[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28798-28800]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11579]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2013-0042]


Dow AgroSciences LLC; Notice of Intent To Prepare an 
Environmental Impact Statement for Determination of Nonregulated Status 
of Herbicide Resistant Corn and Soybeans, and Notice of Virtual Public 
Meeting

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are announcing to the public that the Animal and Plant 
Health Inspection Service (APHIS) intends to prepare an environmental 
impact statement (EIS) on environmental impacts that may result from 
the potential approval of three petitions from Dow AgroSciences LLC 
seeking a determination of nonregulated status of herbicide resistant 
corn and soybeans. Issues to be addressed in the EIS include the 
potential environmental impacts associated with the increased use of 
certain herbicides and possible selection for and spread of weeds 
resistant to the herbicide 2,4-D combined with resistance to other 
herbicides (multiple resistance). We are also requesting public 
comments to further delineate the scope of the alternatives and 
environmental impacts and issues to be included in this EIS. We are 
also announcing that APHIS will be hosting a virtual public meeting 
during the scoping period. The purpose of the scoping meeting will be 
to allow the public an opportunity to comment on the range of 
alternatives and environmental impacts and issues discussed in the EIS.

DATES: We will consider all comments that we receive on or before June 
17, 2013. We will also consider comments made at the virtual public 
meeting that will be held during the comment period.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2013-0042-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2013-0042, 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-2013-
0042 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.
    Other Information: Details regarding the virtual scoping meeting, 
including the time, date, and how to participate, will be available at 
http://www.aphisvirtualmeetings.com.

FOR FURTHER INFORMATION CONTACT: Dr. Rebecca Stankiewicz Gabel, Branch 
Chief, Biotechnology Environmental Analysis Branch, Environmental Risk 
Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River 
Road Unit 147, Riverdale, MD 20737-1238; (301) 851-3954. To obtain 
copies of the petition, contact Ms. Cindy Eck at (301) 851-3882, email: 
cynthia.a.eck@aphis.usda.gov.

SUPPLEMENTARY INFORMATION:

Background

    Under the authority of the plant pest provisions of the Plant 
Protection Act (PPA), as amended, (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 
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. Paragraphs (b) and (c) of Sec.  340.6 describe 
the form that a petition for a determination of nonregulated status 
must take and the information that must be included in the petition.
    APHIS has received three petitions (referred to below as ``the 
petitions'') from Dow AgroSciences LLC (Dow) seeking determinations of 
nonregulated status for corn and soybean cultivars genetically 
engineered to be resistant to herbicides. The first petition, APHIS 
Petition Number 09-233-01p, seeks a determination of nonregulated 
status for corn (Zea mays) designated as event DAS-40278-9, which has 
been genetically engineered for increased resistance to certain 
broadleaf herbicides in the phenoxy auxin group (particularly the 
herbicide 2,4-D) and resistance to grass herbicides in the 
aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase (ACCase) 
inhibitor group (i.e., ``fop'' herbicides, such as quizalofop-p-ethyl). 
The second petition, APHIS Petition Number 09-349-01p, seeks a 
determination of nonregulated status for soybean (Glycine max) 
designated as DAS-68416-4, which has been genetically engineered for 
resistance to certain broadleaf herbicides in the phenoxy auxin growth 
regulator group (particularly the herbicide 2,4-D) and the nonselective 
herbicide glufosinate. The third petition (APHIS Petition Number 11-
234-01p) seeks a determination of nonregulated status for soybean 
designated as event DAS-44406-6, which has been genetically engineered 
for resistance to certain broadleaf herbicides in the auxin growth 
regulator group (particularly the herbicide 2,4-D) and the nonselective 
herbicides glyphosate and glufosinate. The petitions state that these 
articles are unlikely to pose a plant pest risk and, therefore, should 
not be regulated articles under APHIS' regulations in 7 CFR part 340. 
These part 340 regulations are authorized by the PPA to prevent the 
introduction or dissemination of plant pests, and the decision on 
whether or not to approve the petitions will be based on this standard.
    Notices were published \1\ in the Federal Register for each 
petition advising the public that APHIS had

