View Information Collection Request (ICR) Package

OMB Control No: 2070-0214	ICR Reference No: 202305-2070-003
Status: Active	Previous ICR Reference No: 202009-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2619.02
Title: Exemptions of Certain Plant-Incorporated Protectants (PIPs) Derived from Newer Technologies Rulemaking (Final Rule)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/20/2023
	Date Received in OIRA: 06/02/2023
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2026	36 Months From Approved
Responses	10	0	0
Time Burden (Hours)	850	0	0
Cost Burden (Dollars)	0	0	0

Abstract: This information collection request (ICR) addresses the information collection activities in the proposed rule entitled “Pesticides; Exemptions of Certain Plant-Incorporated Protectants (PIPs) Derived from Newer Technologies; Proposed Rule” (RIN 2070-AK54). The Environmental Protection Agency (EPA) is proposing an exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA) for certain PIPs that are created in plants using biotechnology, as long as their pesticidal substances are found in plants that are sexually compatible with the recipient plant and meet the proposed exemption criteria, ensuring their safety. The current exemption for PIPs is limited to PIPs moved through conventional breeding. EPA's proposed rule would allow certain PIPs created through biotechnology to also be exempt under existing regulations, in cases where those PIPs 1) pose no greater risk than PIPs that meet EPA safety requirements, and 2) could have otherwise been created through conventional breeding. The proposed rule also includes a process through which developers of PIPs based on sexually compatible plants created through biotechnology submit either a self-determination letter or request for EPA confirmation that their PIP meets the criteria for exemption. For increased flexibility in bringing PIPs to market, a developer can also submit both. EPA anticipates several benefits that may result from exempting these PIPs. These include lower costs from reduced regulatory burden, increased research, development, and commercialization of pest control options for farmers, particularly in minor crops, and reduced use of conventional pesticides which could provide environmental benefits.

Authorizing Statute(s): US Code: 7 USC 136a Name of Law: Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
2070-AK54	Final or interim final rulemaking	88 FR 34756	05/31/2023

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? Yes

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Exemption for Certain PIPs that are Created in Plants Using Biotechnology	EPA Form No 9600-053

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	10	10
Annual Time Burden (Hours)	850	850
Annual Cost Burden (Dollars)	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This action is a final rule to exempt certain plant-incorporated protectants from the requirements of registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and establishing a tolerance or tolerance exemption under the Federal Food Drug and Cosmetic Act (FFDCA). EPA plans to amend ICR 2070-0060/#0277.23 to fold-in the PIPS Newer Technology rule (#2619.02).

Annual Cost to Federal Government: $4,567

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

Agency Contact: Angela Hofmann 202 260-2922 hofmann.angela@epamail.epa.gov

View ICR - OIRA Conclusion