81_FR_8065 81 FR 8034 - Syngenta Seeds Inc.; Availability of a Preliminary Finding of No Significant Impact and Preliminary Decision for an Extension of a Determination of Nonregulated Status of Corn Genetically Engineered for Insect and Glufosinate-Ammonium Resistance

81 FR 8034 - Syngenta Seeds Inc.; Availability of a Preliminary Finding of No Significant Impact and Preliminary Decision for an Extension of a Determination of Nonregulated Status of Corn Genetically Engineered for Insect and Glufosinate-Ammonium Resistance

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 81, Issue 31 (February 17, 2016)

Page Range8034-8035
FR Document2016-03193

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 Pioneer corn event DP-004114-3 (hereinafter Pioneer 4114 corn) to Syngenta's corn event MZIR098 in response to a request from Syngenta Seeds Inc. MZIR098 corn has been genetically engineered for resistance to insects and to the herbicide glufosinate-ammonium using the same mechanism of action as Pioneer 4114. We are making available for public comment our preliminary regulatory determination, preliminary finding of no significant impact, and plant pest risk similarity assessment for the proposed determination of nonregulated status.

Federal Register, Volume 81 Issue 31 (Wednesday, February 17, 2016)
[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Notices]
[Pages 8034-8035]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-03193]


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Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

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Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / 
Notices

[[Page 8034]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2016-0002]


Syngenta Seeds Inc.; Availability of a Preliminary Finding of No 
Significant Impact and Preliminary Decision for an Extension of a 
Determination of Nonregulated Status of Corn Genetically Engineered for 
Insect and Glufosinate-Ammonium Resistance

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 Pioneer corn event DP-004114-3 
(hereinafter Pioneer 4114 corn) to Syngenta's corn event MZIR098 in 
response to a request from Syngenta Seeds Inc. MZIR098 corn has been 
genetically engineered for resistance to insects and to the herbicide 
glufosinate-ammonium using the same mechanism of action as Pioneer 
4114. We are making available for public comment our preliminary 
regulatory determination, preliminary finding of no significant impact, 
and plant pest risk similarity assessment for the proposed 
determination of nonregulated status.

DATES: We will consider all comments that we receive on or before March 
18, 2016.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2016-0002.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2016-0002, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    The Syngenta Seeds Inc. extension request, our preliminary finding 
of no significant impact, our preliminary determination, and any 
comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2016-0002 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 organism, 
Pioneer 4114 corn, can be found at http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0026. Supporting documents may also be 
found on the APHIS Web site for MZIR098 corn (the organism under 
evaluation) under APHIS Petition Number 15-218-01p, and the antecedent 
organism Pioneer 4114 corn under APHIS Petition Number 11-244-01p.

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) 851-3892, 
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 (GE) 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.
    On June 20, 2013,\1\ APHIS announced its determination of 
nonregulated status of Pioneer 4114 corn, which was genetically 
engineered for resistant to certain lepidopteran and coleopteran pests 
and resistance to the herbicide glufosinate-ammonium. APHIS has 
received a request for an extension of a determination of nonregulated 
status of Pioneer 4114 corn to corn designated as event MZIR098 (APHIS 
Petition Number 15-218-01p) from Syngenta Seeds Inc. (Syngenta) of 
Research Triangle Park, NC. MZIR098 corn expresses resistance to both 
coleopteran pests and the herbicide glufosinate-ammonium. In its 
request, Syngenta stated that this corn is similar to the antecedent 
organism Pioneer 4114 corn and, based on the similarity to the 
antecedent organism, is unlikely to pose a plant pest risk and, 
therefore, should not be a regulated article under APHIS' regulations 
in 7 CFR part 340.
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    \1\ https://www.aphis.usda.gov/brs/aphisdocs/11_24401p_det.pdf.
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    As described in the extension request, MZIR098 corn was developed 
through agrobacterium-mediated transformation to stably incorporate 
genes designated as ecry3.1Ab and mcry3A, which encode the insecticidal 
proteins eCry3.1Ab and mCry3A, and pat-08, which encodes the enzyme 
phosphinothricin acetyltransferase (PAT) to provide herbicide 
resistance. The native Cry3A, derived from the soil bacterium Bacillus 
thuringiensis subsp. Tenebrionis, is active against certain coleopteran 
pests. MZIR098 contains a modified version, mCry3A, which has enhanced 
activity against western corn rootworm (Diabrotica virgifera virgifera) 
and other related coleopteran pests of corn. The other insecticidal 
protein in MZIR098 is the engineered eCry3.1Ab protein which is a 
chimera of mCry3A and Cry1Ab. Like mCry3A, eCry3.1Ab is

