Dr. Warner North, a member of the Prop 65 Science Advisory Panel.
Michele Corash, a San Francisco lawyer advising industry on Prop 65.
Thomas Warriner, Undersecretary, California Health and Welfare Agency.
David Roe, an attorney with the Environmental Defense Fund.
Proposition 65 warning sign.
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DAVIS, CA.-It is theater in the round at the barn-like Wyatt Pavilion on the University of California campus here. But the people on the raised stage are not actors and the audience is obviously not a student crowd. Instead, a phalanx of briefcase-bearing representatives of industry and government. more than 100-strong, have come to hear a 12-mernber scientific advisory panel deliberate about which chemicals cause cancer or birth defects.

The play is called Proposition 65, a long-running drama without an ending that is being watched around the world as a harbinger of what can happen when citizens-concerned about the environment but distrustful of existing government and business efforts-take control of toxic chemicals into their own hands.

Persuaded by a colorful cast of environmental, consumer. and labor activists, as well as politicians like state Rep. Tom Hayden and his movie star wife Jane Fonda, California voters handily passed Proposition 65 in November 1986. Formally called the Safe Drinking Water and Toxic Enforcement Act. its extraordinary breadth went far beyond existing state or federal toxic control laws.

Proponents billed it the toughest weapon to date in controlling toxic chemicals, while critics called it more of a bludgeon. But only now is rhetoric being replaced by reality as the state of California seeks to implement what the voters hath wrought. The outcome could shape commerce across the country. changing the way in which major products are sold, packaged, and labeled far beyond California's borders.

Prop 65, as it is popularly called, forces the hand of government and industry. It orders the Governor to create a list of chemicals "known to the state to cause cancer or reproductive toxicity." It puts the burden on business to provide "clear and reasonable" warnings to those who may be exposed to designated chemicals, whether in consumer products, the worksite or the environment at large. It prohibits discharges into the drinking water supply of chemicals on the list. And it allows exceptions only if a chemical is shown to pose "no significant risk."

There is little leeway for delay. The law set in motion an inflexible timetable for implementation. as well as provisions for enforcement by citizen suits among the dissatisfied. Warnings go into effect one year after a state listing: the first warning appeared on Feb. 27~ 1988. Drinking water restrictions begin 20 months after listing. with the first in effect October 27, 1988.

"Prop 65 threatens the whole rabbit warren of nooks and crannies in existing laws. It says. ‘Here's the line. Are you above or below?' It turns out to be a powerful approach." Said David Roe. a 10 year old lawyer for the Environmental Defense Fund who was a principal draftsman of' the new law.

"The law really gets at all paths of exposure. whether workplace, environment or consumer products. It is broad-based. It is unique. It shifts the burden of proof to industry," said Dr. Steven Book, the state's science advisor on Prop 65.

"Proposition 65 is a bold. largely misunderstood experiment to force technical decisions into Policy. It is potentially dangerous or alternatively a golden opportunity, depending on how well we bring science to bear on the decision-making process." says Boston consultant Charles Powers. "It took evervthieg ever thou-ht about regulation and turned it on its head. It is a complete Copernican revolution" in "ways we are just beginning to understand. We don't know where it is going to go."

Despite a slow start. the Governor has already listed more than 235 cancer-causing substances and 30 reproductive toxicants as known hazards. The state's first major actions have focused on some familiar dangers with which few could disagree: warnings on all alcoholic beverages and non-cigarette tobacco products. such as cigars and pipe tobacco. It has launched enforcement actions against those that fail to comply.

As affected industries and government agencies are coming to realize. the act has potential repercussions in virtually every area of risk: the assessment. regulation, and management of toxic Substances, as well as communication of the risks to the public. It raises tough questions of science (what is "no significant risk?"). turf (what is the role of the state versus federal laws and agencies?) and ultimately impact (what is a "clear and reasonable warning" and when do too many warnings become clearly unreasonable?)

In a state where the stakes are high-California can either be a trendsetter or an aberration-powerful business opponents across the country have sought to portray the law in the most dire terms: it will send industry out of the state, create chaos in the federal regulatory laws. confuse the consumer with an overabundance of warnings on just about everything in sight, and cause a liability nightmare, they say. The underlying concern is the potential rebound effect on commerce outside the state.

