80 FR 53101 - J.R. Simplot Co.; Determination of Nonregulated Status of Potato Genetically Engineered for Late Blight Resistance, Low Acrylamide Potential, Reduced Black Spot Bruising, and Lowered Reducing Sugars

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 170 (September 2, 2015)

Page Range		53101-53102
FR Document		2015-21747

We are advising the public of our determination that Innate\TM\ 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, 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 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.

Federal Register, Volume 80 Issue 170 (Wednesday, September 2, 2015)

[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)]
[Notices]
[Pages 53101-53102]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-21747]


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Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

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Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / 
Notices

[[Page 53101]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2014-0076]


J.R. Simplot Co.; 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.

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SUMMARY: We are advising the public of our determination that 
Innate\TM\ 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, 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 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 September 2, 2015.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received 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) 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 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 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 Sec.  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 
14-093-01p) from J.R. Simplot Company (Simplot) of Boise, ID, seeking a 
determination of nonregulated status of potatoes (Solanum tuberosum) 
designated as Innate\TM\ W8, which have been genetically engineered for 
late blight resistance, to express low acrylamide potential, reduced 
black spot bruising, and lowered reducing sugars. 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 November 10, 2014 (79 FR 66689-66690, Docket No. APHIS-
2014-0076), APHIS announced the availability of the Simplot petition 
for public comment. APHIS solicited comments on the petition for 60 
days ending on January 9, 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.
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    \1\ On 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=APHIS-2011-0129.
    \2\ To view the notice, the petition, the comments we received, 
and other supporting documents, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0076.
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    APHIS received 130 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 22,673 
comments. Issues raised during the comment period include contamination 
of conventional potato production, the potential for disruption of 
trade due to the presence of unwanted genetically engineered 
commodities in exports, the need for more research prior to approval of 
the petition, the potential for negative impacts to plant fitness and 
the environment, and human health concerns. 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 preliminary plant

[[Page 53102]]

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 preliminary 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, a preliminary PPRA, and 
whether the subject potatoes are likely to pose a plant pest risk from 
May 5, 2015, to June 4, 2015.\3\ APHIS received 24 comments on the 
petition. Nineteen comments supported the determination of nonregulated 
status, and five comments did not support the determination of 
nonregulated status. The majority of the comments opposing the 
determination expressed general opposition to APHIS making a 
determination of nonregulated status of GE organisms. Issues raised 
during the comment period included concerns regarding the potential for 
disruption of trade and potential human 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.
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    \3\ 80 FR 25660-25661.
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National Environmental Policy Act

    After reviewing and evaluating the comments received during the 
comment period on the draft EA and preliminary 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 Innate^TM W8 potato. 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 
Innate^TM W8 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 Innate\TM\ 
Potato designated as Russet Burbank event W8 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 28th day of August 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-21747 Filed 9-1-15; 8:45 am]
 BILLING CODE 3410-34-P

