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

Forms and Documents

Document	Type	Status	Availability
1204.12_Supporting Statement_2014-08-01.docx	Supporting Statement A	Uploaded 2014-08-21	Repair queued
Attachment K- pollinator protection letter to registrant_July 2013.pdf	Supplementary Document	Uploaded 2014-08-15	Repair queued
Attachment J_Imprelis Stop Sale Letter.pdf	Supplementary Document	Uploaded 2014-08-15	Available
Attachment I_Spot-on-Meeting_May_2009.pdf	Supplementary Document	Uploaded 2014-08-15	Available
1204attach-H.pdf	Supplementary Document	Uploaded 2014-08-15	Available
Consultation.sysco.doc	Supplementary Document	Uploaded 2014-08-15	Repair queued
Consultation.Syngenta.doc	Supplementary Document	Uploaded 2014-08-15	Repair queued
Consultation.Clorox.doc	Supplementary Document	Uploaded 2014-08-15	Available
Consultation.canberra.doc	Supplementary Document	Uploaded 2014-08-15	Available
Consultation.Bayer.pdf	Supplementary Document	Uploaded 2014-08-15	Available
1204attach-F.pdf	Supplementary Document	Uploaded 2014-08-15	Available
1204attach-E.pdf	Supplementary Document	Uploaded 2014-08-15	Available
1204attach-D.pdf	Supplementary Document	Uploaded 2014-08-15	Repair queued
1204attach-C.pdf	Supplementary Document	Uploaded 2014-08-15	Available
1204attach-B.pdf	Supplementary Document	Uploaded 2014-08-15	Available
1204attach-A.pdf	Supplementary Document	Uploaded 2014-08-15	Repair queued

IC Document Collections

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: 201408-2070-001
Status: Historical Active	Previous ICR Reference No: 201009-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 1204.12
Title: Submission of Unreasonable Adverse Effects Information Under FIFRA Section 6(a)(2)
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: 09/08/2015
	Date Received in OIRA: 09/15/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2018	36 Months From Approved	09/30/2015
Responses	112,985	0	91,979
Time Burden (Hours)	272,246	0	203,236
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. Specifically, registrants are required 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, EPA has defined the scope of factual information that the registrant must submit. EPA regulations at 40 CFR 159 provide a detailed description of the reporting obligations of registrants under FIFRA section 6(a)(2). Potential respondents affected by the collection activities under this ICR include anyone who holds or ever held a registration for a pesticide product issued under FIFRA section 3 or 24(c). The North American Industrial Classification System (NAICS) code is 325320 (Pesticide and Other Agricultural Chemical Manufacturing).

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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:
	79 FR 6897	02/05/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 54977	09/15/2014
Did the Agency receive public comments on this ICR? No

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

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

	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	112,985	91,979	0	0	21,006	0
Annual Time Burden (Hours)	272,246	203,236	0	0	69,010	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: This increase is due to an adjustment based on activities under the ICR during the current approval period. Specifically, EPA is increasing the number of potential responses and the number of registrants of products, which results in a small increase in the number of employees being trained. There is also an increase in incident information collected on spot-on treatments and neonicotinoid pesticides due to bee kills and colony loses.

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Annual Cost to Federal Government: $1,540,778

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 09/15/2014

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