Environmental Impact Statements; Availability, etc.: Bayer; Draft Plant Risk Assessment for Determination of Nonregulated Status for Maize Developed Using Genetic Engineering[...]

Bayer; Availability of a Draft Environmental Impact Statement and a Draft Plant Risk Assessment for Determination of Nonregulated Status for Maize Developed Using Genetic Engineering for Dicamba, Glufosinate, Quizalofop, and 2,4-Dichlorophenoxyacetic Acid Resistance, With Tissue-Specific Glyphosate Resistance Facilitating the Production of Hybrid Maize Seed

Dates

We will consider all comments that we receive on or before May 6, 2024.

Supplementary Information

Background

Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701 et seq. ), the regulations in 7 CFR part 340, "Movement of Organisms Modified or Produced Through Genetic Engineering," regulate, among other things, the importation, interstate movement, or release into the environment of organisms modified or produced through genetic engineering that are plant pests or pose a plausible plant pest risk.

The petition for nonregulated status described in this notice is being evaluated under the version of the regulations effective at the time that it was received. The Animal and Plant Health Inspection Service (APHIS) issued a final rule, published in the Federal Register on May 18, 2020 (85 FR 29790-29838, Docket No. APHIS-2018-0034), ⁽¹⁾ revising 7 CFR part 340. However, the final rule was implemented in phases. The new Regulatory Status Review (RSR) process, which replaces the petition for determination of nonregulated status process, became effective on April 5, 2021, for corn, soybean, cotton, potato, tomato, and alfalfa. The RSR process became effective for all crops as of October 1, 2021. However, "[u]ntil RSR is available for a particular crop . . . APHIS will continue to receive petitions for determination of nonregulated status for the crop in accordance with the [legacy] regulations at 7 CFR 340.6" (85 FR 29815). This petition for a determination of nonregulated status is being evaluated in accordance with the regulations at 7 CFR 340.6 (2020) as it was received by APHIS on June 27, 2019.

Bayer submitted a petition (APHIS Petition Number 19-316-01p) to APHIS seeking a determination of nonregulated status for a maize  ⁽²⁾ (identified as MON 87429) that has been developed using genetic engineering for dicamba, glufosinate, quizalofop, and 2,4-dichlorophenoxyacetic acid (2,4-D) resistance with tissue-specific glyphosate resistance facilitating the production of hybrid maize seed. The Bayer petition stated that MON 87429 maize is unlikely to pose a plant pest risk and, therefore, should not be regulated under APHIS' regulations at 7 CFR part 340.

According to our process  ⁽³⁾ for soliciting public comment when considering petitions for determination of nonregulated status of regulated organisms, APHIS accepts written comments regarding a petition once APHIS deems it complete. On May 8, 2020, APHIS announced the availability of the Bayer petition for public comment in the Federal Register   ⁽⁴⁾ (85 FR 27354-27355, Docket No. APHIS-2020-0021). APHIS solicited comments on the petition for 60 days ending July 7, 2020, in order to help identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition. We received 4,112 comments by the close of the comment period.

Based on comments received on the petition and new information that APHIS became aware of after our May 8, 2020, Federal Register publication, we determined that an environmental impact statement (EIS), as opposed to an environmental assessment, was the appropriate National Environmental Policy Act (NEPA) analysis for the Bayer petition. Specifically, APHIS became aware of new information regarding potential issues with dicamba spray drift and volatilization and associated potential economic impacts, and the Environmental Protection Agency's (EPA) issuance of a cancellation order on June 8, 2020, for three products (Xtendimax with Vaporgrip Technology, EPA Reg. No. 524-6 17, Engenia, EPA Reg. No. 7969-345, and FeXapan, EPA Reg. No. 352-9 13) that contain dicamba. Additionally, on October 27, 2020, the EPA approved limited 5-year registrations for two end-use dicamba products and the extension of the registration for one dicamba product (EPA Reg. Nos. 100-1623, 264-1210, and 7969-472).

