[Federal Register Volume 69, Number 144 (Wednesday, July 28, 2004)]
[Notices]
[Pages 45035-45037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17187]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0220; FRL-7370-6]


2,4-DB (4-2,4-dichlorophenoxy) butyric acid and 2,4-DB-DMAS 
(Dimethylamine 4-2,4-dichlorophenoxy) butyrate; Availability of Risk 
Assessments (Interim Process)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of risk assessments 
that were developed as part of EPA's process for making pesticide 
Reregistration Eligibility Decisions (REDs) and tolerance reassessments 
consistent with the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act (FQPA) of 1996. These risk 
assessments are the human health and environmental fate and effects 
risk assessments and related documents for 2,4-DB and 2,4-DB-DMAS. This 
notice also starts a 60-day public comment period for the risk 
assessments. By allowing access and opportunity for comment on the risk 
assessments, EPA is seeking to strengthen stakeholder involvement and 
help ensure decisions made under FQPA are transparent and based on the 
best available information. The tolerance reassessment process will 
ensure that the United States continues to have the safest and most 
abundant food supply.

DATES: Comments, identified by the docket identification (ID) number 
OPP-2004-0220, must be received on or before September 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: Mika Hunter, Special Review and 
Reregistration Division (7508-C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-0041; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, nevertheless, a 
wide range of stakeholders will be interested in obtaining the risk 
assessments for 2,4-DB and 2,4-DB-DMAS, including environmental, human 
health, and agricultural advocates; the chemical industry; pesticide 
users; and members of the public interested in the use of pesticides on 
food. Since other entities also may be interested, 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 ID number OPP-2004-0220. 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, 1801 S. Bell St., 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 EPA's Dockets. 
Information

[[Page 45036]]

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.

II. How Can I Respond to this Action?

A. 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.
    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-2004-0220. 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-2004-0220. 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-2004-0220.
    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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2004-0220. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

B. 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.

[[Page 45037]]

C. 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 copies of 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 the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the notice or collection 
activity.
    7. Make sure to submit your comments by the deadline in this 
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

III. What Action is the Agency Taking?

    EPA is making available to the public the risk assessments that 
have been developed as part of the Agency's interim public 
participation process for tolerance reassessment and reregistration. 
During the next 60 days, EPA will accept comments on the human health 
and environmental fate and effects risk assessment and other related 
documents for 2,4-DB and 2,4-DB-DMAS, available in the individual 
pesticide docket. Like other REDs for pesticides developed under the 
interim process, the 2,4-DB and 2,4-DB-DMAS RED will be made available 
for public comment.
    EPA and the United States Department of Agriculture have been using 
a pilot public participation process for the assessment of 
organophosphate pesticides since August 1998. In considering how to 
accomplish the movement from the current pilot being used for the 
organophosphate pesticides to the public participation process that 
will be used in the future for non-organophosphates, such as 2,4-DB and 
2,4-DB-DMAS, EPA and USDA have adopted an interim public participation 
process. EPA is using this interim process in reviewing the non-
organophosphate pesticides scheduled to complete tolerance reassessment 
and reregistration in 2001 and early 2002. The interim public 
participation process ensures public access to the Agency's risk 
assessments while also allowing EPA to meet its reregistration 
commitments. It takes into account that the risk assessment development 
work on these pesticides is substantially complete. The interim public 
participation process involves: A registrant error correction period; a 
period for the Agency to respond to the registrant's error correction 
comments; the release of the refined risk assessments and risk 
characterizations to the public via the docket and EPA's internet 
website; a significant effort on stakeholder consultations, such as 
meetings and conference calls; and the issuance of the risk management 
decision document (i.e., RED) after the consideration of issues and 
discussions with stakeholders. USDA plans to hold meetings and 
conference calls with the public (i.e., interested stakeholders such as 
growers, USDA Cooperative Extension Offices, commodity groups, and 
other Federal Government agencies) to discuss any identified risks and 
solicit input on risk management strategies. EPA will participate in 
USDA's meetings and conference calls with the public. This feedback 
will be used to complete the risk management decisions and the RED. EPA 
plans to conduct a close-out conference call with interested 
stakeholders to describe the regulatory decisions presented in the RED. 
REDs for pesticides developed under the interim process will be made 
available for public comment.
    Included in the public version of the official record are the 
Agency's risk assessments and related documents for 2,4-DB and 2,4-DB-
DMAS. As additional comments, reviews, and risk assessment 
modifications become available, these will also be docketed. The 2,4-DB 
and 2,4-DB-DMAS risk assessments reflect only the work and analysis 
conducted as of the time they were produced and it is appropriate that, 
as new information becomes available and/or additional analyses are 
performed, the conclusions they contain may change.

List of Subjects

    Environmental protection, Chemicals, Pesticides and pests.

    Dated: July 22, 2004
Debra Edwards,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 04-17187 Filed 7-27-04 8:45 am]
BILLING CODE 6560-50-S