Federal Register / Vol. 79, No. 167 / Thursday, August 28, 2014 / Notices 51297 

1To view the notice, our determination, 

supporting documents, and the comments we 

received, go to http://www.regulations.gov/

#!docketDetail;D=APHIS–2011–0038. 

logs, pulpwood, and other articles from 

gypsy moth-infested provinces in 

Canada; and private individuals 

entering the United States with mobile 

homes or outdoor household articles. 

Estimated annual number of 

respondents: 2,131. 

Estimated annual number of 

responses per respondent: 1.090. 

Estimated annual number of 

responses: 2,325. 

Estimated total annual burden on 

respondents: 128 hours. (Due to 

averaging, the total annual burden hours 

may not equal the product of the annual 

number of responses multiplied by the 

reporting burden per response.) 

All responses to this notice will be 

summarized and included in the request 

for OMB approval. All comments will 

also become a matter of public record. 

Done in Washington, DC, this 22nd day of 

August 2014. 

Kevin Shea, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2014–20492 Filed 8–27–14; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2014–0055] 

Monsanto Company; Availability of 

Preliminary Finding of No Significant 

Impact and Preliminary Decision for an 

Extension of a Determination of 

Nonregulated Status of Soybean 

Genetically Engineered for Resistance 

to Lepidopteran Insects 

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 

soybean event MON 87701 to soybean 

event MON 87751 in response to a 

request from the Monsanto Company. 

Soybean event MON 87751 has been 

genetically engineered for resistance to 

lepidopteran insects, including 

resistance to fall armyworm beyond that 

provided to soybean event MON 87701. 

We are making available for public 

comment our preliminary finding of no 

significant impact for the proposed 

determination of nonregulated status. 

DATES: We will consider all comments 

that we receive on or before September 

29, 2014. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/

#!docketDetail;D=APHIS-2014-0055. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2014–0055, Regulatory Analysis 

and Development, PPD, APHIS, Station 

3A–03.8, 4700 River Road Unit 118, 

Riverdale, MD 20737–1238. 

The Monsanto Company extension 

request, our 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-2014-0055 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, MON 87701 

soybean, can be found at http://

www.regulations.gov/

#!docketDetail;D=APHIS-2011-0038. 

Supporting documents and any 

comments we received regarding our 

determination of nonregulated status of 

MON 89034 corn, a referenced organism 

for this action, can be found at http:// 

www.regulations.gov/

#!docketDetail;D=APHIS-2007-0030. 

Combined supporting documents 

regarding our determination of 

nonregulated status for the referenced 

organism MON 15985 cotton can be 

found on the APHIS Web site at http:// 

www.aphis.usda.gov/biotechnology/

petitions_table_pending.shtml under 

APHIS Petition Number 00–342–01p. 

Supporting documents may also be 

found on the APHIS Web site for MON 

87751 soybean (the organism under 

evaluation) under APHIS Petition 

Number 13–337–01p, MON 87701 

soybean (the antecedent organism) 

under APHIS Petition Number 09–082– 

01p, and MON 89034 corn (a referenced 

organism) under APHIS Petition 

Number 06–298–01p. 

FOR FURTHER INFORMATION CONTACT: Dr. 

John Turner, Director, Environmental 

Risk Analysis Programs, Biotechnology 

Regulatory Services, APHIS, 4700 River 

Road Unit 147 Riverdale, MD 20737– 

1236; (301) 851–3954, email: 

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

copies of the supporting documents, 

contact Ms. Cindy Eck at (301) 851– 

3885, email: cynthia.a.eck@

aphis.usda.gov. 

SUPPLEMENTARY INFORMATION: Under the 

authority of the plant pest provisions of 

the Plant Protection Act (PPA) (7 U.S.C. 

7701 et seq.), the regulations in 7 CFR 

part 340, ‘‘Introduction of Organisms 

and Products Altered or Produced 

Through Genetic Engineering Which 

Are Plant Pests or Which There Is 

Reason to Believe Are Plant Pests,’’ 

regulate, among other things, the 

introduction (importation, interstate 

movement, or release into the 

environment) of organisms and products 

altered or produced through genetic 

engineering that are plant pests or that 

there is reason to believe are plant pests. 

