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Pesticides; Draft Guidance on Labeling Statements on Products
Used for Adult Mosquito Control; Notice of Availability
[Federal Register: April 28, 2004 (Volume 69, Number 82)]
[Notices]
[Page 23200-23202]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap04-62]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0018; FRL-7352-2]
Pesticides; Draft Guidance on Labeling Statements on Products
Used for Adult Mosquito Control; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Agency seeks public comment on a draft Pesticide
Registration (PR) Notice entitled ``Labeling Statements on Products
Used for Adult Mosquito Control.'' This draft PR Notice provides
guidance to registrants and others concerning EPA's policy on labeling
statements for pesticide products used for wide-area applications to
control adult mosquitoes. The specific label statements and label
organization principles recommended in the draft PR Notice are intended
to improve existing labels by clarifying language conveying
environmental hazards posed by these products, as well as specific use
directions and instructions to the applicators. The Agency believes
that adoption of these recommendations will help pesticide users and
pesticide enforcement officials to achieve more effective mosquito
control and protection of public health, while ensuring that use of
these products will not pose unreasonable risks to the environment.
DATES: Comments, identified by docket ID number OPP-2004-0018, must be
received on or before July 27, 2004.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Jim Roelofs, Field and External
Affairs Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-2964; fax number: (703) 308-1850; e-
mail address: roelofs.jim@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to pesticide registrants, pesticide
regulatory officials, mosquito and vector control agencies, pesticide
users, and the general public. Although this action may be of
particular interest to those persons who have a specific interest in
the labeling of pesticide products used for the control of adult
mosquitoes, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2004-0018. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
[[Page 23201]]
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/
edocket/, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2004-0018. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID Number OPP-2004-0018. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2004-0018.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID Number OPP-2004-0018. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
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 CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any 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 and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide any technical information and/or data you used that
support your views.
4. If you estimate potential burden or costs, explain how you
arrived at your estimate.
5. Provide specific examples to illustrate your concerns.
6. Offer alternatives.
7. Make sure to submit your comments by the comment period deadline
identified.
8. To ensure proper receipt by EPA, identify the appropriate docket
ID number in the subject line on the first page of your response. It
would also be helpful if you provided the name, date, and Federal
Register citation related to your comments.
II. What Action Is the Agency Taking?
A. Background
In recent years, State pesticide regulators and vector control
agencies have raised a variety of concerns about the labeling of
pesticides used for adult mosquito control. The class of products of
most concern have been those used for control of adult mosquitoes
through the application of Ultra-Low Volume (ULV) sprays or fogs. Since
State agencies enforce pesticide use regulations under cooperative
agreements with EPA, and since section 12(a)(2)(G) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) makes it an
unlawful act ``to use any registered pesticide in a manner inconsistent
with its labeling,'' the interpretation of label requirements is a
critical issue for EPA, its regional offices, and State pesticide
regulatory agencies, as well as for users.
In 2001, EPA sponsored an Inter-Regional Mosquito Control
Conference for EPA and State agency representatives. Although labeling
was one of many subjects discussed at the conference, participants felt
label improvements were an area that should be addressed. It was agreed
that a group representing EPA's Office of Pesticide Programs (OPP),
Office of Enforcement and Compliance Assurance (OECA), EPA Regions, and
State lead agency volunteers would develop initial, informal proposals
for improving mosquito control-product labels, with the focus on
adulticides only. The EPA-State workgroup developed a paper which
included seven recommendations. In April 2003, the initial
recommendations were discussed at a public meeting of the Pesticide
Program Dialogue Committee (PPDC). The PPDC is chartered under the
Federal Advisory Committee Act to advise EPA on pesticide issues. Its
members represent a broad spectrum of interests, including the
pesticide industry, grower groups, public health
[[Page 23202]]
agencies, academic researchers, and public interest and advocacy
organizations. PPDC recommended that EPA develop the initial
recommendations into more formal Agency positions.
