A Proposition for You: Putting Ethics into No. 65

By Dr. Marc Lappé

Proposition 65 was put in place over 15 years ago as a result of a ballot initiative by California voters. Also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, this Proposition was to provide a way for consumers to appreciate where and when they were being exposed to substances "known to the State" as causing reproductive harms or cancer. In this piece, I am discussing where and when ethical issues come into play in evoking this measure to protect our welfare; it is expressly not intended to offer legal advice or guidance (I am not a lawyer), or to provide a template for actions that may or may not be consistant with the law.

Under the existing law, the governor must annually revise and republish a list of offending chemicals that require what are termed "Proposition 65" warnings. The level at which a given chemical exposure triggers the requirement is determined by a California agency known as OEHHA, the Office of Environmental Health Hazard Assessment; but, it is the Attorney General who determines when and if a violation has occurred, or if evidence supporting the claim as a whole is "meritorious." (This latter point has been put into place just this last December, under a provision known as the Certificate of Merit. A Certificate, duly signed and prepared by a knowledgeable person, must now be supplied along with each violation claim that establishes that there is reasonable likelihood of exposure and possible harm from the chemical in question).

The language of Prop 65 imposes a duty on the producer of a listed chemical to disprove the initial claim. If the claim is upheld, the producer must provide and post a warning that discloses the contained chemical (or metal element), and possibly, as in the case of tobacco, that the product itself "Is known by the State of California to produce reproductive toxicity or cancer" or words to that effect.

What was "new" about Proposition 65 then and to the present day is that any citizen may sue a company that has failed to disclose the presence of one of the listed chemicals, and has notified the company that he/she believes the company is in violation of Proposition 65. If the company disagrees or fails to comply with the "violation notice" it may be subject to penalties and fines, some of which are put aside for distribution to groups (like CETOS) that are engaged in public education about toxic substances and their possible harms. Now, with the bare skeletal outlines of the legal requirements in place, where does ethics come into play?

On the face of it, Proposition 65 appears to satisfy the growing emphasis in business and medical ethics for the right of a consumer to know of any unreasonable and likely dangers arising from the use of a given product or medicine. In this sense, Prop 65 falls squarely in the realm of the so-called "right to know", and the principle of informed consent that requires disclosure of risks to medical procedures. On the face of it, the duty on the part of the company to make such a disclosure would seem appropriately matched to these ethical principles, if not prudent from a purely litigious point of view. But the key to making propositions like No. 65 that requires disclosure of risks work is that the duty is reasonable and fair.

As to the reasonableness of any alleged violation, the newly imposed "Certificate of Merit" goes a long way to satisfying the concern that frivolous suits were being filed in the first years of the Proposition's operation. But even here, the question of whether or not a claim is ethically justified turns on factors outside the current bounds of the regulations governing the Proposition. For instance, is the consumer product customarily used on an ongoing, rather than strictly seasonal or sporadic basis? Are the alleged 'contacts' with the product or its ingredients reasonable and common? Is it reasonable to conclude that the level of exposure will in fact exceed the safe harbor level set by OEHHA?

Left out of the equation is the key issue of the effectiveness of any given warning. While the Attorney General and the law itself provide guidance for certain product encounters, notably cigarette smoke, as to where and how warnings must be posted for workers, consumers or (in this case in particular) hotel guests, he does not dictate specifically where the warning must be posted for maximal consumer attention and notice. So-called "warnings experts" have pointed out that warnings themselves are vulnerable to a Cry Wolf Syndrome, in which multiple or ubiquitous warnings for many products, all written in the same language and same print size tend to blunt the avoidance or control value of the language.

From my perspective as a toxicologist/health policy and ethics expert, a second more important issue is the proportionality of the warning: Proposition 65 warnings should be given priority scores and adjudicated accordingly proportional to the number of persons potentially affected, their vulnerability or susceptibility to the harms in question, and the seriousness of the resulting damage or harm should exposure occur. For this reason, some claims, such as those for seasonal exposure to products with limited opportunity to protracted exposure and contact (e.g., Christmas lights) should carry less weight than claims for products (e.g., galvanized piping) where many consumers will have contact, both during and after the installation of the product. (By way of disclosure here, CETOS assisted in providing technical support for several cases involving galvanized piping, but not for Christmas lights).