Such genetically engineered organisms 

(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. 

In a notice 1 published in the Federal 

Register on October 12, 2011 (76 FR 

63279–63280, Docket No. APHIS–2011– 

0038), APHIS announced our 

determination of nonregulated status of 

soybean (Glycine max) designated as 

event MON 87701, which was 

genetically engineered for lepidopteran 

resistance. APHIS has received a request 

for an extension of a determination of 

nonregulated status of soybean event 

MON 87701 (APHIS Petition Number 

09–082–01p) to soybean designated as 

event MON 87751 (APHIS Petition 

Number 13–337–01p) from the 

Monsanto Company (Monsanto) of St. 

Louis, MO. MON 87751 soybean 

expresses resistance to lepidopteran 

pests similar to that of MON 87701 

soybean, with the exception of 

increased resistance to fall armyworm 

(Spodoptera frugiperda). In its request, 

Monsanto stated that this soybean is 

similar to lepidopteran-resistant 

soybean event MON 88701 and, based 

on the similarity to the antecedent 

organism, is unlikely to pose a plant 

pest risk and, therefore, should not be 


pmangrum on DSK3VPTVN1PROD with NOTICES
51298 Federal Register / Vol. 79, No. 167 / Thursday, August 28, 2014 / Notices 

a regulated article under APHIS’ 

regulations in 7 CFR part 340. 

As described in the extension request, 

soybean event MON 87751 soybean has 

been genetically engineered to express 

two Bacillus thuringiensis proteins 

(Cry1A.105 and Cry2Ab2) that confer 

resistance to certain lepidopteran pests 

of soybeans. The antecedent organism, 

MON 87701 soybean, was similarly 

genetically engineered to express the B. 

thuringiensis Cry1Ac insecticidal 

protein. The Cry1A.105 and Cry2Ab2 

expressed in MON 87751 soybean are 

both similar to the Cry1Ac protein 

expressed in MON 87701 soybean. 

Based on the information in the request, 

we have concluded that soybean 

designated as event MON 88751 is 

similar to soybean designated as event 

MON 88701. Soybean event MON 87751 

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, MON 87701 soybean, in 

which we concluded that MON 87701 

soybean is unlikely to present a plant 

pest risk. MON 87751 soybean differs 

from MON 87701 soybean in the 

proteins expressed, specifically, 

Cry1A.105 and Cry2Ab2 are expressed 

in MON 87751 while only Cry1Ac is 

expressed in MON 87701. However, the 

activity spectra are quite similar. APHIS 

has evaluated Cry1A.105 and Cry2Ab2 

when expressed in corn and cotton 

(MON 89034 and MON 15985, 

respectively). In the PPRAs that APHIS 

completed for MON 89034 corn and 

MON 15985 cotton, we concluded that 

the organisms did not pose a plant pest 

risk. As mentioned previously, the 

Cry1A.105 and Cry2Ab2 expressed in 

MON 87751 soybean are together 

similar to the Cry1Ac protein expressed 

in MON 87701 soybean, and APHIS has 

concluded that the increased activity 

toward fall armyworm from the proteins 

expressed in MON 87751 soybean is 

unlikely to affect the plant pest risk of 

MON 87751 soybean. Furthermore, the 

Environmental Protection Agency 

reviewed the safety of Cry1A.105 and 

Cry2Ab2 in corn and concluded that 

adverse effects will not occur to 

nontarget organisms. Therefore, based 

on our PPRAs for MON 87701 soybean, 

MON 89034 corn, and MON 15985 

cotton, the similarity between MON 

87751 soybean and MON 87701 

soybean, the limited difference in 

activity spectra between MON 87751 

soybean and MON 87701 soybean, and 

other information, APHIS has 

concluded that Cry1A.105 and Cry2Ab2 

in MON 87751 soybean are unlikely to 

pose a plant pest risk and that MON 

87751 soybean is unlikely to pose a 

different plant pest risk than MON 

87701. 

