[Federal Register Volume 69, Number 82 (Wednesday, April 28, 2004)]
[Notices]
[Pages 23200-23202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9621]



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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Pesticides; Draft Guidance on Labeling Statements on Products 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: [email protected].

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.

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    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 [email protected], 
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

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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