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Bad Chemistry from California Regulators

Monday, August 13, 2007

You might be surprised to learn what is “known to the state of California”…

The magicians Penn & Teller have a great video on YouTube in which they persuade people to sign a petition banning “di-hydrogen monoxide,” a ubiquitous chemical found in many raw and prepared foods. “Di-hydrogen monoxide” is another name for H2O—that is, water.

Their point is that, too often, scientific facts are lost in the rush to protect ourselves from some phantom menace—trace chemicals in our bodies, minuscule pesticide residues on foods, whatever. One of the most egregious examples is California’s notorious two-decade-old referendum proposition commonly known as “Prop 65.” It requires signs in most commercial establishments, from supermarkets and pet stores to hotel lobbies, warning that consumers of their products or services may be exposed to chemicals that are “known to the state of California” to pose a risk of cancer or birth defects.  Not that in the overwhelming majority of cases there’s any hint of risk greater than, say, the household cleaners in your home, but the law requires a warning about any product that contains even tiny amounts of a chemical that, at high doses, can cause cancer or birth defects.

The public doesn’t benefit when regulators turn a well tested product that has been found safe into an “untouchable.”

There are a number of problems, both scientific and legal, with Prop 65. It ignores the most basic principle of toxicology: the dose makes the poison. In other words, any substance can be toxic at high enough levels. An example known to all medical students: Part of the workup for hypertension (high blood pressure) is to inquire whether the patient eats large amounts of licorice, which contains glycyrrhizin, a chemical that has steroid-like properties, promotes sodium and fluid retention and raises blood pressure.

Moreover, because Prop 65 is enforced entirely through litigation, it has created a system of legalized extortion. To initiate a lawsuit, a plaintiff need only show that a listed chemical is present in a consumer product and that the defendant business “knowingly” exposes Californians to that product without posting the warnings. Prior to filing the suit, the plaintiff must send the defendant a notice describing the exposure; 60 days thereafter, the plaintiff may sue. That notice may be the first inkling a retailer has that his products are exposing consumers to listed chemicals.

The latest chemical to run afoul of Prop 65 is di-isodecyl phthalate, or DIDP, an important and extremely useful additive used to soften hard vinyl plastic and found in dozens of common items, including shower curtains. It is also used to insulate the wires in the walls of homes across America. Safely used for more than 50 years, it is one of the most thoroughly tested products in the world and has been closely examined by numerous regulatory agencies throughout the United States and Europe. Through all that evaluation, no credible scientific review has found DIDP to be dangerous in normal use.

However, those favorable conclusions didn’t faze regulators at California’s Office of Environmental Health Hazard Assessment (OEHHA), who recently decided that DIDP may pose a risk of developmental harm in humans and, therefore, should be listed under Prop 65.

But the mere presence of something does not imply that it’s dangerous; one needs to know the dose, length of exposure, how the body disposes of it, and so forth. Prop 65 standards only look at the potential for risk as criteria for listing. Using that logic, since people regularly suffocate from a chunk of meat blocking their windpipe, maybe steaks should be listed too. (One hates to give the regulators ideas, however.)

The DIDP decision applies a bad law illogically and unscientifically. It increases risk to individuals and to society as a whole.

The study OEHHA used to justify its listing was conducted by the National Toxicology Program’s Center for the Evaluation of Risks to Human Reproduction. What is ironic is that this study is actually favorable to the continued use of DIDP, since it found DIDP’s potential to cause developmental effects in humans of “minimal concern.”

That conclusion is carefully worded, because no scientist can ever offer assurance that something is completely risk-free. Again, however, we have to look at the dose, and apparently OEHHA did not consider that it’s not possible to consume enough DIDP to pose a health risk. That might have been noticed if OEHHA had referred the issue to its science advisory panel, the Developmental and Reproductive Toxicant committee, but it didn’t.

The public doesn’t benefit when regulators turn a well tested product that has been found safe into an “untouchable.” Instead, manufacturers will simply turn to—and consumers will be exposed to—alternatives, which aren’t likely to be as well tested. The result is that we could end up at greater risk with a Prop 65 listing for DIDP than without it. Does that really make sense?

A challenge to OEHHA’s decision on DIDP is certainly appropriate, and it raises an important, broader issue: Wouldn’t society be far better off without Prop 65? It’s detrimental to commerce and fails to provide any benefit to public health. And remember who ultimately foots the bill: Not just Californians, but every American consumer who buys a product or service from a Prop 65-affected company.

Henry I. Miller, a physician and fellow at the Hoover Institution, headed the FDA’s Office of Biotechnology from 1989-1993. Barron’s selected his latest book, “The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution,” as one of the Best 25 Books of 2004.

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