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
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- EPA Reg No: **524-585**
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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: 2022-11-28
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- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00585-20221128.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 28, 2022
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Edwards Allen, Ph.D.
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Global Regulatory Manager
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Bayer U.S. – Crop Science
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700 Chesterfield Parkway West
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Chesterfield, Missouri 63017
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Subject: Non-PRIA Amendment – Extension of the registration, minor alterati ons to the registration
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terms, and inclusion of example graphics on the label for MON 89034 x TC1507
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Product Name: MON 89034 x TC1507
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EPA Registration Number: 524-585
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Submission Date: May 13, 2022
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OPP Case Number: 00365262
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Dear Dr. Allen:
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The amendment referenced above, submitted in connection with registration under Section 3(c)(5) of the
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Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), is acceptable provided that you comply with
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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, 2023.
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2. The subject registration will be limited to Bacillus thuringiensis Cry1A.105 protein and the genetic
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material necessary for its production (vector PV-ZMIR245) in corn event MON 89034 (OECD Unique
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Identifier: MON-8934-3), Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary
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for its production (vector PV-ZMIR245) in corn event MON 89034 (OECD Unique Identifier: MON-
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8934-3), and Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production
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(vector PHP8999) in corn event TC1507 (OECD Unique Identifier: DAS-157-1) for use in field
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corn.
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3. Submit and/or cite all data required for registration or registration review of MON 89034 x TC1507
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when the EPA requires all 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. Bayer CropScience LP (Bayer ) must commit to do the following Insect Resistance Management (IRM)
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Program, consisting of the following elements:
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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 conjunction with the planting of any acreage of
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Page 2 of 13
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EPA Reg. No. 524‐585
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OPP Case No. 00365262
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MON 89034 x TC1507 corn;
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Requirements for Bayer to prepare and require MON 89034 x TC1507 corn users to sign
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grower agreements that impose binding contractual obligations on growers to comply with the
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refuge requirements.
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Requirements for Bayer to develop, implement, and report to EPA on programs to educate
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growers about IRM requirements.
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Requirements for Bayer 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 Bayer to develop, implement, and report to EPA on monitoring programs to
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evaluate whether there are statistically significant and biologically relevant changes in
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susceptibility to the Cry1A.105, Cry2Ab2, and Cry1F proteins in the target insects.
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Requirements for Bayer to develop, and if triggered, to implement a remedial action plan that
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would contain measures Bayer would take in the event that any field-relevant insect resistance
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to Cry1A.105, Cry2Ab2, and Cry1F was detected, as well as to report on activity under the
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plan to EPA.
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Requirements for Bayer to maintain, and provide the Agency upon request, the number of
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units sold by state and county, IRM grower agreement results, and substantive changes to
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educational programs. Bayer 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 corn. Seed bags and/or bag tags for corn
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hybrids that contain plant- incorporated protectants produced in MON 89034 x TC1507 corn
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must display the registration number and active ingredients, and stipulate that growers read the
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Bayer Stewardship Guide (or equivalent guidance) prior to planting these hybrids. The refuge
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size requirement must be displayed on the bag or bag tag in both text and graphic format.
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Requirements for Bayer, on or before January 31st of each year, to submit reports on Cry1A.105,
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Cry2Ab2, and Cry1F resistance monitoring.
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a. Refuge Requirements for MON 89034 x TC1507 Corn
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The following information must be included on the product bag or bag-tag as sold per respective region
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and in the Grower Guide:
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These refuge requirements do not apply to seed propagation of inbred and hybrid corn seed up to a total
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of 20,000 acres per county and up to a combined U.S. total of 250,000 acres per PIP active ingredient
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per registrant per year. Grower agreements (also known as stewardship agreements) will specify that
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growers must adhere to the following refuge requirements as described in the grower guide/product use
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guide and/or in supplements to the grower guide/product use guide.
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1. Corn Belt Refuge Requirements for Bt Corn. For MON 89034 x TC1507 field corn grown outside
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cotton-growing areas (e.g., the Corn Belt), grower agreements (also known as stewardship
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agreements) will specify that growers must adhere to the refuge requirements as described in the
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Page 3 of 13
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EPA Reg. No. 524‐585
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OPP Case No. 00365262
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growers guide/product use guide and/or in supplements to the growers guide/product use guide.
