[Federal Register Volume 64, Number 56 (Wednesday, March 24, 1999)]
[Notices]
[Pages 14229-14231]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6784]



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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00565; FRL-6046-4]


Renewal of Pesticide Information Collection Activities; Data 
Call-In for Special Review Chemicals and Registration Review Program; 
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): ``Data 
Call-In for Special Review Chemicals and Registration Review Program,'' 
(EPA ICR No. 0922.06, OMB No. 2070-0057). This ICR involves a 
collection activity that is currently approved and recently amended to 
reflect the Agency's need to collect additional information to meet the 
new requirements in the Food Quality Protection Act of 1996. 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 must be received on or before May 24, 1999.

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 this document.

FOR FURTHER INFORMATION CONTACT: Cameo Smoot, Office of Pesticide 
Programs, Mail Code (7506C), Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460, Telephone: 703-305-5454, fax: 703-305-
5884, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Does This Notice Apply To Me?

    You may be potentially affected by this notice if you are a 
pesticide registrant of a pesticide product and are required to submit 
data to support continued registration of your product. By law, EPA 
must periodically review each pesticide registration (see section 3(g) 
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)). 
The EPA may require registrants to generate and submit data to the 
Agency when data is needed to assess whether the existing pesticide 
registration poses an unreasonable risk to human health or the 
environment (see section 3(c)(2)(B) of FIFRA).
    Potentially affected categories and entities may include, but are 
not limited to the following:

----------------------------------------------------------------------------------------------------------------
                                                                                        Example of Potentially
              Category                     NAICS Code               SIC Codes              Affected Entity
----------------------------------------------------------------------------------------------------------------
Pesticide and other agricultural     325320                  286--Industrial         Pesticide registrants
 chemical manufacturing                                       organic chemicals
                                                             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. You or your business are affected by this action if you have 
registered a pesticide with the Agency pursuant to FIFRA. If you have 
any questions regarding the applicability of this action to a 
particular entity, consult the technical person listed in the ``FOR 
FURTHER INFORMATION CONTACT'' section.

II. How Can I Get Additional Information or Copies of This Document 
or Other Support Documents?

A. Electronic Availability

    Electronic copies of this document and the ICR are available from 
the EPA Home Page at the Federal Register - Environmental Documents 
entry for this document under ``Laws and Regulations'' (http://
www.epa.gov/fedrgstr/). You can easily follow the menu to find this 
Federal Register notice using the publication date or the Federal 
Register citation for this notice. Although a copy of the ICR is posted 
with the Federal Register notice, you can also access a copy of the ICR 
by going directly to http://www.epa.gov/icr/. You can then easily 
follow the menu to locate this ICR by the EPA ICR number, the OMB 
control number, or the title of the ICR.

B. Fax-on-Demand

    Using a faxphone call 202-401-0527 and select item 6056 for a copy 
of the ICR.

C. In Person or By Phone

    If you have any questions or need additional information about this 
notice or the ICR referenced, please contact the person identified in 
the ``FOR FURTHER INFORMATION CONTACT'' section.
    In addition, the official record for this notice, including the 
public version, has been established for this notice under docket 
control number OPP-00565 (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as Confidential Business 
Information (CBI), is available for inspection in the Office of 
Pesticide Programs (OPP) Public Docket, Rm. 119, CM #2, 1921 Jefferson 
Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The OPP Public Docket telephone 
number is 703-305-5805.

III. How Can I Respond To This Notice?

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

    You may submit comments through the mail, in person, or 
electronically. Be sure to identify the appropriate docket control 
number, OPP-00565, in your correspondence.
    1. By mail. Submit written comments to: OPP Public Docket, Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver written comments to: OPP Public 
Docket, Public Information and Records Integrity Branch, Rm. 119, CM 
#2, 1921 Jefferson Davis Highway, Arlington, VA, Telephone: 703-305-
5805.
    3. Electronically. Submit your comments and/or data electronically 
by e-mail to: [email protected]. Please note that you should not 
submit any information electronically that you consider to be CBI. 
Electronic comments must be submitted as an ASCII file avoiding the use 
of special characters and any form of encryption. Comment

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and data will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII 
file format. All comments and data in electronic form must be 
identified by the docket control number OPP-00565. Electronic comments 
on this notice may also be filed online at many Federal Depository 
Libraries.

