[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Notices]
[Pages 8034-8035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03193]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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  Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / 
Notices  

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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]
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