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i. Specifically, growers must plant a structured refuge of at least 5% non-Bt corn and/or non-
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lepidopteran resistant Bt corn that may be treated with insecticides as detailed below, to control
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lepidopteran stalk-boring and other pests.
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ii. The refuge and MON 89034 x TC1507 corn should be sown on the same day, or with the
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shortest window possible between planting dates to ensure development is similar among
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varieties.
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iii. Refuge planting options include: separate fields, blocks within fields (e.g., along the edges or
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headlands), and strips across the field.
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iv. External refuges must be planted within ½ mile of the Bt fields.
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v. When planting the refuge as strips across the field or as perimeter strips, refuges must be at least
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4 consecutive rows wide.
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vi. Insecticide treatments for control of ECB, CEW, Southwestern Corn Borer (SWCB), and other
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lepidopteran target pests listed on the label, grower guides, or other educational material may be
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applied only if economic thresholds are reached for one or more of those target pests. Economic
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thresholds will be determined using methods recommended by local or regional professionals
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(e.g., Extension Service agents or crop consultants). Instructions to growers will specify that
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microbial Bt insecticides must not be applied to non-Bt corn and/or non-lepidopteran resistant Bt
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corn refuges.
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2. Cotton-Growing Area Refuge Requirements for Bt Corn. For Bt field corn grown in cotton-growing
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areas, grower agreements (also known as stewardship agreements) will specify that growers must
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adhere to the refuge requirements as described in the growers guide/product use guide and/or in
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supplements to the growers guide/product use guide.
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i. Specifically, growers in these areas must plant a structured refuge of at least 20% non-Bt corn
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and/or non-lepidopteran resistant Bt corn that may be treated with insecticides as needed to
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control lepidopteran stalk-boring and other pests.
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ii. The refuge and MON 89034 x TC1507 corn should be sown on the same day, or with the
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shortest window possible between planting dates to ensure development is similar among
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varieties.
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iii. Refuge planting options include: separate fields, blocks within fields (e.g., along the edges or
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headlands), and strips across the field.
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iv. External refuges must be planted within ½ mile of the Bt fields.
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v. When planting the refuge as strips across the field or as perimeter strips, refuges must be at least
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(4) consecutive rows wide.
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vi. Insecticide treatments for control of ECB, CEW, Southwestern Corn Borer (SWCB), and other
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lepidopteran target pests listed on the label, grower guides, or other educational material may be
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Page 4 of 13
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EPA Reg. No. 524‐585
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OPP Case No. 00365262
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applied only if economic thresholds are reached for one or more of those target pests. Economic
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thresholds will be determined using methods recommended by local or regional professionals
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(e.g., Extension Service agents or crop consultants). Instructions to growers will specify that
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microbial Bt insecticides must not be applied to non-Bt corn and/or non-lepidopteran resistant Bt
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corn refuges.
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vii. Cotton-growing areas include the following states: Alabama, Arkansas, Florida, Georgia,
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Louisiana, North Carolina, Mississippi, South Carolina, Oklahoma (only the counties of
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Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, and
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Washita), Tennessee (only the counties of Carroll, Chester, Crockett, Dyer, Fayette, Franklin,
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Gibson, Hardeman, Hardin, Haywood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford,
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Shelby, and Tipton), Texas (except the counties of Carson, Dallam, Hansford, Hartley,
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Hutchinson, Lipscomb, Moore, Ochiltree, Roberts, and Sherman), Virginia (only the counties of
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Dinwiddie, Franklin City, Greensville, Isle of Wight, Northampton, Southampton, Suffolk City,
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Surrey, and Sussex), and Missouri (only the counties of Dunklin, New Madrid, Pemiscot, Scott,
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and Stoddard).
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b. Grower Agreements for MON 89034 x TC1507 Corn
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1. Persons purchasing MON 89034 x TC1507 corn must sign a grower agreement. The term grower
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agreement refers to any grower purchase contract, license agreement, or similar legal document.
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2. The grower agreement and/or specific stewardship documents referenced in the grower agreement
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must clearly set forth the terms of the current IRM program. By signing the grower agreement, a
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grower must be contractually bound to comply with the requirements of the IRM program.
