Pesticide Product Performance Data Requirements for Products Claiming Efficacy Against Certain Invertebrate Pests (Proposed 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	Modified
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
0277ss21.docx Supporting Statement A	2021-03-25
Attachment E -- PLAW-116publ8.pdf Supplementary Document	2021-03-25
0277ss20.docx Supplementary Document	2021-03-25
0277-20_ss_Attachment B.pdf Supplementary Document	2020-05-29
0277-20_ss_Attachment A.pdf Supplementary Document	2020-05-29

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	Modified
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: 202103-2070-002
Status: Received in OIRA	Previous ICR Reference No: 202005-2070-003
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0277.21
Title: Pesticide Product Performance Data Requirements for Products Claiming Efficacy Against Certain Invertebrate Pests (Proposed Rule)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 03/25/2021

	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: This information collection request (ICR) addresses the information collection activities in the proposed rule entitled Pesticide Product Performance Data Requirements for Products Claiming Efficacy Against Certain Invertebrate Pests (RIN 2070-AJ49). EPA is proposing to codify product performance data requirements to support registration of pesticidal products claiming efficacy against three categories of invertebrate pests: Those identified to be of significant public health importance (e.g., ticks, mosquitoes, cockroaches, etc.), wood-destroying insects (e.g., termites), and certain invasive invertebrate species (e.g., Asian longhorned beetle). The two latter categories are non-agricultural pests considered to be of significant economic or ecological importance. Product performance data (efficacy studies) document how well the pesticide performs the intended function (such as killing or repelling) against an invertebrate pest. This ICR is designed to serve as an amendment to the existing ICR entitled Application for New and Amended Pesticide Registration, identified as EPA ICR No. 0277 and approved under OMB Control No.: 2070-0060. The existing ICR addresses the information collection activities associated with the registration of a pesticide product under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3. FIFRA provides EPA with the authority to regulate the distribution, sale and use of pesticides in the United States and ensure that pesticides will not pose unreasonable adverse effects to human health and the environment.

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Authorizing Statute(s): US Code: 7 USC 136 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	Proposed rulemaking	86 FR 15362	03/22/2021

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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 8570-1, 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	8,216	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: The information collection activities related to this proposed rule are associated with the application for a new or amended registration of a pesticide that are currently approved under OMB Control No. 2070-0060 (EPA ICR No. 0277.20). The proposed rule is expected to reduce burden hours by 4,683 hours annually, including 4,515 hours from reduced paperwork burden associated with data generation and 168 hours from reduced paperwork burden associated with the application process, for a total burden cost savings of $330,000.

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Annual Cost to Federal Government: $33,930,000

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: 03/25/2021

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