82_FR_18490 82 FR 18416 - Availability of an Environmental Assessment for the Field Release of Genetically Engineered Diamondback Moths

82 FR 18416 - Availability of an Environmental Assessment for the Field Release of Genetically Engineered Diamondback Moths

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 82, Issue 74 (April 19, 2017)

Page Range18416-18417
FR Document2017-07840

We are advising the public that the Animal and Plant Health Inspection Service is making available for public comment an environmental assessment prepared in connection with a permit application for the field release of diamondback moths that have been genetically engineered for repressible female lethality and to express red fluorescence as a marker. The purpose of the proposed field release is to assess the feasibility and efficacy of these moths in reducing populations of diamondback moths that are known plant pests and a serious threat to agriculture.

Federal Register, Volume 82 Issue 74 (Wednesday, April 19, 2017)
[Federal Register Volume 82, Number 74 (Wednesday, April 19, 2017)]
[Notices]
[Pages 18416-18417]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-07840]


========================================================================
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. 74 / Wednesday, April 19, 2017 / 
Notices

[[Page 18416]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2014-0056]


Availability of an Environmental Assessment for the Field Release 
of Genetically Engineered Diamondback Moths

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service is making available for public comment an 
environmental assessment prepared in connection with a permit 
application for the field release of diamondback moths that have been 
genetically engineered for repressible female lethality and to express 
red fluorescence as a marker. The purpose of the proposed field release 
is to assess the feasibility and efficacy of these moths in reducing 
populations of diamondback moths that are known plant pests and a 
serious threat to agriculture.

DATES: We will consider all comments that we receive on or before May 
19, 2017.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0056.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2014-0056, 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;D=APHIS-2014-
0056 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: Ms. Chessa Huff-Woodard, Esq., Policy, 
Program and International Collaboration Chief, Biotechnology Regulatory 
Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; 
(301) 851-3943, 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.'' A permit must be 
obtained or a notification acknowledged before a regulated article may 
be released into the environment. The regulations set forth the permit 
application requirements and the notification procedures for the 
importation, interstate movement, or release into the environment of a 
regulated article.
    The Animal and Plant Health Inspection Service (APHIS) has 
previously issued Cornell University a permit (APHIS Permit Number 12-
227-102m) authorizing the importation of GE diamondback moths (DBM, 
Plutella xylostella) strains OX4319L-Pxy, OX4319N-Pxy, and OX4767A-Pxy 
from the United Kingdom to the university's New York State Agricultural 
Experiment Station (NYSAES) in Geneva, NY. The GE DBM were genetically 
engineered to exhibit red fluorescence (DsRed2) as a marker and 
repressible female lethality, also known as female autocide. The GE 
DBMs are considered a regulated article under the regulations in 7 CFR 
part 340 because the recipient organism is a plant pest.
    On October 24, 2013, APHIS received a permit application from 
Cornell University (APHIS Permit Number 13-297-102r) seeking the 
permitted field release of the three imported strains of GE DBM. 
Permits were issued and caged releases occurred in 2015. However, all 
permits relative to the October 2013 application have since been 
withdrawn.
    On March 16, 2016, APHIS received a permit application from Cornell 
University (APHIS Permit Number 16-076-101r) seeking the permitted 
field release of a single strain of GE DBM, designated as OX4319L-Pxy, 
in both open and caged releases.
    The purpose of the requested field release is to assess the 
feasibility and efficacy of GE DBM strain OX4319L-Pxy in reducing pest 
populations of DBM. According to the applicant, these GE DBM may serve 
as an insecticide-free means of controlling field populations of DBM in 
a species-specific manner.
    The proposed release would be at the NYSAES and would not exceed 2 
years in length. The release would be limited to an experimental field, 
up to 10 acres in size, within which there would be a single point at 
which the open air release would occur. The release site is surrounded 
by other agricultural fields within NYSAES' 870 total acres where DBMs 
occur naturally. The applicant would release up to 10,000 male GE DBMs 
per release (up to 30,000 males per week). Post-experiment monitoring 
of DBM with traps would continue until no GE DBMs are captured for 2 
consecutive months.
    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
proposed release of the GE DBM, an environmental assessment (EA) has 
been prepared. The EA was prepared in accordance with: (1) The National 
Environmental Policy Act of 1969 (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). APHIS will accept 
written comments on our EA regarding the proposed release of the GE DBM 
from interested or affected persons for a period of 30 days from the 
date of this notice. Copies of the EA are available as indicated in the 
ADDRESSES and FOR

