Federal Register / Vol. 78, No. 216 / Thursday, November 7, 2013 / Notices 66891 

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, the comments 

we received, and other supporting documents, go to 

http://www.regulations.gov/

#!docketDetail;D=APHIS-2012-0020. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0020] 

Monsanto Co.; Determination of 

Nonregulated Status of Soybean 

Genetically Engineered for Increased 

Yield 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public of 

our determination that a soybean event 

developed by the Monsanto Company, 

designated as MON 87712, which has 

been genetically engineered for 

increased yield, is no longer considered 

a regulated article under our regulations 

governing the introduction of certain 

genetically engineered organisms. Our 

determination is based on our 

evaluation of data submitted by the 

Monsanto Company in its petition for a 

determination of nonregulated status, 

our analysis of available scientific data, 

and comments received from the public 

in response to our previous notices 

announcing the availability of the 

petition for nonregulated status and its 

associated environmental assessment 

and plant pest risk assessment. This 

notice also announces the availability of 

our written determination and finding 

of no significant impact. 

DATES: Effective Date: November 7, 

2013. 

ADDRESSES: You may read the 

documents referenced in this notice and 

the comments we received at http://

www.regulations.gov/

#!docketDetail;D=APHIS-2012-0020 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 are also 

available on the APHIS Web site at 

http://www.aphis.usda.gov/

biotechnology/petitions_table_

pending.shtml under APHIS Petition 

Number 11–202–01p. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Rebecca Stankiewicz Gabel, Chief, 

Biotechnology Environmental Analysis 

Branch, Environmental Risk Analysis 

Programs, Biotechnology Regulatory 

Services, APHIS, 4700 River Road Unit 

147, Riverdale, MD 20737–1236; (301) 

851–3927, email: rebecca.l.stankiewiczgabel@aphis.usda.gov. To obtain copies 

of the supporting documents for this 

petition, contact Ms. Cindy Eck at (301) 

851–3892, email: cynthia.a.eck@

aphis.usda.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

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 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 11–202–01p) from the 

Monsanto Company (Monsanto) of St. 

Louis, MO, seeking a determination of 

nonregulated status of soybean (Glycine 

max) designated as MON 87712, which 

has been genetically engineered for 

increased yield. The petition states that 

this soybean is unlikely to pose a plant 

pest risk 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 genetically 

engineered (GE) organisms, APHIS 

accepts written comments regarding a 

petition once APHIS deems it complete. 

In a notice 2 published in the Federal 

Register on July 13, 2012, (77 FR 41354– 

41355, Docket No. APHIS–2012–0020), 

APHIS announced the availability of the 

Monsanto petition for public comment. 

APHIS solicited comments on the 

petition for 60 days ending on 

September 11, 2012, 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 66 comments on the 

petition. Several of these comments 

included electronic attachments 

consisting of a consolidated document 

of many identical or nearly identical 

letters, for a total of 4,665 comments. 

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. According to our public review 

process for such petitions (see footnote 

1), APHIS first solicits written 

comments from the public on a draft 

environmental assessment (EA) and 

plant pest risk assessment (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 PPRA 

and other information, APHIS revises 

the PPRA as necessary and prepares a 

final EA and, based on the final EA, a 

National Environmental Policy Act 

(NEPA) decision document (either a 

finding of no significant impact (FONSI) 

or a notice of intent to prepare an 

environmental impact statement). If a 

FONSI is reached, APHIS furnishes a 

response to the petitioner, either 

approving or denying the petition. 

APHIS also publishes a notice in the 

Federal Register announcing the 

regulatory status of the GE organism and 

the availability of APHIS’ final EA, 

PPRA, FONSI, and our regulatory 

determination. 

In a notice (see footnote 2) published 

in the Federal Register on August 5, 

2013, (78 FR 47272–47273, Docket No. 

APHIS–2012–0020), APHIS announced 

the availability of a PPRA and a draft EA 

for public comment. APHIS solicited 

comments on the draft EA, the PPRA, 

and whether the subject soybeans are 

likely to pose a plant pest risk for 30 

days ending on September 4, 2013. 

