EPA 25b Pesticide Registration Testing

Project Description

USA Certified Contract Laboratory needed for a large number of tests for a EPA 25b listed pesticide for registration in several USA states.
25(b) Pesticide Product Efficacy Data Expectations:
1. Data must be included that supports all pesticidal label claims.
a. Topical Insect Repellents with claims for ticks and mosquitoes should demonstrate
higher efficacy (e.g. =90%) because these pests are vectors* of human disease causing
pathogens. Spatial repellents with claims to repel mosquitoes should demonstrate =75%
efficacy.
b. If a label claims to kill a pest of significant public health importance** , testing should be
done on that organism. Other pests may be grouped as acceptable.
c. To make "knockdown", "quick kill", or "kills on contact" claims, data should show =90%
knockdown within 10 seconds for wasps, bees, or fire ants or within 30 seconds for all
other insects or spiders.
d. Pesticides with claims to kill or repel any pest of significant public health importance,
excluding microorganisms and those already mentioned above, should demonstrate
=80% efficacy.
e. Data for all other products, excluding those with claims for pests of public health
importance, should demonstrate =60% efficacy. Some states may consider an
alternative "soft claim"*** on a case-by-case basis for products demonstrating an
efficacy lower than 60%.
2. Data must be credible, independently collected, reproducible, and replicated. GLP studies are
not required.
a. Testimonials are not acceptable.
b. Journal articles may be acceptable if, in the state's judgement, the design and conduct
of the study provide results that are scientifically reliable. Note: Journal articles are not
acceptable for Indiana and New Mexico
c. In-house studies may be acceptable if the study is conducted in a GLP-like manner by a qualified study director.
i. A qualified study director is someone who exhibits knowledge and expertise in a
scientifically valid study design and conduct. To be a qualified study director, a
resume or CV may be required that clearly indicates the study director has
academic and/or real-world experience with designing and conducting scientific
studies.
d. Data should include a minimum of three (3) replicates per test.
e. Studies that involve humans, such as repellency testing, should be double-blind studies.
Studies that do not involve humans, such as direct kill testing, should be blind studies.
f. Names and addresses of researchers conducting the evaluation(s) must be included.
g. Efficacy data should be submitted for Anopheles, Aedes, or Culex for any labeling claims
against mosquitoes.
h. Data should address Complete Protection Time (CPT) for mosquito repellents.
i. Efficacy data should be submitted for blacklegged tick (Ixodes scapularis), American dog
tick (Dermancentor variabilis), brown dog tick (Rhipicephalus sanguineus), or lone star
tick (Amblyomma americanum) for any labeling claims against ticks.
3. Data should describe the full experimental design. This includes:
a. Material and Methods.
b. Full results, using standard scientific statistical procedures.
c. Interpretation and conclusion of the results.
4. Data should be generated with the product (formulation) submitted for registration.
5. Data should include an untreated control.
6. Labeling of products should include an advisory statement when data does not meet efficacy
data expectations.
Examples:
 The effectiveness of this product may not meet the level of protection required
for EPA-registered pesticides.
 This product has not been shown to protect people from biting mosquitoes for
at least 2 hours.
 Reduces or May reduce (name of pest).
 Suppresses or Aids in the suppression of (name of pest