83_FR_43800 83 FR 43634 - Nuseed Americas Inc.; Determination of Nonregulated Status of Canola Genetically Engineered for Altered Oil Profile

83 FR 43634 - Nuseed Americas Inc.; Determination of Nonregulated Status of Canola Genetically Engineered for Altered Oil Profile

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 83, Issue 166 (August 27, 2018)

Page Range43634-43635
FR Document2018-18565

We are advising the public of our determination that canola designated as event B0050-027, which has been genetically engineered to accumulate the long chain omega-3 fatty acid known as docosahexaenoic acid in seed, 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 Nuseed Americas Inc. 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.

Federal Register, Volume 83 Issue 166 (Monday, August 27, 2018) 
[Federal Register Volume 83, Number 166 (Monday, August 27, 2018)]
[Notices]
[Pages 43634-43635]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-18565]


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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.

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Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / 
Notices

[[Page 43634]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2017-0096]


Nuseed Americas Inc.; Determination of Nonregulated Status of 
Canola Genetically Engineered for Altered Oil Profile

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that canola 
designated as event B0050-027, which has been genetically engineered to 
accumulate the long chain omega-3 fatty acid known as docosahexaenoic 
acid in seed, 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 Nuseed Americas Inc. 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: This change in regulatory status will be recognized August 27, 
2018.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received at http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0096 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 website at 
http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml 
under APHIS Petition 17-236-01p.

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

SUPPLEMENTARY INFORMATION: 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 
17-236-01p) from Nuseed Americas Inc. (Nuseed) of Breckenridge, MN, 
seeking a determination of nonregulated status of canola (Brassica 
spp.) designated as event B0050-027, which has been genetically 
engineered to accumulate the long chain omega-3 fatty acid known as 
docosahexaenoic acid (DHA) in seed. The Nuseed petition states that 
information collected during field trials and laboratory analyses 
indicates that B0050-027 canola is not likely to be a plant pest 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 December 11, 2017 (82 FR 58167-58168, Docket No. APHIS-
2017-0096), APHIS announced the availability of the Nuseed petition for 
public comment. APHIS solicited comments on the petition for 60 days 
ending on February 9, 2018, 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.
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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-
2017-0096.
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    APHIS received four comments on the petition. Issues raised during 
the comment period included concerns regarding product stewardship 
during production and marketing. These concerns were addressed by 
Nuseed with supplemental product stewardship data provided to APHIS in 
support of the petition.
    APHIS decided, based on its review of the petition and its 
evaluation and analysis of the 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 is following 
Approach 2, where we first solicit written comments from the public on 
a draft environmental assessment (EA) and a draft 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 the draft PPRA and other information, 
APHIS revises the draft PPRA as necessary and prepares a final EA and, 
based on the final EA, a National Environmental Policy Act (NEPA) 
finding document

[[Page 43635]]

(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 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.
    APHIS sought public comment on a draft EA and a draft PPRA from 
June 26, 2018, to July 26, 2018.\3\ APHIS solicited comments on the 
draft EA, the draft PPRA, and whether the subject canola is likely to 
pose a plant pest risk. APHIS received two comments on the petition, 
both of which supported a decision of nonregulated status for event 
B0050-027 canola.
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    \3\ 83 FR 29742-29743.
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National Environmental Policy Act

    After reviewing and evaluating the comments received during the 
comment period on the draft EA and draft 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 canola designated as event B0050-027. 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 
canola designated as event B0050-027).

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
Nuseed, 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 canola designated as 
event B0050-027 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 22nd day of August 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-18565 Filed 8-24-18; 8:45 am]
 BILLING CODE 3410-34-P

