81_FR_53552 81 FR 53396 - 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® Apple Event NF872 Apple

81 FR 53396 - 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® Apple Event NF872 Apple

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 81, Issue 156 (August 12, 2016)

Page Range53396-53398
FR Document2016-19222

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.

Federal Register, Volume 81 Issue 156 (Friday, August 12, 2016)
[Federal Register Volume 81, Number 156 (Friday, August 12, 2016)]
[Notices]
[Pages 53396-53398]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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: john.t.turner@aphis.usda.gov. To obtain copies 
of the supporting documents, contact Ms. Cindy Eck at (301) 851-3885, 
email: cynthia.a.eck@aphis.usda.gov.

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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



                                                  53396                         Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Notices

                                                  Export Act that the importation of viable                 Dated: July 22, 2016.                               room 1141 of the USDA South Building,
                                                  cannabis seeds must be carried out by                   Leslie Kux,                                           14th Street and Independence Avenue
                                                  persons registered with the DEA to do                   Associate Commissioner for Policy, Food and           SW., Washington, DC. Normal reading
                                                  so. In addition, any USDA phytosanitary                 Drug Administration.                                  room hours are 8 a.m. to 4:30 p.m.,
                                                  requirements that normally would apply                  [FR Doc. 2016–19146 Filed 8–11–16; 8:45 am]           Monday through Friday, except
                                                  to the importation of plant material will               BILLING CODE 3410–01–P                                holidays. To be sure someone is there to
                                                  apply to the importation of industrial                                                                        help you, please call (202) 799–7039
                                                  hemp seed.                                                                                                    before coming.
                                                    • Section 7606 did not amend the                      DEPARTMENT OF AGRICULTURE                               Supporting documents and any
                                                  Federal Food, Drug, and Cosmetic Act.                                                                         comments we received regarding our
                                                                                                          Animal and Plant Health Inspection                    determination of nonregulated status of
                                                  For example, section 7606 did not alter                 Service
                                                  the approval process for new drug                                                                             the antecedent organisms (apple events
                                                  applications, the requirements for the                  [Docket No. APHIS–2016–0043]                          GD743 and GS784), can be found at
                                                  conduct of clinical or nonclinical                                                                            http://www.regulations.gov/
                                                                                                          Okanagan Specialty Fruits, Inc.;                      #!docketDetail;D=APHIS-2012-0025.
                                                  research, the oversight of marketing
                                                                                                          Availability of Preliminary Finding of                Supporting documents may also be
                                                  claims, or any other authorities of the
                                                                                                          No Significant Impact, Preliminary                    found on the APHIS Web site for NF872
                                                  FDA as they are set forth in that Act.
                                                                                                          Plant Pest Risk Similarity Assessment,                ‘Arctic® Fuji apple’ (the organism under
                                                    • The Federal Government does not                     and Preliminary Determination for an                  evaluation) under APHIS Petition
                                                  construe section 7606 to alter the                      Extension of a Determination of                       Number 16–004–01p, and the
                                                  requirements of the Controlled                          Nonregulated Status for Non-Browning                  antecedent organisms (apple events
                                                  Substances Act (CSA) that apply to the                  Arctic® Apple Event NF872 Apple                       GD743 and GS784) under APHIS
                                                  manufacture, distribution, and                                                                                Petition Number 10–161–01p.
                                                  dispensing of drug products containing                  AGENCY:  Animal and Plant Health
                                                                                                          Inspection Service, USDA.                             FOR FURTHER INFORMATION CONTACT: Dr.
                                                  controlled substances. Manufacturers,
                                                                                                          ACTION: Notice.                                       John Turner, Director, Biotechnology
                                                  distributors, dispensers of drug products
                                                                                                                                                                Risk Analysis Programs, Biotechnology
                                                  derived from cannabis plants, as well as                SUMMARY:   We are advising the public                 Regulatory Services, APHIS, 4700 River
                                                  those conducting research with such                     that the Animal and Plant Health                      Road Unit 147, Riverdale, MD 20737–
                                                  drug products, must continue to adhere                  Inspection Service has reached a                      1236; (301) 851–3954, email:
                                                  to the CSA requirements.                                preliminary decision to extend our                    john.t.turner@aphis.usda.gov. To obtain
                                                    • Institutions of higher education and                determination of nonregulated status of               copies of the supporting documents,
                                                  other participants authorized to carry                  Okanagan Specialty Fruits’ (OSF) GS784                contact Ms. Cindy Eck at (301) 851–
                                                  out agricultural pilot programs under                   and GD743 apples to OSF NF872                         3885, email: cynthia.a.eck@
                                                  section 7606 may be able to participate                 ‘Arctic® Fuji apple’. OSF’s NF872 apple               aphis.usda.gov.
