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.
table that charts list comparision
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