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3. Bayer 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
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89034 x TC1507 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. Bayer must continue to use its current grower agreement for MON 89034 x TC1507 corn. If Bayer
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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
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legal enforceability of the provisions of the agreement relating to the IRM program, then thirty (30)
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days prior to implementing a proposed change, Bayer must submit to EPA the text of such changes
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to ensure that it is consistent with the terms and conditions of this amended registration.
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5. Bayer shall maintain records of all MON 89034 x TC1507 corn grower agreements for a period of
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three (3) years from December 31st of the year in which the agreement was signed.
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6. Bayer shall make available to the Agency upon request records of the number of units of MON
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89034 x TC1507 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. Bayer is
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required to submit reports within three months of the Agency’s request.
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7. Bayer 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,
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Page 5 of 13
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EPA Reg. No. 524‐585
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OPP Case No. 00365262
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will be protected.
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c. IRM Education and IRM Compliance Monitoring Program for MON 89034 x TC1507 Corn
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1. Bayer 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 corn users the
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importance of complying with the IRM program. The program shall include information
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encouraging MON 89034 x TC1507 corn users to pursue optional elements of the IRM program
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relating to refuge configuration and proximity to MON 89034 x TC1507 corn fields. The education
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program shall involve the use of multiple media, e.g. face-to-face meetings, mailing written
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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
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least one written communication annually to each MON 89034 x TC1507 corn user separate from
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the grower technical guide. The communication shall inform the user of the current IRM
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requirements. Bayer shall coordinate its education program with the educational efforts of other
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registrants and other organizations, such as the National Corn Growers Association and state
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extension programs.
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2. Bayer shall revise, and expand as necessary, its education program to take into account the
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information collected through the compliance survey, required under paragraphs 6–9 of this section,
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and from other sources. The changes shall address aspects of grower compliance that are not
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sufficiently high.
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3. Upon EPA request, Bayer 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
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conducted either individually or as part of the industry working group Agricultural Biotechnology
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Stewardship Technical Committee (ABSTC). Bayer is required to submit reports within three
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months of the Agency’s request. The required features of the compliance assurance program are
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described in paragraphs 4–22 of this section.
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4. Bayer 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 corn are compliant with
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the IRM program, and that takes such actions as are reasonably needed to assure that growers who
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have not complied with the program either do so in the future or lose their access to Bayer’s Bt corn
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products. Bayer shall coordinate with other Bt corn registrants in improving its compliance
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assurance program and integrate this registration into the current compliance assurance program
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used for its other Bt corn plant-incorporated protectants. Other required features of the program are
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described in paragraphs 5–22 of this section.
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5. Bayer 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
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general criteria for choosing among options for responding to any non-compliant growers after the
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first year of non-compliance). While recognizing that for reasons of difference in business practices
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there are needs for flexibility between different companies, Bayer must use a consistent set of
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standards for responding to non-compliance. An individual grower found to be significantly out of
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compliance two (2) years in a row would be denied access the next year to Bayer’s Bt corn products
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for which the grower is required to plant a separate structured refuge. Similarly, seed dealers who
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are not fulfilling their obligations to inform/educate growers of their IRM obligations will lose their
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opportunity to sell Bt corn.
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Page 6 of 13
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EPA Reg. No. 524‐585
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OPP Case No. 00365262
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6. The IRM compliance assurance program shall include an annual survey, conducted by an
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independent third party, of a statistically representative sample of growers MON 89034 x TC1507
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corn. The survey shall be conducted in odd-numbered years beginning in 2023 and shall include
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growers who plant 100 or more acres of corn in the Southern U.S. corn-cotton areas. Bayer may
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collaborate with other registrants of Bt corn [for example, through the industry working group the
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Agricultural Biotechnology 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 corn if
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Bayer can demonstrate that the industry-wide adoption of integrated refuge products (i.e., refuge
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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
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the Corn Belt, an anonymous grower survey shall also be conducted in this region during the next
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growing season using a statistically representative sample of growers who plant 200 or more acres
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of corn, and grower surveys shall be continued every odd-numbered year until the industry-wide
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adoption of integrated refuge products (i.e., refuge seed blends) is again equal to or greater than
|
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70% of Bt corn acres in this region. Bayer may collaborate with other registrants of Bt corn (for
|
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example, through the industry working group the ABSTC) to compile the integrated refuge
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adoption data and to conduct the surveys.