                                                  in USDA research or other programs to                   has been genetically engineered for
                                                  the extent otherwise eligible for                       enzymatic browning resistance using                   SUPPLEMENTARY INFORMATION:      Under the
                                                  participation in those programs.                        the same mode of action as GS784 and                  authority of the plant pest provisions of
                                                                                                          GD743 apples. We are making available                 the Plant Protection Act (PPA) (7 U.S.C.
                                                  2. Regulatory Requirements                              for public comment our preliminary                    7701 et seq.), the regulations in 7 CFR
                                                                                                          determination, preliminary plant pest                 part 340, ‘‘Introduction of Organisms
                                                     This Statement of Principles does not                                                                      and Products Altered or Produced
                                                  establish any binding legal                             risk similarity assessment, and
                                                                                                          preliminary finding of no significant                 Through Genetic Engineering Which
                                                  requirements. It is, therefore, exempt                                                                        Are Plant Pests or Which There Is
                                                  from notice and comment rulemaking                      impact for the proposed determination
                                                                                                          of nonregulated status.                               Reason to Believe Are Plant Pests,’’
                                                  requirements under the Administrative                                                                         regulate, among other things, the
                                                  Procedure Act pursuant to 5 U.S.C.                      DATES: We will consider all comments
                                                                                                          that we receive on or before September                introduction (importation, interstate
                                                  553(b). Because no notice of proposed                                                                         movement, or release into the
                                                  rulemaking is required, the Regulatory                  12, 2016.
                                                                                                                                                                environment) of organisms and products
                                                  Flexibility Act does not require an                     ADDRESSES: You may submit comments
                                                                                                                                                                altered or produced through genetic
                                                  initial or final regulatory flexibility                 by either of the following methods:
                                                                                                                                                                engineering that are plant pests or that
                                                  analysis. 5 U.S.C. 603(a), 604(a). USDA                    • Federal eRulemaking Portal: Go to
                                                                                                                                                                there is reason to believe are plant pests.
                                                  has determined that this Statement of                   http://www.regulations.gov/
                                                                                                                                                                Such genetically engineered organisms
                                                  Principles does not impose any new or                   #!docketDetail;D=APHIS-2016-0043.
                                                                                                             • Postal Mail/Commercial Delivery:                 and products are considered ‘‘regulated
                                                  revise any existing recordkeeping,                                                                            articles.’’
                                                  reporting, or disclosure requirements on                Send your comment to Docket No.
                                                                                                          APHIS–2016–0043, Regulatory Analysis                     The regulations in § 340.6(a) provide
                                                  covered entities or members of the                                                                            that any person may submit a petition
                                                  public that would be collections of                     and Development, PPD, APHIS, Station
                                                                                                          3A–03.8, 4700 River Road Unit 118,                    to the Animal and Plant Health
                                                  information requiring OMB approval                                                                            Inspection Service (APHIS) seeking a
                                                  under the Paperwork Reduction Act, 44                   Riverdale, MD 20737–1238.
                                                                                                             The Okanagan Specialty Fruits                      determination that an article should not
                                                  U.S.C. 3501, et seq.                                                                                          be regulated under 7 CFR part 340.
                                                                                                          extension request, our preliminary
                                                    Dated: July 25, 2016.                                 determination, preliminary plant pest                 Further, the regulations in § 340.6(e)(2)
mstockstill on DSK3G9T082PROD with NOTICES




                                                  Thomas J. Vilsack,                                      risk similarity assessment, preliminary               provide that a person may request that
                                                  Secretary of Agriculture.                               finding of no significant impact, and                 APHIS extend a determination of
                                                                                                          any comments we receive on this docket                nonregulated status to other organisms.
                                                    Dated: July 21, 2016.                                 may be viewed at http://                              Such a request must include
                                                  Louis J. Milione,                                       www.regulations.gov/                                  information to establish the similarity of
                                                  Deputy Assistant Administrator, Drug                    #!docketDetail;D=APHIS-2016-0043 or                   the antecedent organism and the
                                                  Enforcement Administration.                             in our reading room, which is located in              regulated article in question.


