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.

Notices Federal Register

43634 

Vol. 83, No. 166 

Monday, August 27, 2018 

1On 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=APHIS2011-0129. 

2To view the notice, the petition, and the 

comments we received, go to http://

www.regulations.gov/#!docketDetail;D=APHIS2017-0096. 

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. 

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: 

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: 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 § 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. 

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 


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Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Notices 43635 

3 83 FR 29742–29743. 

(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. 

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 

DEPARTMENT OF AGRICULTURE 

Foreign Agricultural Service 

Adjustment of Appendices Under the 

Dairy Tariff-Rate Import Quota 

Licensing Regulation for the 2018 

Tariff-Rate Quota Year 

AGENCY: Foreign Agricultural Service, 

USDA. 

ACTION: Notice. 

SUMMARY: This notice publishes the 

document ‘‘Articles Subject to: 

Appendix 1, Historical Licenses; 

Appendix 2 Non-historical Licenses; 

and Appendix 3 and 4, Designated 

Importers Licenses for Quota Year 

2018.’’ The quantities in Appendices 1 

and 2 have been revised under the Dairy 

Tariff-Rate Import Quota Licensing 

Regulation for the 2018 quota year to 

reflect the cumulative annual transfers 

from Appendix 1 to Appendix 2 for 

certain dairy product import licenses 

permanently surrendered by licensees 

or revoked by the Licensing Authority. 

DATES: August 27, 2018. 

ADDRESSES: Abdelsalam El-Farra, Dairy 

Import Licensing Program, Import 

Policies and Export Reporting Division, 

Foreign Agricultural Service, U.S. 

Department of Agriculture, Stop 1021, 

1400 Independence Avenue SW, 

Washington, DC 20250–1021. 

FOR FURTHER INFORMATION CONTACT: 

Abdelsalam El-Farra, (202) 720–9439, 

Abdelsalam.El-Farra@fas.usda.gov. 

SUPPLEMENTARY INFORMATION: The 

Foreign Agricultural Service, under a 

delegation of authority from the Under 

Secretary for Trade and Foreign 

Agricultural Affairs, administers the 

Dairy Tariff-Rate Import Quota 

Licensing Regulation codified at 7 CFR 

6.20–6.36 that provides for the issuance 

of licenses to import certain dairy 

articles under tariff-rate quotas (TRQs) 

as set forth in the Harmonized Tariff 

Schedule (HTS) of the United States. 

These dairy articles may only be entered 

into the United States at the low-tier 

tariff by or for the account of a person 

or firm to whom such licenses have 

been issued and only in accordance 

with the terms and conditions of the 

regulation. 

Licenses are issued on a calendar year 

basis, and each license authorizes the 

license holder to import a specified 

quantity and type of dairy article from 

a specified country of origin. The Import 

Policies and Export Reporting Division, 

Foreign Agricultural Service, U.S. 

Department of Agriculture, issues these 

licenses and, in conjunction with U.S. 

Customs and Border Protection, U.S. 

Department of Homeland Security, 

monitors their use. 

The regulation at 7 CFR 6.34(a) states: 

‘‘Whenever a historical license 

(Appendix 1) is not issued to an 

applicant pursuant to the provisions of 

6.23, is permanently surrendered or is 

revoked by the Licensing Authority, the 

amount of such license will be 

transferred to Appendix 2.’’ Section 

6.34(b) provides that the cumulative 

annual transfers will be published by 

notice in the Federal Register. 

Accordingly, this document sets forth 

the revised Appendices 1 and 2 for the 

2018 tariff-rate quota year below. 

Issued at Washington, DC, the 6th day of 

July 2018. 

Ronald Lord, 

Licensing Authority. 


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