25942 Federal Register / Vol. 78, No. 86 / Friday, May 3, 2013 / Notices 

2To view the notice, petition, draft EA, the PPRA, 

and the comments we received, go to http:// 

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

2012–0033. 

a regulated article under APHIS’ 

regulations in 7 CFR part 340. 

On February 27, 2013, APHIS 

published a notice 2 in the Federal 

Register (78 FR 13303–13304, Docket 

No. APHIS–2012–0033) announcing the 

availability of a draft environmental 

assessment (EA) and plant pest risk 

assessment (PPRA) for public comment 

for the Stine Seed extension request. 

The extension request and APHIS’ 

preliminary decision were also 

published with that notice. APHIS 

received three comments on the subject 

EA and PPRA during the designated 30- 

day public comment period, which 

ended March 29, 2013. Issues raised 

during the comment period included 

effects of glyphosate, pollen drift, crop 

diversity, and human health concerns. 

APHIS has addressed the issues raised 

during the comment period and has 

provided responses to these comments 

as an attachment to the finding of no 

significant impact (FONSI). 

National Environmental Policy Act 

To provide the public with 

documentation of APHIS’ review and 

analysis of any potential environmental 

impacts associated with the 

determination of nonregulated status of 

maize line HCEM485, an 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). 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. 

Determination 

Based on APHIS’ analysis of field and 

laboratory data submitted by Stine Seed, 

references provided in the extension 

request, peer-reviewed publications, 

information analyzed in the EA, the 

similarity of maize line HCEM485 to the 

antecedent organism, Roundup Ready®

corn line GA21, comments provided by 

the public, and information provided in 

APHIS’ response to those public 

comments, APHIS has determined that 

maize line HCEM485 is unlikely to pose 

a plant pest risk. We are therefore 

extending the determination of 

nonregulated status of Roundup Ready®

corn line GA21 to maize line HCEM485, 

whereby maize line HCEM485 is no 

longer subject to our regulations 

governing the introduction of certain 

genetically engineered organisms. 

Copies of the signed determination 

document, as well as copies of the 

extension request, PPRA, EA, and 

FONSI and response to comments, 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 29th day of 

April 2013. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2013–10510 Filed 5–2–13; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0067] 

J.R. Simplot Co.; Availability of 

Petition for Determination of 

Nonregulated Status of Potato 

Genetically Engineered for Low 

Acrylamide Potential and Reduced 

Black Spot Bruise 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public 

that the Animal and Plant Health 

Inspection Service (APHIS) has received 

a petition from the J.R. Simplot 

Company (Simplot) seeking a 

determination of nonregulated status of 

potatoes designated as InnateTM

potatoes (events E12, E24, F10, F37, J3, 

J55, J78, G11, H37, and H50), which 

have been genetically engineered for 

low acrylamide potential (acrylamide is 

a human neurotoxicant and potential 

carcinogen that may form in potatoes 

and other starchy foods under certain 

cooking conditions) and reduced black 

spot bruise. The petition has been 

submitted in accordance with our 

regulations concerning the introduction 

of certain genetically engineered 

organisms and products. We are making 

the Simplot petition available for review 

and comment to help us identify 

potential environmental and 

interrelated economic issues and 

impacts that APHIS may determine 

should be considered in our evaluation 

of the petition. 

DATES: We will consider all comments 

that we receive on or before July 2, 

2013. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/ 

#!documentDetail;D=APHIS-2012-0067- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0067, 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-2012-0067 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. 

The petition is also available on the 

APHIS Web site at http:// 

www.aphis.usda.gov/brs/aphisdocs/ 

13_02201p.pdf. 

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 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 


erowe on DSK2VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 86 / Friday, May 3, 2013 / Notices 25943 

1To view the notice, go to http:// 

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

2011-0129. 

to the Animal and Plant Health 

Inspection Service (APHIS) seeking a 

determination that an article should not 

be regulated under 7 CFR part 340. 

Paragraphs (b) and (c) of § 340.6 

describe the form that a petition for a 

determination of nonregulated status 

must take and the information that must 

be included in the petition. 

APHIS has received a petition (APHIS 

Petition Number 13–022–01p) from the 

J.R. Simplot Company (Simplot) of 

Boise, ID, seeking a determination of 

nonregulated status of potatoes 

(Solanum tuberosum) designated as 

InnateTM potatoes (events E12, E24, F10, 

F37, J3, J55, J78, G11, H37, and H50), 

which have been genetically engineered 

for low acrylamide potential and 

reduced black spot bruise. Acrylamide 

is a human neurotoxicant and potential 

carcinogen that may form in potatoes 

and other starchy foods under certain 

cooking conditions. The petition states 

that these potatoes are 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 petition, InnateTM

potatoes have been genetically 

engineered through the insertion of 

genetic elements from potato or wild 

potato (a group of related plant species 

that are sexually compatible with 

potato) using Simplot’s InnateTM

technologies. Simplot’s InnateTM

technologies allow researchers to isolate 

genetic elements from any plant 

genome, rearrange them, or link them 

together in desired permutations, and 

introduce them back into the genome, 

without incorporating anything other 

than plant DNA. InnateTM potatoes are 

currently regulated under 7 CFR part 

340. Interstate movements and field 

tests of InnateTM potatoes have been 

conducted under notifications 

acknowledged by APHIS. 

