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)

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, 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: [email protected]. To obtain copies 
of the supporting documents for this petition, contact Ms. Cindy Eck at 
(301) 851-3892, email: [email protected].

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