[[Page 18417]]

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 April 2017.
 Michael C. Gregoire,
 Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-07840 Filed 4-18-17; 8:45 am]
 BILLING CODE 3410-34-P



                                                  18416

                                                  Notices                                                                                                       Federal Register
                                                                                                                                                                Vol. 82, No. 74

                                                                                                                                                                Wednesday, April 19, 2017



                                                  This section of the FEDERAL REGISTER                    room 1141 of the USDA South Building,                 University (APHIS Permit Number 13–
                                                  contains documents other than rules or                  14th Street and Independence Avenue                   297–102r) seeking the permitted field
                                                  proposed rules that are applicable to the               SW., Washington, DC. Normal reading                   release of the three imported strains of
                                                  public. Notices of hearings and investigations,         room hours are 8 a.m. to 4:30 p.m.,                   GE DBM. Permits were issued and caged
                                                  committee meetings, agency decisions and                Monday through Friday, except                         releases occurred in 2015. However, all
                                                  rulings, delegations of authority, filing of
                                                                                                          holidays. To be sure someone is there to              permits relative to the October 2013
                                                  petitions and applications and agency
                                                  statements of organization and functions are            help you, please call (202) 799–7039                  application have since been withdrawn.
                                                  examples of documents appearing in this                 before coming.                                           On March 16, 2016, APHIS received
                                                  section.                                                FOR FURTHER INFORMATION CONTACT: Ms.                  a permit application from Cornell
                                                                                                          Chessa Huff-Woodard, Esq., Policy,                    University (APHIS Permit Number 16–
                                                                                                          Program and International Collaboration               076–101r) seeking the permitted field
                                                  DEPARTMENT OF AGRICULTURE                               Chief, Biotechnology Regulatory                       release of a single strain of GE DBM,
                                                                                                          Services, APHIS, 4700 River Road Unit                 designated as OX4319L-Pxy, in both
                                                  Animal and Plant Health Inspection                      147, Riverdale, MD 20737–1236; (301)                  open and caged releases.
                                                  Service                                                 851–3943, email: chessa.d.huff-                          The purpose of the requested field
                                                  [Docket No. APHIS–2014–0056]                            woodard@aphis.usda.gov.                               release is to assess the feasibility and
                                                                                                          SUPPLEMENTARY INFORMATION: The                        efficacy of GE DBM strain OX4319L-Pxy
                                                  Availability of an Environmental                        regulations in 7 CFR part 340,                        in reducing pest populations of DBM.
                                                  Assessment for the Field Release of                     ‘‘Introduction of Organisms and                       According to the applicant, these GE
                                                  Genetically Engineered Diamondback                      Products Altered or Produced Through                  DBM may serve as an insecticide-free
                                                  Moths                                                   Genetic Engineering Which Are Plant                   means of controlling field populations
                                                                                                          Pests or Which There Is Reason to                     of DBM in a species-specific manner.
                                                  AGENCY:  Animal and Plant Health                                                                                 The proposed release would be at the
                                                  Inspection Service, USDA.                               Believe Are Plant Pests,’’ regulate,
                                                                                                          among other things, the introduction                  NYSAES and would not exceed 2 years
                                                  ACTION: Notice.                                                                                               in length. The release would be limited
                                                                                                          (importation, interstate movement, or
                                                  SUMMARY:   We are advising the public                   release into the environment) of                      to an experimental field, up to 10 acres
                                                  that the Animal and Plant Health                        organisms and products altered or                     in size, within which there would be a
                                                  Inspection Service is making available                  produced through genetic engineering                  single point at which the open air