[[Page 8035]]

active against D. virgifera virgifera and certain other coleopteran 
pests of corn. The native Cry1Ab from B. thuringiensis subsp. kurstaki 
is active against certain lepidopteran pests, however, the portion of 
Cry1Ab included in eCry3.1Ab does not retain activity against 
lepidopterans. The transgene pat-08 was derived from the soil bacterium 
Streptomyces viridochromogenes. The PAT enzyme deactivates glufosinate 
herbicides thus conferring glufosinate resistance to the plants. PAT 
was also used as a selectable marker in the development of MZIR098 
corn. The antecedent organism, Pioneer 4114 corn, was similarly 
genetically engineered to produce proteins which have the same 
mechanisms of action as do the proteins produced in MZIR098 corn. Based 
on the information in the request, we have concluded that MZIR098 corn 
is similar to Pioneer 4114 corn. MZIR098 corn is currently regulated 
under 7 CFR part 340.
    As part of our decisionmaking process regarding a GE 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) on the 
antecedent organism in which we concluded that Pioneer 4114 corn is 
unlikely to present plant pest risks. APHIS also prepared a plant pest 
risk similarity assessment (PPRSA) to compare MZIR098 to the 
antecedent. As described in the PPRSA, the proteins expressed in 
MZIR098 corn are similar to those expressed in Pioneer 4114 corn, and 
APHIS has concluded that the proteins expressed in Pioneer 4114 corn 
are unlikely to pose a plant health risk. Furthermore, the 
Environmental Protection Agency reviewed the safety of the proteins 
expressed in MZIR098 corn and concluded that there would ``no 
unreasonable adverse effects on the environment'' from exposures to 
these proteins. Therefore, based on our PPRA for Pioneer 4114 corn and 
the similarity between Pioneer 4114 corn and MZIR098 corn as described 
in the PPRSA, APHIS has concluded that the proteins expressed in 
MZIR098 corn are unlikely to pose a plant pest risk.
    In addition, APHIS has carefully examined the existing National 
Environmental Policy Act (NEPA) documentation completed for Pioneer 
4114 corn and has concluded that Syngenta's request to extend a 
determination of nonregulated status to MZIR098 corn encompasses the 
same scope of environmental analysis as Pioneer 4114 corn. Therefore, 
based on the similarity of MZIR098 corn to Pioneer 4114 corn, APHIS has 
prepared a preliminary finding of no significant impact (FONSI) on 
MZIR098 corn. The FONSI was prepared in accordance with: (1) 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).
    APHIS is considering the following alternatives: (1) Take no 
action, i.e., APHIS would not change the regulatory status of MZIR098 
corn and it would continue to be a regulated article, or (2) make a 
determination of nonregulated status of MZIR098 corn. APHIS' preferred 
alternative is to make a determination of nonregulated status of 
MZIR098 corn.
    APHIS has analyzed information submitted by Syngenta, references 
provided in the extension request, peer-reviewed publications, and 
information in the NEPA documentation prepared for the antecedent 
organism. APHIS has also analyzed information in the PPRA for the 
antecedent organism and other information. Based on APHIS' analysis of 
this information and the similarity of MZIR098 corn to the antecedent 
organism Pioneer's 4114 corn, APHIS has determined that MZIR098 corn 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 Pioneer 4114 corn to MZIR098 corn, whereby 
MZIR098 corn 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 Pioneer 4114 corn to MZIR098 corn.
    APHIS will accept written comments on the preliminary FONSI 
regarding a determination of nonregulated status of MZIR098 corn 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 with appended 
PPRSA for MZIR098 corn, 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 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 MZIR098 corn.

