[Federal Register: November 13, 2002 (Volume 67, Number 219)]
[Notices]
[Page 68866-68868]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no02-84]
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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Draft Guidance on How to Comply with Data Citation Regulations;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SUMMARY: This notice announces the availability of draft guidance on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:
caulkins.peter@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
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 opp-docket@epa.gov,
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
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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