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Alternatively, if Bayer is not a participant of an industry working group (e.g., the ABSTC) and
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Bayer’s sales of integrated refuge products are equal to or greater than 70% of Bayer’s total Bt corn
|
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sales in the prior year, then no anonymous grower survey is required in the U.S. Corn Belt. If
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Bayer’s sales of integrated refuge products fall below 70% of Bayer’s total Bt corn sales, an
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anonymous grower survey shall also be conducted in this region during the next growing 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 sales of integrated refuge
|
||||
products (i.e., refuge seed blends) are again equal to or greater than 70% of Bayer’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
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a 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,
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and 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
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tools and initiatives.
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||||
9. In years in which the survey is conducted, Bayer shall provide a final written summary of the
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||||
results of the survey (together with a description of the regions, the methodology used, and the
|
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supporting data) to EPA on or before January 31st of the following year. Bayer shall confer with
|
||||
other registrants and EPA on the design and content of the survey prior to its implementation.
|
||||
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||||
10. Bayer 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 from other sources. The changes shall address aspects of grower compliance that are
|
||||
not sufficiently high. Bayer must confer with EPA prior to adopting any changes.
|
||||
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||||
Page 7 of 13
|
||||
EPA Reg. No. 524‐585
|
||||
OPP Case No. 00365262
|
||||
|
||||
11. Bayer shall conduct and enhance an annual on-farm assessment program. Bayer shall train its
|
||||
representatives who make on-farm visits with MON 89034 x TC1507 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, Bayer shall take appropriate action, consistent with its phased compliance
|
||||
approach, to promote compliance.
|
||||
|
||||
12. Bayer shall implement a program for investigating legitimate tips and complaints that MON 89034
|
||||
x TC1507 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, Bayer
|
||||
shall take appropriate action, consistent with its phased compliance approach.
|
||||
|
||||
13. If a grower, who purchases MON 89034 x TC1507 corn for planting, was specifically identified as
|
||||
not being in compliance during the previous year, Bayer 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, Bayer must provide a report to EPA summarizing the MON
|
||||
89034 x TC1507 compliance assurance program activities and results for the prior year and plans
|
||||
for the MON 89034 x TC1507 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 seed
|
||||
on the basis of continued non-compliance with the insect resistance management refuge
|
||||
requirements. Bayer may elect to coordinate information with other registrants and report
|
||||
collectively the results of compliance assurance programs.
|
||||
|
||||
15. Bayer and the seed corn dealers for Bayer 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. Bayer 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. Bayer 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 sold
|
||||
and delivered. The purpose of this bag tag is to remind growers that MON 89034 x TC1507
|
||||
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. Bayer will focus the majority of on-farm assessments on regions with the greatest risks for
|
||||
|
||||
Page 8 of 13
|
||||
EPA Reg. No. 524‐585
|
||||
OPP Case No. 00365262
|
||||
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 is
|
||||
used.
|
||||
|
||||
19. Bayer will use its available MON 89034 x TC1507 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 corn product but may have purchased little or no
|
||||
refuge seed from the registrant, licensee, or affiliated company.
|
||||
|
||||
20. Bayer 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. Bayer will annually refine the on-farm assessment program for the MON 89034 x TC1507 corn
|
||||
product to reflect the adoption rate and level of refuge compliance for the product.
|
||||
|
||||
22. Bayer 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 Bayer, seed
|
||||
supplier, or third-party assessor, after completing the assessment process;
|
||||
|
||||
Bayer 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
|
||||
Bayer’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 Corn
|
||||
|
||||
EPA is imposing the following conditions for the Cry1A.105, Cry2Ab2, and Cry1F toxins
|
||||
expressed in MON 89034 x TC1507
|
||||
|
||||
Bayer will monitor for resistance to Cry1A.105, Cry2Ab2, and Cry1F expressed in MON 89034 x
|
||||
TC1507 corn. The monitoring program shall consist of two approaches: (1) focused population
|
||||
|
||||
Page 9 of 13
|
||||
EPA Reg. No. 524‐585
|
||||
OPP Case No. 00365262
|
||||
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
|
||||
|
||||
Bayer 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 corn and/or changes in resistance allele
|
||||
frequency in response to the use of MON 89034 x TC1507 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 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 corn. EPA shall be
|
||||
consulted prior to the implementation of such modifications.
