[Federal Register: January 16, 2008 (Volume 73, Number 11)]
[Notices]
[Page 2907-2910]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ja08-46]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0923; FRL-8152-5]
Agency Information Collection Activities; Proposed Renewal and
Consolidation of Several Currently Approved Collections; Comment
Request; Pesticide Data Call-In Program; EPA ICR No. 2288.01, OMB
Control No. 2070-new
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 document announces that EPA is planning to
submit a request to renew and consolidate several existing approved
Information Collection Requests (ICRs) to the Office of Management and
Budget (OMB). Before submitting the consolidated ICR to OMB for review
and approval, EPA is soliciting comments on specific aspects of this
information collection. The consolidated ICR, entitled: ``Pesticide
Data Call-In Program'' (identified by EPA ICR No. 2288.01 and OMB
Control No. 2070-new), will consolidate the following currently
approved ICRs: ``Data Call-Ins for the Special Review and Registration
Review Programs'' (identified by EPA ICR No. 0922.07 and OMB Control
No. 2070-0057); ``Data Generation for Pesticide Reregistration''
(identified by EPA ICR No. 1504.05 and OMB Control
[[Page 2908]]
No. 2070-0107); and ``Data Acquisition for Anticipated Residue and
Percent of Crop Treated'' (identified by EPA ICR No. 1911.02 and OMB
Control No. 2070-0164).
DATES: Comments must be received on or before March 17, 2008.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0923, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0923. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Cameo Smoot, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5454; fax number: (703) 305-5884; e-
mail address: smoot.cameo@epa.gov.
SUPPLEMENTARY INFORMATION:
I. 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 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. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.
II. 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 and provide specific
examples.
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 identified
under DATES.
8. To ensure proper receipt by EPA, be sure to identify the docket
ID 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.
III. What Do I Need to Know About the PRA?
Under the PRA, an Agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information subject to
PRA approval unless it displays a currently valid OMB control number.
The OMB control numbers for EPA's regulations in title 40 of the CFR,
after appearing in the preamble of the final rule, are further
displayed either by publication in the Federal Register or by other
appropriate means, such as on the related collection instruments or
form, if applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in a list at 40 CFR part 9.1.
The PRA defines burden to mean 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. This
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 which have subsequently changed; train
personnel to be able to respond to a collection of
[[Page 2909]]
information; search data sources; complete and review the collection of
information; and transmit or otherwise disclose the information.
IV. What ICR Does this Request Apply to?
Title: Pesticide Data Call-In Program.
ICR numbers: EPA ICR No. 2288.01, OMB Control No. 2070-new.
ICR status: This ICR reflects the consolidation of the following
currently approved ICRs: ``Data Call-Ins for the Special Review and
Registration Review Programs'' (identified by EPA ICR No. 0922.07 and
OMB Control No. 2070-0057); ``Data Generation for Pesticide
Reregistration'' (identified by EPA ICR No. 1504.05 and OMB Control No.
2070-0107); and ``Data Acquisition for Anticipated Residue and Percent
of Crop Treated'' (identified by EPA ICR No. 1911.02 and OMB Control
No. 2070-0164). These ICRs are all scheduled to expire on June 30,
2008.
Affected entities: Entities potentially affected by this ICR
include pesticide registrants, which may be identified by the North
American Industrial Classification System (NAICS) code 32532, pesticide
and other agricultural chemical manufacturing.
Abstract: Under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), every pesticide product must be registered with EPA. An
applicant for registration must supply data to demonstrate that the
pesticide product will not cause ``unreasonable adverse effects'' on
humans or to the environment. Under the Federal Food, Drug, and
Cosmetic Act (FFDCA), EPA must determine, from data supplied by the
applicant or registrant, that the level of pesticide residues in food
and feed will be safe for human consumption, defined as ``a reasonable
certainty that no harm'' will result from exposures to pesticide
residues. Although data is provided with the initial applications, the
Agency issues Data Call-Ins (DCIs) when it has determined that more
information is necessary to make the necessary decision pursuant to the
mandates in FIFRA and FFDCA.