43634 Notices Federal Register Vol. 83, No. 166 Monday, August 27, 2018 This section of the FEDERAL REGISTER through Friday, except holidays. To be According to our process 1 for contains documents other than rules or sure someone is there to help you, soliciting public comment when proposed rules that are applicable to the please call (202) 799–7039 before considering petitions for determinations public. Notices of hearings and investigations, coming. of nonregulated status of GE organisms, committee meetings, agency decisions and APHIS accepts written comments Supporting documents are also rulings, delegations of authority, filing of available on the APHIS website at regarding a petition once APHIS deems petitions and applications and agency statements of organization and functions are http://www.aphis.usda.gov/ it complete. In a notice 2 published in examples of documents appearing in this biotechnology/petitions_table_ the Federal Register on December 11, section. pending.shtml under APHIS Petition 2017 (82 FR 58167–58168, Docket No. 17–236–01p. APHIS–2017–0096), APHIS announced FOR FURTHER INFORMATION CONTACT: Dr. the availability of the Nuseed petition DEPARTMENT OF AGRICULTURE John Turner, Director, Environmental for public comment. APHIS solicited Risk Analysis Programs, Biotechnology comments on the petition for 60 days Animal and Plant Health Inspection ending on February 9, 2018, in order to Regulatory Services, APHIS, 4700 River Service help identify potential environmental Road, Unit 147, Riverdale, MD 20737– [Docket No. APHIS–2017–0096] 1236; (301) 851–3954, email: and interrelated economic issues and impacts that APHIS may determine john.t.turner@aphis.usda.gov. To obtain Nuseed Americas Inc.; Determination should be considered in our evaluation copies of the supporting documents for of Nonregulated Status of Canola of the petition. this petition, contact Ms. Cindy Eck at APHIS received four comments on the Genetically Engineered for Altered Oil (301) 851–3892, email: cynthia.a.eck@ Profile petition. Issues raised during the aphis.usda.gov. comment period included concerns AGENCY: Animal and Plant Health SUPPLEMENTARY INFORMATION: The regarding product stewardship during Inspection Service, USDA. regulations in 7 CFR part 340, production and marketing. These ACTION: Notice. ‘‘Introduction of Organisms and concerns were addressed by Nuseed Products Altered or Produced Through with supplemental product stewardship SUMMARY: We are advising the public of Genetic Engineering Which Are Plant data provided to APHIS in support of our determination that canola Pests or Which There Is Reason to the petition. designated as event B0050–027, which Believe Are Plant Pests,’’ regulate, APHIS decided, based on its review of has been genetically engineered to among other things, the introduction the petition and its evaluation and accumulate the long chain omega-3 fatty (importation, interstate movement, or analysis of the comments received acid known as docosahexaenoic acid in release into the environment) of during the 60-day public comment seed, is no longer considered a regulated organisms and products altered or period on the petition, that the petition article under our regulations governing produced through genetic engineering involves a GE organism that raises the introduction of certain genetically that are plant pests or that there is substantive new issues. According to engineered organisms. Our reason to believe are plant pests. Such our public review process for such determination is based on our genetically engineered (GE) organisms petitions (see footnote 1), APHIS is evaluation of data submitted by Nuseed and products are considered ‘‘regulated following Approach 2, where we first Americas Inc. in its petition for a articles.’’ solicit written comments from the determination of nonregulated status, The regulations in § 340.6(a) provide public on a draft environmental our analysis of available scientific data, that any person may submit a petition assessment (EA) and a draft plant pest and comments received from the public to the Animal and Plant Health risk assessment (PPRA) for a 30-day in response to our previous notices Inspection Service (APHIS) seeking a comment period through the announcing the availability of the determination that an article should not publication of a Federal Register notice. petition for nonregulated status and its be regulated under 7 CFR part 340. Then, after reviewing and evaluating the associated environmental assessment APHIS received a petition (APHIS comments on the draft EA and the draft and plant pest risk assessment. This Petition Number 17–236–01p) from PPRA and other information, APHIS notice also announces the availability of Nuseed Americas Inc. (Nuseed) of revises the draft PPRA as necessary and our written determination and finding Breckenridge, MN, seeking a prepares a final EA and, based on the of no significant impact. determination of nonregulated status of final EA, a National Environmental DATES: This change in regulatory status canola (Brassica spp.) designated as Policy Act (NEPA) finding document will be recognized August 27, 2018. event B0050–027, which has been 1 On March 6, 2012, APHIS published in the ADDRESSES: You may read the genetically engineered to accumulate Federal Register (77 FR 13258–13260, Docket No. documents referenced in this notice and the long chain omega-3 fatty acid known APHIS–2011–0129) a notice describing our public the comments we received at http:// as docosahexaenoic acid (DHA) in seed. review process for soliciting public comments and amozie on DSK3GDR082PROD with NOTICES1 The Nuseed petition states that information when considering petitions for www.regulations.gov/#!docketDetail;D determinations of nonregulated status for GE =APHIS-2017-0096 or in our reading information collected during field trials organisms. To view the notice, go to http:// room, which is located in room 1141 of and laboratory analyses indicates that www.regulations.gov/#!docketDetail;D=APHIS- the USDA South Building, 14th Street B0050–027 canola is not likely to be a 2011-0129. 2 To view the notice, the petition, and the and Independence Avenue SW, plant pest and therefore should not be comments we received, go to http:// Washington, DC. Normal reading room a regulated article under APHIS’ www.regulations.gov/#!docketDetail;D=APHIS- hours are 8 a.m. to 4:30 p.m., Monday regulations in 7 CFR part 340. 2017-0096. VerDate Sep<11>2014 18:31 Aug 24, 2018 Jkt 244001 PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 E:\FR\FM\27AUN1.SGM 27AUN1

Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Notices 43635 (either a finding of no significant impact comments provided by the public, and Policies and Export Reporting Division, (FONSI) or a notice of intent to prepare information provided in APHIS’ Foreign Agricultural Service, U.S. an environmental impact statement). If response to those public comments, Department of Agriculture, Stop 1021, a FONSI is reached, APHIS furnishes a APHIS has determined that canola 1400 Independence Avenue SW, response to the petitioner, either designated as event B0050–027 is Washington, DC 20250–1021. approving or denying the petition. unlikely to pose a plant pest risk and FOR FURTHER INFORMATION CONTACT: APHIS also publishes a notice in the therefore is no longer subject to our Federal Register announcing the regulations governing the introduction Abdelsalam El-Farra, (202) 720–9439, regulatory status of the GE organism and of certain GE organisms. Abdelsalam.El-Farra@fas.usda.gov. the availability of APHIS’ final EA, Copies of the signed determination SUPPLEMENTARY INFORMATION: The PPRA, FONSI, and our regulatory document, PPRA, final EA, FONSI, and Foreign Agricultural Service, under a determination. response to comments, as well as the delegation of authority from the Under APHIS sought public comment on a previously published petition and Secretary for Trade and Foreign draft EA and a draft PPRA from June 26, supporting documents, are available as Agricultural Affairs, administers the 2018, to July 26, 2018.3 APHIS solicited indicated in the ADDRESSES and FOR Dairy Tariff-Rate Import Quota comments on the draft EA, the draft FURTHER INFORMATION CONTACT sections Licensing Regulation codified at 7 CFR PPRA, and whether the subject canola is of this notice. 6.20–6.36 that provides for the issuance likely to pose a plant pest risk. APHIS of licenses to import certain dairy Authority: 7 U.S.C. 7701–7772 and 7781– received two comments on the petition, 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and articles under tariff-rate quotas (TRQs) both of which supported a decision of 371.3. as set forth in the Harmonized Tariff nonregulated status for event B0050– Done in Washington, DC, this 22nd day of Schedule (HTS) of the United States. 027 canola. August 2018. These dairy articles may only be entered National Environmental Policy Act Kevin Shea, into the United States at the low-tier After reviewing and evaluating the Administrator, Animal and Plant Health tariff by or for the account of a person comments received during the comment Inspection Service. or firm to whom such licenses have period on the draft EA and draft PPRA [FR Doc. 2018–18565 Filed 8–24–18; 8:45 am] been issued and only in accordance and other information, APHIS has BILLING CODE 3410–34–P with the terms and conditions of the prepared a final EA. The EA has been regulation. prepared to provide the public with Licenses are issued on a calendar year documentation of APHIS’ review and DEPARTMENT OF AGRICULTURE basis, and each license authorizes the analysis of any potential environmental license holder to import a specified impacts associated with the Foreign Agricultural Service quantity and type of dairy article from determination of nonregulated status of a specified country of origin. The Import canola designated as event B0050–027. Adjustment of Appendices Under the Dairy Tariff-Rate Import Quota Policies and Export Reporting Division, The EA was prepared in accordance Foreign Agricultural Service, U.S. with: (1) NEPA, as amended (42 U.S.C. Licensing Regulation for the 2018 Tariff-Rate Quota Year Department of Agriculture, issues these 4321 et seq.), (2) regulations of the licenses and, in conjunction with U.S. Council on Environmental Quality for AGENCY: Foreign Agricultural Service, Customs and Border Protection, U.S. implementing the procedural provisions USDA. Department of Homeland Security, of NEPA (40 CFR parts 1500–1508), (3) ACTION: Notice. monitors their use. USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS’ NEPA The regulation at 7 CFR 6.34(a) states: SUMMARY: This notice publishes the Implementing Procedures (7 CFR part ‘‘Whenever a historical license document ‘‘Articles Subject to: 372). Based on our EA, the response to (Appendix 1) is not issued to an Appendix 1, Historical Licenses; public comments, and other pertinent applicant pursuant to the provisions of Appendix 2 Non-historical Licenses; scientific data, APHIS has reached a 6.23, is permanently surrendered or is and Appendix 3 and 4, Designated FONSI with regard to the preferred revoked by the Licensing Authority, the Importers Licenses for Quota Year alternative identified in the EA (to make amount of such license will be 2018.’’ The quantities in Appendices 1 a determination of nonregulated status transferred to Appendix 2.’’ Section and 2 have been revised under the Dairy of canola designated as event B0050– 6.34(b) provides that the cumulative Tariff-Rate Import Quota Licensing 027). annual transfers will be published by Regulation for the 2018 quota year to notice in the Federal Register. Determination reflect the cumulative annual transfers Accordingly, this document sets forth from Appendix 1 to Appendix 2 for Based on APHIS’ analysis of field and the revised Appendices 1 and 2 for the certain dairy product import licenses laboratory data submitted by Nuseed, 2018 tariff-rate quota year below. permanently surrendered by licensees references provided in the petition, Issued at Washington, DC, the 6th day of or revoked by the Licensing Authority. peer-reviewed publications, information July 2018. analyzed in the EA, the PPRA, DATES: August 27, 2018. ADDRESSES: Abdelsalam El-Farra, Dairy Ronald Lord, 3 83 FR 29742–29743. Import Licensing Program, Import Licensing Authority. amozie on DSK3GDR082PROD with NOTICES1 VerDate Sep<11>2014 17:51 Aug 24, 2018 Jkt 244001 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 E:\FR\FM\27AUN1.SGM 27AUN1


Document Created: 2018-08-25 01:49:38
Document Modified: 2018-08-25 01:49:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThis change in regulatory status will be recognized August 27, 2018.
ContactDr. 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 supporting documents for this petition, contact Ms. Cindy Eck at (301) 851-3892, email: [email protected]
FR Citation83 FR 43634 
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