[Federal Register Volume 68, Number 83 (Wednesday, April 30, 2003)]
[Notices]
[Pages 23128-23130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10662]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0084; FRL-7303-9]


Adverse Effects Reporting Under Section 6(a)(2) of FIFRA; Renewal 
of Pesticide Information Collection Activities and Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44 
U.S.C. 3501 et seq.), this notice announces that EPA is seeking public 
comment on the following Information Collection Request (ICR): Adverse 
Effects Reporting Under Section 6(a)(2) of FIFRA; (EPA ICR No. 1204.09, 
OMB Control No. 2070-0039). This is a request to renew an existing ICR 
that is currently approved and due to expire January 31, 2004. The ICR 
describes the nature of the information collection activity and its 
expected burden and costs. Before submitting this ICR to the Office of 
Management and Budget (OMB) for review and approval under the PRA, EPA 
is soliciting comments on specific aspects of the collection.

DATES: Written comments, identified by the docket ID number OPP-2003-
0084, must be received on or before June 30, 2003.

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

FOR FURTHER INFORMATION CONTACT: Nancy Vogel, Field and External 
Affairs Division (7506C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: 703-305-6475; fax number: 703-305-5884; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Does This Action Apply to Me?

    You may be potentially affected by this action if you hold or ever 
held a registration for a pesticide product issued under FIFRA section 
3 or 24(c). Potentially affected entities may include, but are not 
limited to:
    [sbull] Pesticide and other agricultural chemical manufacturing 
(NAICS 325320), e.g., persons or companies who hold or ever held a 
registration for a pesticide product under FIFRA section 3 or 24(c).
    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 above 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 section 6(a)(2) of 
FIFRA. If you have any questions regarding the applicability of this 
action to a particular entity, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

II. How Can I Get Copies of This Document and Other Related 
Information?

A. Docket

    EPA has established an official public docket for this action under 
docket identification (ID) number OPP-2003-0084. 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.

B. 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

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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 II.A. 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.

III. 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 
III.B. 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-2003-0084. 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-2003-0084. 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 III.A. 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-2003-0084.
    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-2003-0084. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit II.A.

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

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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.

C. What Should I Consider When 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 collection activity.
    7. Make sure to submit your comments by the deadline in this 
notice.
    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.

D. What Information is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically 
solicits comments and information to enable it to:
    1. Evaluate whether the proposed collections of information are 
necessary for the proper performance of the functions of the Agency, 
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burdens 
of the proposed collections of information.
    3. Enhance the quality, utility, and clarity of the information to 
be collected.
    4. Minimize the burden of the collections of information on those 
who are to respond, including through the use of appropriate automated 
or electronic collection technologies or other forms of information 
technology, e.g., permitting electronic submission of responses.

IV. What Information Collection Activity or ICR Does This Action Apply 
to?

    EPA is seeking comments on the following ICR:
    Title: Adverse Effects Reporting Under Section 6(a)(2) of FIFRA
    ICR numbers: EPA ICR No. 1204.09; OMB Control No. 2070-0039
    ICR status: This ICR is a renewal of an existing ICR that is 
currently approved by OMB and is due to expire January 31, 2004.
    Abstract: Section 6(a)(2) of the Federal Insecticide, Fungicide and 
Rodenticide Act (FIFRA) requires pesticide registrants to submit 
information to the Agency that they acquire which may be relevant to 
the balancing of the risks and benefits of a pesticide product. The 
statute requires the registrant to submit any factual information that 
it acquires regarding adverse effects associated with its pesticidal 
products, and it is up to the Agency to determine whether or not that 
factual information constitutes an unreasonable adverse effect. 
Responses to this collection are mandatory. The authority for this 
information collection is pursuant to section 6(a)(2) of FIFRA. 
Compliance regulations are contained in Title 40 of the Code of Federal 
Regulations (CFR) part 159. CBI submitted to EPA in response to this 
information collection is protected from disclosure under FIFRA section 
10. In order to limit the amount of less meaningful information that 
might be submitted to the Agency, the EPA has limited the scope of 
factual information that the registrant must submit. On September 19, 
1997, the Agency published final regulations (62 FR 49370) that 
provided a detailed description of the reporting obligations of 
registrants under FIFRA section 6(a)(2). The regulations became 
effective on August 17, 1998.

V. What are EPA's Burden and Cost Estimates for This ICR?

    Under the PRA, ``burden'' means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
or disclose or provide information to or for a Federal Agency. For this 
collection it includes the time needed to review instructions; develop, 
acquire, install, and utilize technology and systems for the purposes 
of collecting, validating, and verifying information, processing and 
maintaining information, and disclosing and providing information; 
adjust the existing ways to comply with any previously applicable 
instructions and requirements; train personnel to be able to respond to 
a collection of information; search data sources; complete and review 
the collection of information; and transmit or otherwise disclose the 
information.
    The ICR provides a detailed explanation of this estimate, which is 
only briefly summarized in this notice. The annual public burden for 
this information collection is estimated to be 155,640 hours. The 
following is a summary of the estimates taken from the ICR:
    Respondents/affected entities: Pesticide registrants who sell or 
distribute pesticide products in the United States.
    Estimated total number of potential respondents: 1,877
    Frequency of response: As necessary
    Estimated total/average number of responses for each respondent: 1 
to 3
    Estimated total annual burden hours: 155,640
    Estimated total annual burden costs: $12,057,947

VI. Are There Changes in the Estimates From the Last Approval?

    The burden hour estimate in this ICR has decreased from 166,266 to 
155,640, which reflects a number of adjustments. First, there are 
slightly fewer registrants of active pesticide products and fewer 
employees to be trained than reflected in the previous ICR. Burden 
estimates associated with the number of studies the respondents might 
submit on an annual basis have decreased from 350 to 325. For studies, 
the burden hours are reduced from 5.9 to 3.2 hours per study. These 
reductions reflect a mature program and the familiarity with the 
regulations that comes with experience. Burden costs, however, are not 
comparably reduced because of higher labor rates.

VII. What is the Next Step in the Process for This ICR?

    EPA will consider the comments received and amend the ICR as 
appropriate. The final ICR package will then be submitted to OMB for 
review and approval pursuant to 5 CFR 1320.12. EPA will issue another 
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce 
the submission of the ICR to OMB and the opportunity to submit 
additional comments to OMB. If you have any questions about this ICR or 
the approval process, please contact the person listed under FOR 
FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.


    Dated: April 23, 2003.
Susan B. Hazen,
Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 03-10662 Filed 4-29-03; 8:45 am]
BILLING CODE 6560-50-S