How to Approach Testing for Proposition 65 Compliance Effectively
Lab testing can be a critical part of Prop 65 compliance, but there are several considerations to take into account before proceeding and I hope this post provides a valuable roadmap for you!
First and foremost, before contacting a lab you will need to know what chemicals you want them to test for – there is no one “Prop 65 test” as there are ~900 chemicals on the list. Each chemical and matrix (type of material) is tested in a different way. But realistically, only a handful of chemicals from the list will be relevant to any one product type. Which handful is the key question!
This is where your investigations can help: contact your suppliers and ask them if there are any listed chemicals in their products, check safety data sheets (SDS), technical data sheets, etc, to see if anything is clearly disclosed. Beyond that you may need to narrow it down based on the types of materials being used in your products and historical evidence of chemicals being present.
Once you have a list of chemicals that may be in your product (even if listed chemicals are part of input materials, it doesn’t mean they will remain in the final product), you should contact several accredited labs with experience in running those types of tests to obtain cost quotes – some specialize in metal analysis, others in food, some have wide-ranging expertise.
You will also want to check what the detection limit will be and work with the lab to choose the method with lowest one (different methods have different limits) – you don’t want to test your product to 10 ppm if there is a readily available method that goes down to 1 ppm! The methods should also be validated to ensure they are defensible should the need arise.
It would be wise to test several samples of your product so that you get a reasonable representation of your product line and see if there is any product-to-product variation. You may consider doing these tests every so often to ensure the product remains consistent.
So you’ve chosen your lab and they’ve run the tests, you’ve received the results – now what?
Hopefully, the results come back negative. But if not, there are some additional considerations.
Some labs will compare the test results to Prop 65 settlement limits, if they exist, and inform you if these limits are exceeded in the lab report.
These limits are established during the settlement process after a company has been served a Notice of Violation (NOV) for alleged non-compliance of a product. During this process a compliance standard for a product is set (i.e., 1,000 ppm for DEHP) that the company must meet in order to meet the requirements of the settlement. A discussion on the settlement process can be found here.
By law, that limit value is only applicable/enforcing to the company (or companies) and the products that were part of the settlement process. Labs may provide these settlement values as a way to help prioritize results, but you should be aware that using these limits themselves may not protect you if you are targeted by a bounty hunter. Not only are they specific to the company, they sometimes have additional requirements regarding the testing methods that should be used and/or the products (as per the settlement) may not really be a perfect match.
If you end up with a positive hit on a chemical, then you may need to have an exposure assessment conducted to determine whether a warning is actually required for that product (you only need a warning when estimated exposure to the chemical from use of the product exceeds the safe harbor level). Some companies may choose to provide a Prop 65 warning even without actually determining whether warning is required but they may not be actually compliant.
As with getting quotes from several labs, collect estimates from several Proposition 65 consultants/toxicologists to ensure you are getting the best expertise and value. They can be indispensable partners in navigating the complexities of this regulation, and a strong proactive approach may be far less expensive than being unprepared or taking short-cuts and facing stiff settlement fees (the average settlement payout for 2018 was ~$40,000/settlement plus additional costs). It doesn’t guarantee that you won’t be targeted, but a strong defense may increase your chances of having the settlement reduced or even eliminated.
Need more Prop 65 testing advice – contact RegTox today!