The law itself (Health and Safety Code Section 25249.7 (d)) gives some credence to this proportionality rule by requiring that the identified parties are required to provide "clear and reasonable warnings" about the presence of chemicals in their product that may be contacted by a consumer, specifically where that contact exceeds a certain "safe harbor" level of concentration. In the case of lead, for instance, the Proposition 65 warning is required for any product whose customary use will lead to a level of 0.5 micrograms of lead or greater entering the body of a consumer or public citizen. From a toxicological perspective, such a warning appears appropriate where children or pregnancy mothers may contact the offending product, since very small amounts of lead may produce lasting harm to the developing brain.

Another ethical key to the acceptability of a Proposition 65 suit is the requirement that there be significant public benefit from the warning. This means not only that a warning did not previously exist, but that the warning be consonant with the actual or likely exposure of people to the product: where no significant exposure can be shown to occur, the claim for a needed warning is not considered to confer a public benefit.

The disclosure requirement also carries both ethical and legal baggage. It is probably insufficient that warnings be "reasonably conspicuous" to fulfill the need for disclosure: they should also be linked to some understanding of product use or disposal, such that the consumer can understand what should be avoided. For instance, CETOS was involved with a Proposition 65 case involving mercury in fluorescent fixtures: the consumer would encounter the contained mercury when and if the fixture broke or was fractured during disposal or handling. A further warning alerting the consumer to WHEN the danger would be incurred would be appropriate here.

The final requirement that the warning be proportionate to the perceived risk is only partially handled by the present system of establishing the safe harbor level: OEHHA is required to put a 1000 fold safety factor under no-observable-effect-level (NOEL) determined for a putative reproductive or developmental toxicant. The resulting value is considered the maximum allowable dose level. Yet, using a 100-fold safety factor in extrapolating data from animals to humans may have already set that level. Conversely, for carcinogens, OEHHA sets an exposure level at 1 in 100,000 for a putative 70 year exposure (a no-significant-risk-level), a level at least 10 times less protective than the de minimus risk level set by federal agencies for protection of the public from some airborne carcinogens.

While many toxicologists (including myself) are gratified to see any reasonable level of safety put into consumer alerts or warnings, it is crucial that there be congruence between what California requires of products with possible reproductive harm, and federal regulatory agencies, like the FDA or EPA. These agencies permit the marketing or sale of drugs or pesticides, respectively where consumer exposure may exceed Proposition 65 levels. In the case of hormonal replacement therapy, for instance, the FDA permits the marketing of products containing estrogen where body doses may exceed the reproductive harm level set for 17 beta estradiol, a listed carcinogen. Similarly, the EPA allows certain pesticide residues in foods where the level in certain products in certain seasons may pose a risk for developmental harm under Proposition 65, but not under the USDA guidelines (an example would be one or more of the reproductively active fungicides). A governmental agency would not necessarily take action against a manufacturer for the small percentage of his crop or product that exceeded the Proposition 65 limit, while a consumer would in theory be free to take action alleging a violation would be likely to occur.

As we have seen, the Attorney General is charged to ensure that the proposed "relief" under Proposition 65 offers some measure of public benefit. But that benefit is not defined as reduction of actual risk of harm, only that the warning be clear and reasonable; the existence of risk is inferred from the warning level itself. But a clear and reasonable warning in one product area (say consumer goods) may not be found in another (say wastewater or radioactive contamination), where Proposition 65 may not find a meaningful "target." For society to be vouchsafed from allegedly harmful products, the requirement of proportionality demands that all avenues of possible harm be regulated to the same degree of protection. This may prove to be a Herculean task, given the expanding knowledge of the breadth of harms possible, the varying periods of vulnerability, and the divergent genetic bases that make some persons resistant and others susceptible to harm from the same dose. Nonetheless, Proposition 65 is a wonderful step in the direction away from caveat emptor and towards an enlightened public, free and armed with information to take steps to design and shape their own lives.

While this may not have been what John Locke had in mind when he declared that governments govern best when they inform and not restrict liberty. The related principle of autonomy has become the bedrock of American thought and action - and Proposition 65 is congruent - in spades - with the notion that persons have a right to shape their own lives and destinies, informed by knowledge and disclosure of the risks and benefits of certain courses of action. Where Proposition 65 will flounder, is when and if it encourages the proliferation of so many warnings as to be disproportionate and virtually meaningless in providing guidance for consumer action. For that to be prevented, some measure of proportionality of risk, is sorely needed in the language of warning and resulting labeling. What Proposition 65 achieves in its universality and simplicity, it loses in its lack of specificity and disproportionate relationship to the reality of risk in a heterogeneous world. Figuring out how to rectify these two values is a challenge for the first decade of the new millennium.