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
8036 Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices 

1On March 6, 2012, APHIS published in the 

Federal Register (77 FR 13258–13260, Docket No. 

APHIS–2011–0129) a notice describing our public 

review process for soliciting public comments and 

information when considering petitions for 

determinations of nonregulated status for GE 

organisms. To view the notice, go to http://

www.regulations.gov/#!docketDetail;D=APHIS2011-0129. 

2To view the notice, the petition, and the 

comments we received, go to http://

www.regulations.gov/#!docketDetail;D=APHIS2015-0048. 

SUMMARY: We are advising the public 

that the Animal and Plant Health 

Inspection Service has prepared a 

preliminary determination regarding a 

request from Monsanto Co. seeking a 

determination of nonregulated status for 

maize designated as event MON 87419, 

which has been genetically engineered 

for resistance to the herbicides dicamba 

and glufosinate. We are also making 

available for public review and 

comment our preliminary plant pest risk 

assessment, draft environmental 

assessment, and preliminary finding of 

no significant impact for the 

preliminary 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-2015-0048. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2015–0048, Regulatory Analysis 

and Development, PPD, APHIS, Station 

3A–03.8, 4700 River Road Unit 118, 

Riverdale, MD 20737–1238. 

Supporting documents for this 

petition and any comments we receive 

on this docket may be viewed at http:// 

www.regulations.gov/#!docketDetail;D=

APHIS-2015-0048 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) 7997039 before coming. 

Supporting documents for this 

petition are also available on the APHIS 

Web site at http://www.aphis.usda.gov/ 

biotechnology/petitions_table_

pending.shtml under APHIS Petition 

Number 15–113–01p. 

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 petition, 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 (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 (GE) organisms 

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. 

APHIS received a petition (APHIS 

Petition Number 15–113–01p) from the 

Monsanto Company (Monsanto) of St. 

Louis, MO, seeking a determination of 

nonregulated status of maize (Zea mays) 

designated as event MON 87419, which 

has been genetically engineered for 

resistance to the herbicides dicamba and 

glufosinate. The Monsanto petition 

states that information collected during 

field trials and laboratory analyses 

indicates that MON 87419 maize is not 

likely to be a plant pest and therefore 

should not be a regulated article under 

APHIS’ regulations in 7 CFR part 340. 

According to our process 1 for 

soliciting public comment when 

considering petitions for determinations 

of nonregulated status of GE organisms, 

APHIS accepts written comments 

regarding a petition once APHIS deems 

it complete. In a notice 2 published in 

the Federal Register on August 13, 2015 

(80 FR 48489–48490, Docket No. 

APHIS–2015–0048), APHIS announced 

the availability of the Monsanto petition 

for public comment. APHIS solicited 

comments on the petition for 60 days 

ending on October 13, 2015, in order to 

help identify potential environmental 

and interrelated economic issues and 

impacts that APHIS may determine 

should be considered in our evaluation 

of the petition. APHIS received 21 

comments on the petition, one of which 

included over 23,000 signatures 

opposing the petition. APHIS has 

evaluated the issues raised during the 

comment period and, where 

appropriate, has provided a discussion 

of these issues in our draft 

environmental assessment (EA). 

After public comments are received 

on a completed petition, APHIS 

evaluates those comments and then 

provides a second opportunity for 

public involvement in our 

decisionmaking process. According to 

our public review process (see footnote 

1), the second opportunity for public 

involvement follows one of two 

approaches, as described below. 

If APHIS decides, based on its review 

of the petition and its evaluation and 

analysis of comments received during 

the 60-day public comment period on 

the petition, that the petition involves a 

GE organism that raises no substantive 

new issues, APHIS will follow 

Approach 1 for public involvement. 

Under Approach 1, APHIS announces in 

the Federal Register the availability of 

APHIS’ preliminary regulatory 

determination along with its draft EA, 

preliminary finding of no significant 

impact (FONSI), and its preliminary 

plant pest risk assessment (PPRA) for a 

30-day public review period. APHIS 

will evaluate any information received 

related to the petition and its supporting 

documents during the 30-day public 

review period. For this petition, we are 

using Approach 1. 

Had APHIS decided, based on its 

review of the petition and its evaluation 

and analysis of comments received 

during the 60-day public comment 

period on the petition, that the petition 

involves a GE organism that raises 

substantive new issues, APHIS would 

follow Approach 2. Under Approach 2, 

APHIS first solicits written comments 

from the public on a draft EA and 

preliminary PPRA for a 30-day comment 

period through the publication of a 

Federal Register notice. Then, after 

reviewing and evaluating the comments 

on the draft EA and preliminary PPRA 

and other information, APHIS would 

revise the preliminary PPRA as 

necessary and prepare a final EA and, 

based on the final EA, a National 

Environmental Policy Act (NEPA) 

decision document (either a FONSI or a 

notice of intent to prepare an 

environmental impact statement). 

As part of our decisionmaking process 

regarding a GE organism’s regulatory 

status, APHIS prepares a PPRA to assess 

the plant pest risk of the article. APHIS 

also prepares the appropriate 

environmental documentation—either 

an EA or an environmental impact 

statement—in accordance with NEPA, 

to provide the Agency and the public 

with a review and analysis of any 

potential environmental impacts that 

may result if the petition request is 

approved. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices 8037 

APHIS has prepared a preliminary 

PPRA and has concluded that maize 

designated as event MON 87419, which 

has been genetically engineered for 

resistance to the herbicides dicamba and 

glufosinate, is unlikely to pose a plant 

pest risk. In section 403 of the Plant 

Protection Act, ‘‘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 or 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 has also prepared a draft EA in 

which we present two alternatives based 

on our analysis of data submitted by 

Monsanto, a review of other scientific 

data, field tests conducted under APHIS 

oversight, and comments received on 

the petition. APHIS is considering the 

following alternatives: (1) Take no 

action, i.e., APHIS would not change the 

regulatory status of maize designated as 

event MON 87419, or (2) make a 

determination of nonregulated status of 

maize designated as event MON 87419. 

