This ICR covers
the Agency's issuance of Data Call-Ins (DCIs) to require the
submission of data that it has determined is necessary for it to
properly assess whether the registration of a pesticide (whether
new or existing) would cause unreasonable adverse effects on human
health or the environment, and may involve active or inert
ingredients. This package is treated as a generic clearance because
the specific chemicals and related products that may require
additional data as part of the registration process can not be
identified in advance. This collection is approved for three years
based on the following agreed upon terms of clearance. 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 satisfy the requirements
contained in these terms of clearance and 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).
The submission should also contain any additional information
necessary to demonstrate compliance with 5 CFR 1320.5(d). For all
DCIs that involve List 1 Inerts where data are required that are
not listed in 40 CFR 158 (i.e., special studies), EPA should submit
the proposed DCI in the same manner as described above. However,
prior to submitting a DCI that involves List 2 Inerts, EPA should
first seek stakeholder involvement and provide an opportunity for
public comment on the proposed DCI by publishing a notice in the
Federal Register. This public process is intended to ensure that
the products and parties affected by the DCI can be identified so
that they may participate in the development of the DCI. EPA is
already engaged in an open process and is working with industry to
determine an appropriate approach and schedule for collecting
necessary information on inert ingredients. After providing this
opportunity for comment, EPA should submit the proposed DCI to OMB
in the same manner as described above. EPA should also provide OMB
with a summary of the comments received during the comment period
and the Agency reaction/response to such comments. In addition, for
DCIs involving inert ingredients that are otherwise chemicals
regulated under the Toxic Substances Control Act (TSCA), EPA should
take care to ensure that the information requested in the DCI is
not already being sought under a collection activity initiated
under TSCA, e.g., health and safety data collected under TSCA
section 8(d). When EPA resubmits this ICR for renewal, the agency
should pay special attention to potential duplication. 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 5 CFR 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
EPA seeks to renew this ICR in three years, it must include as an
attachment a copy of each report submitted to OMB during this
approval period. In addition, to the extent that it is feasible,
when EPA resubmits this ICR to OMB in three years, the Agency
should make a concerted attempt to identify each DCI that it may
reasonably anticipate being issued over the period for which
approval is sought. For each of the proposed DCIs, the package
should contain the same information identified above, and any
additional information necessary to demonstrate compliance with 5
CFR 1320.5(d). Although OMB recognizes that it may be difficult to
specifically identify all the potential individual data needs and
the importance of implementing these collections in a timely manner
in the context of an ongoing licensing program such as pesticide
registrations, OMB believes that EPA should attempt to predict the
types and numbers of potential DCIs that may be reasonably
anticipated during the ICR approval period. 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
12/31/2004
12/31/2004
01/31/2002
20
0
30
117,256
0
208,132
0
0
0
This information collection program
provides means of collecting the data needed to assess whether the
registration of a pesticide would cause unreasonable, adverse
effects on human health or the environment, and grants EPA the
authority to require registrants to provide additional data to
maintain an existing registration.
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 Registration