[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48691-48692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     Federal eRulemaking Portal: http://www.regulations.gov. 
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.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    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 https://www.epa.gov/dockets.

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: 
[email protected].

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 
regulations.gov 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 http://www.epa.gov/dockets/comments.html.
    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 https://www.regulations.gov/document/EPA-HQ-OPP-2019-0274-0359, and response to 
comment document https://www.regulations.gov/document/EPA-HQ-OPP-2019-0274-0354, are publicly available and accessible through 
regulations.gov 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 https://www.epa.gov/pesticides/biopesticides.
    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]
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