a97107de46
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>
1223 lines
73 KiB
Markdown
1223 lines
73 KiB
Markdown
# MON 89034 X MON 88017
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- EPA Reg No: **524-576**
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- Registrant: BAYER CROPSCIENCE, LLC
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- Signal word: Caution
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- Active ingredients: Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary (vector ZMIR39) for its production in corn (0.007%); Bacillus thuringiensis Cry1A.105 protein and genetic material necessary (vector PV-ZMIR245) for its production in corn (0.0024%); Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary (vector PV-ZMIR245) for its production in corn (0.0057%)
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- Label accepted: 2019-03-07
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- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00576-20190307.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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March 7, 2019
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David Chi
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Regulatory Affairs Manager
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Monsanto Company
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800 North Lindberg Blvd.
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St. Louis, MO 63167
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Subject: Pesticide Registration Improvement Act (PRIA) Amendment – B900 Amendment to extend the
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expiration date of the registration, update the registration terms, remove sweet corn as a use, and
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remove alternate brand names from the product label.
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Product Name: MON 89034 x MON 88017
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EPA Registration Number: 524-576
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Submission Date: September 7, 2018
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OPP Decision Number: 544525
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Dear Mr. Chi:
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The amendment referenced above, submitted in connection with registration under Section 3(c)(7)(A) 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 December 31, 2020.
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2. Monsanto must adhere to the transition strategy detailed in its submission titled “Amended Phase Out
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Plan for MON 89034 x MON 88017 (VT Triple PRO®)” (dated September 7, 2018) (MRID: 506395-
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02).
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3. The subject registration will be limited to the subject registration will be limited to Bacillus
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thuringiensis Cry1A.105 and Cry2Ab2 proteins and the genetic material necessary for their production
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(vector PVZMIR245) in MON 89034 corn (OECD Unique Identifier: MON-8934-3 x MON-8817-
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3) and Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production
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(vector PV-ZMIR39) in MON 88017 corn (OECD Unique Identifier: MON-8934-3 x MON-8817-3)
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for use in field corn.
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4. Submit and/or cite all data required for registration or registration review of MON 89034 x MON 88017
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when the EPA requires all registrants of similar products to submit such data.
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5. 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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Page 2 of 20
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EPA Reg. No. 524‐576
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OPP Decision No. 544525
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6. Monsanto must commit to do the following Insect Resistance Management (IRM) Program, consisting
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of the following elements:
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Requirements for Monsanto to implement an IPM-based stewardship program designed to
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reduce selection pressure for corn rootworm (CRW) resistance.
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Requirements relating to creation of a refuge for the Cry3Bb1, Cry1A.105, and Cry2Ab2
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components that meets the requirements of the individual traits. The refuge for both traits may
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be combined by planting non-Bacillus thuringiensis (Bt) corn as the refuge, or the refuge for
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each trait may be planted separately. In the latter case, corn rootworm-resistant Bt corn may be
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planted in the lepidopteran refuge for the Cry1A.105 and Cry2Ab2 components, and
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lepidopteran-resistant Bt corn may be planted in the corn rootworm refuge for the Cry3Bb1
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component.
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Requirements for Monsanto to prepare and require MON 89034 x MON 88017 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 Monsanto 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 Monsanto to develop, implement, and report to EPA on programs to evaluate
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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 and 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 and/or Cry2Ab2 was detected, as well as to report on activity under
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the plan to EPA.
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Requirements for Monsanto to investigate reports of unexpected CRW damage to MON 89034
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x MON 88017 from growers (“performance inquiries”) and sample CRW to determine if the
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insects are resistant to Cry3Bb1.
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Requirements for Monsanto to recommend CRW management options to growers in response
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to cases of unexpected CRW damage to MON 89034 x MON 88017.
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Requirements regarding mitigation and notification actions that Monsanto would take in
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the event that CRW resistance is detected.
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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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Page 3 of 20
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EPA Reg. No. 524‐576
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OPP Decision No. 544525
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Bag Tag Requirements for MON 89034 x MON 88017. Seed bags and/or bag tags for corn
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hybrids that contain plant- incorporated protectants produced in MON 89034 x MON 88017
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must display the registration number and active ingredients, and stipulate that growers read the
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Monsanto Stewardship Guide (or equivalent guidance) prior to planting these hybrids. The
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refuge size requirement must be displayed on the bag or bag tag in both text and graphic
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format.
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Requirements for Monsanto, on or before August 31st of each year, to submit reports on
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Cry1A.105 and Cry2Ab2 resistance monitoring.
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a. Integrated Pest Management Stewardship Program
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1. Monsanto must implement an IPM-based stewardship program for MON 89034 x MON 88017. This
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program must be designed to reduce selection pressure for corn rootworm (CRW) resistance by encouraging
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growers to engage in a multi-year crop rotation strategy involving the use of one or more of the following: a
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non-CRW host crop (e.g., soybean), pyramided Bt corn Plant Incorporated Protectants (PIPs), other PIP
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corn products with different modes of action, and/or non-Bt or non-CRW protected Bt corn. As part of the
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stewardship program, Monsanto must update the technology use guide/grower guide and other grower
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educational materials to indicate that application of an insecticide to the soil surface, in furrows, and/or
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incorporated into the soil (referred to as “soil applied insecticide”, “soil insecticide” or “SAI”) with MON
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89034 x MON 88017 is not recommended for control of CRW except under limited circumstances and in
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consultation with extension, crop consultants or other local experts. As part of the stewardship program,
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Monsanto must promote the ABSTC/NCGA Best Management Practices (BMPs) for CRW control.
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Implementation of the IPM strategy can include:
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Grower education initiatives or incentives.
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Outreach to extension and consultant groups.
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2. Monsanto must submit an annual report to EPA documenting activities conducted under the IPM
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stewardship program. This report must include an anonymous survey of grower practices, including
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adoption levels of the various crop rotation options (if employed) and other elements of the stewardship
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program. Monsanto may combine this product with other registered products to submit one annual report.
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The report must be submitted by January 31
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st each year.
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b. Refuge Requirements for MON 89034 x MON 88017
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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.
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Grower agreements (also known as stewardship agreements) will specify that growers must adhere to the refuge
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requirements as described in the grower guide/product use guide and/or in supplements to the grower
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guide/product use guide.
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1) Corn-Belt Refuge Requirements
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For MON 89034 x MON 88017 grown outside cotton-growing areas (e.g., the Corn Belt), grower agreements
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(also known as stewardship agreements) will specify that growers must adhere to the refuge requirements as
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Page 4 of 20
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EPA Reg. No. 524‐576
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OPP Decision No. 544525
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described in the grower guide/product use guide and/or in supplements to the grower guide/product use guide.
