82 FR 58167 - Nuseed Americas Inc.; Availability of Petition for Determination of Nonregulated Status of Canola Genetically Engineered for Altered Oil Profile
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service Federal Register Volume 82, Issue 236 (December 11, 2017)
Animal and Plant Health Inspection Service
Federal Register Volume 82, Issue 236 (December 11, 2017)
| Page Range | 58167-58168 | |
| FR Document | 2017-26584 |
[Federal Register Volume 82, Number 236 (Monday, December 11, 2017)] [Notices] [Pages 58167-58168] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26584] ======================================================================== 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. 82, No. 236 / Monday, December 11, 2017 / Notices [[Page 58167]] DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2017-0096] Nuseed Americas Inc.; Availability of Petition for Determination of Nonregulated Status of Canola Genetically Engineered for Altered Oil Profile 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 Nuseed Americas Inc. (Nuseed) seeking a determination of nonregulated status of 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. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the Nuseed 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 February 9, 2018. ADDRESSES: You may submit comments by either of the following methods:Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0096. Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2017-0096, 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 Detail;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. The petition is also available on the APHIS Web site 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 petition, contact Ms. Cindy Eck at (301) 851-3892, email: [email protected]. 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.'' 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 17-236-01p) from Nuseed Americas Inc. (Nuseed), 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. As described in the petition, B0050-027 canola was developed through Agrobacterium tumefaciens-mediated transformation of canola cultivar AV Jade with binary vector pJP3416_GA7-ModB. Characterization of the DHA canola event revealed two DNA inserts which matched the reference of the vector. The expressed DHA pathway enzymes are very low in concentration and are only expressed in the seed, and the agronomic properties of the event are no different than AV Jade. B0050-027 canola is currently regulated under 7 CFR part 340. Interstate movements and field tests of B0050-027 canola have been conducted under notifications acknowledged by APHIS. Field tests conducted under APHIS oversight allowed for evaluation in a natural agricultural setting while imposing measures to minimize the likelihood 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 \1\ 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 [[Page 58168]] would accept written comments regarding a petition once APHIS deemed it complete. --------------------------------------------------------------------------- \1\ To view the notice, go to http://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. 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 decision-making documents. As part of our decision-making 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 1) 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 5th day of December 2017. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2017-26584 Filed 12-8-17; 8:45 am] BILLING CODE 3410-34-P
![58167
Notices Federal Register
Vol. 82, No. 236
Monday, December 11, 2017
This section of the FEDERAL REGISTER 3A–03.8, 4700 River Road, Unit 118, APHIS has received a petition (APHIS
contains documents other than rules or Riverdale, MD 20737–1238. Petition Number 17–236–01p) from
proposed rules that are applicable to the Supporting documents and any Nuseed Americas Inc. (Nuseed), seeking
public. Notices of hearings and investigations, a determination of nonregulated status
comments we receive on this docket
committee meetings, agency decisions and of canola (Brassica spp.) designated as
rulings, delegations of authority, filing of may be viewed at http://
www.regulations.gov/#!docket event B0050–027, which has been
petitions and applications and agency
statements of organization and functions are Detail;D=APHIS-2017-0096 or in our genetically engineered to accumulate
examples of documents appearing in this reading Room, which is located in Room the long chain omega-3 fatty acid known
section. 1141 of the USDA South Building, 14th as docosahexaenoic acid (DHA) in seed.
Street and Independence Avenue SW., The Nuseed petition states that
Washington, DC. Normal reading room information collected during field trials
DEPARTMENT OF AGRICULTURE hours are 8 a.m. to 4:30 p.m., Monday and laboratory analyses indicates that
through Friday, except holidays. To be B0050–027 canola is not likely to be a
Animal and Plant Health Inspection sure someone is there to help you, plant pest and therefore should not be
Service please call (202) 799–7039 before a regulated article under APHIS’
[Docket No. APHIS–2017–0096] coming. regulations in 7 CFR part 340.
As described in the petition, B0050–
The petition is also available on the
Nuseed Americas Inc.; Availability of 027 canola was developed through
APHIS Web site at: http://
Petition for Determination of Agrobacterium tumefaciens-mediated
www.aphis.usda.gov/biotechnology/
Nonregulated Status of Canola transformation of canola cultivar AV
petitions_table_pending.shtml under
Genetically Engineered for Altered Oil Jade with binary vector pJP3416_GA7–
APHIS petition 17–236–01p.
