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Related Topics: PRIA Fees 

# Guidance on IR-4 Exemptions On this page:

• Eligibility for an IR-4 regi stration service fee exemption

• Application procedures to qualifyfor the service fee exemption

• Applicability of the 21-day initial content screen

• Common issues when developing these submissions

• Starting the decisi on-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 toleran ce petition submitted in connection with IR–4 and • an exemption from registration servic e fees is in the public interest. 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 appl ication may be considered under the "minor use" provisions of FIFRA, or under the "smallbusiness 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 Secti on 33(b)(7)(F)) – on page 157 of file Application Procedures to Qualif y for the Service Fee Exemption 

### Initial Application The registration request must be submitted in the same application with th e IR-4 tolerance petition. If the registration request or petition is delayed, EP A will determine that th e registration request is not solely associated with an IR-4 tolerance petition and a regi stration service fee will be due. The registration application must be accompanied by the notice of filing for the tolerance petition. Exit Page 1 of 3 Guidance on I R -4 Exemptions | Pesticide Registration Improvement Extension Act (PRI A

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### 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will require a new application that will be subject to a PRIA fee unless the original application and petition are withdrawn and then submitted again with a request for an IR-4 exemption.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, Applicat ion for Pesticide Registration To request an IR-4 exemption, include the follow ing statement in the "Explanation" box of Section II: "This application is being submitted with a tolerance petition subm itted 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, referenc e 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 applicati on 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 th e Agency to consider your application again,

you must submit a new application. • To qualify for the IR-4 exemption, the IR-4 to lerance 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 a pplication rates and the formulations used in the IR-4 field residue trials. • Requests to change the use directions or th e formulation submitted after the submission of

the IR-4 petition do not qualify for a PRIA exem ption since the requests will not be solely associated with submissi on 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 re gistrant 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 es tablish 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. Page 2 of 3 Guidance on I R -4 Exemptions | Pesticide Registration Improvement Extension Act (PRI A

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## Starting the Decision Review Period The decision review period will be gin 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 kunkel@aesop.rutgers.edu

Last updated on November 16, 2015 Page 3 of 3 Guidance on I R -4 Exemptions | Pesticide Registration Improvement Extension Act (PRI A

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