APHIS also prepared an 

environmental assessment (EA) for the 

antecedent organism MON 87701 

soybean based on our analysis of data 

submitted by Monsanto, a review of 

other scientific data, and field tests 

conducted under APHIS oversight. The 

EA was prepared to provide the APHIS 

decisionmaker with a review and 

analysis of any potential environmental 

impacts associated with the 

determination of nonregulated status 

soybean event MON 87701. The EA was 

prepared in accordance with: (1) The 

National Environmental Policy Act of 

1969 (NEPA), as amended (42 U.S.C. 

4321 et seq.); (2) regulations of the 

Council on Environmental Quality for 

implementing the procedural provisions 

of NEPA (40 CFR parts 1500–1508); (3) 

USDA regulations implementing NEPA 

(7 CFR part 1b); and (4) APHIS’ NEPA 

Implementing Procedures (7 CFR part 

372). 

APHIS has carefully examined the 

existing NEPA documentation 

completed for MON 87701 soybean and 

has concluded that Monsanto’s request 

to extend a determination of 

nonregulated status to MON 87751 

soybean encompasses the same scope of 

environmental analysis as MON 87701 

soybean. Therefore, based on the 

similarity of MON 87751 soybean to 

MON 87701 soybean, APHIS has 

prepared a preliminary finding of no 

significant impact (FONSI) on MON 

87751 soybean using the EA prepared 

for MON 87701 soybean. APHIS is 

considering the following alternatives: 

(1) Take no action, i.e., APHIS would 

not change the regulatory status of 

soybean event MON 87751 and it would 

continue to be a regulated article, or (2) 

make a determination of nonregulated 

status of soybean event MON 87751 

soybean. APHIS’ preferred alternative is 

to make a determination of nonregulated 

status of soybean event MON 87751. 

APHIS has analyzed information 

submitted by Monsanto, references 

provided in the extension request, peerreviewed publications, and information 

in the EA of the antecedent organism 

MON 87701 soybean. APHIS has also 

analyzed information in the PPRA for 

the antecedent organism MON 87701 

soybean, information in the PPRAs for 

MON 89034 corn and MON 15985 

cotton, the limited difference in activity 

spectra between MON 87751 soybean 

and the antecedent organism MON 

87701 soybean, and other information. 

Based on APHIS’ analysis of this 

information, the similarity of MON 

87751 soybean to the antecedent 

organism MON 87701 soybean, our 

conclusion that the Cry1A.105 and 

Cry2Ab2 in MON 87751 soybean are 

unlikely to pose a plant pest risk, and 

our conclusion that MON 87751 is 

unlikely to pose a different plant pest 

risk than MON 87701, APHIS has 

determined that soybean event MON 

87751 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 soybean event 

MON 87701 to soybean event MON 

87751, whereby soybean event MON 

87751 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 soybean event 

MON 87701 to soybean event MON 

87751. 

APHIS will accept written comments 

on the FONSI regarding a determination 

of nonregulated status of soybean event 

MON 87751 for a period of 30 days from 

the date this notice is published in the 

Federal Register. The FONSI, as well as 

the extension request, supporting 

documents, and our preliminary 

determination for soybean event MON 

87751, 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 


pmangrum on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 167 / Thursday, August 28, 2014 / Notices 51299 

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 soybean event 

MON 87751. 

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 22nd day of 

August 2014. 

Kevin Shea, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2014–20495 Filed 8–27–14; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2014–0056] 

Availability of an Environmental 

Assessment for the Field Release of 

Genetically Engineered Diamondback 

Moths 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public 

that the Animal and Plant Health 

Inspection Service is making available 

for public comment our environmental 

assessment for the field release of 

diamondback moths which have been 

genetically engineered for repressible 

female lethality and to express red 

fluorescence as a marker. The purpose 

of the field release is to assess the 

feasibility and efficacy of these moths in 

reducing populations of non-genetically 

engineered diamondback moths. 

