Application for New and Amended Pesticide Registration (Renewal)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form EPA Form 8570-36 Summary of the Physical/Chemical Properties	Form and Instruction	Unchanged	Available
Form EPA Form 8570-35 Data Matrix	Form and Instruction	Unchanged	Available
Form EPA Form 8570-37 Self-Certification Statement for the Physical/Chemical Properties	Form	Unchanged	Available
Form EPA Form 8570-34 Certification with Respect to Citation of Data	Form	Unchanged	Available
Form EPA Form 8570-27 Formulator's Exemption Statement	Form	Unchanged	Available
Form EPA Form 8570-4 Confidential Statement of Formula	Form and Instruction	Unchanged	Available
Form EPA Form 8570-1 Application for Pesticide, Registration, Amendment, Other	Form and Instruction	Unchanged	Available
Form EPA Form 8570-35 Data Matrix	Form and Instruction	Unchanged	Available
Form EPA Form 8570-36 Summary of the Physical/Chemical Properties	Form and Instruction	Unchanged	Available
Form EPA Form 8570-37 Self-Certification Statement for the Physical/Chemical Properties	Form	Unchanged	Available
Form EPA Form 8570-34 Certification with Respect to Citation of Data	Form	Unchanged	Available
Form EPA Form 8570-27 Formulator's Exemption Statement	Form	Unchanged	Available
Form EPA Form 8570-4 Confidential Statement of Formula	Form and Instruction	Unchanged	Available
Form EPA Form 8570-1 Application for Pesticide, Registration, Amendment, Other	Form and Instruction	Unchanged	Available
Form EPA Form 8570-37 Self-Certification Statement for the Physical/Chemical Properties	Form	Unchanged	Available
Form EPA Form 8570-35 Data Matrix	Form and Instruction	Unchanged	Available
Form EPA Form 8570-36 Summary of the Physical/Chemical Properties	Form and Instruction	Unchanged	Available
Form EPA Form 8570-34 Certification with Respect to Citation of Data	Form	Unchanged	Available
Form EPA Form 8570-27 Formulator's Exemption Statement	Form	Unchanged	Repair queued
Form EPA Form 8570-4 Confidential Statement of Formula	Form and Instruction	Unchanged	Available
Form EPA Form 8570-1 Application for Pesticide, Registration, Amendment, Other	Form and Instruction	Unchanged	Available
0277ss17 Non Substantive Change Justification.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2019-09-16	Available
0277.17_Attachment N-Pesticide Submission Portal (PSP); Instructions, Screenshots and Related Guidance.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment L-Registrant Communication with EPA (Bayer CropScience LP).pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment I-2 - Form Instructions and Relevant Information_Guidance for Completing the CSPS.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment I-1 - Proposed New Joint Confidential Statement of Product Specifications.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment M-Public Comments & EPA Responses.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment K-Display Related to OMB Control # 2070-0060.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment J-Labor Wage Formulas - Sec 3 ICR.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment H-Consultations Contacts, Questionnaire, and Responses.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment G-40 CFR 158-Data Requirements for Pesticide Registration.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment F-40 CFR 156-Labeling Requirements for Pesticides and Devices.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment E-40 CFR 152-Pesticide Registration and Classification Procedures.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277 17_Attachment D-PR Notice 97-3 Guidelines for Expedited Review of Conventional Pesticides under the Reduced-Risk Initiative and for Bio-Pestici.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277 17_Attachment B-Statute-Registration Service Fees.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment A-Statute-Registration.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277ss17.docx	Supporting Statement A	Uploaded 2016-07-01	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
24913	"Type A" application for registration of a new active ingredient or a new use for a currently registered active ingredient	Form and Instruction	Unchanged	Summary of the Physical/Chemical Properties
24913	"Type A" application for registration of a new active ingredient or a new use for a currently registered active ingredient	Form and Instruction	Unchanged	Data Matrix
24913	"Type A" application for registration of a new active ingredient or a new use for a currently registered active ingredient	Form	Unchanged	Self-Certification Statement for the Physical/Chemical Properties
24913	"Type A" application for registration of a new active ingredient or a new use for a currently registered active ingredient	Form	Unchanged	Certification with Respect to Citation of Data
24913	"Type A" application for registration of a new active ingredient or a new use for a currently registered active ingredient	Form	Unchanged	Formulator's Exemption Statement
24913	"Type A" application for registration of a new active ingredient or a new use for a currently registered active ingredient	Form and Instruction	Unchanged	Confidential Statement of Formula
24913	"Type A" application for registration of a new active ingredient or a new use for a currently registered active ingredient	Form and Instruction	Unchanged	Application for Pesticide, Registration, Amendment, Other
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	Data Matrix
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	Summary of the Physical/Chemical Properties
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	Unchanged	Self-Certification Statement for the Physical/Chemical Properties
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	Unchanged	Certification with Respect to Citation of Data
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	Unchanged	Formulator's Exemption Statement
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	Confidential Statement of Formula
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	Application for Pesticide, Registration, Amendment, Other
187235	"Type B" application for registration of a new or amended product that contains a currently registered active ingredient	Form	Unchanged	Self-Certification Statement for the Physical/Chemical Properties
187235	"Type B" application for registration of a new or amended product that contains a currently registered active ingredient	Form and Instruction	Unchanged	Data Matrix
187235	"Type B" application for registration of a new or amended product that contains a currently registered active ingredient	Form and Instruction	Unchanged	Summary of the Physical/Chemical Properties
187235	"Type B" application for registration of a new or amended product that contains a currently registered active ingredient	Form	Unchanged	Certification with Respect to Citation of Data
187235	"Type B" application for registration of a new or amended product that contains a currently registered active ingredient	Form	Unchanged	Formulator's Exemption Statement
187235	"Type B" application for registration of a new or amended product that contains a currently registered active ingredient	Form and Instruction	Unchanged	Confidential Statement of Formula
187235	"Type B" application for registration of a new or amended product that contains a currently registered active ingredient	Form and Instruction	Unchanged	Application for Pesticide, Registration, Amendment, Other

