[Federal Register Volume 86, Number 123 (Wednesday, June 30, 2021)]
[Notices]
[Pages 34713-34714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13901]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2021-0027]


Okanagan Specialty Fruits Inc.; Availability of a Request, a 
Draft Plant Pest Risk Similarity Assessment, and Preliminary 
Determination for an Extension of Determination of Nonregulated Status 
for Non-Browning Apple

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has received a request from Okanagan Specialty 
Fruits Inc. (OSF) to extend our determination of nonregulated status of 
GD743 apple and GS784 apple to PG451 apple which has been developed 
using genetic engineering to resist browning. We are making the OSF 
extension request, the preliminary determination, and the draft plant 
pest risk similarity assessment available for public comment.

DATES: We will consider all comments that we receive on or before July 
30, 2021.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and enter APHIS-2021-0027 in the Search field. 
Select the Documents tab, then select the Comment button in the list of 
documents.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2021-0027, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    The OSF extension request, the preliminary determination, and the 
draft plant pest risk similarity assessment, and any comments we 
receive on this docket may be viewed at www.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,

[[Page 34714]]

please call (202) 799-7039 before coming.
    Supporting documents for this petition are also available on the 
APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status.

FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Biotechnology 
Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 
20737-1236; (301) 851-3892; email: [email protected].

SUPPLEMENTARY INFORMATION: 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 extension 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 is being implemented 
in phases. This extension of 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 July 31, 2020.
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    \1\ To view the final rule, go to www.regulations.gov and enter 
APHIS-2018-0034 in the Search field.
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    On February 18, 2015,\2\ APHIS announced its determination of 
nonregulated status of Okanagan Specialty Fruits Inc.'s (OSF) GD743 and 
GS784 apple lines which were developed using genetic engineering to 
resist browning. OSF has submitted a request to extend a determination 
of nonregulated status of GD743 and GS784 apple lines to PG451 apple 
(APHIS Petition Number 20-213-01ext) which has been developed using 
genetic engineering to resist browning.
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    \2\ To view the notice, go to www.regulations.gov and enter 
APHIS-2012-0025 in the Search field.
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    As described in the extension request, PG451 apple was developed 
through Agrobacterium-mediated transformation of apple leaf tissue 
using the binary plasmid vector pGEN-03 to suppress genes for 
polyphenol oxidase, which causes browning. GD743 and GS784 apple lines 
were developed using the same plasmid vector and the same 
Agrobacterium-mediated transformation method.
    Based on the information in the request, we have concluded that 
PG451 apple is similar to GD743 and GS784 apple lines. PG451 apple is 
currently regulated under 7 CFR part 340.
    As part of our decision-making process regarding the regulatory 
status of an organism developed using genetic engineering, APHIS 
prepared a draft plant pest risk similarity assessment (PPRSA) to 
compare PG451 apple to the antecedents. Based on the similarity of 
PG451 apple to the antecedents GD743 and GS784 apple lines as described 
in the PPRSA, APHIS concludes that PG451 apple is unlikely to pose a 
greater plant pest risk than the unmodified organism from which it was 
derived and should no longer be regulated under 7 CFR part 340.
    APHIS has analyzed information submitted by OSF, references 
provided in the extension request, peer-reviewed publications, and 
supporting documentation prepared for the antecedent organism. Based on 
APHIS' analysis of this information and the similarity of PG451 apple 
to the antecedents GD743 and GS784 apple lines, APHIS has determined 
that PG451 apple is unlikely to pose a plant pest risk. We have 
therefore reached a preliminary decision to approve the request to 
extend the determination of nonregulated status for PG451 apple line, 
whereby PG451 apple would no longer be subject to our regulations 
governing organisms developed using genetic engineering.
    We are therefore publishing this notice to make available our 
evaluation and inform the public of our preliminary decision to extend 
the determination of nonregulated status of PG451 apple.
    APHIS will accept written comments on the request for extension, 
PPRSA, and our preliminary determination for PG451 apple for 30 days. 
These documents are available for public review as indicated under 
ADDRESSES and FOR FURTHER INFORMATION CONTACT above. Copies of these 
documents may also be obtained by contacting the person listed under 
FOR FURTHER INFORMATION CONTACT.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. All comments will be available for public review. After 
reviewing and evaluating the comments, if APHIS determines that no 
substantive information has been received that would warrant APHIS 
altering its preliminary regulatory determination, our preliminary 
regulatory determination will become final and effective upon 
notification of the public through an announcement on our website at 
https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status. APHIS will also 
furnish a response to the petitioner regarding our final regulatory 
determination. No further Federal Register notice will be published 
announcing the final regulatory determination of PG451 apple.

    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 24th day of June 2021.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2021-13901 Filed 6-29-21; 8:45 am]
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