83 FR 52377 - Texas A&M AgriLife Research; Determination of Nonregulated Status of Cotton Genetically Engineered for Ultra-low Gossypol Levels in the Cottonseed

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 83, Issue 201 (October 17, 2018)

Page Range		52377-52378
FR Document		2018-22545

We are advising the public of our determination that cotton designated as event TAM66274, which has been genetically engineered for ultra-low gossypol levels in the cottonseed, 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 Texas A&M AgriLife Research 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 83 Issue 201 (Wednesday, October 17, 2018)

[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52377-52378]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-22545]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2017-0097]


Texas A&M AgriLife Research; Determination of Nonregulated Status 
of Cotton Genetically Engineered for Ultra-low Gossypol Levels in the 
Cottonseed

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that cotton 
designated as event TAM66274, which has been genetically engineered for 
ultra-low gossypol levels in the cottonseed, 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 Texas A&M AgriLife Research 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: This change in regulatory status will be recognized October 17, 
2018.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received at http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0097 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.
    Supporting documents are also available on the APHIS website at 
http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml 
under APHIS Petition 17-292-01p.

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

[[Page 52378]]

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 
17-292-01p) from Texas A&M AgriLife Research of College Station, TX 
(Texas A&M), seeking a determination of nonregulated status of cotton 
(Gossypium hirsutum) designated as event TAM66274, which has been 
genetically engineered for ultra-low gossypol levels in the cottonseed. 
The Texas A&M petition states that information collected during field 
trials and laboratory analyses indicates that TAM66274 cotton is not 
likely to be a plant pest 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 December 5, 2017 (82 FR 57426-57427, Docket No. APHIS-2017-
0097), APHIS announced the availability of the Texas A&M petition for 
public comment. APHIS solicited comments on the petition for 60 days 
ending on February 5, 2018, 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, we published in the Federal Register (77 
FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing our 
process for soliciting public comments and information when 
considering petitions for determinations of nonregulated status for 
GE organisms (see http://www.regulations.gov/#!docketDetail;D=APHIS-
2011-0129).
    \2\ To view the notice, the petition, and the comments we 
received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-
2017-0097.
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    APHIS received 47 comments on the petition. Of those, 44 were 
supportive, two opposed, and one was not related to the petition.
    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 is following 
Approach 2, where we first solicit written comments from the public on 
a draft environmental assessment (EA) and a draft 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 draft PPRA and other information, 
APHIS revises the draft PPRA as necessary and prepares a final EA and, 
based on the final EA, a National Environmental Policy Act (NEPA) 
finding 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 draft PPRA from 
August 1, 2018, to August 31, 2018.\3\ APHIS solicited comments on the 
draft EA, the draft PPRA, and whether the subject cotton is likely to 
pose a plant pest risk. APHIS received two comments on the petition, 
both of which supported a decision of nonregulated status for event 
TAM66274 cotton.
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    \3\ 83 FR 37459-37460.
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National Environmental Policy Act

    After reviewing and evaluating the comments received during the 
comment period on the draft EA and draft 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 cotton designated as event TAM66274. 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 
cotton designated as event TAM66274).

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
Texas A&M, 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 cotton designated as 
event TAM66274 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 10th day of October 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-22545 Filed 10-16-18; 8:45 am]
 BILLING CODE 3410-34-P

Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices 52377

ensuring that meat, poultry, and egg SUPPLEMENTARY INFORMATION: On March ACTION: Notice.
products are safe, wholesome, 7, 2017, we published in the Federal
unadulterated, and properly labeled and Register (FR DOC# 2017–11216, Page SUMMARY: We are advising the public of
packaged. FSIS intends to collect 25224) a Notice of Solicitation for our determination that cotton
information from food industry and Nominations. Applications were designated as event TAM66274, which
academic experts on vulnerabilities and required to be received on or before June has been genetically engineered for
research activities in the areas of food 16, 2017. Previous applicants do not ultra-low gossypol levels in the
defense for FSIS-regulated food need to reapply. cottonseed, is no longer considered a
products. We are soliciting nominations from regulated article under our regulations
Need and Use of the Information: socially disadvantaged farming and governing the introduction of certain
FSIS will collection information using a ranching producers; civil rights genetically engineered organisms. Our
series of questionnaires to food industry professionals; private nonprofit determination is based on our
and academic experts on vulnerabilities organizations that support socially evaluation of data submitted by Texas
and research activities in food defense disadvantaged producers; and higher A&M AgriLife Research in its petition
for FSIS-regulated food products. education institutions that work with for a determination of nonregulated
Description of Respondents: Business socially disadvantaged producers. The status, our analysis of available
or other for-profit. membership term shall not exceed 2 scientific data, and comments received
Number of Respondents: 170. years from the date of appointment. The from the public in response to our
Frequency of Responses: Reporting: Secretary may also appoint others as previous notices announcing the
On Occasion. deemed necessary and appropriate to availability of the petition for
Total Burden Hours: 113. fulfill the Committee charter. An nonregulated status and its associated
organization may nominate individuals environmental assessment and plant
Ruth Brown, pest risk assessment. This notice also
Departmental Information Collection from within or outside its membership;
alternatively, an individual may announces the availability of our
Clearance Officer. written determination and finding of no
[FR Doc. 2018–22521 Filed 10–16–18; 8:45 am]
nominate herself or himself.
Nomination packages should include a significant impact.
BILLING CODE 3410–DM–P DATES: This change in regulatory status
nomination form along with a cover
letter or resume that documents the will be recognized October 17, 2018.
nominee’s background and experience. ADDRESSES: You may read the
DEPARTMENT OF AGRICULTURE
The Secretary will fill 15 vacancies documents referenced in this notice and
Office of Partnerships and Public from among those organizations and the comments we received at http://
Engagement (OPPE); Advisory individuals solicited in order to obtain www.regulations.gov/#!docketDetail;D=
Committee on Minority Farmers and the broadest possible representation on APHIS-2017-0097 or in our reading
Ranchers Request for Nominations the Committee. Equal opportunity Room, which is located in Room 1141
practices, in line with the USDA of the USDA South Building, 14th Street
AGENCY: Office of Advocacy and policies, will be followed in all and Independence Avenue SW,
Outreach, USDA. appointments to the Committee. To Washington, DC. Normal reading room
ACTION: Solicitation for applications. ensure that the recommendations of the hours are 8 a.m. to 4:30 p.m., Monday
Committee have taken into account the through Friday, except holidays. To be
SUMMARY: We are giving notice that U.S. sure someone is there to help you,
needs of the diverse groups served by
Department of Agriculture (USDA) is please call (202) 7997039 before coming.
the Department, membership should
soliciting nominations and applications Supporting documents are also
include, to the extent practicable,
to serve on the Advisory Committee on available on the APHIS website at
individuals with demonstrated ability to
Minority Farmers and Ranchers (the http://www.aphis.usda.gov/
represent minorities, women, and
‘‘Committee’’). Interested persons must biotechnology/petitions_table_
persons with disabilities.
submit applications and nomination pending.shtml under APHIS Petition
packages which can be downloaded at Signed in Washington, DC, this 13th day of
September, 2018.
17–292–01p.
the link below: https:// FOR FURTHER INFORMATION CONTACT: Dr.
www.ocio.usda.gov/document/ad-755. Christian Obineme,
John Turner, Director, Environmental
DATES: Consideration will be given to Deputy Director, Office of Partnerships and
Public Engagement.
Risk Analysis Programs, Biotechnology
nominations received on or before Regulatory Services, APHIS, 4700 River
November 1, 2018. [FR Doc. 2018–22149 Filed 10–16–18; 8:45 am]
Road Unit 147, Riverdale, MD 20737–
BILLING CODE 3410–P
FOR FURTHER INFORMATION CONTACT: Mrs. 1236; (301) 851–3954, email:
Kenya Nicholas, Designated Federal john.t.turner@aphis.usda.gov. To obtain
Official, USDA OPPE, 1400 copies of the supporting documents for
DEPARTMENT OF AGRICULTURE
Independence Avenue SW, Room 520– this petition, contact Ms. Cindy Eck at
A, Washington, DC 20250–0601; Animal and Plant Health Inspection (301) 851–3892, email: cynthia.a.eck@
Telephone (202) 720–6350; Fax (202) Service aphis.usda.gov.
720–7704; Email: kenya.nicholas@ SUPPLEMENTARY INFORMATION: The
osec.usda.gov. [Docket No. APHIS–2017–0097] regulations in 7 CFR part 340,
ADDRESSES: Nomination packages may Texas A&M AgriLife Research; ‘‘Introduction of Organisms and
daltland on DSKBBV9HB2PROD with NOTICES

