[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Notices]
[Pages 88609-88610]
[FR Doc No: 2023-28211]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0476; FRL-11412-01-OCSPP]

Pesticide Registration Notice 2023-2; Establishment of the Vector
Expedited Review Voucher (VERV) Program; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of Pesticide Registration Notice (PR Notice) 2023-2,
entitled ``Establishment of the Vector Expedited Review Voucher (VERV)
Program.'' PR Notices are issued by the Office of Pesticide Programs
(OPP) to inform pesticide registrants and other interested persons
about important program policies, procedures, and registration related
decisions, and serve to provide guidance to pesticide registrants and
OPP personnel. This PR Notice establishes and describes the new VERV
Program. The implementation of the VERV Program will incentivize the
development of new insecticides to control and prevent the spread of
vector-borne disease.

DATES: PR Notice 2023-2 is effective upon signature. Since the revised
form is already approved and in use, all older versions of the form
will not be accepted.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2023-0476, is available online at
https://www.regulations.gov. Additional instructions for visiting the
docket, along with more information about dockets generally, is
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Jennings, Office of Pesticide
Programs (7501M), Environmental

Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    This action is directed to the public in general, although this PR
Notice may be of particular interest to those persons who may seek a
pesticide registration under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. Since other entities may
also be interested or affected based on future activities, the Agency
has not attempted to describe all the specific entities that this PR
Notice may apply to.

II. What is the Agency's authority for taking this action?

    FIFRA section 4(k)(7), 7 U.S.C. 136a-1(k)(7), as established in an
amendment to FIFRA contained in the Pesticide Registration Improvement
Act of 2022 (PRIA 5).

III. What guidance does this PR Notice provide?

    As outlined in FIFRA section 4(k)(7), the Agency must establish the
VERV Program by December 29, 2023, to incentivize development of new
insecticides to control the spread of vector-borne disease to protect
public health from mosquito born illnesses by granting vouchers for
successfully registered products. If granted, the voucher may be
redeemed to shorten the decision review time for a future pesticide
application falling under certain specified PRIA categories. To achieve
this, EPA is issuing PR Notice 2023-2 to establish the new VERV Program
by providing guidance on applicable requirements and procedures for
registrants to apply for, track, and redeem vouchers under the VERV
Program.
    Specifically, the Agency has amended the current form used for
pesticide registration applications by adding optional fields to allow
pesticide registrants to apply for the voucher program and to redeem
previously granted vouchers for expediated review. An optional check
box was added to the registration form for both the initial voucher
application and the application for which expedited review is sought.
Registration applicants may also attach an explanation for their
voucher request, that includes a description of the insecticide and
public health impacts with other required information, electronically
or by paper with the registration form. The Agency will review the
voucher application and award the voucher if the application meets the
requirements of FIFRA section 4(k)(7). If a voucher is granted, an
applicant may redeem the voucher by choosing the expedited review
option on the amended registration form.
    In addition, as specified in EPA regulations at 40 CFR 152.119(c),
applicant-submitted information, including that provided on EPA Form
No. 8570-1, entitled ``Application for Pesticide Registration/
Amendment,'' will, on request, be made available to the public for
inspection after a pesticide product is registered. EPA has previously
determined that none of the information that applicants provide on EPA
Form No. 8570-1 is confidential business information (CBI) or otherwise
protected under FIFRA. As such, the Agency is able to release the form
in response to a request under the Freedom of Information Act (FOIA), 5
U.S.C. 552 and EPA implementing regulations at 40 CFR 2.100.

IV. Do PR Notices impose binding requirements?

    The PR Notice discussed in this document is intended to provide
guidance to EPA personnel and decisionmakers and to pesticide
registrants. While requirements in statutes and Agency regulations are
binding on EPA and pesticide registrants, the PR Notice does not impose
new binding requirements on either EPA or pesticide registrants, and
EPA may depart from the guidance presented in the PR Notice where
circumstances warrant and without prior notice. Likewise, pesticide
registrants may assert that the guidance is not appropriate generally
or not applicable to a specific pesticide or situation.

V. Is the revised form approved under the Paperwork Reduction Act
(PRA)?

    According to the PRA, 44 U.S.C. 3501 et seq., an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires approval under the PRA, unless
it has been approved by the Office of Management and Budget (OMB) and
displays a currently valid OMB control number. This PR Notice does not
create any paperwork burdens that require additional approval by OMB
under the PRA because the information collection activities associated
with EPA Form No. 8570-1 and the activities described in this PR Notice
are already approved by OMB under OMB Control No. 2070-0226. The
approved activities and related instruments are contained in the
Information Collection Requests (ICR), entitled ``Consolidated
Pesticide Registration Submission Portal'', identified as EPA ICR No.
2624.02 and approved under OMB Control No. 2070-0226.
    Authority: 7 U.S.C. 136 et seq.

    Dated: December 18, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-28211 Filed 12-21-23; 8:45 am]
BILLING CODE P


	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

	WASHINGTON, D.C.  20460

                                                    OFFICE OF
PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

May 22, 2008

MEMORANDUM

SUBJECT:	Review of Coumaphos Incident Reports

FROM:	Monica Hawkins, M.P.H., Environmental Health Scientist

		Toxicology and Exposure Branch

		Health Effects Division (7509P)

THRU:	Elizabeth Mendez, Acting Chief

		Toxicology and Exposure Branch

		Health Effects Division (7509P)

TO:		Wilhelmina Livingston, CRM

		Special Review and Reregistration Division (7508P)

BACKGROUND

The OPP Incident Data System (IDS) was consulted for poisoning incident
data on the active ingredient coumaphos.  The purpose of the database
search is to identify potential patterns on the extent and severity of
the health effects attributed to coumaphos exposure.  The IDS includes
reports of incidents from various sources, including mandatory Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6 (a) (2)
reports from registrants, other federal and state health and
environmental agencies and individual consumers.  The following
databases were not searched for poisoning incident data:  the American
Association of Poison Control Centers Toxic Exposure Surveillance System
(TESS), the California Pesticide Illness Surveillance Program, and the
National Institute of Occupational Safety and Health’s Sentinel Event
Notification System for Occupational Risks (NIOSH SENSOR).  The EPA is
supplying the following incident report to fulfill our requirement to
docket summaries of incident data that were reported to the Agency.
This report represents incidents occurring in the United States from
2000 to the present for the single chemical only.

IDS Report	5/20/2008

Coumaphos	036501	Human Incidents

Incident Number	Incident Date	Product Name	Registration Number	City
State	Exposure Type*	Incident Description

013417	009	9/23/2001	ASUNTOL LIQUID 20%	 	LOS ANGELES	CA	HB	A 3 year
old girl accidentally ingested 1-2 ounces of the product.  She reported
respiratory distress, wet lungs, sweating, lacrimation, diarrhea, and
pinpoint pupils.  The girl was treated in the ICU for 6 days.

014020	005	4/13/2000	COUMAPHOS TECHNICAL<PHONE_NUMBER>1	LIVINGSTON	MT	HC	A
man reported erythema after he used the product about 3 years ago.

014457	004	8/1/2003	BALCOM ZIPCIDE CATTLE DUST BAG<PHONE_NUMBER>9 034704
DAWSON	PA	HC	An 11 year old girl reported a rash and edema after the
product was applied to pigs 3 days ago.  The girl was treated by a
physician.