Despite years of legal wrangling and the instigation of new scientific studies, the safety risk of toluene is not yet clear. NAILS talks to the parties involved in the lawsuit about this important industry issue.
Toluene, now infamous among nail polish manufacturers and nail technicians because of a drawn-out legal fight in California and many misleading news reports, has become known in the nail industry as, not affectionately, “the T word.” Nail polish manufacturers contend that the amount of toluene in nail polish is so minuscule that it poses no danger to nail technician users or their customers; but the consumer advocacy group As You Sow (AYS), which sued a group of polish manufacturers on behalf of the citizens of California for not labeling their products, maintains the opposite position. On February 25, 1994, the California Slate Attorney General’s office announced that “nail enamels containing ... toluene do not require warnings to customers.” This announcement came from deputy attorney general Ed Weil, after his office reviewed a study of nail technicians’ exposure to toluene that was submitted by a group of professional nail polish manufacturers.
Toluene has been in the headlines over the past two years because it is one of 542 chemicals listed in California’s Proposition 65 as known to cause cancer, birth defects, or reproductive harm. Proposition 65, passed in 1986 and effective in 1987, requires that products with any of the listed chemicals bear a written warning.
Whether toluene in nail polish does or doesn’t pose a threat has still not been determined conclusively, despite the out of court settlement of the lawsuit between AYS and nail polish manufacturers and marketers. At issue is not whether toluene can cause birth defects or reproductive harm, but whether the amount of toluene in nail products is hazardous. Each side has done studies on women’s exposure to toluene — AYS says its study shows that women are exposed to five times the level allowed by Proposition 65, while manufacturers say their studies show that even day-long exposure lo toluene is below the level that requires a warning. To understand the controversy, professional nail technicians need lo understand a little more about this chemical that has been used in polish for nearly 65 years.
How It All Got Started
Proposition 65 is a state law that, in theory, affects only consumers in California, but the toluene case gained national exposure because nail polish is such a widely used consumer product. After Califford Chanler of Chanler and Associates in San Francisco. Calif., legal counsel for AYS. filed the suit against polish manufacturers on April 5. 1993, news reports like the KNBC News report called “Can Getting Your Nails Done Kill You?” began popping up across the country.
Although toluene got the media’s attention in 1993, polish manufacturers, industry associations, and even AYS and the attorney general’s office started dealing with the issue much earlier.
In 1990, when The Cosmetic, Toiletry, and Fragrance Association (CTFA), an association for cosmetics manufacturers, realized toluene was going to be added to the Proposition 65 list, CTFA scientists launched a study to show that nail polish was not harmful. They asked 15 women (not nail technicians) to apply a base coat, two coals of polish, and a top coat while working in a room the size of an average bathroom with a controlled ventilation rate.
Says Dr. Stephen Gettings, director of toxicology for CTFA. “They were to apply the polish as they normally would, with no restriction on the time they took or the amount of product they applied.” As the women polished their nails. CAFA collected the air from their breathing zone and calculated the amount of toluene they were exposed to. “We found that the average amount of toluene per exposure period was approximately 0.6 milligrams; California’s limit is 13 milligrams. There is a considerable margin of safety [in avoiding overexposure],” asserts Gettings. He emphasizes that the toluene issue is not one of safety, bill of regulations. “The 13 milligrams [amount] has a safety factor of 1,000 times built into it. Really, this is not a safety issue al all.”
By this, Gettings means that someone using nails polish is exposed to toluene, but she’s exposed at a level so far below the law that she is not at risk. The way Proposition 65 is written, warnings are required on products that contain a chemical listed in the law, unless the amount of the chemical in the product is 1/1,000 of the “no observable effect level” (NOEL). Explains Myriam Clifford, president of Orly International, “The state of California says that at a certain point the amount of chemical you breathe is not going to cause any harm. This point is called the ‘no observable effect level.’ The level of a chemical in your product has to be greater than 1/1,000 of the NOEL before you to warn.” Clifford is also chairman of the legislative affairs committee for the Nail Manufacturers Council (NMC), which has expanded considerable resources in pursuing research to better understand the health issues for nail technicians and in representing manufacturers in the lawsuit.
The state says that toluene has a warning threshold of 13,000 milligrams. Proposition 65 requires that products containing a chemical listed in the law be labeled with warnings unless the product contains 1,000 times less than that level (for toluene, it must be less than 13 milligrams). The CTFA’s 15-woman study found that the average woman’s level of exposure to toluene from nail polish was 22 times below Proposition 65’s limit. CTFA made the results of the study available to its members, as well as to members of the American Beauty Association and the NMC.
“Based on those test results, we fell comfortable that we were going to be OK under the law,” says Clifford. So in 1992, the nail product manufacturers believed they were exempt from the warning requirement.