APHIS received one comment during 

the comment period. The comment did 

not address the regulatory status of 

MON 87712 soybean, but rather raised 

concerns regarding APHIS’ authority to 

regulate GE plants and the Agency’s 

NEPA process. APHIS has addressed the 

issues raised during the comment 

period and has provided responses to 

this comment as an attachment to the 

FONSI. 

National Environmental Policy Act 

After reviewing and evaluating the 

comment received during the comment 


tkelley on DSK3SPTVN1PROD with NOTICES
66892 Federal Register / Vol. 78, No. 216 / Thursday, November 7, 2013 / 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://

period on the draft EA and PPRA and 

other information, APHIS has prepared 

a final EA. The EA has been prepared 

to provide the public with 

documentation of APHIS’ review and 

analysis of any potential environmental 

impacts associated with the 

determination of nonregulated status of 

Monsanto’s MON 87712 soybean. The 

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 EA, the response to 

public comments, and other pertinent 

scientific data, APHIS has reached a 

FONSI with regard to the preferred 

alternative identified in the EA (to make 

a determination of nonregulated status 

of MON 87712 soybean). 

Determination 

Based on APHIS’ analysis of field and 

laboratory data submitted by Monsanto, 

references provided in the petition, 

peer-reviewed publications, information 

analyzed in the EA, the PPRA, 

comments provided by the public, and 

information provided in APHIS’ 

response to those public comments, 

APHIS has determined that Monsanto’s 

MON 87712 soybean is unlikely to pose 

a plant pest risk and therefore is no 

longer subject to our regulations 

governing the introduction of certain GE 

organisms. 

Copies of the signed determination 

document, PPRA, final EA, FONSI, and 

response to comments, as well as the 

previously published petition and 

supporting documents, 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. 

Done in Washington, DC, this 1st day of 

November 2013. 

Kevin Shea, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2013–26703 Filed 11–6–13; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0028] 

BASF Plant Science LP; Availability of 

Plant Pest Risk Assessment and 

Environmental Assessment for 

Determination of Nonregulated Status 

of Soybean Genetically Engineered for 

Herbicide 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 is making available 

for public comment our plant pest risk 

assessment and our draft environmental 

assessment regarding a request from 

BASF Plant Science LP seeking a 

determination of nonregulated status of 

soybean designated as event BPS– 

CV127–9, which has been genetically 

engineered for resistance to herbicides 

in the imidazolinone family. We are 

soliciting comments on whether this 

genetically engineered soybean is likely 

to pose a plant pest risk. 

DATES: We will consider all comments 

that we receive on or before December 

9, 2013. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/

#!documentDetail;D=APHIS-2012-0028. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0028, 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-2012-0028 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 are also 

available on the APHIS Web site at 

http://www.aphis.usda.gov/

biotechnology/petitions_table_

pending.shtml under APHIS Petition 

Number 09–015–01p. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Rebecca Stankiewicz Gabel, Chief, 

Biotechnology Environmental Analysis 

Branch, Environmental Risk Analysis 

Programs, Biotechnology Regulatory 

Services, APHIS, 4700 River Road Unit 

147, Riverdale, MD 20737–1236; (301) 

851–3927, email: rebecca.l.stankiewiczgabel@aphis.usda.gov. To obtain copies 

of the supporting documents for this 

petition, contact Ms. Cindy Eck at (301) 

851–3892, email: cynthia.a.eck@

aphis.usda.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

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 has received a petition (APHIS 

Petition Number 09–015–01p) from 

BASF Plant Science LP (BASF) of 

Research Triangle Park, NC, seeking a 

determination of nonregulated status of 

soybean (Glycine max) designated as 

event BPS–CV127–9, which has been 

genetically engineered for resistance to 

herbicides in the imidazolinone family. 

The petition states that this soybean is 

unlikely to pose a plant pest risk 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 


tkelley on DSK3SPTVN1PROD with NOTICES