[Federal Register Volume 64, Number 115 (Wednesday, June 16, 1999)]
[Notices]
[Pages 32225-32228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14863]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00602; FRL-6082-5]
Data Generation for Pesticide Reregistration; 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): ``Data
Generation for Pesticide Reregistration,'' [EPA ICR No.1504, OMB No.
2070-0107]. This ICR involves a collection activity that is currently
approved and scheduled to expire on July 31, 1999. 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-
00602, must be received on or before August 16, 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 the ``SUPPLEMENTARY INFORMATION'' section of
this notice.
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 and are required to submit data to support
continued registration of your product. EPA must assess health and
safety data for all pesticide active ingredients originally registered
before November 1, 1984, to determine whether the pesticide use poses
unreasonable risks to human health or the environment. Section 4 of the
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),
amended, also establishes a process and a schedule for the development
of the information EPA needs before these pesticides can be
reregistered. The EPA may require registrants to generate and submit
data to the Agency when data is needed to determine whether the
pesticide is eligible for reregistration (see section 3(c)(2) (B) of
FIFRA).
Potentially affected categories and entities may include, but are
not limited to the following:
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Examples of Potentially
Category NAICS Code SIC Codes Affected Entities
----------------------------------------------------------------------------------------------------------------
Pesticide and other agricultural 325320 286--Industrial Pesticide registrants
chemical manufacturing organic chemicals
287--Agricultural
chemicals
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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 the Federal
Insecticide, Fungicide, and Rodenticide Act. 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.
[[Page 32226]]
B. Fax-on-Demand
Using a faxphone call 202-401-0527 and select item 6072 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 under docket control number OPP-
00602, (including comments and data submitted electronically as
described below). A public version of this record, including printed,
paper versions of any 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-00602, 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. Comments and data
will also be accepted on standard computer 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-00602. 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 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 Generation for Pesticide Reregistration.
ICR numbers: EPA ICR No. 1507.04, OMB No. 2070-0107.
ICR status: This ICR is currently scheduled to expire on July 31,
1999. 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 Paperwork Reduction Act, 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: Under the FIFRA section 4 reregistration program, EPA
examines health and safety data for active ingredients in pesticides
initially registered before November 1, 1984, and determines whether
they are eligible for reregistration. To be eligible, a pesticide must
have a substantially complete data base and the Agency must assess all
the information/data necessary to determine whether use of a pesticide
presents unreasonable risks to man or the environment when used in
accordance with its approved label directions. Registrants may be
required to generate additional information on human health and
environmental effects beyond the information submitted to the Agency
when a pesticide was first registered. Prior to 1984, only acute
testing or short-term environmental testing was required for many
pesticides before registration. However, by 1984, EPA had determined
that data on chronic health
[[Page 32227]]
effects and long-term environmental effects (e.g., tests for
carcinogenicity or mutagenicity, or life cycle tests of organisms
exposed to a pesticide) are necessary in many cases and issued updated
data requirements for registration.
In addition, all pesticides must meet the safety standards of the
Food Quality Protection Act of 1996 (FQPA). FQPA directs the Agency to
consider aggregate exposures from dietary and other non-occupational
sources when assessing the risks of a chemical. In addition to dietary
exposure, such sources as drinking water and residential use need to be
considered. EPA must make the statutory determination that the
resulting pesticide residues in food or feed will result in a
reasonable certainty of no harm to human health from aggregate exposure
through dietary, non-occupational, and drinking water routes of
exposure as part of the consideration for reregistration. FQPA also
directs EPA to consider the cumulative effects of pesticides that share
a ``common mechanism of toxicity,'' consider special sensitivities of
infants and children, and consider possible endocrine disruptor
effects. The Agency is to reassess all existing tolerances (maximum
limits for pesticides residues in food or feed) by 2006. EPA is
implementing these new FQPA provisions primarily through the
reregistration program.
When the need for additional information/data occurs in developing
pesticide reregistration decisions, the Office of Pesticide Programs
(OPP) will issue a data call-in (DCI) pursuant to FIFRA section
3(c)(2)(B) to obtain data and when necessary, the registrant may be
required to certify compliance with data compensation requirements
under the authority of FIFRA section 3(c)(2)(D). Agency scientists and
analysts integrate the new data received from registrants with the
existing data in EPA's files. EPA reviews all relevant information to
assess the potential risks associated with the use of the pesticide to
make a determination whether the pesticide should be reregistered. If a
determination is made that a pesticide is eligible to be reregistered,
and the registrant submits acceptable product-specific data and revised
labeling, products containing the pesticide shall be reregistered
within a specified time period. However, if after a review of the data,
it is determined that a pesticide should not be reregistered, the
Agency will take appropriate regulatory action.
A record of each study submitted is maintained in the Agency's
Pesticide Document Management System (PDMS), and the public may access
the PDMS bibliography through the National Pesticides Information
Retrieval System (NPIRS). NPIRS supports searches of the PDMS database
by chemical, subject, submission date, laboratory, guideline number,
and document type. The public may request copies of studies that are
non-confidential, through the mechanism of a Freedom of Information Act
(FOIA) request.