    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 10th day of February 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-03193 Filed 2-16-16; 8:45 am]
BILLING CODE 3410-34-P



                                                    8034

                                                    Notices                                                                                                       Federal Register
                                                                                                                                                                  Vol. 81, No. 31

                                                                                                                                                                  Wednesday, February 17, 2016



                                                    This section of the FEDERAL REGISTER                    3A–03.8, 4700 River Road Unit 118,                       The regulations in § 340.6(a) provide
                                                    contains documents other than rules or                  Riverdale, MD 20737–1238.                             that any person may submit a petition
                                                    proposed rules that are applicable to the                  The Syngenta Seeds Inc. extension                  to the Animal and Plant Health
                                                    public. Notices of hearings and investigations,         request, our preliminary finding of no                Inspection Service (APHIS) seeking a
                                                    committee meetings, agency decisions and                significant impact, our preliminary                   determination that an article should not
                                                    rulings, delegations of authority, filing of            determination, and any comments we                    be regulated under 7 CFR part 340.
                                                    petitions and applications and agency
                                                    statements of organization and functions are
                                                                                                            receive on this docket may be viewed at               Further, the regulations in § 340.6(e)(2)
                                                    examples of documents appearing in this                 http://www.regulations.gov/#!docket                   provide that a person may request that
                                                    section.                                                Detail;D=APHIS-2016-0002 or in our                    APHIS extend a determination of
                                                                                                            reading room, which is located in room                nonregulated status to other organisms.
                                                                                                            1141 of the USDA South Building, 14th                 Such a request must include
                                                    DEPARTMENT OF AGRICULTURE                               Street and Independence Avenue SW.,                   information to establish the similarity of
                                                                                                            Washington, DC. Normal reading room                   the antecedent organism and the
                                                    Animal and Plant Health Inspection                      hours are 8 a.m. to 4:30 p.m., Monday                 regulated article in question.
                                                    Service                                                 through Friday, except holidays. To be                   On June 20, 2013,1 APHIS announced
                                                                                                            sure someone is there to help you,                    its determination of nonregulated status
                                                    [Docket No. APHIS–2016–0002]
                                                                                                            please call (202) 799–7039 before                     of Pioneer 4114 corn, which was
                                                    Syngenta Seeds Inc.; Availability of a                  coming.                                               genetically engineered for resistant to
                                                    Preliminary Finding of No Significant                      Supporting documents and any                       certain lepidopteran and coleopteran
                                                    Impact and Preliminary Decision for an                  comments we received regarding our                    pests and resistance to the herbicide
                                                    Extension of a Determination of                         determination of nonregulated status of               glufosinate-ammonium. APHIS has
                                                    Nonregulated Status of Corn                             the antecedent organism, Pioneer 4114                 received a request for an extension of a
                                                    Genetically Engineered for Insect and                   corn, can be found at http://www.                     determination of nonregulated status of
                                                    Glufosinate-Ammonium Resistance                         regulations.gov/#!docketDetail;D=                     Pioneer 4114 corn to corn designated as
                                                                                                            APHIS-2012-0026. Supporting                           event MZIR098 (APHIS Petition Number
                                                    AGENCY:  Animal and Plant Health                        documents may also be found on the                    15–218–01p) from Syngenta Seeds Inc.
                                                    Inspection Service, USDA.                               APHIS Web site for MZIR098 corn (the                  (Syngenta) of Research Triangle Park,
                                                    ACTION: Notice.                                         organism under evaluation) under                      NC. MZIR098 corn expresses resistance
                                                                                                            APHIS Petition Number 15–218–01p,                     to both coleopteran pests and the
                                                    SUMMARY:   We are advising the public                   and the antecedent organism Pioneer                   herbicide glufosinate-ammonium. In its
                                                    that the Animal and Plant Health                        4114 corn under APHIS Petition                        request, Syngenta stated that this corn is
