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Federal Register / Vol. 86, No. 149 / Friday, August 6, 2021 / Notices
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Health Inspection Service APHIS
issued a final rule, published in the Federal Register on May 18, 2020 85
FR 2979029838, Docket No. APHIS
20180034,1 revising 7 CFR part 340;
however, the final rule is being implemented in phases. The new Regulatory Status Review RSR process, which replaces the determination of nonregulated status petition process, became effective on April 5, 2021 for corn, soybean, cotton, potato, tomato, and alfalfa. The RSR process is effective for all crops as of October 1, 2021.
However, until 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 January 21, 2020.
APHIS received a petition from the State University of New York College of Environmental Science and Forestry ESF APHIS Petition Number 19309
01p 2 seeking a determination of nonregulated status for blight-tolerant Darling 58 American chestnut Castanea dentata. The petition states that Darling 58 American chestnut is unlikely to pose a plant pest risk and, therefore, should not be regulated under APHIS
regulations in 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 August 19, 2020, we announced in the Federal Register 85 FR 5100851009, Docket No. APHIS20200030 the availability of the blight-tolerant chestnut petition for public comment.4 We solicited comments on the petition for 60 days to 1 To view the final rule, go to www.regulations.gov and enter APHIS20180034
in the Search field.
2 To view the petition, go to https
www.aphis.usda.gov/aphis/ourfocus/biotechnology/
permits-notifications-petitions/petitions/petitionstatus.
3 On March 6, 2012, APHIS published in the Federal Register 77 FR 1325813260, Docket No.
APHIS20110129 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
20110129 in the Search field.
4 To view the notice, supporting documents, and the comments that we received, go to www.regulations.gov and enter APHIS20200030
in the Search field.

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help us identify potential environmental and interrelated economic issues and impacts that APHIS should consider in evaluation of the petition. We received 4,320 comments on the petition from the academic sector, farmers, nongovernmental organizations, nonprofit organizations, industry, Tribes, and unaffiliated individuals.
Comments in favor of the petition emphasized the positive environmental and socio-economic benefits of restoring American chestnut throughout its preblight range. Issues raised in the opposing comments included environmental impacts of the unconfined release of a forest tree developed using genetic engineering, impacts to native communities, human health and safety impacts of using a wheat gene, the need for long term studies, the potential for chestnut to be more susceptible to chestnut blight as well as other diseases, the potential for impacts to organic producers, impacts to trade, and general anti-biotech sentiments. APHIS evaluated all comments received on the petition. A
full record of comments received is available online at www.regulations.gov see footnote 4. As part of our evaluation of the petition and consideration of public comments, APHIS has determined that this proposed action has potential to significantly affect the quality of the human environment.5 As such, APHIS
is deciding to prepare an environmental impact statement EIS in order to conduct the level of detailed and rigorous environmental analysis required to make an informed decision about the proposed deregulation of Darling 58 American chestnut.
The EIS is being prepared in accordance with: 1 National Environmental Policy Act NEPA, as amended 42 U.S.C. 4321 et seq., 2 the Council on Environmental Qualitys CEQ NEPA-implementing regulations 40 CFR parts 15001508, 3 USDAs NEPA-implementing regulations 7 CFR
part 1b, and 4 APHIS NEPA
Implementing Procedures 7 CFR part 372.
Proposed Action and Alternative the EIS Will Consider The EIS will analyze the preferred alternative, approval of ESFs petition 5 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 such as the effects on employment, social, or health effects see 40 CFR
1508.1.

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for a determination of nonregulated status for Darling 58 American chestnut, as well as the no action alternative, denial of the petition for nonregulated status. Both alternatives will receive APHIS full consideration. APHIS has developed a list of topics for consideration in the EIS based on public comments on the petition, prior environmental assessments EAs/EISs for plants developed using genetic engineering, public comments submitted for other EAs/EISs evaluating petitions for nonregulated status, scientific literature on biotechnology, and issues identified by APHIS specific to American chestnut and other Castanea species. The following topics were identified as relevant to the scope of analysis: Action Area Historic, Present, and Potential Future Range of American Chestnut; Physical Environment Soil Quality, Water Resources, Air Quality and Climate Change; Biological Resources Animal Communities, Plant Communities, Gene Flow and Weediness, Microorganisms, and Biodiversity; Human Health Considerations; Animal Health and Welfare; and Socioeconomic Considerations Domestic Economic Environment, International Trade. In addition, potential impacts on threatened and endangered species, as well as adherence of the Agencys decision to Executive Orders, and environmental laws and regulations to which the action may be subject will also be examined.
Summary of Potential Impacts APHIS anticipates the potential impacts of the proposed action could include impacts on the physical environment, biological resources, and socioeconomic impacts.
Anticipated Permits and Authorizations Darling 58 American chestnut, if deregulated, could be cultivated to produce food or animal feed, subject to any Environmental Protection Agencys EPA and/or U.S. Food and Drug Administration FDA requirements under the Coordinated Framework.6 For example, any human food or animal feed derived from Darling 58 American chestnut would be subject to the Federal Food, Drug, and Cosmetic Act FFDCA;
21 U.S.C. 301 et seq. and FDA
requirements. ESF may voluntarily consult with the FDA to ensure compliance with the FFDCA.
6 See Coordinated Framework. U.S. Department of Agriculture, Animal and Plant Health Inspection Service, Biotechnology Regulatory Services, https
usbiotechnologyregulation.mrp.usda.gov/
biotechnologygov/home/.

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