You’ve been warned

INGREDIENTS in Preparation H once included a mercury compound known to cause reproductive problems. Nail polish came with toluene, a toxin that can cause developmental delays in children. Kiwi brand spray shoe polish contained a cancer-causing solvent.

Progresso tomatoes and Old El Paso chiles were packed in cans sealed with lead solder. California wine was tightly sealed with lead foil, and when people popped Tums to settle a stomach or took Kaopectate to treat diarrhea, they unknowingly dosed themselves with microscopic amounts of lead.

For those products and more, the toxic chemicals have been removed for California consumers, and in many cases, for consumers throughout the world.

Now the law behind these changes is fueling a debate about another cancer-causing chemical -- and once again coming under attack itself. This time around, the battle is over whether acrylamide, found in French fries and many other foods, warrants a warning to consumers.

Rodent studies will be held up as cautionary tales -- then mocked and ridiculed. Epidemiology studies analyzing people’s medical records and their dietary memories will be thrown into the mix. Some experts will argue that the limited evidence fits neatly into the puzzle of cancer causes. Other experts will say that studies based on self-report and memories are flawed and confounding variables render them useless.

The battles are continual, but the targets have shifted from the oil and gas industries to consumer goods, cosmetics and, most recently, food.

Proponents of the law say consumers have a right to know what’s in the products they buy and make their own decisions about the risks they’re willing to take.

Opponents say the measure just adds up to unnecessary alarm -- and big bills for California businesses.

And after almost 20 years of lawsuits, legal settlements, altered ingredients and warning messages, the effect of the law on human health is, and will likely remain, scientifically unprovable.

A prickly ballot initiative

Voters approved the California Safe Drinking Water and Toxic Enforcement Act, commonly known as Proposition 65, in 1986 by a 2-to-1 margin. The law has two essential strengths.

There’s the “behind the scenes” part, in which manufacturers change formulas -- Preparation H, Tums, wine wrappers -- rather than acknowledge the potential dangers of the products.

Then there’s the “in your face” part. It’s seen in hardware stores, gas stations and garages, on dinnerware displays and fish counters. That’s where Californians confront signs, with some variations in wording, stating “WARNING: This product contains chemicals which are known to the state of California to cause cancer, birth defects or other reproductive harm.”

David Roe, credited with crafting the law, has seen the law attacked time and again.”They hire PhDs and argue back and forth about how rats aren’t people,” he says. “But the law is deceptively simple. All it says is the government has to make a list of certain bad-guy chemicals, those known to cause cancer or reproductive problems.” Then, if a listed chemical remains in the product and the company cannot prove the level is safe, the product’s users must be warned.

Proposition 65 gives industry or government 20 months after a chemical is listed to come up with a safe level of exposure. If no safe level is established, warnings are required. In legal terms, says Roe, the law shifted the burden of proof. No longer did a person exposed to a carcinogen have to prove that the level of exposure was unsafe. Instead industry has to prove that exposure levels of chemicals on the state’s list are within safety limits.

“In the first four years of Prop. 65, the state of California set numerical standards for 282 chemicals,” says Roe. That compares with the federal government, using the traditional burden of proof, taking 20 years to set standards for seven hazardous chemicals under the Clean Air Act.

Aimed at manufacturers but visible to consumers, the law was a spur to industry to literally get the lead out -- as well as other toxic chemicals -- through market incentives.

“Would you want your hair dye to be the only one on the shelf with a warning label?” Roger Carrick of the Carrick Law Group asks rhetorically. Carrick wrote “The Proposition 65 Handbook,” a 587-page tome tracking lawsuits, dollars and trends since the initiative took effect. He has represented plaintiffs and defendants in Proposition 65 lawsuits.

Many businesses have decided they’d rather quietly remove the chemicals rather than be legally required to warn customers about them.

There are now 767 chemicals on the state’s toxic list; 494 are carcinogens, 269 are possible reproductive hazards and four are linked to cancer and birth defects. They include some that routinely send a shudder down a health-conscious spine, such as asbestos, lead and benzene.

Ensuing lawsuits

Not all fights are noble ones. One lawsuit claimed that Baccarat crystal baby bottles, which contain lead but are intended as keepsake mementos of a birth, could be used as infant feeders and therefore should carry a warning.

“The overwhelming majority of cases are just silly,” says Michele Corash, an attorney with Morrison & Foerster in San Francisco who fought against passage of the law in 1986 and still doesn’t like it. But Carrick says so far, no Proposition 65 lawsuit has been dismissed as frivolous.

Thousands of people have brought claims, and all but a few have been settled, with money changing hands through fines or payments to those who filed suit.

A lot of money. More than 9,343 letters have been sent to more the 26,000 separate businesses, giving them 60 days to respond. When they haven’t adequately responded (as specified by the law), 1,561 lawsuits have been filed by the state, environmental groups or individual consumers. The settlements resulted in more than $18 million in civil penalties, nearly $75 million in restitution to plaintiffs, $12 million in “in lieu of penalties” payments and more than $61 million in plaintiffs’ attorney’s fees and costs, according to Carrick’s research. He estimates that defendants have spent an additional $189 million in total defense costs. That might add up to a major thorn in the side of businesses, but the real economic toll takes place behind the scenes. The effort to reformulate products such as Liquid Paper (to get the trichloroethylene out), Tums (to remove the lead), and thousands of other products, Carrick estimates, probably cost industries $1 billion.