ICR Details

OMB Control No: 2070-0060	ICR Reference No: 201909-2070-001
Status: Historical Active	Previous ICR Reference No: 201606-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0277.17
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/01/2019
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/16/2019
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2020	09/30/2020	09/30/2020
Responses	8,203	0	8,203
Time Burden (Hours)	1,524,893	0	1,524,893
Cost Burden (Dollars)	0	0	0

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Abstract: This data collection program is designed to provide EPA with necessary data to evaluate an application for registration of a pesticide product as required under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA). Under FIFRA, EPA must evaluate pesticides thoroughly before they can be marketed and used in the United States, to ensure that they will not pose unreasonable adverse effects to human health and the environment. Pesticides that meet this test are granted a license or "registration" which permits their distribution, sale and use according to requirements set by EPA to protect human health and the environment.

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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:
	80 FR 34153	06/15/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 43197	07/01/2016
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

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 8570-4, EPA Form 8570-1, EPA Form 8570-27, EPA Form 8570-34, EPA Form 8570-37, EPA Form 8570-35, 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 ,   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, EPA Form 8570-35, 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 ,   Summary of the Physical/Chemical Properties ,   Data Matrix ,   Self-Certification Statement for 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, EPA Form 8570-36, EPA Form 8570-35	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 ,   Summary of the Physical/Chemical Properties ,   Data Matrix
Data Generation (for New AIs & New Products)

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ICR Summary of Burden

table that charts list 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	8,203	8,203	0	0	0	0
Annual Time Burden (Hours)	1,524,893	1,524,893	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: There is a net increase of 1,356,689 hours in the total estimated respondent burden compared with the ICR previously approved by OMB. The increase is the result of EPA’s updating of the methodology used to estimate the paperwork burden that involves the addition of previously unaccounted for burden for study data generation; while a decrease of approximately 23,000 hours reflects EPA's receipt of fewer applications. These changes are an adjustment.

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Annual Cost to Federal Government: $35,843,792

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? 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: 09/16/2019

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