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Two options for the deployment of the refuge are available to growers.
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The first option is planting a common refuge for both corn borers and corn rootworms. The common refuge
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must be planted with corn hybrids that do not contain Bt technologies for the control of corn rootworms or corn
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borers. The refuge area must represent at least 20% of the grower’s corn acres (i.e., sum of MON 89034 x MON
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88017 acres and refuge acres). It must be planted as a block adjacent to the MON 89034 x MON 88017 field,
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perimeter strips, or in-field strips. If perimeter or in-field strips are implemented, the strips must be at least 4
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consecutive rows wide. The common refuge may be treated with a soil-applied or seed-applied insecticide to
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control rootworm larvae and other soil pests. The refuge may also be treated with a non-Bt foliar insecticide for
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control of late season pests if pest pressure reaches an economic threshold for damage (determined using
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methods recommended by local or regional professionals); however, if rootworm adults are present at the time
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of foliar applications, then the MON 89034 x MON 88017 field must be treated in a similar manner.
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The second option is planting separate refuge areas for corn borers and corn rootworms. The corn borer refuge
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must be planted with a non-Bt/lepidopteran-protected hybrid, must represent at least 5% of the grower’s corn
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acres (i.e. sum of MON 89034 x MON 88017 acres and corn borer refuge acres), and must be planted within ½
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mile of the MON 89034 x MON 88017 field. Refuge planting options include: separate fields, blocks within
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fields (e.g., along the edges or headlands), perimeter strips, or in-field strips. If perimeter or in-field strips are
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implemented, the strips must be at least 4 consecutive rows wide. The corn borer refuge may be treated with a
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soil-applied or seed-applied insecticide for corn rootworm larval control or a non-Bt foliar-applied insecticide
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for corn borer control if pest pressure reaches an economic threshold for damage (determined using methods
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recommended by local or regional professionals). The corn rootworm refuge must be planted with a non-Bt/corn
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rootworm-protected hybrid but may be planted with Bt corn hybrids that control corn borers. The corn
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rootworm refuge must represent at least 20% of the grower’s corn acres (i.e. sum of MON 89034 x MON 88017
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acres and corn rootworm refuge acres) and must be planted as an adjacent block, perimeter strips, or in-field
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strips. If perimeter or in-field strips are implemented, the strips must be at least 4 consecutive rows wide. The
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corn rootworm refuge may be treated with a soil-applied or seed- applied insecticide to control rootworm larvae
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and other soil pests. The refuge may also be treated with a non-Bt foliar insecticide for control of late season
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pests; however, if rootworm adults are present at the time of foliar applications, then the MON 89034 x MON
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88017 field must be treated in a similar manner.
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2) Cotton-Growing Area Refuge Requirements
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For MON 89034 x MON 88017 grown in cotton-growing areas, 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 grower
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guide/product use guide and/or in supplements to the grower guide/product use guide.
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Cotton-growing areas include the following states: Alabama, Arkansas, Georgia, Florida, Louisiana, North
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Carolina, Mississippi, South Carolina, Oklahoma (only the counties of Beckham, Caddo, Comanche, Custer,
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Greer, Harmon, Jackson, Kay, Kiowa, Tillman, Washita), Tennessee (only the counties of Carroll, Chester,
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Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Haywood, Lake, Lauderdale, Lincoln, Madison,
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Obion, Rutherford, 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 Dinwiddie,
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Franklin City, Greensville, Isle of Wight, Northampton, Southampton, Suffolk City, Surrey, Sussex), and
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Missouri (only the counties of Dunklin, New Madrid, Pemiscot, Scott, and Stoddard).
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Two options for the deployment of the refuge are available to growers.
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Page 5 of 20
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EPA Reg. No. 524‐576
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OPP Decision No. 544525
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The first option is planting a common refuge for both corn borers and corn rootworms. The common refuge
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must be planted with corn hybrids that do not contain Bt technologies for the control of corn rootworms or corn
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borers. The refuge area must represent at least 20% of the grower’s corn acres (i.e. sum of MON 89034 x MON
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88017 acres and refuge acres). It must be planted as a block adjacent to the MON 89034 x MON 88017 field,
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perimeter strips, or in-field strips. If perimeter or in-field strips are implemented, the strips must be at least 4
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consecutive rows wide. The common refuge may be treated with a soil-applied or seed-applied insecticide to
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control rootworm larvae and other soil pests. The refuge may also be treated with a non-Bt foliar insecticide for
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control of late season pests if pest pressure reaches an economic threshold for damage (determined using
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||
methods recommended by local or regional professionals); however, if rootworm adults are present at the time
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of foliar applications, then the MON 89034 x MON 88017 field must be treated in a similar manner.
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The second option is planting separate refuge areas for corn borers and corn rootworms. The corn borer refuge
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||
must be planted with a non-Bt/lepidopteran-protected hybrid, must represent at least 20% of the grower’s corn
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acres (i.e. sum of MON 89034 x MON 88017 acres and corn borer refuge acres), and must be planted within ½
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mile of the MON 89034 x MON 88017 field.
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Refuge planting options include: separate fields, blocks within fields (e.g., along the edges or headlands),
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perimeter strips, or in-field strips. If perimeter or in-field strips are implemented, the strips must be at least 4
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consecutive rows wide. The corn borer refuge may be treated with a soil- applied or seed-applied insecticide for
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corn rootworm larval control or a non-Bt foliar-applied insecticide for corn borer control if pest pressure reaches
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an economic threshold for damage (determined using methods recommended by local or regional
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professionals). The corn rootworm refuge must be planted with a non-Bt/corn rootworm-protected hybrid but
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may be planted with Bt corn hybrids that control corn borers. The corn rootworm refuge must represent at least
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20% of the grower’s corn acres (i.e. sum of MON 89034 x MON 88017 acres and corn rootworm refuge acres)
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and must be planted as an adjacent block, perimeter strips, or in-field strips. If perimeter or in-field strips are
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implemented, the strips must be at least 4 consecutive rows wide. The corn rootworm refuge may be treated
|
||
with a soil-applied or seed-applied insecticide to control rootworm larvae and other soil pests. The refuge may
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also be treated with a non-Bt foliar insecticide for control of late season pests; however, if rootworm adults are
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present at the time of foliar applications then the MON 89034 x MON 88017 field must be treated in a similar
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manner.