                                             VerDate Sep<11>2014   18:42 Aug 11, 2016   Jkt 238001   PO 00000   Frm 00002   Fmt 4703   Sfmt 4703   E:\FR\FM\12AUN1.SGM   12AUN1


                                                                                Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Notices                                          53397

                                                     In a notice 1 published in the Federal               NF872 apple expresses the same                        the following alternatives: (1) Take no
                                                  Register on November 8, 2013 (78 FR                     resistance to enzymatic browning as the               action, i.e., APHIS would not change the
                                                  67100, Docket No. APHIS–2012–0025),                     antecedent apples. Therefore, based on                regulatory status of NF872 apple and it
                                                  APHIS announced our determination of                    our PPRA for the antecedents and the                  would continue to be a regulated article,
                                                  nonregulated status of apples (Malus                    similarity between NF872 apple and the                or (2) make a determination of
                                                  domestica) designated as events GD743                   antecedents, APHIS has concluded that                 nonregulated status of NF872 apple.
                                                  and GS784, which have been genetically                  NF872 apple is unlikely to pose a plant               APHIS’ preferred alternative is to make
                                                  engineered to resist browning. APHIS                    pest risk. APHIS also prepared a plant                a determination of nonregulated status
                                                  has received a request for an extension                 pest risk similarity assessment (PPRSA)               of NF872 apple.
                                                  of a determination of nonregulated                      to compare NF872 to the antecedents.                     APHIS has carefully examined the
                                                  status of GD743 and GS784 apples to                     As described in the PPRSA, the NF872                  existing NEPA documentation
                                                  Arctic® apple event NF872 (hereinafter                  apple was obtained using a polyphenol                 completed for GD743 and GS784 apples
                                                  NF872 apple) (APHIS Petition Number                     oxidase (PPO) suppression construct                   and has concluded that OSF’s request to
                                                  16–004–01p) from Okanagan Specialty                     designed to reduce the expression of                  extend a determination of nonregulated
                                                  Fruits, Inc. (hereinafter referred to as                four apple genes coding for PPO                       status to NF872 apple encompasses the
                                                  OSF), of British Columbia, Canada. In                   proteins. The PPO suppression                         same scope of environmental analysis as
                                                  the extension request, OSF named the                    construct used in the NF872 apple event               the antecedent apples.
                                                  two previously deregulated apple events                 is the same construct used in the                        Based on APHIS’ analysis of
                                                  as antecedents. Like the antecedents,                   antecedent apple events GD743 and                     information submitted by OSF,
                                                  NF872 apple is genetically engineered                   GS784, and APHIS has concluded that                   references provided in the extension
                                                  to be resistant to enzymatic browning.                  the PPO suppression construct used in                 request, peer-reviewed publications,
                                                  In its request, OSF stated that NF872                   GD743 and GS784 is unlikely to affect                 information analyzed in the EA, and the
                                                  apple was produced by transforming an                   the plant pest risk of NF872.                         similarity of NF872 apple to the
                                                  additional variety of apple using the                   Furthermore, APHIS has previously                     antecedent organisms, APHIS has
                                                  same DNA and method that was used                       reviewed the potential impacts on non-                determined that NF872 apple is unlikely
                                                  for the antecedent apples and, based on                 target organisms beneficial to                        to pose a plant pest risk. We have
                                                  the similarity, is unlikely to pose a plant             agriculture and concluded that it is                  therefore reached a preliminary decision
                                                  pest risk. Therefore, the request stated                unlikely that NF872 apple will have an                to approve the request to extend the
                                                  that NF872 apple should not be a                        adverse effect on nontarget organisms.                determination of nonregulated status of
                                                  regulated article under APHIS’                          Therefore, based on our PPRA for                      GD743 and GS784 apples to NF872
                                                  regulations in 7 CFR part 340.                          GD743 apple and GS784 apple and the                   apple, whereby NF872 apple would no
                                                     As described in the extension request,               similarity between GD743 apple, GS784                 longer be subject to our regulations
                                                  NF872 apple has been genetically                        apple, and NF872 apple as described in                governing the introduction of certain
                                                  engineered through the insertion of                     the PPRSA, APHIS has concluded that                   genetically engineered organisms.
                                                                                                          the PPO suppression construct used to                    Paragraph (e) of § 340.6 provides that
                                                  genetic elements from apples. APHIS
                                                                                                          obtain the NF872 apple is unlikely to                 APHIS will publish a notice in the
                                                  has previously assessed the risks
                                                                                                          pose a plant pest risk and that NF872                 Federal Register announcing all
                                                  associated with the insertion of these
                                                                                                          apple is unlikely to pose a different                 preliminary decisions to extend
                                                  same genetic elements into apples and
                                                                                                          plant pest risk than GD743 apple and                  determinations of nonregulated status
                                                  concluded that the resulting organisms                                                                        for 30 days before the decisions become