After considering the comments and suggestions of State agencies,
the PPDC and other interested parties, the Agency has decided to make
the specific recommendations in the draft PR Notice as a means to
achieve improvements in the labeling of adult mosquito control
products. The recommendations consist of some specific statements that
should appear on all labels for this class of products, some model
statements that registrants may adapt to the specific characteristics
of their products, and some principles on organizing elements of the
label.
B. Summary of the Labeling Recommendations
The recommendations in the draft PR Notice are meant to apply only
to products labeled for wide-area application by ground or aerial
equipment, typically as ULV sprays or fogs, and not to home and garden
use products which may list mosquitoes on the label. Control of
mosquito larvae is a wholly different use pattern from adult mosquito
control, and thus, products registered as mosquito larvicides are not
included in the scope of the draft PR Notice.
The draft PR Notice sets forth seven recommendations for improving
labels of adult mosquito control products. In brief form, the
recommendations are:
1. Adult mosquito control applications should be limited to trained
personnel.
2. Mosquito control directions and precautions should be clearly
distinguished from those applicable to any other use allowed on the label.
3. Label precautions and directions should be revised as needed to
make hazards to aquatic life as specific as possible, and also to allow
the application of these products over a body of water allowable under
some circumstances.
4. Users should consult with the State or Tribal lead agency for
pesticide regulation to determine if permits or other regulatory
requirements exist.
5. Labels should specify a spectrum of spray/fog droplet sizes, and
indicate that droplet size should be determined according to the nozzle
manufacturer's directions.
6. Precautionary language to protect bees should have a provision
to allow mosquito control applications in order to respond to immediate
threats to public health.
7. Mosquito adulticide labels should include specific statements on
timing and allowable frequency of applications to a specific site.
C. What Questions/Issues Should You Consider?
Commenters are free to raise any issue, but the following question
is of particular interest to the Agency, and comments on it are invited.
As presented in the draft PR Notice, recommendations 6 and 7 both
propose to allow applications that might otherwise be disallowed by the
label, if there is a threat to public health that warrants overriding
either bee precautions or timing and frequency limitations. How and by
whom should such a determination be made?
D. PR Notices are Guidance Documents
PR Notices are intended to provide guidance to EPA personnel and
decisionmakers and to pesticide registrants. PR Notices are not binding
on either EPA or pesticide registrants, and EPA may depart from the
guidance 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.
E. Relationship to Interim Clean Water Act Guidance
On July 11, 2003, EPA issued Interim Guidance regarding the
application of pesticides and the requirement to obtain a National
Pollutant Discharge Elimination System (NPDES) permit under the Clean
Water Act. The Interim Guidance stated that the following applications
of pesticides do not require NPDES permits if the pesticides are
applied consistent with all relevant requirements of FIFRA:
1. The application of pesticides directly to waters of the United
States in order to control pests.
2. The application of pesticides to control pests that are present
over waters of the United States that results in a portion of the
pesticides being deposited to waters of the United States.
EPA solicited public comments on the Interim Guidance, and the
Agency is currently reviewing the comments received and anticipates
taking final action on the Interim Guidance later this year. See the
Federal Register of August 13, 2003 (68 FR 48385) (FRL-7542-9)).
EPA believes that the recommended label language contained in
Recommendation No. 3 of the draft PR Notice would be consistent with
the Interim Guidance. If EPA decides to modify the Interim Guidance in
any way when it takes final action on the guidance, the Agency will
take steps to ensure that the conclusions reached in the final
Pesticide Registration Notice are consistent with the final guidance on
NPDES permitting requirements for pesticide applications.
List of Subjects
Environmental protection, Administrative practice and procedure,
Pesticides and pests, Water.
Dated: April 21, 2004.
James Jones,
Director, Office of Pesticide Programs.
[FR Doc. 04-9621 Filed 4-27-04; 8:45 am]
BILLING CODE 6560-50-S
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