Prop 65 Update October, 2012 T.C.J.J.P. WARNING: This product contains a chemical known to the State of California to cause cancer and birth defects or other reproductive harm

What to do now  Know your products  Know your typical concentrations  Know your exposure  Know your NSRLs MADLs  Defend your ingredient  If you receive a Prop 65 Notice  Compounds of concern

Know Your Products  Formula ingredients (Sulfur dioxide, Flavors, i.e., Acetaldehyde, Pulegone-pepperment flavor )  Suppliers and material sources (Country of origin)  Contaminants (Lead, Pesticides)  Reaction by-products (Benzene,)  Product packaging (DEHP)  In-product reactions (4-MEI, Methanol)  Avoidable, removable or manageable?

Know Your Typical Concentrations  Intentionally added ingredients, i.e., sulfur dioxide, flavor – Calculate the concentration in your final product  Contaminants – Calculate the theoretical maximum using specification limits of ingredients – Test ingredients and final product to determine average levels – Determine if you can use the naturally occurring exemption

Know your exposure  Prop 65 limits are based on a per day exposure of the typical consumer  Determine Consumer Usage – Consumer Habits and Usage – Published Studies and Models – Primary Intended Exposure(s) – Secondary Routes/Mechanisms for Exposure – Foreseeable Misuse

Know your NSRLs and MADLs  Determine your No Significant Risk Level (NSRL) and/or Maximum Allowable Dose Level MADL. – Office of Environmental Health Hazard Assessment (OEHHA) has published some NSRLs and MADLs. – Where not published, calculate using OEHHA Methods – Request a Safe Use Determination?

Defend Your Ingredients  Monitor OEHHA for listing-related notices and announcements  Track activities of “authoritative bodies” which allow for streamlined chemical listings – National Toxicology Program  Challenge proposed listings of chemicals important to your business  Once a chemical is listed work with OEHHA to get the highest No Significant Risk Level (NSRL) and/or Maximum Allowable Dose Level (MADL) possible.

If you receive a Prop 65 Notice  Obtain Counsel that specializes in Prop 65  Test product to determine if plaintiff’s data is correct  If possible, challenge plaintiffs methodology and references – Test data – Exposure model

Compounds of Concern  Heavy Metals – Lead 0.5 µg/day (240 ml serving = 2 ppb) – Arsenic 10 µg/day (240 ml serving = 41.6 ppb)  Methanol – 23000* µg/day (240 ml serving = 95 ppm)  Pesticide – MADL dependant on individual pesticide  Sulfur Dioxide – First Priority for MADL Development * Proposed MADL

Julie Hill Vice President, Chemistry