Attachment K -Factors for IR-4

Factors for IR-4 Public Interest Finding | Pesticide Registration Improvement Extension ...

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Related Topics: PRIA Fees

Factors for IR-4 Public Interest Finding
Under the Pesticide Registration Improvement Extension Act (PRIA 3) (FIFRA Section 33(b)(7)
(E)), the Administrator shall exempt an application from the registration service fee if the
Administrator determines that the application meets both of the following criteria:
(i) the application is solely associated with a tolerance petition submitted in connection with the
Inter-Regional Project Number 4 (IR-4) as described in Section 2 of Public Law 89-106 (7 U.S.C.
450i(e)), and
(ii) the exemption is in the public interest.

Public Interest Presumption
An application will be presumed to be in the public interest if it is for a biopesticide or if the
following criteria are met:
• the data submitted have been developed by IR-4; and
• the active ingredient, for which the data are developed, must have been already registered for
use on a food commodity; and
• the active ingredient/crop combination has been pre-screened by EPA prior to the Food Use
Workshop, and EPA has discussed any risk concerns that might hinder registration or the
establishment of tolerances with IR-4; and
• the use is for:
◦ a minor crop (≤ 300,000 acres) or a specialty crop1, which the 2004 Specialty Crop
Competitiveness Act defines to include:
◾ fruits;
◾ vegetables;
◾ tree nuts;
◾ dried fruits; and
◾ nursery crops (including floriculture); or
◦ a major crop that is a representative commodity for a crop group/subgroup that is being
submitted to establish tolerances for the minor uses/specialty crops in the crop
group/subgroup, and where the accompanying label amendment adds at least one new
minor use/specialty crop from that crop group to the label; or
◦ control of a niche pest on a major crop (where the most likely number of acres treated
is ≤ 300,000 acres at the time the application is submitted); or

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12/3/2015

Factors for IR-4 Public Interest Finding | Pesticide Registration Improvement Extension ...

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◦ control of a public health pest on the List of Pests of Significant Public Health
Importance; or
◦ control of a pest identified as critical by the federal government National Plant Disease
Recovery System (NPDRS) as called for in Homeland Security Presidential Directive
# 9 (HSPD-9) (PDF) (5 pp, 135.5 K, About PDF); or
◦ control of a pest identified as critical by the USDA OPMP or APHIS Plant Protection
and Quarantine (PPQ) Program Pests; or
◦ pesticide/crop combination associated with a Section 18 and there likely is insufficient
economic incentive for the registrant to generate the data.
For other actions that do not meet the criteria listed above, EPA will determine if a fee exemption is
warranted on a case-by-case basis using a weight-of-evidence approach considering the following
factors:
• Insufficient economic incentive for the registrant to support the use for which IR-4 is
generating the data.
• Pesticide provides a new mode of action for the proposed use.
• Pesticide plays a significant role in integrated pest management program.
• Pesticide has characteristics that other registered alternatives do not have, including but not
limited to the following:
◦ pesticide provides an entirely new method of control;
◦ more effectively targets critical pest life stages;
◦ avoids use of prophylactic treatments;
◦ is easier on beneficial insects; or
◦ allows for different timing intervals or novel placement where pests are found and is
compatible with other IPM methods.
• Insufficient efficacious alternatives.
• Reduced risk compared to existing alternatives for the proposed crop use.

Background Information Regarding EPA Input on IR-4
Candidate List of AI/Crop Combinations
IR-4 develops residue field trial data for projects based on requests from growers, grower groups
and state/federal research and extension agents. For a project to be considered, a request is made
through the IR-4 website by completion of an IR-4 Minor Use Project Clearance Request Form Exit
. IR-4 receives more requests for projects than there are resources, so the potential researchable
projects are prioritized by various stakeholders each year at the annual IR-4 Food Use Workshop.
The workshop is usually held in September.
Before the IR-4 Food Use Workshop, EPA's pesticide program receives a list of all project requests
that have been submitted to IR-4. We review these candidates and identify if there are any risk
concerns that would likely prevent the registration of the proposed use and the establishment of its
tolerance (e.g., full risk cup for the active ingredient, cumulative risk concerns for the class of
chemicals that share a common mechanism of toxicity). We provide feedback to IR-4 on any risk
concerns with the proposed projects.

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12/3/2015

Factors for IR-4 Public Interest Finding | Pesticide Registration Improvement Extension ...

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Following the Food Use Workshop and IR-4 determination of its list of projects, EPA encourages
IR-4 to discuss with the Agency any projects that may not clearly meet the criteria described in this
document before IR-4 commits any resources to these projects. While responsibility for providing
an adequate public interest rationale rests with the submitter, EPA retains the final responsibility
for approving a public interest finding.
These policies are being implemented in considering project proposals to be evaluated at the IR-4
Food Use Workshop. If the funding for an IR-4 project occurred before this policy was
implemented in September 2013, where the project doesn’t meet the criteria listed above, the fact
of such funding will be taken into serious consideration by EPA in our weight-of-evidence
deliberation regarding the public interest finding.
1

Only those applications for specialty crops that would require the establishment of a tolerance or
tolerance exemption would meet condition (i) “application is solely associated with a tolerance
petition…” and therefore could qualify for exemption from the PRIA registration fee.

Last updated on November 16, 2015

http://www2.epa.gov/pria-fees/factors-ir-4-public-interest-finding

12/3/2015