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c. Grower Agreements for MON 89034 x MON 88017
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1. Persons purchasing MON 89034 x MON 88017 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 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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MON 88017 will affirm annually that they are contractually bound to comply with the requirements of the
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IRM program.
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4. Monsanto must continue to use its current grower agreement for MON 89034 x MON 88017. If Monsanto
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wishes to change any part of the grower agreement or any specific stewardship documents referenced in
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the grower agreement that would affect either the content of the IRM program or the legal enforceability of
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the provisions of the agreement relating to the IRM program, then thirty (30) days prior to implementing a
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Page 6 of 20
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EPA Reg. No. 524‐576
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OPP Decision No. 544525
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proposed change, Monsanto must submit to EPA the text of such changes to ensure that it is consistent
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with the terms and conditions of this amended registration.
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5. Monsanto shall maintain records of all MON 89034 x MON 88017 grower agreements for a period of three
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(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 MON 88017 seed sold or shipped and not returned, and the number of such units that were sold to
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persons who have signed grower agreements for the previous growing season. Monsanto is required to
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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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d. IRM Education and IRM Compliance Monitoring Program for MON 89034 x MON 88017
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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 MON 88017 users the importance
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of complying with the IRM program and guidance to growers on actions to take when unexpected damage
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occurs. The program shall include information encouraging MON 89034 x MON 88017 users to pursue
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optional elements of the IRM program relating to refuge configuration and proximity to MON 89034 x
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MON 88017 fields. The education program shall involve the use of multiple media, e.g. face-to-face
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meetings, mailing written materials, EPA-reviewed language on IRM requirements on the bag or bag tag,
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and electronic communications such as by internet, radio, or television commercials. The program shall
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involve at least one written communication annually to each MON 89034 x MON 88017 user separate
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from the grower technical guide. The communication shall inform the user of the current IRM
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requirements. Monsanto 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 extension
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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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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
|
||
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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|
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4. Monsanto must implement and improve an ongoing IRM compliance assurance program designed to
|
||
evaluate the extent to which growers purchasing MON 89034 x MON 88017 are compliant with the
|
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requirement of a 20% refuge for lepidopteran pests in cotton growing areas, and that takes such actions as
|
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are reasonably needed to assure that growers who have not complied with the program either do so in the
|
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future or lose their access to Monsanto’s Bt corn products. Monsanto shall coordinate with other Bt corn
|
||
|
||
Page 7 of 20
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EPA Reg. No. 524‐576
|
||
OPP Decision No. 544525
|
||
registrants in improving its compliance assurance program and integrate this registration into the current
|
||
compliance assurance program used for its other Bt corn plant-incorporated protectants. Other required
|
||
features of the program are described in paragraphs 5–22 of this section.
|
||
|
||
5. Monsanto must maintain and publicize a phased compliance approach (i.e., a guidance document that
|
||
indicates how it will address instances of non-compliance with the terms of the IRM program and general
|
||
criteria for choosing among options for responding to any non-compliant growers after the first year of
|
||
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
|
||
non-compliance. An individual grower found to be significantly out of compliance two (2) years in a row
|
||
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
|
||
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
|
||
party, of a statistically representative sample of growers MON 89034 x MON 88017. The survey shall be
|
||
conducted in odd-numbered years beginning in 2019 and shall include growers who plant 100 or more
|
||
acres of corn in the Southern U.S. corn-cotton areas. Monsanto may collaborate with other registrants of Bt
|
||
corn [for example, through the industry working group the Agricultural Biotechnology Stewardship
|
||
Technical Committee (ABSTC)] to conduct the survey.
|
||
|
||
In the U.S. Corn Belt, no anonymous grower survey is required for MON 89034 x MON 88017 if
|
||
Monsanto can demonstrate that the industry-wide adoption of integrated refuge products (i.e., refuge seed
|
||
blends) is equal to or greater than 70% of Bt corn acres in the Corn Belt. If industry- wide adoption of
|
||
integrated refuge products (i.e., refuge seed blends) falls below 70% of Bt corn acres in the Corn Belt, an
|
||
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 grower surveys
|
||
shall be continued every odd-numbered year until the industry-wide adoption of integrated refuge products
|
||
(i.e., refuge seed blends) is again equal to or greater than 70% of Bt corn acres in this region. Monsanto
|
||
may collaborate with other registrants of Bt corn (for example, through the industry working group the
|
||
ABSTC) to compile the integrated refuge adoption data and to conduct the surveys.
|
||
|
||
Alternatively, if Monsanto is not a participant of an industry working group (e.g., the ABSTC) and
|
||
Monsanto’s sales of integrated refuge products are equal to or greater than 70% of Monsanto’s total Bt corn
|
||
sales in the prior year, then no anonymous grower survey is required in the U.S. Corn Belt. If Monsanto’s
|
||
sales of integrated refuge products fall below 70% of Monsanto’s total Bt corn sales, an 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 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 Monsanto’s total Bt corn sales in this region.
|
||
|
||
A third party is classified as a party other than the registrant, the grower, or anyone else with a
|
||
direct interest in IRM compliance for Bt corn.
|
||
|
||
7. The survey shall be designed to provide an understanding of any difficulties growers encounter in
|
||
implementing IRM requirements. An analysis of survey results must include the reasons, extent, and
|
||
potential biological significance of any implementation deviations.
|
||
|
||
8. The survey shall be designed to obtain grower feedback on the usefulness of specific educational tools and
|
||
|
||
Page 8 of 20
|
||
EPA Reg. No. 524‐576
|
||
OPP Decision No. 544525
|
||
initiatives.
|
||
|
||
9. In years in which the survey is conducted, Monsanto shall provide a final written summary of the results of
|
||
the survey (together with a description of the regions, the methodology used, and the supporting data) to
|
||
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.
|
||
|
||
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
|
||
from other sources. The changes shall address aspects of grower compliance that are not sufficiently high.
|
||
Monsanto must confer with EPA prior to adopting any changes.
|
||
|
||
11. Monsanto shall conduct and enhance an annual on-farm assessment program. Monsanto shall train its
|
||
representatives who make on-farm visits with MON 89034 x MON 88017 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
|
||
MON 88017 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 MON 88017 for planting, was specifically identified as not
|
||
being in compliance during the previous year, Monsanto shall visit with the grower and evaluate whether
|
||
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 MON 88017 compliance assurance program activities and results for the prior year and plans for
|
||
the MON 89034 x MON 88017 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. Monsanto may elect to
|
||
coordinate information with other registrants and report collectively the results of compliance assurance
|
||
programs.
