Hi Carrie.
I hate to say this in this manner but unfortunately it is true - Prop 65 is just one more of the nebulous regulations that we deal with in our world of Regulatory requirements. That said, Prop 65 has a basic tenet - you must warn the individual who uses your product (in your case the patient and potentially all of the healthcare providers who might come into contact with it) if your product "exposes the person to risk based on contact with the item listed under Proposition 65". So, what does this mean in reality? I interpret it to mean that there are times when you might use a chemical where such an exposure does not endanger the safety of the person(s) exposed. I believe that this is a fair interpretation especially in light of the fact that OEHHA in California (the state agency charged with creating the regulations and with keeping the chemicals listing updated) has seen fit to provide "safe harbor" levels for certain chemicals. If exposure to the chemical with a safe harbor falls below that level then you have an affirmative defense to any action brought against you for failure to warn users of the exposure to the chemical.
So - here are the real questions. 1) Does my product cause a person to be exposed to ethylene oxide? If yes, is there a safe harbor determination for ethylene oxide? 3a) If there is a safe harbor does my product cause less of an exposure to ethylene oxide than is allowed by the safe harbor? If yes, then no warning is required. 3b) If there is not a safe harbor does my product continue to expose a person to ethylene oxide after processing? 4b) If it does not, then no warning is needed; if it does then you need to warn users.
Here is the thing for Prop 65 - a chemical can be listed for several different reasons and none are mutually exclusive. For example, I just pulled up my latest download of the Prop 65 listing that contains both the reason for listing and any safe harbors. Ethylene oxide has been listed for 4 separate reasons - cancer, female reproductive toxicity, developmental toxicity and male reproductive toxicity. Cancer and female reproductive toxicity each have safe harbors (2 and 20 micrograms per day respectively). Developmental and male reproductive toxicity have not had safe harbors set for them. So as I interpret the requirement if your product could expose anyone to any level of ethylene oxide then the warning would be required at least for male reproductive toxicity and developmental toxicity. If you can show that the product does not expose any person to levels above 20 micrograms/day then female reproductive toxicity does not need to be in the warning and similarly if you can show that your product does not cause an exposure exceeding 2 micrograms/day then neither female reproductive toxicity nor cancer would be required in the warning. So here is the problem - how do you prove the negative (that there is no exposure to ethylene oxide) in your product's case? That is a no-win situation because science has a nearly impossible time proving something isn't there. This is probably what lead the one company to include the warning on the IFU. The other company I suspect is betting on the fact that the risk of finding ethylene oxide on the product is so low (especially since ethylene oxide is so unstable - hence one of the reasons it is such a viable sterilant!) that the risk of someone suing the company for failure to warn under Prop 65 is almost non-existent. Remember though - Prop 65 has a right of private action (what some call a bounty-hunter-rule) that allows anyone in California to initiate a suit against a company for failing to provide necessary warnings provide that the person can get a certificate from the Attorney General's office that says that the suit has some level of merit. And from what I have seen - in many cases at least - those certificates are not all that difficult to obtain.
So - what does this mean? From a purely technical perspective if you feel you can not detect any level of ETO in the product or emanating from the product then a warning is technically unnecessary because to initiate a suit the state or the private individual will need to show that they were exposed from your product. However, if you are not sure you could substantiate that or you consider a Prop 65 suit to be a potential significant liability that your company cannot afford, a Prop 65 warning on the IFU would be the way to go (at least for the two items with no safe harbor [male reproductive toxicity and developmental toxicity]). Sorry for the dissertation on this one but this is obviously a rather complex set or requirements and rules that boil down to a simple caveat - if you think your product could expose someone above the safe harbor then you should provide warning on the label for that toxicity.
Hope some of this helps!
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Victor Mencarelli
Sr. Manager - Regulatory Affairs
Hain Celestial Group
United States
Original Message:
Sent: 04-14-2016 15:05
From: Carrie Eddings
Subject: California Proposition 65 Warning for Medical Devices Sterilized with Ethylene Oxide
I have seen inconsistent use of the California Proposition 65 warning for medical devices sterilized with Ethylene Oxide in Instructions for Use (IFU) for the U.S. market.
One company I worked with has this Prop 65 warning in their U.S. IFU…another company I have worked with has not included a Prop 65 warning in their U.S. IFUs for devices sterilized with Ethylene Oxide.
Can anyone provide guidance on when, and if, this warning should be used?
Thanks,
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Carrie
Regulatory Affairs
United States