be sent by postal mail or commercial Determination of Nonregulated Status Products Altered or Produced Through
delivery to: Mrs. Kenya Nicholas, of Cotton Genetically Engineered for Genetic Engineering Which Are Plant
Designated Federal Official, USDA Ultra-low Gossypol Levels in the Pests or Which There Is Reason to
OPPE, 1400 Independence Avenue SW, Cottonseed Believe Are Plant Pests,’’ regulate,
Room 520–A, Washington, DC 20250– among other things, the introduction
0601. Nomination packages may also be AGENCY: Animal and Plant Health (importation, interstate movement, or
faxed to (202) 720–7704. Inspection Service, USDA. release into the environment) of

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52378 Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices

organisms and products altered or involves a GE organism that raises a determination of nonregulated status
produced through genetic engineering substantive new issues. According to of cotton designated as event
that are plant pests or that there is our public review process for such TAM66274).
reason to believe are plant pests. Such petitions (see footnote 1), APHIS is
Determination
genetically engineered (GE) organisms following Approach 2, where we first
and products are considered ‘‘regulated solicit written comments from the Based on APHIS’ analysis of field and
articles.’’ public on a draft environmental laboratory data submitted by Texas
The regulations in § 340.6(a) provide assessment (EA) and a draft plant pest A&M, references provided in the
that any person may submit a petition risk assessment (PPRA) for a 30-day petition, peer-reviewed publications,
to the Animal and Plant Health comment period through the information analyzed in the EA, the
Inspection Service (APHIS) seeking a publication of a Federal Register notice. PPRA, comments provided by the
determination that an article should not Then, after reviewing and evaluating the public, and information provided in
be regulated under 7 CFR part 340. comments on the draft EA and the draft APHIS’ response to those public
APHIS received a petition (APHIS PPRA and other information, APHIS comments, APHIS has determined that
Petition Number 17–292–01p) from revises the draft PPRA as necessary and cotton designated as event TAM66274 is
Texas A&M AgriLife Research of College prepares a final EA and, based on the unlikely to pose a plant pest risk and
Station, TX (Texas A&M), seeking a final EA, a National Environmental therefore is no longer subject to our
determination of nonregulated status of Policy Act (NEPA) finding document regulations governing the introduction
cotton (Gossypium hirsutum) designated (either a finding of no significant impact of certain GE organisms.
as event TAM66274, which has been (FONSI) or a notice of intent to prepare Copies of the signed determination
genetically engineered for ultra-low an environmental impact statement). If document, PPRA, final EA, FONSI, and
gossypol levels in the cottonseed. The a FONSI is reached, APHIS furnishes a response to comments, as well as the
Texas A&M petition states that response to the petitioner, either previously published petition and
information collected during field trials approving or denying the petition. supporting documents, are available as
and laboratory analyses indicates that APHIS also publishes a notice in the indicated in the ADDRESSES and FOR
TAM66274 cotton is not likely to be a Federal Register announcing the FURTHER INFORMATION CONTACT sections
plant pest and therefore should not be regulatory status of the GE organism and of this notice.
a regulated article under APHIS’ the availability of APHIS’ final EA,
Authority: 7 U.S.C. 7701–7772 and 7781–
regulations in 7 CFR part 340. PPRA, FONSI, and our regulatory 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
According to our process 1 for determination. 371.3.
soliciting public comment when APHIS sought public comment on a
considering petitions for determinations draft EA and a draft PPRA from August Done in Washington, DC, this 10th day of
of nonregulated status of GE organisms, October 2018.
1, 2018, to August 31, 2018.3 APHIS
