BASF Plant Sciences, LP; Determination of Nonregulated Status of Soybean Genetically Engineered for Resistance to the Herbicide Imidazolinone, 15095-15096 [2014-06016]

Download as PDF 15095 Notices Federal Register Vol. 79, No. 52 Tuesday, March 18, 2014 This section of the FEDERAL REGISTER contains documents other than rules or proposed rules that are applicable to the public. Notices of hearings and investigations, committee meetings, agency decisions and rulings, delegations of authority, filing of petitions and applications and agency statements of organization and functions are examples of documents appearing in this section. DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2012–0028] BASF Plant Sciences, LP; Determination of Nonregulated Status of Soybean Genetically Engineered for Resistance to the Herbicide Imidazolinone Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: emcdonald on DSK67QTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: Background We are advising the public of our determination that a soybean event developed by BASF Plant Sciences, LP designated as BPS–CV127–9, which has been genetically engineered for resistance to treatment with imidazolinone herbicides, 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 BASF Plant Sciences, LP 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: Effective Date: March 18, 2014. ADDRESSES: You may read the documents referenced in this notice and the comments we received at https:// www.regulations.gov/ #!docketDetail;D=APHIS-2012-0028 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 SUMMARY: VerDate Mar<15>2010 18:34 Mar 17, 2014 Jkt 232001 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 are also available on the APHIS Web site at https://www.aphis.usda.gov/ biotechnology/ petitions_table_pending.shtml under APHIS Petition Number 09–015–01p. 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 supporting documents for this petition, contact Ms. Cindy Eck at (301) 851–3892, email: cynthia.a.eck@aphis.usda.gov. 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. APHIS received a petition (APHIS Petition Number 09–015–01p) from BASF Plant Sciences, LP (BASF) of Research Triangle Park, NC, seeking a determination of nonregulated status of soybean (Glycine max) designated as BPS–CV127–9 (CV127), which has been genetically engineered for resistance to the herbicide imidazolinone. The petition states that this soybean is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS’ regulations in 7 CFR part 340. PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 According to our process 1 for soliciting public comment when considering petitions for determinations of nonregulated status of genetically engineered (GE) organisms, APHIS accepts written comments regarding a petition once APHIS deems it complete. In a notice 2 published in the Federal Register on July 13, 2012, (77 FR 41363– 41364, Docket No. APHIS–2012–0028), APHIS announced the availability of the BASF petition for public comment. APHIS solicited comments on the petition for 60 days ending on September 11, 2012, 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 75 comments on the petition. Several of these comments included electronic attachments consisting of a consolidated document of many identical or nearly identical letters, for a total of 4,676 comments. APHIS decided, 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. According to our public review process for such petitions (see footnote 1), APHIS first solicits written comments from the public on a draft environmental assessment (EA) and 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 PPRA and other information, APHIS revises the PPRA as necessary and prepares a final EA and, based on the final EA, a National Environmental Policy Act (NEPA) decision 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 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 https:// www.regulations.gov/#!docketDetail;D=APHIS2011-0129. 2 To view the notice, the petition, the comments we received, and other supporting documents, go to https://www.regulations.gov/ #!docketDetail;D=APHIS-2012-0028. E:\FR\FM\18MRN1.SGM 18MRN1 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

Agencies

[Federal Register Volume 79, Number 52 (Tuesday, March 18, 2014)]
[Notices]
[Pages 15095-15096]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06016]


========================================================================
Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

========================================================================


Federal Register / Vol. 79, No. 52 / Tuesday, March 18, 2014 / 
Notices

[[Page 15095]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0028]


BASF Plant Sciences, LP; Determination of Nonregulated Status of 
Soybean Genetically Engineered for Resistance to the Herbicide 
Imidazolinone

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

SUMMARY: We are advising the public of our determination that a soybean 
event developed by BASF Plant Sciences, LP designated as BPS-CV127-9, 
which has been genetically engineered for resistance to treatment with 
imidazolinone herbicides, 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 BASF Plant Sciences, LP 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: Effective Date: March 18, 2014.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received at https://www.regulations.gov/#!docketDetail;D=APHIS-2012-0028 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 are also available on the APHIS Web site at 
https://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml 
under APHIS Petition Number 09-015-01p.

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 supporting documents for this petition, contact Ms. Cindy Eck at 
(301) 851-3892, email: cynthia.a.eck@aphis.usda.gov.

SUPPLEMENTARY INFORMATION: 

Background

    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. APHIS received a petition (APHIS Petition Number 
09-015-01p) from BASF Plant Sciences, LP (BASF) of Research Triangle 
Park, NC, seeking a determination of nonregulated status of soybean 
(Glycine max) designated as BPS-CV127-9 (CV127), which has been 
genetically engineered for resistance to the herbicide imidazolinone. 
The petition states that this soybean is unlikely to pose a plant pest 
risk 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 
genetically engineered (GE) organisms, APHIS accepts written comments 
regarding a petition once APHIS deems it complete. In a notice \2\ 
published in the Federal Register on July 13, 2012, (77 FR 41363-41364, 
Docket No. APHIS-2012-0028), APHIS announced the availability of the 
BASF petition for public comment. APHIS solicited comments on the 
petition for 60 days ending on September 11, 2012, 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.
---------------------------------------------------------------------------

    \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 
https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
    \2\ To view the notice, the petition, the comments we received, 
and other supporting documents, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2012-0028.
---------------------------------------------------------------------------

    APHIS received 75 comments on the petition. Several of these 
comments included electronic attachments consisting of a consolidated 
document of many identical or nearly identical letters, for a total of 
4,676 comments. APHIS decided, 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. According to our public 
review process for such petitions (see footnote 1), APHIS first 
solicits written comments from the public on a draft environmental 
assessment (EA) and 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 
PPRA and other information, APHIS revises the PPRA as necessary and 
prepares a final EA and, based on the final EA, a National 
Environmental Policy Act (NEPA) decision 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

[[Page 15096]]

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 herbicide-resistant 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.

National Environmental Policy Act

    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).

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
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