But in late 1992, Solano County, Calif., assistant district attorney Mark Pollock inquired of manufacturers about whether the level of toluene in nail polish required a warning under Proposition 65. Says Tom Donegan, general counsel for CTFA, “We had lengthy discussions with him over time and were fairly close to reaching a resolution with him when Cliff Chanler who wanted to look at all types of salon exposure and home use [of nail polish].” Chanler says he was concerned about all users’ exposure to the toluene in nail polish – from the woman who paints her nails technician who polishes 10 sets of nails a day in the salon.
If AYS, polish manufacturers, and Pollock had reached an agreement at that point, the lawsuits may never have been filed. But negotiations dragged on too long, says Weil. “The environmental unit of the Solano county district attorney’s office was closed during the negotiations due to a lack of funding [which stalled negotiations]. If that had not happened, then maybe the [negotiation] process would have continued,” he says.
“I also think AYS ran out of patience. There was an effort by everyone concerned for a period of negotiation, and as that period extended to a few months, I think AYS got impatient and decided they were going to start filing suits,” concludes Weil, who was also involved in the negotiations.
Chanler contends that it wasn’t impatience motivating him; it was a need to spur the manufacturers to action. Chanler claims, “Toluene is the 37th most dangerous chemical, according to the government. It’s a reproductive toxin. [Not labeling or reformulating by manufacturers] was a violation of the law.” CTFA strongly disputes this claim.
AYS conducted its own study to determine the level of toluene nail polish users are exposed to. Chanler claimed in an April 12, 1993, new story with United Press International, that “average users are exposed to toluene at levels five times higher than the level that triggers a warning under Proposition 65…. Manicurists who work with nail polish all day are exposed to toluene at levels over 40 times higher than the Proposition 65 times threshold ….” In February 1993. Chanler served 60-day notices of his intent to sue to 21 nail polish companies and to the state attorney general (who has the option to join the suit as a plaintiff on behalf of the state).
The attorney general declined to join the suit because, as Weil explained in the April 13, 1993, edition of the San Francisco Chronicle, “If we were convinced that [allowing toluene in nail polish without warnings] was a clear violation of Proposition 65 and that it posed a health hazard to women and their unborn children, we would have filed an action and pursued it by now. We’ve decided it would not be appropriate to pursue it. We always have the option of pursuing it later.”
AYS filed three lawsuits on April 5, 1993, against 14 retail polish manufacturers and seven professional manufacturers, as well as some retailers who sold nail polishes containing toluene. The number of companies named in the suit eventually grew to 43, as AYS attempted to cast as wide a net as possible. A week after AYS filed its lawsuits. CTFA filed a countersuit against AYS, asking a Sacramento, Calif., court to declare that polish manufacturers had complied with Proposition 65 when they relied on CTFA’s 1990 study. Said CTFA president Ed Kavanaugh at the time, “AYS is fully aware that scientific studies have shown that any exposure resulting from normal use of nail enamel with toluene is well below the exposure level that would trigger a warning requirement under Proposition 65.”
How could two scientific studies vary so widely, and whose study was correct? It was never determined because the case never went to court. Despite the favorable study done by CTFA, some nail polish manufacturers elected to settle with AYS instead of getting involved in a potentially long and financially draining legal battle. “At first,” says Paul Dykstra, executive director for the ABA and NMC, “the industry was going to try to maintain a united front, believing the level of toluene was below the required limit.” But several individual companies settled with AYS, agreeing to reformulate their polish and to pay undisclosed fees to AYS. In the early days, settlements reportedly came cheap. One large professional manufacturer was offered the opportunity to settle for just $2,000 in May 1993, and retail giant Revlon settled for just $16,000 in June 1993. Chanler said this about the settlements in the June 23 issue of The Recorder, “The low figure was designed to reward early settlements. Recalcitrant defendants can expect to pay more if they settle later.” It was statements like that that caused many involved in this matter to see Chanler as an opportunist and out as much for the money as to protect the people of California.
Although some companies settled independently, others negotiated as a group, sharing legal counsel and consolidating their bargaining power. According to Donegan, the group of retail manufacturers under CTFA settled in August 1993. The group of professional manufacturers, working closely with the NMC, was the last to settle, which they did in October 1993. The professional manufacturers who settled included six of the seven originally named in the lawsuit, plus an additional 33 who “opted-in” to the settlement. “Opt-ins” are companies who are not named in the original lawsuit but who are allowed to abide by the terms of the settlement (and protect themselves fro further suits). All professional polish manufacturers were offered the opportunity to opt-in for a fee that was based on their gross polish sales in California. In exchange for the money, paid to AYS, the opt-ins were covered by the settlement and protected from future lawsuits. Professional manufacturers who didn’t opt-in to the settlement, says Clifford, are still at risk of being sued in the future.
