, Lake, Lauderdale, Lincoln, Madison, Obion, Rut herford, Shelby, and
|
||||
Tipton), Texas (except the counties of Carson, Dallam, Hansford , Hartley, Hutchinson,
|
||||
Lipscomb, Moore, Ochiltree, Roberts, and Sherman), Virginia (on ly the counties of
|
||||
Dinwiddie, Franklin City, Greensville, Isle of Wight, Northampt on, Southampton,
|
||||
Suffolk City, Surrey, and Sussex) and Missouri (only the counti es of Dunklin, New
|
||||
Madrid, Pemiscot, Scott, and Stoddard).
|
||||
|
||||
Corn Insects Controlled or Suppressed
|
||||
|
||||
European corn borer (ECB) Ostrinia nubilalis
|
||||
Southwestern corn borer (SWCB) Diatraea grandiosella
|
||||
Southern cornstalk borer (SCSB) Diatraea crambidoides
|
||||
Corn earworm (CEW) Helicoverpa zea
|
||||
Fall armyworm (FAW) Spodoptera frugiperda
|
||||
Stalk borer Papaipema nebris
|
||||
Lesser corn stalk borer Elasmopalpus lignosellus
|
||||
Sugarcane borer (SCB) Diatraea saccharalis
|
||||
Black cutworm Agrotis ipsilon
|
||||
|
||||
MON 89034 × TC1507 Seed Blend is a product of Monsanto’s and Dow AgroSciences’
|
||||
research programs, offering unique genetic characteristics for specific grower needs and
|
||||
may be protected by one or more U.S. patents found at the following web page:
|
||||
www.monsantotechnology.com
|
||||
Reference in New Issue
Block a user