[Federal Register Volume 63, Number 74 (Friday, April 17, 1998)]
[Notices]
[Pages 19250-19252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-10228]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00531; FRL-5780-8]
Renewal of Pesticide Information Collection Activities;
Application for New or Amended Pesticide Registration; Request for
Comments
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this notice announces that EPA is planning to submit the
following continuing Information Collection Request (ICR) to the Office
of Management and Budget (OMB) pursuant to the procedures described in
5 CFR 1320.12: ``Application for New or Amended Pesticide
Registration'' (EPA ICR No. 277.10; OMB No. 2070-0060). Before
submitting the following ICR to OMB for review and reapproval, EPA is
soliciting comments on specific aspects of and recent changes to
activities associated with the information collection which is briefly
described below. This ICR relates to section 3 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and covers the
information collection related pesticide registration. This ICR has
recently undergone several changes that impact the Agency's burden
estimates. An Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations are listed in 40 CFR part 9.
Dates: Comments must be submitted on or before June 16, 1998.
ADDRESSES: Submit written comments to: 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. In person, deliver comments to: Rm. 119
of Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically to: opp-
[email protected]. Follow the instructions under Unit III. of this
document. No Confidential Business Information (CBI) should be
submitted through e-mail.
All comments which contain information claimed as CBI must be
clearly marked as such. Three sanitized copies of any comments
containing information claimed as CBI must also be submitted and will
be placed in the public record for this document. The public docket is
available for public inspection in Rm. 119 at the Virginia address
given above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. Persons submitting information any portion of which
they believe is entitled to treatment as CBI by EPA must assert a
business confidentially claim in accordance with 40 CFR part 2 for each
such portion. This claim must be made at the time that the information
is submitted to EPA. If a submitter does not assert a confidentiality
claim at the time of submission, EPA will consider this a waiver of any
confidentiality claim and the information may be made available to the
public by EPA without further notice to the submitter.
FOR FURTHER INFORMATION CONTACT: Cameo Smoot, Field and External
Affairs Division, Mail Code (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460,
Telephone: (703) 305-5454, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
Electronic Availability:
Internet
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/).
Fax-on-Demand
Using a faxphone call 202-401-0527 and select item 6052 for a copy
of the ICR.
I. Background
Affected entities: Entities potentially affected by the activities
covered by this ICR are individuals or entities engaged in activities
related to the registration of a pesticide product.
For the collection of information addressed in this notice, EPA
would like to solicit comments to:
1. Evaluate whether the proposed collection of information is
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 burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
3. Enhance the quality, utility, and clarity of the information to
be collected.
4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate, automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
The Agency is particularly interested in comments and information
about the burden estimates, including examples that could be used to
reflect the burdens imposed.
II. Information Collection
EPA is seeking comments on the following ICR, as well as the
Agency's intention to renew the corresponding OMB approval.
Expiration date: This ICR is currently scheduled to expire on May
31, 1998. However, EPA will be seeking an extension until August 1998,
in order to provide adequate time for comments to be received and
evaluated, and any necessary changes made to the ICR prior to its
submission to OMB.
Title: Application for New or Amended Pesticide Registrations.
ICR numbers: EPA No. 277.10 and OMB No. 2070-0060.
Abstract: In compliance with the Paperwork Reduction Act (44 U.S.C.
[[Page 19251]]
3501 et seq.), this notice announces that EPA is planning to submit the
following continuing ICR to the Office of Management and Budget (OMB)
pursuant to the procedures described in 5 CFR 1320.12: ``Application
for New or Amended Pesticide Registration'' (EPA ICR No. 277.10; OMB
No. 2070-0060). EPA requires individuals or entities seeking a
registration for a pesticide product to submit an application package
consisting of information relating to the identity and composition of
the product, and supporting data (or compensation for other's data) for
the product as outlined in 40 CFR part 158. EPA bases registration
decisions for pesticides on its evaluation of a battery of test data
provided primarily by the 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, and product performance. If the data show that the
benefits of the pesticide product outweigh the risks, then a
registration is approved. All pesticides, under FIFRA, must be
registered by EPA before they may be sold or distributed in U.S.
commerce. Responses to this collection of information are voluntary.
As part of the registration process, applicants are asked to
complete and submit at least four forms which are necessary in order to
register and/or amend a pesticide product registration. These forms
include:
EPA Form 8570-1 (``Application for Pesticide Registration,
Amendment, Other'').
