[Federal Register Volume 66, Number 181 (Tuesday, September 18, 2001)]
[Notices]
[Pages 48130-48132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23226]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00739; FRL-6801-3]


Application for New and Amended Pesticide Registration; 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): 
``Application for New and Amended Pesticide Registration'' (EPA ICR No. 
0277.13, OMB No. 2070-0060). This is a request to renew an existing ICR 
that is currently approved and due to expire April 30, 2002. 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 control number OPP-
00739, must be received on or before November 19, 2001.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit III. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPP-00739 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Nancy Vogel, Field and 
External Affairs Division (7506C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; 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 are an 
individual or entity engaged in activities related to the registration 
of a pesticide product. Potentially affected categories and entities 
may include, but are not limited to:

----------------------------------------------------------------------------------------------------------------
                                                                                         Examples of potentially
               Category                      NAICS codes               SIC codes            affected entities
----------------------------------------------------------------------------------------------------------------
Pesticide and other agricultural       325320                   286--Industrial organic  Individuals or entities
 chemical manufacturing                                          chemicals                engaged in activities
                                                                                          related to the
                                                                                          registration of a
                                                                                          pesticide product.
                                                                287--Agricultural
                                                                 chemicals
----------------------------------------------------------------------------------------------------------------

    This table 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 table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes and the Standard Industrial Classification (SIC) codes are 
provided to assist you and others in determining whether or not this 
action might apply to certain entities. If you have 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 Additional Information, Including Copies of this 
Document and Other Related Documents?

A. Electronically

    You may obtain electronic copies of this document, and certain 
other related documents that might be available electronically, from 
the EPA Internet homepage at http://www.epa.gov/. On the homepage 
select ``Laws and Regulations,'' ``Regulations and Proposed Rules,'' 
and then look up the entry for this document under the ``Federal 
Register--Environmental Documents.'' You can also go directly to the 
Federal Register listings at http://www.epa.gov/fedrgstr/.

B. Fax-on-Demand

    Using a faxphone call (202) 401-0527 and select item 6090 for a 
copy of the ICR.

C. In Person

    The Agency has established an official record for this action under 
docket control number OPP-00739. The official record consists of the 
documents specifically referenced in this action, any public comments 
received during an applicable comment period, and other information 
related to this action, including any information claimed as 
Confidential Business Information (CBI). This official record includes 
the documents that are physically located in the docket, as well as the 
documents that are referenced in those documents. The public version of 
the official record does not include any information claimed as CBI. 
The public version of the official record, which includes printed, 
paper versions of any electronic comments submitted during an 
applicable comment period, is available for inspection in the Public 
Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The PIRIB telephone 
number is (703) 305-5805.

[[Page 48131]]

III. How Can I Respond to this Action?

A. How and to Whom Do I Submit the Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-00739 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments and/or data 
electronically by e-mail to: [email protected], or you can submit a 
computer disk as described in Units III.A.1. and III.A.2. Do not submit 
any information electronically that you consider to be CBI. Avoid the 
use of special characters and any form of encryption. Electronic 
submissions will be accepted in WordPerfect 6.1/8.0 or ASCII file 
format. All comments in electronic form must be identified by docket 
control number OPP-00739. Electronic comments may also be filed online 
at many Federal Depository Libraries.

B. How Should I Handle CBI that I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
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 version of the 
official record. Information not marked confidential will be included 
in the public version of the official record 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 
control 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 Paperwork Reduction Act 
(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: Application for New and Amended Pesticide Registration.
    ICR numbers: EPA ICR No. 0277.13, OMB No. 2070-0060.
    ICR status: This ICR is a renewal of an existing ICR that is 
currently approved by OMB and is due to expire April 30, 2002.
    Abstract: This data collection program is designed to provide EPA 
with necessary data to evaluate an application of a pesticide product 
as required under section 3 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA).
    An individual or entity wanting to obtain a registration for a 
pesticide product must submit an application package consisting of 
information relating to the identity and composition of the product, 
proposed labeling, and supporting data (or compensation for others' 
data) for the product as outlined in 40 CFR part 158. The EPA bases 
registration decisions for pesticides on its evaluation of a battery of 
test data provided primarily by applicants for registration. Required 
studies include testing to show whether a pesticide has the potential 
to cause unreasonable adverse human health or environmental effects. 
The Agency currently collects data on physical chemistry, acute and 
chronic toxicology, environmental fate, ecological effects, worker 
exposure, residue chemistry, environmental chemistry, and product 
performance. If EPA's evaluation of the data show that the statutory 
requirements of FIFRA are met, then a registration is approved. Under 
FIFRA, all pesticides must be registered by EPA before they may be sold 
or distributed in U.S. commerce.
    Registrants of EPA-registered pesticide products at times become 
subject to regulations or guidance that include labeling revisions. The 
revised labeling is submitted as an amendment to the Agency along with 
the completed application form. Normally, data are not required or 
reviewed for revised labeling regulations or guidance; however, it is 
necessary that the revised labeling be reviewed and approved. This 
review is most often accomplished by a Product Manager (PM) or Team 
Leader, in one of the three regulatory divisions responsible for 
pesticide registration (the Registration Division, the Antimicrobial 
Division, and the Biopesticides and Pollution Prevention Division), who 
ensure that revisions are in compliance with the applicable labeling 
requirement or guidance.

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

    Under the PRA, ``burden'' means the total time, effort, or 
financial resources

[[Page 48132]]

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 ICR is estimated to be 231,280 hours, with an annual respondent 
cost of $16,426,080. The following is a summary of the estimates taken 
from the ICR:
    Respondents/affected entities: Individuals or entities engaged in 
activities related to the registration of a pesticide product.
    Estimated total number of potential respondents: 2,100.
    Frequency of response: As needed.
    Estimated total/average number of responses for each respondent: 3-
5.
    Estimated total annual burden hours: 231,280.
    Estimated total annual burden costs: $16,426,080.

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

    The total respondent burden hour estimate under this ICR has 
increased from 212,640 to 231,280 hours per year, or a total net 
increase of 18,640 hours. The total applicant costs have increased from 
approximately $6.0 million to $16.4 million per year, for a total net 
increase of approximately $10.4 million. This increase in costs is due 
mainly to the update in the loaded labor hourly rates used to calculate 
the costs. There are no capital costs associated with this information 
collection activity.

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: September 6, 2001.
Susan B. Hazen,
Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 01-23226 Filed 9-17-01; 8:45 am]
BILLING CODE 6560-50-S