Document ID: EPA-HQ-OPP-2008-0480-0014
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-11-22T05:00Z

Registration Service Fees

Guidance on IR-4 Exemptions 

Resources

  HYPERLINK "http://www.epa.gov/pesticides/fees/index.htm"  About
Registration Service Fees  

Questions and Answers on: 

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/pira21day-screen.htm"  21
Day Screening Worksheet  

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/actions_not_covered.htm" 
Actions Not Covered by Registration Service Fees  

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/biopesticides.htm" 
Biopesticides  

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/fee_payments.htm"  Fee
Payments  

  HYPERLINK "http://www.epa.gov/pesticides/fees/questions/waivers.htm" 
Fee Waivers  

  HYPERLINK "http://www.epa.gov/pesticides/fees/questions/fundmanag.htm"
 Fund Management  

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/exemptions.html"  Guidance
on Federal and State Agency Exemptions  

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" 
Guidance on IR-4 Exemptions  

  HYPERLINK "http://www.epa.gov/pesticides/fees/questions/processin.htm"
 In-Processing of Applications  

  HYPERLINK "http://www.epa.gov/pesticides/fees/questions/inerts.htm" 
Inert Ingredients  

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" \l
"1#1"  Under what circumstances am I eligible for an Inter-Regional
Project Number 4 (IR-4) registration service fee exemption? 

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" \l
"2#2"  How must I submit the registration request to qualify for the
service fee exemption?  

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" \l
"3#3"  What do I do if I want to amend the application?  

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" \l
"4#4"  How do I request an IR-4 exemption on EPA Form 8570-1,
Application for Pesticide Registration?  

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" \l
"5#5"  Who is the IR-4 contact coordinating submissions?  

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" \l
"6#6"  Are applications solely associated with IR-4 tolerance petitions
and in the public interest subject to the 21-day initial content screen?
 

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" \l
"7#7"  What are some common issues that should be considered when
developing these submissions?  

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" \l
"8#8"  Are applications associated with non-food use data submitted by
the IR-4 program eligible for the IR-4 exemption?  

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" \l
"9#9"  If I request an IR-4 exemption, when will the decision review
period for my application begin?  

Under what circumstances am I eligible for an Inter-Regional Project
Number 4 (IR-4) registration service fee exemption? 

   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.

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" \l
"content#content"  Top of page  

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.

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" \l
"content#content"  Top of page  

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.

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" \l
"content#content"  Top of page  

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.

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" \l
"content#content"  Top of page  

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 

  HYPERLINK "mailto:kunkel@aesop.rutgers.edu"  kunkel@aesop.rutgers.edu 

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" \l
"content#content"  Top of page  

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. 

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" \l
"content#content"  Top of page  

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
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 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.

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" \l
"content#content"  Top of page  

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)].

  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm" \l
"content#content"  Top of page  

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.