                                                    Inspection Service has reached a                        Number 11–244–01p.                                    similar to the antecedent organism
                                                    preliminary decision to extend our                      FOR FURTHER INFORMATION CONTACT: Dr.                  Pioneer 4114 corn and, based on the
                                                    determination of nonregulated status of                 John Turner, Director, Biotechnology                  similarity to the antecedent organism, is
                                                    Pioneer corn event DP–004114–3                          Risk Analysis Programs, Biotechnology                 unlikely to pose a plant pest risk and,
                                                    (hereinafter Pioneer 4114 corn) to                      Regulatory Services, APHIS, 4700 River                therefore, should not be a regulated
                                                    Syngenta’s corn event MZIR098 in                        Road Unit 147 Riverdale, MD 20737–                    article under APHIS’ regulations in 7
                                                    response to a request from Syngenta                     1236; (301) 851–3954, email:                          CFR part 340.
                                                    Seeds Inc. MZIR098 corn has been                        john.t.turner@aphis.usda.gov. To obtain                  As described in the extension request,
                                                    genetically engineered for resistance to                copies of the supporting documents,                   MZIR098 corn was developed through
                                                    insects and to the herbicide glufosinate-               contact Ms. Cindy Eck at (301) 851–                   agrobacterium-mediated transformation
                                                    ammonium using the same mechanism                       3892, email: cynthia.a.eck@                           to stably incorporate genes designated
                                                    of action as Pioneer 4114. We are                       aphis.usda.gov.                                       as ecry3.1Ab and mcry3A, which
                                                    making available for public comment                                                                           encode the insecticidal proteins
                                                                                                            SUPPLEMENTARY INFORMATION: Under the
                                                    our preliminary regulatory                                                                                    eCry3.1Ab and mCry3A, and pat-08,
                                                                                                            authority of the plant pest provisions of             which encodes the enzyme
                                                    determination, preliminary finding of                   the Plant Protection Act (PPA) (7 U.S.C.
                                                    no significant impact, and plant pest                                                                         phosphinothricin acetyltransferase
                                                                                                            7701 et seq.), the regulations in 7 CFR               (PAT) to provide herbicide resistance.
                                                    risk similarity assessment for the                      part 340, ‘‘Introduction of Organisms
                                                    proposed determination of nonregulated                                                                        The native Cry3A, derived from the soil
                                                                                                            and Products Altered or Produced                      bacterium Bacillus thuringiensis subsp.
                                                    status.                                                 Through Genetic Engineering Which
                                                    DATES: We will consider all comments
                                                                                                                                                                  Tenebrionis, is active against certain
                                                                                                            Are Plant Pests or Which There Is                     coleopteran pests. MZIR098 contains a
                                                    that we receive on or before March 18,                  Reason to Believe Are Plant Pests,’’                  modified version, mCry3A, which has
                                                    2016.                                                   regulate, among other things, the                     enhanced activity against western corn
                                                    ADDRESSES: You may submit comments                      introduction (importation, interstate
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                                                                                                                                  rootworm (Diabrotica virgifera virgifera)
                                                    by either of the following methods:                     movement, or release into the                         and other related coleopteran pests of
                                                       • Federal eRulemaking Portal: Go to                  environment) of organisms and products                corn. The other insecticidal protein in
                                                    http://www.regulations.gov/#!docket                     altered or produced through genetic                   MZIR098 is the engineered eCry3.1Ab
                                                    Detail;D=APHIS-2016-0002.                               engineering that are plant pests or that              protein which is a chimera of mCry3A
                                                       • Postal Mail/Commercial Delivery:                   there is reason to believe are plant pests.           and Cry1Ab. Like mCry3A, eCry3.1Ab is
                                                    Send your comment to Docket No.                         Such genetically engineered organisms
                                                    APHIS–2016–0002, Regulatory Analysis                    (GE) and products are considered                        1 https://www.aphis.usda.gov/brs/aphisdocs/11_

                                                    and Development, PPD, APHIS, Station                    ‘‘regulated articles.’’                               24401p_det.pdf.