53101

Notices Federal Register
Vol. 80, No. 170

Wednesday, September 2, 2015

This section of the FEDERAL REGISTER SW., Washington, DC. Normal reading unlikely to pose a plant pest risk and,
contains documents other than rules or room hours are 8 a.m. to 4:30 p.m., therefore, should not be a regulated
proposed rules that are applicable to the Monday through Friday, except article under APHIS’ regulations in 7
public. Notices of hearings and investigations, holidays. To be sure someone is there to CFR part 340.
committee meetings, agency decisions and help you, please call (202) 799–7039 According to our process 1 for
rulings, delegations of authority, filing of soliciting public comment when
before coming.
petitions and applications and agency
statements of organization and functions are
Supporting documents are also considering petitions for determinations
examples of documents appearing in this available on the APHIS Web site at of nonregulated status of GE organisms,
section. http://www.aphis.usda.gov/ APHIS accepts written comments
biotechnology/petitions_table_ regarding a petition once APHIS deems
pending.shtml under APHIS Petition it complete. In a notice 2 published in
DEPARTMENT OF AGRICULTURE Number 14–093–01p. the Federal Register on November 10,
FOR FURTHER INFORMATION CONTACT: Dr. 2014 (79 FR 66689–66690, Docket No.
Animal and Plant Health Inspection John Turner, Director, Environmental APHIS–2014–0076), APHIS announced
Service Risk Analysis Programs, Biotechnology the availability of the Simplot petition
Regulatory Services, APHIS, 4700 River for public comment. APHIS solicited
[Docket No. APHIS–2014–0076]
Road Unit 147, Riverdale, MD 20737– comments on the petition for 60 days
J.R. Simplot Co.; Determination of 1236; (301) 851–3954, email: ending on January 9, 2015, in order to
Nonregulated Status of Potato john.t.turner@aphis.usda.gov. To obtain help identify potential environmental
Genetically Engineered for Late Blight copies of the supporting documents for and interrelated economic issues and
Resistance, Low Acrylamide Potential, this petition, contact Ms. Cindy Eck at impacts that APHIS may determine
Reduced Black Spot Bruising, and (301) 851–3892, email: cynthia.a.eck@ should be considered in our evaluation
Lowered Reducing Sugars aphis.usda.gov. of the petition.
APHIS received 130 comments on the
SUPPLEMENTARY INFORMATION: The
AGENCY: Animal and Plant Health petition; one of these comments
regulations in 7 CFR part 340,
Inspection Service, USDA. included electronic attachments
‘‘Introduction of Organisms and
ACTION: Notice. consisting of a consolidated document
Products Altered or Produced Through
of many identical or nearly identical
Genetic Engineering Which Are Plant
SUMMARY: We are advising the public of letters, for a total of 22,673 comments.
Pests or Which There Is Reason to
our determination that InnateTM Potato Issues raised during the comment
Believe Are Plant Pests,’’ regulate,
designated as Russet Burbank event W8, period include contamination of
among other things, the introduction
which has been genetically engineered conventional potato production, the
(importation, interstate movement, or
for late blight resistance, low acrylamide potential for disruption of trade due to
release into the environment) of the presence of unwanted genetically
potential, reduced black spot bruising,
organisms and products altered or engineered commodities in exports, the
and lowered reducing sugars, is no
produced through genetic engineering need for more research prior to approval
longer considered a regulated article
that are plant pests or that there is of the petition, the potential for negative
under our regulations governing the
reason to believe are plant pests. Such impacts to plant fitness and the
introduction of certain genetically
genetically engineered (GE) organisms environment, and human health
engineered organisms. Our
and products are considered ‘‘regulated concerns. APHIS decided, based on its
determination is based on our
articles.’’ review of the petition and its evaluation
evaluation of data submitted by J.R. The regulations in § 340.6(a) provide
Simplot Company, in its petition for a and analysis of the comments received
that any person may submit a petition during the 60-day public comment
determination of nonregulated status, to the Animal and Plant Health
our analysis of available scientific data, period on the petition, that the petition
Inspection Service (APHIS) seeking a involves a GE organism that raises
and comments received from the public determination that an article should not
in response to our previous notices substantive new issues. According to
be regulated under 7 CFR part 340. our public review process for such
announcing the availability of the APHIS received a petition (APHIS
petition for nonregulated status and its petitions (see footnote 1), APHIS first
Petition Number 14–093–01p) from J.R. solicits written comments from the
associated environmental assessment Simplot Company (Simplot) of Boise,
and plant pest risk assessment. This public on a draft environmental
ID, seeking a determination of assessment (EA) and a preliminary plant
notice also announces the availability of nonregulated status of potatoes
our written determination and finding (Solanum tuberosum) designated as 1 On March 6, 2012, APHIS published in the
of no significant impact. InnateTM W8, which have been Federal Register (77 FR 13258–13260, Docket No.
DATES: Effective September 2, 2015. genetically engineered for late blight APHIS–2011–0129) a notice describing our public
review process for soliciting public comments and
mstockstill on DSK4VPTVN1PROD with NOTICES