"As other states watch California's experiment, it is worth asking whether this new law will indeed improve human health or whether it is just another novelty from the land of fruits and nuts and sunshine." Michele Corash. a San Francisco lawyer and Counsel to the Environmental Working Group, an industry coalition. wrote recently.

"It's a frontal assault on the federal regulatory system." says Eve Bachrach, a lawyer with the Proprietary Association. a Washington-based trade group representing the over-the counter drug industry. "California wants to preempt the country." She and the association's chief scientist flew in for the Davis meeting, to address the reproductive warnings under Prop 65.

"It raises the questions of who is setting standards on a national level. They've sitting here and second-guessing what the Food and Drug Administration and the Environmental Protection Agency have done…. This is supposed to be a United States of America. But this is designed to create chaos rather than constructive improvement," says another Washington immigrant at the meeting. Dr. Sherwin Gardner. A vice-president of the Grocery Manufacturers Association and former deputy FDA commissioner.

Taken aback that an environmental law would cross over into the supermarket. food manufacturers have been among the most vigorous opponents since the law was passed. They have ridiculed its broad language. arguing that many of the 15,000 products on supermarket shelves could require warning labels because of trace amounts of both manmade and natural carcinogens. On the other side, the Environmental Defense Fund, Sierra Club and other groups responsible for the law's creation have toned down their post-passage rhetoric, seeking to demonstrate that Prop 65 is a law that can work and not another off-the-wall creation by California crazies.

"Industry has tried to paint the law as totally crazy, outrageous. draconian," complained lawyer Roe. Rather than the threatened deluge of warnings, he insists it was intended to put -real warnings on the few things that need it."

Walking a tightrope down the middle has been the state's Health and Welfare Agency, charged by the Governor with carrying out the law. Despite opposition of the Republican administration of California Gov. George Deukmejian prior to Prop 65's passage, the department's leadership has largely translated the law in a commonsense, open way that has drawn grudging support, if not agreement. from both sides. It has not gone far enough for environmentalists, but too far for industry's comfort.

Setting a tone of quiet reasonableness amidst the competing camps is Undersecretary Thomas Warriner. an unflappable 46-year-old lawyer whose more than 20 years of service in state government have honed his ability to merge science, policy, and politics. "I'm not obligated to do anything stupid. We've done things that make sense." says Warriner.

Two years after Prop 65's passage, he is pleased that it is slowly but surely marching along without causing California to slide into the Pacific. "There was a lot of noise associated with the proposition in the beginning and a rambunctious public dialogue. But we've had good cooperation from industry. environmental and consumer groups. So far it's worked pretty well," says the understated Warriner.

"We never thought the world was going to come to an end," adds his top science advisor Steven Book.

In the beginning, however, the battle over Proposition 65 made it seem earth-shattering. at the very least. In an initiative-mad state where crucial issues are often taken directly to the voters rather than hashed over by the state legislature. Proposition 65 appealed to the California public's concern about toxic chemicals, mistrust of government and business institutions and desire to gain sonic control in the process.

"Get tough on tonics" was a catchy slogan and commercials like that of a woman holding a sick child, with the warning that "California's children are dying of cancer," struck strong emotional cords. "Nearly every week sees a new toxic catastrophe." said the Prop 65 ballot argument, which emphasized that "the health of innocent people is jeopardized."

Opponents, including prominent University of California biochemist Bruce Ames, saw it not as a preventive health measure but a misdirected waste of resources. "The simple scientific fact of the matter is that manmade carcinogens represent only a tiny fraction of the total carcinogens we are exposed to, most of which are natural substances such as tobacco, alcohol and chemicals in green plants.... This initiative will result in chasing after trivial amounts of manmade carcinogens at enormous cost with minimal benefit to our health," said the ballot argument that he signed opposing the initiative.

By a vote of 63 percent to 37 percent, however, the public supported the novel proposal, even though industry outspent the Yes on 65 campaign by about six to one.

Industry's opposition to the initiative stemmed from the novel legal underpinnings of the popular referendum, which push science and regulation to the edge of a cliff -there's no where else to run.

Its creators, particularly EDF's Roe and Sierra Club political director Carl Pope, were frustrated that the traditional approach offered by federal environmental laws had allowed -even encouraged -endless delays on the part of regulators and the businesses they regulated.

