Application for New and Amended Pesticide Registration (Renewal)

ICR 202005-2070-003

OMB: 2070-0060

Federal Form Document

Forms and Documents
Document
Name
Status
Form
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Supporting Statement A
2020-09-29
Supplementary Document
2020-09-23
Supplementary Document
2020-05-29
Supplementary Document
2020-05-29
Supplementary Document
2020-05-29
Supplementary Document
2020-05-29
Supplementary Document
2020-05-29
Supplementary Document
2020-05-29
Supplementary Document
2020-05-29
Supplementary Document
2020-05-29
Supplementary Document
2020-05-29
Supplementary Document
2020-05-29
Supplementary Document
2020-09-22
Supplementary Document
2020-09-22
Supplementary Document
2020-09-22
Supplementary Document
2020-09-22
Supplementary Document
2020-09-22
Supplementary Document
2020-09-22
Supplementary Document
2020-09-22
Supplementary Document
2020-05-29
Supplementary Document
2020-05-29
ICR Details
2070-0060 202005-2070-003
Received in OIRA 201909-2070-001
EPA/OCSPP 0277.20
Application for New and Amended Pesticide Registration (Renewal)
Extension without change of a currently approved collection   No
Regular 09/29/2020
  Requested Previously Approved
36 Months From Approved 01/31/2021
8,228 8,203
1,562,517 1,524,893
0 0

This is a renewal of an existing information collection request (ICR) designed to provide the Environmental Protection Agency (EPA) with the necessary information to evaluate an application for the 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) (see Attachment A). 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. Pesticides that meet this test receive a license or "registration."

PL: Pub.L. 80 - 104 3 Name of Law: Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
  
None

Not associated with rulemaking

  85 FR 6944 02/06/2020
85 FR 60992 09/29/2020
Yes

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)

  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 8,203 0 211 -186 0
Annual Time Burden (Hours) 1,562,517 1,524,893 0 40,689 -3,065 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
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.

$33,929,979
No
    No
    No
No
No
No
No
Angela Hofmann 202 260-2922 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
09/29/2020


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