On April 28, 2021, APHIS published a notice of intent (NOI) in the Federal Register (86 FR 22384-22386, Docket No. APHIS-2020-0021), announcing that as part of our evaluation of the Bayer petition, we planned to prepare an EIS to consider the potential impacts of a determination of nonregulated status for MON 87429 maize on the human environment. ⁽⁵⁾

APHIS solicited public comment for a period of 30 days, ending May 28, 2021, as part of its scoping process to identify issues to address in the draft EIS. On June 30, 2021, APHIS announced in the Federal Register (86 FR 34714-34715, Docket No. APHIS-2020-0021) that the comment period was reopened for 30 days to allow interested persons additional time to prepare and submit comments until July 30, 2021. APHIS received a total of 3,069 comments by the end of the comment period.

Comments received were from the agricultural industry, nongovernmental organizations, Tribal governments, and individuals. The most common topics and issues of concern raised in the comments received on the NOI for the draft EIS included: The potential for dicamba or 2,4-D drift to adversely impact crops not resistant to these herbicides, as well as adversely impact wild plants and plants on residential and commercial properties; the potential economic impacts of herbicide drift on crop and non-crop plants; herbicide-resistant crops and their influence on herbicide use; the potential for development of weed resistance to herbicides; potential effects of pesticides on the soil microbiome, pollinators, wildlife, biodiversity, and endangered species; potential effects on Tribal nations, including Tribal nation corn production, indigenous corn varieties, and food sovereignty; and potential benefits of MON 87429 corn in weed and herbicide resistant weed management, and U.S. corn production.

APHIS evaluated all comments received on the NOI in developing the draft EIS. A summary of the comments received and APHIS response to comments are provided in appendix 1 of the draft EIS.

Because the introduced trait genes in MON 87429 maize are involved in weed management, and considering public comments received on the NOI, the primary topics of focus in the draft EIS, in relation to potential impacts on the human environment are: (1) Weed and herbicide resistant weed management, (2) herbicide use with MON 87429 maize, (3) the potential effects of exposure to the introduced trait genes and gene products on human health and wildlife, (4) gene flow and potential weediness of MON 87429 maize, and (5) potential socioeconomic impacts.

The draft EIS has been prepared in accordance with (1) The National Environmental Policy Act of 1969 (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). APHIS is making available the draft EIS, as well as a draft plant pest risk assessment (PPRA), for a 45-day public review and comment period. The draft EIS and draft PPRA are available as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT .

A notice of availability regarding the draft EIS will also be published by the Environmental Protection Agency in the Federal Register .

⁽¹⁾  To view the final rule, go to www.regulations.gov and enter APHIS-2018-0034 in the Search field.

⁽²⁾  Maize is the common botanical term used globally for the cereal plant Zea mays. In the United States, maize is also referred to as corn. Both terms are used interchangeably in this document. For consistency with the common plant name and petition, APHIS uses the term maize, but also refers to corn in certain instances, such as in reference to food products.

⁽³⁾  On March 6, 2012, APHIS published in the Federal Register (77 FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing our public review process for soliciting public comments and information when considering petitions for determinations of nonregulated status for organisms developed using genetic engineering. To view the notice, go to www.regulations.gov and enter APHIS-2011-0129 in the Search field.

⁽⁴⁾  To view the notice, its supporting documents, or the comments that we received, go to www.regulations.gov and enter APHIS-2020-0021 in the Search field.

⁽⁵⁾  The National Environmental Policy Act as amended, and Council on Environmental Quality NEPA implementing regulations at 40 CFR 1500-1508 require Federal agencies to thoroughly assess the potential environmental consequences of federal actions on the "human environment". Human environment means comprehensively the natural and physical environment and the relationship of present and future generations of Americans with that environment. Impacts/effects include ecological (such as effects on natural resources, and on the components, structures, and functioning of affected ecosystems), aesthetic, historic, cultural, economic, social, or health effects (see 40 CFR 1508.1).