By operating on a case-by-case, the federal Safe Drinking Water Act, the Toxic Substances Control Act and the air toxics section of the Clean Air Act had led toward specific regulation of fewer than two dozen dangerous chemicals each, averaging not much more than one chemical per year, noted Roe. The federal Occupational Safety and Health Administration had also been tediously slow in acting on specific cancer-causing chemicals.

Such statutes basically put the burden on government to prove that a chemical is hazardous and develop a standard for controlling it. Under Prop 65, the onus is on industry.

"The use of chemicals known to cause cancer or reproductive toxicity will no longer be considered 'innocent' until proven 'guilty' of harming public health by governmental agencies.... Businesses must prove that discharges of or exposures to toxic chemicals do not pose health risks if they want to avoid regulation," said an analysis of Prop 65 by William S. Pease. He worked in the campaign to pass Prop 65 and has worked as a consultant to the state health department.

"This reversal of burden of proof has profound consequences," noted lawyer Roe. Industry "is suddenly eager for regulations" and "has a strong incentive to help the regulatory process succeed. Under this new incentive, California has managed to draw the line for more chemicals in the last twelve months than the federal government has managed under the Toxic Substances Control Act in the last twelve years," wrote Roe in a commentary for "The Recorder," a San Francisco legal newspaper.

Because of the built-in, non-negotiable timetable for implementation, there is also little time for delay. "The inflexible calendar does force people to take action. There has been prodigious accomplishment," said Undersecretary Warriner.

In theory, at least, the state government could have carried out the law by playing a minimal role, letting the courts define and enforce Prop 65 through a sea of litigation. But, as Roe predicted, there was pressure from industry for the state to give some direction and predictable guidance to the bare bones language of the ballot initiative.

"A crucial issue for the Administration was to make sure science played a key role. Proposition 65 focused a lot of scientific concern on which chemicals are dangerous and in what levels," said Warriner.

He credits much of the accomplishments to date to a 12-person scientific advisory panel appointed to advise the state on which chemicals to list as carcinogens and reproductive hazards.

Led by environmental toxicologist Wendell Kilgore of the University of California at Davis, it drew fire initially from environmentalists for including the outspoken scientist Ames, an opponent of Prop 65 prior to passage. It also included a number of scientists, including Kilgore, consultant Warner North of Decision Focus Inc., and Herschel Griffin of San Diego State University, who had extensive national experience on EPA advisory boards.

Prodded by the panel, the state's strongest actions thus far have gone in a direction that Prop 65's proponents may not have foreseen. While the campaign rhetoric of Prop 65 focused largely on environmental pollution, the implementation has targeted chemicals of lifestyle as well.

"The two most dangerous things people do are abuse alcohol and use tobacco. We saw an opportunity to deal with public health issues," explained Warriner.

The science advisory panel recommended first that alcohol be listed as a "reproductive toxicant," based on growing evidence that even small amounts of alcohol during pregnancy can pose dangers to the developing fetus. As of Oct. 1, signs began appearing in grocery and liquor stores, restaurants and bars throughout the state, warning "that drinking distilled spirits, beers, coolers, wine and other alcoholic beverages during pregnancy can cause birth defects."

Later, the panel also indicted alcohol as a carcinogen because of evidence that longterm abuse can lead to liver damage and liver cancer. Warnings adding that alcohol abuse poses a cancer risk are required by mid-1989.

Despite the strong wine lobby in California, the panel and state did not flinch in listing alcohol, although the state regulations did allow the alcohol warnings to be posted as signs rather than placed on the label itself.

In late 1988, after a two-decade debate, Congress finally passed a federal alcohol warning law that may have been spurred in part by Prop 65's recent pressure. The law requires that by November, 1989, all alcoholic beverages must be labeled with the warning "According to the Surgeon General, women should not drink alcoholic beverages during pregnancy because of the risk of birth defects. Consumption of alcoholic beverages impairs your ability to drive a car or operate machinery, and may cause health problems."

"Prop 65 was important in heightening people's awareness about the risks of alcohol. It definitely contributed to the climate of raised concern," said Karen Lieberman, of the Washington-based Center for Science in the Public Interest.

Even when the federal warning -which does not mention a cancer risk -goes into effect, Prop 65 warning signs will still he required in California, say state officials.

California took a similarly stern approach toward tobacco products, other than cigarettes, for which no federal health warnings are currently required. Under Prop 65's aegis, warnings that pipe tobacco, loose tobacco for roll-your-own cigarettes and cigars contain chemicals that can cause cancer or reproductive harm are required for the first time.