                                               VerDate Sep<11>2014   19:05 Feb 16, 2016   Jkt 238001   PO 00000   Frm 00001   Fmt 4703   Sfmt 4703   E:\FR\FM\17FEN1.SGM   17FEN1


                                                                              Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices                                                  8035

                                                    active against D. virgifera virgifera and               documentation completed for Pioneer                   determination of nonregulated status of
                                                    certain other coleopteran pests of corn.                4114 corn and has concluded that                      MZIR098 corn for a period of 30 days
                                                    The native Cry1Ab from B. thuringiensis                 Syngenta’s request to extend a                        from the date this notice is published in
                                                    subsp. kurstaki is active against certain               determination of nonregulated status to               the Federal Register. The preliminary
                                                    lepidopteran pests, however, the portion                MZIR098 corn encompasses the same                     FONSI, as well as the extension request,
                                                    of Cry1Ab included in eCry3.1Ab does                    scope of environmental analysis as                    supporting documents, and our
                                                    not retain activity against lepidopterans.              Pioneer 4114 corn. Therefore, based on                preliminary determination with
                                                    The transgene pat-08 was derived from                   the similarity of MZIR098 corn to                     appended PPRSA for MZIR098 corn, are
                                                    the soil bacterium Streptomyces                         Pioneer 4114 corn, APHIS has prepared                 available for public review as indicated
                                                    viridochromogenes. The PAT enzyme                       a preliminary finding of no significant               under ADDRESSES and FOR FURTHER
                                                    deactivates glufosinate herbicides thus                 impact (FONSI) on MZIR098 corn. The                   INFORMATION CONTACT above. Copies of
                                                    conferring glufosinate resistance to the                FONSI was prepared in accordance                      these documents may also be obtained
                                                    plants. PAT was also used as a                          with: (1) NEPA, as amended (42 U.S.C.                 by contacting the person listed under
                                                    selectable marker in the development of                 4321 et seq.); (2) regulations of the                 FOR FURTHER INFORMATION CONTACT.
                                                    MZIR098 corn. The antecedent                            Council on Environmental Quality for                     After the comment period closes,
                                                    organism, Pioneer 4114 corn, was                        implementing the procedural provisions                APHIS will review all written comments
                                                    similarly genetically engineered to                     of NEPA (40 CFR parts 1500–1508); (3)                 received during the comment period
                                                    produce proteins which have the same                    USDA regulations implementing NEPA                    and any other relevant information. All
                                                    mechanisms of action as do the proteins                 (7 CFR part 1b); and (4) APHIS’ NEPA                  comments will be available for public
                                                    produced in MZIR098 corn. Based on                      Implementing Procedures (7 CFR part                   review. After reviewing and evaluating
                                                    the information in the request, we have                 372).                                                 the comments, if APHIS determines that
                                                    concluded that MZIR098 corn is similar                     APHIS is considering the following                 no substantive information has been
                                                    to Pioneer 4114 corn. MZIR098 corn is                   alternatives: (1) Take no action, i.e.,               received that would warrant APHIS
                                                    currently regulated under 7 CFR part                    APHIS would not change the regulatory                 altering its preliminary regulatory
                                                    340.                                                    status of MZIR098 corn and it would                   determination or FONSI, our
                                                       As part of our decisionmaking process                continue to be a regulated article, or (2)            preliminary regulatory determination
                                                    regarding a GE organism’s regulatory                    make a determination of nonregulated                  will become final and effective upon
                                                    status, APHIS evaluates the plant pest                  status of MZIR098 corn. APHIS’                        notification of the public through an
                                                    risk of the article. In section 403 of the              preferred alternative is to make a                    announcement on our Web site at http://
                                                    PPA, ‘‘plant pest’’ is defined as any                   determination of nonregulated status of               www.aphis.usda.gov/biotechnology/
                                                    living stage of any of the following that               MZIR098 corn.                                         petitions_table_pending.shtml. APHIS
                                                    can directly or indirectly injure, cause                   APHIS has analyzed information                     will also furnish a response to the
                                                    damage to, or cause disease in any plant                submitted by Syngenta, references                     petitioner regarding our final regulatory
                                                    product: A protozoan, a nonhuman                        provided in the extension request, peer-              determination. No further Federal
                                                    animal, a parasitic plant, a bacterium, a               reviewed publications, and information                Register notice will be published