                                                  for public comment an environmental                     that are plant pests or that there is                 release would occur. The release site is
                                                  assessment prepared in connection with                  reason to believe are plant pests. Such               surrounded by other agricultural fields
                                                  a permit application for the field release              genetically engineered (GE) organisms                 within NYSAES’ 870 total acres where
                                                  of diamondback moths that have been                     and products are considered ‘‘regulated               DBMs occur naturally. The applicant
                                                  genetically engineered for repressible                  articles.’’ A permit must be obtained or              would release up to 10,000 male GE
                                                  female lethality and to express red                     a notification acknowledged before a                  DBMs per release (up to 30,000 males
                                                  fluorescence as a marker. The purpose                   regulated article may be released into                per week). Post-experiment monitoring
                                                  of the proposed field release is to assess              the environment. The regulations set                  of DBM with traps would continue until
                                                  the feasibility and efficacy of these                   forth the permit application                          no GE DBMs are captured for 2
                                                  moths in reducing populations of                        requirements and the notification                     consecutive months.
                                                  diamondback moths that are known                        procedures for the importation,                          To provide the public with
                                                  plant pests and a serious threat to                     interstate movement, or release into the              documentation of APHIS’ review and
                                                  agriculture.                                            environment of a regulated article.                   analysis of any potential environmental
                                                                                                             The Animal and Plant Health                        impacts associated with the proposed
                                                  DATES: We will consider all comments                    Inspection Service (APHIS) has                        release of the GE DBM, an
                                                  that we receive on or before May 19,                    previously issued Cornell University a                environmental assessment (EA) has
                                                  2017.                                                   permit (APHIS Permit Number 12–227–                   been prepared. The EA was prepared in
                                                  ADDRESSES:   You may submit comments                    102m) authorizing the importation of GE               accordance with: (1) The National
                                                  by either of the following methods:                     diamondback moths (DBM, Plutella                      Environmental Policy Act of 1969
                                                    • Federal eRulemaking Portal: Go to                   xylostella) strains OX4319L-Pxy,                      (NEPA), as amended (42 U.S.C. 4321 et
                                                  http://www.regulations.gov/                             OX4319N-Pxy, and OX4767A-Pxy from                     seq.), (2) regulations of the Council on
                                                  #!docketDetail;D=APHIS-2014-0056.                       the United Kingdom to the university’s                Environmental Quality for
                                                    • Postal Mail/Commercial Delivery:                    New York State Agricultural Experiment                implementing the procedural provisions
                                                  Send your comment to Docket No.                         Station (NYSAES) in Geneva, NY. The                   of NEPA (40 CFR parts 1500–1508), (3)
                                                  APHIS–2014–0056, Regulatory Analysis                    GE DBM were genetically engineered to                 USDA regulations implementing NEPA
                                                  and Development, PPD, APHIS, Station                    exhibit red fluorescence (DsRed2) as a                (7 CFR part 1b), and (4) APHIS’ NEPA
                                                  3A–03.8, 4700 River Road Unit 118,                                                                            Implementing Procedures (7 CFR part
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                                                                          marker and repressible female lethality,
                                                  Riverdale, MD 20737–1238.                               also known as female autocide. The GE                 372). APHIS will accept written
                                                    Supporting documents and any                          DBMs are considered a regulated article               comments on our EA regarding the
                                                  comments we receive on this docket                      under the regulations in 7 CFR part 340               proposed release of the GE DBM from
                                                  may be viewed at http://                                because the recipient organism is a                   interested or affected persons for a
                                                  www.regulations.gov/                                    plant pest.                                           period of 30 days from the date of this
                                                  #!docketDetail;D=APHIS-2014-0056 or                        On October 24, 2013, APHIS received                notice. Copies of the EA are available as
                                                  in our reading room, which is located in                a permit application from Cornell                     indicated in the ADDRESSES and FOR


