0597.11_Attachment K

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

Page 1 of 3

http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm
Last updated on Friday, February 22, 2013

Pesticides: Regulating Pesticides
You are here: EPA Home
Pesticides
Guidance on IR-4 Exemptions

Regulating Pesticides

Registration Service Fees

Registration Service Fees
Guidance on IR-4 Exemptions
Resources

1. Under what circumstances am I eligible for an InterRegional Project Number 4 (IR-4) registration service
fee exemption?
2.

What is the Agency's IR-4 Public Interest Finding
Policy?

3. How must I submit the registration request to qualify
for the service fee exemption?
4. What do I do if I want to amend the application?
5. How do I request an IR-4 exemption on EPA Form
8570-1, Application for Pesticide Registration?
6. Who is the IR-4 contact coordinating submissions?
7. Are applications solely associated with IR-4 tolerance
petitions and in the public interest subject to the 21day initial content screen?

About Registration Service
Fees
Questions and Answers on:
21 Day Screening
Worksheet
Actions Not Covered by
Registration Service Fees
Fee Inquiries
Biopesticides
Fee Payments
Fee Waivers
Fund Management
Guidance on Federal and
State Agency Exemptions
Guidance on IR-4
Exemptions
In-Processing of
Applications
Inert Ingredients

8. What are some common issues that should be considered when developing these
submissions?
9. Are applications associated with non-food use data submitted by the IR-4 program
eligible for the IR-4 exemption?
10. If I request an IR-4 exemption, when will the decision review period for my
application begin?

1. Under what circumstances am I eligible for an Inter-Regional Project
Number 4 (IR-4) registration service fee exemption?
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.
2. What is the Agency's IR-4 Public Interest Finding Policy?
See Policy for IR-4 Public Interest Findings (PDF) (3 pp, 225k).

http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm

2/28/2013

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

Page 2 of 3

3. How must I submit the registration request to qualify for the service fee
exemption?
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.
4. What do I do if I want to amend the application?
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.
5. 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.
6. 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]
7. Are applications solely associated with IR-4 tolerance petitions and in the
public interest subject to the 21-day initial content screen?
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 IR-4 tolerance petition must be withdrawn and then
submitted simultaneously with the new application.

http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm

2/28/2013

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

Page 3 of 3

8. 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 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 IR4 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 IR4 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.
9. 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)].
10. 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.

http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm

2/28/2013