DATES: We will consider all comments 

that we receive on or before September 

29, 2014. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/

#!docketDetail;D=APHIS-2014-0056. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2014–0056, Regulatory Analysis 

and Development, PPD, APHIS, Station 

3A–03.8, 4700 River Road Unit 118, 

Riverdale, MD 20737–1238. 

Supporting documents and any 

comments we receive on this docket 

may be viewed at http://

www.regulations.gov/

#!docketDetail;D=APHIS-2014-0056 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. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Cindy Eck, Document Control Officer/

Team Leader, Environmental Risk 

Analysis Programs, Biotechnology 

Regulatory Services, APHIS, 4700 River 

Road Unit 147, Riverdale, MD 20737– 

1236; (301) 851–3892, email: 

cynthia.a.eck@aphis.usda.gov. 

SUPPLEMENTARY INFORMATION: 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.’’ A permit must be obtained or 

a notification acknowledged before a 

regulated article may be released into 

the environment. The regulations set 

forth the permit application 

requirements and the notification 

procedures for the importation, 

interstate movement, or release into the 

environment of a regulated article. 

On October 24, 2013, the Animal and 

Plant Health Inspection Service (APHIS) 

received a permit application from 

Cornell University (APHIS Permit 

Number 13–297–102r) seeking the 

permitted field release of three strains of 

GE diamondback moth (DBM), Plutella 

xylostella, strains designated as 

OX4319L-Pxy, OX4319N-Pxy, and 

OX4767A-Pxy. The GE DBM have been 

genetically engineered to exhibit red 

fluorescence (DsRed2) as a marker and 

repressible female lethality, also known 

as female autocide. The GE DBMs are 

considered a regulated article under the 

regulations in 7 CFR part 340 because 

the recipient organism is or may be a 

plant pest. APHIS has previously issued 

Cornell University a permit authorizing 

the importation of GE DBM strains 

OX4319L-Pxy, OX4319N-Pxy, and 

OX4767A-Pxy from the United Kingdom 

to the Cornell University New York 

State Agricultural Experiment Station 

(NYSAES, APHIS Permit Number 12– 

227–102m) in Geneva, NY. 

The purpose of the requested field 

release is to assess the efficacy of GE 

DBM strains OX4319L-Pxy, OX4319NPxy, and OX4767A-Pxy in reducing pest 

populations of non-GE DBM. The female 

autocidal trait permits the selection of 

DBM males during rearing. When 

released, it is likely that any female 

progeny produced from GE DBM males 

and non-GE DBM females will die. 

The proposed release would be at 

NYSAES and would not exceed 3 years. 

The release would be limited to 6 sites 

not exceeding 10 acres per site, 

surrounded by other agricultural fields 

within NYSAES’ 870 total acres. The 

release of 20,000 GE DBMs per release 

per site would be allowed, with up to 

5 releases per week per site. Postexperiment monitoring of DBM with 

traps would continue for 2 weeks after 

the conclusion of each release to assess 

field longevity of GE DBM. The red 

fluorescent marker will allow the GE 

DBMs to be positively identified. 

To provide the public with 

documentation of APHIS’ review and 

analysis of any potential environmental 

impacts associated with the proposed 

release of the GE DBM, an 

environmental assessment (EA) has 

been prepared. The EA was prepared in 

accordance with: (1) The National 

Environmental Policy Act of 1969 

(NEPA), as amended (42 U.S.C. 4321 et 

seq.), (2) regulations of the Council on 

Environmental Quality for 

implementing the procedural provisions 

of NEPA (40 CFR parts 1500–1508), (3) 

USDA regulations implementing NEPA 

(7 CFR part 1b), and (4) APHIS’ NEPA 

Implementing Procedures (7 CFR part 

372). APHIS will accept written 

comments on our EA regarding the 

proposed release of the GE DBM from 

interested or affected persons for a 

period of 30 days from the date of this 

notice. Copies of the EA are available as 

indicated in the ADDRESSES and FOR

FURTHER INFORMATION CONTACT sections 

of this notice. 

Authority: 7 U.S.C. 7701–7772 and 7781– 

7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 

371.3. 


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