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)