[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)]
[Notices]
[Pages 30432-30434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12817]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2013-0113]


Dow AgroSciences LLC: Availability of a Preliminary Plant Pest 
Risk Assessment, Draft Environmental Assessment, Preliminary Finding of 
No Significant Impact, and Preliminary Determination of Nonregulated 
Status for Cotton Genetically Engineered for Resistance to 2,4-D and 
Glufosinate

AGENCY: Animal and Plant Health Inspection Service, USDA.

[[Page 30433]]


ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has prepared a preliminary determination regarding a 
request from Dow AgroSciences LLC seeking a determination of 
nonregulated status for cotton designated as DAS-8191[Oslash]-7, which 
has been genetically engineered for resistance to the herbicides 2,4-D 
and glufosinate. We are also making available for public review and 
comment our preliminary plant pest risk assessment, draft environmental 
assessment, and preliminary finding of no significant impact for the 
preliminary determination of nonregulated status.

DATES: We will consider any information that we receive on or before 
June 29, 2015.

ADDRESSES: You may submit any information by either of the following 
methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0113.
     Postal Mail/Commercial Delivery: Send your information to 
Docket No. APHIS-2013-0113, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents for this petition and any other information we 
receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0113 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 for this petition are also available on the 
APHIS Web site at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under APHIS Petition Number 13-262-01p.

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 petition, contact Ms. Cindy Eck at (301) 851-3892, email: 
[email protected].

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 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 
13-262-01p) from Dow AgroSciences LLC (DAS) of Indianapolis, IN, 
seeking a determination of nonregulated status of cotton (Gossypium 
hirsutum) designated as DAS-8191[Oslash]-7, which has been genetically 
engineered for resistance to certain broadleaf herbicides in the 
phenoxy auxin group (particularly the herbicide 2,4-D) and resistance 
to the herbicide glufosinate. The petition states that information 
collected during field trials and laboratory analyses indicates that 
cotton designated as DAS-8191[Oslash]-7 is not likely to be a plant 
pest or result in weediness potential 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 March 18, 2014 (79 FR 15096-15097, Docket No. APHIS-2013-
0113), APHIS announced the availability of the DAS petition for public 
comment. APHIS solicited comments on the petition for 60 days ending on 
May 19, 2014, 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 
193 comments on the petition; 1 comment from a consumer organization 
included an attached petition with 31,947 signatures and 2,643 unique 
comments. Relevant issues raised by commenters focused on potential 
impacts to cotton plants from off-target drift, weed management, human 
health considerations from exposure to herbicides, and domestic and 
international economic impacts associated with the development and 
marketing of a new herbicide-resistant product. APHIS has evaluated the 
issues raised during the comment period and, where appropriate, has 
provided a discussion of these issues in our draft environmental 
assessment (EA).
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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, and the comments we 
received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-
2013-0113.
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    After public comments are received on a completed petition, APHIS 
evaluates those comments and then provides a second opportunity for 
public involvement in our decisionmaking process. According to our 
public review process (see footnote 1), the second opportunity for 
public involvement follows one of two approaches, as described below.
    If APHIS decides, based on its review of the petition and its 
evaluation and analysis of comments received during the 60-day public 
comment period on the petition, that the petition involves a GE 
organism that raises no substantive new issues, APHIS will follow 
Approach 1 for public involvement. Under Approach 1, APHIS announces in 
the Federal Register the availability of APHIS' preliminary regulatory 
determination along with its draft EA, preliminary finding of no 
significant impact (FONSI), and its preliminary plant pest risk 
assessment (PPRA) for a 30-day public review period. APHIS will 
evaluate any information received related to the petition and its 
supporting documents during the 30-day public review period. For this 
petition, we are using Approach 1.
    If APHIS decides, based on its review of the petition and its 
evaluation and analysis of comments received during the 60-day public 
comment period on the petition, that the petition involves a GE 
organism that raises substantive new issues, APHIS will follow Approach 
2. Under Approach 2, APHIS first solicits written comments from the 
public on a draft EA and preliminary 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 preliminary 
PPRA and other information, APHIS will revise the PPRA as necessary and 
prepare a final

