Renewal of Pesticide Information Collection Activities; Data Call-In for Special Review Chemicals and Registration Review Program; Request for Comments

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: March 24, 1999 (Volume 64, Number 56)]
[Notices]
[Page 14229-14231]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24mr99-55]

[[Page 14229]]

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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: smoot.cameo@epa.gov.

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: opp-docket@epa.gov. 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

[[Page 14230]]

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:
<bullet> Explain your views as clearly as possible.
<bullet> Describe any assumptions that you used.
<bullet> Provide solid technical information and/or data to support
your views.
<bullet> If you estimate potential burden or costs, explain how you
arrived at the estimate.
<bullet> Provide specific examples to illustrate your concerns.
<bullet> Offer alternative ways to improve the collection activity.
<bullet> Make sure to submit your comments by the deadline in this
notice.
<bullet> 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

[[Page 14231]]

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:
<bullet> Product Chemistry
<bullet> Residue Chemistry
<bullet> Environmental Fate
<bullet> Toxicology
<bullet> Reentry Protection
<bullet> Spray Drift
<bullet> Wildlife and Aquatic Organisms
<bullet> Plant Protection
<bullet> Nontarget Insect
<bullet> Product Performance
<bullet> Biochemical Pesticides
<bullet> 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]
BILLING CODE 6560-50-F

Renewal of Pesticide Information Collection Activities; Data Call-In for Special Review Chemicals and Registration Review Program; Request for Comments

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