July 2, 2018
Regulatory Analysis and Development
PPD, APHIS, Station 3A-03.8,
4700 River Road Unit 118,
Riverdale, MD 20737-1238
Dr. John Turner
Director, Environmental Risk Analysis Programs
Biotechnology Regulatory Services
4700 River Road Unit 147
Riverdale, MD 20737-1236
RE: Docket ID Number APHIS-2017-0073. Cotton Genetically Engineered for Resistance to HPPD-Inhibitor Herbicides (e.g. Isoxaflutole) and Glyphosate. Transformation Event GHB811.
Dear Dr. Turner:
The National Cotton Council (NCC) appreciates the opportunity to comment on the Animal and Plant Health Inspection Service’s (APHIS) “Petitions: Bayer CropScience LP; Determination of Nonregulated Status of Cotton Genetically Engineered for Resistance to Glyphosate and Isoxaflutole (GHB811).”
The NCC is the central organization of the United States cotton industry. Its members include farmers, ginners, cottonseed processors and merchandizers, merchants, cooperatives, warehousers and textile manufacturers. A majority of the industry is concentrated in 17 cotton-producing states stretching from California to Virginia. U.S. cotton farmers cultivate between 9 and 12 million acres of cotton with production averaging 12 to 18 million 480-lb bales annually. The downstream manufacturers of cotton apparel and home furnishings are located in virtually every state. Farms and businesses directly involved in the production, distribution and processing of cotton employ more than 125,000 workers and produce direct business revenue of more than $21 billion. Annual cotton production is valued at more than $5.5 billion at the farm gate, the point at which the farmer markets the crop. Accounting for the ripple effect of cotton through the broader economy, direct and indirect employment surpasses 280,000 workers with economic activity of almost $100 billion. In addition to the cotton fiber, cottonseed products are used for livestock feed and cottonseed oil is used as an ingredient in food products as well as being a premium cooking oil.
Genetically engineered cotton was first introduced in 1993 (BXN Cotton, Calgene, Inc., Petition for Determination of Nonregulated Status under 7 CFR 340, BXN™ Cotton, Statement for Grounds for Decision, July 14, 1993) and U.S. cotton farmers have adopted the new technology rapidly. Currently, approximately 90% of U.S. cotton is planted with insect resistant or herbicide tolerant genetically engineered cotton varieties. The latest estimates of the benefits of these insect resistant varieties are 185 million lbs/year increase in production; 1.9 million lbs/year decrease in insecticide use; and $103 million/year increase in net revenue for U.S. cotton farmers.1 The benefits of herbicide tolerant biotech cotton in the U.S. include a 6.2 million lbs/year decrease in herbicide active ingredients applied and $133 million/year savings in weed control costs.2
APHIS has prepared a preliminary plant pest risk assessment (PPRA) and has concluded that cotton designated as event GHB811, which has been genetically engineered for dual herbicides resistance, is unlikely to pose a plant pest risk. In section 403 of the Plant Protection Act, “plant pest” is defined as any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product: A protozoan, a nonhuman animal, a parasitic plant, a bacterium, a fungus, a virus or viroid, an infectious agent or other pathogen, or any article similar to or allied with any of the foregoing.
APHIS has also prepared a draft EA in which they selected an alternative to make a determination of nonregulated status of cotton designated as event GHB811. The draft EA was prepared in accordance with (1) NEPA, as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372). Based on their draft EA and other pertinent scientific data, APHIS has prepared a preliminary finding of no significant impact (FONSI) with regard to the preferred alternative identified in the draft EA.
Based on APHIS' analysis of field and laboratory data submitted by Bayer, references provided in the petition, peer-reviewed publications, information analyzed in the draft EA, the preliminary PPRA, comments provided by the public on the petition, and discussion of issues in the draft EA, APHIS has determined that cotton designated as event GHB811 is unlikely to pose a plant pest risk. Therefore, APHIS has reached a decision to make a preliminary determination of nonregulated status of cotton designated as event GHB811, whereby cotton designated as event GHB811 would no longer be subject to regulations governing the introduction of certain GE organisms.
The NCC supports the deregulation of this event as it provides tolerance to both glyphosate, an herbicide in group 9, and to HPPD-inhibitors in group 27. HPPD-inhibitors, including isoxaflutole, have the ability to provide cotton farmers with a new mode of action (MOA) in wide spectrum of broadleaf weed control as well as offer pre-plant burn down and residual activity. They also provide an additional MOA to help reduce resistance pressure on other active ingredients. Similar HPPD traits have already been reviewed and approved in soybeans by USDA and we support approval for use in cotton in the future. The use of GHB811 will enable effective pre-emergence control of weeds by providing residual and recharge benefits and can also provide cotton farmers with another management tool to help reduce the selection pressure on existing herbicide active ingredients.
The NCC appreciates the opportunity to comment on this petition and urges APHIS to grant this event a nonregulated status under 7 CFR part 340 to ensure multiple MOAs are available to cotton famers as they look to produce their crop in the most safe and efficient manner.
Thank you for your consideration of our comments.
Senior Scientist, Regulatory and Environmental Issues