                                                  did not pose a plant pest risk. Based on                GS784 apple.
                                                                                                             The environmental assessment (EA)                  final and effective. In accordance with
                                                  the information in the request, we have                                                                       § 340.6(e) of the regulations, we are
                                                  concluded that NF872 apple is similar                   for the antecedent organisms was
                                                                                                          prepared using data submitted by OSF,                 publishing this notice to inform the
                                                  to the antecedent apples. NF872 apple                                                                         public of our preliminary decision to
                                                                                                          a review of other scientific data, and
                                                  is currently regulated under 7 CFR part                                                                       extend the determination of
                                                                                                          field tests conducted under APHIS
                                                  340.                                                                                                          nonregulated status of the antecedent
                                                     As part of our decisionmaking process                oversight. The EA was prepared to
                                                                                                          provide the APHIS decisionmaker with                  apples to NF872 apple.
                                                  regarding a genetically engineered                                                                               APHIS will accept written comments
                                                  organism’s regulatory status, APHIS                     a review and analysis of any potential
                                                                                                          environmental impacts associated with                 on the preliminary FONSI regarding a
                                                  evaluates the plant pest risk of the                                                                          determination of nonregulated status of
                                                                                                          the proposed determination of
                                                  article. In section 403 of the PPA, ‘‘plant                                                                   NF872 apple for a period of 30 days
                                                                                                          nonregulated status of the antecedent
                                                  pest’’ is defined as any living stage of                                                                      from the date this notice is published in
                                                                                                          apples. The EA was prepared in
                                                  any of the following that can directly or                                                                     the Federal Register. The preliminary
                                                                                                          accordance with (1) the National
                                                  indirectly injure, cause damage to, or                                                                        FONSI, as well as the extension request,
                                                                                                          Environmental Policy Act of 1969
                                                  cause disease in any plant product: A                                                                         supporting documents, and our
                                                                                                          (NEPA), as amended (42 U.S.C. 4321 et
                                                  protozoan, a nonhuman animal, a                                                                               preliminary determination for NF872
                                                                                                          seq.); (2) regulations of the Council on
                                                  parasitic plant, a bacterium, a fungus, a                                                                     apple, are available for public review as
                                                                                                          Environmental Quality for
                                                  virus or viroid, an infectious agent or                                                                       indicated under ADDRESSES and FOR
                                                                                                          implementing the procedural provisions
                                                  other pathogen, or any article similar to                                                                     FURTHER INFORMATION CONTACT above.
                                                                                                          of NEPA (40 CFR parts 1500–1508); (3)
                                                  or allied with any of the foregoing.                    USDA regulations implementing NEPA                    Copies of these documents may also be
                                                     APHIS completed a plant pest risk                                                                          obtained by contacting the person listed
                                                                                                          (7 CFR part 1b); and (4) APHIS’ NEPA
                                                  assessment (PPRA) for the antecedent                                                                          under FOR FURTHER INFORMATION
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                                                                                                          Implementing Procedures (7 CFR part
                                                  organisms in which we concluded that                                                                          CONTACT.
                                                                                                          372).
                                                  the GD743 and GS784 apples are                             Based on the similarity of NF872                      After the comment period closes,
                                                  unlikely to present a plant pest risk.                  apple to the antecedent apples, APHIS                 APHIS will review all written comments
                                                    1 To view the notice, our determination,
                                                                                                          has prepared a preliminary finding of no              received during the comment period
                                                  supporting documents, and the comments we have
                                                                                                          significant impact (FONSI) on NF872                   and any other relevant information. All
                                                  received, go to http://www.regulations.gov/             apple using the EA prepared for GD743                 comments will be available for public
                                                  #!docketDetail;D=APHIS-2012-0025.                       and GS784 apples. APHIS considered                    review. After reviewing and evaluating


