[Federal Register Volume 81, Number 156 (Friday, August 12, 2016)]
[Notices]
[Pages 53396-53398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19222]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2016-0043]


Okanagan Specialty Fruits, Inc.; Availability of Preliminary 
Finding of No Significant Impact, Preliminary Plant Pest Risk 
Similarity Assessment, and Preliminary Determination for an Extension 
of a Determination of Nonregulated Status for Non-Browning 
Arctic[supreg] Apple Event NF872 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 reached a preliminary decision to extend our 
determination of nonregulated status of Okanagan Specialty Fruits' 
(OSF) GS784 and GD743 apples to OSF NF872 `Arctic[supreg] Fuji apple'. 
OSF's NF872 apple has been genetically engineered for enzymatic 
browning resistance using the same mode of action as GS784 and GD743 
apples. We are making available for public comment our preliminary 
determination, preliminary plant pest risk similarity assessment, and 
preliminary finding of no significant impact for the proposed 
determination of nonregulated status.

DATES: We will consider all comments that we receive on or before 
September 12, 2016.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2016-0043.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2016-0043, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    The Okanagan Specialty Fruits extension request, our preliminary 
determination, preliminary plant pest risk similarity assessment, 
preliminary finding of no significant impact, and any comments we 
receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2016-0043 or in our reading room, which is 
located in room 1141 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 and any comments we received regarding our 
determination of nonregulated status of the antecedent organisms (apple 
events GD743 and GS784), can be found at http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0025. Supporting documents may also be 
found on the APHIS Web site for NF872 `Arctic[supreg] Fuji apple' (the 
organism under evaluation) under APHIS Petition Number 16-004-01p, and 
the antecedent organisms (apple events GD743 and GS784) under APHIS 
Petition Number 10-161-01p.

FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, 
Biotechnology Risk Analysis Programs, Biotechnology Regulatory 
Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; 
(301) 851-3954, email: [email protected]. To obtain copies 
of the supporting documents, contact Ms. Cindy Eck at (301) 851-3885, 
email: [email protected].

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, ``Introduction of Organisms and 
Products Altered or Produced Through Genetic Engineering Which Are 
Plant Pests or Which There Is Reason to Believe Are Plant Pests,'' 
regulate, among other things, the introduction (importation, interstate 
movement, or release into the environment) of organisms and products 
altered or produced through genetic engineering that are plant pests or 
that there is reason to believe are plant pests. Such genetically 
engineered organisms and products are considered ``regulated 
articles.''
    The regulations in Sec.  340.6(a) provide that any person may 
submit a petition to the Animal and Plant Health Inspection Service 
(APHIS) seeking a determination that an article should not be regulated 
under 7 CFR part 340. Further, the regulations in Sec.  340.6(e)(2) 
provide that a person may request that APHIS extend a determination of 
nonregulated status to other organisms. Such a request must include 
information to establish the similarity of the antecedent organism and 
the regulated article in question.

[[Page 53397]]

