View Information Collection Request (ICR) Package

OMB Control No: 2070-0142	ICR Reference No: 200704-2070-007
Status: Historical Inactive	Previous ICR Reference No: 200407-2070-002
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 1693.04
Title: Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting (Proposed Rule Related Addendum)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 05/21/2007
	Date Received in OIRA: 04/19/2007
Terms of Clearance: In accordance with 5 CFR 1320, OMB is not approving the collection associated with the rulemaking at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments on the information collection and any changes made in response to those comments. The agency is also reminded that the abstract should reflect the overall purpose of the collection, not the "addendum". They are also reminded that OMB will grant three year approvals only if an agency submits a complete revision to a collection -- not an addendum which describes only a portion of a collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2007	36 Months From Approved	01/31/2008
Responses	14	0	14
Time Burden (Hours)	303	0	303
Cost Burden (Dollars)	0	0	0

Abstract: This information collection request (ICR) addendum covers exemptions from FIFRA that EPA is proposing for certain plant-incorporated protectants (PIPs) based on plant viral coat protein genes (PVCP-PIPs). EPA is proposing to define a PVCP-PIP as "a plant-incorporated protectant derived from one or more genes that encode a coat protein of a virus that naturally infects plants. This includes plant-incorporated protectants derived from one or more plant viral coat protein genes that produce only RNA and no virus-related protein." PVCP-PIPs introduced into plants with the intention of preventing or mitigating viral disease meet the FIFRA section 2(u) definition of "pesticide" because they are introduced into plants with the intention of "preventing, destroying, repelling, or mitigating any pest..." (7 U.S.C. 136(u)) and plant viruses meet the FIFRA section 2 definition of "pest" (7 U.S.C. 136(t)). EPA is proposing this exemption because the Agency believes that the PVCP-PIPs covered by this exemption would be of a character which is unnecessary to be subject to FIFRA in order to carry out the purposes of the Act. A PIP can be exempt from the requirements of FIFRA, other than the adverse effects reporting requirements of 40 CFR 174.71, if it meets all three of the requirements listed in 40 CFR 174.21. Section 174.21(a) requires that the PIP meet the criteria listed in at least one of the sections in 174.25 through 174.50. Section 174.21(b) requires that when the PIP is intended to be produced and used in a crop used as food, the residues of the PIP are either exempted from the requirement of a tolerance under FFDCA or no tolerance would otherwise be required for the PIP. Section 174.21(c) requires that any inert ingredient that is part of the PIP is on the list codified at sections 174.485 through 174.490. The proposed rule would establish 40 CFR 174.27, which would contain three criteria that when met would allow PVCP-PIPs to meet the general requirement for exemption for all PIPs listed at 40 CFR 174.21(a). In order to be exempt from the requirements of FIFRA, a PVCP-PIP must satisfy the criteria for proposed 40 CFR 174.21(a) and comply with sections 174.21(b) and (c). The three criteria that EPA is proposing to be inserted at 40 CFR 174.27 are intended to address three issues that may be associated with a PVCP-PIP: (1) the potential for increased weediness or invasiveness of the crop plant containing the PVCP-PIP or any wild or weedy relatives that could acquire the PVCP-PIP through gene flow thereby causing negative effects on either the agro-ecosystem or natural environments (addressed in proposed section 174.27(a)), (2) the potential for viruses with novel properties to develop through novel viral interactions (addressed in proposed section 174.27(b)), and (3) human or nontarget organism exposure to proteins that have not previously existed in nature and thus should be examined to determine whether they have potentially toxic or allergenic properties (addressed in proposed section 174.27(c)).

Authorizing Statute(s): US Code: 7 USC 136-136y 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-AD49	Proposed rulemaking	72 FR 19589	04/18/2007

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting (Proposed Rule Related Addendum)

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:

Annual Cost to Federal Government: $18,168

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Angela Hofmann

View ICR - OIRA Conclusion