This ICR covers
the activities carried out to meet the requirements under the FQPA
of 1996 requiring that tolerance decisions based on anticipated or
actual residue (ARs) or percent crop treated (PCT) data to be
verified to ensure that residues in or on food are not above the
residue levels relied on for establishing the tolerance. It is
OMB's understanding that, if EPA relies on anticipated or actual
residue levels in establishing, modifying or leaving in effect a
tolerance, it must call in data within five years for all crops for
which AR's were used for a pesticide. It is understood that EPA may
obtain this data by issuing a data call-in. It is also understood
that PCT reviews will generally be conducted within the Agency and
only in rare instances would a registrant need to gather the
information. As such, instead of approving the requested 59 hours
for PCT data call-ins, OMB has approved only 1 hour for this
activity. Should it become necessary for EPA to seek PCT related
data through a data call-in, EPA may submit an Information
Collection Worksheet (ICW) to request an adjustment in the total
approved hours. The ICW must be submitted and approved by OMB to
account for the issuance of the PCT data call-in before it is
issued. This collection is approved for three years based on the
agreed upon terms of clearance stated below. EPA will not issue any
DCI unless the DCI has first been approved by relevant high-level
management in the Office of Pesticide Programs, i.e., the directors
or deputy directors of the division(s) responsible for requesting
the particular studies. Before EPA can issue a specific DCI under
this ICR, EPA must use one of the following approaches to provide
notice and an opportunity for OMB to review the DCI: (1)
Prospective Report. To obtain prior approval for any DCIs that may
be planned or anticipated at any point during the approval period
for this ICR, EPA should prepare a prospective report that is
submitted to OMB as soon as EPA determines that such DCIs are
needed. OMB may approve or disapprove any number of the proposed
DCIs at the time this report is provided. Furthermore, at any time
after the report is submitted to OMB and before the Agency issues
the DCI, OMB has the discretion to request that any number of the
proposed DCIs included in the prospective report be submitted to
OMB on a case by case basis. Finally, these prospective reports
should only include those DCIs that are planned or anticipated to
occur within 6 months of the submission of the report to OMB. Any
DCIs not initiated within the 6 month time frame should be included
in a subsequent prospective report. (2) Case-by-case Submissions.
If prior approval for the DCI is not obtained as described in (1)
above, may submit the individual specific DCI to OMB on a
case-by-case basis. Both types of submissions should also contain
the following: information about the pesticide, total respondents
potentially affected by the DCI, the planned schedule for issuing
the DCI and the data due date, the studies to be required, the
total costs of the studies, the practical utility of the data, and
the estimated paperwork burden and costs related to the DCI,
including effects on small businesses (costs should be broken down
to include labor and non-labor costs). In its submission to OMB,
EPA should also establish grounds for initiating the Data Call-In:
** Under the Special Review Program, EPA should provide a
discussion of the evidence used to determine that the use of a
particular pesticide may result in "unreasonable adverse effects on
the environment" as defined by FIFRA 2(bb). ** Under the
Registration Review Program, EPA should provide a discussion of the
special circumstances necessitating a collection prior to
promulgation of the final rule establishing procedural requirements
for that program. It is OMB's understanding that any Registration
Review DCI's issued during this approval period would only involve
a request for specific information necessary to meet the new
statutory requirements established in the Food Quality Protection
Act of 1996 which established the Registration Review Program. OMB
review of these submissions is expected to be prompt (no more than
15 working days after OMB has confirmed its receipt of the
submission); prompt OMB review is more likely where burden is small
and practical utility clearly demonstrated. Issues with the DCI --
e.g. lack of transparency or demonstration of compliance with the
requirements of 1320.5 (d) may necessitate extended review. OMB may
request additional information to help in its determination. OMB
may require EPA to publish a Federal Register notice seeking public
comment on the DCI and to develop a complete supporting statement
for the ICR if the DCI appears highly unusual, controversial, or
inconsistent with this clearance. When deciding to require a
separate review, OMB will consider the following: (1) total amount
of burden/cost and burden/cost per respondent; (2) the number of
respondents affected; (3) the degree of similarity (i.e. frequency
of use, level of burden and content) with other collections
administered under the generic clearance; (4) the evidence of
duplication with other collections; and (5) the degree and extent
of public concern expected. In addition, the following criteria
would also be considered in deciding whether a separate review is
appropriate: (1) the environmental and health consequences if the
collection is given a separate review and (2) the statutory or
judicial deadlines missed if the collection is given a separate
review. Note that, because of this second provision, the burden is
on EPA to submit supporting material for DCIs as expeditiously as
possible. At the end of each 12-month period after the approval of
this ICR, EPA must submit a report to OMB that identifies the
specific DCIs that were issued under this ICR during that period.
Such report should include information about the pesticide, total
respondents affected or potentially affected by the DCI, the
studies required, the total costs of the studies (including a
breakdown of labor vs. non-labor costs based on consultation with
respondents), and the estimated paperwork burden and costs related
to the DCI. If the aggregate paperwork burden for the DCIs issued
during any 12-month period after the approval of this ICR exceeds
the estimated annual burden, EPA must submit an ICR Correction
Worksheet (ICW) to amend the total annual burden hours in the OMB
inventory for this ICR. For future DCI ICR packages, EPA should
include as much information as possible about future potential DCIs
under this ICR. A more detailed ICR will allow for meaningful
public comment and thorough evaluation by OMB, as required in 5 CFR
1320.
Inventory as of this Action
Requested
Previously Approved
06/30/2005
06/30/2005
31
0
0
29,807
0
0
0
0
0
This information collection activity
will enable EPA's Office of Pesticide Programs (OPP) to obtain
information needed to re- evaluate the Agency's original tolerance
decisions. The collection and verification of data is necessary to
comply with the law. Specifically, Section 408(b)(2)(E)(ii) of
FFDCA re- quires data to be called in within five years after each
tole- rances decision that relies on anticipated or actual
residues; section 408(b)(2)(F)(iv) of FFDCA requires periodic
re-evaluation if percent crop treated estimates are used.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Data Acquisition for Anticipated Residue and Percent Crop Treated