EPA Form 8570-4 (``Confidential Statement of Formula'').
EPA Form 8570-27 (``Formulator's Exemption Statement'').
EPA Form 8570-34 & 35 (``Certification With Respect to
Citation of Data'' and Data Matrix'').
Applicants may also submit additional forms, which are available
upon request, that can be useful in the process of registering a
pesticide:
EPA Form 8570-36 (``Summary of the Physical/Chemical
Properties'').
EPA Form 8570-37 (``Self-Certification Statement for the
Physical/Chemical Properties'').
In addition, registrants of EPA-registered pesticide products at
times become subject to regulations that include labeling revision
requirements. A revised label is submitted as an amendment to the
Agency along with the basic application form, EPA Form 8570-1, to
notify EPA that revised product labeling is being submitted.
This information collection request has changed since the last OMB
approval. After extensive consultation with stakeholders, the Office of
Pesticide Programs has streamlined several forms and created two new
ones. The revised and new forms take less time to complete and reduce
the volume of paper pesticide registrants send to the Agency. Burden
time and cost will decrease for the industry and the Agency. The first
streamlining measure created two forms from three existing ones. The
revised data compensation form (EPA Form 8570-34) replaced two older
forms. This new form allows pesticide registrants to indicate the data
requirements they have completed and to reference existing data
produced by another company. The second revised form, the data matrix
(EPA Form 8570-35), replaced an older form by clarifying the
instructions and providing more protection for data submitters. For
consistency, both revised forms are used for registration and
reregistration.
In response to the President's Reinventing Government Initiative,
EPA developed through a public notice and comment process a self-
certification initiative. The outcome of this effort was the creation
of two new forms, (EPA Forms 8570-36 and 8570-37), for the voluntary
self-certification of product chemistry data for manufacturing-use and
end-use products. The forms reduce industry's paperwork burden,
expedite the review process, and reduce the amount of time the Agency
needs to review the product chemistry for registration or
reregistration of these products.
Other changes in this information collection request will result in
the reduction of the burden hours because certain information
collection activities are no longer a part of this information
collection. This new information collection request no longer includes
burden hour estimates for activities conducted for the EPA Training
Verification Program because this information is now collected under a
separate information collection request. Additionally, information
previously collected as a one-time information collection to support
amended labeling requirements for termiticide products, Pesticide
Regulation Notice 96-7, is no longer estimated in this information
request.
Burden statement: According to the Paperwork Reduction Act,
``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 determine applicability; 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
and review the collection of information; and transmit or otherwise
disclose the information.
The information covered by this request is collected when an
individual or entity applies for registration of a pesticide product.
EPA makes small businesses aware of the ``Formulators's Exemption
Statement'' (EPA Form 8570- 27) that allows an applicant to reduce
their data submission burden when the pesticide product is comprised of
an EPA-registered pesticide product by exempting the applicant from
furnishing much of the data. Estimates for the annual applicant
respondent burden for collection of information associated with the
four categories of pesticide product applicants average: 188 hours per
application for ``Type A'' antimicrobial products; 188 hours per
application for new active ingredient, biochemical, new food use and
new use products; 8 hours per application for ``Type B'' antimicrobial
products; and 8 hours per application for amendments and notifications,
etc. These estimates include the time reading the regulations, planning
the necessary data collection activities, conducting tests, analyzing
data, generating reports and completing other required paperwork, and
storing, filing, and maintaining the data. The estimate of the number
of respondents for the four categories of pesticide product applicants
include: 60 applicants for ``Type A'' antimicrobial products; 200
applicants for new active ingredient, biochemical, new food use and new
use products; 2,100 applicants for ``Type B'' antimicrobial products;
and 10,000 applications containing amendments and notifications, etc.
The total burden hours for this information collection request would
decrease the annual respondent burden from 218,938 to 162,640.
III. Public Record and Electronic Submissions
The official record for this notice, as well as the public version,
has been established for this document under docket control number
``OPP-00531''
[[Page 19252]]
(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 CBI, is available for inspection from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The official
rulemaking record is located at the Virginia address in ``ADDRESSES''
at the beginning of this document.
Electronic comments can be sent directly to EPA at:
[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comment 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-00531.'' Electronic comments on this
notice may be filed online at many Federal Depository Libraries.
List of Subjects
Environmental protection and Information collection requests.
Dated: April 9, 1998.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 98-10228 Filed 4-16-98; 8:45 am]
BILLING CODE 6560-50-F