|
||
|
||
15. Monsanto and the seed corn dealers for Monsanto must allow a review of the compliance records by EPA
|
||
or by a State 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
|
||
|
||
Page 9 of 20
|
||
EPA Reg. No. 524‐576
|
||
OPP Decision No. 544525
|
||
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 MON 88017 seed sold
|
||
and delivered. 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 MON 88017 is used.
|
||
|
||
19. Monsanto will use its available MON 89034 x MON 88017 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 MON 88017 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 MON 88017 product
|
||
to reflect the adoption rate and level of refuge compliance for the product.
|
||
|
||
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.
|
||
|
||
Page 10 of 20
|
||
EPA Reg. No. 524‐576
|
||
OPP Decision No. 544525
|
||
e. Insect Resistance Monitoring and Mitigation Plan for MON 89034 x MON 88017
|
||
|
||
1. EPA is imposing the following conditions for the Cry1A.105 and Cry2Ab2 toxins expressed in
|
||
MON 89034 x MON 88017
|
||
|
||
Monsanto must monitor for resistance to Cry1A.105 and Cry2Ab2 expressed in MON 89034 x MON 88017.
|
||
|
||
The monitoring program shall consist of two approaches: (1) focused population sampling and laboratory
|
||
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 MON 88017 and/or changes in resistance allele frequency in response to the use of MON 89034 x
|
||
MON 88017 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 MON 88017. 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 and/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
|
||
|
||
Page 11 of 20
|
||
EPA Reg. No. 524‐576
|
||
OPP Decision No. 544525
|
||
following:
|
||
|
||
1. Re-test progeny of the collected population to determine whether the unusual bioassay
|
||
response is reproducible and heritable. If it is not reproducible and heritable, no further action
|
||
is required.
|
||
|
||
2. If the unusual response is reproducible and heritable, progeny of insects that survive the
|
||
diagnostic concentration will be tested using methods that are representative of exposure to
|
||
MON 89034 x MON 88017 under field conditions. If progeny do not survive to adulthood,
|
||
any suspected resistance is not field relevant and no further action is required.
|
||
|
||
3. If insects survive steps 1 and 2, resistance is confirmed, and further steps will be taken to
|
||
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,
|
||
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
|
||
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
|
||
|
||
Page 12 of 20
|
||
EPA Reg. No. 524‐576
|
||
OPP Decision No. 544525
|
||
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 MON 88017 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 MON 88017 fields in the affected region to
|
||
control the target pest during the immediate growing season.
|
||
|
||
Destroy MON 89034 x MON 88017 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).
|
||
|
||
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 LC
|
||
50 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;
|
||
|
||
Page 13 of 20
|
||
EPA Reg. No. 524‐576
|
||
OPP Decision No. 544525
|
||
|
||
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.
|
||
|
||
2. EPA is imposing the following conditions for the Cry3Bb1 toxin expressed in MON 89034 x MON
|
||
88017:
|
||
a) Investigation of Reports of Unexpected Levels of Damage (UXD) by Corn Rootworm (CRW):
|
||
Performance Inquiries
|
||
|
||
(1) Monsanto is required to investigate "performance inquiries" (i.e., reports of unexpected CRW
|
||
damage to MON 89034 x MON 88017) from growers. Fields (defined as a tract separated by
|
||
permanent boundaries such as fences, permanent waterways, woodlands, croplines not subject
|
||
to change because of farming practices, or other similar features) with unexpected damage that
|
||
meet both of the criteria below must be subjected to the follow-up actions in part 2) below:
|
||
|
||
a. The affected plants are confirmed to be MON 89034 x MON 88017 plants (take leaf
|
||
samples to determine the presence of the CRW-active Bt protein); and
|
||
|
||
b. Corn rootworm feeding caused root damage with a Node Injury Score (NIS) > 1.0 on
|
||
|
||
Page 14 of 20
|
||
EPA Reg. No. 524‐576
|
||
OPP Decision No. 544525
|
||
at least 50% of plants surveyed in a transect sampling of the damaged site(s) within the
|
||
field.
|
||
|
||
(2) Follow-up actions (performance inquiries). For MON 89034 x MON 88017 fields meeting the
|
||
criteria in part 1) above, Monsanto must take the following actions:
|
||
|
||
a. Collect at least 250 (ideally 500 or more) CRW adult individuals from the damaged
|
||
site within the field in question. Collections may be extended to the whole field, if
|
||
necessary to obtain sufficient CRW adult individuals. Collected populations must be
|
||
subjected to the steps described for "investigation of populations of concern" in section
|
||
e(2)(b) below.
|
||
|
||
o If collections are unsuccessful, visit affected farm or field the following year
|
||
(assuming the grower continues to be a customer and repurchases seed and does
|
||
not rotate the field to a non-host crop) and attempt to collect CRW adults. If beetles
|
||
are not present the subsequent year, see section e(2)(b)(3)(c) below.
|
||
|
||
b. Review with the grower their CRW management practices and provide CRW
|
||
management recommendations including an assessment of corn fields with similar
|
||
trait(s) adjacent to the affected corn field that are managed by the same grower.
|
||
|
||
c. Use of single trait products containing the CRW traits in MON 89034 x MON 88017
|
||
in fields with unexpected damage in previous years should be discouraged.
|
||
Recommended management options include, but are not limited to, the following:
|
||
|
||
o Primary option:
|
||
|
||
• Rotation to non-host crop (e.g., soybean)
|
||
|
||
o Secondary options:
|
||
|
||
• Use of pyramided Bt corn products one or more different CRW PIP trait(s)
|
||
|
||
• Use of different single-CRW PIP traits (i.e., an alternative CRW-active PIP)
|
||
|
||
• Use of non-Bt or non-CRW protected corn
|
||
|
||
o Tertiary options:
|
||
|
||
• If additional pest management need is determined beyond the sec
|
||
ondary
|
||
options listed above, additional corn rootworm control tools (e.g., soil
|
||
insecticides, seed-applied insecticides, chemigation) should be used.
|
||
|
||
d. If field(s) with UXD is/are planted to a non-host crop (e.g., soybean) the following
|
||
year, then the area will be considered “mitigated” (as discussed in section e(2)(b)(3)(d)
|
||
below) even if subsequent bioassay results show that the population was resistant. No
|
||
further action will be required by Monsanto for the UXD case.
|
||
|
||
(3) Monsanto must submit an annual report to EPA detailing activities related to investigations of
|
||
|
||
Page 15 of 20
|
||
EPA Reg. No. 524‐576
|
||
OPP Decision No. 544525
|
||
unexpected damage (UXD). This report will include the information from the most recent and
|
||
previous corn growing seasons:
|
||
|
||
a. Information from the most recent season:
|
||
|
||
o The number of UXD reports investigated.