[[Page 28799]]

received the petition and was seeking public comments on the petition. 
The notices for the first two petitions also sought comment on our 
plant pest risk assessment (PPRA) and our draft environmental 
assessment (EA) for each petition; we have not yet published a PPRA or 
EA for the third petition, so that notice sought comment on the 
petition, only.
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    \1\ Docket No. APHIS-2010-0103 published on December 27, 2011, 
76 FR 80872-80873; Docket No. APHIS-2012-0019 published on July 13, 
2012, 77 FR 41367-41368; and Docket No. APHIS-2012-0032 published on 
July 13, 2012, 77 FR 41361-41362. The Federal Register notices for 
the petitions and supporting and related materials, including public 
comments, are available at http://www.regulations.gov/#!docketDetail;D=APHIS-2010-0103; http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0019; and http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0032.
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    Under the provisions of the National Environmental Policy Act of 
1969, as amended (42 U.S.C. 4321 et seq.) (NEPA), Federal agencies must 
examine the potential environmental impacts of proposed major Federal 
actions significantly affecting the quality of the human environment 
before those actions can be taken. In accordance with NEPA, regulations 
of the Council on Environmental Quality for implementing the procedural 
provisions of NEPA (40 CFR parts 1500-1508), U.S. Department of 
Agriculture (USDA) regulations implementing NEPA (7 CFR part 1b), and 
APHIS' NEPA Implementing Procedures (7 CFR part 372), APHIS has 
considered how to properly examine the potential environmental impacts 
of decisions for petitions for determinations of nonregulated status. 
For each petition for a determination of nonregulated status under 
consideration in the past, APHIS prepared an EA to provide the APHIS 
decisionmaker with a review and analysis of any potential environmental 
impacts. In two cases,\2\ APHIS prepared an environmental impact 
statement (EIS).
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    \2\ Glyphosate-Tolerant Alfalfa Events J101 and J163: Request 
for Nonregulated Status, Final Environmental Impact Statement-
December 2010; Glyphosate-Tolerant H7-1 Sugar Beet: Request for 
Nonregulated Status, Final Environmental Impact Statement-May 2012.
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    In reviewing petitions for determinations of nonregulated status of 
crop cultivars genetically engineered to be resistant to various 
herbicides, APHIS has identified the potential selection of herbicide 
resistant weeds as a potential environmental impact. We have concluded 
for the three Dow petitions that it is appropriate to complete an EIS 
for the potential determinations of nonregulated status requested by 
the petitions in order to perform a comprehensive environmental 
analysis of the potential selection of 2,4-D resistant weeds and other 
potential environmental impacts that may occur as a result of making 
determinations of nonregulated status of these events. An EIS can 
examine the broad and cumulative environmental impacts of making 
determinations of nonregulated status of the three requested corn and 
soybean cultivars, including potential impacts of the proposed action 
on the human environment, alternative courses of action, and possible 
mitigation measures for reducing potential impacts.

