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Pesticide Registration Improvement Renewal Act (PRIA 2) - "R" Action Code Excercises for Conventional Pesticides Workshop Session

This working document was presented during the break-out session for conventional pesticide issues at the Office of Pesticide Program's November 2007 Workshop for Pesticide Registration Improvement Renewal Act (PRIA 2).

"R" Code Excercises:

Example #1

Company X submitted an application for an insecticide product for use on fire ants in residential settings.  Under Box 6 “Expedited Review” of the EPA application form, a substantially similar, registered  product is listed.  The Certification with Respect to Citation of Data form indicates the Selective Method of data compensation with the Cite-All option also checked. The product is formulated from an unregistered technical.  According to the data matrix, product chemistry data are submitted on the formulation and “cite-all” is typed beside the acute toxicity and efficacy data requirements. 

What is the appropriate R code designation for this application? 

Example #2 

Company Y submitted a label amendment for their herbicide product.  The pre-harvest interval (PHI) for cabbage is being reduced from 14 days to 5 days.   Additional tank mixes are also added to the label amendment.  Finally, the company is upgrading their First Aid section to comply with PR Notice 2001-1.  The EPA Application form does not list a substantial similar product in box 6 under Expedited Review.  A data matrix is included along with the Certification with Respect to Citation of data form (which is marked for the Selective method of data compensation).  In their cover letter, the registrant explains that the field trial data submitted 10 years ago as part of the petition for a tolerance in cabbage also supports the reduced PHI.  A copy of the residue chemistry review from that time is included in the label amendment package.  The registrant claims that this label amendment should be reviewed on the PM team and does not need to be sent to HED. 

What is the appropriate R code designation for this application? 

Example #3

Company Z submits an application for a fungicide product for use on grapes.  There are no product specific data submitted with the application.  The cover letter and CSF indicate that the pending product is a 100% repack.  The EPA application form lists (2) substantially similar registered products (EPA Reg. No.  XX-1 and EPA Reg. No. XY-10) under box 6 (Expedited Review).  The cover letter mentions that although the pending product is a 100% repack of EPA Reg. No. XX-1, the label follows that from EPA Reg. No. XY-10.  A Formulator’s Exemption form and Certification with Respect to Citation of Data form are included in the application. 

What is the appropriate R code designation for this application? 

Example #4 

Company T submits (2) applications (product A and product B) for pesticide R, a herbicide registered for use on lawns.  Product chemistry data is submitted with the Product A application.  Product A’s label is intended for residential homeowner use.  A Formulator’s Exemption form and Certification with Respect to Citation of Data form are included.  On the data matrix, MRID Nos. from another company are provided in order to satisfy the acute toxicity data requirements.  There is no letter of authorization from the company whose acute tox data are being cited.  The CSF indicates that a registered technical is being used to formulate from.  Product B does not have any product specific data with it.  The registrant claims that Product B is identical to Product A, the only difference between the applications is in the labeling.  Product B is labeled for use by professional lawn care operators. This application also contains the Formulator’s Exemption, Certification with Respect to Citation of data and data matrix.  The CSF indicates that the source of active ingredient is the same registered technical as is indicated in Product A’s CSF. 

What are the R code designations for these 2 applications?

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