|
||
|
||
o Location (by county and state).
|
||
|
||
o CRW sampling (number and location of populations collected).
|
||
|
||
b. Information from the previous season:
|
||
|
||
o The final disposition of UXD fields from the previous season (i.e., the management
|
||
practices employed in response to UXD if the grower continues to be a customer.
|
||
|
||
o Results from bioassays conducted on CRW populations from UXD fields where the
|
||
primary management option, rotation to non-host crop, was not used.
|
||
|
||
c. Grower information, such as farm addresses or other personally identifiable information,
|
||
or other sensitive business/customer information must not be included in this report. This
|
||
report must be submitted by November 30th each year.
|
||
|
||
b) Investigation of Population of Concern
|
||
|
||
1. Monsanto must conduct investigations of all CRW populations collected as part of the performance
|
||
inquiry process in section e(2)(a) above. These investigations must include the use of an EPA-approved
|
||
bioassay to determine if sampled CRW populations are resistant to Cry3Bb1. Acceptable assays must be
|
||
able to function as diagnostic tools capable of distinguishing resistant populations from susceptible ones.
|
||
Unless previously approved, Monsanto must consult with EPA on their bioassay prior to its use.
|
||
|
||
2. A CRW population will be considered by EPA to be resistant to a CRW PIP toxin if the following
|
||
criteria are met and additional collections and testing are not deemed to be necessary (based on part 3)
|
||
below):
|
||
|
||
a. An initial performance inquiry investigation results in a finding of Unexpected Damage; and
|
||
|
||
b. Where green tissues are available and if plants are unusually stressed due to agronomic and/or
|
||
environmental factors, Bt protein levels in affected plants are found to be within the
|
||
documented range for that hybrid (if data are available); and
|
||
|
||
c. Either (A): On-plant bioassays of insect collections from the UXD fields result in the
|
||
following two statistically relevant comparisons
|
||
|
||
i. A statistically significant difference in measures of either mortality or sublethal effects
|
||
(growth/development) between the field population and a relevant susceptible control
|
||
population (i.e., one that responds as a typical susceptible field population) on Bt corn
|
||
containing the single PIP and/or lack of a statistically significant difference in measures
|
||
|
||
Page 16 of 20
|
||
EPA Reg. No. 524‐576
|
||
OPP Decision No. 544525
|
||
of mortality or sublethal effect between the field population and a resistant positive
|
||
control population1; and
|
||
|
||
ii. A lack of a statistically significant difference in the same measures of the field population
|
||
raised on Bt corn containing the single PIP and non-Bt corn plants.
|
||
|
||
Or (B): Sublethal seedling bioassay of insect collections from the UXD fields result in two
|
||
statistically relevant comparisons
|
||
|
||
i. A statistically significant difference in measures of sublethal effects
|
||
(growth/development) for populations on Bt corn containing the single PIP (normalized
|
||
using non-Bt) seedlings between the field population and a relevant susceptible control
|
||
population where available or historical field populations and/or lack of a statistically
|
||
significant difference in measures between the field population and a resistant positive
|
||
control population
|
||
1; and
|
||
|
||
ii. A lack of a statistically significant difference in the same measures of the field population
|
||
raised on Bt corn seedlings containing the single PIP and non-Bt corn seedlings
|
||
|
||
Or (C): Diet-based bioassays of insect collections from the UXD fields result in two
|
||
statistically relevant comparisons
|
||
|
||
i. A statistically significant difference in measures of lethal or sublethal effects
|
||
(growth/development) on diet containing the Bt protein (diagnostic concentration or
|
||
concentration-response measures) between the field population and a relevant
|
||
susceptible control population where available or historical field populations and/or
|
||
lack of a statistically significant difference in measures between field population and a
|
||
resistant positive control population
|
||
1; and
|
||
|
||
ii. Either a lack of a statistically significant difference in the same measures of the field
|
||
population exposed to diet containing the Bt protein (diagnostic concentration) and diet
|
||
not containing the Bt protein and/or lack of a statistically significant difference in
|
||
measures between the field population and a resistant positive control population, or
|
||
lack of a statistically significant concentration and/or lack of a statistically significant
|
||
difference in concentration response between the field and a resistant positive control
|
||
population1.
|
||
|
||
3. Mitigation, as detailed in section e(2)(c) below, is required for any CRW population that meets EPA’s
|
||
resistance criteria above for any of the CRW traits in MON 89034 x MON 88017, unless the
|
||
circumstances described below are applicable.
|
||
|
||
a. To minimize the potential for incorrectly reaching a conclusion of resistance, another year of
|
||
CRW adult collections and additional testing is needed to determine resistance if:
|
||
|
||
i. The results of the bioassays are inconclusive (e.g., the results of the statistical analysis are
|
||
unclear because of low sample sizes) or
|
||
|
||
|
||
1 If a resistant positive control population is not available or accessible, Monsanto must consult with EPA prior to initiating bioassays
|
||
and work to develop an appropriate resistant positive control population.
|
||
|
||
Page 17 of 20
|
||
EPA Reg. No. 524‐576
|
||
OPP Decision No. 544525
|
||
ii. Another reasonable explanation for the unexpected damage exists (e.g., high pest pressure
|
||
and/or high plant stress).
|
||
|
||
b. In these cases, Monsanto and EPA will discuss and align on next steps before reaching any
|
||
resistance conclusion.
|
||
|
||
c. If CRW collections are not possible in the current year or subsequent year due to successful
|
||
management practices, then no further investigation is needed. The population would be
|
||
considered "mitigated" meaning, in this case, that the population is suppressed or extirpated for
|
||
the UXD field. However, EPA recommends that Monsanto continue to be vigilant in areas where
|
||
CRW populations were successfully mitigated.
|
||
|
||
d. If a UXD field receives non-host crop (e.g., soybean) rotation the following year as described in
|
||
Section e(2)(a)(2) above, no additional mitigation is subsequently required.
|
||
|
||
c) Mitigation of CRW Populations Meeting EPA’s Resistance Criteria
|
||
|
||
1. For any CRW population found to be resistant to the Cry3Bb1 trait in MON 89034 x MON 88017 under
|
||
EPA’s criteria described in section e(2)(b) above, Monsanto must take the following steps:
|
||
|
||
a) Monsanto must inform EPA of all the results of the bioassays as soon as possible, but at least
|
||
within 30 days if measures are triggered.