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                                                  53398                         Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Notices

                                                  the comments, if APHIS determines that                  APHIS–2016–0031, Regulatory Analysis                  Although OFF is not established in the
                                                  no substantive information has been                     and Development, PPD, APHIS, Station                  continental United States, new
                                                  received that would warrant APHIS                       3A–03.8, 4700 River Road, Unit 118,                   infestations have been detected on an
                                                  altering its preliminary regulatory                     Riverdale, MD 20737–1238.                             almost annual basis since it was first
                                                  determination or FONSI, our                               Supporting documents and any                        detected in California in 1960. The
                                                  preliminary regulatory determination                    comments we receive on this docket                    Mexfly has been introduced repeatedly
                                                  will become final and effective upon                    may be viewed at http://                              to Texas and eradicated since its first
                                                  notification of the public through an                   www.regulations.gov/                                  introduction in 1927. The risk of
                                                  announcement on our Web site at http://                 #!docketDetail;D=APHIS-2016-0031 or                   introduction along the Mexican and
                                                  www.aphis.usda.gov/biotechnology/                       in our reading room, which is located in              U.S. border continues to increase as the
                                                  petitions_table_pending.shtml. APHIS                    Room 1141 of the USDA South                           rate of infestations in Mexico increases
                                                  will also furnish a response to the                     Building, 14th Street and Independence                annually.
                                                  petitioner regarding our final regulatory               Avenue SW., Washington, DC. Normal                       The regulations in ‘‘Subpart—Fruit
                                                  determination. No further Federal                       reading room hours are 8 a.m. to 4:30                 Flies’’ (7 CFR 301.32 through 301.32–10,
                                                  Register notice will be published                       p.m., Monday through Friday, except                   referred to below as the regulations),
                                                  announcing the final regulatory                         holidays. To be sure someone is there to              restrict the movement of certain
                                                  determination regarding NF872 apple.                    help you, please call (202) 799–7039                  regulated articles from quarantined
                                                    Authority: 7 U.S.C. 7701–7772 and 7781–               before coming.                                        areas in order to prevent the spread of
                                                  7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and             FOR FURTHER INFORMATION CONTACT: For                  fruit flies to noninfested areas of the
                                                  371.3.                                                  questions related to the Fruit Fly                    United States. Within the quarantined
                                                    Done in Washington, DC, this 8th day of               Eradication Program, contact Mr. John                 areas, Animal and Plant Health
                                                  August 2016.                                            C. Stewart, APHIS National Fruit Fly                  Inspection Service (APHIS) works with
                                                  Kevin Shea,                                             Eradication Program Manager, Center                   State and local officials to eradicate fruit
                                                  Administrator, Animal and Plant Health                  for Plant Health Science and                          flies, after which the quarantine can be
                                                  Inspection Service.                                     Technology, PPQ, APHIS, 1730 Varsity                  removed.
                                                  [FR Doc. 2016–19222 Filed 8–11–16; 8:45 am]             Drive, Suite 400, Raleigh NC 27606,                      Current efforts to eradicate
                                                  BILLING CODE 3410–34–P                                  John.C.Stewart@aphis.usda.gov; (919)                  infestations include chemical and
                                                                                                          855–7426. For questions related to the                nonchemical control measures.
                                                                                                          environmental impact statement,                       Chemical options may include
                                                  DEPARTMENT OF AGRICULTURE                               contact Dr. Jim Warren, Environmental                 applications of insecticides and/or the
                                                                                                          Protection Specialist, Environmental                  use of detection and control attractants
                                                  Animal and Plant Health Inspection                      and Risk Analysis Services, PPD,                      that can be applied using various
                                                  Service                                                 APHIS, 4700 River Road, Unit 149,                     methods. Nonchemical control methods
                                                  [Docket No. APHIS–2016–0031]                            Riverdale, MD 20737; Jim.E.Warren@                    include sterile insect technique (SIT)
                                                                                                          aphis.usda.gov; (202) 316–3216.                       and host removal from areas in and