The draft EA 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). Based on 

our draft EA and other pertinent 

scientific data, APHIS has prepared a 

preliminary FONSI with regard to the 

preferred alternative identified in the 

draft EA. 

Based on APHIS’ analysis of field and 

laboratory data submitted by Monsanto, 

references provided in the petition, 

peer-reviewed publications, information 

analyzed in the draft EA, the 

preliminary PPRA, comments provided 

by the public on the petition, and 

discussion of issues in the draft EA, 

APHIS has determined that maize 

designated as event MON 87419 is 

unlikely to pose a plant pest risk. We 

have therefore reached a decision to 

make a preliminary determination of 

nonregulated status of maize designated 

as event MON 87419, whereby maize 

designated as event MON 87419 would 

no longer be subject to our regulations 

governing the introduction of certain GE 

organisms. 

We are making available for a 30-day 

review period APHIS’ preliminary 

regulatory determination of maize 

designated as event MON 87419, along 

with our preliminary PPRA, draft EA, 

and preliminary FONSI for the 

preliminary determination of 

nonregulated status. The draft EA, 

preliminary FONSI, preliminary PPRA, 

and our preliminary determination for 

maize designated as event MON 87419, 

as well as the Monsanto petition and the 

comments received on the petition, are 

available as indicated under ADDRESSES

and FOR FURTHER INFORMATION CONTACT

above. Copies of these documents may 

also be obtained from the person listed 

under FOR FURTHER INFORMATION

CONTACT. 

After the 30-day review period closes, 

APHIS will review and evaluate any 

information received during the 30-day 

review period. If, after evaluating the 

information received, APHIS determines 

that we have not received substantive 

new information that would warrant 

APHIS altering our preliminary 

regulatory determination or FONSI, 

substantially changing the proposed 

action identified in the draft EA, or 

substantially changing the analysis of 

impacts in the draft EA, APHIS will 

notify the public through an 

announcement on our Web site of our 

final regulatory determination. If, 

however, APHIS determines that we 

have received substantive new 

information that would warrant APHIS 

altering our preliminary regulatory 

determination or FONSI, substantially 

changing the proposed action identified 

in the draft EA, or substantially 

changing the analysis of impacts in the 

draft EA, then APHIS will conduct the 

additional analysis and prepare an 

amended EA, a new FONSI, and/or a 

revised PPRA, which would be made 

available for public review in a 

subsequent notice in the Federal 

Register, similar to an Approach 2 

petition. APHIS will also notify the 

petitioner. 

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. 2016–03194 Filed 2–16–16; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Forest Service 

Ochoco National Forest, Lookout 

Mountain Ranger District; Oregon; 

Ochoco Summit Trail System Project 

Supplemental EIS 

AGENCY: Forest Service, USDA. 

ACTION: Notice of intent to prepare a 

supplemental environmental impact 

statement. 

SUMMARY: The Ochoco National Forest is 

preparing a supplemental 

environmental impact statement (EIS) to 

analyze the effects of changing the 

existing motorized trail system to create 

and designate a sustainable system of 

roads, trails and areas open to motor 

vehicles that will provide legal public 

access, enhance regulation of 

unmanaged wheeled motor vehicle 

travel, protect resources, and decrease 

conflicts between motorized and nonmotorized use on the Ochoco National 

Forest. Consistent with the Ochoco 

National Forest Land and Resource 

Management Plan, as amended, this 

action is needed to provide to the public 

a diversity of road and trail 

opportunities for experiencing a variety 

of environments and modes of travel. 

The original notice of intent to prepare 

an environmental impact statement was 

published in the Federal Register on 

November 20, 2009 (74 FR 60235– 

60236). The supplemental 

environmental impact statement is 

being prepared because a 2014 wildfire 

in the project area changed the 

conditions initially analyzed so that 

additional analysis was required, and 

because the responsible official desired 

to have additional discussions with 

stakeholders prior to making a decision. 

The Ochoco Summit Trail System 

decision and the reasons for the 

decision will be documented in the 

record of decision. That decision will be 

subject to the Forest Service Projectlevel Predecisional Administrative 

Review Process (36 CFR part 218). 

DATES: The supplemental draft 

environmental impact statement is 

expected to be completed and available 

for public comment in February 2016. 

The final environmental impact 

statement is expected to be completed 

in the fall of 2016. 

ADDRESSES: Ochoco Summit Trail 

System Planning Team, Ochoco 

National Forest, 3160 NE Third Street, 

Prineville, Oregon 97754. 

FOR FURTHER INFORMATION CONTACT: 

Marcy Anderson, Project Leader, at 3160 

NE Third Street, Prineville, Oregon 

97754, or at (541) 416–6463, or by email 

at marcelleanderson@fs.fed.us. 

Dated: February 10, 2016. 

Stacey L. Forson, 

Forest Supervisor. 

[FR Doc. 2016–03174 Filed 2–16–16; 8:45 am] 

BILLING CODE 3410–11–P 


asabaliauskas on DSK5VPTVN1PROD with NOTICES