Attachment E -Guidance IR-4

Guidance on IR-4 Exemptions | Pesticide Registration Improvement Extension Act (PRIA... Page 1 of 3

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Guidance on IR-4 Exemptions
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Eligibility for an IR-4 registration service fee exemption
Application procedures to qualify for the service fee exemption
Applicability of the 21-day initial content screen
Common issues when developing these submissions
Starting the decision-review period
For more information

Eligibility for an Inter-Regional Project Number 4 (IR-4)
Registration Service Fee Exemption
An application would be exempt from registration service fees if the Agency determines that the
application:
• is solely associated with a tolerance petition submitted in connection with IR–4
• an exemption from registration service fees is in the public interest.

Exit

and

See Policy for IR-4 Public Interest Findings.
If the application is for a non-food use, which does not require a tolerance, the application is not
eligible for an IR-4 exemption. However, an application may be considered under the "minor use"
provisions of FIFRA, or under the "small business waiver" provisions of FIFRA.
• Full text of FIFRA (PDF) (168 pp, 444 K, About PDF)
◦ Minor use provisions (FIFRA Section 33(b)(7)(D)) – on page 156 of file
◦ Small business waiver (FIFRA Section 33(b)(7)(F)) – on page 157 of file
Application Procedures to Qualify for the Service Fee Exemption

Initial Application
The registration request must be submitted in the same application with the IR-4 tolerance petition.
If the registration request or petition is delayed, EPA will determine that the registration request is
not solely associated with an IR-4 tolerance petition and a registration service fee will be due. The
registration application must be accompanied by the notice of filing for the tolerance petition.

http://www2.epa.gov/pria-fees/guidance-ir-4-exemptions

12/3/2015

Guidance on IR-4 Exemptions | Pesticide Registration Improvement Extension Act (PRIA... Page 2 of 3

Amended Applications
Any changes to the application will require a new application that will be subject to a PRIA fee
unless the original application and petition are withdrawn and then submitted again with a request
for an IR-4 exemption.

Using EPA Form 8570-1, Application for Pesticide Registration
To request an IR-4 exemption, include the following statement in the "Explanation" box of Section
II:
"This application is being submitted with a tolerance petition submitted in connection with IR-4. I
request that EPA exempt the registration service fee for this application under the IR-4 exemption
provisions at FIFRA Section 33(b)(7)(E)."
Also in this section, reference the commodities that are the subject of the IR-4 petition.

Applicability of the 21-day Initial Content Screen
• An application must contain all the necessary forms, data, and draft labeling, formatted in
accordance with guidance published by the Agency.
• If it does not, corrections to the application must be made by the end of the 21 days,
beginning the day the exemption is granted.
• If EPA rejects an application and you wish the Agency to consider your application again,
you must submit a new application.
• To qualify for the IR-4 exemption, the IR-4 tolerance petition must be withdrawn and then
submitted simultaneously with the new application.

Common Issues when Developing These Submissions
• A Section 3 label amendment must reflect the application rates and the formulations used in
the IR-4 field residue trials.
• Requests to change the use directions or the formulation submitted after the submission of
the IR-4 petition do not qualify for a PRIA exemption since the requests will not be solely
associated with submission of the IR-4 petition.
• Any requests to change/add formulations, REI, PPE, PHI, use rate, number of applications,
or add aerial application after the submission of the original application will constitute a new
request and will be subject to PRIA fees.
• The Notice of Filing (NOF) provided by the registrant and submitted by IR-4 must list the
same commodities and proposed tolerance levels listed in section “F” of the IR-4 petition
request.
◦ EPA will only be able to establish tolerances for commodities that were proposed in
the Federal Register and discussed in the NOF.
• The Agency encourages registrants to work with IR-4 to ensure that applications are
complete when the Agency receives them.

http://www2.epa.gov/pria-fees/guidance-ir-4-exemptions

12/3/2015

Guidance on IR-4 Exemptions | Pesticide Registration Improvement Extension Act (PRIA... Page 3 of 3

Starting the Decision Review Period
The decision review period will begin on the date the exemption is granted. Applicants will be
notified by mail when the exemption has been granted.

For More Information
The IR-4 Program has agreed to coordinate the submission of requests for IR-4 exemptions. If you
have any questions, contact:
Dr. Daniel L. Kunkel
IR-4 Project Headquarters
Phone: 732-932-9575 ext. 4616
Fax: 609-514-2612
[email protected]

Last updated on November 16, 2015

http://www2.epa.gov/pria-fees/guidance-ir-4-exemptions

12/3/2015