But in preparing emergency regulations in early 1988 to carry out Prop 65, the state did bend, at least in part, to the demands of the food industry to minimize the immediate effects of Prop 65.

In a major lobbying effort, grocery, cosmetics and drug producers sought out-and-out federal preemption in areas under FDA's jurisdiction. FDA commissioner Dr. Frank Young flew in to address the advisory panel about his concerns. One of the most prominent Washington industry lawyers, former FDA general counsel Peter Barton Hutt, took on the case, blanketing the state with paper and personal contacts.

Following a science advisory board recommendation, the state took a compromise position, adopting temporary regulations allowing FDA standards to apply to food, drugs and cosmetics on an interim basis.

Warriner stresses that he gave the industry a reprieve in time, but not the exemption it sought. He says that as the state gets time to look at the chemicals in these products on an individual basis, FDA interim standards will be phased out in favor of state standards, if they are stricter.

The action has been challenged in court by environmental groups. And the still unhappy food industry, worried about the longterm impact of Prop 65, took its concerns back to the Washington halls of power. In July, a White House task force considered a federal order preempting FDA-regulated products from Prop 65's jurisdiction, but postponed action once the proposal was publicized.

While food industry officials proffered arguments that the administration should exempt them from Prop 65 as a matter of "regulatory reform," proponents of Prop 65 urged the Reagan administration to keep out of this California matter by digging out its own federalism statements on the importance of states' rights.

A federal interagency working group assigned to study the issue reportedly concluded in December that there was no evidence of major interstate economic burden from Prop 65 and therefore" struck strong emotional cords. "Nearly every week sees a new toxic catastrophe," said the Prop 65 ballot argument, which emphasized that "the health of innocent people is jeopardized."

Opponents, including prominent University of California biochemist Bruce Ames, saw it not as a preventive health measure but a misdirected waste of resources. "The simple scientific fact of the matter is that manmade carcinogens represent only a tiny fraction of the total carcinogens we are exposed to, most of which are natural substances such as tobacco, alcohol and chemicals in green plants... This initiative will result in chasing after trivial amounts of manmade carcinogens at enormous cost with minimal benefit to our health," said the ballot argument that he signed opposing the initiative.

By a vote of 63 percent to 37 percent, however, the public supported the novel proposal, even though industry outspent the Yes on 65 campaign by about six to one.

Industry's opposition to the initiative stemmed from the novel legal underpinnings of the popular referendum, which push science and regulation to the edge of a cliff -there's no where else to run.

Its creators, particularly EDF's Roe and Sierra Club political director Carl Pope, were frustrated that the traditional approach offered by federal environmental laws had allowed -even encouraged -endless delays on the part of regulators and the businesses they regulated.

By operating on a case-by-case, the federal Safe Drinking Water Act, the Toxic Substances Control Act and the air toxics section of the Clean Air Act had led toward specific regulation of fewer than two dozen dangerous chemicals each, averaging not much more than one chemical per year, noted Roe. The federal Occupational Safety and Health Administration had also been tediously slow in acting on specific cancer-causing chemicals.

Such statutes basically put the burden on government to prove that a chemical is hazardous and develop a standard for controlling it. Under Prop 65, the onus is on industry.

"The use of chemicals known to cause cancer or reproductive toxicity will no longer be considered ‘innocent' until proven 'guilty' of harming public health by governmental agencies... Businesses must prove that discharges of or exposures to toxic chemicals do not pose health risks if they want to avoid regulation," said an analysis of Prop 65 by William S. Pease. He worked in the campaign to pass Prop 65 and has worked as a consultant to the state health department.

"This reversal of burden of proof has profound consequences," noted lawyer Roe. Industry "is suddenly eager for regulations" and "has a strong incentive to help the regulatory process succeed. Under this new incentive, California has managed to draw the line for more chemicals in the last twelve months than the federal government has managed under the Toxic Substances Control Act in the last twelve years," wrote Roe in a commentary for "The Recorder," a San Francisco legal newspaper.

Because of the built-in, non-negotiable timetable for implementation, there is also little time for delay. "The inflexible calendar does force people to take action. There has been prodigious accomplishment," said Undersecretary Warriner.

In theory, at least, the state government could have carried out the law by playing a minimal role, letting the courts define and enforce Prop 65 through a sea of litigation. But, as Roe predicted, there was pressure from industry for the state to give some direction and predictable guidance to the bare bones language of the ballot initiative.