|
||||
|
||||
Bayer will report to EPA, on or before January 31st of each year, the results of the population
|
||||
sampling and bioassay monitoring program.
|
||||
|
||||
Any incidence of unusually low sensitivity to the Cry1A.105, Cry2Ab2, and Cry1F proteins in
|
||||
bioassays shall be investigated as soon as possible to understand any field relevance of such a finding.
|
||||
Such investigations shall proceed in a stepwise manner until the field relevance can be either
|
||||
confirmed or refuted, and results of these shall be reported to EPA annually on or before January 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.
|
||||
|
||||
Page 10 of 13
|
||||
EPA Reg. No. 524‐585
|
||||
OPP Case No. 00365262
|
||||
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 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 resistance appears to be increasing or
|
||||
spreading, Bayer 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
|
||||
|
||||
Bayer will follow up on grower, extension specialist, or consultant reports of unexpected levels of
|
||||
damage by the lepidopteran pests listed on the pesticide label. Bayer will instruct its customers to
|
||||
contact them if such incidents occur. Bayer 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), Bayer 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 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
|
||||
|
||||
Page 11 of 13
|
||||
EPA Reg. No. 524‐585
|
||||
OPP Case No. 00365262
|
||||
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 corn in commercial production fields before responsive measures are undertaken.
|
||||
|
||||
If resistance is suspected, Bayer will instruct growers to do the following:
|
||||
|
||||
Use alternative control measures in MON 89034 x TC1507 corn fields in the affected region
|
||||
to control the target pest during the immediate growing season.
|
||||
|
||||
Destroy MON 89034 x TC1507 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, Bayer will collect samples of the insect population in the affected fields for
|
||||
laboratory rearing and testing. Such rearing and testing shall be conducted as expeditiously as
|
||||
practical.
|
||||
|
||||
Confirmed Resistance
|
||||
|
||||
EPA defines confirmed resistance to mean, in the case of field reports of unexpected levels of damage
|
||||
from the key target pests, that all the following criteria are met:
|
||||
|
||||
There is >30% insect survival and commensurate insect feeding in a bioassay, initiated with
|
||||
neonate larvae, that uses methods that are representative of exposure to Bt corn hybrids
|
||||
under field conditions (ECB and SWCB only).
|
||||
|
||||
In standardized laboratory bioassays using diagnostic concentrations of the Bt protein suited to
|
||||
the target pest in question, the pest exhibits resistance that has a genetic basis and the level of
|
||||
survivorship indicates that there may be a resistance allele frequency of ≥ 0.1 in the sampled
|
||||
population.
|
||||
|
||||
In standardized laboratory bioassays, the LC50 exceeds the upper limit of the 95% confidence
|
||||
interval of the LC50 for susceptible populations surveyed both in the original baselines
|
||||
developed for this pest species and in previous years of field monitoring.
|
||||
|
||||
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 Bayer:
|
||||
|
||||
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;
|
||||
|
||||
Page 12 of 13
|
||||
EPA Reg. No. 524‐585
|
||||
OPP Case No. 00365262
|
||||
|
||||
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;
|
||||
|
||||
Bayer will develop a case-specific resistance management action plan within 90 days
|
||||
according to the characteristics of the resistance event and local agronomic needs. Bayer 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;
|
||||
|
||||
Bayer 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 January 31st of each year, for the duration of the registration.
|
||||
|
||||
e. Annual Reporting Requirements for MON 89034 x TC1507 corn
|
||||
|
||||
The following annual reports must be submitted:
|
||||
|
||||
1. Compliance Assurance Plan: Compliance Assurance Program activities, including IRM Grower
|
||||
Survey results (only for years in which survey was conducted) 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, Cry2Ab2, and Cry1F): results of monitoring and
|
||||
investigations of damage reports, on or before January 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
|
||||
|
||||
Page 13 of 13
|
||||
EPA Reg. No. 524‐585
|
||||
OPP Case No. 00365262
|
||||
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.
|
||||
|
||||
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 basic Confidential Statement of Formula dated
|
||||
November 13, 2013 is on file for this product.