B. How Should I Handle CBI Information That I Want To Submit To the 
Agency?

    You may claim information that you submit in response to this 
notice 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. A copy of the comment that does 
not contain CBI must also be submitted for inclusion in the public 
record. Information not marked confidential will be included in the 
public docket by EPA without prior notice. If you have any questions 
about CBI or the procedures for claiming CBI, please consult with the 
technical person listed in the ``FOR FURTHER INFORMATION CONTACT'' 
section.

C. What Information is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of 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.

D. What Should I Consider When I Prepare My Comments for EPA?

    We invite you to provide your views on the estimates provided, new 
approaches we haven't considered, the potential impacts of the various 
options (including possible unintended consequences), and any data or 
information that you would like the Agency to consider during the 
development of the final action. You may find the following suggestions 
helpful for preparing your comments:
     Explain your views as clearly as possible.
     Describe any assumptions that you used.
     Provide solid technical information and/or data to support 
your views.
     If you estimate potential burden or costs, explain how you 
arrived at the estimate.
     Provide specific examples to illustrate your concerns.
     Offer alternative ways to improve the collection activity.
     Make sure to submit your comments by the deadline in this 
notice.
     At the beginning of your comments (e.g., as part of the 
``Subject'' heading), be sure to properly identify the document you are 
commenting on. You can do this by providing the docket control number 
assigned to the notice, along with the appropriate EPA and OMB ICR 
numbers.

IV. What Information Collection Activity or ICR Does This Notice 
Apply To?

    EPA is seeking comments on the following ICR:
    Title: Data Call-In for Special Review Chemicals and Registration 
Review Program.
    ICR numbers: EPA ICR No. 0922.06, OMB No. 2070-0057.
    ICR status: This ICR is currently scheduled to expire on March 31, 
1999, but EPA intends to seek a 90 day extension to ensure that there 
is adequate time to review comments. An agency may not conduct or 
sponsor, and a person is not required to respond to a collection of 
information that is subject to approval under the PRA, unless it 
displays a currently valid OMB control number. The OMB control numbers 
for EPA's information collections appear on the collection instruments 
or instructions, in the Federal Register notices for related 
rulemakings and ICR notices, and, if the collection is contained in a 
regulation, in a table of OMB approval numbers in 40 CFR part 9.
    Abstract: This ICR has been amended to include two information 
collection programs: the Special Review Program and the Registration 
Review Program. The Special Review program is part of the existing ICR 
while the Registration Review Program is being added to the ICR with 
this renewal. The Registration Review Program was created by the Food 
Quality Protection Act in 1996. Under the new Registration Review 
Program, EPA must periodically review all pesticide registrations (see 
section 3(g) of FIFRA). Therefore, continued registration of all 
pesticides, regardless of whether a hazard or potential hazard is 
identified, requires that the Agency obtain additional data, if 
necessary, and assess all the information to determine whether a 
registration should continue. Language in FIFRA suggests that EPA 
review registrations at least once every 15 years. The Agency will 
establish procedural regulations for scheduling registration review as 
mandated under the new provisions of FIFRA. EPA believes that there are 
certain similarities between the information collection in the 
Registration Review Program and the information collection in the 
Special Review Program. Since both collections derive their authority 
and procedures from FIFRA section 3(c)(2)(B), which allows EPA to 
collect information related to the maintenance of an existing pesticide 
registration, and both collections are based, in part, on concerns 
about potential hazard, EPA believes both information collection 
activities should be covered in the same ICR.
    The EPA is responsible for the registration of pesticides as 
mandated by FIFRA. Currently, as part of the on-going administrative 
process under section 6 of FIFRA, registrants are required to submit 
additional information to EPA regarding unreasonable adverse effects on 
the environment from the use of the pesticide. EPA may also determine 
that additional information is needed from the registrant to maintain 
an existing registration. When the Agency identifies a hazard or a 
potential hazard from the use of a pesticide that was not known at the 
time of registration, this information collection is used in the 
Special Review Program to determine whether regulatory actions are 
needed. This information collection program is separate from the 
information collection program described in the ICR entitled ``Data 
Generation for Reregistration.'' The information collection activity 
described in that ICR results from implementation of the FIFRA 
Amendments of 1988 (i.e., section 4 of FIFRA) and focuses on the new 
collection of information necessary to reregister pesticides which were 
registered before 1984. The reregistration program is expected to be 
completed by 2006.
    Under both the Special Review Program and the Registration Review 
Program, EPA may require registrants to generate and submit data to the 
Agency when data is needed to assess whether the existing pesticide 
registration poses an unreasonable risk to human health or the 
environment. When the need for additional information/data occurs, the

