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Pesticides; Data Submitter Rights for Data Submitted in Support of Tolerance Actions; Notice of Availability; Extension of Comment Period

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 
[Federal Register: July 15, 2003 (Volume 68, Number 135)]
[Notices]
[Page 41789-41791]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jy03-48]

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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2002-0296; FRL-7318-4]
 
Pesticides; Data Submitter Rights for Data Submitted in Support 
of Tolerance Actions; Notice of Availability; Extension of Comment 
Period

AGENCY: Evironmental Protection Agency (EPA).
ACTION: Notice; extension of comment period.

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SUMMARY: On April 17, 2003, EPA announced the availability for comment 
on a proposal discussing a program to enable the Agency to 
appropriately implement the new provisions contained in section 408(i) 
of the Federal Food, Drug, and Cosmetic Act (FFDCA) to address 
exclusive use and compensation rights for data submitted to EPA in 
support of tolerance and tolerance exemption actions. The Agency 
received a request to extend the comment period and this notice 
announces the extension of the comment period for 60 days.

DATES: Comments, identified by the docket ID number OPP-2002-0296, must 
be received on or before September 16, 2003.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in

[[Page 41790]]

Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Cameo G. Smoot, Field and External 
Affairs Division (7506C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5454; fax number: (703) 308-5884; e-
mail address: smoot.cameo@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

     You may be potentially affected by this action if you submit data 
to EPA in support of establishing, maintaining or exempting tolerances 
for pesticides under the FFDCA, or are a pesticide registrant or a 
person applying for pesticide registration under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA). Potentially 
affected entities may include, but are not limited to:
    ? Pesticide manufacturing (NAICS code 32532) e.g., 
individuals or entities engaged in activities related to the 
registration of a pesticide product.
     This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in 40 CFR part 152 
Pesticide Registration and Classification Procedures and section 408(i) 
of the FFDCA. 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-2002-0296. 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.regulations.gov/ 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. 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. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

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.
    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-2002-0296. 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-2002-0296. 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-2002-0296.
    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-2002-0296. Such deliveries are only accepted

[[Page 41791]]

during the docket's normal hours of operation as identified in Unit 
I.A.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.

II. What Action Is EPA Taking?

     This document extends the public comment period established in the 
Federal Register issued on April 17, 2003 (68 FR 18977) (FRL-7279-9). 
In that document, EPA sought comment on a proposal for implementing a 
data compensation program under FFDCA. EPA is hereby extending the 
comment period, which was set to end on July 16, 2003, to September 16, 
2003.

III. What Is the Agency's Authority for Taking This Action?

     As part of the Food Quality Protection Act of (FQPA) 1996, 
Congress amended the FFDCA to address exclusive use and compensation 
rights for data submitted to EPA in support of tolerance and tolerance 
exemption actions, and to amend treatment of confidential information 
under the statute. This proposal addresses the implementation of the 
statutory requirement.

Lists of Subjects

    Environmental protection, Pesticides, Tolerance, and Data 
compensation.

    Dated: July 7, 2003.
Jim Jones,
Director, Office of Pesticide Programs.
[FR Doc. 03-17901 Filed 7-14-03; 8:45 am]
BILLING CODE 6560-50-S

 
 

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