So, this is kind of inside baseball, but it's incredibly important in the world of Proposition 65 defense, and pretty important particularly in the world of phthalates. For those of you who are novices in this strange and wondrous area,
1. Proposition 65 is California's voter-approved regulatory scheme for banning companies from causing exposure to a wide range of chemicals without first giving "clear and reasonable warning;" (you can learn more than you want to know on this subject here and here and a bunch of other places on this blawg) and
Phthalates are plasticizers -- the chemicals that make plastic products soft, and they appear in all kinds of soft vinyl applications, such as shower curtains, intravenous bags, rubber balls, plastic food wrapping, etc., etc. California listed the phthalate DEHP as a carcinogen long ago, and as a reproductive toxicant more recently. The feds quite recently banned it from children's toys, and in the intervening years, California has been adding other phthalate plasticizers to the Proposition 65 list.
- In Baxter Healthcare Corp. v. Denton (2004) 120 Cal.App.4th 333 (hearty backslap to self -- my case) Baxter established, by way of declaratory relief, that DEHP wasn't a human carcinogen, so there was no duty to warn. Nobody has yet gone to court to establish that it isn't a human reproductive toxicant at the levels humans encounter it in the real world -- if anybody's interested, come see me at the break.
That brings us to the spanking brand new Court of Appeal case, Exxon Mobile Corporation v. Office of Environmental Health Hazard Assessment (January 7, 2009) ___ Cal.App.4th ___, Second District, B204987, about which we will continue the discussion after the jump.
Anyway, in 2007, California's Office of Environmental Health Hazard Assessment (OEHHA), the "lead agency" for Proposition 65, listed another phthalate plasticizer, DIDP, as a reproductive toxicant. There are three ways a chemical can be listed, and the one we're concerned with here is the "authoritative body" mechanism -- that a "body considered to be authoritative" by the state's "qualified experts" (in this case, California's Developmental and Reproductive Toxicant ("DART") Identification Committee -- no kidding, I'm not making this stuff up -- has "formally identified" the chemical as causing as causing cancer or reproductive toxicity. So, the DART Committee decides whether a body is "authoritative," the "authoritative body" considers whether the chemical causes cancer or reproductive harm and, if so, OEHHA lists the chemical. Got it? Good, 'cuz we're nowhere near done, and we'll move on now.
So OEHHA promulgated regulations designating the National Toxicology Program, FDA, IARC, EPA and NIOSH as authoritative bodies. Cal. Code Regs., tit. 27, § 25306, subd. (l). And it promulgated other regulations,§ 25306, subd. (d) providing that a chemical is "formally identified" if if is "included on a list of chemicals causing cancer or repoructive toxicity issued by the authoritative body" or "is the subject of a report which is publishedby the authoritative body and which concludes that the chemical causes cancer or reproductive toxicity," or some others we don't care about here. And OEHHA defined "As causing reproductive toxicity" as meaning either there is human evidence (which there rarely is), or
Studies in experimental animals indicate that there are sufficient data, taking into account the adequacy of the experimental design and other parameters such as, but not limited to, route of administration, frequency and duration of exposure, numbers of test animals, choice of species, choice of dosage levels, and consideration of maternal toxicity, indicating that an association between adverse reproductive effects in humans and the toxic agent in question is biologically plausible. (Regs., § 25306, subd. (g)(2) Emphasis most definitely supplied).
That's right folks. We're not looking for evidence that the chemical actually causes the disease. Here in California, we establish toxicity by showing it is "biologically plausiblee."
So in this case -- you knew I'd get to the case eventually, right? -- OEHHA listed DDIP as a reproductive toxicant based on the chemical's listing by the National Toxicology Program. And in its listing, the NTP didn't make any findings about the sufficiency of the underlying study designs, or duration of exposure, number of animals, or any of that stuff, nor did it find that the association was "biologically plausible.
So Exxon Corporation said "wait a minute. The NTP list -- or brief -- didn't address these criteria, and didn't make the required determination that there was a "biologically plausible" association between the chemical and reproductive toxicity. And, predictably, the Court of Appeal said "Thanks for playing, next case, please."
To wit: the language of Regs., § 25306 is sufficiently broad that OEHHA can premise its conclusion that the chemical is a reproductive toxicant (or carcinogen in a proper case) on not just the "authoritative body's" report or listing, but on "other factors," such as the scientific methodology on which the "authoritative body" relied, and OEHHA's knowledge of the authoritative body's methodology. Furthermore, the Court can only review whether OEHHA's interpretation was "reasonable," not whether it was right.
Interestingly, the NTP's report and related documents provide a wealth of evidence that in almost all circumstances, the DIDP doses encountered by humans are insufficient to cause reproductive harm in humans; the only open questions seem to be "levels of exposure of children mouthing DIDP-containing objects or in pregnant women occupationally exposed to DIDP." Thus, while the regulations and statute did not provide Exxon with a basis to prevent listing of the chemical, with some more risk analysis this would seem, like Baxter v. Denton, to be a case with potential for declaratory relief that the chemical causes no adverse effect in humans at 1000 times the level in question, so that there should be no obligation to warn.