# Presentation: 682268

## PRIA Workshop - Information to Support Successful Waiver RequestsArlington, VA - November 27, 2007

**   ****Waiver Requests**
- 		Russell S. Jones, Ph.D., Senior Biologist
- 		Biochemical Pesticides Branch (7511P)
- 		Biopesticides & Pollution Prevention Division
- 		US EPA Office of Pesticide Programs
- jones.russell@epa.gov
- 703/308-5071

## PRIA Workshop - Information to Support Successful Waiver RequestsArlington, VA - November 27, 2007

***Waiver Requests***
**A Guide Through the Maze:  Traps and Pitfalls to Avoid on the Path to a Successful Waiver Request**

## PRIA Workshop - Information to Support Successful Waiver RequestsArlington, VA - November 27, 2007

- _Waiver:_
** **
**Release from the necessity to conduct a Guideline Study in fulfillment of a particular Data Requirement**
**  ****40 CFR 158.900 - 158.2084  Biochemicals**
**40 CFR 158.2100 - 158.2174  Microbials**
*** Read the Footnotes**

## PRIA Workshop - Information to Support Successful Waiver RequestsArlington, VA - November 27, 2007

- _General Considerations for a Successful Waiver Request__ _
**Address on Guideline-by-Guideline Basis **
**Specifically Address**** *****EACH***** ****Route of exposure**
**No “Blanket” waivers **

## PRIA Workshop - Information to Support Successful Waiver RequestsArlington, VA - November 27, 2007

**General Considerations:  Waiver Requests**
- Toxicity (Lethality)
- vs.
- Exposure

## PRIA Workshop - Information to Support Successful Waiver RequestsArlington, VA - November 27, 2007

**General Considerations:  Waiver Requests**
**“****Non-Toxic”  Semiochemicals & non-SCLPs may have:**** **
**Adverse effects on humans**
**Lethal effects on non-targets**

## PRIA Workshop - Information to Support Successful Waiver RequestsArlington, VA - November 27, 2007

**General Considerations:  Waiver Requests**
**Exposure to A.I. via label use directions:**
**How are humans (workers & public) exposed**
**How are non-targets exposed**

## PRIA Workshop - Information to Support Successful Waiver RequestsArlington, VA - November 27, 2007

**Waiver Requests:  Information/Data Sources**
**Published & Unpublished Technical Literature**
**“****In-house” Studies**
**Should provide info/data that is equivalent to that obtained from a Guideline study.**

## PRIA Workshop - Information to Support Successful Waiver RequestsArlington, VA - November 27, 2007

**Waiver Requests:  Information/Data Sources**
**Registrant must prepare summary of information/data used to support a waiver**
**Provide list of citations (full articles, preferred)**

## PRIA Workshop - Information to Support Successful Waiver RequestsArlington, VA - November 27, 2007

**Waiver Requests:  Information/Data Sources**
_***Do Not Submit***_
**Abstracts**
**Testimonials**
**Anecdotal Reports**

## PRIA Workshop - Information to Support Successful Waiver RequestsArlington, VA - November 27, 2007

**Guideline Studies **
**vs. **
**Waiver Requests**

## PRIA Workshop - Information to Support Successful Waiver RequestsArlington, VA - November 27, 2007

**Guideline Studies Are Unambiguous**
**OPPTS Harmonized Guidelines**
**http://www.epa.gov/opptsfrs/home/guidelin.htm**

## PRIA Workshop - Information to Support Successful Waiver RequestsArlington, VA - November 27, 2007

**Guideline Studies =   $$$   &     Time Consuming**

## PRIA Workshop - Information to Support Successful Waiver RequestsArlington, VA - November 27, 2007

**Waivers =  Lower Cost    &     Less Labor Intensive**
**                                       ****www.CartoonStock.com**

## PRIA Workshop - Information to Support Successful Waiver RequestsArlington, VA - November 27, 2007

**Waiver Impediments**** **
**No information on new active ingredient**
**Surrogates not sufficiently similar**
**Surrogates not widespread in nature**

## PRIA Workshop - Information to Support Successful Waiver RequestsArlington, VA - November 27, 2007

**Waivers**
**40 CFR 158.45**
**      **

## PRIA Workshop - Information to Support Successful Waiver RequestsArlington, VA - November 27, 2007

**QUESTIONS?****      **