View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
2070-0039
ICR Reference No:
201809-2070-002
Status:
Historical Active
Previous ICR Reference No:
201408-2070-001
Agency/Subagency:
EPA/OCSPP
Agency Tracking No:
1204.13
Title:
Submission of Unreasonable Adverse Effects Information Under FIFRA Section 6(a)(2) (Renewal)
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
09/09/2019
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/27/2018
Terms of Clearance:
Upon re-submission, EPA needs to consolidate all the OMB control numbers associated with the PSP Portal (2070-0040, 2070-0142, 2070-0039, 2070-0182, 2070-0060, 2070-0044, and 2070-0024). The agency is reminded to include a burden statement on the initial online screen for all collection activities within the PSP Portal and to provide updated screen shots of the PSP Portal and associated form questions.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2021
36 Months From Approved
09/30/2019
Responses
125,459
0
112,985
Time Burden (Hours)
301,110
0
272,246
Cost Burden (Dollars)
0
0
0
Abstract:
Section 6(a)(2) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires pesticide registrants to submit information to the Agency which may be relevant to the balancing of the risks and benefits of a pesticide product. The statute requires the registrant to submit any factual information that it acquires regarding adverse effects associated with its pesticidal products, and it is up to the Agency to determine whether or not that factual information constitutes an unreasonable adverse effect. In order to limit the amount of less meaningful information that might be submitted to the Agency, the EPA has limited the scope of factual information that the registrant must submit. The Agencys regulations at 40 CFR part 159 provide a detailed description of the reporting obligations of registrants under FIFRA section 6(a)(2).
Authorizing Statute(s):
US Code:
7 USC 136d(a)(2)
Name of Law: Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
83 FR 2526
02/08/2018
30-day Notice:
Federal Register Citation:
Citation Date:
83 FR 48307
09/24/2018
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
FIFRA Section 6(a)(2) - Training
FIFRA Section 6(a)(2) Submissions - Incidents
FIFRA Section 6(a)(2) Submisssions - Studies
ICR Summary of Burden
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
125,459
112,985
0
0
12,474
0
Annual Time Burden (Hours)
301,110
272,246
0
0
28,864
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
The increase in burden hours and cost is primarily due to the expected increase in the number of responses. The increase in number of responses is due to EPAs revised expectations regarding the number of incident reports that will be submitted to the Agency, which reflects historical information on the number of responses received. The increase in the number of incident reports has also prompted the need for additional data in certain subject areas under 40 CFR 159. First, due to a significant increase in the number of adverse incidents for spot-on domestic animal pet products from several registrants, EPA began requiring more standardized post-market surveillance reporting on adverse effects and submission of sales information, so the Agency can better evaluate incident rates. Second, the Agency requested additional information from the registrant of an herbicide to help explain circumstances for incidents of alleged tree and plant damage. Finally, new concerns about neonicotinoid pesticides and the loss of bee colonies led to EPAs request for more documentation from registrants for these products.
Annual Cost to Federal Government:
$1,540,778
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Angela Hofmann 202 260-2922 hofmann.angela@epamail.epa.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
09/27/2018
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