[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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