[[Page 30434]]

EA and, based on the final EA, a National Environmental Policy Act 
(NEPA) decision document (either a FONSI or a notice of intent to 
prepare an environmental impact statement).
    As part of our decision making process regarding a GE organism's 
regulatory status, APHIS prepares a PPRA to assess the plant pest risk 
of the article. APHIS also prepares the appropriate environmental 
documentation--either an EA or an environmental impact statement--in 
accordance with NEPA, to provide the Agency and the public with a 
review and analysis of any potential environmental impacts that may 
result if the petition request is approved.
    APHIS has prepared a preliminary PPRA and has concluded that cotton 
designated as DAS-8191[Oslash]-7, which has been genetically engineered 
for resistance to the herbicides 2,4-D and glufosinate, is unlikely to 
pose a plant pest risk. In section 403 of the Plant Protection Act, 
``plant pest'' is defined as any living stage of any of the following 
that can directly or indirectly injure, cause damage to, or cause 
disease in any plant or plant product: A protozoan, a nonhuman animal, 
a parasitic plant, a bacterium, a fungus, a virus or viroid, an 
infectious agent or other pathogen, or any article similar to or allied 
with any of the foregoing.
    APHIS has also prepared a draft EA in which we present two 
alternatives based on our analysis of data submitted by DAS, a review 
of other scientific data, field tests conducted under APHIS oversight, 
and comments received on the petition. APHIS is considering the 
following alternatives: (1) Take no action, i.e., APHIS would not 
change the regulatory status of cotton designated as DAS-8191[Oslash]-
7, or (2) make a determination of nonregulated status of cotton 
designated as DAS-8191[Oslash]-7.
    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 draft EA and other pertinent scientific data, APHIS has 
prepared a preliminary FONSI with regard to the preferred alternative 
identified in the EA.
    Based on APHIS' analysis of field and laboratory data submitted by 
DAS, references provided in the petition, peer-reviewed publications, 
information analyzed in the draft EA, the preliminary PPRA, comments 
provided by the public on the petition, and discussion of issues in the 
draft EA, APHIS has determined that cotton designated as DAS-
8191[Oslash]-7 is unlikely to pose a plant pest risk. We have therefore 
reached a preliminary decision to make a determination of nonregulated 
status of cotton designated as DAS-8191[Oslash]-7, whereby cotton 
designated as DAS-8191[Oslash]-7 would no longer be subject to our 
regulations governing the introduction of certain GE organisms.
    We are making available for a 30-day review period APHIS' 
preliminary regulatory determination of cotton designated as DAS-
8191[Oslash]-7, along with our preliminary PPRA, draft EA, and 
preliminary FONSI for the preliminary determination of nonregulated 
status. The draft EA, preliminary FONSI, preliminary PPRA, and our 
preliminary determination for cotton designated as DAS-8191[Oslash]-7, 
as well as the DAS petition and the comments received on the petition, 
are available as indicated under ADDRESSES and FOR FURTHER INFORMATION 
CONTACT above. Copies of these documents may also be obtained from the 
person listed under FOR FURTHER INFORMATION CONTACT.
    After the 30-day review period closes, APHIS will review and 
evaluate any information received during the 30-day review period. If, 
after evaluating the information received, APHIS determines that we 
have not received substantive new information that would warrant APHIS 
altering our preliminary regulatory determination or FONSI, 
substantially changing the proposed action identified in the draft EA, 
or substantially changing the analysis of impacts in the draft EA, 
APHIS will notify the public through an announcement on our Web site of 
our final regulatory determination. If, however, APHIS determines that 
we have received substantive new information that would warrant APHIS 
altering our preliminary regulatory determination or FONSI, 
substantially changing the proposed action identified in the draft EA, 
or substantially changing the analysis of impacts in the draft EA, then 
APHIS will notify the public of our intent to conduct additional 
analysis and to prepare an amended EA, a new FONSI, and/or a revised 
PPRA, which would be made available for public review through the 
publication of a notice of availability in the Federal Register. APHIS 
will also notify the petitioner.

    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 21st day of May 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-12817 Filed 5-27-15; 8:45 am]
 BILLING CODE 3410-34-P