|
||||
|
||||
If you have any questions, please contact Matt Weiner of my team via email at weiner.matthew@epa.gov or
|
||||
by phone at (703) 347-0333.
|
||||
|
||||
Sincerely,
|
||||
|
||||
|
||||
Alan Reynolds, Team Leader
|
||||
Emerging Technologies Branch
|
||||
Biopesticides and Pollution
|
||||
Prevention Division (7511M)
|
||||
Office of Pesticide Programs
|
||||
|
||||
|
||||
Enclosure: Stamped label for MON 89034 x TC1507 corn
|
||||
|
||||
Plant-Incorporated Protectant Label
|
||||
MON 89034 × TC1507
|
||||
Insect-Protected, Herbicide-Tolerant Corn
|
||||
(OECD Unique Identifier: MON-89Ø34-3 × DAS-Ø15Ø7-1)
|
||||
Active Ingredients:
|
||||
Bacillus thuringiensis Cry1A.105 protein and the genetic material necessary (vector
|
||||
39=0,5 IRU LWV SURGXFWLRQ LQ FRUQ HYHQW 021
|
||||
Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary (vector
|
||||
39=0,5 IRU LWV SURGXFWLRQ LQ FRUQ HYHQW 021
|
||||
Bacillus thuringiensis Cry1F protein and the genetic material necessary (vector
|
||||
3+3 IRU LWV SURGXFWLRQ LQ FRUQ HYHQW 7&
|
||||
Other Ingredients:
|
||||
PAT protein (Phosphinothricin Acetyl transferase) and the genetic material necessary
|
||||
YHFWRU 3+3 IRU LWV SURGXFWLRQ LQ FRUQ HYHQW 7&
|
||||
*Maximum percent (wt/wt) of dry forage
|
||||
KEEP OUT OF REACH OF CHILDREN
|
||||
CAUTION
|
||||
NET CONTENTS_______
|
||||
EPA Registration No. 524-585
|
||||
EPA Establishment No. 524-MO-002
|
||||
Bayer CropScience LP
|
||||
800 North Lindbergh Blvd.
|
||||
St. Louis, MO 63167
|
||||
11/28/2022
|
||||
524-585
|
||||
|
||||
DIRECTIONS FOR USE
|
||||
It is a violation of Federal law to use this product in any manner inconsistent with its
|
||||
labeling. Information regarding commercial production as specified in the terms and
|
||||
conditions of this registration must be included in the Technology Use Guide.
|
||||
MON 89034 x TC1507 can be used to protect corn plants from leaf, stalk, and ear
|
||||
damage caused by lepidopteran corn pests listed on this label.
|
||||
This plant-incorporated protectant (PIP) may be combined through conventional breeding
|
||||
with other registered PIPs that are similarly approved for use in combination, through
|
||||
conventional breeding, with other registered plant-incorporated protectants to produce
|
||||
inbred corn lines and hybrid corn varieties with combined pesticidal traits.
|
||||
INSECT RESISTANCE MANAGEMENT
|
||||
To help preserve the effectiveness of B.t. corn technologies, growers planting
|
||||
MON 89034 x TC1507 field corn are required to follow an Insect Resistance
|
||||
Management (IRM) Plan.
|
||||
These refuge requirements do not apply to seed increase/propagation of inbred and hybrid
|
||||
seed corn up to a total of 20,000 acres per c ounty and up to a combined United States
|
||||
(U.S.) total of 250,000 acres per PIP active ingredient per registrant per year.
|
||||
a) Corn-Belt/Non-Cotton-Growing Area Refuge Requirements
|
||||
For MON 89034 x TC1507 field corn grown outside the cotton-growing areas (e.g., the
|
||||
Corn Belt), grower guides must specify that growers must adhere to the following refuge
|
||||
requirements.
|
||||
Growers must plant a structured refuge of at least 5% corn, which is not a lepidopteran-
|
||||
protected B.t. corn hybrid. The refuge may be trea ted with insecticides, as described
|
||||
below, to control lepidopteran stalk-boring and other pests.
|
||||
Refuge planting options include : separate fields, blocks within fields (e.g., along the
|
||||
edges or headlands), and strips across the field.
