By USDA APHIS BRS Document Control Officer at 2:18 Pm, Dec 11
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CBI Deleted EXECUTIVE SUMMARY The Animal and Plant Health Inspection Service (APHIS) of the United States (U.S.) Department of Agriculture (USDA) has responsibility under the Plant Protection Act (Title IV Pub. L. 106-224, 114 Stat. 438, 7 U.S.C. § 7701-7772) to prevent the introduction and dissemination of plant pests into the U.S. APHIS regulation 7 CFR § 340.6 provides that an applicant may petition APHIS to evaluate submitted data to determine that a particular regulated article does not present a plant pest risk and no longer should be regulated. If APHIS determines that the regulated article does not present a plant pest risk, the petition is granted, thereby allowing unrestricted introduction of the article. Monsanto Company is submitting this request to APHIS for a determination of nonregulated status for the new biotechnology-derived maize product, MON 87429, any progeny derived from crosses between MON 87429 and conventional maize, and any progeny derived from crosses of MON 87429 with biotechnology-derived maize that have previously been granted nonregulated status under 7 CFR Part 340. Product Description Monsanto Company has developed herbicide tolerant MON 87429 maize, which is tolerant to the herbicides dicamba, glufosinate, aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase (ACCase) inhibitors (so called “FOPs” herbicides such as quizalofop) and 2,4-dichlorophenoxyacetic acid (2,4-D). In addition, it provides tissue-specific glyphosate tolerance to facilitate the production of hybrid maize seeds. MON 87429 contains a demethylase gene from Stenotrophomonas maltophilia that expresses a dicamba mono-oxygenase (DMO) protein to confer tolerance to dicamba herbicide, the phosphinothricin-N-acetyltransferase (pat) gene from Streptomyces viridochromogenes that expresses the PAT protein to confer tolerance to glufosinate herbicide and the ft_t gene, a modified version of the R-2,4-dichlorophenoxypropionate dioxygenase (Rdpa) gene from Sphingobium herbicidovorans, that expresses a FOPs and 2,4-D dioxygenase protein (FT_T) that confers tolerance to quizalofop and 2,4-D herbicides. MON 87429 maize also produces the 5-enolpyruvylshikimate-3-phosphate synthase protein from Agrobacterium sp. strain CP4 (CP4 EPSPS) to confer tolerance to glyphosate for use in hybrid seed production. MON 87429 maize utilizes an endogenous maize regulatory element to target CP4 EPSPS mRNA for degradation in tassel tissues, resulting in reduced CP4 EPSPS protein expression in pollen. Appropriately timed glyphosate applications produce a non-viable pollen phenotype and allow for desirable cross pollinations to be made in maize without using mechanical or manual detasseling methods to control self-pollination in female inbred parents. Tissue-specific expression of CP4 EPSPS protein in MON 87429, allowing for glyphosate induced non-viable pollen phenotype, is the second generation of Monsanto’s Roundup® Hybridization System (RHS) for hybrid seed production. The first-generation RHS event, MON 87427 maize, was deregulated in 2013 (USDA-APHIS Petition #10-281-01p). The second-generation RHS trait in MON 87429 allows inbred MON 87429 lines, treated with glyphosate at the appropriate timings, to serve as a female parent in the production of hybrid Monsanto Company CR279-19U4 4 CBI Deleted seed. Female inbred MON 87429 lines receive two glyphosate applications at vegetative growth stages ranging from V8 to V13 that correspond to the time when immature male reproductive tissues are forming. Treatment with glyphosate at these stages results in the intended non-viable pollen phenotype in MON 87429 inbred lines due to tissue-specific glyphosate sensitivity in the immature male reproductive tissue. In hybrid maize production systems, treatment of female inbred MON 87429 plants with glyphosate during the time immature male reproductive tissue is developing will inhibit self-pollination. MON 87429 female inbreds instead will be pollinated by a desired male pollen donor inbred grown in close proximity that contains a deregulated glyphosate tolerance trait, such as NK603. This cross-pollination results in hybrid offspring (e.g., MON 87429 × NK603) with full plant tolerance to glyphosate, both in vegetative and reproductive tissues, as well as tolerance to dicamba, glufosinate, quizalofop, and 2,4-D herbicides. The RHS trait in MON 87429 maize offers the same benefits to hybrid maize seed production as the RHS trait in MON 87427, described in detail in USDA-APHIS Petition #10-281-01p. Briefly, these benefits include enabling hybrid seed producers to discontinue the practice of manually or mechanically detasseling female inbred plants in their production field, which must occur during