Despite their settling with AYS and their acquiescence to the settlement’s terms, most of the involved manufacturers were convinced that not only was toluene in nail polish safe, but that it allowed them to produce a superior product. And October 1993 settlement agreement between manufacturers and AYs required manufacturers and AYS required manufacturers to reformulate their polish or warn consumers by March 1, 1994. However, a clause in the settlement agreement allowed the manufacturers to attempt to prove through a future study that exposure to toluene from the use of nail enamel products in salons does not require a Proposition 65 warning. So, soon after the settlement, the professional manufacturers contacted the California attorney general’s office, which the agreement said was to set the protocol for the study and have the final say on its validity. If the study proved to the attorney general’s office that technicians’ exposure to toluene was less than the safety level set by Proposition 65, the manufacturers would not have to put warning labels on nail polish sold in California.
The manufacturers’ group proposed a study that had nail technicians in approximately 10 salons – some nails-only, some full-service, some hair with nails – wear badges on their shirt collars to measure the amount of toluene in their breathing zone (the two-cubic-foot area around their face) over the course of an eight-hour day. The technicians did not work they would normally do in eight hours; they did not polish nails all day. Manufacturers say their 1994 study proved that nail technicians’ exposure to toluene was 11.5 milligrams, 1.5 milligrams less than Proposition 65’s warning level.
When the study was complete, it was reviewed by the attorney general’s office, which found that “1. Nail enamels containing 1% toluene or less, when sold for use in salons, do not require warnings to employees or customers. 2. Nail enamels containing more than 1% toluene do not require warnings to customers.” This same letter, signed by Weil, also states, however, “... we do not agree that the study establishes that exposures to nail enamels of 20% [toluene] or higher do not require warnings for employees.”
While professional manufacturers had hoped not to have to provide warnings to anyone — consumers or nail technicians — they were now only required to provide California salons with a warning sign about the potential danger of working with toluene products to post in an employee area. On March 18, 1994, 15 of the professional manufacturers named in the settlement mailed a warning sign with an explanatory letter to 30,000 California salons. The sign, printed in English, Spanish, and Vietnamese, says, “Vapors from many nail polish products contain toluene, a chemical known to the state of California to cause birth defects or other reproductive harm. (Check product labeling for toluene content and follow safety tips to minimize exposures”.
Although many professional manufacturers were then not required to reformulate their polish, many retail polish companies, including Del Labs, Maybelline, Revlon, and Proctor & Gamble, had already agreed to reformulate their nail polish and remove toluene by September 1, 1994. Because they agreed to reformulate: their polishes they must do so, regardless of the attorney general’s announcement. So salon customers who also shop in retail stores will see only that polishes in retail stores are toluene-free, while those sold in salons may not be.
If They Had It to Do Over …
“In retrospect,” says Clifford, “when we found out that toluene was going to be listed we should have done comprehensive testing [on technicians’ exposure] on our own as an industry. But those were the early years of the NMC. We weren’t organized as a group.”
Says George Schaeffer, president of OPI Products, “Knowing now what we should have known then, if we had another chemical coming down the pike, we would be proactive instead of reactive. If we were guilty of anything, we were guilty of not being corrective; not going out and doing the proper testing and spending the money up front.”
But these manufacturers say they really believed they were prepared. Says Chris Christopher, chief financial officer and general counsel of Creative Nail Design Systems, another company named in the lawsuit: “We looked at it and said. ‘If we are challenged, are we acting responsibly and in accordance with the law?’ Based on the CTFA’s study, we all felt comfortable that the level of exposure was below the 1/1,000 minimum threshold level. So we believed and continue to believe that we are in compliance with the law.”
Adds Schaeffer, “As it turned out, having done the testing at a later date, it confirmed what CTFA had already told us, that the levels of [toluene in nail polish] are safe.”
Even so, the lawsuit probably could not have been avoided. A company can’t seek exemption from Proposition 65; it can only have evidence that supports its claim that the levels of a chemical in its product are below the required warning limit if its product is challenged under the law.
According to the March 8, 1994, edition of The Recorder, AYS collected $993,000 in settlements from 43 different polish companies. Clifford and Schaeffer say the professional manufacturers alone paid $250,000 to settle their suit. The six professional companies each paid a portion of the settlement, with some help from the NMC, which Dykstra says spent more than $50,000 over the course of the suit. In addition to their share of the $250,000, each company had to pay its share of fees to their own lawyers. One professional manufacturer reports that her company spent in excess of $50,000.
Should manufacturers have just reformulated polish to remove toluene? “We were all investigating toluene-free formulas, obviously, since it was a concern. But we were not going to reformulate, we could not reformulate, based on alternative formulas available,” asserts Clifford.