BASF Plant Science, LP; Availability of Petition for Determination of Nonregulated Status of Canola Genetically Engineered for Altered Oil Profile and Resistance to an Imidazolinone Herbicide, 13722-13723 [2018-06399]

Download as PDF 13722 Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Notices DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2018–0014] BASF Plant Science, LP; Availability of Petition for Determination of Nonregulated Status of Canola Genetically Engineered for Altered Oil Profile and Resistance to an Imidazolinone Herbicide 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 BASF Plant Science, LP, seeking a determination of nonregulated status of canola designated as event LBFLFK, which has been genetically engineered (GE) to allow for the synthesis of long chain omega-3 polyunsaturated fatty acids, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), from oleic acid in canola seed. The GE canola has also been genetically engineered for resistance to an imidazolinone herbicide. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms. We are making the BASF Plant Science, LP 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 29, 2018. SUMMARY: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docket Detail;D=APHIS-2018-0014. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2018–0014, 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/#!docket Detail;D=APHIS-2018-0014 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 amozie on DSK30RV082PROD with NOTICES ADDRESSES: VerDate Sep<11>2014 18:57 Mar 29, 2018 Jkt 244001 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 website at: https:// www.aphis.usda.gov/biotechnology/ petitions_table_pending.shtml under APHIS petition 17–321–01p. 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,’’ the Animal and Plant Health Inspection Service (APHIS) regulates, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms 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 are considered ‘‘regulated articles.’’ The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition. APHIS has received a petition (APHIS Petition Number 17–321–01p) from BASF Plant Science, LP, of Florham Park, NJ (BASF), seeking a determination of nonregulated status of canola (Brassica napus L.) designated as event LBFLFK, which has been genetically engineered to allow for the synthesis of long chain omega-3 polyunsaturated fatty acids (LC– PUFAs), including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), from oleic acid in canola seed. The GE canola has also been genetically engineered for resistance to an imidazolinone herbicide. The BASF petition states that information collected during field trials and laboratory PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 analyses indicates that LBFLFK 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, LBFLFK canola was developed through Agrobacterium rhizogenes-mediated transformation of canola variety Kumily using a single transformation vector to introduce fatty acid synthesis genes (desaturases and elongases) and an herbicide resistance gene. Characterization of the LBFLFK canola event demonstrated that there are no safety concerns according to the applicant. LBFLFK canola is currently regulated under 7 CFR part 340. Interstate movements and field tests of LBFLFK canola have been conducted under APHIS authorizations. Field tests conducted under APHIS oversight allowed for evaluation in a natural agricultural setting while imposing measures to minimize the risk of dissemination and persistence in the environment after completion of the tests. Data were gathered on multiple parameters and used by the applicant to evaluate agronomic characteristics and product performance. These and other data will be 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 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 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 1 To view the notice, go to https:// www.regulations.gov/#!docketDetail;D=APHIS2011-0129. E:\FR\FM\30MRN1.SGM 30MRN1 Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Notices 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 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 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). FURTHER INFORMATION CONTACT amozie on DSK30RV082PROD with NOTICES 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, on March 26, 2018. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2018–06399 Filed 3–29–18; 8:45 am] BILLING CODE 3410–34–P VerDate Sep<11>2014 19:48 Mar 29, 2018 Jkt 244001 DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2018–0016] Notice of Request for Revision to and Extension of Approval of an Information Collection; Infectious Salmon Anemia; Payment of Indemnity Animal and Plant Health Inspection Service, USDA. ACTION: Revision to and extension of approval of an information collection; comment request. AGENCY: In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service’s intention to request a revision to and extension of approval of an information collection associated with the regulations for the payment of indemnity due to infectious salmon anemia. DATES: We will consider all comments that we receive on or before May 29, 2018. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docket Detail;D=APHIS-2018-0016. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2018–0016, 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/#!docket Detail;D=APHIS-2018-0016 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. FOR FURTHER INFORMATION CONTACT: For information on the regulations for the payment of indemnity due to infectious salmon anemia, contact Mrs. Teresa Robinson, USDA–APHIS–VS, Maine ISA Program Aquaculture Liaison, 253 King Street, Edmunds Township, ME 04628; (207) 319–3703. For copies of more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS’ Information Collection Coordinator, at (301) 851– 2483. SUPPLEMENTARY INFORMATION: SUMMARY: PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 13723 Title: Infectious Salmon Anemia; Payment of Indemnity. OMB Control Number: 0579–0192. Type of Request: Revision to and extension of approval of an information collection. Abstract: Under the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture is authorized, among other things, to prevent the interstate spread of serious diseases and pests of livestock within the United States when feasible. In connection with this mission, APHIS established regulations in 9 CFR part 53 to pay indemnity to salmon producers in Maine whose fish are destroyed because of infectious salmon anemia (ISA). However, payment is subject to the availability of funding. ISA is a foreign animal disease of Atlantic salmon that is caused by an orthomyxovirus. The disease affects wild and farmed Atlantic salmon. ISA poses a substantial threat to the economic viability and sustainability of salmon aquaculture in the United States. To take part in this indemnity program, producers must enroll in the cooperative ISA control program administered by APHIS and the State of Maine. Program participants must also inform the ISA Program Veterinarian in writing of the name of their accredited veterinarian, develop biosecurity protocols and a site-specific ISA action plan, submit fish inventory and mortality information, complete an appraisal and indemnity claim form, complete a proceeds from animals sold for slaughter form, and assist APHIS or State officials with onsite disease surveillance, testing, and biosecurity audits. Program participants, who may include certain aquaculture industry business owners, managers, site employees, accredited veterinarians, and designated laboratories, must also assist APHIS with certain disease surveillance activities. We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities, as described, for an additional 3 years. The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us: (1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; E:\FR\FM\30MRN1.SGM 30MRN1