                                                    fungus, a virus or viroid, an infectious                in the NEPA documentation prepared                    announcing the final regulatory
                                                    agent or other pathogen, or any article                 for the antecedent organism. APHIS has                determination regarding MZIR098 corn.
                                                    similar to or allied with any of the                    also analyzed information in the PPRA
                                                                                                            for the antecedent organism and other                   Authority: 7 U.S.C. 7701–7772 and 7781–
                                                    foregoing.                                                                                                    7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
                                                       APHIS completed a plant pest risk                    information. Based on APHIS’ analysis                 371.3.
                                                    assessment (PPRA) on the antecedent                     of this information and the similarity of
                                                    organism in which we concluded that                     MZIR098 corn to the antecedent                          Done in Washington, DC, this 10th day of
                                                                                                                                                                  February 2016.
                                                    Pioneer 4114 corn is unlikely to present                organism Pioneer’s 4114 corn, APHIS
                                                    plant pest risks. APHIS also prepared a                 has determined that MZIR098 corn is                   Kevin Shea,
                                                    plant pest risk similarity assessment                   unlikely to pose a plant pest risk. We                Administrator, Animal and Plant Health
                                                    (PPRSA) to compare MZIR098 to the                       have therefore reached a preliminary                  Inspection Service.
                                                    antecedent. As described in the PPRSA,                  decision to approve the request to                    [FR Doc. 2016–03193 Filed 2–16–16; 8:45 am]
                                                    the proteins expressed in MZIR098 corn                  extend the determination of                           BILLING CODE 3410–34–P
                                                    are similar to those expressed in Pioneer               nonregulated status of Pioneer 4114
                                                    4114 corn, and APHIS has concluded                      corn to MZIR098 corn, whereby
                                                    that the proteins expressed in Pioneer                  MZIR098 corn would no longer be                       DEPARTMENT OF AGRICULTURE
                                                    4114 corn are unlikely to pose a plant                  subject to our regulations governing the
                                                                                                                                                                  Animal and Plant Health Inspection
                                                    health risk. Furthermore, the                           introduction of certain genetically
                                                                                                                                                                  Service
                                                    Environmental Protection Agency                         engineered organisms.
                                                    reviewed the safety of the proteins                        Paragraph (e) of § 340.6 provides that             [Docket No. APHIS–2015–0048]
                                                    expressed in MZIR098 corn and                           APHIS will publish a notice in the
                                                    concluded that there would ‘‘no                         Federal Register announcing all                       Monsanto Co.; Availability of a
                                                    unreasonable adverse effects on the                     preliminary decisions to extend                       Preliminary Plant Pest Risk
                                                    environment’’ from exposures to these                   determinations of nonregulated status                 Assessment, Draft Environmental
                                                    proteins. Therefore, based on our PPRA                  for 30 days before the decisions become               Assessment, Preliminary Finding of No
                                                    for Pioneer 4114 corn and the similarity                final and effective. In accordance with               Significant Impact, and Preliminary
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    between Pioneer 4114 corn and                           § 340.6(e) of the regulations, we are                 Determination of Nonregulated Status
                                                    MZIR098 corn as described in the                        publishing this notice to inform the                  for Maize Genetically Engineered for
                                                    PPRSA, APHIS has concluded that the                     public of our preliminary decision to                 Resistance to Dicamba and
                                                    proteins expressed in MZIR098 corn are                  extend the determination of                           Glufosinate
                                                    unlikely to pose a plant pest risk.                     nonregulated status of Pioneer 4114                   AGENCY:  Animal and Plant Health
                                                       In addition, APHIS has carefully                     corn to MZIR098 corn.                                 Inspection Service, USDA.
                                                    examined the existing National                             APHIS will accept written comments
                                                                                                                                                                  ACTION: Notice.
                                                    Environmental Policy Act (NEPA)                         on the preliminary FONSI regarding a


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Document Created: 2016-02-17 01:17:00
Document Modified: 2016-02-17 01:17:00
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 March 18, 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) 851-3892, email: [email protected]
FR Citation81 FR 8034 

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