|
||||
|
||||
External refuges must be planted within ½ mile. A schematic of on e refuge option with
|
||||
the refuge planted within a ½ mile of the MON 89034 × TC1507 field is shown below:
|
||||
When planting the refuge in stri ps across the field or as peri meter strips, refuges must be
|
||||
at least four (4) consecutive rows wide.
|
||||
Insecticide treatments for control of insects included on this label may be applied only if
|
||||
economic thresholds are reached for one or more of these targeted pests. Economic
|
||||
thresholds will be determined using methods recommended by local or regional
|
||||
professionals (e.g., Extension Se rvice agents or crop consul tants). Instructions to
|
||||
growers will specify that microbial B.t. insecticides must not be applied to non- B.t. corn
|
||||
refuges.
|
||||
b) Cotton-Growing Area Refuge Requirements
|
||||
For MON 89034 x TC1507 field corn grown in co tton-growing areas, as defined below,
|
||||
grower guides must specify that growers must adhere to the following refuge
|
||||
requirements.
|
||||
Growers must plant a structured refuge of at least 20% corn which is not a lepidopteran-
|
||||
protected B.t. corn hybrid. The refuge may be treated with insecticides, as detailed below,
|
||||
to control insects included on this label.
|
||||
Refuge planting options include : separate fields, blocks within fields (e.g., along the
|
||||
edges or headlands), perimeter strips, and strips across the field.
|
||||
MON 89034 ×
|
||||
TC1507 ч½ mile
|
||||
Refuge
|
||||
Non-Bt lepidopteran
|
||||
protected corn
|
||||
MON 89034 ×
|
||||
TC1507
|
||||
Refuge
|
||||
Non-Bt lepidopteran
|
||||
protected corn
|
||||
|
||||
External refuges must be planted within ½ mile. A schematic of on e refuge option with
|
||||
the refuge planted within a ½ mile of the MON 89034 field is shown below:
|
||||
When planting the refuge in st rips across the field, refuge s must be at least four (4)
|
||||
consecutive rows wide.
|
||||
Insecticide treatments for control of insects included on this label may be applied only if
|
||||
economic thresholds are reached for one or more of these targeted pests. Economic
|
||||
thresholds will be determined using methods recommended by local or regional
|
||||
professionals (e.g., Extension Service agents or crop consultants). Instructions to growers
|
||||
will specify that microbial B.t. insecticides must not be applied to non-B.t. corn refuges.
|
||||
Cotton-growing areas include the following states: Alabama, Arkansas, Georgia, Florida,
|
||||
Louisiana, North Carolina, Mississippi, Sout h 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, Hayw ood, Lake, Lauderdale, Lincoln, Madison,
|
||||
Obion, Rutherford, Shelby, and Tipton), Texas (except the counties of Carson, Dallam,
|
||||
Hansford, Hartley, Hutchinson, Lipscomb, Moor e, Ochiltree, Roberts, and Sherman),
|
||||
Virginia (only the counties of Dinwiddie, F ranklin City, Greensville, Isle of Wight,
|
||||
Northampton, Southampton, Suffolk City, Sur rey, and Sussex), and Missouri (only the
|
||||
counties of Dunklin, New Madrid, Pemiscot, Scott, and Stoddard).
|
||||
MON 89034 ×
|
||||
TC1507 òPLOH
|
||||
Refuge
|
||||
Non-Bt lepidopteran
|
||||
protected corn
|
||||
MON 89034 ×
|
||||
TC1507
|
||||
Refuge
|
||||
Non-Bt lepidopteran
|
||||
protected corn
|
||||
|
||||
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
|
||||
Sales of corn hybrids that contain Bayer’s B.t. corn plant-incorporated protectant must be
|
||||
accompanied by a grower guide which incl udes information on planting, production, and
|
||||
insect resistance management and notes that routine applications of insecticides to control
|
||||
these insects are usually unnecessary when corn containing the B.t. proteins is planted.
|
||||
MON 89034 × TC1507 is a product of Bayer’ s and Dow AgroSciences’ research
|
||||
programs, offering unique geneti c characteristics for specific grower needs and may be
|
||||
protected by one or more of the followin g U.S. patents that can be found at
|
||||
http://www.monsantotechnology.com
|
||||
Reference in New Issue
Block a user