The programs represented in this proposed ICR renewal and
consolidation share a common statutory authority, section 3(c)(2)(B) of
FIFRA, which authorizes EPA to require pesticide registrants to
generate and submit data to the Agency, when such data are needed to
maintain an existing registration of a pesticide. EPA's determination
that additional data are needed can occur for various reasons, with the
following four reasons being the most common:
The reregistration program: Section 4 of FIFRA requires EPA to re-
assess the health and safety data for all pesticide active ingredients
registered before November 1, 1984, to determine whether these
``older'' pesticides meet the criteria for registration that would be
expected of a pesticide being registered today for the first time.
FIFRA section 4 directs EPA to use FIFRA section 3(c)(2)(B) authority
to obtain the required data. While, Reregistration Eligibility
Decisions are expected to be completed by 2006 for food-use pesticide
ingredients and 2008 for non-food use pesticide ingredients, the Agency
may still need to issue DCIs after FY 2008 to close out the program
The registration review program: Section 3(g) of FIFRA contains
provisions to help achieve the goal of reviewing each pesticide every
15 years to assure that the pesticide continues to pose no risk of
unreasonable adverse effects on human health or the environment. FIFRA
section 3(g) instructs EPA to use the FIFRA section 3(c)(2)(B)
authority to obtain the required data.
The special review program: Though rare, EPA may conduct a Special
Review if EPA believes that a pesticide poses risks of unreasonable
adverse effects on human health or the environment. Section 3(c)(2)(B)
of FIFRA provides a means of obtaining any needed data.
Anticipated residue/percent crop treated information: Under section
408 of FFDCA, before a pesticide may be used on food or feed crops, the
Agency must establish a tolerance for the pesticide residues on that
crop or established an exemption from the requirement to have a
tolerance. Section 408(b)(2)(E) and (F) of FFDCA authorize the use of
anticipated or actual residue (ARs) data and percent crop treated (PCT)
data to establish, modify, maintain, or revoke a tolerance for a
pesticide. The FFDCA requires that if AR data are used, data must be
reviewed five years after a tolerance is initially established. If PCT
data are used, the FFDCA affords EPA the discretion to obtain
additional data if any or all of several conditions are met.
The Agency issues DCIs when it has determined that more information
is necessary to make decision about pesticides pursuant to the mandates
in FIFRA and FFDCA. Agency decisions requiring additional data are
based on the data requirements set forth in 40 CFR parts 150 through
180, with the majority of the data requirements captured in 40 CFR part
158.
In addition, EPA is seeking public review and comment on a draft
document that describes the methodology it uses to estimate the
paperwork burden hours and costs for entities responding to DCIs. EPA's
methodology for estimating paperwork burden hours and costs for DCI
recipients uses the average cost of the specific test that generates
the data requested as the basis for estimating the paperwork burden
activities. Once the estimated test costs are established, the Agency
estimates the paperwork burden hours and costs as a percentage of the
test cost. The document describing the methodology, and a spreadsheet
with available test cost estimates listed by name and guideline number,
is available in the docket.
Burden statement: The average annual public reporting and
recordkeeping burden for this consolidated ICR varies depending on the
review program and the specific data being sought through the DCI. The
consolidated ICR, a copy of which is available in the docket, provides
a detailed explanation of the Agency's estimated burden for issuing
DCIs under these review programs, which is only briefly summarized
here:
Estimated total number of potential respondents: 1,643.
Frequency of response: On occasion.
Estimated total average number of responses for each respondent:
Ranges from 1 to 16.
Estimated total annual burden hours: 240,490 hours.
Estimated total annual costs: $10,974,873. This ICR does not
involve any capital investment or maintenance and operational costs.
V. Are There Changes in the Estimates from the Last Approvals?
The consolidation of the currently approved ICRs is expected to
result in an overall decrease of 134,274 hours in the total estimated
combined respondent burden that is currently approved by OMB. This
decrease reflects an anticipated reduction in the number of DCIs EPA
plans to issue relating to the reregistration review program, which is
expected to come to a close during the approval period for the next
ICR. This reduction may be offset to some extent by an anticipated
increase in DCIs related to the registration review program. This
change is considered to be an adjustment.
VI. What is the Next Step in the Process for this ICR?
EPA will consider the comments received and amend the consolidated
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
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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: December 20, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E8-602 Filed 1-15-08; 8:45 am]
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