ADDRESSES: You may read the resistance, to express low acrylamide
information when considering petitions for
documents referenced in this notice and potential, reduced black spot bruising, determinations of nonregulated status for GE
the comments we received at http:// and lowered reducing sugars. organisms. To view the notice, go to http://
www.regulations.gov/ Acrylamide is a human neurotoxicant www.regulations.gov/#!docketDetail;D=APHIS-
#!docketDetail;D=APHIS-2014-0076 or and potential carcinogen that may form 2011-0129.
2 To view the notice, the petition, the comments
in our reading room, which is located in in potatoes and other starchy foods we received, and other supporting documents, go to
room 1141 of the USDA South Building, under certain cooking conditions. The http://www.regulations.gov/
14th Street and Independence Avenue petition states that these potatoes are #!docketDetail;D=APHIS-2014-0076.

VerDate Sep<11>2014 19:04 Sep 01, 2015 Jkt 235001 PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 E:\FR\FM\02SEN1.SGM 02SEN1

53102 Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices

pest risk assessment (PPRA) for a 30-day Implementing Procedures (7 CFR part DATES: To ensure consideration, written
comment period through the 372). Based on our EA, the response to comments must be submitted on or
publication of a Federal Register notice. public comments, and other pertinent before November 2, 2015.
Then, after reviewing and evaluating the scientific data, APHIS has reached a ADDRESSES: Direct all written comments
comments on the draft EA and the FONSI with regard to the preferred to Jennifer Jessup, Departmental
preliminary PPRA and other alternative identified in the EA (to make Paperwork Clearance Officer,
information, APHIS revises the PPRA as a determination of nonregulated status Department of Commerce, Room 6616,
necessary and prepares a final EA and, of InnateTM W8 potatoes). 14th and Constitution Avenue NW.,
based on the final EA, a National Washington, DC 20230 (or via the
Environmental Policy Act (NEPA) Determination
Internet at jjessup@doc.gov).
decision document (either a finding of Based on APHIS’ analysis of field and FOR FURTHER INFORMATION CONTACT:
no significant impact (FONSI) or a laboratory data submitted by Simplot, Direct all requests for additional
notice of intent to prepare an references provided in the petition, information, or copies of the
environmental impact statement). If a peer-reviewed publications, information information collection instrument(s),
FONSI is reached, APHIS furnishes a analyzed in the EA, the PPRA, and instructions to Michael A. Hall,
response to the petitioner, either comments provided by the public, and Bureau of the Census, 4600 Silver Hill
approving or denying the petition. information provided in APHIS’ Road, Field Division, Special Census
APHIS also publishes a notice in the response to those public comments, Branch, Location 5H149, Washington,
Federal Register announcing the APHIS has determined that Simplot’s DC 20233 and/or call (301) 763–1429.
regulatory status of the GE organism and InnateTM Potato designated as Russet SUPPLEMENTARY INFORMATION:
the availability of APHIS’ final EA, Burbank event W8 is unlikely to pose a
PPRA, FONSI, and our regulatory plant pest risk and therefore is no longer I. Abstract
determination. subject to our regulations governing the The Special Census Program is a
APHIS sought public comment on a introduction of certain GE organisms. reimbursable service offered and
draft EA, a preliminary PPRA, and performed by the Census Bureau for the
Copies of the signed determination
whether the subject potatoes are likely government of any state, county, city, or
document, PPRA, final EA, FONSI, and
to pose a plant pest risk from May 5, other political subdivision within a
response to comments, as well as the
2015, to June 4, 2015.3 APHIS received state. This includes the District of
previously published petition and
24 comments on the petition. Nineteen Columbia, the government of any
supporting documents, are available as
comments supported the determination possession or area over which the U.S.
indicated in the ADDRESSES and FOR
of nonregulated status, and five exercises jurisdiction, control, or
FURTHER INFORMATION CONTACT sections
comments did not support the sovereignty, and other governmental
determination of nonregulated status. of this notice.
units that require current population
The majority of the comments opposing Authority: 7 U.S.C. 7701–7772 and 7781–
data between decennial censuses.
the determination expressed general 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
Many states use Special Census
opposition to APHIS making a 371.3.
population statistics to determine the
determination of nonregulated status of Done in Washington, DC, this 28th day of distribution of funds to local
GE organisms. Issues raised during the August 2015. jurisdictions. The local jurisdictions
comment period included concerns Kevin Shea, may also use the data to plan new
regarding the potential for disruption of Administrator, Animal and Plant Health schools, transportation systems, housing
trade and potential human health and Inspection Service. programs, or water treatment facilities.
environmental impacts. APHIS has [FR Doc. 2015–21747 Filed 9–1–15; 8:45 am] The Census Bureau will use the
addressed the issues raised during the BILLING CODE 3410–34–P following forms to conduct the various
comment period and has provided Special Census operations:
responses to comments as an attachment SC–1, Special Census Enumerator
to the FONSI. Questionnaire—This interview form
National Environmental Policy Act DEPARTMENT OF COMMERCE will be used to collect special census
data at regular housing units (HU), and
After reviewing and evaluating the Census Bureau eligible units in Transient Locations
comments received during the comment (TL) such as RV parks, marinas,
period on the draft EA and preliminary Proposed Information Collection; campgrounds, hotels or motels.
PPRA and other information, APHIS has Comment Request; Special Census SC–1(SUPP), Continuation Form for
prepared a final EA. The EA has been Program Enumerator Questionnaires—This
prepared to provide the public with interview form will be used to collect
documentation of APHIS’ review and AGENCY: U.S. Census Bureau, special census data at a regular HU or
analysis of any potential environmental Commerce. eligible units in a TL, when there are
impacts associated with the ACTION: Notice. more than five members in a household.
determination of nonregulated status of SC–1 (Phone/WYC), Special Census
Simplot’s InnateTM W8 potato. The EA SUMMARY: The Department of Enumeration Questionnaire—This
was prepared in accordance with: (1) Commerce, as part of its continuing interview form will be used to collect
NEPA, as amended (42 U.S.C. 4321 et effort to reduce paperwork and special census data when a respondent
mstockstill on DSK4VPTVN1PROD with NOTICES

