2021-08625. J.R. Simplot Co.: Determination of Nonregulated Status for Z6 Potatoes With Late Blight Protection, Low Acrylamide Potential, Lowered Reducing Sugars, and Reduced Black Spot

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are notifying the public that we have extended our determination of nonregulated status of J.R. Simplot Company's (Simplot's) W8 potato to event Z6 (hereafter Z6 potato). Z6 potato has been developed using genetic engineering for late blight protection, low acrylamide potential, lowered reducing sugars, and reduced black spot using the same construct and method of transformation as W8 potato. Our decision was based on our evaluation of data submitted by Simplot in its request for an extension of a determination of nonregulated status, an analysis of other scientific data, and comments received from the public in response to a previous notice announcing our preliminary determination.

DATES:

This determination was effective on August 28, 2020.

FOR FURTHER INFORMATION CONTACT:

Ms. Cindy Eck, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone], email: [e-mail].

SUPPLEMENTARY INFORMATION:

Background

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 extension 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 is being implemented in phases. This extension of a determination of nonregulated status was evaluated in accordance with the regulations at 7 CFR 340.6 (2020).

In a notice published in the Federal Register on June 25, 2020 (85 FR 38110-38111, Docket No. APHIS-2020-0048),^[2] we notified the public that we had received a request to extend our determination of nonregulated status of J.R. Simplot Company's (Simplot's) W8 potato to event Z6 (hereafter Z6 potato). Like W8 potato, Z6 potato has been developed using genetic engineering for late blight protection, low acrylamide potential, lowered reducing sugars, and reduced black spot, and had been developed using the same construct and method of transformation as W8 potato. This notice also made available the extension request, our plant pest risk similarity assessment (PPRSA), and our preliminary determination to extend nonregulated status to Z6 potato.

Comments on the notice were due by July 27, 2020. APHIS received 27 comments by the close of the comment period.

While several commenters expressed general disapproval regarding organisms developed using genetic engineering, the comments received did not call into question the conclusions of the PPRSA or our preliminary determination. Accordingly, on August 28, 2020, APHIS determined that extension of nonregulated status should be granted to Z6 potato. This notice serves as an official notice and public record of that action.

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 21st day of April 2021.

Michael Watson,

Acting 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.  To view the notice, its supporting documents, or the comments that we received, go to www.regulations.gov and enter APHIS-2020-0048 in the Search field.