Agencies

[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)]
[Notices]
[Pages 13722-13723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06399]



[[Page 13722]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2018-0014]


BASF Plant Science, LP; Availability of Petition for 
Determination of Nonregulated Status of Canola Genetically Engineered 
for Altered Oil Profile and Resistance to an Imidazolinone Herbicide

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 BASF Plant Science, LP, 
seeking a determination of nonregulated status of canola designated as 
event LBFLFK, which has been genetically engineered (GE) to allow for 
the synthesis of long chain omega-3 polyunsaturated fatty acids, 
including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), 
from oleic acid in canola seed. The GE canola has also been genetically 
engineered for resistance to an imidazolinone herbicide. The petition 
has been submitted in accordance with our regulations concerning the 
introduction of certain genetically engineered organisms. We are making 
the BASF Plant Science, LP 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 
29, 2018.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2018-0014.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2018-0014, 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-2018-
0014 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 website at: https://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under 
APHIS petition 17-321-01p.

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,'' the Animal and 
Plant Health Inspection Service (APHIS) regulates, among other things, 
the introduction (importation, interstate movement, or release into the 
environment) of organisms 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 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 17-321-01p) 
from BASF Plant Science, LP, of Florham Park, NJ (BASF), seeking a 
determination of nonregulated status of canola (Brassica napus L.) 
designated as event LBFLFK, which has been genetically engineered to 
allow for the synthesis of long chain omega-3 polyunsaturated fatty 
acids (LC-PUFAs), including eicosapentaenoic acid (EPA) and 
docosahexaenoic acid (DHA), from oleic acid in canola seed. The GE 
canola has also been genetically engineered for resistance to an 
imidazolinone herbicide. The BASF petition states that information 
collected during field trials and laboratory analyses indicates that 
LBFLFK 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, LBFLFK canola was developed through 
Agrobacterium rhizogenes-mediated transformation of canola variety 
Kumily using a single transformation vector to introduce fatty acid 
synthesis genes (desaturases and elongases) and an herbicide resistance 
gene. Characterization of the LBFLFK canola event demonstrated that 
there are no safety concerns according to the applicant. LBFLFK canola 
is currently regulated under 7 CFR part 340. Interstate movements and 
field tests of LBFLFK canola have been conducted under APHIS 
authorizations.
    Field tests conducted under APHIS oversight allowed for evaluation 
in a natural agricultural setting while imposing measures to minimize 
the risk of dissemination and persistence in the environment after 
completion of the tests. Data were gathered on multiple parameters and 
used by the applicant to evaluate agronomic characteristics and product 
performance. These and other data will be 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 would accept written comments regarding a petition once APHIS 
deemed it complete.
---------------------------------------------------------------------------

    \1\ 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

[[Page 13723]]

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, on March 26, 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-06399 Filed 3-29-18; 8:45 am]
 BILLING CODE 3410-34-P
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