Dow AgroSciences LLC; Availability of Petition for Determination of Nonregulated Status of Cotton Genetically Engineered for Resistance to 2,4-D and Glufosinate, 15096-15097 [2014-06013]

Download as PDF 15096 Federal Register / Vol. 79, No. 52 / Tuesday, March 18, 2014 / Notices 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. In a notice (see footnote 2) published in the Federal Register on November 7, 2013, (78 FR 66892–66893, Docket No. APHIS–2012–0028), APHIS announced the availability of a PPRA and a draft EA for public comment. APHIS solicited comments on the draft EA, the PPRA, and whether the subject soybeans are likely to pose a plant pest risk for 30 days ending on December 9, 2013. APHIS received 10 comments during the comment period. All comments submitted to the docket were carefully analyzed by APHIS. A number of these comments were generally opposed to GE organisms or the use of herbicideresistant crops. Others had concerns about potential impacts associated with the herbicides used on GE crops. In general, commenters expressed their opposition to our determination of nonregulatory status but did not identify elements in the PPRA or EA that they perceived to be inadequate or provide any specific supporting evidence for their opposition. APHIS has addressed the issues raised during the comment period and has provided responses to these comments as an attachment to the FONSI. Determination Based on APHIS’ analysis of field and laboratory data submitted by BASF, 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 BASF’s CV127 soybean 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 12th day of March 2014. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2014–06016 Filed 3–17–14; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service emcdonald on DSK67QTVN1PROD with NOTICES National Environmental Policy Act [Docket No. APHIS–2013–0113] After reviewing and evaluating the comments received during the comment period on the draft EA and 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 BASF’s CV127 soybean. 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 BASF’s CV127 soybean). Dow AgroSciences LLC; Availability of Petition for Determination of Nonregulated Status of Cotton Genetically Engineered for Resistance to 2,4–D and Glufosinate VerDate Mar<15>2010 18:34 Mar 17, 2014 Jkt 232001 Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Dow AgroSciences LLC (DAS) seeking a determination of nonregulated status of cotton designated as DAS–8191;-7, which has been genetically engineered for resistance to the herbicides 2,4–D and glufosinate. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the DAS petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that the SUMMARY: PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 Animal and Plant Health Inspection Service may determine should be considered in our evaluation of the petition. We will consider all comments that we receive on or before May 19, 2014. DATES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!documentDetail;D=APHIS-2013-01130001. • Postal Mail/Commercial Delivery: Send your comment 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 and any comments we receive on this docket may be viewed at https:// 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. The petition is also available on the APHIS Web site at: https:// 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: john.t.turner@aphis.usda.gov. To obtain copies of the petition, contact Ms. Cindy Eck at (301) 851–3892, email: cynthia.a.eck@aphis.usda.gov. 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.’’ ADDRESSES: E:\FR\FM\18MRN1.SGM 18MRN1 emcdonald on DSK67QTVN1PROD with NOTICES Federal Register / Vol. 79, No. 52 / Tuesday, March 18, 2014 / Notices 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 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;–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 DAS petition states that information collected during field trials and laboratory analyses indicates that DAS–8191;–7 cotton 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. As described in the petition, DAS developed DAS–8191;–7 cotton using Agrobacterium-mediated transformation to incorporate the aad–12 gene from Delftia acidovorans and the pat gene from Streptomyces viridochromogenes into cotton. The aad–12 gene encodes the enzyme aryloxyalkanoate dioxygenase-12 (AAD–12) which, when expressed in plants, degrades 2,4–D to herbicidally-inactive 2,4dichlorophenol. The pat gene encodes the enzyme phosphinothricin acetyltransferase that inactivates glufosinate. DAS has submitted information on the use of 2,4–D on DAS–8191;–7 cotton to the U.S. Environmental Protection Agency (EPA), which is responsible for evaluating and approving the use of any herbicides or pesticides on plants, including GE plants.1 Field tests conducted under APHIS oversight allowed for evaluation in a natural agricultural setting while imposing measures to minimize the risk of persistence in the environment after completion of the tests. Data are gathered on multiple parameters and used by the applicant to evaluate agronomic characteristics and product performance. These and other data are 1 The roles of the Federal agencies responsible for regulating the safe use of GE organisms is described in a notice published in the Federal Register on June 26, 1986 (51 FR 23302). The notice may be viewed at https://www.aphis.usda.gov/brs/ fedregister/coordinated_framework.pdf. VerDate Mar<15>2010 18:34 Mar 17, 2014 Jkt 232001 used by APHIS to determine if the new variety poses a plant pest risk. Paragraph (d) of § 340.6 provides that APHIS will publish a notice in the Federal Register providing 60 days for public comment for petitions for a determination of nonregulated status. On March 6, 2012, we published in the Federal Register (77 FR 13258–13260, Docket No. APHIS–2011–0129) a notice 2 describing our process for soliciting public comment when considering petitions for determinations of nonregulated status for GE organisms. In that notice we indicated that APHIS would accept written comments regarding a petition once APHIS deemed it complete. In accordance with § 340.6(d) of the regulations and our process for soliciting public input when considering petitions for determinations of nonregulated status for GE organisms, we are publishing this notice to inform the public that APHIS will accept written comments regarding the petition for a determination of nonregulated status from interested or affected persons for a period of 60 days from the date of this notice. The petition is available for public review and comment, and copies are available as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above. We are interested in receiving comments regarding potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition. 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. We also request that, when possible, commenters provide relevant information regarding specific localities or regions as cotton growth, crop management, and crop utilization may vary considerably by geographic region. After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information. Any substantive issues identified by APHIS based on our review of the petition and our evaluation and analysis of comments will be considered in the development of our decisionmaking documents. As part of our decisionmaking process regarding a GE organism’s regulatory status, APHIS prepares a plant pest risk 2 To view the notice, go to https:// www.regulations.gov/#!docketDetail;D=APHIS2011-0129. PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 15097 assessment to assess its plant pest risk and the appropriate environmental documentation—either an environmental assessment (EA) or an environmental impact statement (EIS)— in accordance with the National Environmental Policy Act (NEPA), to provide the Agency with a review and analysis of any potential environmental impacts associated with the petition request. For petitions for which APHIS prepares an EA, APHIS will follow our published process for soliciting public comment (see footnote 2) and publish a separate notice in the Federal Register announcing the availability of APHIS’ EA and plant pest risk assessment. Should APHIS determine that an EIS is necessary, APHIS will complete the NEPA EIS process in accordance with Council on Environmental Quality regulations (40 CFR part 1500–1508) and APHIS’ NEPA implementing regulations (7 CFR part 372). 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 12th day of March 2014. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2014–06013 Filed 3–17–14; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF COMMERCE Bureau of the Census Census Scientific Advisory Committee Bureau of the Census, Department of Commerce. ACTION: Notice of public meeting. AGENCY: The Bureau of the Census (U.S. Census Bureau) is giving notice of a meeting of the Census Scientific Advisory Committee (C–SAC). The C– SAC will meet in a plenary session on April 10–11, 2014. The Committee will address policy, research, and technical issues relating to a full range of Census Bureau programs and activities, including communications, decennial, demographic, economic, field operations, geographic, information technology, and statistics. Last minute changes to the agenda are possible, which could prevent giving advance public notice of schedule adjustments. DATES: April 10 and April 11, 2014. On April 10, the C–SAC meeting will begin at approximately 8:30 a.m. and adjourn at approximately 4 p.m. On April 11, the meeting will begin at approximately 8:30 a.m. and adjourn at approximately 1:30 p.m. SUMMARY: E:\FR\FM\18MRN1.SGM 18MRN1