|
||
|
||
b) The mitigation action area (MAA) is defined as the growers’ farming operation up to a ½ mile
|
||
radius from the damaged site that produced the resistant population.
|
||
|
||
c) Within 30 days of informing EPA of the results of the bioassays, Monsanto must notify state
|
||
extension agents and crop consultants who operate within the county in which resistance was
|
||
identified. Information shared must include identification of the county in which resistance was
|
||
detected and trait(s) affected.
|
||
|
||
d) Within the MAA, Monsanto must do the following:
|
||
|
||
i. Prior to finalizing the grower’s seed order for the following season, inform the affected
|
||
grower and other registrants that hold registrations containing the compromised trait(s).
|
||
Monsanto must also inform neighboring growers if those growers are customers of
|
||
Monsanto. Information shared must include identification of the county in which
|
||
resistance was detected and trait(s) affected;
|
||
|
||
ii. Discontinue sales/planting of products containing the compromised trait(s) without
|
||
additional/alternative (i.e. non-compromised) CRW traits until resistance has been
|
||
demonstrated to have been mitigated. Other Bt registrants selling such products in the
|
||
MAA are encouraged, but cannot be required, to follow suit;
|
||
|
||
iii. Monsanto must monitor the resistant population in the MAA, as long as grower remains a
|
||
customer of the company, until mitigation has been demonstrated as described in part e
|
||
below unless otherwise agreed with EPA.
|
||
|
||
iv. Require any pyramids sold by Monsanto containing the compromised trait(s) be planted
|
||
with a 20% refuge until resistance has been demonstrated to have been mitigated. Other
|
||
|
||
Page 18 of 20
|
||
EPA Reg. No. 524‐576
|
||
OPP Decision No. 544525
|
||
Bt corn registrants selling such pyramided products in the MAA are encouraged, but
|
||
cannot be required by this term of registration, to follow suit;
|
||
|
||
v. For Monsanto’s affected customer’s field(s), the mitigation goal is to control the resistant
|
||
CRW population. Within the MAA Monsanto shall encourage the use of “Mitigation
|
||
Practices” including:
|
||
|
||
1. Primary option: Rotation to a non-host crop (e.g., soybean);
|
||
|
||
2. Secondary options:
|
||
a. Use of pyramided Bt corn products with different CRW PIP traits;
|
||
|
||
b. Use of different single-CRW PIP traits (i.e., an alternative CRW-active PIP);
|
||
|
||
c. Use of non-Bt corn or non-CRW protected corn (with/without soil-applied
|
||
insecticide);
|
||
|
||
3. Tertiary options:
|
||
|
||
a. If additional pest management need is determined beyond the secondary
|
||
options listed above, additional CRW control tools (e.g., soil insecticides,
|
||
seed-applied insecticides, chemigation) should be used.
|
||
|
||
b. Use of foliar applications to control adults (when appropriate economic
|
||
thresholds have been met) may be used in conjunction with one or more of
|
||
the above;
|
||
|
||
e) A resistant CRW population in the MAA will be considered mitigated if one of the following
|
||
criteria is met:
|
||
|
||
i. Corn fields within the MAA are rotated to a non-host crop (e.g. soybean) for one
|
||
growing season.
|
||
|
||
ii. After implementation of mitigation practices (part d.v above), resistance
|
||
monitoring (sampling) is conducted but few CRW are found (i.e., <0.1 adults per
|
||
plant) and environmental conditions (e.g., weather) are unlikely to be responsible
|
||
for the lack of adult CRW presence. If environmental conditions are a factor, then
|
||
monitoring should continue for another season.
|
||
|
||
iii. After implementation practices (part d.v above), resistance monitoring (sampling)
|
||
is conducted, CRW are found and collected, and bioassays (section e(2)(b)(2)
|
||
above) show that the population susceptibility to the compromis
|
||
ed trait(s) has
|
||
returned to baseline levels.
|
||
|
||
f) The mitigation actions in part d above can be lifted, and growers can resume the use of MON
|
||
89034 x MON 88017 as a primary tool for CRW management in the MAA, only when Monsanto
|
||
demonstrates that successful mitigation as described in part e above has been achieved.
|
||
|
||
2. Based on further research to understand CRW resistance to Bt PIPs, EPA will consider refinements to
|
||
the resistance mitigation program. Such research may include characterizing the genetics of resistance
|
||
|
||
Page 19 of 20
|
||
EPA Reg. No. 524‐576
|
||
OPP Decision No. 544525
|
||
(e.g., number of genes, functional dominance, mechanism of resistance, and cross-resistance) and the
|
||
biology of resistant insects (e.g., fitness in the presence and absence of the product), and other control
|
||
tactics.
|
||
|
||
f. Annual Reporting Requirements for MON 89034 x MON 88017
|
||
|
||
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 and Cry2Ab2 only): results of monitoring and
|
||
investigations of damage reports, August 31st of each year.
|
||
|
||
3. IPM Stewardship Program (Cry3Bb1 only): Activities conducted under the IPM stewardship program,
|
||
including an anonymous survey of grower practices, adoption levels of the various crop rotation options
|
||
(if employed) and other elements of the stewardship program, on or before January 31st of each year.
|
||
|
||
4. Unexpected Damage Investigations (Cry3Bb1 only): Activities related to investigations of unexpected
|
||
damage (UXD), including number and location of UXD cases, insect sampling, bioassays, and final
|
||
disposition of UXD fields from the most recent and previous corn growing seasons, on or before
|
||
November 30th 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.
|
||
|
||
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 July 2, 2013 is on file for this product.
|
||
|
||
Page 20 of 20
|
||
EPA Reg. No. 524‐576
|
||
OPP Decision No. 544525
|
||
|
||
If you have any questions, please contact Matthew Weiner by phone at (703) 347-0333 or by email at
|
||
weiner.matthew@epa.gov.
