Attachment K: Registration Service Fees Guidance on IR-4 Exemptions

Registration Service Fees, Questions on Fund Management | Pesticides | US EPA

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Guidance on IR-4 Exemptions

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Registration Service Fees
Guidance on IR-4 Exemptions
1. Under what circumstances
am I eligible for an InterRegional Project Number 4
(IR-4) registration service
fee exemption?
2. How must I submit the
registration request to
qualify for the service fee
exemption?
3. What do I do if I want to
amend the application?

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21 Day Screening Worksheet
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Registration Service Fees
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Fee Payments
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Fund Management
Guidance on IR-4 Exemptions
In-Processing of Applications
Inert Ingredients

4. How do I request an IR-4
●
exemption on EPA Form
8570-1, Application for Pesticide Registration?

5. Who is the IR-4 contact coordinating submissions?
6. Are applications solely associated with IR-4 tolerance petitions and
in the public interest subject to the 21-day initial content screen?
7. What are some common issues that should be considered when
developing these submissions?
8. Are applications associated with non-food use data submitted by
the IR-4 program eligible for the IR-4 exemption?
9. If I request an IR-4 exemption, when will the decision review
period for my application begin?
On March 6, 2008, the President signed a technical correction to PRIA 2 to
exempt fees for certain registration applications associated with IR-4
tolerance petitions which became effective retroactively to October 1, 2007.
1. Under what circumstances am I eligible for an InterRegional Project Number 4 (IR-4) registration service fee
exemption?

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Registration Service Fees, Questions on Fund Management | Pesticides | US EPA

If the Agency determines that an application is solely
associated with a tolerance petition submitted in
connection with IR–4

and an

exemption from registration service fees is in the
public interest, such an application would be exempt
from registration service fees. The public interest
finding is being discussed within the Agency.

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2. How must I submit the registration request to qualify for
the service fee exemption?
The registration request must be submitted
simultaneously with the IR-4 tolerance petition or
within 14 days of the 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. If you choose to submit the Section 3
registration application separately from the IR-4
petition but within the 14 days, reference the
commodities and the date of the IR-4 tolerance
submission so the Agency can link the submissions.

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3. What do I do if I want to amend the application?
Once the 14 days have elapsed, 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
simultaneously again with a request for an IR-4
exemption.
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Registration Service Fees, Questions on Fund Management | Pesticides | US EPA

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4. How do I request an IR-4 exemption on 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.

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5. Who is the IR-4 contact coordinating submissions?
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]

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6. Are applications solely associated with IR-4 tolerance
petitions and in the public interest subject to the 21-day
initial content screen?
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Registration Service Fees, Questions on Fund Management | Pesticides | US EPA

Yes. 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 IR4 tolerance petition must be withdrawn and then
submitted simultaneously with the new application.

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7. What are some common issues that should be considered
when developing these submissions?
A Section 3 label amendment must reflect the
application rates and the formulations used in the IR4 field residue trials.
Requests to change the use directions or the
formulation submitted after 14 days of 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 14 days have elapsed 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

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Registration Service Fees, Questions on Fund Management | Pesticides | US EPA

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.

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8. Are applications associated with non-food use data
submitted by the IR-4 program eligible for the IR-4
exemption?
No. Under PRIA, this exemption only applies to
applications solely associated with tolerance petitions
submitted by the IR-4 program. Under the Federal
Food, Drug, and Cosmetic Act, a non-food use
application does not require a tolerance; therefore
the application is not eligible for an IR-4 exemption.
However, an application may be considered under the
“minor use” provisions of FIFRA [Section 33(b)(7)
(D)], or under the “small business waiver” provisions
of FIFRA [Section 33(b)(7)(F)].

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9. If I request an IR-4 exemption, when will the decision
review period for my application begin?
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.

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Last updated on Thursday, October 9th, 2008.
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