1. Comments on Using Existing Data for the Endocrine Screening Testing Lorenz Rhomberg, PhD Principal Gradient
ISRTP 2009 Endocrine Workshop

2. Tiers Tier 1 SCREENING Tier 2 TESTING
Determine whether substances may interact with the Endocrine System (EAT)
Tier 2 TESTING
Determine whether substances cause adverse effects
Information for HazID (and QRA)
WoE Triggers ??

3. From: U.S. Environmental Protection Agency, Office of Prevention, Pesticides, and Toxic Substances, Office of Science Coordination and Policy. TECHNICAL REVIEW DOCUMENT for ENDOCRINE DISRUPTOR SCREENING PROGRAM (EDSP): PROPOSED TIER 1 SCREENING BATTERY. March 7, 2008.

4. Validation INTERNAL VALIDITY
(Reliability – Rigor, Reproducibility among Laboratories)
EXTERNAL VALIDITY
(Relevance – meaningful and useful for a particular purpose)

5. Purposes
“Technical” – measure/detect a particular material event or activity
e.g., ability to bind to ER
Assay-for-assay swap, technically equivalent
Validation?

6. Purposes
“Technical”
“Functional” – measure/detect/characterize a force, process, or action
e.g., interaction with androgen signaling
Assays that address the same system and functioning (albeit in a somewhat different way)
Equivalent in ability to detect “interaction with endocrine system”
False negatives?

7. Purposes “Technical” “Functional”
“Dispositional” – enable the motivating decision
e.g., enable the conditional triggering of Tier 2 testing
What are triggers? WoE considerations?

8. Purposes “Technical” “Functional” “Dispositional”
“Final” – address the ultimate question
e.g., Tier 2 test already done
What are Tier 2 tests? What would substitute?
Can one (should one) obviate screening?

9. Thank you for the opportunity
to present these ideas