2023-26458. Pioneer Hi-Bred International, Inc.; Determination of Nonregulated Status for Insect Resistant and Herbicide-Tolerant Maize

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public of our determination that DP23211 maize (corn), which has been developed using genetic engineering for insect resistance to western corn rootworm and contains the gene that codes for the phosphinothricin acetyltransferase protein responsible for tolerance to glufosinate-ammonium herbicides, and also the gene that encodes for the phosphomannose isomerase protein as a selectable marker, is no longer considered regulated. Our determination is based on our evaluation of information Pioneer Hi-Bred International, Inc. submitted in its petition for a determination of nonregulated status, our analyses, and public comments received in response to previous notices announcing the availability of the petition for nonregulated status and our associated environmental assessment and plant pest risk assessment. This notice also announces the availability of our written determination and finding of no significant impact.

DATES:

This change in regulatory status will be recognized on December 1, 2023.

ADDRESSES:

You may read the documents referenced in this notice and the comments we received at regulations.gov, or in our reading room which is located in room 1620 of the USDA South Building, 14th Street and Independence Avenue SW, Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799–7039 before coming.

Supporting documents are also available on the APHIS website at https://www.aphis.usda.gov/​aphis/​ourfocus/​biotechnology/​regulatory-processes/​petitions/​petition-status/​petitions-table.

FOR FURTHER INFORMATION CONTACT:

Dr. Alan Pearson, Biotechnology Regulatory Services, APHIS, USDA, 4700 River Road, Unit 147, Riverdale, MD 20737–1236; (301) 851–3944; email: [e-mail].

SUPPLEMENTARY INFORMATION:

Under the authority of the plant pest provisions of the Plant Protection Act (PPA) (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 was 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 was evaluated in accordance with the regulations at 7 CFR 340.6 (2020) as it was received by APHIS on July 21, 2020.

Pioneer Hi-Bred International (Pioneer) submitted a petition (APHIS Petition Number 20–203–01p) to APHIS, seeking a determination of nonregulated status for DP23211 maize (corn), which was developed using genetic engineering for insect resistance to western corn rootworm and contains the gene that codes for the phosphinothricin acetyltransferase protein responsible for tolerance to glufosinate-ammonium herbicides. DP23211 corn also contains the gene that encodes for the phosphomannose isomerase protein, which is used as a selectable marker. The petition stated that DP23211 corn 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 ^[2] for soliciting public comment when considering petitions for determination of nonregulated status for organisms developed using genetic engineering, APHIS accepts written comments regarding a petition once APHIS deems it complete. On November 3, 2020, APHIS published a notice in the Federal Register (85 FR 69564–69566, Docket No. APHIS–2020–0098) announcing the availability of the Pioneer petition for public comment. Four comments were received. One comment was from an individual, which stated opposition to biotechnology-derived crops in general. Three comments were received from industry organizations, which generally supported approval of the petition. APHIS evaluated the issues raised during the initial comment period and, where appropriate, incorporated a discussion of them within a draft environmental assessment (EA).

A second opportunity for public involvement was provided on April 11, 2023, with a notice published in the Federal Register (88 FR 21602–21603, Docket No. APHIS–2020–0098) announcing the availability of the draft EA and draft plant pest risk assessment (PPRA) for public review and comment. That comment period closed on May 11, 2023. APHIS received three comments. One commenter expressed concern that the DvSSJ1 dsRNA insect resistant trait in DP23211 corn is associated with an animal and thus presents cultural/dietary concerns for plant-based diet adherents who may inadvertently consume DP23211 corn, and thereby DvSSJ1 dsRNA. We responded that the potential risk of exposure to insect DNA/RNA via inadvertent consumption of DP23211 corn products is not expected to appreciably increase in the event of deregulation and subsequent production of DP23211 corn, and that DvSSJ1 dsRNA poses no health risk to humans. Another commenter expressed opposition to biotechnology-derived crops, in general. A comment from a State organization representing farmers expressed support for the deregulation of DP23211 corn. APHIS provided a response to the comments in Appendix 2 of our final EA. None of the comments identified new information or data regarding the draft EA or draft PPRA.

National Environmental Policy Act

After reviewing and evaluating the comments received during the comment period on the draft EA, draft PPRA, and other information, APHIS has prepared a final EA, which provides the public with documentation of APHIS' review and analysis of any potential environmental impacts associated with the determination of nonregulated status of DP23211 corn. The EA was prepared in accordance with: (1) the National Environmental Policy Act (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 our EA, public comments, and other pertinent scientific data, APHIS has reached a finding of no significant impact (FONSI) with regard to the preferred alternative identified in the EA (to make a determination of nonregulated status for DP23211 corn).

Determination

Based on APHIS' analysis of field and laboratory data submitted by Pioneer, references provided in the petition, peer-reviewed publications, information analyzed in the EA, the PPRA, the public comments, and information provided in APHIS' response to those public comments, APHIS has determined that DP23211 corn is unlikely to pose a plant pest risk and therefore is no longer subject to our regulations governing the movement of organisms developed using genetic engineering.

Copies of the signed determination document, PPRA, final EA, and FONSI, as well as the previously published petition and supporting documents, are available as indicated under ADDRESSES and from the person listed under the FOR FURTHER INFORMATION CONTACT section in this notice.

Authority:7 U.S.C. 7701–7772 and 7781–7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

Done in Washington, DC, this 27th day of November 2023.

Michael Watson,

Administrator, Animal and Plant Health Inspection Service.

Footnotes

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

2.  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.