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
10/31/2007
36 Months From Approved
01/31/2008
14
0
14
303
0
303
0
0
0
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)).
US Code:
7 USC 136-136y
Name of Law: Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)
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.
ICR 1693 Addendum Supporting Statement 03-08-2007.pdf
Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting (Proposed Rule Related Addendum)