This information collection program is separate from the
information collection program described in the ICR entitled ``Data
Call in for Special Review Chemicals and Registration Review Program''
(OMB No. 2070-0057) implemented pursuant to section 3(g) of FIFRA. The
Registration Review Program is a recent amendment to the OMB No. 2070-
0057 ICR authorized by the 1996 amendments to FIFRA and requires EPA to
establish a procedure for periodic review of all pesticide
registrations every 15 years. Similar to the FIFRA section 4
reregistration program, the Registration Review Program directs EPA to
use the authority in FIFRA section 3(c)(2)((B) to require pesticide
registrants to generate and submit data to the Agency where such data
is needed to assess whether registration of an existing pesticide poses
unreasonable risk to man or the environment. By the time the
reregistration program is completed, the new section 3(g) Registration
Review Program should be fully implemented.
Process and Program Status
Section 4 of FIFRA mandates reregistration of all pesticides
registered before November 1, 1984, with the goal that these pesticides
were to be reregistered by 1997. The reregistration process is divided
into in five phases with mandated deadlines.
Phase 1-List active ingredients: FIFRA directs EPA to create a list
of the active ingredients used in pesticides registered before November
1, 1984, and requested pesticide registrants to notify EPA of the
intent to seek reregistration. EPA created a list that is divided into
four categories, Lists A through D.
Phase 2-Declare intent and identify studies: This phase requires
pesticide registrants to notify EPA, whether or not they intended to
reregister their products; to identify and commit to providing the
necessary studies including either making a generic data exemption
claim or commitment to generate or share data; and to pay the first
installment of the reregistration fee. During this phase, EPA issued
guidance for registrants to assist in Phase 2 and Phase 3 responses.
Phase 2 was completed in 1990.
Phase 3-Summarize studies: This phase required registrants to
submit summaries and reformat acceptable studies, ``flag'' studies
indicating adverse effects, re-commit to satisfying all applicable data
requirements, and pay the final installment of the reregistration fee.
Phase 3 was completed in October 1990.
Phase 4-EPA review and data call-in: During Phase 4, EPA reviewed
all data submitted in Phase 2 and Phase 3 and required registrants to
meet any unsatisfactory data requirements within 4 years. This phase
was completed in 1993.
Phase 5-Reregistration decisions: Currently, EPA is implementing
Phase 5. The Agency is actively reviewing the studies submitted on each
active ingredient and determining whether or not the pesticide is
eligible for reregistration.
It was OPP's intent to complete all DCI's for necessary information
under the ICR approved through June 30, 1999. However, this goal was
not met because of workload demands. The chemicals on List A moved
directly to Phase 5 because the Agency had substantially reviewed these
under the Registration Standard program. Therefore, the data call-in
for List A chemicals has been completed and no additional data call-ins
are expected unless the submitted data are inadequate or tiered
requirements need to be satisfied. For chemicals on lists B, C, and D,
data call-ins will not be completed during the current ICR
authorization. Once an eligibility decision is made, the Agency will
issue a Reregistration Eligibility Document (RED) to the registrant who
then must provide product-specific data to EPA within 8 months of
receipt of the RED.
Therefore, the Agency seeks a renewal of this ICR because there may
be a need to request additional or supplemental data before final
reregistration decisions can be made. This re-approval will also allow
EPA to continue to use all forms associated with this ICR; e.g., EPA
Data Call-In Response Form; EPA Requirements Status and Registrant's
Response Form; Certification of Offer to Cost Share in the Development
of Data Form (EPA No. 8570-32); and Certification with Respect to
Citation of Data (EPA No. 8570-34).
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
[[Page 32228]]
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
the Data Generation for Pesticide Reregistration information collection
is estimated to average 359.5 hours per an average 111 respondents. The
average burden estimates assume that that respondents recieving product
specific DCIs have an average of 8.9 products. The following is a
summary of the estimates taken from the ICR:
Respondents/affected entities: Pesticide registrants.
Estimated total number of potential respondents: 111.
Frequency of response: As needed only when specific data is
required.
Estimated total/average number of responses for each respondent:
8.9.
Estimated total annual burden hours: 2,715 to 33,120.
Estimated total annual burden costs: $183,870 to $2,701,872.
VI. Are There Changes in the Estimates from the Last Approval?
Yes. Three factors distinguish this ICR from the previous one. Both
the unit test costs and labor rates were updated to reflect more
current values. The unit test costs for list ``C'' and ``D'' chemicals
almost doubled from the prior ICR. Secondly, the data requirements for
list ``B'', ``C'', and ``D'' chemicals were revised. Lastly, the
anticipated number of cases per year, the number per chemical list and
the respondents affected changed from the previous ICR. The previous
ICR anticipated an average number of 668 respondents and this ICR
estimated a total of 269 respondents over 3 years or 90 per year which
is about 60 percent lower.
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 in the ``FOR
FURTHER INFORMATION CONTACT'' section.
List of Subjects
Environmental protection, Information collection requests.
Dated: June 3, 1999.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 99-14863 Filed 6-15-99; 8:45 am]
BILLING CODE 6560-50-F
