66688 Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / 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, the comments 

we received, and other supporting documents, go to 

http://www.regulations.gov/

#!docketDetail;D=APHIS-2012-0067. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0067] 

J.R. Simplot Co.; 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 of 

our determination that 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, are 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 J.R. 

Simplot 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 November 10, 2014. 

ADDRESSES: You may read the 

documents referenced in this notice and 

the comments we received 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. 

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 13–022–01p. 

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 for 

this petition, contact Ms. Cindy Eck at 

(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.’’ 

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 13–022–01p) from 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. 

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 May 3, 2013 (78 

FR 25942–25943, Docket No. APHIS– 

2012–0067), APHIS announced the 

availability of the Simplot petition for 

public comment. APHIS solicited 

comments on the petition for 60 days 

ending on July 2, 2013, 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 308 comments on the 

petition; one of these comments 

included electronic attachments 

consisting of a consolidated document 

of many identical or nearly identical 

letters, for a total of 41,475 comments. 

Issues raised during the comment 

period include concerns regarding 

potential effects on conventional potato 

production, export markets, and plant 

fitness. APHIS decided, based on its 

review of the petition and its evaluation 

and analysis of the 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 a 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 the 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. 

APHIS sought public comment on a 

draft EA and a PPRA from May 30, 

2014, to June 30, 2014. APHIS solicited 

comments on the draft EA, the PPRA, 

and whether the subject potatoes are 

likely to pose a plant pest risk. APHIS 

received 60 comments during the 

comment period. The majority of 

comments expressed general opposition 

to APHIS making a determination of 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Notices 66689 

nonregulated status of GE organisms. 

Issues raised during the comment 

period included concerns regarding the 

potential transfer of genes from GE to 

non-GE potatoes and potential health 

and environmental impacts. APHIS has 

addressed the issues raised during the 

comment period and has provided 

responses to comments as an attachment 

to the FONSI. 

APHIS received additional 

information from Simplot on the 

molecular characterization of one of the 

events, J3, after publication of the 

petition, PPRA, and draft EA. The new 

information indicates rearranged 

repeated sequences of the inserted 

genetic material at the right border. 

APHIS has reviewed the revised 

structure and concluded the revision 

does not change the analyses or 

conclusions in either the PPRA or the 

EA because there are no new sequences 

present that were not previously 

described, no new insertion site(s), and 

no expected change in functionality. 

The updated characterization of J3 has 

been appended to the petition as 

Appendix 11. 

National Environmental Policy Act 

After reviewing and evaluating the 

comments received during the comment 

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 

Simplot’s InnateTM potatoes. 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 InnateTM potatoes). 

Determination 

Based on APHIS’ analysis of field and 

laboratory data submitted by Simplot, 

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 Simplot’s 

InnateTM potatoes are unlikely to pose a 

plant pest risk and therefore are 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 3rd day of 

November 2014. 

Kevin Shea, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2014–26593 Filed 11–7–14; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2014–0076] 

J.R. Simplot Co.; Availability of 

Petition for Determination of 

Nonregulated Status of Potato 

Genetically Engineered for Late Blight 

Resistance, Low Acrylamide Potential, 

Reduced Black Spot Bruising, and 

Lowered Reducing Sugars 

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 received a 

petition from the J.R. Simplot Company 

seeking a determination of nonregulated 

status for InnateTM Potato designated as 

Russet Burbank event W8, which has 

been genetically engineered for late 

blight resistance, low acrylamide 

potential, reduced black spot bruising, 

and lowered reducing sugars. The 

petition has been submitted in 

accordance with our regulations 

concerning the introduction of certain 

genetically engineered organisms and 

products. We are making the J.R. 

Simplot Company petition available for 

review and comment to help us identify 

potential environmental and 

interrelated economic issues and 

impacts that the Animal and Plant 

Health Inspection Service may 

determine should be considered in our 

evaluation of the petition. 

DATES: We will consider all comments 

that we receive on or before January 9, 

2015. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/

#!docketDetail;D=APHIS-2014-0076. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2014–0076, 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-2014-0076 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. 

The petition is also available on the 

APHIS Web site at: http://

www.aphis.usda.gov/biotechnology/

petitions_table_pending.shtml under 

APHIS petition number 14–093–01p. 

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 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. 


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