Application for New and Amended Pesticide Registration (Renewal)

Forms and Documents

Document Name	Status
Form EPA Form 8570-27 "Type A" application for registration of a new active ingredient or a new use for a currently registered active ingredient Form	Unchanged
Form EPA Form 8570-1 "Type C" application for registration of new conventional active ingredients or uses that may qualify as "reduced risk" chemicals and/or OP replacements Form and Instruction	Unchanged
Form EPA Form 8570-1 "Type B" application for registration of a new or amended product that contains a currently registered active ingredient Form and Instruction	Unchanged
eCSF Screen Captures__0277.22.pptx Supplementary Document	2021-07-15
WIP_CDX 00048 eCSF XML Guide v.01__0277.22.docx Supplementary Document	2021-07-15
WIP_CDX 00048 eCSF User Guide v.01__0277.22.docx Supplementary Document	2021-07-15
eCSF_Change Request_Justification__0277.22.docx Justification for No Material/Nonsubstantive Change	2021-07-15

IC Document Collections

IC ID	Document Title	Status
24913	"Type A" application for registration of a new active ingredient or a new use for a currently registered active ingredient Form	Unchanged
222287	Data Generation (for New AIs & New Products)	Unchanged
187236	"Type C" application for registration of new conventional active ingredients or uses that may qualify as "reduced risk" chemicals and/or OP replacements Form and Instruction	Unchanged
187235	"Type B" application for registration of a new or amended product that contains a currently registered active ingredient Form and Instruction	Unchanged

ICR Details

OMB Control No: 2070-0060	ICR Reference No: 202107-2070-001
Status: Received in OIRA	Previous ICR Reference No: 202005-2070-003
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0277.22
Title: Application for New and Amended Pesticide Registration (Renewal)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/21/2021

	Requested	Previously Approved
Expiration Date	03/31/2024	03/31/2024
Responses	8,228	8,228
Time Burden (Hours)	1,562,517	1,562,517
Cost Burden (Dollars)	0	0

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Abstract: This change will not increase the annual ICR burden estimate. It is not mandatory for stakeholders to take advantage of this electronic reporting option. This action will not change the scope or content of submissions, nor would it prescribe a format. The burden associated with CDX registration is covered by another approved ICR (OMB control no. 2025-0003 and ICR No. 2002.07). EPA estimates that this 73% of CSF submitters are already registered in CDX and already use the PSP for other purposes. In most cases, these entities are pesticide registrants. Those that choose to submit electronically may experience some savings related to postage and materials (paper, ink, etc.). Because the electronic reporting option is both time-limited and voluntary, these cost savings are likely to be de minimis. Although there will be additional burden in establishing the eCSF file, subsequent submissions will be faster because of the saved data.

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Authorizing Statute(s): PL: Pub.L. 80 - 104 3 Name of Law: 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:
	85 FR 6944	02/06/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 60992	09/29/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
"Type A" application for registration of a new active ingredient or a new use for a currently registered active ingredient	EPA Form 8570-27, EPA Form 8570-34, EPA Form 8570-37, EPA Form 8570-35, EPA Form 8570-36	Formulator's Exemption Statement ,   Certification with Respect to Citation of Data ,   Self-Certification Statement for the Physical/Chemical Properties ,   Data Matrix ,   Summary of the Physical/Chemical Properties
"Type B" application for registration of a new or amended product that contains a currently registered active ingredient	EPA Form 8570-1, EPA Form 8570-4, EPA Form 8570-27, EPA Form 8570-34, EPA Form 8570-36	Application for Pesticide, Registration, Amendment, Other ,   Confidential Statement of Formula ,   Formulator's Exemption Statement ,   Certification with Respect to Citation of Data ,   Summary of the Physical/Chemical Properties
"Type C" application for registration of new conventional active ingredients or uses that may qualify as "reduced risk" chemicals and/or OP replacements	EPA Form 8570-1, EPA Form 8570-4, EPA Form 8570-27, EPA Form 8570-34, EPA Form 8570-37	Application for Pesticide, Registration, Amendment, Other ,   Confidential Statement of Formula ,   Formulator's Exemption Statement ,   Certification with Respect to Citation of Data ,   Self-Certification Statement for the Physical/Chemical Properties
Data Generation (for New AIs & New Products)

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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	8,228	8,228	0	0	0	0
Annual Time Burden (Hours)	1,562,517	1,562,517	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: The activities in this ICR increase net respondent burden by 37,624 hours annually over the levels approved in the currently approved collection. While burden per response levels remain unchanged, the number of responses expected in certain categories has shifted as a result of using an updated data set (Section 3 registration actions annually, on average, during the years 2015-2017) to predict future registration application levels. Additionally, in this iteration of the ICR, the Agency calculates the expected annual application burden of three proposed programs that are anticipated to come online in the next three years. The average annual number of Section 3 registration actions dropped during the years 2015-2017 from 7,478 to 7,292. As a result, baseline registration levels, exclusive of the new programs, were reset at an annual averages of 205 “Type A” activities, 7,082 “Type B” activities, and 5 “Type C” activities. EPA estimates that the addition of several new fee-for-service PRIA categories will increase the annual number of Type B actions by 40. The Agency does not anticipate any paperwork burden from data generation for new products or for new active ingredients resulting from these new PRIA categories. The Antimicrobial Performance Evaluation Program (APEP) may impact up to 99 products annually, with an application burden for the registrant of each product. The Agency expects this burden to be similar to a Type B action. Furthermore, there may be a data generation burden for these products annually under this program. EPA conservatively estimates the paperwork burden for data generation under APEP may look similar to the burden for an Antimicrobial new product and has included this burden in the calculations for the Data Generation IC in this ICR. The Agency anticipates that the “Interim Process for Evaluating Potential Synergistic Effects of Pesticides During the Registration Process” will not cause a change in the number of product registrations, but will impose an additional Type A burden on registrants equivalent to about 8 active ingredients annually. The Agency does not anticipate a paperwork burden from data generation for new active ingredients or new products for the draft GTA guidance.

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Annual Cost to Federal Government: $33,929,979

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

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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: 07/21/2021

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