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California’s Proposition 65: The Wide-Ranging Applications of Chemical Analysis

Thursday, September 27 | 1:30 PM – 2:30 PM

Learning Level: Competent | Topic: Banned/Restricted Substances

With nearly 1,000 chemicals listed and more being added regularly, manufacturers are left with a daunting task of ensuring compliance. Unfortunately, some manufacturers’ first interaction with Prop 65 occurs with the arrival of a Notification of Violation.  This session will help demystify the complex subject of Prop 65, providing a systematic understanding of various aspects of this law and strategies for manufacturers, attorneys and toxicologists with respect to their products. The benefits and limitations of chemical analysis will be presented and discussed in relationship to No Significant Risk Levels (NSRLs), Maximum Allowable Dose Levels (MADLs), existing Consent Decrees, exposure simulation scenarios, and Safe Use Determinations (SUDs).  Applications of laboratory testing in defense cases, settlement negotiations and in proactive product evaluations will also be presented.

Learning Objectives

  1. Effectively and successfully interact with testing laboratories and toxicologists to target the best approach to chemical testing to address Prop 65-related concerns.
  2. Understand the limitations of chemical analysis related to Prop 65 issues including the likelihood of false positives and the inability of state-of-the-art instrumentation and methodologies to answer every question.
  3. Understand the differences between total content, wipe, leachate, vapor-phase and various exposure simulation studies and where each of these approaches to chemical analysis best fits into Prop 65 regulations.  
Carla Kagel, President & CEO, K Prime, Inc.
Richard Kagel, Laboratory Director, K Prime, Inc.