"A crucial issue for the Administration was to make sure science played a key role. Proposition 65 focused a lot of scientific concern on which chemicals are dangerous and in what levels," said Warriner.

He credits much of the accomplishments to date to a 12-person scientific advisory panel appointed to advise the state on which chemicals to list as carcinogens and reproductive hazards.

Led by environmental toxicologist Wendell Kilgore of the University of California at Davis, it drew fire initially from environmentalists for including the outspoken scientist Ames, an opponent of Prop 65 prior to passage. It also included a number of scientists, including Kilgore, consultant Warner North of Decision Focus Inc., and Herschel Griffin of San Diego State University, who had extensive national experience on EPA advisory boards.

Prodded by the panel, the state's strongest actions thus far have gone in a direction that Prop 65's proponents may not have foreseen. While the campaign rhetoric of Prop 65 focused largely on environmental pollution, the implementation has targeted chemicals of lifestyle as well.

"The two most dangerous things people do are abuse alcohol and use tobacco. We saw an opportunity to deal with public health issues," explained Warriner.

The science advisory panel recommended first that alcohol be listed as a "reproductive toxicant," based on growing evidence that even small amounts of alcohol during pregnancy can pose dangers to the developing fetus. As of Oct. 1, signs began appearing in grocery and liquor stores, restaurants and bars throughout the state, warning "that drinking distilled spirits, beers, coolers, wine and other alcoholic beverages during pregnancy can cause birth defects."

Later, the panel also indicted alcohol as a carcinogen because of evidence that long-term abuse can lead to liver damage and liver cancer. Warnings adding that alcohol abuse poses a cancer risk are required by mid-1989.

Despite the strong wine lobby in California, the panel and state did not flinch in listing alcohol, although the state regulations did allow the alcohol warnings to be posted as signs rather than placed on the label itself.

In late 1988, after a two-decade debate, Congress finally passed a federal alcohol warning law that may have been spurred in part by Prop 65's recent pressure. The law requires that by November, 1989, all alcoholic beverages must be labeled with the warning "According to the Surgeon General, women should not drink alcoholic beverages during pregnancy because of the risk of birth defects. Consumption of alcoholic beverages impairs your ability to drive a car or operate machinery, and may cause health problems."

"Prop 65 was important in heightening people's awareness about the risks of alcohol. It definitely contributed to the climate of raised concern," said Karen Lieberman, of the Washington-based Center for Science in the Public Interest.

Even when the federal warning -which does not mention a cancer risk -goes into effect, Prop 65 warning signs will still he required in California, say state officials.

California took a similarly stern approach toward tobacco products, other than cigarettes, for which no federal health warnings are currently required. Under Prop 65's aegis, warnings that pipe tobacco, loose tobacco for roll-your-own cigarettes and cigars contain chemicals that can cause cancer or reproductive harm are required for the first time.

But in preparing emergency regulations in early 1988 to carry out Prop 65, the state did bend, at least in part, to the demands of the food industry to minimize the immediate effects of Prop 65.

In a major lobbying effort, grocery, cosmetics and drug producers sought out-and-out federal preemption in areas under FDA's jurisdiction. FDA commissioner Dr. Frank Young flew in to address the advisory panel about his concerns. One of the most prominent Washington industry lawyers, former FDA general counsel Peter Barton Hutt, took on the case, blanketing the state with paper and personal contacts.

Following a science advisory board recommendation, the state took a compromise position, adopting temporary regulations allowing FDA standards to apply to food, drugs and cosmetics on an interim basis.

Warriner stresses that he gave the industry a reprieve in time, but not the exemption it sought. He says that as the state gets time to look at the chemicals in these products on an individual basis, FDA interim standards will be phased out in favor of state standards, if they are stricter.

The action has been challenged in court by environmental groups. And the still unhappy food industry, worried about the long-term impact of Prop 65, took its concerns back to the Washington halls of power. In July, a White House task force considered a federal order preempting FDA-regulated products from Prop 65's jurisdiction, but postponed action once the proposal was publicized.

While food industry officials proffered arguments that the administration should exempt them from Prop 65 as a matter of "regulatory reform," proponents of Prop 65 urged the Reagan administration to keep out of this California matter by digging out its own federalism statements on the importance of states' rights.