Agencies

[Federal Register Volume 79, Number 52 (Tuesday, March 18, 2014)]
[Notices]
[Pages 15096-15097]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06013]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2013-0113]


Dow AgroSciences LLC; Availability of Petition for Determination 
of Nonregulated Status of Cotton Genetically Engineered for Resistance 
to 2,4-D and Glufosinate

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has received a petition from Dow AgroSciences LLC 
(DAS) seeking a determination of nonregulated status of cotton 
designated as DAS-8191[Oslash]-7, which has been genetically engineered 
for resistance to the herbicides 2,4-D and glufosinate. The petition 
has been submitted in accordance with our regulations concerning the 
introduction of certain genetically engineered organisms and products. 
We are making the DAS petition available for review and comment to help 
us identify potential environmental and interrelated economic issues 
and impacts that the Animal and Plant Health Inspection Service may 
determine should be considered in our evaluation of the petition.

DATES: We will consider all comments that we receive on or before May 
19, 2014.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!documentDetail;D=APHIS-2013-0113-0001.
     Postal Mail/Commercial Delivery: Send your comment 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 and any comments we receive on this docket may 
be viewed at https://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.
    The petition is also available on the APHIS Web site at: https://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: john.t.turner@aphis.usda.gov. To obtain copies 
of the petition, contact Ms. Cindy Eck at (301) 851-3892, email: 
cynthia.a.eck@aphis.usda.gov.

