2013-11580. Monsanto Co.; Notice of Intent To Prepare an Environmental Impact Statement for Determination of Nonregulated Status of Herbicide Resistant Soybeans and Cotton, and Notice of Virtual Public Meeting

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

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 two petitions from the Monsanto Company (Monsanto) seeking a determination of nonregulated status of herbicide resistant soybeans and cotton. 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 dicamba 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 a 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-2013-0043-0001.
• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2013-0043, 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-2013-0043 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 [phone] before coming.

Other Information: Details regarding the virtual scoping meeting, including times, dates, 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; [phone]. To obtain copies of the petition, contact Ms. Cindy Eck at [phone], email: [e-mail].

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 § 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 § 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 two petitions (referred to below as “the petitions”) from the Monsanto Company (Monsanto) seeking a determination of nonregulated status for soybean and cotton cultivars genetically engineered to be resistant to herbicides. The first petition, APHIS Petition Number 10-188-01p, seeks a determination of nonregulated status of soybean (Glycine max) designated as event MON 87708, which has been genetically engineered for tolerance to the herbicide dicamba. The second petition, APHIS Petition Number 12-185-01p, seeks a determination of nonregulated status of cotton (Gossypium spp.) designated as event MON 88701, which has been genetically engineered for tolerance to the herbicides dicamba 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 received the petition and was seeking public comments on the petitions. The notices also announced that APHIS would prepare either an environmental assessment (EA) or an environmental impact statement (EIS) in accordance with the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321 et seq.) (NEPA) to provide the Agency with a review and analysis of any potential environmental impacts associated with the petition request.

Under the provisions of 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, the 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 EIS.

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 that for the two Monsanto petitions 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 dicamba 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 two requested soybean and cotton 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 two 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 two petitions. We will be hosting a virtual meeting during the scoping period to discuss the 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 soybean and cotton events and they would continue to be regulated articles, (2) approve both the petitions for determinations of nonregulated status of the soybean event and the cotton event, (3) approve the petition for determination of nonregulated status of the soybean event and deny the petition for determination of nonregulated status of the cotton event, or (4) approve the petition for determination of nonregulated status of the cotton event and deny the petition for determination of nonregulated status of the soybean event.

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 herbicide-resistant crops?
• In which weeds would the approval of the two 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 dicamba herbicide and what is their natural frequency and occurrence in soy and cotton crops, other crops, and in non-crop ecosystems?
• Would the increased use of dicamba associated with the approval of these two petitions cause an acceleration of the selection and spread of dicamba-resistant biotypes? Are there weeds that are more likely to be difficult to control if they become resistant to dicamba?
• In which crops or non-cropland weeds would the selection and spread of dicamba-resistant biotypes be most problematic in terms of available alternate weed management strategies and agronomic production?
• In which weeds would the approval of the two petitions likely contribute to the selection and spread of biotypes that are resistant to more the one herbicide mode of action and which would be most problematic for weed management strategies in cropland or managed non-cropland?
• 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 could 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.

Footnotes

1.  Docket No. APHIS-2012-0047 published on July 13, 2012, 77 FR 41356-41357; Docket No. APHIS-2012-0097 published on February 27, 2013, 78 FR 13308-13309. 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-2012-0047 and http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2012-0097.

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.