A federal interagency working group assigned to study the issue reportedly concluded in December that there was no evidence of major interstate economic burden from Prop 65 and therefore no grounds for federal intervention. But industry lobbyists have not given up on their campaign to seek federal relief from the controversial California law.

Jeffrey Nedelman, vice-president of the Grocery Manufacturers Association, called the economic report "only a narrow aspect" and said that "legal and policy questions" were being pursued vigorously. "We've been working on federal preemption for two years. And if it takes two more years, we'll work two more years," he said.

In the meantime, a battle has erupted within industry factions over Prop 65's requirements for warning the public about hazardous chemicals. The proposition itself does not spell out exactly how the warning is to be done and state regulations have allowed flexibility on the part of industry to decide how to carry out the warnings.

Initially, perhaps out of concern about citizen suits for failing to warn, some companies took out vague blanket warnings that did little to explain just what they were warning about.

For example, a "community notice" ad in San Francisco bay area newspapers by members of the Peninsula Industrial and Business Association warned that "the following facilities contain chemicals known to the State of California to cause cancer, birth defects or other reproductive harm." A long list of companies like Hewlett-Packard and Data General followed, but readers were not told just what these chemicals were.

Another strategy was developed to deal with consumer products, particularly in supermarkets and other retail outlets. While the stores did not want responsibility for posting individual warning signs on their shelves, manufacturers did not want to put the warnings right on the package labels. Instead, under the auspices of an industry-backed group called the Ingredient Communication Council, Inc., notices were posted in stores telling customers to call a tollfree number if they had any questions about the hazards of specific products sold there.

Prop 65 proponents quickly dubbed the number 800 BALONEY, saying it was impossible to warn the public adequately this way. In August, four environmental groups gave notice that they were ready to test the 800 number in the courts, targeting certain tobacco products and supermarket chains for the first major enforcement action.

Under Prop 65, any group or citizen wishing to sue is required to give 60 days notice to allow the state government time to consider the case. The law allows a penalty of up to $2,500 a day for failure to comply, with a bounty hunter provision that allows the plaintiff to recover 25 percent of the damages. In the case of the tobacco suit, the environmental groups estimated potential penalties as much as $1.3 billion.

The notice quickly made a difference. In October, the state Attorney General John Van de Kamp sued eight retailers and 25 tobacco companies for failing to comply with the law's warning requirements. Days later, supermarkets themselves decided to force the issue.

Vons, the state's largest supermarket chain, ordered tobacco products removed from its shelves if the manufacturers did not put warnings on their own products. Several other chains said they were contemplating similar actions. The Attorney General and tobacco companies soon settled part of the suit, with the companies opting to put warnings on their products by March, 1989.
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The action has national importance. Although directed initially at tobacco products, all other consumer product producers are on notice that they too must label or certify that their products do not contain significant amounts of hazardous chemicals. If the manufacturers are forced to label products they sell in California, they are more likely for convenience, cost and legal liability to do the same elsewhere.

So Prop 65 is likely to have widespread consumer repercussions even if no other states enact their own laws. Several states did consider their own versions of Prop 65 in 1988, but none have yet passed. For their part, the environmental proponents have urged a go slow approach elsewhere, saying they want to see how it plays in California before putting the show on the road.

It is unclear how Prop 65 warnings will effect consumer behavior. Susan Hadden, a University of Texas associate professor who has written a book on warning labels and is completing one on right-to-know laws, is skeptical about the generic warnings that have been used by industry thus far.

"Everything we know about labeling and providing people with information says the way Prop 65 is working right now is not likely to be successful. When people see the same words over and over again they just blank them out," she said.

She believes that to be effective, warnings need to be more specific, tell the public what to do about the danger and need a "lot of public education... I would prefer to see it executed as a public education program rather than a warning notice program." But she added, the most positive effect is that it may "put pressure on industry to consider how much it needs to include those hazardous ingredients."

Advocate Roe agrees that the warning provision of Prop 65 will have its greatest effect as a deterrent to manufacturers rather than customers. Instead of warnings, he hopes that there will be changes in product formulation to get carcinogens and reproductive hazards out of products, the environment and workplace, whenever possible.

It's too early to tell what long-term impact Prop 65 will have -chaotic, constructive or somewhere in between. In the early stages, it is working better than either critics or proponents might have expected. But several key questions remain unanswered.