Field tests conducted under APHIS 

oversight allowed for evaluation in a 

natural agricultural setting while 

imposing measures to minimize the risk 

of persistence in the environment after 

completion of the tests. Data are 

gathered on multiple parameters and 

used by the applicant to evaluate 

agronomic characteristics and product 

performance. These and other data are 

used by APHIS to determine if the new 

variety poses a plant pest risk. 

Paragraph (d) of § 340.6 provides that 

APHIS will publish a notice in the 

Federal Register providing 60 days for 

public comment for petitions for a 

determination of nonregulated status. 

On March 6, 2012, we published in the 

Federal Register (77 FR 13258–13260, 

Docket No. APHIS–2011–0129) a 

notice 1 describing our process for 

soliciting public comment when 

considering petitions for determinations 

of nonregulated status for GE organisms. 

In that notice we indicated that APHIS 

would accept written comments 

regarding a petition once APHIS 

deemed it complete. 

In accordance with § 340.6(d) of the 

regulations and our process for 

soliciting public input when 

considering petitions for determinations 

of nonregulated status for GE organisms, 

we are publishing this notice to inform 

the public that APHIS will accept 

written comments regarding the petition 

for a determination of nonregulated 

status from interested or affected 

persons for a period of 60 days from the 

date of this notice. The petition is 

available for public review, and copies 

are available as indicated under 

ADDRESSES and FOR FURTHER

INFORMATION CONTACT above. We are 

interested in receiving comments 

regarding potential environmental and 

interrelated economic issues and 

impacts that APHIS may determine 

should be considered in our evaluation 

of the petition. We are particularly 

interested in receiving information 

regarding the extent of true potato seed 

use for planting in the United States as 

compared to the use of asexually 

propagated fragments of potato tubers. 

We are also interested in receiving 

comments regarding biological, cultural, 

or ecological issues, and we encourage 

the submission of scientific data, 

studies, or research to support your 

comments. We also request that, when 

possible, commenters provide relevant 

information regarding specific localities 

or regions as potato growth, crop 

management, and crop utilization may 

vary considerably by geographic region. 

After the comment period closes, 

APHIS will review all written comments 

received during the comment period 

and any other relevant information. Any 

substantive issues identified by APHIS 

based on our review of the petition and 

our evaluation and analysis of 

comments will be considered in the 

development of our decisionmaking 

documents. 

As part of our decisionmaking process 

regarding a GE organism’s regulatory 

status, APHIS prepares a plant pest risk 

assessment to assess its plant pest risk 

and the appropriate environmental 

documentation—either an 

environmental assessment (EA) or an 

environmental impact statement (EIS)— 

in accordance with the National 

Environmental Policy Act (NEPA), to 

provide the Agency with a review and 

analysis of any potential environmental 

impacts associated with the petition 

request. For petitions for which APHIS 

prepares an EA, APHIS will follow our 

published process for soliciting public 

comment (see footnote 1) and publish a 

separate notice in the Federal Register 

announcing the availability of APHIS’ 

EA and plant pest risk assessment. 

Should APHIS determine that an EIS is 

necessary, APHIS will complete the 

NEPA EIS process in accordance with 

Council on Environmental Quality 

regulations (40 CFR part 1500–1508) 

and APHIS’ NEPA implementing 

regulations (7 CFR part 372). 

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 29th day of 

April 2013. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2013–10504 Filed 5–2–13; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0023] 

Changes to Scrapie Flock Certification 

Program 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice and request for 

comments. 

SUMMARY: We are giving notice of 

changes to the Scrapie Flock 

Certification Program (SFCP), a 

voluntary program for sheep and goat 

flock owners who wish to reduce and/ 

or eliminate the risk of introducing 

classical scrapie into their flocks. In 

order to refocus the program’s risk 

reduction strategy on animal sampling, 

we plan to eliminate the Complete 

Monitored category of the SFCP. This 

will affect all ‘‘Complete Monitored’’ 

and ‘‘Certified’’ flocks. Flock owners 

who are currently enrolled in the 

Complete Monitored or Certified 

category who wish to remain in the 

SFCP will be allowed to enroll in either 

the Select category or the Export 

category. This change will allow us to 

apply limited agency resources to areas 

that most effectively contribute to 

scrapie eradication, such as nationwide 

surveillance activities for the disease in 

sheep and goats. 


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