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.''

[[Page 15097]]

    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 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 DAS petition states that information 
collected during field trials and laboratory analyses indicates that 
DAS-8191[Oslash]-7 cotton 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.
    As described in the petition, DAS developed DAS-8191[Oslash]-7 
cotton using Agrobacterium-mediated transformation to incorporate the 
aad-12 gene from Delftia acidovorans and the pat gene from Streptomyces 
viridochromogenes into cotton. The aad-12 gene encodes the enzyme 
aryloxyalkanoate dioxygenase-12 (AAD-12) which, when expressed in 
plants, degrades 2,4-D to herbicidally-inactive 2,4-dichlorophenol. The 
pat gene encodes the enzyme phosphinothricin acetyltransferase that 
inactivates glufosinate.
    DAS has submitted information on the use of 2,4-D on DAS-
8191[Oslash]-7 cotton to the U.S. Environmental Protection Agency 
(EPA), which is responsible for evaluating and approving the use of any 
herbicides or pesticides on plants, including GE plants.\1\
---------------------------------------------------------------------------

    \1\ The roles of the Federal agencies responsible for regulating 
the safe use of GE organisms is described in a notice published in 
the Federal Register on June 26, 1986 (51 FR 23302). The notice may 
be viewed at https://www.aphis.usda.gov/brs/fedregister/coordinated_framework.pdf.
---------------------------------------------------------------------------

    Field tests conducted under APHIS oversight allowed for evaluation 
in a natural agricultural setting while imposing measures to minimize 
the risk of persistence in the environment after completion of the 
tests. Data are gathered on multiple parameters and used by the 
applicant to evaluate agronomic characteristics and product 
performance. These and other data are used by APHIS to determine if the 
new variety poses a plant pest risk.
    Paragraph (d) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register providing 60 days for public comment for 
petitions for a determination of nonregulated status. On March 6, 2012, 
we published in the Federal Register (77 FR 13258-13260, Docket No. 
APHIS-2011-0129) a notice \2\ describing our process for soliciting 
public comment when considering petitions for determinations of 
nonregulated status for GE organisms. In that notice we indicated that 
APHIS would accept written comments regarding a petition once APHIS 
deemed it complete.
---------------------------------------------------------------------------

    \2\ To view the notice, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
---------------------------------------------------------------------------

    In accordance with Sec.  340.6(d) of the regulations and our 
process for soliciting public input when considering petitions for 
determinations of nonregulated status for GE organisms, we are 
publishing this notice to inform the public that APHIS will accept 
written comments regarding the petition for a determination of 
nonregulated status from interested or affected persons for a period of 
60 days from the date of this notice. The petition is available for 
public review and comment, and copies are available as indicated under 
ADDRESSES and FOR FURTHER INFORMATION CONTACT above. We are interested 
in receiving comments regarding potential environmental and 
interrelated economic issues and impacts that APHIS may determine 
should be considered in our evaluation of the petition. 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. We also 
request that, when possible, commenters provide relevant information 
regarding specific localities or regions as cotton growth, crop 
management, and crop utilization may vary considerably by geographic 
region.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. Any substantive issues identified by APHIS based on our 
review of the petition and our evaluation and analysis of comments will 
be considered in the development of our decisionmaking documents.
    As part of our decisionmaking process regarding a GE organism's 
regulatory status, APHIS prepares a plant pest risk assessment to 
assess its plant pest risk and the appropriate environmental 
documentation--either an environmental assessment (EA) or an 
environmental impact statement (EIS)--in accordance with the National 
Environmental Policy Act (NEPA), to provide the Agency with a review 
and analysis of any potential environmental impacts associated with the 
petition request. For petitions for which APHIS prepares an EA, APHIS 
will follow our published process for soliciting public comment (see 
footnote 2) and publish a separate notice in the Federal Register 
announcing the availability of APHIS' EA and plant pest risk 
assessment. Should APHIS determine that an EIS is necessary, APHIS will 
complete the NEPA EIS process in accordance with Council on 
Environmental Quality regulations (40 CFR part 1500-1508) and APHIS' 
NEPA implementing regulations (7 CFR part 372).

    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 12th day of March 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-06013 Filed 3-17-14; 8:45 am]
BILLING CODE 3410-34-P
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