Submission of Unreasonable Adverse Effects Information Under FIFRA Section 6(a)(2) (Renewal)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
1204ss13_Attachment H_ Worksheet for Estimating ICR Wage Rates.xlsx	Supplementary Document	Uploaded 2018-09-27	Available
1204ss13_Attachment D_ Consultation Questionnaire.docx	Supplementary Document	Uploaded 2018-09-27	Available
1204ss13.docx	Supporting Statement A	Uploaded 2018-09-27	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
24885	FIFRA Section 6(a)(2) Submisssions - Studies		Modified
194496	FIFRA Section 6(a)(2) - Training		Modified
194495	FIFRA Section 6(a)(2) Submissions - Incidents		Modified

ICR Details

OMB Control No: 2070-0039	ICR Reference No: 201809-2070-002
Status: 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
	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.

table that charts list comparision

	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

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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).

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
FIFRA Section 6(a)(2) Submissions - Incidents
FIFRA Section 6(a)(2) Submisssions - Studies
FIFRA Section 6(a)(2) - Training

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ICR Summary of Burden

table that charts list 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.

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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

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Common Form ICR:  No

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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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