a critical 3-4 day time period of maize tassel development, which can be influenced by changes in weather (e.g., extreme heat). The ability to treat MON 87429 maize female inbreds with glyphosate (between V8 to V13), in place of detasseling, provides flexibility to hybrid maize seed producers as well as reduces the cost of hybrid seed production by removing the reliance on costly, labor intensive manual/mechanical detasseling. An additional benefit of including the RHS trait in MON 87429 maize, along with dicamba-, glufosinate-, and quizalofop- and 2,4-D-tolerance traits, is the reduction in the number of trait loci that would otherwise need to be managed and combined, via traditional breeding methods. The MON 87429 event confers glyphosate tolerance in specific plant tissues (i.e., not in tassels) and will be used to facilitate the production of hybrid seed. MON 87429 is not intended to be offered for commercial use as a stand-alone product, but will be combined, through traditional breeding methods, with other deregulated events that confer full-plant glyphosate tolerance (e.g., NK603). MON 87429 maize combined with the glyphosate-tolerant maize system through traditional breeding will provide growers: 1) an opportunity for an efficient, effective weed management system for hard-to-control and herbicide-resistant weeds; 2) a flexible system with multiple herbicide sites-of-action for in-crop application in current maize production systems; 3) an opportunity to delay selection for further resistance to glyphosate and other herbicides that are important in crop production; 4) excellent crop tolerance to dicamba, glufosinate, quizalofop, 2,4-D and glyphosate; and 5) additional weed management tools to enhance weed management systems necessary to maintain or improve maize yield and quality to meet the growing needs of the food, feed, and industrial markets. MON 87429 maize will offer growers multiple choices for effective weed management including tough-to-control and herbicide-resistant broadleaf and grass weeds. The flexibility to use combinations of dicamba, glufosinate, 2,4-D, quizalofop and glyphosate herbicides representing multiple sites-of-action provides an effective weed management system for maize production. Dicamba provides effective control of over 95 annual and biennial broadleaf weed species, approximately 50 perennial broadleaf species and control or suppression of over 50 woody plant species. Glufosinate, a broad-spectrum contact herbicide, provides effective control of Monsanto Company CR279-19U4 5 CBI Deleted approximately 70 annual broadleaf weed species, over 30 grass weeds and control or suppression of over 30 biennial and perennial grass and broadleaf weed species. Quizalofop, a selective postemergence herbicide, provides effective control of approximately 35 annual and perennial grass weeds including glyphosate-resistant grasses. 2,4-D provides effective control of over 70 annual broadleaf weed species, and approximately 30 perennial broadleaf species. Glyphosate provides control of approximately 100 annual weed species (grass and broadleaf), over 60 perennial weed species (grass and broadleaf) and control or suppression of approximately 65 woody brush, trees and vines. Additionally, dicamba, glufosinate, and 2,4-D individually or in certain combinations provide control of herbicide-resistant weeds, including glyphosate-resistant biotypes of Palmer amaranth (Amaranthus palmeri), marestail (Conyza canadensis), common ragweed (Ambrosia artemisiifolia), giant ragweed (Ambrosia trifida) and waterhemp (Amaranthus tuberculatus). Data and Information Presented Confirms the Lack of Plant Pest Potential and the Food and Feed Safety of MON 87429 Compared to Conventional Maize The data and information presented in this petition demonstrate MON 87429 is agronomically and phenotypically comparable to commercially cultivated maize, with the exception of the introduced traits. Moreover, the data and information presented demonstrate MON 87429 is not expected to pose an increased plant pest risk, including weediness, compared to commercially cultivated maize. The food, feed, and environmental safety of MON 87429 was confirmed based on multiple, well-established lines of evidence: • Maize is a familiar crop that does not possess any of the attributes commonly associated with weeds and has a history of safe consumption. The conventional control used for the transformation process was included in studies to serve as an appropriate basis of comparison for MON 87429. • A detailed molecular characterization of the inserted DNA demonstrates a single, intact copy of the T-DNA insert in a single locus within the maize genome. • Extensive evaluation of the FT_T protein and previous assessments of the DMO, PAT and CP4 EPSPS proteins expressed in MON 87429, confirm they