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# Registration Service Fees Guidance on IR-4 Exemptions

1. Under what circumstances am I eligible for an Inter

Regional 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? 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 deci sion review period for my application begin?

1. Under what circumstances am I eligib le for an Inter-Regional Project Number 4 (IR-4) registration service fee exemption?
If the Agency determines that an app lication 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 di scussed within the Agency.

2. How must I submit the registration re quest to qualify for the service fee exemption?
The registration request must be subm itted 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 Resources About Registration Service Fees Questions and Answers on: 21 Day Screening Worksheet Actions Not Covered by Registration Service Fees Biopesticides Fee Payments Fee Waivers Fund Management Guidance on Federal and State Agency Exemptions Guidance on IR-4 Exemptions In-Processing of Applications Inert In g redients 

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, 2012 

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_ i r -4.htmrequest 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 subm ission so the Agency can link the submissions.

3. What do I do if I want to amend the application?
Once the 14 days have elapsed, an y 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 re quest for an IR-4 exemption.

4. How do I request an IR-4 exemption on EPA Form 8570-1, Application for Pesticide Registration?
To request an IR-4 exemption, incl ude the following statement in the “Explanation” box of Section II:
“This application is being submi tted with a tolerance petition submitted in connection with IR-4 . I request that EPA exempt the registration service fee for th is application under the IR-4 exemption provisions at FI FRA Section 33(b)(7)(E).”

Also in this section, reference the co mmodities that are the subject of the IR-4 petition.

5. Who is the IR-4 contact co ordinating submissions?
The IR-4 Program has agreed to coordi nate 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

6. 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 a ll the necessary forms, data, and draft labeling, formatted in accordance with guidance published by the Agency. If it does not, corrections to the a pplication 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 Agen cy to consider your application again, you must submit a new applic ation. To qua lify for the IR-4 exemption, the IR-4 tolerance petiti on must be withdrawn and then submitted simultaneously with the new application.

7. What are some common issues that should be consid ered when develo p in g 

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A Section 3 label amendment must re flect 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 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 formulat ions, 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 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.

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; therefor e the application is not eligible for an IR-4 exemption. However, an application may be considered under the “minor use” provisions of FIFR A [Section 33(b)(7)(D)], or under the “small business waiver” provisions of FIFRA [Section 33(b)(7)(F)].

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

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