seq.), (2) regulations of the Council on respondent burden, invites the general calls the local special census office.
Environmental Quality for public and other Federal agencies to SC–2, Group Quarters
implementing the procedural provisions take this opportunity to comment on Questionnaire—This interview form
of NEPA (40 CFR parts 1500–1508), (3) proposed and/or continuing information will be used to collect special census
USDA regulations implementing NEPA collections, as required by the data at group quarters (GQ) such as
(7 CFR part 1b), and (4) APHIS’ NEPA Paperwork Reduction Act of 1995, hospitals, prisons, boarding and
Public Law 104–13 (44 U.S.C. rooming houses, college dormitories,
3 80 FR 25660–25661. 3506(c)(2)(A)). military facilities, and convents.

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Document Created: 2018-02-26 10:11:01
Document Modified: 2018-02-26 10:11:01

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Effective September 2, 2015.
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: [email protected] To obtain copies of the supporting documents for this petition, contact Ms. Cindy Eck at (301) 851-3892, email: [email protected]
FR Citation		80 FR 53101

80 FR 53101 - J.R. Simplot Co.; Determination of Nonregulated Status of Potato Genetically Engineered for Late Blight Resistance, Low Acrylamide Potential, Reduced Black Spot Bruising, and Lowered Reducing Sugars

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 80, Issue 170 (September 2, 2015)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service