One of the most feared aspects of the initiative was the threat of law suits overwhelming the court system. So far, only a handful of suits have actually been brought.

While the focus has been on the warning provisions of Prop 65, the second major provision, prohibitions on contaminating drinking water supplies, is just beginning to be implemented.

Whether the science of risk assessment is really ready to fulfill the massive demands of Prop 65 is also a major issue. So far most of the chemicals listed have been well-known carcinogens that have already been on similar lists by national and international cancer panels. But pesticides were initially neglected from consideration. Prodded by a legal suit brought by the environmental groups, the science advisory panel recently listed several agricultural chemicals. Naturally occurring carcinogens have generally been exempted.

In specifying that there be "no significant risk" from carcinogens the law left open a definition of what that meant. The state, in another compromise, has defined it as a lifetime chance of developing one excess cancer per 100,000 people exposed, a cutoff that is less stringent than that of one in a million used by many government agencies.

In a paper prepared for a recent scientific meeting, scientists with the California Department of Health Services noted that the discrepancy may mean that Prop 65 will be superceded by tougher laws already on the books, particularly in term of water discharges.

"Cancer risks greater than one in 100,000 for lifetime exposure represent significant risk and cumulative intakes from multiple sources are not considered when establishing Proposition 65 regulations. As a result of these policies, regulatory levels being derived for the implementation of Proposition 65 are not as stringent as existing regulations established under other environmental laws. Most regulatory programs in the EPA and California Department of Health Services assume cancer risks greater than one in one million are significant and the EPA considers cumulative intake when deriving EPA water quality criteria," said state scientists Lauren Zeise, Kim Hooper and Alex Kelter and outside consultant William Pease.

They added, however, that in other areas, such as occupational, consumer and indoor air exposures, Prop 65 may serve as a safety net that goes farther than existing laws.

The issue of what constitutes a reproductive hazard is also troublesome, both in terms of the science and the initiative itself. The initiative was quite specific about reproductive hazards, requiring a safety factor of 1000. Scientists claim this is an unrealistic figure and industry critics say it is a straitjacket that could trigger a plethora of unneeded warnings. For instance, orange juice and bread both contain small amounts of alcohol that would fall under the 1000-fold number and could possibly require warnings if the statute is taken literally.

Realizing that the law was overly specific, both sides have begun negotiations to work out a change that would require passage by the state legislature.

Meanwhile, the state health department is inundated with the massive job of risk assessment of the more than 200 chemicals already on the list.

They may get some outside assistance from a new body that is being set up to implement Prop 65, seeking funding from government, industry and private foundations. To be called the Institute for Evaluating Health Risk, it would be a nonprofit organization modeled on other efforts in which automotive emissions and hazardous waste cleanup were subjected to similar scientific scrutiny.

Organizer Charles Powers of the Boston-based Institute for Responsible Management has put together a board of prominent Californians to oversee the effort, including Stanford University president Dr. Donald Kennedy, Hewlett-Packard chairman David Packard, publisher Melvin Lane and three University of California chancellors. "We have pretty strong support from across the board," said Powers.

So far, it seems that just about everything falls under Prop 65. But for some, at least, there is relief in finding that even this law has its limits.

Take chlorofluorocarbons, the gases found in aerosol cans and refrigerators. Scientists now agree that they are slowly but inevitably destroying the ozone layer. If this shield is weakened, more ultraviolet light gets through to the earth below and ultimately leads to more skin cancers.

In and of themselves chlorofluorocarbons at ground level are considered relatively nontoxic. But should they be construed as carcinogens because they set in motion a string of events that could eventually increase human cancers? The Prop 65 advisory panel recently pondered this question.

"The issue is so broad and so complex that I would urge this panel not to become involved in it," said panel member North. "We have enough to do."

Biochemist Ames agreed. If such indirect effects are included under the law, "we're in for a big mess. Before that, I think we should call sunshine a carcinogen," he quipped. With that, the panel voted to exclude chlorofluorocarbons and several lobbyists in the audience, there to mount a challenge if needed, picked up their briefcases and left.

Outside, one of them, Arlington, Va. lawyer Kevin J. Fay, representing the Alliance for Responsible CFC Policy, a coalition of U.S. users and producers, said he was "relieved they decided to leave us alone. Now I see where all the lawyers can be found."

Added Fay: "Until they sort out what Prop 65 means, there's no telling where it will stop."