Alternatives

    The Federal action being considered is whether to approve the three 
petitions for nonregulated status. This notice identifies reasonable 
alternatives and potential issues that may be studied in the EIS. We 
are requesting public comments to further delineate the range of 
alternatives and environmental impacts and issues to be evaluated in 
the EIS for the three petitions. We will be hosting a virtual meeting 
during the scoping period to discuss the appropriate scope of the EIS 
(see ADDRESSES above). We are particularly interested in receiving 
comments regarding biological, cultural, or ecological issues, and we 
encourage the submission of scientific data, studies, or research to 
support your comments.
    The EIS will consider a range of reasonable alternatives. APHIS is 
currently considering four alternatives: (1) Take no action, i.e., 
APHIS would not change the regulatory status of the corn and soybean 
events and they would continue to be regulated articles, (2) approve 
the three petitions for determinations of nonregulated status of the 
corn event and both soybean events, (3) approve the petition for 
determination of nonregulated status of the corn event and deny the two 
petitions for determination of nonregulated status of the soybean 
events, or (4) approve the petitions for determination of nonregulated 
status of the two soybean events and deny the petition for 
determination of nonregulated status of the corn event.
    For the purposes of alternatives 3 and 4, APHIS will consider 
either approving both soybean petitions and denying the corn petition 
or denying both soybean petitions and approving the corn petition. Corn 
and soybean are often grown as rotation crops and these alternatives 
can compare the potential impacts of approving petitions for one 
rotation crop without the other. APHIS is grouping the two soybean 
petitions in alternatives 3 and 4 because the two soybean events share 
both 2,4-D and glufosinate resistance. One soybean, DAS 44406-6 is also 
resistant to glyphosate. However, DAS 68416-4 (glufosinate, 2,4-D 
resistant) could be crossed with any glyphosate resistant soybean for 
which APHIS has previously made a determination of nonregulated status 
to create a soybean that is resistant to all three herbicides. Because 
APHIS does not regulate breeding of events for which APHIS has 
previously made a determination of nonregulated status, approving the 
petition for nonregulated status for DAS 68416-4 and not DAS 44406-6 
could still result in a soybean resistant to all three herbicides being 
marketed. Based on the preliminary plant pest risk assessments for each 
soybean event, APHIS has not identified any plant pest risks associated 
with either soybean event. Therefore, APHIS plans to consider either 
approving or denying both soybean petitions together in these 
alternatives.

Environmental Issues for Consideration

    We have also identified the following potential environmental 
issues for consideration in the EIS. We are requesting that the public 
provide information on the following questions during the comment 
period on this Notice of Intent (NOI):
     What are the impacts of weeds, herbicide-resistant weeds, 
weed management practices, and unmet weed management needs for crop 
cultivation, and how may these change with the approval of these 
petitions for nonregulated status of these three herbicide-resistant 
crops?
     In which weeds would the approval of the three petitions 
likely contribute to controlling the spread of biotypes that are 
resistant to more than one herbicide mode of action and how will that 
control influence weed management strategies in cropland or managed 
non-cropland?
     What weeds are currently resistant to herbicides in the 
phenoxyaliphatic acid herbicide class of the auxin growth regulator 
group (e.g., 2,4-D) and what is their natural frequency and occurrence 
in corn and soy crops, other crops, and in non-crop ecosystems?
     Would the increased use of 2,4-D associated with the 
approval of these three petitions cause an acceleration of the 
selection and spread of 2,4-D-resistant biotypes? Are there weeds that 
are more likely to be difficult to control if they become resistant to 
2,4-D?
     In which crops or non-cropland weeds would the selection 
and spread of 2,4-D-resistant biotypes be most problematic in terms of 
available alternate weed management strategies and agronomic 
production?
     In which weeds would the approval of the three petitions 
likely contribute to the selection and spread of biotypes that are 
resistant to more than one herbicide mode of action and which would be 
most problematic for weed management strategies in cropland or managed 
non-cropland?

[[Page 28800]]

     What are the potential changes in agronomic practices, 
including crop rotation and weed management practices (e.g., herbicide 
use, tillage), for control of weeds in rotational crops that may occur 
with the use of these herbicide-resistant crops? What are the current 
and potentially effective strategies for management of herbicide-
resistant weeds in crops? What are the costs associated with these 
practices and strategies?
    Comments that identify other issues or alternatives that chould be 
considered for examination in the EIS would be especially helpful. All 
comments received during the scoping period will be carefully 
considered in developing the final scope of the EIS. Upon completion of 
the draft EIS, a notice announcing its availability and an opportunity 
to comment on it will be published in the Federal Register.

    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 May 2013.
Michael Gregoire,
Deputy Administrator, Biotechnology Regulatory Services, Animal and 
Plant Health Inspection Service.
[FR Doc. 2013-11579 Filed 5-15-13; 8:45 am]
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