This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

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examples of documents appearing in this

section.

Notices Federal Register

8034 

Vol. 81, No. 31 

Wednesday, February 17, 2016 

1https://www.aphis.usda.gov/brs/aphisdocs/11_

24401p_det.pdf. 

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. 

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 glufosinateammonium 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/#!docket

Detail;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/#!docket

Detail;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: 

john.t.turner@aphis.usda.gov. To obtain 

copies of the supporting documents, 

contact Ms. Cindy Eck at (301) 851– 

3892, 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 

(GE) and products are considered 

‘‘regulated articles.’’ 

The regulations in § 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 § 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. 

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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices 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, peerreviewed 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 § 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 

§ 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 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2015–0048] 

Monsanto Co.; Availability of a 

Preliminary Plant Pest Risk 

Assessment, Draft Environmental 

Assessment, Preliminary Finding of No 

Significant Impact, and Preliminary 

Determination of Nonregulated Status 

for Maize Genetically Engineered for 

Resistance to Dicamba and 

Glufosinate 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES