California's Office of Environmental Health Hazard Assessment (OEHHA) recently riled the food industry when it presented its proposed acrylamide work plan, which seems to contemplate that a variety of cooked foods may require carcinogen warnings when sold in California. California's Safe Drinking Water and Toxic Enforcement Act of 1986, better known as Proposition 65, provides that "no person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual . . ." A person caught in violation of this requirement is subject to a civil penalty of $2,500 per day, and enforcement actions may be brought by private citizens or "public interest" groups. Dose makes the poison This may seem reasonable at first blush. However, as many chemists and attorneys are aware, certain substances known to cause cancer or reproductive toxicity at high doses are ubiquitous in the environment, and their presence at low levels in consumer products is unavoidable. Furthermore, as any toxicologist knows, the risk associated with exposure to a chemical carcinogen is critically dependent on the level of exposure: the dose makes the poison. In an imperfect effort to deal with this, Proposition 65 includes an exception whereby the cancer warning is not needed if "the exposure poses no significant risk assuming lifetime exposure at the level in question." California's regulations implementing Proposition 65 establish another important exemption whereby warnings are not required for chemical substances that occur naturally in food. The recent discovery that acrylamide is present in many cooked foods tends to highlight some inherent flaws in Proposition 65. Acrylamide was formally identified in 1990 as a substance known to the state of California to cause cancer pursuant to Proposition 65. A "no-significant-risk level" was later set at 0.2 micrograms per person per day. Back then, it was not known that acrylamide forms naturally in many foods when they are cooked, and that acrylamide has probably been present in the human diet at levels higher than 0.2 micrograms per person per day for a long as we've been eating cooked food. According to analytical data released by the U.S. Food and Drug Administration (FDA), acrylamide is present in many foods at a few hundred parts per billion (ppb) and has been found at levels as high as 2,500 ppb in at least one sample. The types of food analyzed included breads, cereals, coffee, cookies, crackers, potato chips, and other snack foods. Some quick math shows that California's no-significant-risk level for acrylamide can be exceeded when consumers eat typical portions of these foods. Predictably, this has set the stage for numerous lawsuits against food manufacturers that have long sold these products in California without the knowledge that acrylamide was naturally present in them. Indeed, numerous private enforcement actions have already been initiated in California against food manufacturers and restaurants, alleging they have failed to warn consumers about the presence of acrylamide in their products. No immediate relief Unfortunately, OEHHA's work plan for acrylamide does not offer any immediate relief to those segments of the food industry facing acrylamide enforcement actions in California. The work plan promises reconsideration of the no-significant-risk level for acrylamide. However, it also includes identification of "appropriate form and content" for acrylamide warnings, based upon the expectation that some foods will cause acrylamide exposures at levels high enough to require a warning. Missing from the work plan is a finding that acrylamide qualifies for the "naturally occurring" exemption when it forms naturally in food upon cooking. The contours of the "naturally occurring" exemption have long been unclear. The relevant regulatory language states that a chemical is naturally occurring only if it did not result from any known human activity. This language was almost certainly not written with cooking in mind as a human activity that voids the exemption. However, the wording of the regulation seems to create enough doubt about acrylamide's eligibility for the exemption that food manufacturers cannot currently rely on it as protection against enforcement actions. Also missing from OEHHA's work plan is any mechanism to suspend private enforcement actions pending further scientific consideration of the safety of acrylamide. If it had been known in 1990 that acrylamide has been present in the diet for many centuries, California might have thought twice about whether it was properly classified as a human carcinogen in the first place and, if so, what an appropriate no-significant-risk level might have been. In light of its discovery in food, FDA, the World Health Organization, and others are taking a close second look at the safety of acrylamide. Importantly, this will include consideration of the possibility that acrylamide is not dangerous to humans at low exposures even though it has been found to induce cancer in rats and mice at high doses. Unfortunately, before this process is completed, food manufacturers may have to pay penalties in California and/or introduce warning labels in connection with acrylamide. To reiterate, this scenario highlights some flaws inherent in Proposition 65. Among them: * If a cancer warning is placed on every food that contains acrylamide, the warnings could potentially cover 40 percent of the diet, according to an estimate from the National Food Processors Assn. The warnings would become meaningless to consumers at that point. Worse, if consumers were to adjust their eating habits to avoid acrylamide-containing foods, they would no longer enjoy a balanced diet.* If acrylamide warnings appear on food products, they will presumably only appear on pre-cooked foods and will not apply to the formation of acrylamide when foods are cooked in the home.* Warning statements required by Proposition 65 affect commerce outside California. Food manufacturers throughout the U.S., and those operating in other countries, must design a single label per product that can be used in this country. Uniform food safety and labeling requirements under FDA's primary jurisdiction would be preferable to a patchwork of state requirements. Manufacturers cannot reasonably be expected to follow labeling requirements emanating from all 50 states. Moreover, a Proposition 65 warning on acrylamide-containing foods would tend to contradict FDA's advice that consumers not change their diets, pending further study of this issue. * The private enforcement mechanism under Proposition 65 invites abuse. The food industry has been subjected to seemingly extortionate enforcement actions involving substances that are truly ubiquitous. * Proposition 65 has predictably spawned a small industry. At the time of its adoption, it was referred to jokingly as the "Lawyers' Relief Act of 1986." Many consultants, lawyers, toxicologists and trade publications derive a significant amount of their livelihoods from Proposition 65, and this is ultimately funded by the consumer. The benefit that flows back to the consumer is questionable at best. The food industry has been aware of these problems for many years. They are dramatically illustrated by the controversy surrounding acrylamide. During the past year, Californians have had things to worry about other than Proposition 65 reform. At the time of this writing, a more famous ballot initiative is pending in California which is likely to result in the recall of Governor Davis. Perhaps the real problem is that ballot initiatives can produce strange things. For now, we can hope that reasonable thinking will prevail in California on acrylamide and that Proposition 65 will eventually be reformed, federally pre-empted or, better yet, dismantled altogether. DAVID JOY is a partner at the Washington, D.C., law firm of Keller and Heckman LLP. He specializes in food and drug law with emphasis on the domestic and international regulation of food, food additives, food labeling, antimicrobial pesticides, and medical devices. He is a member of the District of Columbia Bar and holds a bachelor's degree in chemistry. For more information about Keller and Heckman, visit the firm's web site at www.khlaw.com.