APHIS accepts written comments solicited comments on the draft EA, the Kevin Shea,
regarding a petition once APHIS deems draft PPRA, and whether the subject Administrator, Animal and Plant Health
it complete. In a notice 2 published in cotton is likely to pose a plant pest risk. Inspection Service.
the Federal Register on December 5, APHIS received two comments on the [FR Doc. 2018–22545 Filed 10–16–18; 8:45 am]
2017 (82 FR 57426–57427, Docket No. petition, both of which supported a BILLING CODE 3410–34–P
APHIS–2017–0097), APHIS announced decision of nonregulated status for event
the availability of the Texas A&M TAM66274 cotton.
petition for public comment. APHIS
National Environmental Policy Act COMMISSION ON CIVIL RIGHTS
solicited comments on the petition for
60 days ending on February 5, 2018, in After reviewing and evaluating the
order to help identify potential comments received during the comment Notice of Public Meeting of the
environmental and interrelated period on the draft EA and draft PPRA Connecticut Advisory Committee
economic issues and impacts that and other information, APHIS has AGENCY: Commission on Civil Rights.
APHIS may determine should be prepared a final EA. The EA has been
prepared to provide the public with ACTION: Announcement of meeting.
considered in our evaluation of the
petition. documentation of APHIS’ review and SUMMARY: Notice is hereby given,
APHIS received 47 comments on the analysis of any potential environmental pursuant to the provisions of the rules
petition. Of those, 44 were supportive, impacts associated with the and regulations of the U.S. Commission
two opposed, and one was not related determination of nonregulated status of on Civil Rights (Commission), and the
to the petition. cotton designated as event TAM66274. Federal Advisory Committee Act
APHIS decided, based on its review of The EA was prepared in accordance (FACA), that a meeting of the
the petition and its evaluation and with: (1) NEPA, as amended (42 U.S.C. Connecticut Advisory Committee to the
analysis of the comments received 4321 et seq.), (2) regulations of the Commission will convene by conference
during the 60-day public comment Council on Environmental Quality for call at 12:00 p.m. (EST) on Wednesday,
period on the petition, that the petition implementing the procedural provisions November 14, 2018. The purpose of the
of NEPA (40 CFR parts 1500–1508), (3) meeting is project planning and
1 On March 6, 2012, we published in the Federal USDA regulations implementing NEPA decision-making on next steps.
Register (77 FR 13258–13260, Docket No. APHIS– (7 CFR part 1b), and (4) APHIS’ NEPA
2011–0129) a notice describing our process for DATES: Wednesday, November 14, 2018
Implementing Procedures (7 CFR part
daltland on DSKBBV9HB2PROD with NOTICES

soliciting public comments and information when
372). Based on our EA, the response to at 12:00 p.m. (EST). Public Call-In
considering petitions for determinations of Information: Conference call-in number:
nonregulated status for GE organisms (see http:// public comments, and other pertinent
www.regulations.gov/#!docketDetail;D=APHIS- scientific data, APHIS has reached a 1–877–260–1479 and conference call
2011-0129).
FONSI with regard to the preferred 5634706.
2 To view the notice, the petition, and the
alternative identified in the EA (to make FOR FURTHER INFORMATION CONTACT:
comments we received, go to http://
www.regulations.gov/#!docketDetail;D=APHIS- Evelyn Bohor at ero@usccr.gov or by
2017-0097. 3 83 FR 37459–37460. phone at 202–376–7533.

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Document Created: 2018-10-17 01:48:11
Document Modified: 2018-10-17 01:48:11

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		This change in regulatory status will be recognized October 17, 2018.
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		83 FR 52377

83 FR 52377 - Texas A&M AgriLife Research; Determination of Nonregulated Status of Cotton Genetically Engineered for Ultra-low Gossypol Levels in the Cottonseed

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 83, Issue 201 (October 17, 2018)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service