Proposition 65 Looks To Net Food Products

Date: Oct 01, 2002

The beneficiaries of Proposition 65, California's notorious Safe Drinking Water and Toxic Enforcement Act, have come up with some pretty crazy theories on products that allegedly result in exposures to substances presenting carcinogenic and reproductive toxicity hazards. Thus far, they have "saved" us from electrical wire, light bulbs, fire logs and even frames.

Although there have been a few suits filed with respect to drug products (such as nicotine patches), medical devices (such as plasticizers in PVC bags) and food products (such as those containing alcohol), by and large most Food and Drug Administration (FDA) regulated products have been left alone.

That's now changing as several groups have set their sights on the food industry - particularly foods that we have all come to know and love. Chocolate. And french fries. And potato chips. And potentially an assortment of other food, unless the authorities in California start distinguishing between real health risks that might justify regulatory action and allegations involving remote risks that do nothing more than line a lawyer's pocket.

Proposition 65 requires, among other things, warnings on consumer products that, when used, would result in exposure to any one or more than 700 substances recognized by the State of California as causing cancer of reproductive toxicity. Civil penalties for violation of the Act are $2,500 per day, and enforcement is permitted by private individuals (aka bounty hunters) who are entitled to keep 25% of what they can collect.

Attacking the foods we love
Earlier this year (a couple of days before Mothers Day), several major chocolate manufacturers were sued under Proposition 65 alleging consumer exposure to lead and cadmium in amounts that require a warning. The plaintiffs in this case claim that these manufacturers should either significantly reduce the trace amounts of these metals that may be present in their products or provide a warning on the label that these products contain substances known to the State of California to cause cancer and/or reproductive toxicity.

Obviously, the latter course of action is simply not tolerable, and the former neither needs to be done, nor should these manufacturers even be put through a trial of proving their products safe.

No evidence has been presented to suggest that the trace levels of these metals in these products present any type of serious risk to anyone. In fact, all evidence indicates that any exposures that may result are below governmentally accepted levels.

Further, available evidence indicates that any of the metals that may be present are there only as a result of the environmental conditions in which cocoa beans are grown, and thus occur naturally in the products. (The presence of "naturally occurring" listed substances in food is supposedly exempt under the law.) Indeed, even the California Attorney General's office has questioned the merits of the plaintiff's actions based upon the substantial data presented by the industry.

What products are next?
Pardon the pun, but this is likely just a taste of things to come. In April, a group of Swedish scientists reported that significant levels of acrylamide have been found in fried foods. Since that time, several governmental agencies have confirmed the results reported by the Swedes, discovering to the great chagrin of the food industry and the surprise of almost everyone that acrylamide is present in potato chips, french fries and other fried and baked high carbohydrate-containing foods. Its presence in food is suspected to result from the reaction of asparagine, a naturally occurring amino acid, and glucose under high-temperature cooking conditions.

Acrylamide is recognized as an animal carcinogen by both FDA and the Environmental Protection Agency (EPA), but so far is only suspected of being a human carcinogen, except in California where the government decided several years ago to list it on Proposition 65.

Most worrisome for the food industry is that this may be only the tip of the iceberg. Some are reporting finding acrylamide in other food products that are exposed to high temperatures, including some roasted vegetables and fruits.

Proposition 65 regulations have always recognized that in the case of food some judgment concerning warnings and their affects might be necessary. For example, the regulation that establishes the basis for determining a no significant risk level for carcinogens recognizes the necessity for an exception when "sound considerations of public health support an alternative level, as, for example - where chemicals and food are produced by cooking necessary to render the food palatable or to avoid microbiological contamination."

Industry groups have already asked the California authorities to recognize this exception with respect to acrylamide in food. However, just as quickly, several companies have already received statutory notice from private bounty hunters alleging violations of Proposition 65. Lawsuits can be expected to follow.

Clearly, the consideration envisioned in the regulations should be given to the potential presence of acrylamide in food products, Again, a little judgment is required to provide people with information that may be truly helpful to them versus information that is simply likely to scare them for no good purpose.

Used with permission. Copyright FOOD & DRUG PACKAGING, October, 2002.

For further information about this article, please contact George G. Misko at 202-434-4170 or by e-mail at misko@khlaw.com.