This ICR covers
the activities carried out under the Special Review and
Registration Review Programs. 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, EPA 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: (1) 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). (2)
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 ro 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; (5) the degree and
extent of public concern expected; and, for DCI's under the Special
Review Program, (6) the weight of the evidence provided to
determine that "unreasonable adverse effects" test has been met. 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 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. When
the final rule establishing the procedural requirements for the
Registration Review Program is promulgated, EPA shall revise this
ICR to reflect the associated changes in burden. For future DCI ICR
packages, EPA should include as much information as possible about
future potential DCIs under this ICR. Once EPA sets schedules for
reviewing pesticides in its procedural regulations for Registration
Review, the Agency should use those schedules to create a more
detailed chemical specific DCI ICR package that avoids the
"generic" approach used in this current package. If, after
establishing its procedural requirements, EPA determines that it
must continue to use the "generic" approach, the Agency shall
provide a detailed discussion in its ICR renewal package,
explaining why it is necessary and appropriate to use the "generic"
approach for future DCIs. The explanation should provide the
necessary justification for using a "generic" approach, including a
discussion of why it is impractical or inefficient to prepare
individual DCI specific ICRs or a more detailed ICR, including a
discussion of the similarity between the proposed collections, the
extent to which EPA can specify the individual characteristics of
the collections, the total and individual burdens, and the
importance of implementing specific collections in a timely manner.
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
08/31/2004
08/31/2004
08/31/2001
68
0
139
71,132
0
127,741
0
0
0
Under section 3(c)(2)(B) of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as
amended, EPA may require pesti- cide registrants to generate and
submit data to the Agency so the Agency may assess whether
registration of an existing pesti- cide causes an unreasonable
adverse effect on human health or the environment. Under section
3(g) of FIFRA, as amended, the Agency is required to periodically
review all pesticide registrations.
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 Call-Ins for the Special Review and Registration Review Programs