[Federal Register Volume 67, Number 219 (Wednesday, November 13, 2002)]
[Notices]
[Pages 68866-68868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28693]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0285; FRL-7278-1]


Draft Guidance on How to Comply with Data Citation Regulations; 
Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of draft guidance on 
how to comply with the Agency's data citation requirements for 
registration of new pesticide products under the Federal Insecticide, 
Fungicide, and Rodenticide Act. When applicants do not fully comply 
with the data citation regulations, the result can be significant 
delays in the processing of registration applications, the potential 
for an increase in adversarial petitions being submitted to the Agency 
by data submitters, and increased expenditures of resources for all 
involved, the Agency, applicants, and data submitters. EPA believes 
that the guidance provided through the notice will assist applicants 
comply with the data citation requirements and ultimately result in 
fewer delays in the registration process.

DATES: Comments, identified by docket ID number OPP-2002-0285, must be 
received on or before December 13, 2002.

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: Peter Caulkins, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5447; fax number: (703) 305-6920; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

     You may be potentially affected by this action if you submit 
applications for registration of pesticides pursuant to the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), or if you submit 
data to the Agency in support of registration or reregistration under 
FIFRA. Potentially affected entities may include, but are not limited 
to:
     Pesticide Manufacturing (NAICS 32532)
     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. 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-2002-0285. 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

[[Page 68867]]

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. 
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 on 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.
    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-2002-0285. 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-2002-0285. 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), Office of Pesticide Programs (OPP), 
Environmental Protection Agency (7502C), 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2002-0285.
    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-2002-0285. Such deliveries are only accepted 
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

[[Page 68868]]

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, 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?

     Applicants who choose to rely on data citation, rather than 
submitting their own data to meet EPA data requirements, must assure 
that the offer-to-pay letters they provide to data submitters satisfy 
EPA's regulatory requirements as provided in 40 CFR part 152, subpart 
E. When applicants do not follow these procedures, delays in the 
processing of registration applications result. In addition, improper 
offer-to-pay letters can increase the potential for adversarial 
petition actions brought under 40 CFR 152.99. When applicants do not 
comply with data citation requirements, EPA, data submitters, and 
applicants expend, unnecessarily, significant resources during the 
application process. In an effort to avoid needless disputes and save 
the resources of all concerned, the Agency believes it would be helpful 
to clarify the obligations of data citers.
     By providing this guidance, the Agency hopes to streamline the 
registration process, provide assistance to applicants for pesticide 
registration, and to help data submitters preserve their data 
protection rights.
     The draft Pesticide Registration Notice does not address the issue 
of when offers-to-pay must be made or when documentation demonstrating 
that offers-to-pay have been made must be submitted to the Agency. EPA 
expects to issue guidance on this related matter through a separate 
means.
     In addition, the Agency will soon make available to the public 
several letters that have been issued recently regarding data 
compensation matters. These letters provide useful guidance to the 
regulated community and the general public, including persons who 
prepare applications for registration and those who submit data in 
support of registration actions. The Agency intends to announce the 
availability of these letters through a separate notice in the Federal 
Register.

List of Subjects

    Environmental protection, Administrative practice and procedures, 
Pesticides and pests.

    Dated: November 1, 2002.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
[FR Doc. 02-28693 Filed 11-12-02; 8:45 am]
BILLING CODE 6560-50-S