Lois Rossi

Director, Registration Division 

Office of Pesticide Programs 

U.S. Environmental Protection Agency

Washington, DC

March 19, 2013
Overview

 Purposes for EPA consideration of product performance 

data requirements, testing and standards.

 Current product performance data 

requirements/practices

 Need for product performance standards 

 EPA Product Performance Guidelines 

 Global harmonization efforts.
Purposes

 Increasing transparency

 Providing clear expectations for data 

development to support product registration

 Outlining consistent testing/evaluation that 

should vary little between registrants, products, 

or lab choice

 Ensuring more consistent efficacy of EPA 

registered products
4

Product Specific Data Requirements for 

Insecticide and Repellent Product 

Registrations

 Product Chemistry

 Acute Toxicity --determines precautionary labeling

 Product Performance –substantiates specific label 

claims, addition of pests, and related use patterns
Product Performance Data

 Document how well the product performs its intended 

function (killing, knockdown, repelling, etc.) against 

an invertebrate pest(s). 
FIFRA

 FIFRA directs EPA to specify the kinds of data that 

applicants and registrants must submit to EPA to 

support regulatory determinations under FIFRA.

 The data that EPA is considering for codification are 

consistent with the agency’s current practices for the 

product performance data needed to register a 

pesticide product that bears a pesticidal claim against 

one or more pests. 
Currently-When are Product 

Performance Data Required?

 Submission of data is typically waived; however, registrants 

are required to have data on record for all pests listed on 

the label.

 When product failures are reported to EPA by the 

registrant.

 When a product makes claims to kill, knockdown, control, 

repel or attract pests that are of significant public health 

importance, wood destroying, and/or considered an 

invasive species. Submission of these data is suppose to be 

case-by-case but has become routine for product 

registration. 
Current Product Performance 

Data Needs

 For public health pests 

of significant public 

health importance 

including mosquitoes, 

ticks, cockroaches, bed 

bugs, etc.

 For pests of economic 

importance including 

wood destroying insects 

and invasive species.

 Agricultural pest data 

requirement waived
Options for Fulfilling Product 

Performance Data Requirements 

 Cite existing data - usually from studies conducted 

with a similar product and use pattern.

 Submit new product specific studies.
Product Performance Standards

 Currently, performance standards are not stated in the 

regulations. Instead, they typically appear in EPA 

guidelines.

 EPA is considering codifying product performance 

standards . Guidelines would be revised to remove all 

standards.

 The Technical Support Document includes a 

discussion of a 95% level of performance as the typical 

standard. 
Product Performance Standards

 A few other standards are also discussed - such as a 100% 

level of performance for soil applied termiticides. 

 A two-hour Complete Protection Time (CPT) is 

considered for skin applied repellents. 
EPA Product Performance Testing 

Guidelines

 Provide guidance on testing methods, designs, data 

reporting.

 810 series guidelines

 810.30-36 last revised in 1998

 EPA is interested in recommendations from this 

Scientific Advisory Panel on revisions to the above 

guidelines
EPA Product Performance 

Testing Guidelines

 More recent guidelines include:

 810.3700 – Skin Applied Insect Repellent products –

completed in 2010.

 810.3800 - Termite Bait products –completed in 2004.

 Draft 810.3900 – Bed bug products – 2012 – in process 

EPA does not want to revisit the above guidelines in this 

meeting because the agency considered the 

recommendations from previous Scientific Advisory 

Panels in the finalization of these EPA guidelines.
EPA Product Performance 

Guidelines

 New Guidelines

 Spatial repellents

 Fumigants

 Insecticide impregnated fabrics

 Attractants

 EPA looks forward to recommendations from the 

panel regarding these guidelines and other suggestions 

for additional guidelines that might be needed.
Conclusions

 Advice from the Scientific Advisory Panel is a vital part 

of our deliberations on the types of product 

performance data that might be needed for EPA to 

evaluate the efficacy of pesticide products. 

 We welcome the SAP’s input and public comments on 

the scientific issues associated with product 

performance data and are looking forward to a 

productive meeting.