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

Forms and Documents

Document Name	Status
1204.14 Attachment H.pdf Supplementary Document	2020-12-29
1204.14 Attachment G.pdf Supplementary Document	2020-12-29
1204.14 Attachment F.pdf Supplementary Document	2020-12-29
1204.14 Attachment E.pdf Supplementary Document	2020-12-29
1204.14 Attachment D.pdf Supplementary Document	2020-12-29
1204.14 Attachment C.pdf Supplementary Document	2020-12-29
1204.14 Attachment B.pdf Supplementary Document	2020-12-29
1204.14 Attachment A.pdf Supplementary Document	2020-12-29
1204fr14.docx Supplementary Document	2020-12-22
1204ss14.docx Supporting Statement A	2020-12-22

IC Document Collections

IC ID	Document Title	Status
24885	FIFRA Section 6(a)(2) Submisssions - Studies	Unchanged
194496	FIFRA Section 6(a)(2) - Training	Unchanged
194495	FIFRA Section 6(a)(2) Submissions - Incidents	Unchanged

ICR Details

OMB Control No: 2070-0039	ICR Reference No: 202012-2070-005
Status: Received in OIRA	Previous ICR Reference No: 201809-2070-002
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 1204.14
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	Date Submitted to OIRA: 12/31/2020

	Requested	Previously Approved
Expiration Date	36 Months From Approved	02/28/2021
Responses	125,459	125,459
Time Burden (Hours)	301,110	301,110
Cost Burden (Dollars)	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:
	85 FR 50022	08/17/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 86917	12/31/2020
Did the Agency receive public comments on this ICR? No

---

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

---

ICR Summary of Burden

	Total Request	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	125,459	0	0	0	0
Annual Time Burden (Hours)	301,110	301,110	0	0	0	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:

---

Annual Cost to Federal Government: $1,933,656

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? No

---

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: 12/31/2020

---