|
||
|
||
|
||
S i n c e r e l y ,
|
||
|
||
|
||
|
||
Alan Reynolds, Team Leader
|
||
E m e r g i n g T e c hnologies Branch
|
||
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 × MON 88017
|
||
|
||
|
||
(OECD Unique Identifier: MON-89Ø34-3 × MON 88Ø17-3)
|
||
|
||
Active Ingredients:
|
||
Bacillus thuringiensis Cry1A.105 protein and the genetic material necessary for its p roduction
|
||
(vector PV-ZMIR245) in MON 89034 × MON 88017 corn (OECD Unique Identifier: MON-
|
||
89Ø34-3 × MON-88Ø17-3) ........................................................................................... ≤ 0.0024%*
|
||
|
||
Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary for its pro duction
|
||
(vector PV-ZMIR245) in MON 89034 × MON 88017 corn (OECD Unique Identifier: MON-
|
||
89Ø34-3 × MON-88Ø17-3) ........................................................................................... ≤ 0.0057%*
|
||
|
||
Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its pro duction
|
||
(vector PV-ZMIR39) in MON 89034 × MON 88017 corn (OECD Unique I dentifier: MON-
|
||
89Ø34-3 × MON-88Ø17-3) .......................................................................................... ≤ 0.0070%*
|
||
|
||
Other Ingredient:
|
||
|
||
CP4 EPSPS protein (5-enolpyruvylshikimate-3-phosphate synthase) and genetic material
|
||
necessary for its production (vector PV-ZMIR39) in MON 89034 × MON 88017 corn (OECD
|
||
Unique Identifier: MON-89Ø34-3 × MON-88Ø17-3) .................................................. ≤ 0.0069%*
|
||
|
||
*Percentage (wt/wt) on a dry weight basis whole plant (forage)
|
||
|
||
KEEP OUT OF REACH OF CHILDREN
|
||
|
||
CAUTION
|
||
|
||
EPA Registration No. 524-576
|
||
EPA Establishment No. 524-MO-002
|
||
|
||
Monsanto Company
|
||
800 North Lindbergh Blvd.
|
||
St Louis, MO 63167
|
||
|
||
NET CONTENTS__________
|
||
|
||
|
||
|
||
|
||
|
||
|
||
03/07/2019
|
||
524-576
|
||
|
||
DIRECTIONS FOR USE
|
||
|
||
It is a violation of Federal law to use this product in any man ner inconsistent with this labeling. This
|
||
product must be used as specified in the terms and conditions of the registration.
|
||
|
||
MON 89034 × MON 88017 protects corn crops from leaf, stalk, and ear damage caused by corn borers
|
||
and root damage caused by corn rootworm larvae.
|
||
|
||
This plant-incorporated protectant (PIP) may be combined throug h conventional breeding with other
|
||
registered PIPs that are similarly approved for use in combinat ion, through conventional breeding, with
|
||
other registered PIPs to produce inbred corn lines and hybrid c orn varieties with combined pesticidal
|
||
traits.
|
||
|
||
1) Refuge Requirements for MON 89034 × MON 88017 Field Corn
|
||
|
||
In order to minimize the risk of corn borers and corn rootworms developing resistance to MON 89034 ×
|
||
MON 88017 corn, an insect resistance management (IRM) plan must be implemented which includes
|
||
planting of a structured refuge.
|
||
|
||
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 county and up to a combined United States (U.S.) total of 250,000 acres per
|
||
PIP active ingredient per registrant per year. Furthermore, th ese refuge requirements do not apply to
|
||
commercial hybrid sweet corn.
|
||
|
||
The refuge and MON 89034 × MON 88017 corn should be sown on the same day, or with the shortest
|
||
window possible between planting dates to ensure that corn root development is similar among varieties.
|
||
If the refuge is planted on rotated ground, then the MON 89034 × MON 88017 corn must also be planted
|
||
on rotated ground. If the combined refuge is planted on contin uous corn, then MON 89034 ×
|
||
MON 88017 may be planted on either continuous or rotated land ( option encouraged where WCRW
|
||
rotation resistant biotype may be present). Refuge options are based on the planting of MON 89034 ×
|
||
MON 88017 in cotton or non-cotton growing regions and the insect pressure present in those locations. If
|
||
insecticides are applied to the refuge for control of CRW adult s, the same treatment must also be applied
|
||
in the same timeframe to MON 89034 × MON 88017.
|
||
|
||
a) Corn-Belt/Non-Cotton Growing Area Refuge Requirements
|
||
|
||
For MON 89034 × MON 88017 field corn grown outside cotton-growi ng areas (e.g., the Corn Belt), two
|
||
options for deployment of the refuge are available to growers.
|
||
|
||
The first option is planting a common refuge for both corn borers and corn rootworms. The common
|
||
refuge must be planted with corn hybrids that do not contain Bt technologies for the control of corn borers
|
||
or corn rootworms. The refuge area must repres ent at least 20% of the grower’s corn acres ( i.e., sum of
|
||
MON 89034 × MON 88017 acres and refuge acres; refuge area must contain 20 acres of corn for every 80
|
||
acres of MON 89034 × MON 88017 corn planted). It must be plant ed as block within or adjacent ( e.g.,
|
||
across the road) to the MON 89034 × MON 88017 field, perimeter strips (i.e., strips around the field), or
|
||
in-field strips. If perimeter or in-field strips are implement ed, the strips must be at least four (4)
|
||
consecutive rows wide. The common refuge can be treated with a soil-applied or seed-applied insecticide
|
||
to control rootworm larvae and other soil pests. The refuge ca n also be treated with a non-Bt foliar
|
||
insecticide for the control of late season pests if pest pressu re reaches an economic threshold for damage;
|
||
however, if rootworm adults are present at the time of foliar a pplications then the MON 89034 ×
|
||
MON 88017 field (acres) must be treated in a similar manner. E conomic thresholds will be determined
|
||
|
||
using methods recommended by local or regional professionals ( e.g., Extension Service agents, crop
|
||
consultants, etc.
|
||
|
||
The second option is planting separate refuge areas ( e.g., two refuge areas, a double refuge, or paired
|
||
refuge areas) for corn borers and corn rootworms. Refuge plant ing options include: separate fields,
|
||
blocks within fields ( e.g., along the edges or headlands), perimeter strips, or in-field strips. If perimeter
|
||
or in-field strips are implemented, the strips must be at least 4 consecutive rows wide. The corn borer
|
||
refuge must be planted with corn that is not a lepidopteran-protected Bt hybrid, must represent at least 5%
|
||
of the grower’s corn acres, and must be planted within ½ mile of the MON 89034 × MON 88017 field.
|
||
The corn borer refuge can be treated with a soil-applied or see d-applied insecticide for corn rootworm
|
||
larval control, or a non-Bt foliar applied insecticide for corn borer control if pest pressure reaches an
|
||
economic threshold for damage. Economic thresholds will be det ermined using methods recommended
|
||
by local or regional professionals (e.g., Extension Service agents, crop consultants, etc.).
