From 60-Day Notice to Compliance: Navigating Prop 65 Testing and Exposure Assessment Challenges

Ari Lewis, M.S. Moderator
cambridge, MA 
United States of America
Kim Reid Presenter
Cambridge, MA 
United States of America
Ms. Carla Kagel, Ph.D. Co-Presenter
K Prime, Inc.
Santa Rosa, CA 
United States of America
Rosemary Mattuck, M.S. Co-Presenter
Cambridge, MA 
United States of America
Wed, 9/11: 4:00 PM  - 5:00 PM 
Standard Session 
Greater Columbus Convention Center 
Room: A 211, A 212 


California Prop 65 compliance became more complicated when new labeling rules took effect in 2018. These changes present numerous technical and logistical challenges for some companies as they may need to identify and test for Prop 65 chemicals for relevant routes of exposure, quantify chemical exposure under multiple scenarios, and develop specific Safe Harbor Levels (SHLs).

During this session, we will review the regulatory changes, their implications, and critical technical considerations for addressing compliance. An exposure expert, a chemist, an analytical testing expert, and a toxicologist will walk the audience through the steps required from the initial 60-day notice through compliance. We will illustrate technical challenges using a case study based on a consumer product, and discuss exposure scenario development, analytical testing design, and exposure assessment to determine whether the product is compliant with Prop 65.

Approaches for designing an appropriate analytical testing program (tiered testing, bioaccessibility testing to address unique exposure pathways) and SHL development will also be discussed. We conclude with recommendations and strategies for proactively addressing Prop 65.

Learning Objectives

At the end of this session, attendees will be able to:
1. Summarize the implications of the revised Prop 65 regulation and its compliance challenges
2. Analyze the need for an integrated, well-designed testing and exposure study that distinguishes between chemical composition and chemical exposure
3. Develop internal strategies to assess products for proactive compliance with Prop 65 and the new labeling requirements 

Learning/Experience Level



Emerging Chemical Regulatory Issues/Global Regulations