                                                  Environmental Impact Statement; Fruit                   SUPPLEMENTARY INFORMATION:                            around the detection sites.
                                                  Fly Eradication Program                                                                                          Under the provisions of the National
                                                                                                          Background                                            Environmental Policy Act of 1969
                                                  AGENCY:  Animal and Plant Health
                                                  Inspection Service, USDA.                                  Non-native (exotic) fruit flies in the             (NEPA), as amended (42 U.S.C 4321 et
                                                                                                          family Tephritidae have a wide host                   seq.), Federal agencies must examine
                                                  ACTION: Notice of intent to prepare an
                                                                                                          range, including more than 400 species                the potential environmental effects of
                                                  environmental impact statement.
                                                                                                          of fruit and vegetables. Introduction of              the proposed Federal actions and
                                                  SUMMARY:   We are advising the public                   these pest species into the United States             alternatives. A final environmental
                                                  that the Animal and Plant Health                        causes economic losses from destruction               impact statement (EIS) was prepared in
                                                  Inspection Service plans to prepare an                  and spoiling of host commodities by                   2001 to examine the environmental
                                                  updated environmental impact                            larvae, costs associated with                         effects of the fruit fly cooperative
                                                  statement to analyze the effects of a                   implementing control measures,                        control program. Since the publication
                                                  program to eradicate exotic fruit fly                   environmental impacts due to increased                of the 2001 EIS, there have been
                                                  species from wherever they might occur                  pesticide usage if fruit flies become                 scientific and technological advances in
                                                  in the United States, including Hawaii,                 established, and loss of market share                 the field. As a result, we are planning
                                                  Guam, American Samoa, Puerto Rico,                      due to restrictions on shipment of host               to prepare a new EIS to analyze and
                                                  and the U.S. Virgin Islands. This notice                commodities. Three species pose the                   examine the environmental effects of
                                                  identifies potential issues and                         greatest risk to United States agriculture:           control alternatives available to the
                                                  alternatives that will be studied in the                the Mediterranean fruit fly (Medfly),                 agency, including a no action
                                                  environmental impact statement, and                     Ceratitis capitata; the Oriental fruit fly            alternative. It will be used for planning
                                                  requests public comments to further                     (OFF), Bactrocera dorsalis; and the                   and decisionmaking and to inform the
                                                  delineate the scope of the alternatives                 Mexican fruit fly (Mexfly), Anastrepha                public about the environmental effects
                                                  and environmental impacts and issues.                   ludens.                                               of APHIS’ fruit fly eradication activities.
                                                  DATES: We will consider all comments                       Currently, Medfly is established in                It will also provide an overview of
                                                  that we receive on or before September                  Hawaii where it was first detected in                 APHIS activities to which we can tier
                                                  26, 2016.                                               1910. Although Medfly has been                        site-specific analyses and environmental
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                                                  ADDRESSES: You may submit comments                      periodically introduced to the United                 assessments if new fruit fly infestations
                                                  by either of the following methods:                     States mainland since 1929, successful                are discovered in the United States.
                                                     • Federal eRulemaking Portal: Go to                  eradication programs have prevented it                   We are requesting public comment to
                                                  http://www.regulations.gov/                             from becoming an established pest in                  help us identify or confirm potential
                                                  #!docketDetail;D=APHIS-2016-0031.                       the continental United States. OFF was                alternatives and environmental issues
                                                     • Postal Mail/Commercial Delivery:                   introduced into Hawaii in the 1940s and               that should be examined in the EIS, as
                                                  Send your comment to Docket No.                         has since became established there.                   well as comments that identify other


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Document Created: 2018-02-09 11:32:49
Document Modified: 2018-02-09 11:32:49
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesWe will consider all comments that we receive on or before September 12, 2016.
ContactDr. 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]
FR Citation81 FR 53396 

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