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                                                                               Federal Register / Vol. 82, No. 74 / Wednesday, April 19, 2017 / Notices                                         18417

                                                  FURTHER INFORMATION CONTACT              sections       Agency name and docket number FSIS–                   additional information concerning
                                                  of this notice.                                         2016–0028. Comments received in                       poultry slaughter:
                                                    Authority: 7 U.S.C. 7701–7772 and 7781–               response to this docket will be made                     • As part of the HACCP system,
                                                  7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and             available for public inspection and                   written procedures to prevent carcasses
                                                  371.3.                                                  posted without change, including any                  afflicted with septicemia and toxemia
                                                   Done in Washington, DC, this 12th day of               personal information, to http://                      from entering the chiller; and
                                                  April 2017.                                             www.regulations.gov.                                     • records that document that the
                                                  Michael C. Gregoire,                                       Docket: For access to background                   products resulting from slaughter
                                                                                                          documents or comments received, go to                 operations meet the definition of ready-
                                                  Acting Administrator, Animal and Plant
                                                  Health Inspection Service.                              the FSIS Docket Room at Patriots Plaza                to-cook poultry.
                                                                                                          3, 355 E Street SW., Room 8–164,                         Additionally, each establishment
                                                  [FR Doc. 2017–07840 Filed 4–18–17; 8:45 am]
                                                                                                          Washington, DC 20250–3700 between                     operating under the NPIS also needs to
                                                  BILLING CODE 3410–34–P
                                                                                                          8:00 a.m. and 4:30 p.m., Monday                       submit on an annual basis an attestation
                                                                                                          through Friday.                                       to the management member of the local
                                                  DEPARTMENT OF AGRICULTURE                               FOR FURTHER INFORMATION CONTACT: Gina
                                                                                                                                                                FSIS circuit safety committee stating
                                                                                                          Kouba, Office of Policy and Program                   that it maintains a program to monitor
                                                  Food Safety and Inspection Service                      Development, Food Safety and                          and document any work-related
                                                                                                          Inspection Service, USDA, 1400                        conditions of establishment workers.
                                                  [Docket No. FSIS–2017–0014]                                                                                      FSIS has made the following
                                                                                                          Independence Avenue SW., Room 6065,
                                                                                                          South Building, Washington, DC 20250;                 estimates based upon an information
                                                  Notice of Request for Renewal of an
                                                                                                          (202) 720–5627.                                       collection assessment:
                                                  Approved Information Collection                                                                                  Estimate of Burden: FSIS estimates
                                                  (Modernization of Poultry Slaughter                     SUPPLEMENTARY INFORMATION:                            that it will take respondents an average
                                                  Inspection)                                                Title: Modernization of Poultry                    of .125 hours to record results and
                                                  AGENCY:  Food Safety and Inspection                     Slaughter Inspection.                                 maintain necessary documentation.
                                                  Service, USDA.                                             OMB Number: 0583–0156.                                Respondents: Official poultry
                                                                                                             Expiration Date of Approval: 9/30/                 establishments.
                                                  ACTION: Notice and request for
                                                                                                          2017.                                                    Estimated No. of Respondents: 289.
                                                  comments.                                                  Type of Request: Renewal of an                        Estimated No. of Annual Responses
                                                  SUMMARY:    In accordance with the                      approved information collection.                      per Respondent: 5,291.3.
                                                  Paperwork Reduction Act of 1995 and                        Abstract: FSIS has been delegated the                 Estimated Total Annual Burden on
                                                  Office of Management and Budget                         authority to exercise the functions of the            Respondents: 19,204 hours.
                                                  (OMB) regulations, the Food Safety and                  Secretary as specified in the Poultry                    Copies of this information collection
                                                  Inspection Service (FSIS) is announcing                 Products Inspection Act (PPIA) (21                    assessment can be obtained from Gina
