Challenges with

Proposition 65

Shannon Cole, PMP

Director of Science Operations, Chemistry & BiochemistryGrocery Manufacturers Association

September 30, 2010 – AOAC Annual Meeting

Prop 65 Outlook

How has Proposition 65 activity transformed?

• Prop 65 was not about food when it was first passed

• Prop 65 does not distinguish between foods and other sources of chemicals

• Vast majority of foods contain detectable traces of one or several Prop 65 chemicals

Foods may be the most

common product category based on vulnerability

to Prop 65

Why are these chemicals found in foods?

1. Because they are naturally occurring in food

• Examples:• Heavy metals in most products grown in soil• Lead in juices and canned foods• Toxin producing molds in grains

Why are these chemicals found in foods?

2. Because they are unavoidable by-products of cooking

• Examples:• Acrylamide in baked or fried potatoes, cereals

and baked goods• PAHs in grilled meats, chicken and fish• Naturally occurring Maillard “browning” reactions

such as 4-MEI in certain caramel colorings• Natural enzymatic reactions in fruits such as

methanol in juices

That “detectable” amount is enough for a plaintiff to file a Prop 65 60-day

Notice

These notices generate adverse publicity and typically initiate a

lawsuit!

How does a defendant proceed?

Defendant must PROVE that the food in questions poses an allowable risk OR that it meets the tortured regulatory definition

of “naturally occurring”

What’s next for the defendant?

• Both of these are factual showings which, to be made, require:• Discovery• Expert Witnesses• Scientific and technical analysis• Depositions• And in most cases, a TRIAL!

What does that mean?

Lots of $ and time!!!!

Industry Burden….

• These “showings” can take years to make and represents a distraction to the business of the defendant

• This literally can cost millions of dollars!!!

Why are foods being targeted?

• For the first 20 years of Prop 65, food was largely left alone

• Both public prosecutors and private plaintiffs focused their attention on the kinds of chemicals at which toxic exposure laws are usually directed• Hardware stores, refineries

and electronics

Then prosecutors discovered that food was a very attractive

target of these cases!

Why….

It was very easy to show that a Prop 65 chemical was present in

food

AND food companies were not putting

cancer or birth defect warnings on their food products

And grocers often put a lot of pressure on the food

manufacturer to settle cases!

Time for Discussion