It is OMB's
understanding that EPA has completed Phase 4 of the process of
calling in generic studies required for pesticides in
reregistration. This three year Information Collection Request
approval covers burden hours associated with data collection
activities necessary to complete Phase 5 of the pesticide
reregistration program, as well as the burden associated with
voluntarily submitted studies. This covers only the 177 chemicals
subject to reregistration. (A list of these chemicals can be found
in the docket.) This package is treated as a generic clearance
because EPA does not have the chemical specific schedule for
review, nor has it identified all of the products containing each
of the 177 chemicals. Before issuing a specific DCI covered by this
ICR, EPA must submit each individual proposed data call in (DCI) to
OMB for approval. OMB will review the information collection
activities associated with each individual DCI to ensure compliance
with 5 CFR 1320.5 (d) --e.g. the collection of information is the
least burdensome necessary for the proper performance of the
agency's functions; the collection of information is not
duplicative of information otherwise accessible to the agency. OMB
may disapprove any individual submission under this clearance if it
fails to meet the criteria outlined in 5 CFR 1320.5 (d). 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) Provide OMB with a 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 may 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 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 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.). EPA should also identify the need for the DCI
--Confirmatory Data or Product-Specific Data, and the specific type
of data (e.g. product chemistry, exposure studies, etc.). Finally,
the submission should contain any additional information necessary
to demonstrate compliance with 1320.5 (d). 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 generic 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. 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 discussion 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 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 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
06/30/2005
06/30/2005
09/30/2001
30
0
111
90,725
0
38,882
0
0
0
This information collectionis designed
to provide the Environ- mental Protection Agency (EPA, the Agency)
with the necessary data to assess health and safety data for all
pesticide active ingredients originally registered before November
1, 1984, to determine whether each pesticide's use poses
unreasonable risks to human health or the environment and reassess
any related tolerances for pesticide chemicals.
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 Generation for Pesticide Reregistration