Profile ModB. Characterization of the DHA
FOR FURTHER INFORMATION CONTACT: Dr. canola event revealed two DNA inserts
AGENCY: Animal and Plant Health John Turner, Director, Environmental which matched the reference of the
Inspection Service, USDA. Risk Analysis Programs, Biotechnology vector. The expressed DHA pathway
ACTION: Notice. Regulatory Services, APHIS, 4700 River enzymes are very low in concentration
Road, Unit 147, Riverdale, MD 20737– and are only expressed in the seed, and
SUMMARY: We are advising the public 1236; (301) 851–3954; email: the agronomic properties of the event
that the Animal and Plant Health john.t.turner@aphis.usda.gov. To obtain are no different than AV Jade. B0050–
Inspection Service has received a copies of the petition, contact Ms. Cindy 027 canola is currently regulated under
petition from Nuseed Americas Inc. Eck at (301) 851–3892, email: 7 CFR part 340. Interstate movements
(Nuseed) seeking a determination of cynthia.a.eck@aphis.usda.gov. and field tests of B0050–027 canola
nonregulated status of canola designated SUPPLEMENTARY INFORMATION: Under the have been conducted under
as event B0050–027, which has been authority of the plant pest provisions of notifications acknowledged by APHIS.
genetically engineered to accumulate the Plant Protection Act (7 U.S.C. 7701 Field tests conducted under APHIS
the long chain omega-3 fatty acid known et seq.), the regulations in 7 CFR part oversight allowed for evaluation in a
as docosahexaenoic acid in seed. The 340, ‘‘Introduction of Organisms and natural agricultural setting while
petition has been submitted in Products Altered or Produced Through imposing measures to minimize the
accordance with our regulations Genetic Engineering Which Are Plant likelihood of persistence in the
concerning the introduction of certain Pests or Which There Is Reason to environment after completion of the
genetically engineered organisms and Believe Are Plant Pests,’’ regulate, tests. Data are gathered on multiple
products. We are making the Nuseed among other things, the introduction parameters and used by the applicant to
petition available for review and (importation, interstate movement, or evaluate agronomic characteristics and
comment to help us identify potential release into the environment) of product performance. These and other
environmental and interrelated organisms and products altered or data are used by APHIS to determine if
economic issues and impacts that the produced through genetic engineering the new variety poses a plant pest risk.
Animal and Plant Health Inspection that are plant pests or that there is Paragraph (d) of § 340.6 provides that
Service may determine should be reason to believe are plant pests. Such APHIS will publish a notice in the
considered in our evaluation of the genetically engineered (GE) organisms Federal Register providing 60 days for
petition. and products are considered ‘‘regulated public comment for petitions for a
DATES: We will consider all comments articles.’’ determination of nonregulated status.
that we receive on or before February 9, On March 6, 2012, we published in the
The regulations in § 340.6(a) provide Federal Register (77 FR 13258–13260,
2018. that any person may submit a petition Docket No. APHIS–2011–0129) a
ADDRESSES: You may submit comments to the Animal and Plant Health notice 1 describing our process for
by either of the following methods: Inspection Service (APHIS) seeking a
soliciting public comment when
daltland on DSKBBV9HB2PROD with NOTICES
• Federal eRulemaking Portal: Go to determination that an article should not
considering petitions for determinations
http://www.regulations.gov/ be regulated under 7 CFR part 340.
of nonregulated status for GE organisms.
#!docketDetail;D=APHIS-2017-0096. Paragraphs (b) and (c) of § 340.6
In that notice we indicated that APHIS
• Postal Mail/Commercial Delivery: describe the form that a petition for a
Send your comment to Docket No. determination of nonregulated status 1 To view the notice, go to http://
APHIS–2017–0096, Regulatory Analysis must take and the information that must www.regulations.gov/#!docketDetail;D=APHIS-
and Development, PPD, APHIS, Station be included in the petition. 2011-0129.
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![58168 Federal Register / Vol. 82, No. 236 / Monday, December 11, 2017 / Notices
would accept written comments Authority: 7 U.S.C. 7701–7772 and 7781– the public may also submit written
regarding a petition once APHIS 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and comments; the comments must be
deemed it complete. 371.3. received in the Regional Programs Unit
In accordance with § 340.6(d) of the Done in Washington, DC, this 5th day of within 30 days following the meeting.
regulations and our process for December 2017. Written comments may be mailed to the
soliciting public input when Kevin Shea, Western Regional Office, U.S.
considering petitions for determinations Administrator, Animal and Plant Health Commission on Civil Rights, 300 North
of nonregulated status for GE organisms, Inspection Service. Los Angeles Street, Suite 2010, Los
we are publishing this notice to inform [FR Doc. 2017–26584 Filed 12–8–17; 8:45 am] Angeles, CA 90012. They may be faxed
the public that APHIS will accept BILLING CODE 3410–34–P to the Commission at (213) 894–0508, or
written comments regarding the petition emailed Ana Victoria Fortes at afortes@
for a determination of nonregulated usccr.gov. Persons who desire
status from interested or affected COMMISSION ON CIVIL RIGHTS additional information may contact the
persons for a period of 60 days from the
Regional Programs Unit at (213) 894–
date of this notice. The petition is Notice of Public Meeting of the Arizona
3437.
available for public review and Advisory Committee
comment, and copies are available as Records and documents discussed
indicated under ADDRESSES and FOR AGENCY: U.S. Commission on Civil during the meeting will be available for
FURTHER INFORMATION CONTACT above.