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Agency's Office of Pesticide Programs (OPP) will issue a data call-in 
(DCI) to obtain the necessary data from the registrant. Agency 
scientists and analysts integrate the new data received from the 
registrant with the existing data in EPA's files. All relevant 
information is reviewed to assess the potential risks and benefits 
associated with the use of the pesticide. If it is determined that 
regulatory actions are needed, the Agency will act accordingly.
    The types of data that may be requested by this ICR will depend on 
whether certain information on the pesticide chemical is lacking in the 
current data base. However, the types of data that can be the subject 
of a data call-in are categorized into various divisions and listed in 
40 CFR part 158. These categories are:
     Product Chemistry
     Residue Chemistry
     Environmental Fate
     Toxicology
     Reentry Protection
     Spray Drift
     Wildlife and Aquatic Organisms
     Plant Protection
     Nontarget Insect
     Product Performance
     Biochemical Pesticides
     Microbial Pesticides
    In addition to these types of data, special studies could be 
required to support continued registration. These special studies would 
be based on the particular characteristics of a particular pesticide 
product, and would be made on a case-by-case basis.
    OPP will issue a data call-in for a pesticide chemical only after 
it reviews the available data and determines that the information is 
not sufficient to satisfy the statutory requirements for continued 
registration. Even after OPP has completed its review and has 
determined that additional data must be called-in, registrants are 
given the opportunity to request a waiver if they believe that OPP can 
properly evaluate the risks of their pesticide chemicals without 
additional data. OPP will review each waiver request individually.

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 amend this list as 
appropriate, but use these terms; 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 
the Special Review Program portion of this information collection is 
estimated to average 920 hours per response and the annual public 
burden for the Registration Review Program portion of this information 
collection is estimated to average 1,063 hours per response. The 
following is a summary of the total estimates taken from the ICR:
    Respondents/affected entities: Pesticide registrants.
    Estimated total number of potential respondents: 4 to 60.
    Frequency of response: As needed only when specific data is 
required.
    Estimated total/average number of responses for each respondent: 2 
to 40.
    Estimated total annual burden hours: 7,360 to 63,800.
    Estimated total annual burden costs: $616,096 to $5.46 million.

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

    Yes. This ICR is being amended to include the information 
collection activities attributable to the Registration Review Program. 
This program was authorized in the 1996 amendments to FIFRA and are 
being incorporated into this ICR because the information collection 
activities are similar and both collections derive their authority and 
procedures from FIFRA section 3(c)(2)(B). EPA is particularly 
interested in receiving comments on the changes related to this 
incorporation and the burden estimates for this new program.

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 1320.10. 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 in the ``FOR 
FURTHER INFORMATION CONTACT'' section.

List of Subjects

    Environmental protection, Information collection requests.

    Dated: March 12, 1999.

Susan H. Wayland,

Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 99-6784 Filed 3-23-99; 8:45 am]
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