Washington, DC, USA
August 6, 2014
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is issuing a final and a draft environmental impact statement (EIS) on several genetically engineered (GE) products as part of its review to determine whether to deregulate them. APHIS is issuing a final EIS today as part of its review to determine whether to deregulate GE corn and soybean plants that are resistant to several herbicides, including one known as 2,4-D. APHIS also announced it will issue a draft EIS for public comment in the coming days as part of its review to determine whether to deregulate GE cotton and soybean plants that are resistant to multiple herbicides, including dicamba.
Final Environmental Impact Statement for Corn and Soybean Plants Resistant to the Herbicide 2,4-D
Under the Plant Protection Act (PPA) and APHIS’ regulations, the agency is specifically required to evaluate whether GE crops are a plant pest to agricultural crops or other plants or plant products.
In January, APHIS issued a draft EIS on the 2,4-D products that examined the regulatory alternatives. APHIS is required by the National Environmental Policy Act (NEPA) to identify the alternative that best meets the purpose and need for the EIS, known as the "preferred alternative." Based on its plant pest risk assessment and under its authority through the Plant Protection Act, APHIS has determined that GE corn and soybeans do not pose a plant pest risk to agricultural crops or other plants in the United States. As a result of that determination, the Plant Protection Act directs APHIS to seek deregulation of all three varieties in such cases as the agency’s “preferred alternative.”
Following the close of the 60-day comment period, APHIS thoroughly reviewed and analyzed the 10,140 comments it received and has addressed them in the final EIS it is making available today.
The final EIS affirms APHIS’ preferred alternative to fully deregulate these new GE crops. This is also consistent with APHIS’ final plant pest risk assessment (PPRA), also being made available today, that found 2,4-D resistant corn and soybeans are unlikely to pose a plant pest risk to agricultural crops or other plants in the United States.
The final EIS enables APHIS to better understand the impacts of its regulatory decision including how the adoption of these products by farmers may lead to an increased risk in the development of new herbicide-tolerant weeds. The final EIS affirms that diversified weed management practices could mitigate the impacts.
APHIS is finalizing its assessment of these GE plants while the U.S. Environmental Protection Agency (EPA) is concluding its concurrent review of the related herbicides. EPA has authority over the review and approval of pesticidal substances and plant-incorporated protectants under the Federal Insecticide, Fungicide, and Rodenticide Act as amended and the Federal Food, Drug, and Cosmetic Act. EPA is currently reviewing information submitted by the developer, Dow, to assess the potential for environmental and human risks associated with the use of 2,4-D. In addition, in June of 2005, EPA completed 2,4-D’s Reregistration Eligibility Decision that reassessed labeled uses to ensure they meet today’s more stringent standards.
The final PPRA and EIS on 2,4-D resistant crops will be available for public review for 30 days upon publication in the Federal Register before APHIS makes its final regulatory determination on the petition for deregulation. APHIS will publish its record of decision for the final EIS and its final regulatory determination after that 30-day public review period has concluded.
APHIS has submitted the final EIS to the EPA for publication in the Federal Register. APHIS anticipates that EPA will publish a notice on August 7,2014. A copy of the final EIS provided to EPA and the final PPRA can be found at www.aphis.usda.gov/biotechnology/news.
Draft Environmental Impact Statement for Cotton and Soybean Plants Resistant to the Herbicide Dicamba
Once APHIS receives a petition for non-regulated status of certain GE plants, as it has from Monsanto, it conducts two required analyses before it makes its regulatory determination on whether or not the newly developed GE plants should be deregulated.
APHIS’ preliminary plant pest risk assessment of these new GE plants finds that they are not likely to pose a plant pest risk. Before making its final regulatory decision, APHIS, pursuant to the National Environmental Policy Act (NEPA), must also evaluate the potential impacts to the environment that may result from its regulatory decision. The NEPA review can take the form of an Environmental Assessment (EA) or, in this case, a more rigorous Environmental Impact Statement (EIS). Through an EIS, APHIS can consider regulatory alternatives and their potential environmental impacts, as well as other potential impacts to public health and endangered species. NEPA does not, however, provide APHIS any additional regulatory authority to address those environmental impacts beyond what the PPA provides.
In its draft EIS for dicamba resistant cotton and soybean, APHIS examines all the available regulatory alternatives. The draft EIS also analyzes the potential development of new herbicide-resistant weeds. While APHIS found that the wider use of these new GE plants would help growers manage weeds, the wider use would also likely result in an increased chance of the development of weeds resistant to dicamba. However, APHIS’ analysis showed that growers can implement diversified weed management practices to mitigate this impact.
APHIS’ “preferred alternative” in the draft EIS is to deregulate these varieties. APHIS selected this alternative consistent with its authority under the PPA and because its preliminary plant pest risk assessment concludes that GE cotton and soybeans are not likely to pose a plant pest risk to agricultural crops or other plants in the United States. As a result of that determination, the Plant Protection Act directs APHIS to seek deregulation of all three varieties in such cases as the agency’s “preferred alternative.”
The draft EIS will be available for a 45-day public review and comment period upon publication by EPA in the Federal Register.
Concurrent with the APHIS regulatory process, EPA is conducting risk assessments to decide upon the approval of the proposed new uses of dicamba and glusofinate. This analysis includes a thorough review of any potential human health and environmental risks associated with the application of these herbicides to the GE cotton and soybean plants, such as additional use of the herbicide and potential off-site movement of these herbicides to other crops or areas.
EPA will make available its proposed regulatory decision in the coming months for public review and comment. After consideration of public comments, EPA will then make its final regulatory decision in coordination with APHIS’ final regulatory decision regarding these plants. In January, APHIS issued a draft EIS on the 2,4-D tolerant plant products that examined the regulatory alternatives.
A copy of the draft EIS provided to EPA and the PPRA can be found at www.aphis.usda.gov/biotechnology/news.
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