    In a notice \1\ published in the Federal Register on November 8, 
2013 (78 FR 67100, Docket No. APHIS-2012-0025), APHIS announced our 
determination of nonregulated status of apples (Malus domestica) 
designated as events GD743 and GS784, which have been genetically 
engineered to resist browning. APHIS has received a request for an 
extension of a determination of nonregulated status of GD743 and GS784 
apples to Arctic[supreg] apple event NF872 (hereinafter NF872 apple) 
(APHIS Petition Number 16-004-01p) from Okanagan Specialty Fruits, Inc. 
(hereinafter referred to as OSF), of British Columbia, Canada. In the 
extension request, OSF named the two previously deregulated apple 
events as antecedents. Like the antecedents, NF872 apple is genetically 
engineered to be resistant to enzymatic browning. In its request, OSF 
stated that NF872 apple was produced by transforming an additional 
variety of apple using the same DNA and method that was used for the 
antecedent apples and, based on the similarity, is unlikely to pose a 
plant pest risk. Therefore, the request stated that NF872 apple should 
not be a regulated article under APHIS' regulations in 7 CFR part 340.
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    \1\ To view the notice, our determination, supporting documents, 
and the comments we have received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0025.
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    As described in the extension request, NF872 apple has been 
genetically engineered through the insertion of genetic elements from 
apples. APHIS has previously assessed the risks associated with the 
insertion of these same genetic elements into apples and concluded that 
the resulting organisms did not pose a plant pest risk. Based on the 
information in the request, we have concluded that NF872 apple is 
similar to the antecedent apples. NF872 apple is currently regulated 
under 7 CFR part 340.
    As part of our decisionmaking process regarding a genetically 
engineered organism's regulatory status, APHIS evaluates the plant pest 
risk of the article. In section 403 of the PPA, ``plant pest'' is 
defined as any living stage of any of the following that can directly 
or indirectly injure, cause damage to, or cause disease in any plant 
product: A protozoan, a nonhuman animal, a parasitic plant, a 
bacterium, a fungus, a virus or viroid, an infectious agent or other 
pathogen, or any article similar to or allied with any of the 
foregoing.
    APHIS completed a plant pest risk assessment (PPRA) for the 
antecedent organisms in which we concluded that the GD743 and GS784 
apples are unlikely to present a plant pest risk. NF872 apple expresses 
the same resistance to enzymatic browning as the antecedent apples. 
Therefore, based on our PPRA for the antecedents and the similarity 
between NF872 apple and the antecedents, APHIS has concluded that NF872 
apple is unlikely to pose a plant pest risk. APHIS also prepared a 
plant pest risk similarity assessment (PPRSA) to compare NF872 to the 
antecedents. As described in the PPRSA, the NF872 apple was obtained 
using a polyphenol oxidase (PPO) suppression construct designed to 
reduce the expression of four apple genes coding for PPO proteins. The 
PPO suppression construct used in the NF872 apple event is the same 
construct used in the antecedent apple events GD743 and GS784, and 
APHIS has concluded that the PPO suppression construct used in GD743 
and GS784 is unlikely to affect the plant pest risk of NF872. 
Furthermore, APHIS has previously reviewed the potential impacts on 
non-target organisms beneficial to agriculture and concluded that it is 
unlikely that NF872 apple will have an adverse effect on nontarget 
organisms. Therefore, based on our PPRA for GD743 apple and GS784 apple 
and the similarity between GD743 apple, GS784 apple, and NF872 apple as 
described in the PPRSA, APHIS has concluded that the PPO suppression 
construct used to obtain the NF872 apple is unlikely to pose a plant 
pest risk and that NF872 apple is unlikely to pose a different plant 
pest risk than GD743 apple and GS784 apple.
    The environmental assessment (EA) for the antecedent organisms was 
prepared using data submitted by OSF, a review of other scientific 
data, and field tests conducted under APHIS oversight. The EA was 
prepared to provide the APHIS decisionmaker with a review and analysis 
of any potential environmental impacts associated with the proposed 
determination of nonregulated status of the antecedent apples. The EA 
was prepared in accordance with (1) the National Environmental Policy 
Act of 1969 (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 the similarity of NF872 apple to the antecedent apples, 
APHIS has prepared a preliminary finding of no significant impact 
(FONSI) on NF872 apple using the EA prepared for GD743 and GS784 
apples. APHIS considered the following alternatives: (1) Take no 
action, i.e., APHIS would not change the regulatory status of NF872 
apple and it would continue to be a regulated article, or (2) make a 
determination of nonregulated status of NF872 apple. APHIS' preferred 
alternative is to make a determination of nonregulated status of NF872 
apple.
    APHIS has carefully examined the existing NEPA documentation 
completed for GD743 and GS784 apples and has concluded that OSF's 
request to extend a determination of nonregulated status to NF872 apple 
encompasses the same scope of environmental analysis as the antecedent 
apples.
    Based on APHIS' analysis of information submitted by OSF, 
references provided in the extension request, peer-reviewed 
publications, information analyzed in the EA, and the similarity of 
NF872 apple to the antecedent organisms, APHIS has determined that 
NF872 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 of GD743 and GS784 apples to NF872 
apple, whereby NF872 apple would no longer be subject to our 
regulations governing the introduction of certain genetically 
engineered organisms.
    Paragraph (e) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register announcing all preliminary decisions to 
extend determinations of nonregulated status for 30 days before the 
decisions become final and effective. In accordance with Sec.  340.6(e) 
of the regulations, we are publishing this notice to inform the public 
of our preliminary decision to extend the determination of nonregulated 
status of the antecedent apples to NF872 apple.
    APHIS will accept written comments on the preliminary FONSI 
regarding a determination of nonregulated status of NF872 apple for a 
period of 30 days from the date this notice is published in the Federal 
Register. The preliminary FONSI, as well as the extension request, 
supporting documents, and our preliminary determination for NF872 
apple, 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

[[Page 53398]]

the comments, if APHIS determines that no substantive information has 
been received that would warrant APHIS altering its preliminary 
regulatory determination or FONSI, our preliminary regulatory 
determination will become final and effective upon notification of the 
public through an announcement on our Web site at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml. 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 regarding NF872 
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 8th day of August 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-19222 Filed 8-11-16; 8:45 am]
BILLING CODE 3410-34-P