Prop 65 Update October, 2012 T.C.J.J.P. WARNING: This product contains a chemical known to the State...
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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
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Transcript of Prop 65 Update October, 2012 T.C.J.J.P. WARNING: This product contains a chemical known to the State...
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
www.TheNFL.com Confidential
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
www.TheNFL.com Confidential
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?
www.TheNFL.com Confidential
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
www.TheNFL.com Confidential
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
www.TheNFL.com Confidential
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?
www.TheNFL.com Confidential
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.
www.TheNFL.com Confidential
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
www.TheNFL.com Confidential
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
