Notice2021-18776
Pesticide Experimental Use Permit; Receipt of Application; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 31, 2021
Issuing agencies
Environmental Protection Agency
Abstract
This notice announces EPA's receipt of an application 93167- EUP-2 from Oxitec, Ltd. requesting an amendment and extension to the experimental use permit (EUP) for the OX5034 Aedes aegypti mosquitoes expressing tetracycline Trans-Activator Variant (tTAV-OX5034) protein. The Agency has determined that the permit may be of regional and national significance. Therefore, because of the potential significance, EPA is seeking comments on this application.
Full Text
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<title>Federal Register, Volume 86 Issue 166 (Tuesday, August 31, 2021)</title>
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[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48691-48692]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18776]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2019-0274; FRL-8736-01-OCSPP]
Pesticide Experimental Use Permit; Receipt of Application;
Comment Request
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces EPA's receipt of an application 93167-
EUP-2 from Oxitec, Ltd. requesting an amendment and extension to the
experimental use permit (EUP) for the OX5034 Aedes aegypti mosquitoes
expressing tetracycline Trans-Activator Variant (tTAV-OX5034) protein.
The Agency has determined that the permit may be of regional and
national significance. Therefore, because of the potential
significance, EPA is seeking comments on this application.
DATES: Comments must be received on or before September 30, 2021.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2019-0274., by one of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="http://www.epa.gov/dockets/contacts.html">http://www.epa.gov/dockets/contacts.html</a>.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
[[Page 48692]]
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (703) 305-7090; email address:
<a href="/cdn-cgi/l/email-protection#87c5d7d7c3c1d5c9e8f3eee4e2f4c7e2f7e6a9e0e8f1"><span class="__cf_email__" data-cfemail="7a382a2a3e3c2834150e13191f093a1f0a1b541d150c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public in general. Although this
action may be of particular interest to those persons who conduct or
sponsor research on pesticides, the Agency has not attempted to
describe all the specific entities that may be affected by this action.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
<a href="http://regulations.gov">regulations.gov</a> or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at <a href="http://www.epa.gov/dockets/comments.html">http://www.epa.gov/dockets/comments.html</a>.
3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the
pesticide(s) discussed in this document, compared to the general
population.
II. What action is the Agency taking?
Under section 5 of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA), 7 U.S.C. 136c, EPA can allow manufacturers to
field test pesticides under development. Manufacturers are required to
obtain an EUP before testing new pesticides or new uses of pesticides
if they conduct experimental field tests on 10 acres or more of land or
one acre or more of water.
Pursuant to 40 CFR 172.11(a), the Agency has determined that the
following EUP amendment and extension application may be of regional
and national significance, and therefore is seeking public comment on
the EUP application:
Submitter: Oxitec, Ltd., (93167-EUP-2).
Pesticide Chemical: OX5034 Aedes aegypti mosquitoes expressing
tetracycline Trans-Activator Variant (tTAV-OX5034) protein.
Summary of Request: Oxitec Ltd. is proposing to extend testing of
OX5034 Aedes aegypti mosquitoes expressing tTAV-OX5034 protein for 2
years in the state of Florida up to 6,240 total acres at a maximum rate
of 0.000082 g active ingredient (tTAV-OX5034), equivalent to 20,000
male OX5034 mosquitoes, per acre, per week. Additionally, Oxitec Ltd is
proposing to expand testing of OX5034 Aedes aegypti mosquitoes
expressing tTAV-OX5034 protein in the state of California on up to
84,600 total acres at a maximum rate of 0.000123 g active ingredient
(tTAV-OX5034), equivalent to 30,000 male OX5034 mosquitoes, per acre,
per week. The proposed experiments are to evaluate the efficacy of
OX5034 mosquitoes as a tool for suppression of wild Aedes aegypti
mosquito populations. Female offspring of the OX5034 mosquitoes in the
environment die before they mature into adults and therefore exposure
to biting female mosquitoes is not anticipated.
EPA made its decision to grant the already issued Oxitec OX5034
Mosquito Experimental Use Permit in April 2020 after extensive
evaluation of the best available science, and after seeking and
addressing public input. EPA's risk assessment <a href="https://www.regulations.gov/document/EPA-HQ-OPP-2019-0274-0359">https://www.regulations.gov/document/EPA-HQ-OPP-2019-0274-0359</a>, and response to
comment document <a href="https://www.regulations.gov/document/EPA-HQ-OPP-2019-0274-0354">https://www.regulations.gov/document/EPA-HQ-OPP-2019-0274-0354</a>, are publicly available and accessible through
<a href="http://regulations.gov">regulations.gov</a> via these links. Common questions and answers regarding
the already issued EUP can be found in the ``The Experimental Use
Permit for the Oxitec Genetically Engineered Aedes aegypti Mosquitoes''
webinar available at <a href="https://www.epa.gov/pesticides/biopesticides">https://www.epa.gov/pesticides/biopesticides</a>.
Following the review of the application and any comments and data
received in response to this solicitation, EPA will decide whether to
issue or deny the EUP request, and if issued, the conditions under
which it is to be conducted. Any issuance of an EUP will be announced
in the Federal Register.
Authority: 7 U.S.C. 136 et seq.
Dated: August 25, 2021.
Charles Smith,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
[FR Doc. 2021-18776 Filed 8-30-21; 8:45 am]
BILLING CODE 6560-50-P
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