Application for New and Amended Pesticide Registration (Final Rule)

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	Modified
0277ss23.docx Supporting Statement A	2022-04-04

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)	Modified
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	Modified

ICR Details

OMB Control No: 2070-0060	ICR Reference No: 202204-2070-001
Status: Received in OIRA	Previous ICR Reference No: 202107-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0277.23
Title: Application for New and Amended Pesticide Registration (Final Rule)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/19/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2024
Responses	8,216	8,228
Time Burden (Hours)	1,557,834	1,562,517
Cost Burden (Dollars)	0	0

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Abstract: The codification of the data requirements will result in increased clarity for regulated entities, reducing burden. Increased clarity is expected to reduce the number of Type B applications in the short term, specifically incomplete applications. The final rule is expected to reduce burden hours by 168 hours from reduced paperwork burden associated with the application process. EPA estimates a total annual respondent burden of 101,094 hours from paperwork burden from application for new and amended products. Increased clarity is expected to reduce the amount of data submitted to EPA, for example unnecessary data pertaining to pests for which efficacy data are not needed. The final rule is expected to reduce burden hours by 4,515 hours from reduced data generation burden and thus reduce paperwork. EPA estimates a total annual respondent burden of 1,416,871 from paperwork burden from data generation for new and amended products. EPA already accounts for the activities associated with the final rule in the currently approved ICR (#0277.20), which covers most activities associated with new and amended registrations.

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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:
2070-AJ49	Final or interim final rulemaking	87 FR 22464	04/15/2022

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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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 8570-34, EPA Form 8570-1, EPA Form 8570-4, EPA Form 8570-27, 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	8,216	8,228	0	-12	0	0
Annual Time Burden (Hours)	1,557,834	1,562,517	0	-4,683	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: Yes

Burden Reduction Due to: Changing Regulations

Short Statement: EPA estimates the final rule will result in an average of 12 fewer submissions of incomplete data packages that do not support desired label claims, saving registrants $15,000 in paperwork costs related to application submission. Further, the Agency estimates the final rule will reduce unnecessary data generation paperwork burden by $315,000 annually. This is a total annual reduction in paperwork burden of $330,000 on average, equivalent to an annual reduction in burden hours of 4,683. This is a program change.

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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: 04/19/2022

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