Data Generation for Pesticide Reregistration

ICR 200005-2070-003

OMB: 2070-0107

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
24952 Migrated
ICR Details
2070-0107 200005-2070-003
Historical Active 199712-2070-002
EPA/OCSPP
Data Generation for Pesticide Reregistration
Extension without change of a currently approved collection   No
Regular
Approved without change 09/07/2001
Retrieve Notice of Action (NOA) 05/30/2000
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.

None
None


No

1
IC Title Form No. Form Name
Data Generation for Pesticide Reregistration 1504.04, 8570-32, 8570-34

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 30 111 0 -81 0 0
Annual Time Burden (Hours) 90,725 38,882 0 51,843 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  No

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.
05/30/2000


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