                                                  its intention to request a renewal of the               U.S.C. 451, et seq.). This statute                    Kouba, Office of Policy and Program
                                                  approved information collection                         provides that FSIS is to protect the                  Development, Food Safety and
                                                  regarding poultry slaughter inspection.                 public by verifying that poultry                      Inspection Service, USDA, 1400
                                                  The approval for this information                       products are safe, wholesome, not                     Independence SW., 6065, South
                                                  collection will expire on September 30,                 adulterated, and properly labeled and                 Building, Washington, DC 20250;
                                                  2017. There are no changes to the                       packaged.                                             (202)720–5627.
                                                  existing information collection.                           FSIS is requesting a renewal of the                   Comments are invited on: (a) Whether
                                                  DATES: Submit comments on or before                     approved information collection                       the proposed collection of information
                                                  June 19, 2017.                                          regarding poultry slaughter inspection.               is necessary for the proper performance
                                                  ADDRESSES: FSIS invites interested                      The approval for this information                     of FSIS’s functions, including whether
                                                  persons to submit comments on this                      collection will expire on September 30,               the information will have practical
                                                  information collection. Comments may                    2017. There are no changes to the                     utility; (b) the accuracy of FSIS’s
                                                  be submitted by one of the following                    existing information collection.                      estimate of the burden of the proposed
                                                  methods:                                                   FSIS requires that all official poultry            collection of information, including the
                                                     • Federal eRulemaking Portal: This                   slaughter establishments, other than                  validity of the methodology and
                                                  Web site provides the ability to type                   establishments that slaughter ratites,                assumptions used; (c) ways to enhance
                                                  short comments directly into the                        maintain as part of their HACCP plan,                 the quality, utility, and clarity of the
                                                  comment field on this Web page or                       sanitation SOP, or other prerequisite                 information to be collected; and (d)
                                                  attach a file for lengthier comments. Go                program, written procedures addressing                ways to minimize the burden of the
                                                  to http://www.regulations.gov. Follow                   (1) the prevention throughout the entire              collection of information, including
                                                  the on-line instructions at that site for               slaughter and dressing operation, of                  through the use of appropriate
                                                  submitting comments.                                    contamination of carcasses and parts by               automated, electronic, mechanical, or
                                                     • Mail, including CD–ROMs, etc.:                     enteric pathogens (e.g., Salmonella and               other technological collection
                                                  Send to Docket Clerk, U.S. Department                   Campylobacter) and by fecal material,                 techniques, or other forms of
                                                  of Agriculture, Food Safety and                         including microbial test results, and (2)             information technology. Comments may
                                                  Inspection Service, Docket Clerk,                       the prevention of carcasses and parts                 be sent to both FSIS, at the addresses
                                                  Patriots Plaza 3, 1400 Independence                     contaminated by visible fecal material                provided above, and the Desk Officer for
                                                                                                          from entering the chiller. This                       Agriculture, Office of Information and
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                                                  Avenue SW., Mailstop 3782, Room 8–
                                                  163A, Washington, DC 20250–3700.                        information was previously collected                  Regulatory Affairs, Office of
                                                     • Hand- or courier-delivered                         under the FSIS information collection                 Management and Budget, Washington,
                                                  submittals: Deliver to Patriots Plaza 3,                for Sanitation SOPs and Pathogen                      DC 20253.
                                                  355 E Street SW., Room 8–163A,                          Reduction/HACCP (0583–0103). Each                        Responses to this notice will be
                                                  Washington, DC 20250–3700.                              establishment operating under the New                 summarized and included in the request
                                                     Instructions: All items submitted by                 Poultry Inspection System (NPIS) is                   for OMB approval. All comments will
                                                  mail or electronic mail must include the                required to collect and maintain                      also become a matter of public record.


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Document Created: 2018-11-14 09:43:42
Document Modified: 2018-11-14 09:43:42
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.
DatesWe will consider all comments that we receive on or before May 19, 2017.
ContactMs. Chessa Huff-Woodard, Esq., Policy, Program and International Collaboration Chief, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3943, email: [email protected]
FR Citation82 FR 18416 

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