Rights. public viewing prior to and after the
We are interested in receiving ACTION: Announcement of meeting. meetings at https://facadatabase.gov/
comments regarding potential committee/meetings.aspx?cid=235.
SUMMARY: Notice is hereby given,
environmental and interrelated Please click on the ‘‘Meeting Details’’
pursuant to the provisions of the rules
economic issues and impacts that and ‘‘Documents’’ links. Records
and regulations of the U.S. Commission
APHIS may determine should be generated from these meetings may also
on Civil Rights (Commission) and the
considered in our evaluation of the be inspected and reproduced at the
Federal Advisory Committee Act
petition. We are particularly interested
(FACA) that a meetings of the Arizona Regional Programs Unit, as they become
in receiving comments regarding
Advisory Committee (Committee) to the available, both before and after the
biological, cultural, or ecological issues,
Commission will be held at 12:00 p.m. meetings. Persons interested in the work
and we encourage the submission of
(Mountain Time) Monday, December 18, of this Committee are directed to the
scientific data, studies, or research to
2017, and 12:00 p.m. (Mountain Time), Commission’s Web site, https://
support your comments.
Wednesday, January 17, 2018. The www.usccr.gov, or may contact the
After the comment period closes, purpose of the meetings is for the
APHIS will review all written comments Regional Programs Unit at the above
Committee to discuss logistics for March email or street address.
received during the comment period 9, 2018 briefing on voting rights.
and any other relevant information. Any Agenda
DATES: The meeting will be held on
substantive issues identified by APHIS
based on our review of the petition and Monday, December 18, 2017, at 12:00 I. Welcome
our evaluation and analysis of p.m. MT, and on Wednesday, January II. Approval of minutes from previous
comments will be considered in the 17, 2018, at 12:00 p.m. MT. meeting
development of our decision-making ADDRESSES: Public call information: III. Discuss Potential Speakers
documents. As part of our decision- Dial: 866–290–0883. IV. Next Steps
making process regarding a GE Conference ID: 2510813. V. Adjournment
organism’s regulatory status, APHIS FOR FURTHER INFORMATION CONTACT: Ana
Exceptional Circumstance: Pursuant
prepares a plant pest risk assessment to Victoria Fortes (DFO) at afortes@
to 41 CFR 102–3.150, the notice for the
assess its plant pest risk and the usccr.gov or (213) 894–3437.
December 18, 2017, meeting is given
appropriate environmental SUPPLEMENTARY INFORMATION: This
less than 15 calendar days prior to the
documentation—either an meetings are available to the public meeting because of the exceptional
environmental assessment (EA) or an through the following toll-free call-in
circumstance of the committee needing
environmental impact statement (EIS)— number: 866–290–0883, conference ID
in accordance with the National to plan a briefing on voting rights to
number: 2510813. Any interested
Environmental Policy Act (NEPA), to satisfy the U.S. Commission on Civil
member of the public may call this
provide the Agency with a review and number and listen to the meetings. Rights’ 2018 Statutory Enforcement
analysis of any potential environmental Callers can expect to incur charges for report timeline.
impacts associated with the petition calls they initiate over wireless lines, Dated: December 6, 2017.
request. For petitions for which APHIS and the Commission will not refund any David Mussatt,
prepares an EA, APHIS will follow our incurred charges. Callers will incur no Supervisory Chief, Regional Programs Unit.
published process for soliciting public charge for calls they initiate over land-
[FR Doc. 2017–26581 Filed 12–8–17; 8:45 am]
comment (see footnote 1) and publish a line connections to the toll-free
separate notice in the Federal Register BILLING CODE 6335–01–P
telephone number. Persons with hearing
announcing the availability of APHIS’ impairments may also follow the
EA and plant pest risk assessment. proceedings by first calling the Federal
daltland on DSKBBV9HB2PROD with NOTICES
Should APHIS determine that an EIS Relay Service at 1–800–877–8339 and
is necessary, APHIS will complete the providing the Service with the
NEPA EIS process in accordance with conference call number and conference
Council on Environmental Quality ID number.
regulations (40 CFR part 1500–1508) Members of the public are entitled to
and APHIS’ NEPA implementing make comments during the open period
regulations (7 CFR part 372). at the end of the meetings. Members of
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Document Created: 2017-12-09 01:49:36
Document Modified: 2017-12-09 01:49:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | We will consider all comments that we receive on or before February 9, 2018. | |
| 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 petition, contact Ms. Cindy Eck at (301) 851-3892, email: [email protected] | |
| FR Citation | 82 FR 58167 |
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