Results are hard to trace

The irony of the continual battles, changes in products and attacks on the law is that we may never know precisely whether the measure has made anyone safer.

This lack of proof stems from the very nature of science. The branches of research that flagged these chemicals as dangerous are largely animal studies and epidemiology. They can provide provocative clues.

But with animal studies, the argument will always be that people are not rodents, even though what is known to cause cancer in people also causes cancer in rodents. And because they have such short life spans, the rodents are heavily dosed with chemicals that in humans can accumulate in much smaller amounts over decades.

When it comes to epidemiology, the lag time between exposure to a toxic chemical and a resulting disease can also be decades. In the intervening years, hundreds of variables make inferring a direct link from a single cause to a disease nearly impossible.

“To get an actual number, or even a reasonable estimate of lives saved, is impossible,” says Richard W. Clapp, professor at the Boston University School of Public Health and researcher into environmental causes of cancer. “But even though we can’t quantify it, we know something is going on.”

In retrospect, the link between tobacco smoke and lung cancer was one of the simplest to prove, says Nancy Evans, health science consultant for the Breast Cancer Fund. Her organization looks to identify and eliminate preventable causes of breast cancer. After all, smokers know how long and how much they’ve smoked. Yet even that took decades and thousands of patients to prove the connection everyone now takes for granted.

Performing the medical gold standard of research, the randomized, controlled clinical trial, would have been impossible for cigarette smoking. Scientists would have needed two sets of thousands of people, matched for age, health and other factors.

“We’d have to have [half the group] smoke, then follow them for 30 years,” says Thomas Mack, USC epidemiologist and chairman of the Proposition 65 Cancer Assessment Committee. “You can’t do that. It’s not ethical. So we’re stuck with observational studies.”

In the medical sleuthing effort, often the first hints of trouble come from workers exposed to high amounts of chemicals. That’s what happened with asbestos, when insulation workers were the first to develop mesothelioma, a rare cancer that occurs with exposure to asbestos. It’s only been since World War II that large numbers of chemicals began to invade the environment. New products used in the war effort began to flood the domestic market, unleashing a chemical revolution. Baby boomers and their offspring have grown up exposed to more than 100,000 chemicals, many of which have never been tested for their health effects, Evans says.

Epidemiology can point out areas in which further research is important. That’s the case with acrylamides. Results reported in the Aug. 10 issue of the International Journal of Cancer found that eating French fries as a preschooler was associated with a higher risk of breast cancer as an adult. Researchers looked at dietary histories of 582 women with breast cancer and compared them with 1,569 healthy women. They asked the mothers of each group of women to report on the eating habits of their daughters when they were 3 to 5 years old, asking about 30 different foods. The only food to show up in significantly greater amounts among women who had breast cancer was French fries.

The link is not proof of cause, but it fuels the current concern.

And knowing there is cause for concern, says Ed Weil, supervising deputy attorney general in the California attorney general’s office, can help individuals make decisions.

“It’s like eating a doughnut. It’s not going to kill me, but I know I have to keep track of it,” he says.

Too many warnings?

But warnings will only work if people pay attention to them.

Many critics of the Proposition 65 argue that the warnings have blended unnoticed into the background of everyday life. Like the smoker who taps the tobacco down against the pack’s Surgeon General’s warning, many Californians have stopped noticing the signs. And that can pose a different kind of danger. People can become numb to all warnings, even those they should heed.

Take lawn mowers, for example. Corash’s law firm represented lawn mower manufacturers, who didn’t want to post a warning that the gas exhaust contains harmful chemicals. The industry’s concern was that a sticker proclaiming what they saw as an obvious risk would lead their customers to tune out the more pertinent risks involved in operating the equipment. “They need their customers to understand that there are real risks to putting your fingers and toes close to the mower,” she said.

Sometimes the warnings could actually lead to increased harm. The California Supreme Court, for example, found that nicotine patches and gum did not have to carry a warning that nicotine can harm a fetus. “It’s obviously infinitely better for a pregnant woman to try to stop smoking than to smoke cigarettes,” says Carrick. “The court said, ‘Let’s not discourage people from using these smoking cessation products.’ ”

When warnings come in the hundreds, then a rational response is to get on with life rather than worry about things beyond personal control. “The effect of too many warnings is to confuse people, or to provoke them to discount what they’re seeing,” says Barry Glassner, sociology professor at USC and author of “A Culture of Fear.”

Such a result may be happening with fish, which have high benefits in heart disease prevention and health promotion along with risks from mercury.

The state attorney general’s office is concerned about over-warning, as well, says Hirsch of the Health Hazard Assessment office. “It can happen when a company may have a very small trace level of something, and they make a decision to just put the warning on rather than risk being sued.”

It’s those better safe than sorry warnings that can overload the system. Ultimately, the effect of the warnings, as well as the effect of the law, may be impossible to measure.