|
||
|
||
The corn rootworm refuge must be planted with corn that is not a corn rootworm-protected Bt hybrid, but
|
||
can be planted with Bt hybrids that control corn borers. The corn rootworm refuge must represent at least
|
||
20% of the grower’s corn acres ( i.e., corn rootworm refuge must contain 20 acres of corn for every 80
|
||
acres of MON 89034 × MON 88017 corn planted) and must be plante d as a block within or adjacent to
|
||
the MON 89034 × MON 88017 field, strips around the field, perim eter strips, or in-field strips. If
|
||
perimeter or in-field strips are implemented, the strips must b e at least four (4) consecutive rows wide.
|
||
The corn rootworm refuge can be treated with a soil-applied or seed-applied insecticide to control
|
||
rootworm larvae and other soil p ests. The refuge can also be t reated with a non-Bt foliar insecticide for
|
||
control of late season pests; however, if corn rootworm adults are present at the time of foliar applications
|
||
then the MON 89034 × MON 88017 field must be treated in a similar manner.
|
||
|
||
b) Cotton-Growing Area Refuge Requirements
|
||
|
||
Cotton-growing areas include the following states: Alabama, Ark ansas, Georgia, Florida, Louisiana,
|
||
North Carolina, Mississippi, South Carolina, Oklahoma (only the counties of Beckham, Caddo,
|
||
Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, Washita), Tennessee (only the
|
||
counties of Carroll, Chester, Crockett, Dyer, Fayette, Franklin , Gibson, Hardeman, Hardin, Haywood,
|
||
Lake, Lauderdale, Lincoln, Madison, ' Obion, Rutherford, Shelby, and Tipton), Texas (except the counties
|
||
of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, Moo re, Ochiltree, Roberts, and Sherman),
|
||
Virginia (only the counties of Dinwiddie, Franklin City, Greens ville, Isle of Wight, Northampton,
|
||
Southampton, Suffolk City, Surrey, Sussex), and Missouri (only the counties of Dunklin, New Madrid,
|
||
Pemiscot, Scott, Stoddard).
|
||
|
||
For MON 89034 × MON 88017 field corn grown in cotton growing ar eas of the U.S. the common refuge
|
||
and separate refuge options ( e.g., two-refuge options, double-refuge options, paired-refuge opti ons) are
|
||
available as specified below.
|
||
|
||
The first option is planting a common refuge for both corn borers and corn rootworms. The common
|
||
refuge must be planted with corn hybrids that do not contain Bt technologies for the control of corn borers
|
||
or corn rootworms. The refuge area must repr esent at least 20% of th e grower’s corn acres ( i.e., sum of
|
||
MON 89034 × MON 88017 acres and refuge acres; refuge area must contain 20 acres of corn for every 80
|
||
acres of MON 89034 × MON 88017 corn planted). It must be plant ed as block within or adjacent ( e.g.,
|
||
across the road) to the MON 89034 × MON 88017 field, perimeter strips (i.e., strips around the field), or
|
||
in-field strips. If perimeter or in-field strips are implement ed, the strips must be at least four (4)
|
||
consecutive rows wide. The common refuge can be treated with a soil-applied or seed-applied insecticide
|
||
to control rootworm larvae and other soil pests. The refuge ca n also be treated with a non-Bt foliar
|
||
|
||
insecticide for the control of late season pests if pest pressu re reaches an economic threshold for damage;
|
||
however, if rootworm adults are present at the time of foliar a pplications then the MON 89034 ×
|
||
MON 88017 field (acres) must be treated in a similar manner. E conomic thresholds will be determined
|
||
using methods recommended by local or regional professionals ( e.g., Extension Service agents, crop
|
||
consultants, etc.).
|
||
|
||
The second option is planting separate refuge areas ( e.g., two refuge areas, a double refuge, or paired
|
||
refuge areas) for corn borers and corn rootworms. Refuge plant ing options include: separate fields,
|
||
blocks within fields ( e.g., along the edges or headlands), perimeter strips, or in-field strips. If perimeter
|
||
or in-field strips are implemented, the strips must be at least 4 consecutive rows wide. The corn borer
|
||
refuge must be planted with corn that is not a lepidopteran-pro tected Bt hybrid, must represent at least
|
||
20% of the grower’s corn acres, and must be planted within ½ mile of the MON 89034 × MON 88017
|
||
field. The corn borer refuge can be treated with a soil-applie d or seed-applied insecticide for corn
|
||
rootworm larval control, or a non-Bt foliar applied insecticide for corn borer control if pest pressure
|
||
reaches an economic threshold for damage. Economic thresholds will be determined using methods
|
||
recommended by local or regional professionals (e.g., Extension Service agents, crop consultants, etc.).
|
||
|
||
The corn rootworm refuge must be planted with corn that is not a corn rootworm-protected Bt hybrid, but
|
||
can be planted with Bt hybrids that control corn borers. The corn rootworm refuge must represent at least
|
||
20% of the grower’s corn acres ( i.e., corn rootworm refuge must contain 20 acres of corn for every 80
|
||
acres of MON 89034 × MON 88017 corn planted) and must be plante d as a block within or adjacent to
|
||
the MON 89034 × MON 88017 field, perimeter strips, or in-field strips. If perimeter or in-field strips are
|
||
implemented, the strips must be at least four (4) consecutive r ows wide. The corn rootworm refuge can
|
||
be treated with a soil-applied or seed-applied insecticide to c ontrol rootworm larvae and other soil pests.
|
||
The refuge can also be treated with a non-Bt foliar insecticide for control of late season pests; however, if
|
||
corn rootworm adults are present at the time of foliar applicat ions then the MON 89034 × MON 88017
|
||
field must be treated in a similar manner.
|
||
|
||
Corn Insects Controlled or Suppressed
|
||
|
||
European corn borer Ostrinia nubilalis
|
||
Southwestern corn borer Diatraea grandiosella
|
||
Southern cornstalk borer Diatraea crambidoides
|
||
Corn earworm Helicoverpa zea
|
||
Fall armyworm Spodoptera frugiperda
|
||
Stalk borer Papaipema nebris
|
||
Lesser corn stalk borer Elasmopappus lignosellus
|
||
Sugarcane borer Diatraea saccharalis
|
||
|
||
Western corn rootworm Diabrotica virgifera virgifera
|
||
Northern corn rootworm Diabrotica barberi
|
||
Mexican corn rootworm Diabrotica virgifera zeae
|
||
|
||
Sales of corn hybrids that contain Monsanto’s Bt corn plant incorporated protectants must be
|
||
accompanied by either a Grower Guide or bag tag which includes information on planting, production and
|
||
insect resistance management.
|
||
|
||
MON 89034 × MON 88017 is a product of Monsanto’s research program 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.
|